title: Doxorubicin and CCNU with or without vincristine in patients with advanced refractory breast cancer. A randomized trial.
abstract: 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. Pretreatment 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 less than 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.
mesh_terms: D001943:Breast Neoplasms / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D004317:Doxorubicin / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008130:Lomustine / Q000008:administration & dosage*; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009607:Nitrosourea Compounds / Q000008:administration & dosage*; D011897:Random Allocation; D013921:Thrombocytopenia / Q000139:chemically induced; D014750:Vincristine / Q000008:administration & dosage*
chemical_list: D009607:Nitrosourea Compounds; D014750:Vincristine; D008130:Lomustine; D004317:Doxorubicin