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Role of Tumor Response

Thomas A. Aloia, MD; Elizabeth Grubbs, MD; Mark Onaitis, MD; Paul J. Mosca, MD, PhD; Tsung-Yen Cheng, MD; Hilliard Seigler, MD; Douglas S. Tyler, MD

Arch Surg. 2005;140:1115-1120.

Hypothesis  Analysis of multiple clinical and pathological factors in patients undergoing therapeutic hyperthermic isolated limb perfusion for extremity melanoma can identify variables with prognostic significance.

Design  Retrospective review of a prospectively collected limb perfusion database with a median follow-up interval of 32.2 months.

Setting  Single-institution tertiary care surgical oncology unit.

Patients  We report a series of 59 consecutive therapeutic hyperthermic isolated limb perfusion treatments (14 upper extremity and 45 lower extremity) in 54 patients with melanoma from January 1, 1995, through December 31, 2002, using a standard melphalan dosing protocol. At the time of perfusion, 31 cases had fewer than 10 lesions, with none greater than 3 cm in diameter. The remaining 28 cases had 10 or more lesions or at least 1 lesion greater than 3 cm in diameter.

Main Outcome Measures  Response, recurrence, and survival were assessed in relation to multiple demographic, clinical, and technical variables using ², log-rank, and Kaplan-Meier survival analyses.

Results  The 3-year survival for the entire cohort was 54%. Thirty-three (56%) of the 59 perfusion treatments resulted in a persistent complete response of at least 6 months’ duration. Statistical analysis showed that patients with no evidence of regional nodal involvement had a significantly lower incidence of distant recurrence (P = .02). Those patients achieving a complete response to therapy had a survival advantage (P = .03).

Conclusion  In patients undergoing therapeutic hyperthermic isolated limb perfusion for in-transit melanoma, the ability to achieve a complete response following treatment, independent of regional nodal status, was the strongest predictor of long-term survival.

Author Affiliations: Division of Surgical Oncology, Department of Surgery, Duke University Medical Center, Durham, NC.

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