Adjuvant chemotherapy in high-risk malignant melanoma

Fifty-nine patients with regional or hematogenous recurrence of malignant melanoma following resection of all the gross tumor were randomized to observation or chemotherapy. The chemotherapy consisted of BCNU 80 mg/M2 I.V. every 4 weeks, actinomycin-D 0.01 mg/kg and vincristine 1.0 mg/M2 I.V. every 2 weeks, for a total of 6 months. The chemotherapy protocol was tolerated well without appreciable objective side effects. At a median follow-up period of 11.5 months, the disease-free survival time for the chemotherapy treated group is significantly longer than for the control group (P = 0.01). The estimated median disease-free survival time is 4 months in the surgical control group and 9 months in the chemotherapy group. At present, the proportion of patients remaining disease-free is 43% for the surgical control and 55% for the chemotherapy treated group. More patients and follow-up are needed, but this preliminary report suggests that nitrosourea-based protocols need to be evaluated further as adjuvant treatment of malignant melanoma.