Randomized trials of heated perfusion of extremity melanoma

Abstract

Regional isolation perfusion has been performed at Tulane Medical Center for a variety of diseases and anatomic locations since 1957. These data were gathered from 897 patients with limb involvement of melanoma treated from 1957 to 1983. Melphalan (1-PAM) has been the drug used most commonly, alone in 69% of the patients and in combination with other drugs in 22%. No emphasis was placed on temperature until the mid-1960s, when temperatures were elevated to 40°C in the limb. Higher temperatures have been related to excessive toxicity; therefore, limb temperatures have been maintained at 39°C to 40°C. Only one death, which was secondary to pulmonary embolism, has occurred since 1967. Locoregional complications with infection, edema, nerve or muscle damage, thrombosis, and amputation have occurred, but have been infrequent since drug dose and temperature were standardized (e.g., only two amputations occurred in the last ten years, both as calculated risks in high-risk patients with vascular disease and extensive metastases). In 381 Stage I patients (primary melanoma), the ten-year survival rate has been 79%; in 39 Stage II patients (local metastases within 3 cm of the primary), 60%; in 333 Stage III patients (regional lymph node or soft tissue metastases, or both), 42%; and in 144 Stage IV patients (positive iliac or supraclavicular nodes, trunk primary with limb metastases, or limb primary with systemic metastases), 8% [1].