Phase III adjuvant studies in operable malignant melanoma (review).

Adjuvant treatments following surgery include nonsurgical and surgical approaches which should be compared to a randomized control. Between the years 1978 and 1986, we identified 21 randomized trials on stage I primary melanoma, using 2,850 patients. None of the systemic chemotherapy, immunotherapy or chemo-immunotherapy protocols improved the results. However, prophylactic isolation perfusion of the limbs with cytostatics represents a promising approach and is currently studied in our international prospective randomized trial (EORTC, WHO, NAPG-NCI) In stage II--regional metastases--15 studies including 1972 patients have been reported. None of the systemic regimen was found efficient. The reasons for these failures are discussed and future approaches are presented.

RCT Entities:   Population Interventions Outcomes