Eighty-one patients with advanced measurable breast cancer were randomized to receive only chemotherapy (Group C) or the same chemotherapy + tamoxifen (Group CH). The chemotherapeutic regimen was based on the cyclic administration of two noncross-resistant cytotoxic combinations: CMFV (cyclophosphamide 300 mg/m2 i.v., days 1 and 5; methotrexate, 20 mg/m2 i.v., days 1 and 4; 5-fluorouracil 325 mg/m2 i.v., days 1-5; vincristine 0.75 mg/m2 i.v., days 2 and 5) and AC (adriamycin 40 mg/m2 i.v., day 1; cyclophosphamide 200 mg/m2 i.v., days 3-5) every 4-5 weeks. Tamoxifen (10 mg) was given twice daily continuously. The treatment results were as follows in Groups C and CH, respectively: PD 19.4 and 6.3%, SD 38.9 and 18.7%, PR 27.8 and 56.2% and CR 13.9 and 18.7%. The difference in response (CR + PR) rate observed between the two treatment groups was highly significant (P <0.025). Median time to progression was 10.6 months in Group C and 17.2 months in Group CH (NS). Median duration of survival was 20 and 34 months, respectively (NS). In conclusion: the addition of tamoxifen to chemotherapy significantly improved the results in terms of response rate and duration of responses. A significant benefit to short-term survival was also evident.
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