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A Phase 2 Evaluation of 1-(2-Chloroethyl)-3-(4- methylcyclohexyl)-1-nitrosourea (NSC 95441) in Patients with Advanced Breast Cancer¹

Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55901

A program utilizing 1-(2-chloroethyl)-3-(4-methylcyclohexyl)-1-nitrosourea (methyl-CCNU) (NSC 95441) at a dosage of 225 mg/sq m p.o. on Day 1 was contrasted with a combination program utilizing 5-fluorouracil, cyclophosphamide, and prednisone with or without vincristine in 43 patients with disseminated breast cancer. Prior to randomization patients were stratified according to dominant disease, free interval, and menstrual category. If the initial treatment failed, a cross-over assignment to the alternate treatment program was made. One of 22 patients responded to methyl-CCNU as primary therapy, contrasting with 7 of 11 responding to the combination program without vincristine and 5 of 10 to the combination program with vincristine. On cross-over, thus far, none have responded to methyl-CCNU but one-third have responded to the combination program. Toxic effects included gastrointestinal upset in 10 of 30 patients who took methyl-CCNU and in 28 of 38 who received the combination programs. Myelosuppression (leukocyte count less than 3000/cu mm of blood) occurred in 13 of 30 patients given methyl-CCNU and in 29 of 38 patients given the combination programs. Platelets were suppressed in 8 of 30 patients by methyl-CCNU and in 10 of 38 patients by the multiple-drug programs. Neurological complications were limited to the group treated with vincristine, in which 17 of 20 patients had peripheral neuropathies. Alopecia was confined to the multiple-treatment group of patients.

¹ This investigation was supported in part by Research Contract 71-2185 from the NIH, USPHS.

Received 6/29/73. Accepted 10/ 1/73.