Percutaneous Radiofrequency Ablation of Painful

Osseous Metastases: A Multi-center American

College of Radiology Imaging Network Trial
RFS Journal Primer

Quick Summary
BOTTOM LINE

This cooperative group trial strongly suggests that RFA can safely palliate pain from bone
metastases.

MAJOR POINTS

RFA had a statistically significant effect in reducing pain at both 1-month and 3-month follow-up for
all four pain assessment measures (pain relief, patient mood, pain intensity and pain severity).

Tumor size had a statistically significant effect on pain severity.

Previous radiotherapy to the site did not statistically correlate with reduction in pain intensity, mood
improvement and increase in pain relief.

CRITICISM

Of the 55 patients who completed RFA, 13 (23.6%) did not have 1-month follow up and 23 (41.8%)
did not have 3-month follow-up.
This study had high" attrition rates which significantly affects the external validity of this study. However,
the clinical improvement with inferential data is robust enough to recommend this option as a palliative
measure for patients who have exhausted contemporary measures of pain management.

Follow-up measurement did not exceed 3 months.

Study design
SINGLE-ARM PROSPECTIVE TRIAL/ NCI-SPONSORED CLINICAL TRIALS
COOPERATIVE PHASE II GROUP STUDY

55 patients completed RFA

1-month and 3-month follow-up

INCLUSION CRITERIA

Pathologically-confirmed malignant disease

Bone lesion with clinical and imaging features of metastatic disease

Pain must be from a solitary site of metastatic disease to the bone

Intractable pain above 50 on a 1-100 scale resulting in a return visit to the

oncologist

EXCLUSION CRITERIA

Patients with primary musculoskeletal malignancies, lymphoma and leukemia

Tumor involves a weight-bearing long bone of lower extremity

Tumor size >8cm

Previous radiation within 30 days or chemotherapy within 14 days

Purpose

The purpose of this study is to determine if radiofrequency ablation can safely and effectively
reduce pain from osseous metastatic lesions. Patients often have persistent unremitting pain
despite radiation and chemotherapy.

62F with T4 NSCLC with persistent pain s/p

chemotherapy and radiotherapy. CT image shows
large lung mass involving T4 vertebral body.

Intervention

RFA was performed using Radionics CC-1 (Valley Lab, Boulder, CO) generator and single 17-gauge or cluster Cool-tip
electrode. CT was used to localize the metastasis. A 14-gauge coaxial bone biopsy needle was placed into the lesion if
cortical bone was intact. After the core was removed, the RF electrode was placed through the outer cannula into the
lesion. If bone cortex was destroyed by the tumor, the RF electrode was placed directly into the metastasis.

Tumors >4 cm were treated with a cluster RF electrode (three 17-gauge needles spaced 5mm apart). Tumors <4 cm
were treated with single electrodes with 1-, 2-, or 3-cm active tips. The initial ablation was performed for a maximum
of 4 minutes using a current of 1100-2000mA (maximum current given impedence of system).

A target intratumoral temperature greater than 60 C was required to ensure adequate thermocoagulation. If the
temperature exceeded 60 C, the electrode was withdrawn in 1-cm increments up to the length of the active tip while
measuring the intratumoral temperature. If the intratumoral temperature dropped below 60 C, then another 4-minute
treatment was performed at the new position. This could be repeated at any given electrode position for a maximum
of 12 minutes (3 treatments).

Once the entire longitudinal dimension of the tumor was treated with a series of overlapping treatments, then the RF
electrode shaft was repositioned 1.5-2 cm away from the longitudinal axis of the prior treatment series. This was
repeated until the cylinder-shaped treatment regions encompassed the entire volume of the mass. Vital signs were
monitored for a minimum of 2 hours post-RFA.

RFA of bone-tumor interface was

performed under CT-guided fluoroscopy

Outcome
Average increase in pain relief:

Average decrease in pain intensity:

Pre-RFA to 1-month follow-up: 26.27% (95% CI, 17.65

to 34.89, P<0.0001)

Pre-RFA to 3-month follow-up: 16.38% (95% CI, 3.37

to 29.39, P=0.02)

Average increase in mood:

Pre-RFA to 1-month follow-up: 19.89% (95% CI, 11.85

to 27.93, P<0.0001)

Pre-RFA to 3-month follow-up: 14.93% (95% CI, 5.03

to 24.83, P=0.005)

Pain scores
by timepoint

Mood scores
by timepoint

Pre-RFA to 1-month follow-up: 26.92% (95% CI, 17.67 to

36.17, P<0.0001)
Pre-RFA to 3-month follow-up: 14.16% (95% CI, 2.93 to 25.39,
P=0.02)

Odds of being in lower pain severity:

At 1-month follow-up: 14.03 times higher than at pre-RFA

(95% CI, 2.33-25.73, P<0.0001)
At 3-month follow-up: 8.00 times higher than at pre-RFA
A(95% CI, 0.85 to 15.15, P<0.01)

Relief scores
by timepoint

Pain description
scores by timepoint

Credits
SUMMARY BY:
David Maldow, MD, PGY-1

FULL CITATION:

Dupuy DE, Liu D, Hartfeil D, Hanna L, Blume J, Ahrar K, Lopez R, Safran H and DiPetrillo T. Percutaneous
Radiofrequency Ablation of Painful Osseous Metastases: A Multi-center American College of Radiology Imaging
Network Trial. Cancer. 2010;116(4): 989-997.

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