Académique Documents
Professionnel Documents
Culture Documents
V9.0
General observations
Breast cancer
Gastrointestinal cancer
Gynaecological cancer
Haematological
Oesophagus
17
Gastric
19
Pancreas
22
Cholangiocarcinoma
24
Hepatocellular carcinoma
25
Neuroendocrine tumours
26
Colorectal
28
Anal
37
Ovarian
38
Endometrial
44
Cervix
46
Hodgkins disease
50
Non-Hodgkins Lymphoma
51
55
Thyroid
58
Lung cancer
Small cell
59
Non-small cell
62
Mesothelioma
67
Melanoma
68
Sarcomas
69
Osteosarcoma
71
Ewings sarcoma
73
Fibromatosis
78
Rhabdomyosarcoma
79
GIST
81
Urological cancer
Bladder
82
Renal
85
Prostate
87
Germ Cell
89
93
Unknown Primary
98
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(continued)
Page
98
Bone metastases
99
Antiemetic protocols
101
GCSF policy
104
Prophylactic antibiotics
104
Erythopoietin policy
105
105
Wright formula
106
106
107
Haematological parameters
108
108
109
110
Hypocalcaemia
110
Hypomagnesaemia
110
111
111
112
119
120
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General observations
There is now an electronic version of the protocol book which is available on CCO Comms. This
will be updated monthly and represents the working version of the book. It also contains more
information and will have a hyperlink to the nurse work instructions for each protocol. The paper
version will continue but will only be updated annually.
Complete the relevant application form which can be found on the North West Cancer
Drugs Fund web site. The easiest way to find this is to type nw cancer drugs fund into
google and select the application forms button in the header on the home page.
E-mail the completed form to the pharmacy dept at CCC using:
ccftr.CytoPharmacy@nhs.net this address can be found by typing cco pharmacy into the
address book in outlook.
The form will be checked in pharmacy and sent to the network pharmacist who will
coordinate approval by the cdf. All request which fulfil the criteria are approved
automatically and the process usually takes about a week.
Trials
Entry to clinical trials should be considered for all patients but individual studies have not been
listed due to frequent changes.
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Co-payment algorithm
The self-funded drug may be a single agent or given in combination with standard treatments, in
which case the costs incurred relate only to the self-funded drug. However it should always be
clear which components of treatment are privately funded and which are provided as NHS
treatments.
The patient commits to self-funding the treatment for the duration of the entire programme under
supervision by the responsible consultant i.e. a specific number of cycles or indefinite period
while there is evidence of a maintained benefit and response. This will include the costs of
treatment preparation and delivery, payment of any investigations needed, and any supportive
care drugs given as a direct consequence of receiving the self-funded treatment.
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Breast Cancer
Adjuvant
Epi-CMF
Epirubicin 100mg/m2 iv day 1 repeated at 21 day intervals x 4 cycles
followed by CMF x 4 cycles
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
LV ejection fraction prior to cycle 1 if history of cardiac problems
Fbc prior to each cycle.
Standard fbc limits for administration apply
CMF
Cyclophosphamide
Methotrexate
5-Fluorouracil
AC
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EC
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
LV ejection fraction prior to cycle 1 if history of cardiac problems
Fbc prior to each cycle
Standard fbc limits for administration apply
FEC / Docetaxel
This protocol is available for node +ve patients according to NICE guidance
Patients may receive primary prophylaxis with pegfilgrastim after each cycle
FEC
5-Fluorouracil
Epirubicin
Cyclophosphamide
500mg/m2 IV day 1
100mg/m2 IV day 1
500mg/m2 IV day 1
Followed by
Docetaxel 100 mg/m2 iv x 3 cycles at 21 day intervals
Pre-medication: Dexamethasone 8mg oral bd x 3 days start 24hrs pre-docetaxel
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Standard fbc limits for administration apply
NB: See section on advanced disease for dose modifications and precautions.
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Trastuzumab
ECOG PS 0 or 1
Baseline LVEF > 55% after completing chemotherapy
No serious cardiac illness
Trastuzumab
8mg/kg iv loading dose over 90min then 6mg/kg over 60min and thereafter over
30 min every 3 weeks for 12 months (18 cycles) if no problems.
Stop at any time if CCF develops
LVEF at 3, 6, 9 and 12 months
Stop trastuzumab if LVEF falls by 10 points or to <50%
Repeat after 3-4 weeks and if LVEF:
50+ continue with trastuzumab
44-49 and within 10 points of baseline continue with trastuzumab
< 44 stop trastuzumab
Neo-adjuvant
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AC/EC
Doxorubicin
Epirubicin
Cyclophosphamide
60mg/m2 iv day 1
or
90mg/m2 iv day 1
+
600mg/m2 iv day 1
Docetaxel
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Standard fbc limits for administration apply
NB: See section on advanced disease for dose modifications and precautions.
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Advanced disease
First line
Doxorubicin
75mg/m2 iv day 1
Repeat at 21 day intervals usually to a maximum of 6 cycles
AC
Doxorubicin
Cyclophosphamide
50mg/m2 iv day 1
500mg/m2 iv day 1
Docetaxel
Criteria
NB: See section on 2nd/3rd line treatment for dose modifications and precautions.
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
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Docetaxel / Capecitabine
Docetaxel
Capecitabine
Pre-medication
75mg/m2 iv day 1
+
1000mg/m2 bd oral days 1-14
NB see capecitabine renal function recommendations p105
Dexamethasone 8mg bd x 3 days start 24hrs pre-docetaxel
Paclitaxel / Gemcitabine
Paclitaxel
175mg/m2 iv day 1
Gemcitabine
Pre-medication
Chlorpheniramine
Dexamethasone
Ranitidine
10mg
16mg
50mg
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Cyclophosphamide
Methotrexate
5-Fluorouracil
CMF
Folinic acid rescue not normally required unless patients develop signs of Methotrexate toxicity,
then 15mg 6 hourly x 6 doses starting 24hrs post Methotrexate with subsequent cycles
For patients unable to tolerate oral cyclophosphamide substitute
iv cyclophosphamide 600mg/m2 days 1 and 8
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion but care if
renal function significantly deranged
Fbc prior to each cycle, not required day 8
Standard fbc limits for administration apply
Cycles are repeated at 28 days from day 1 to a total of 6
CMF (iv) Cyclophosphamide
Methotrexate
5-Fluorouracil
600mg/m2 iv day 1
40mg/m2 iv day 1
600mg/m2 iv day 1
Folinic acid rescue not normally required unless patients develop signs of Methotrexate toxicity,
then 15mg 6 hourly x 6 doses starting 24hrs post Methotrexate with subsequent cycles
Cycles repeated every 21 days to a maximum of 6
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion but consider
omitting Methotrexate if renal function abnormal
Fbc prior to each cycle
Normal fbc limits for administration apply
*Bevacizumab
10mg/kg iv infusion
Repeat at 14 day intervals
Criteria Advanced disease
Triple negative
First line chemotherapy
In combination with paclitaxel
*NB available via the Cancer Drugs fund
*Eribulin
cycle
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Doxorubicin
20mg/m2 iv weekly for patients with compromised liver or marrow function due to tumour
infiltration
Laboratory Investigations
Ensure normal renal function prior to cycle 1 and repeat during subsequent cycles if clinically
indicated
Patients with abnormal hepatic function should be treated cautiously
Where renal / hepatic function are abnormal treatment is at physician discretion
LV ejection fraction prior to cycle 1 if history of cardiac problems
Fbc prior to each cycle.
Normal limits for administration apply with the exception that for patients with marrow
infiltration treatment may be continued at lower platelet and neutrophil counts at treating
physician discretion.
Continue with weekly treatment usually for 6-8 weeks before changing to fortnightly or 21 day
cycles depending on response. Maximum total dose 450mg/m2
Paclitaxel 80mg/m2 iv weekly for patients with compromised liver or marrow function who have previously
received anthracyclines.
Pre-medication
Dexamethasone
Chlorpheniramine
Ranitidine
Laboratory investigations
Ensure normal renal function prior to cycle 1 and repeat during subsequent cycles if clinically
indicated
Patients with abnormal hepatic function should be treated cautiously
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle.
Normal limits for administration apply with the exception that for patients with marrow
infiltration treatment may be continued at lower platelet and neutrophil counts at treating
physician discretion.
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Vinorelbine
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
75-100mg/m2 iv q21 days maximum 6 cycles
or
60-75mg/m2 if moderately impaired liver function / heavily pre-treated / extensive
bone metastases
NB: severe toxicity may result in patients with major impairment of liver
function
Docetaxel
Pre-medication
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
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Capecitabine
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Bisphosphonate
Zoledronic acid
4mg iv in 100mls Sodium chloride 0.9% over 15-30 minutes repeated at 28 day
intervals.
Criteria:
Calcium supplements:
Patients should have their serum calcium measured every four weeks and Adcal
D3 tablets prescribed as necessary.
Renal impairment
Cr clearance
Dose
>60
50 - 60
40 - 49
30 39
< 30
4.0mg
3.5mg
3.3mg
3.0mg
no treatment
Serum creatinine should be repeated every 4 weeks and if it rises significantly during
treatment zoledronic acid should be witheld until the creatinine has returned to within
10% of the baseline prior to starting.
For patients with creatinine clearance < 30ml/min ibandronic acid 50mg weekly oral
may be considered. *This is available via the off-protocol mechanism
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4 mg/kg loading dose i.v. over 90 minutes followed by 2mg/kg/week i.v. over 30 minutes
for 8 doses then 6mg/kg every 3 weeks over 30minutes.
or
8mg/kg iv loading dose over 90min then 6mg/kg over 60min for one dose and then over
30 min thereafter if no problems every 3 weeks
Criteria:
NB not with anthracycline and with care within close proximity to anthracycline
therapy (< 6 months).
LVEF: baseline ECHO/MUGA + 3 monthly repeat advised for patients receiving
treatment with trastuzumab.
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
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Gastrointestinal Cancer
Oesophageal Carcinoma
Adjuvant
Not currently recommended as standard therapy
Neoadjuvant
Cisplatin/5FU
Cisplatin
5-Fluorouracil
Capecitabine
80mg/m2 iv day 1
1g/m2 over 24hrs iv days 1-4
or
1000mg/m2 bd x 14 days
PS 0-1
Cr Cl > 50ml/min
Operable oesophageal cancer
Laboratory Investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Locally advanced
Chemo-radiation protocol
Cisplatin/5FU
Cisplatin
80mg/m2 iv day 1 and 29
5Fluorouracil 1g/m2 iv over 24hrs days 1-4 and 29-32
or
Capecitabine 825mg/m2 oral bd Mon-Fri during XRT
+ XRT
followed by two additional cycles after completion of XRT
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
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Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Metastastic
Cisplatin/5FU
Cisplatin
5-Fluorouracil
Capecitabine
80mg/m2 iv day 1
1g/m2 iv over 24hrs days 1-4
or
1000mg/m2 bd x 14 days
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ECF/X
Epirubicin
50mg/m2 iv day 1
Cisplatin
60mg/m2 iv day 1
5-Fluorouracil 200mg/m2 / day via continuous iv infusion for 21 days
or
Capecitabine 625mg/m2 bd days 1-21
NB see capecitabine renal function recommendations p105
Repeat at 21 day intervals
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
ECF/X
Epirubicin
50mg/m2 iv day 1
Cisplatin
60mg/m2 iv day 1
5-Fluorouracil 200mg/m2 / day via continuous iv infusion for 21 days
or
Capecitabine 625mg/m2 bd days 1-21
NB see capecitabine renal function recommendations p105
Repeat at 21 day intervals for a maximum of 4-6 cycles
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
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Epirubicin
50mg/m2 iv day 1
Oxaliplatin
130mg/m2 iv day 1
5-Fluorouracil 200mg/m2 / day via continuous iv infusion for 21 days
or
Capecitabine 625mg/m2 bd days 1-21
NB see capecitabine renal function recommendations p105
EOF/X
Cisplatin/fluoropyrimidine/Herceptin
80mg/m2 iv day 1
5-Fluorouracil
Cisplatin
Capecitabine
Criteria
PS 0-1
Cr Cl > 50ml/min
HER 2 status IHC 3+ or FISH +ve
Laboratory Investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
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Second line
Irinotecan
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Pancreatic cancer
Adjuvant
5-Fluorouracil+Folinic acid
NB: For patients over 70yrs and those with borderline performance status the dose of 5Fluorouracil should be reduced to 370mg/m2 per day.
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Gemcitabine
1g/m2
Criteria
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
NB: transaminases may rise during gemcitabine therapy
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Advanced
First line
Gemcitabine + Capecitabine
Gemcitabine
1g/m2
Capecitabine
po bd for 21 days
825mg/m2
NB see capecitabine renal function recommendations p105
Repeat 28 day intervals for up to 6 cycles.
Criteria
iv days 1, 8, 15
PS 0-1
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
NB: transaminases may rise during gemcitabine therapy
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
CA19-9 every 4 weeks
Day 8 or 15
Platelets 75 99 x109/l continue at full dose
Platelets < 75x109/l omit gemcitabine
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Gemcitabine
1g/m2
Criteria
PS 0-2
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
NB: transaminases may rise during gemcitabine therapy
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
CA19-9 every 4 weeks
Day 8 or 15
Platelets 75 99 x109/l continue at full dose
Platelets < 75x109/l omit gemcitabine
Second line
Ox-Cap
Oxaliplatin
Capecitabine
85 mg/m2 iv day 1
900mg/m2 oral bd x 9 days
NB see capecitabine renal function recommendations p105
PS 0-2
Relapse < 6 months post adjuvant chemotherapy
Progression free interval > 3 months following first line therapy
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc and creatinine prior to each cycle
Normal fbc limits for administration apply with the exception that the lower limit for platelets
for administration of Ox-Cap is 75 x 109/l
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Cisplatin
Gemcitabine
1g/m2
PS 0-2
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
CA19-9 every 4 weeks
Normal fbc limits for administration apply
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ECF/EOX
Epirubicin
50mg/m2 iv day 1
Cisplatin
60mg/m2 iv day 1
5-Fluorouracil 200mg/m2 / day via continuous iv infusion
or
Oxaliplatin
130mg/m2 iv day 1
Epirubicin
50mg/m2 iv day 1
Capecitabine 625mg/m2 bd days 1-21
NB see capecitabine renal function recommendations p105
Repeat at 21 day intervals for a maximum of 4-6 cycles
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Hepatocellular carcinoma*
Sorafenib
0-2
Normal bilirubin
Transaminases < 2xULN
Normal renal function
Laboratory investigations
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Neuroendocrine tumours
High mitotic rate, anaplastic histology, clinically aggressive
Etoposide
Cisplatin
Etoposide / cisplatin
PS 0-1
Cr cl > 50ml/min
Patients with rapidly progressive disease
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Somatostatin
*Everolimus (Afinitor)
Laboratory Investigations
Criteria
*NB
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*Sunitinib (Sutent)
Criteria
*NB
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
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Colorectal
Adjuvant
5FU/FA
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to every fourth week
Normal fbc limits for administration apply
Capecitabine
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Repeat creatinine if clinically indicated
Normal fbc limits for administration apply
OxMdG
85 mg/m2 iv day 1
350mg flat dose two hour infusion day 1
400mg/m2 15 minute bolus day 1
2400mg/m2 46hr infusion day 1
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Capecitabine + XRT
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc each week during chemotherapy
Normal fbc limits for administration apply
5FU/FA
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to every fourth week
Normal fbc limits for administration apply
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First line
Single agent
MdG:
MdG
Folinic acid
5-Fluorouracil
5FU
Capecitabine
Issue Date:
Ensure normal renal and hepatic function prior to cycle 1 if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc and creatinine prior to each cycle
Normal fbc limits for administration apply
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Combination chemotherapy
Consider for good PS status patients with relatively bulky disease who need a more rapid response.
IrinMdG Irinotecan 180mg/m2 iv + atropine 600ug s/c prior to irinotecan
MdG:
Folinic acid
5-Fluorouracil
5-Fluorouracil
SD / response.
Acceptable toxicity
Criteria: PS 0-2
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
I-Cap
SD / response.
Acceptable toxicity
Criteria: PS 0-1
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc and creatinine prior to each cycle
Normal fbc limits for administration apply
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OxMdG
Oxaliplatin
Folinic acid
5-Fluorouracil
5-Fluorouracil
85 mg/m2 iv day 1
350mg flat dose two hour iv infusion day 1
400mg/m2 15 minute iv bolus day 1
2400mg/m2 46hr iv infusion start day 1
Ox-Cap
Oxaliplatin
85 mg/m2 iv day 1
Capecitabine
900mg/m2 oral bd x 9 days
NB see capecitabine renal function recommendations p105
Repeat at 14 day intervals for 6 cycles then reassessment
Avoid in patients with pre-existing neuropathy
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc and creatinine prior to each cycle
Normal fbc limits for administration apply with the exception that the lower limit for platelets
for administration of Ox-Cap is 75 x 109/l
XELOX
Oxaliplatin
130 mg/m2 iv day 1
Capecitabine
1000mg/m2 oral bd x 14 days
NB see capecitabine renal function recommendations p105
Repeat at 21 day intervals for 4 cycles then reassessment
Avoid in patients with pre-existing neuropathy
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply.
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OxMdG + Cetuximab
Oxaliplatin
Folinic acid
5-Fluorouracil
5-Fluorouracil
Cetuximab
85 mg/m2 iv day 1
350mg flat dose two hour iv infusion day 1
400mg/m2 15 minute iv bolus day 1
2400mg/m2 46hr iv infusion start day 1
Week 1 400mg/m2 iv day 1 over 2 hours using 0.2um in-line filter
Then 500mg/m2 iv over 1 hour every 2 weeks
Premedication
Dexamethasone 8mg
Chlorpheniramine 10mg
Ranitidine 150mg
IrinMdG + Cetuximab
Irinotecan
Folinic acid
5-Fluorouracil
5-Fluorouracil
Cetuximab
Premedication
Dexamethasone 8mg
Chlorpheniramine 10mg
Ranitidine 150mg
SD / response.
Acceptable toxicity
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc and biochemistry prior to each cycle
Normal fbc limits for administration apply with the exception that the lower limit for platelets
for administration of OxMdG is 75 x 109/l
Criteria
Issue Date:
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Criteria
*NB
Irinotecan
Issue Date:
Ensure normal renal and hepatic function prior to cycle 1 and repeat during
subsequent cycles if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Page 34 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
*Irinotecan + Cetuximab
Criteria
- Must have KRAS wild type cancers
- Previously responded to chemotherapy
- Second or third line chemotherapy
- performance status (0-1)
400mg/m2 iv day 1 over 2 hours using 0.2um in-line filter
500mg/m2 iv over 1 hour every 2 weeks
Cetuximab
Week 1
Then
Irinotecan
Premedication
Dexamethasone 8mg
Chlorpheniramine 10mg
Ranitidine 150mg
Week 1
Then
Premedication
Dexamethasone 8mg
Chlorpheniramine 10mg
Ranitidine 150mg
Issue Date:
Page 35 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
MMC + MdG
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
MMC + Capecitabine
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc and biochemistry prior to each cycle
Normal fbc limits for administration apply
Issue Date:
Page 36 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Anal Carcinoma
Localised squamous carcinoma of the anus
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Palliative / Metastatic
Cisplatin/5FU
Cisplatin
5-Fluorouracil
Capecitabine
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Issue Date:
Page 37 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Gynaecological Cancer
Epithelial Ovarian Cancer
First Line Chemotherapy
Paclitaxel/Carboplatin
175mg/m2 iv over 3 hours
AUC 5/6
iv over 1 hour
Paclitaxel
Carboplatin
Paclitaxel premedication
Chlorpheniramine
Dexamethasone
Ranitidine
10mg
16mg
50mg
Criteria
Stage Ib-IV
Minimal residual disease / bulk residual disease
PS 0-1
Cr Cl > 50ml/min
Laboratory Investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if
clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
CA125 prior to each cycle
Fbc prior to each cycle
Normal fbc limits for administration apply
or
Carboplatin
Carboplatin AUC 5/6 x (GFR + 25) iv at 21-28 day intervals x max 6 cycles
Laboratory Investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if
clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
CA125 prior to each cycle
Fbc prior to each cycle
Normal fbc limits for administration apply
Issue Date:
Page 38 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Paclitaxel + carboplatin
See 1st line section for doses + pre-medication schedule
Repeat at 21 day intervals, max 6 doses
Laboratory Investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if
clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
CA125 prior to each cycle
Fbc prior to each cycle
Normal fbc limits for administration apply
Issue Date:
Page 39 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Carboplatin + Gemcitabine
Carboplatin
Gemcitabine
AUC5
30mg/m2 iv
Laboratory investigations
Ensure normal renal function prior to cycle 1 and repeat during subsequent cycles if clinically
indicated
Patients with abnormal hepatic function should be treated cautiously
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle.
Normal limits for administration apply with the exception that for patients with marrow
infiltration treatment may be continued at lower platelet and neutrophil counts at treating
physician discretion.
Issue Date:
Page 40 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Chlorpheniramine
Dexamethasone
Ranitidine
10mg iv
16mg iv
50mg iv
PS 0-1
No prior taxane therapy
Previous platinum
PS 0-2
Platinum resistant / refractory
No evidence of intestinal obstruction
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
CA125 prior to each cycle
Fbc prior to each cycle
Normal fbc limits for administration apply
Topotecan
or
3mg/m2 iv weekly on days 1, 8, 15 of a 28 day cycle
Maximum 4 cycles
Criteria
PS 0-2
Platinum resistant / refractory
Cr Cl > 40ml/min
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
CA125 prior to each cycle
Fbc prior to each dose
Normal fbc limits for administration apply
Issue Date:
Page 41 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Gemcitabine
PS 0-2
Platinum resistant / refractory
Chlorambucil
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
CA125 prior to each cycle
Fbc prior to each cycle
Normal fbc limits for administration apply
Doxorubicin
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
CA125 prior to each cycle
Fbc prior to each cycle
Normal fbc limits for administration apply
Consider LV ejection fraction if history of cardiac disease
Issue Date:
Page 42 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Platinum refractory
Capecitabine
I-Cap
SD / response.
Acceptable toxicity
Criteria: PS 0-1
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc and creatinine prior to each cycle
Normal fbc limits for administration apply
Issue Date:
Page 43 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Ox-Cap
Oxaliplatin
85 mg/m2 iv day 1
Capecitabine
900mg/m2 oral bd x 9 days
NB see capecitabine renal function recommendations p105
Repeat at 14 day intervals for 6 cycles then re-assessment
Avoid in patients with pre-existing neuropathy
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc and creatinine prior to each cycle
Normal fbc limits for administration apply with the exception that the lower limit for platelets
for administration of Ox-Cap is 75 x 109/l
Endometrial Carcinoma
Epithelial
Advanced
Doxorubicin/Cisplatin/Paclitaxel
Doxorubicin
Cisplatin
Paclitaxel
45mg/m2 iv day 1
50mg/m2 iv day 1
160mg/m2 iv day 2
Premedication
Chlorpheniramine
Dexamethasone
Ranitidine
10mg
16mg
50mg
Issue Date:
Page 44 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Doxorubicin
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Consider LV ejection fraction if history of cardiac disease
or
Cisplatin Cisplatin 80mg/m2 iv at 21 day intervals x 6 cycles
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
or
Doxorubicin/Cisplatin
Doxorubicin 50mg/m2 iv
Cisplatin
50mg/m2 iv
Issue Date:
Page 45 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Cervical Cancer
Adjuvant
Not currently recommended as standard therapy
Pre-XRT
BMC
Bleomycin
Mitomycin-C
Cisplatin
30,000 iu iv day 1
10mg/m2 cycles 1,3
50mg/m2 iv day 1
Cisplatin / Topotecan
Criteria
Cisplatin
Topotecan
1.
2.
3.
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Issue Date:
Page 46 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Paclitaxel/Cisplatin
135mg/m2 iv over 3 hours
50mg/m2 iv
Paclitaxel
Cisplatin
Paclitaxel premedication
Chlorpheniramine
Dexamethasone
Ranitidine
10mg
16mg
50mg
1.
2.
3.
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Topotecan
Criteria
1.
2.
3.
Topotecan
PS 0-2
<6 months post chemoradiation
prior radiosensitising cisplatin
1.2mg/m2 (max 2mg) iv days 1-5
Issue Date:
Page 47 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
1.
2.
3.
Paclitaxel
Cisplatin
Paclitaxel premedication
Chlorpheniramine
Dexamethasone
Ranitidine
10mg iv
16mg iv
50mg iv
Laboratory Investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if
clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Paclitaxel
Criteria
1.
2.
3.
PS 0-2
<6 months post chemoradiation
prior radiosensitising cisplatin
Chlorpheniramine
Dexamethasone
Ranitidine
10mg
16mg
50mg
Laboratory Investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Issue Date:
Page 48 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Chemo-radiotherapy schedules
Criteria
bulky 1B or 2B
PS 0-1
Normal liver / renal / haematology
(1)
40mg/m2 iv (max 70mg) in 1 litre Sodium chloride 0.9% over 60min weekly x max 6 weeks
30mg/m2 if XRT fields large
Cisplatin
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
or
(2)
Cisplatin
5-Fluorouracil
80mg/m2 iv day 1
1g/m2 iv days 1-4 and 29-32
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Erythropoietin may be used to maintain haemoglobin levels during combined modality therapy in these patients.
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Issue Date:
Page 49 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Haematological Malignancies
Hodgkins disease
Early HD
Group I
Group II
ABVD x 3 + IF XRT
Group III
Advanced HD
Stages III / IV or I / II with mediastinal bulk + / - B symptoms
ABVD
Doxorubicin
Bleomycin
Hydrocortisone
Vinblastine
Dacarbazine
ChlVPP
Issue Date:
Page 50 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Non-Hodgkins Lymphoma
Low grade
First line
CVP-R
600mg/m2 iv day 1
1.4mg/m2 iv day 1 (maximum 2mg)
50mg orally days 1-5
iv day 1
375mg/m2
Cyclophosphamide
Vincristine
Prednisolone
Rituximab
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
CHOP-R
Cyclophosphamide
Doxorubicin
Vincristine
Prednisolone
750mg/m2
50mg/m2
1.4mg/m2
50mg po
iv day 1
iv day 1
iv day 1
days 1-5
Rituximab
375mg/m2
iv day 1
Issue Date:
Page 51 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
*Maintenance Rituximab
Rituximab
375mg/m2
Second Line
*Bendamustine 120mg/m2 iv days 1 and 2
Repeat at 21 day intervals to a maximum of 8 cycles
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Criteria
Issue Date:
Page 52 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Chlorambucil
+
Prednisolone
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Fludarabine
Fludarabine
Rituximab
Issue Date:
375mg/m2
Criteria
Page 53 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Stage II-IV
Cyclophosphamide
Doxorubicin
Vincristine
Prednisolone
Rituximab
CHOP-R
750mg/m2
50mg/m2
1.4mg/m2
50mg po
375mg/m2
iv day 1
iv day 1
iv day 1
days 1-5
iv day 1
Issue Date:
Page 54 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
80mg/m2 iv day 1
1g/m2 over 24hrs iv days 1-4
Cisplatin
5Fluorouracil
80mg/m2 iv day 1
1000mg/m2 over 24hrs iv days 1-4
75mg/m2 iv day 1
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Issue Date:
Page 55 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
XRT + Cetuximab*
400mg/m2 iv loading dose 1 week prior to XRT
250mg/m2 iv weekly during XRT
Cetuximab
Criteria
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
80mg/m2 iv day 1
1g/m2 iv over 24hrs days 1-4
Cisplatin
5Fluorouracil
or
Cisplatin
Cisplatin
100mg/m2 iv
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Issue Date:
Page 56 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Chlorpheniramine
Dexamethasone
Ranitidine
10mg iv
16mg iv
50mg iv
PS 0-1
Nasopharyngeal Carcinoma
Chemoradiation + Adjuvant Chemotherapy
Criteria
Chemoradiation
Cisplatin 100mg/m2 days 1, 22, 43 to start prior to XRT
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
followed by:
Adjuvant chemotherapy
Commencing 21 days after 3rd cycle of cisplatin
Cisplatin
5Fluorouracil
80mg/m2 iv day 1
1g.m2 iv over 24 hrs days 1-4
Issue Date:
Page 57 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Thyroid Cancer
Medullary Thyroid Cancer
Sorafenib
PS
0-2
Locally advanced unresectable / metastatic
First line
Laboratory investigations
Sorafenib
PS 0-2
Refractory to radioiodine
Laboratory investigations
Issue Date:
Page 58 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Lung Cancer
Small Cell
Good PS + Limited stage
Concurrent chemotherapy + XRT
Cisplatin/etoposide
Etoposide
Cisplatin
Good / Intermediate PS
Carboplatin / Etoposide
Carboplatin
Etoposide
Etoposide
AUC 5 iv day 1
100mg/m2 iv day 1
200mg/m2 po days 2 and 3
Issue Date:
Page 59 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Poor PS
Many poor PS patients will be too ill potentially to benefit from chemotherapy and symptomatic care will be
the most appropriate option. For those judged to be fit enough the following may be considered:
(1) Carboplatin
Laboratory Investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if
clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
(2) Etoposide
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
(1) Etoposide
50mg oral bd x 7 - 10 days repeat at 21 days from day 1max 6 cycles / progression
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
(2) Carboplatin
Laboratory Investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if
clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Issue Date:
Page 60 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Cyclophosphamide
Doxorubicin
Vincristine
(3) CAV
750mg/m2 iv
50mg/m2 iv
1.4mg/m2 iv
(4) Topotecan
PS 0-2
Cr Cl > 40ml/min
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
CA125 prior to each cycle
Fbc prior to each dose
Normal fbc limits for administration apply
Issue Date:
Page 61 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Cisplatin/Vinorelbine
Cisplatin
80mg/m2 iv day 1
Vinorelbine 25mg/m2 iv day 1 and 8 or oral 60mg/m2 day 1 and 8
Repeated at 21 day intervals x 3 cycles
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
or
Carboplatin/Vinorelbine
Carboplatin AUC x 5 iv
Vinorelbine 25mg/m2 iv days 1 and 8 or 60mg/m2 oral day 1 and 8
21 28 day cycle x 3 cycles
Laboratory Investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if
clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Carboplatin/Vinorelbine (split dose) Carboplatin AUC x 2.5 iv days 1 and 8
Vinorelbine 25mg/m2 iv days 1 and 8 or 60mg/m2 oral day 1 and 8
21 28 day cycle x 3 cycles
Laboratory Investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if
clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Issue Date:
Page 62 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Locally advanced
Chemotherapy + XRT
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Advanced
Cisplatin / Pemetrexed
Cisplatin 75mg/m2 iv
Pemetrexed 500mg/m2 iv
Repeat at 21 day intervals x 4 cycles
Vitamin B12 inj 1 week prior to start + every 9 weeks until completion
Folic acid 400ug daily oral during treatment
Dexamethasone 4mg tds for 3 days start day before pemetrexed
Stop all NSAIDS during chemotherapy
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Issue Date:
Page 63 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Cisplatin/Vinorelbine
Cisplatin
80mg/m2 iv day 1
Vinorelbine 25mg/m2 iv day 1 and 8 (oral vinorelbine 60mg/m2 day 1and 8)
Repeated at 21 day intervals x 4 cycles
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Gemcitabine/Carboplatin
Carboplatin AUC x 5 iv
Gemcitabine 1250mg/m2 iv days 1 and 8
21 28 day cycle x 4 cycles
Laboratory Investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
NB: transaminases may rise during treatment
Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if
clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Carboplatin/Vinorelbine
Carboplatin
Vinorelbine
Or
oral vinorelbine
AUC x 4/5 iv
25mg/m2 iv days 1 and 8
60mg/m2 day 1 and 8
Issue Date:
Page 64 of 120
Filename:
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Issue No:
Copy No:
9.0
Vinorelbine
No prior chemotherapy
PS 0-2
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Gemcitabine
Laboratory Investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
NB: transaminases may rise during treatment
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Gefitinib
Maintenance Pemetrexed
Pemetrexed
500mg/m2 iv
Repeat at 21 day intervals until progression
Vitamin B12 inj 1 week prior to start + every 9 weeks until completion
Folic acid 400ug daily oral during treatment
Dexamethasone 4mg tds for 3 days start day before pemetrexed
Stop all NSAIDS during chemotherapy
Issue Date:
Page 65 of 120
Filename:
MCHACPROTO
Issue No:
Copy No:
9.0
Docetaxel
PS 0-1
Previous response or stable disease to platinum based chemotherapy
Progression free interval following platinum based chemotherapy > 6m
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Erlotinib (Tarceva)
150mg oral daily initially for 4 weeks and continued thereafter if
symptomatic or objective response
Erlotinib
Criteria
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
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9.0
Mesothelioma
Cisplatin / Pemetrexed
Cisplatin 75mg/m2 iv
Pemetrexed 500mg/m2 iv
Repeat at 21 day intervals for a maximum of 6 cycles
Vitamin B12 inj 1 week prior to start + every 9 weeks until completion
Folic acid 400ug daily oral during treatment
Dexamethasone 4mg b5 for 5 days start day before pemetrexed
Stop all NSAIDS during chemotherapy
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
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9.0
Melanoma
Advanced
850mg/m2 iv q 21 days max 6 cycles
Dacarbazine
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Gemcitabine + treosulphan
Gemcitabine 1000mg/m2 iv days 1 and 8
Treosulphan 3500mg/m2 iv days 1 and 8
Repeat at 28 day intervals for a maximum of 6 cycles
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Carboplatin
Carboplatin AUC 5/6 x (GFR + 25) iv at 21-28 day intervals x max 6 cycles
Laboratory Investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if
clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
*Ipilimumab
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Neo-adjuvant
Suggested protocol for down sizing prior to surgery
Doxorubicin
Mesna prior to ifosfamide
Ifosfamide + Mesna
Mesna post ifos/mesna infusion
Advanced
There is no evidence that combinations are superior to single agents as palliative chemotherapy
First line
Doxorubicin
Doxorubicin
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent
cycles if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Second line
Pre Ifosfamide Mesna
Ifosfamide/Mesna
Post Ifosfamide Mesna
Ifosfamide
Issue Date:
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent
cycles if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
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Dacarbazine
800mg/m2 iv day 1
Repeat at 21 day intervals for up to 6 cycles
Laboratory Investigations
Trabectedin
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent
cycles if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent
cycles if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
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9.0
PAM
Methotrexate level
< 0.1M
<0.5-5M
5-50M
>50M
Stop rescue
15-30mg 6hrly
200mg/m2 6hrly
1000mg/m2 6hrly
Cisplatin/Doxorubicin
Cisplatin
100mg/m2 iv day 1
Doxorubicin 25mg/m2 iv days 1,2,3 (20mg/m2 days 1-3 age > 60yrs)
Repeat at 21 days x 3 cycles then surgery then 3 further cycles.
Criteria
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Issue Date:
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9.0
Advanced Osteosarcoma
Cisplatin/Doxorubicin
Cisplatin
100mg/m2 iv day 1
Doxorubicin 25mg/m2 iv days 1,2,3
Repeat at 21 days x 6 cycles
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
LV ejection fraction prior to cycle 1 if history of cardiac problems
Fbc prior to each cycle
Normal fbc limits for administration apply
Issue Date:
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9.0
Ewings Sarcoma
Non-metastatic Ewings Sarcoma/PNET/Askin tumour / Rhabdomyosarcoma
Laboratory Investigations
Neoadjuvant
VIDE (cycles 1-6)
1.5mg/m2 (max 2mg) iv
20mg/m2 iv
1g/m2
150mg/m2 iv
1.5g/m2 / 1.5g/m2 iv
1.5g/m2 iv
Vincristine
Doxorubicin
Mesna
Etoposide
Ifosfamide/Mesna
Mesna
Pegfilgrastim
day 1
days 1-3
day 1
days 1-3
days 1-3
days 3
Cardiac function
LVEF < 40% omit doxorubicin and substitute Actinomycin-D 1.5mg/m2
Repeat echo after next cycle and consider reintroducing doxorubicin if LVEF has recovered.
Definitive local treatment
Surgery should occur 21 days after cycle 6 or as soon as recovery allows.
Radiotherapy should commence concurrent with cycle 7 omitting Actinomycin-D from concurrent cycles.
If radiation is required following surgery it should commence after cycle 8 omitting Actinomycin-D from
concurrent cycles.
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Vincristine
Actinomycin D
Pre Ifosfamide Mesna
Ifosfamide/Mesna
Post Ifosfamide Mesna
day 1
days 1-2
days 1-2
days 1-2
Haematological toxicity
Delayed recovery of wbc / platelets > 6 days reduce Act-D and Ifosfamide by 20%
Neutropenic sepsis grade 3 or 4 reduce Act D and Ifosfamide by 20% + add GCSF
Further episodes should be managed with serial 20% reductions
GI / Mucositis
Grade 3 or 4 reduce Ifosfamide + Act D by 20%
Renal Toxicity
GFR > 60 no change
GFR 40-59 reduce Ifosfamide by 30%, reduce etoposide by 30%
GFR < 40 switch Ifosfamide to cyclophosphamide 1500mg/m2 on day 1 only reduce
etoposide by 30%
Cardiac function
LVEF < 40% or 10% decrease from previous level, delay chemotherapy and repeat in 7
days. If recovered proceed with chemotherapy. If still impaired consider omission or
dose reduction of Ifosfamide.
VAC
Vincristine
Actinomycin-D
Mesna
Cyclophosphamide/Mesna
Mesna
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VACA
(In patients unsuitable for VIDE previously NOT exposed to anthracyclines actinomycin D and
doxorubicin on alternate cycles)
Vincristine
Mesna
Cyclophosphamide/Mesna
Mesna
Actinomycin-D
Doxorubicin
Etopside / Ifosfamide
Etoposide
Pre-Ifosfamide Mesna
Ifosfamide/Mesna
Post ifosfamide Mesna
120mg/m2 iv
500mg/m2
3g/m2 / 3g/m2 iv
1.5g/m2 iv
days 1-3
days 1-3
days 1-3
days 1-3
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Issue Date:
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9.0
Palliative Ewings
Etoposide / cisplatin
Etoposide 120mg/m2 iv days 1-3
Cisplatin 50mg/m2 iv days 1-2
or
Carboplatin AUC 5 iv day 1
Etoposide 120mg/m2 iv day1 240mg/m2 po days 2,3
Repeat at 21 day intervals max 6 cycles
Criteria
PS 0-1
Cr cl > 50ml/min for cisplatin
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Cyclophosphamide/ Topotecan
Relapsed Ewings sarcoma
Relapsed/ 2nd line rhabdomyosarcoma
D1-5
Topotecan 0.75 mg/m2
Cyclophosphamide 250 mg/m2 D1-5
Cycle repeated every 21 days
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9.0
Gemcitabine/Docetaxel
Relapsed metastatic osteosarcoma
Selected metastatic soft tissue sarcomas (3rd line)/ uterine leiomyosarcoma
Relapsed Ewings (if other 2nd line is not suitable)
D1
D8
Irinotecan/Temozolomide
Relapsed Ewings sarcoma
Relapsed/ 2nd line rhabdomyosarcoma
D1-5, D8-12
Irinotecan 20 mg/m2 iv
D1-5
Temozolomide 100mg/m2 po
Cycle repeated every 21-28 days
Paclitaxel
Angiosarcomas
(2nd line or 1st line if not suitable for doxorubicin)
80 mg/m2 weekly up to 12 weeks
175 mg/m2 every 21 days (4-6 cycles, review after cycle 3)
Oral Etoposide
Palliative metastatic Ewings or rhabdomyosarcoma
Etoposide 50-100mg bd 7-14 days (at clinicians discretion)
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9.0
Aggressive fibromatosis
1st Line
Tamoxifen +/- NSAIDs
2nd Line
Methotrexate 30 mg/m2 (usually 50mg total dose)
Vinblastine 6 mg/m2 (usually 10mg total dose)
Every 1-2 weeks
Duration of course at clinicians discretion
Vinorelbine can replace vinblastine if neuropathy a problem.
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Rhabdomyosarcoma
Baseline investigations:
- FBC, U+Es, LFTs Bone chemistry
- CT thorax / Abdo staging
- Bone marrow aspirate and trephine
- Bone Scan
- If paramningeal site- CSF
- Consider early morning urine for phosphate, creatinine, osmolarity for Ifosfamide containing regimes
For patients aged < 40 years:
IVADo regime for high risk rhabdomyosarcoma (see separate regime)
Maintenance therapy:
Vinorelbine 25 mg/m2 IV D 1, 8, 15
Cyclophosphamide 25 mg/m2 PO OD D 1-28
Every 28 days
Maintenance therapy following IVADo to be used in:
1.
2.
For Alveolar Rhabdomyosarcoma maintenance therapy following IVADo for 6 cycles ( i.e. 6 months)
For metastatic disease on intensive treatment, if no residual disease or limited residual disease, IVADo to
be followed by maintenance treatment for 12 cycles
VAC
Vincristine
Actinomycin-D
Mesna
Cyclophosphamide/Mesna
Mesna
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Week
Cycle 2
IVADo
IVADo
IVADo
Cycle
5
Week
I=
Cycle 3
IVA
13
Cycle
6
14
IVA
16
15
Cycle 4
IVADo
Cycle
7
17
18
IVA
19
Surgery/
Radiotherapy
10
Cycle
8
20
IVA
22
21
Cycle
9
23
24
IVA
25
D1, D2
V=
A=
Do=
Each cycle:
WCC>2
Neutrophils> 1.0 ( or physicians discretion)
Platelets > 80
Weekly vincristine to be given irrespective of pancytopenia unless unwell
Reassess after cycle 3. If not CR or PR > 1/3rd consider 2nd line treatment + RT
Week
Cycle 1
M
2 3 4
M
5
AP
6
Cycle 4
AP
17
Week
AP -
18
19
M
20
M
21
A
22
Cycle 2
M
7 8 9
SURGERY
M
10
11
Cycle 5
M M
23 24 25
Cycle 3
AP
12
A
26
Cycle 6
M
27 28
13
14
M
15
M
16
M
29
M-
A-
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Criteria
Tumour
> 5cm
Mitoses
> 5 mitoses/50 HPF
SI / colonic primary
Imatinib (Glivec)
Criteria
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc / biochemistry prior to each visit
Normal fbc limits for administration apply
Dose reduce if significant toxicity / rising hepatic transaminases
Sunitinib (Sutent)*
Criteria
Sunitinib
PS 0-2
c-Kit positive
locally advanced / metastatic disease
previous response to imatinib
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles
if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc / biochemistry prior to each visit
Normal fbc limits for administration apply
Issue Date:
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9.0
Urological Cancer
Bladder Cancer - Transitional cell
Neoadjuvant
Cisplatin/Gemcitabine
70mg/m2 iv day 1
1g /m2 iv days 1,8,15
Cisplatin
Gemcitabine
35mg/m2
1000mg/m2
iv days
iv days
1 and 8
1 and 8
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Cisplatin
Criteria
PS 0-1
Poorly differentiated TCC bladder
pT2-4a, N0, M0
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Advanced
Cisplatin/Gemcitabine
70mg/m2 iv day 1
1g /m2 iv days 1,8
Cisplatin
Gemcitabine
35mg/m2
1000mg/m2
iv days
iv days
1 and 8
1 and 8
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Carboplatin/Gemcitabine
Carboplatin
Gemcitabine
AUC4 / 5 iv
1g /m2 iv days 1,8 of a 21 day cycle
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9.0
Renal cancer
Advanced
First line
Alpha Ifn
Interferon
by s/c injection:
week 1
Mon 5mu
Wed 5mu
Weeks 2 + 10mu Mon / Wed / Fri
Criteria
Fri 10mu
PS 0-1
Relapse post nephrectomy > 12 months
Low volume disease
Patients should have 2 out of 3 criteria
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent
cycles if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
50mg daily x 4 weeks followed by 2 week break
Sunitinib (Sutent)
PS 0-1
Laboratory Investigations
Pazopanib
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent
cycles if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
800mg daily
Criteria
Laboratory Investigations
Issue Date:
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent
cycles if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
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Sorafenib
PS 0-1
Progression on/following cytokine therapy
Laboratory Investigations
*Temsirolimus
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent
cycles if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
25mg iv weekly
Premedication
Chlorpheniramine 10mg
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent
cycles if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Criteria
*NB
*Everolimus (Afinitor)
Laboratory Investigations
Criteria
*NB
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Prostate Cancer
Mitoxantrone
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent
cycles if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Docetaxel
*Abiraterone
Issue Date:
Castrate resistant
Prior docetaxel chemotherapy
*NB
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*Cabazitaxel
Cabazitaxel
25mg/m2 iv infusion.
premedication
Chlorpheniramine 10mg
Dexamethasone 16mg
Ranitidine
50mg
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent
cycles if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
*NB
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Laboratory investigations
30000iu iv day 1, 8, 15
165mg/m2 iv days 1-3
50mg/m2 iv days 1-2
Bleomycin
Etoposide
Cisplatin
30000iu iv day 1, 8, 15
165mg/m2 iv days 1-3
50mg/m2 iv days 1-2
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9.0
BEP5
Repeat at 21 day intervals x 3 cycles then EP5 for a further 3 cycles (i.e. omit
bleomycin)
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Tumour markers: HCG,AFP,LDH where appropriate prior to each cycle
Fbc prior to each cycle
Normal fbc limits for administration apply
CNS disease
POMB / ACE + Intrathecal (IT) Methotrexate
POMB
Day 1
Day 2
Day 3
Day 4
Vincristine
Methotrexate
Folinic acid
Bleomycin
Bleomycin
Cisplatin
2mg iv
1g/m2 iv over 24hrs (Standard dose is 300mg/m2)
15mg 6hrly x 12 doses start 12 hrs after completion of Methotrexate
15mg iv over 24hr
15mgiv over 24 hr
120mg/m2 iv over 12hr
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Tumour markers: HCG,AFP,LDH where appropriate prior to each cycle
Fbc prior to each cycle
Normal fbc limits for administration apply
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9.0
ACE
Act D
Etoposide
Cyclophosphamide
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Repeat cycles at 14 days from day 1, POMB, POMB, ACE, POMB, ACE etc 4-5 cycles of POMB.
Cisplatin 20mg/m2 iv
Etoposide 100mg/m2 iv
Repeat daily x 2-3days depending on clinical situation
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Tumour markers: HCG,AFP,LDH where appropriate prior to each cycle
Fbc prior to each cycle
Normal fbc limits for administration apply
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Relapsed NSGCT
TIP
Paclitaxel
Ifosfamide
Cisplatin
Premedication
Chlorpheniramine
Dexamethasone
Ranitidine
10mg iv
20mg iv
50mg iv
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9.0
Temozolomide
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically
indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc weekly
if neutrophils < 1.5
or
Platelets < 100
Withhold Temozolomide until neuts > 1.5 and platelets > 100
If neutrophils < 0.5 or platelets < 10 stop Temozolomide
Criteria
Age 18 70
PS 0 1
Absence of HIV, chronic hepatitis B and hepatitis C
Adjuvant Temozolomide
Temozolomide 150mg/m2 oral days 1-5 cycle 1
200mg/m2 oral days 1-5 cycle 2-6 if nadir neutrophil count > 1.5 on cycle 1
Laboratory investigations
Issue Date:
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
If at any time neutrophil recovery is delayed by > 21 days treatment is discontinued
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9.0
Astrocytoma
First line
Lomustine (CCNU)
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent
cycles if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Second line
(1)
Temozolomide
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent
cycles if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
(1)
Etoposide
Laboratory Investigations
Issue Date:
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent
cycles if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
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(2)
Procarbazine
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent
cycles if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Procarbazine
60mg/m2 oral days 8-21
Lomustine (CCNU) 110mg/m2 oral day 1
Vincristine
1.4mg/m2 (max 2mg) iv day 8 and 29
Repeat on a 6 week schedule
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent
cycles if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Second line
Consider radiotherapy
Third line
Temozolomide 150mg/m2 oral daily for 5 days
Temozolomide
Issue Date:
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent
cycles if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
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9.0
Weeks 1, 5, 9
Vincristine
Methotrexate
Procarbazine
Weeks 3, 7
Vincristine
Methotrexate
Dexamethasone
16mg/day week 1
12mg / day week 2
8mg/day week 3
6mg/day week 4
4mg/day week 5
2mg/day week 6
Methotrexate level
< 0.1M
<0.5-5M
5-50M
>50M
Stop rescue
15-30mg 6hrly
200mg/m2 6hrly
1000mg/m2 6hrly
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer methotrexate only if clearance
is > 50mls/min
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
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Medulloblastoma (adult)
Relapse following surgery / XRT
First line
PCV
Procarbazine
CCNU
Vincristine
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent
cycles if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Second line
Temozolomide 150mg/m2 oral daily for 5 days
Temozolomide
Issue Date:
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent
cycles if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
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Carboplatin 5 x (GFR+25)
Carboplatin / Gemcitabine
Laboratory investigations
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if
clinically indicated
Calculate creatinine clearance prior to each cycle and administer cisplatin according to
guidelines
Where renal / hepatic function are abnormal treatment is at physician discretion
Fbc prior to each cycle
Normal fbc limits for administration apply
Lymphoma
Germ Cell Tumours
Small Cell Lung Cancer
Drugs Available
Cisplatin
Etoposide
Doxorubicin
Cyclophosphamide
Vincristine
Pegfilgrastim
These drugs will be stored in oncology pharmacy in the fridge in the dispensary area labelled Fridge 3. The fridge
will be labelled as containing Emergency Chemotherapy Drugs. Cisplatin will be stored at room temperature on top
of fridge 3.
Emergency chemotherapy should be prescribed by a consultant and entry to the pharmacy will be via the CCC bleep
holder only.
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Bone Metastases
There is increasing evidence from studies in a number of malignancies that intravenous bisphosphonate therapy can
ameliorate bone pain and reduce the risk of skeletal complications in patients with bone metastases. At present for
suitable patients the recommended treatment is zelodronate + Adcal D3 until progression.
Bisphosphonates
Zoledronic acid
4mg iv in 100mls Sodium chloride 0.9% over 15-30 minutes repeated at 28 day intervals.
Criteria: Performance status 0-2
Symptomatic / extensive bone metastases
Calcium supplements:
Renal impairment
Patients should have their serum calcium measured every four weeks and
Adcal D3 prescribed as necessary.
Cr clearance
(Cockcroft-Gault)
>60
50 - 60
40 - 49
30 39
< 30
Serum creatinine should be repeated every 4 weeks and if it rises significantly during treatment
zoledronic acid should be witheld until the creatinine has returned to within 10% of the baseline
prior to starting.
Cockcroft-Gault Creatinine Clearance Formula
Men
((140 age) x wt x1.23) / creatinine
Women
((140 age) x wt x1.04) / creatinine
NB
Ibandronate (Bondranat)
Bondranat has yet to be shown to be as effective as zoledronic acid in reducing the incidence of
skeletal events and thus we cannot recommend it as routine treatment. However for patients who
have difficulties with venous access or renal impairment it may be requested via the off protocol
mechanism.
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*Denosumab
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LEVEL
High Emetic Risk
(>90 % frequency of
emesis)
AGENT
Cisplatin 50mg/m
Cyclophosphamide > 1500mg/m
Dacarbazine
Procarbazine (oral)
Streptozocin
AC Combination defined as either doxorubicin or epirubicin with
cyclophosphamide
Doxorubicin >60mg/m2
Epirubicin >90ml/m2
Ifosfamide > 10g/m2
Bendamustine
Carboplatin
Cisplatin < 50mg/m
Cyclophosphamide 1500mg/m
Cyclophosphamide (oral)
Dactinomycin
Doxorubicin <60mg/m2
Epirubicin <90mg/m2
Etoposide (oral)
Ifosfamide <10g/m2
Interferon alpha <10million international
units/m2
Irinotecan
Lomustine
Melphalan >50mg/m
Methotrexate 250 mg/m
Oxaliplatin
Temozolomide (oral)
Vinorelbine (oral)
Cabazetaxel
Capecitabine
Docetaxel
Doxorubicin (Liposomal)
Eribulin
Etoposide (IV)
Evorolimus
Fludarabine (oral)
Fluorouracil
Gemcitabine
Alemtuzumab
Alpha Interferon
Bevacizumab
Bleomycin
Cetuximab
Chlorambucil (oral)
Erlotinib
Fludarabine
Gefitinib
Imatinib (oral)
Interferon alpha <5million
international units/m2
Ipilimumab
Lapatinib
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Emetic Risk
HIGH CISPLATIN REGIMENS
Aprepitant 125mg PO day 1, 80mg PO
daily days 2-3
+
Dexamethasone 12mg PO/IV day
1then 4mg BD PO days 2-4 (as TTH)
+
Ondansetron 24mg PO or 12mg IV
(maximum 32mg) day 1
+
Domperidone 10-20mg four times a
day as required
HIGH NOT CONTAINING
CISPLATIN
Dexamethasone 12mg IV/oral PO/IV
day 1 then 4mg BD PO days 2-4 (as
TTH)
+
Ondansetron 24mg PO or 12mg IVday
1, then 8mg twice a day PO days 2-4
(as TTH)
+
Domperidone 10-20mg four times a
day as required
MODERATE
Dexamethasone 8mg PO/IV day 1 then
4mg twice a day PO days 2-4 (as TTH)
+
Ondansetron 16mg PO or 8mg IV
(maximum 32mg/day) day 1
+
Domperidone 10-20mg four times a
day as required
Second Line
Antiemetic Failure
Ondansetron 8mg
+
dexamethasone 8mg
+
Lorazepam 1mg by
LOW
Dexamethasone 8 mg PO or IV
day 1
+
Domperidone 10-20mg four times a
day as required
MINIMAL
Routine prophylaxis not always
required.
Domperidone 10-20mg four times a
day as required
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ALTERNATIVES/BREAKTHROUGH
Cyclizine 50mg three times a day is often used for protracted nausea
Prochlorperazine 5-10mg oral three times a day
Prochlorperazine Suppositories 25mg three times a day
Metoclopramide 10-20mg four times a day
Levomepromazine 6mg at night (this can be increased to 12mg)
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GCSF
Primary Prophylaxis
Patients receiving FEC/Docetaxel adjuvant chemotherapy for breast cancer and VIDE for STS have a high risk of
neutropenic events and in line with ASCO guidelines we recommend primary prophylaxis with pegfilgrastim 6mg
24hrs post chemotherapy.
Secondary Prophylaxis
In other situations where the risk of neutropenic events is lower we do not routinely recommend primary
prophylaxis with GCSF and CCC policy is that secondary prophylaxis is reserved for the following situations:
(1) To maintain dose intensity in potentially curable malignancies where the dose limiting toxicity is neutropenia eg
-
Palliative Chemotherapy
Patients who are receiving palliative chemotherapy should be managed with appropriate dose reductions if problems
with neutropenia arise.
Prophylactic antibiotics
The use of prophylactic antibiotics following cyctotoxic chemotherapy can result in a small reduction in febrile
episodes but at the expense of side effects and the potential risk of inducing antibiotic resistance and increasing the
risk of clostridium difficile infection. The use of prophylactic antibiotics is not therefore recommended routinely but
should be reserved for patients thought to be at particularly high risk of infection. The current CCC protocol is:
Ciprofloxacin 500mg oral daily days 9 20 post chemotherapy
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Erythropoietin
Erythropoietin may be used to maintain haemoglobin levels during chemotherapy in patients where transfusion is
contra-indicated eg.
Religious grounds
Cardiac failure
In addition erythrpoietin may be considered in patients who have required two or more transfusions and who are due
to receive further chemotherapy.
Erythropoietin may also be used to maintain haemoglobin levels during combined modality therapy for cervical
cancer
Protocol
Hb > 12 no treatment required
Hb < 12 darbepoetin 150ug / sc weekly
If Hb rises to > 14 stop until Hb < 12 then restart at 100ug / week
If Hb rises by > 2g/dl / month reduce dose to 100ug / week
If Hb does not rise after 4 weeks treatment increase to 300ug / week
If no response after a further weeks then stop treatment.
Methotrexate is the only drug we use as intrathecal therapy at a flat dose of 12.5mg.
Cytosine, thiotepa and hydrocortisone may also be given intrathecally.
All other chemotherapy drugs are potentially lethal when administered intrathecally
In addition any diluent used to prepare an intrathecal drug must be aqueous based and not alcohol based.
Intrathecal chemotherapy must always be given under the direction of a consultant and administered by one of the
doctors on the CCC approved list.
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Creatinine Clearance
Women
((6580 (38.8 x age)) x bsa x 0.832) /creatinine
Men
((6580 (38.8 x age)) x bsa ) /creatinine
Weight in kg
Creatinine in umol/l
NB
Creatinine clearance
Cisplatin dose
100%
40 50 mls / min
75%
no further cisplatin
Patients should only commence cisplatin chemotherapy if they have an adequate performance status ie 0-2. The
only exception to this is patients with advanced germ cell tumours with poor PS who may commence treatment
with low dose etoposide / platinum.
Patients should only receive second and subsequent cycles of cisplatin if they are well and have suffered no
deterioration in performance status.
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IV over 1 hour
Post-hydration
IV over 1 hour
IV over 1 hour
IV over 1 hour
Prehydration
Post-hydration
Furosemide
Sodium Chloride 0.9% 1000mL (+ 20mmol Potassium
Chloride)
Monitor Urine Output
Cisplatin in 1000mL Sodium Chloride 0.9%
Sodium Chloride 0.9% 1000mL (+ 20mmol Potassium
Chloride )
PO 20mg
IV over 90 minutes
IV over 90 minutes
IV over 90 minutes
Prehydration
Post-hydration
Furosemide
Sodium Chloride 0.9% 1000mL (+ 20mmol Potassium
Chloride)
Monitor Urine Output
Cisplatin in 1000mL Sodium Chloride 0.9%
Sodium Chloride 0.9% 1000mL (+ 20mmol Potassium
Chloride)
Sodium Chloride 0.9% 1000mL
PO 20mg
IV over 2 hour
IV over 4 hours
IV over 4 hour
IV over 4 hour
n.b. Where Urine Output is of concern, please contact a clinician for advice.
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administer
administer
administer
(2)
Platelets <100x109/l
or
Total WBC < 2.9 x109/l
or
Neutrophils < 1.0x109/l
physician discretion
physician discretion
physician discretion
These guidelines assume that patients are well with good performance status, that other acute toxicities have
resolved and the patient has not had a previous episode of neutropenic sepsis.
In some situations chemotherapy is given despite lower blood count values than those noted above. These
include patients receiving adjuvant chemotherapy, those with curable metastatic malignancies such as germ cell
tumours and lymphomas and also patients with bone marrow infiltration. These situations will be dealt with on
a case by case basis.
Capecitabine
Renal function recommendations
Prior to starting treatment:
Cr cl > 50
full dose
Cr cl 30 49
75% dose
Cr cl <30
omit
During treatment if there was a rise in serum creatinine the Cr cl should be re-calculated and
further treatment adjusted according to the above
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> 60yrs
< 60
=0
=2
No
Yes
=3
=0
Hypotensive
Systolic <90
>90
=0
=5
Presence of COPD
Yes
No
=0
=4
None
Mild
Moderate
Severe
=5
=5
=3
=0
Yes
No
=0
=3
Score
17 + = low risk
<17 = high risk
Low risk:
Co-amoxiclav 625mg tds + ciprofloxaxin 750mg bd
or
Oral doxycycline 200mg bd + ciprofloxaxin 750mg bd
If penicillin allergy
or
Ceftazidime iv 1g bolus then 2g / 24 hours continuous infusion
If unable to take oral medication or already on antibiotics at home
or
Ceftazidime iv 1g bolus then 2g / 24 hours continuous infusion + vancomycin
If evidence of central line infection
High risk:
Gentamicin + piperacillin/tazobactam (Tazocin) 4.5g tds
Gentamicin + iv ciprofloxacin 400mg bd if penicillin allergy
Add vancomycin if central line infection suspected
Other pathogens
Anaerobic infection suspected: metronidazole 500mgtds
Atypical respiratory infection suspected: Clarithromycin 500mg bd
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Hypocalcaemia
Calcium gluconate 10% 10mls tds then orally if needed
Hypomagnesaemia
Patients who present with symptoms suggestive of hypomagnesaemia
Patients who have previously had hypomagnesaemia and who are due to have further platinum
chemotherapy.
Symptomatic patients with Mg <0.5 or <0.4 regardless of symptoms.
Consider urgent replacement if Mg <0.4 and cardiac history (IHD, AF, AVF).
If normal renal function: 40 mmol in 250 mls Sodium chloride 0.9% over 2 hours.
If suspected abnormal renal function (Cr >125umol/l) or already an inpatient: 40 mmol in 1L Sodium
chloride 0.9% over 8 hours.
Give 40 mmol and re-assess symptoms.
Re-check Mg if symptoms persist or if indicated for other reasons
Do not give more than 40 mmol in one day.
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Serum
Na, K, Ca, PO4, Cl, total CO2/HCO3, AP
Early morning urine
PO4 Creatinine, Osmolarity
GFR
> 60
40-59
< 40
Tp/Creat
>1.0
0.8-0.99
<0.8
HCO3
>17.0
14.0-16.9
>14.0
Action
Ifosfamide 100%
Ifosfamide 70%
Switch to cyclophosphamide 1500mg/m2
IV Day 1
24 HRS
48 hrs
72 hrs
96 hrs
120 hrs
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0.5 5M
5 50M
>50M
Stop rescue
15mg-30mg
200mg/m2
1000mg/m2
6 hourly
6 hourly
6 hourly
15mg-30mg
200mg/m2
1000mg/m2
6 hourly
6 hourly
6 hourly
15mg-30mg
200mg/m2
1000mg/m2
6 hourly
6 hourly
6 hourly
15mg-30mg
200mg/m2
1000mg/m2
6 hourly
6 hourly
6 hourly
Stop rescue
Stop rescue
Stop rescue
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1.3 -1.49
1.5- 1.69
1.7-1.89
>1.9
60mg
70mg
80mg
90mg
5FU Dose
800mg
900mg
1000mg
1100mg
1200mg
Methotrexate Dose
55mg
60mg
65mg
70mg
80mg
Cyclophosphamide Dose
50mg TDS14/7
50mg TDS 14/7
50mg TDS 14/7
50mg TDS 14/7
50mg TDS 14/7
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1.54 1.69
1.70 1.89
>1.90
Epirubicin 100mg/m2
DOSE (mg)
1.31 1.34
1.35 1.44
1.45 1.54
1.55 1.64
1.65 1.74
1.75 1.84
1.85 1.92
>1.93
130
140
150
160
170
180
190
200
Epirubicin and Doxorubicin doses > 80mg should be dose banded to the nearest 10mg dose
Epirubicin and Doxorubicin doses < 80mg should be rounded to nearest 2mg dose
5-Fluorouracil (500mg / 100ml Vial)
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Dose
3500mg
3750mg
4000mg
4250mg
4500mg
4750mg
2800mg/m2
BSA
1.45 1.47
1.48 1.56
1.57 1.65
1.66 1.72
1.73 1.86
1.87 2.00
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Dose
4000mg
4250mg
4500mg
4750mg
5000mg
5500mg
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Dose
1300mg
1400mg
1500mg
1600mg
1700mg
1800mg
1900mg
2000mg
BSA (m2)
1.40 1.49
1.50 1.69
1.70 1.89
1.90 2.00
1800mg
2000mg
2300mg
2500mg
1400mg
1600mg
1800mg
2000mg
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Dose
230mg
240mg
250mg
270mg
300mg
330mg
350mg
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BSA (m2 )
1.25 to 1.34
1.35 to 1.44
1.45 to 1.54
1.55 to 1.64
1.65 to 1.74
1.75 to 1.84
1.85 to 1.94
1.95
IV dose
25 mg/m2
Dose (mg)
30
30
35
40
40
45
45
50
Oral dose
60 mg/m2
Dose (mg)
80
80
90
100
100
110
110
120
IV dose
30 mg/m2
Dose (mg)
40
45
50
50
55
55
55
60
Oral dose
80 mg/m2
Dose (mg)
100
110
120
130
140
140
150
160
References
1.
2.
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Complete the relevant application form which can be found on the North West
Cancer Drugs Fund web site. The easiest way to find this is to type nw
cancer drugs fund into google and select the application forms button in the
header on the home page.
The form will be checked in pharmacy and sent to the network pharmacist
who will coordinate approval by the cdf. All request which fulfil the criteria
are approved automatically and the process usually takes about a week.
Please wait until the funding approval notification is received before arranging
the treatment appointment.
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