BCNU, hydroxyurea, a n d imidazole carboxamide (DTIC) were administered to 89 patients with disseminated malignant melanoma. A response rate of 27% was observed. The addition of vincristine in another 89 patients did not significantly improve the response rate (30%). This includes patients who died during or after one course of therapy (<28 days). If the early deaths are not considered, the over-all response rate was 38%. The best responses occurred in patients with skin, lung, and/or lymph node involvement. Liver and brain involvement heralded poor responses. This response rate appeared to be independent of age, sex, or previous therapy. Moderate and severe toxicity, predominantly nausea and vomiting, was noted in most patients. The median survival for all evaluable patients was 17 months, and was independent of the regimen used.
Cancer 35:342-346, 1975. HE RESPONSE RATE OF DISSEMINATED MA-T lignant melanoma to single agent chemotherapy has been discouragingly low. Studies utilizing single alkylating agents have included response rates ranging from 9-15%;10 hydroxyurea (NSC 32065) has produced a 21y0 response rate,' J' v*O although these responses are short lived.10 Clinical trials with 5 (3,3dimethyl-l-triazeno) imidazole 4-carboxamide (NSC 45388, DTIC) have produced a response rate of 20-2570.6J2.13 T h e response rate for l,%bis (2-chloroethy1)-1-nitrosourea (NSC 409962, BCNU) is reported to be 16%,2 and for vincristine (NSC 67574), 10%.
T h e data on vincristine are fragmentary and the number of patients is small. BCNU plus vincristine has produced a 17y0 response rate.s Some combination chemotherapeutic programs have been more promising. Cyclophosphamide, vincristine, methotrexate,~~~ and BCNU, vincristine, It is the purpose of this paper to report the response of patients with disseminated malignant melanoma, randomly allocated to one of two combination chemotherapeutic programs: BCNU, hydroxyurea, and DTIC (BHD), vs. BCNU, hydroxyurea, DTIC, and vincristine