STRATEGY OF THE EORTC-MCG TRIAL PROGRAM FOR ADJUVANT TREATMENT OF MODERATE-RISK AND HIGH-RISK MELANOMA

Trials in high-risk melanoma patients evaluating the role of postopera tive adjuvant treatment with interferons or other cytokines, gangliosi de-based vaccines, or vaccines based on melanoma cells are ongoing or planned internationally. In Europe, the two largest randomised trials are carried out by the European Organization for Research and Treatmen t of Cancer-Melanoma Cooperative Group (EORTC-MCG). In stage IIA patie nts (T3N0M0) with a moderate risk of micrometastatic disease (35-40%), Trial 18961 compares observation with ganglioside GM2 vaccination. Th is trial will be activated during the spring of 1998 and is expected t o enrol 1000 patients. In stage IIB-IIIB (T4N0M0-TxN1-2M0) patients wi th a high risk of micrometastatic disease (approximately 80%), trial 1 8952 compares observation with adjuvant therapy using two intermediate dosage regimens of interferon alfa-2b (IFN-alpha 2b). These trials an d the philosophy of the EORTC-MCG programme allow more toxic treatment regimens to be investigated in patients with high-risk disease and on ly treatments with minimal toxicity to be evaluated in patients with m oderate- to low-risk disease. Recently completed and other ongoing tri als also are discussed. Overall, if clinical efficacy is demonstrated, the toxicity, impact on quality of life and treatment costs determine the acceptance and applicability of a treatment. (C) 1998 Published b y Elsevier Science Ltd. All rights reserved.