Doxorubicin and CCNU with or without vincristine in patients with advanced refractory breast cancer a randomized trial

Thirty‐five patients with advanced breast cancer refractory to initial chemotherapy were randomized to receive two‐drug doxorubicin‐CCNU or three‐drug doxorubicin‐CCNU‐vincristine (VCR) treatment. Doxorubicin (25–40 mg/m2) and VCR (1.4 mg/m2) were given intravenously every 21 days; CCNU (65–90 mg/m2) was given orally every 42 days. Patients with liver or bone marrow metastases initially received the lower range doses. All patients failed prior chemotherapy with cyclophosphamide and 5‐FU with or without methotrexate and prednisone; 67% received prior hormonal therapy. Pre‐treatment patient characteristics were comparable in both groups. Objective responses (greater than 50% reduction in tumor size) were seen in 7 of 18 patients (39%) on the VCR containing arm and in 8 of 17 patients (46%) on the doxorubicin‐CCNU arm, Survival was not improved by VCR addition with overall survival on the doxorubicin‐CCNU arm, approximately 10% greater at all intervals (median 9.1 versus 7.0 months; not statistically significant). However, neurotoxicity was significantly greater in the VCR arm (36% versus 0%; P < 0.05). In advanced breast cancer, no benefit to VCR addition was seen in prior randomized studies of first‐line combinations where VCR was the treatment variable. Such results, combined with our experience with VCR in a salvage regimen, question the value of VCR addition to combination regimens in advanced breast cancer.

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