Chemotherapy with or without tamoxifen in postmenopausal patients with late breast cancer. A randomized study

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 less than 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).

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.