Chemoimmunotherapy (CI) of disseminated malignant melanoma (DM) with imidazole carboxamide (DTIC), a nitrosourea (MeCCNU) and BCG

BCG immunotherapy added to DTIC chemotherapy (BD) prolonged remission and survival compared to DTIC alone or with other drugs. The results of CI with DTIC, MeCCNU and BCG (DMB) are reported. MeCCNU was added since as a single agent, it induces an overall response rate of 17% in DM. Seventy three patients (pts) received DTIC 250 mg/m² IV daily on days 1-5, MeCCNU 100 mg/m² PO on day 1 and Tice BCG, 6 x 10⁸ viable units by scarification on day 7, 12 and 17. Courses were repeated every 21 to 28 days. Among 64 pts with an adequate trial of DMB the overall response, complete remission (CR) partial remission (PR), stable (for >2 mth) and progression rates were 26, 14, 12, 40 and 34%, respectively compared to the BD regimen for which these rates were 27, 6, 21, 32 and 41%. The mean durations of remission (CR plus PR), stable disease, and survival for DMB were 6, 5 and 7 mth and for BD were 6, 4, and 7 mth. An additional 6 pts who had only brain metastases received Xray therapy followed by DMB. All are disease free at a median of 12⁺ mth. This was superior to the survival of an appropriate control group. The efficacy of BCG in DM is confirmed. The addition of MeCCNU has increased the CR rate and the percent of pts with stable DM. Continued low response rates particularly with visceral DM indicates the need for improved chemotherapy and delivery of immunotherapy to visceral sites.