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Eva M. Noorda, MD, PhD; Bart C. Vrouenraets, MD, PhD; Omgo E. Nieweg, MD, PhD; Bert N. van Geel, MD, PhD; Alexander M. M. Eggermont, MD, PhD; Bin B. R. Kroon, MD, PhD

Arch Surg. 2004;139:1237-1242.

Hypothesis  In patients with truly unresectable melanoma of the extremities, results after isolated limb perfusion (ILP) are absent in the literature. Complete response rates are probably lower than the reported 54% for locoregional recurrent melanoma. In these patients, ILP with melphalan and tumor necrosis factor (TNF-) could be superior to ILP with melphalan alone.

Design  Retrospective analysis with a median follow-up period of 21 months (interquartile range, 9-40 months).

Setting  Two tertiary care cancer centers in the Netherlands.

Patients  We assessed all 130 consecutive patients who underwent ILP for unresectable melanoma of the extremities, performed between 1978 and 2001. Of these patients, 38% had stage IIIA melanoma and 45% had stage IIIAB melanoma according to criteria of the MD Anderson Cancer Center. Lesions were considered unresectable on the basis of their size, number, or localization.

Interventions  Forty ILPs were performed with melphalan, and 90 were done with TNF- and melphalan.

Main Outcome Measures  Response rate, disease-free survival, limb salvage rate, and overall survival.

Results  In 45% of the patients, a complete response was attained after ILP with melphalan (95% confidence interval, 29%-61%) compared with 59% after ILP with TNF- and melphalan (95% confidence interval, 49%-69%; P = .14). The time to complete response was 3 months (interquartile range, 2-6 months) vs 2 months (interquartile range, 1-3 months; P = .01), respectively. The recurrence rate and median limb recurrence–free survival were not significantly different for both ILP types. The overall limb salvage rate was 96%. Overall 5-year survival was 29% (95% confidence interval, 20%-38%). The ILP type was not an independent prognostic factor for complete response, nor was limb recurrence–free survival, whereas stage IIIA was a favorable prognostic factor (P = .01 and P = .02, respectively). Favorable prognostic factors for improved survival were complete response (P<.001) and a tumor size of 3 cm or less (P = .01).

Conclusions  In more than half of the patients with truly unresectable melanoma of the extremities, a complete response was obtained after ILP with melphalan with or without TNF-. The ILP type was not an independent prognostic factor for complete response, limb recurrence–free survival, or overall survival.

Author Affiliations: Department of Surgery, the Netherlands Cancer Institute and Antoni van Leeuwenhoek Hospital, Amsterdam (Drs Noorda, Vrouenraets, Nieweg, and Kroon); and Department of Surgery, Erasmus Medical Center–Daniel den Hoed Cancer Center, Rotterdam (Drs van Geel and Eggermont), the Netherlands.

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