RFA of Osseous Mets

Percutaneous Radiofrequency Abla5on of Painful Osseous Metastases: A Mul5-‐center American College of Radiology Imaging Network Trial

RFS Journal Primer

BOTTOM LINE •  This cooperative group trial strongly suggests that RFA can safely palliate pain from bone

metastases. MAJOR POINTS •  RFA had a statistically signi>icant 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 signi>icant 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.

ü  This study had ”high" attrition rates which signi>icantly 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.

Quick Summary

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-‐con>irmed 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

Study design

•  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.

Purpose

62F with T4 NSCLC with persistent pain s/p chemotherapy and radiotherapy. CT image shows large lung mass involving T4 vertebral body.

•  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.

Interven7on

RFA of bone-‐tumor interface was performed under CT-‐guided >luoroscopy

Outcome

Average increase in pain relief: •  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)

Average decrease in pain intensity: •  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)

Pain scores by timepoint

Mood scores by timepoint

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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RFA of Osseous Mets