A comparison of intermittent vs. continuous and of adriamycin vs. methotrexate 5-drug chemotherapy for advanced breast cancer A Cancer and Leukemia Group B study

Abstract
The therapeutic effectiveness of intermittent vs. continuous combination chemotherapy and of the substitution of adriamycin (A) for methotrexate (M) in a 5-drug regimen was evaluated in women with metastatic breast carcinoma. Patients were randomly allocated to receive continuous therapy with cyclophosphamide, M, 5-fluorouracil, vincristine, prednisone (CMFVP-C, 86 patients); intermittent CMFVP (CMFVP-I, 109 patients); or intermittent CAFVP (107 patients). The CR [complete response] + PR [partial response] rate with CAFVP (71%) was superior to CMFVP-C (50%, P = 0.003) and to CMFVP-I (50%, P = 0.002). The remission duration with CAFVP (14 mo., median) was superior to CMFVP-I (7 mo.) (P < 0.01), and tended to be superior to CMFVP-C (9 mo.) (P = 0.07). There was a survival advantage of CAFVP (19 mo., median) over CMFVP-I (13 mo.) (P = 0.01), but not over CMFVP-C (16 mo.) (P = 0.24). Among CR + PR patients, the survival with CAFVP (29 mo., median) was superior (P = 0.02) to CMFVP-I (18 mo.) and CMFVP-C (21 mo.). The CMFVP-C regimen was associated with the highest incidence of leukopenia and neurologic toxicity, but the lowest incidence of GI [gastrointestinal] toxicity Apparently, the CAFVP regimen is well tolerated and is superior to the CMFVP regimens.