title: Chemotherapy versus combination of chemotherapy and endocrine therapy in advanced breast cancer. A prospective randomized study.
abstract: One hundred-forty-five postmenopausal women with metastatic breast cancer entered a prospective randomized trial comparing treatment A (cyclophosphamide, methotrexate, and 5-fluorouracil; CMF) with treatment B (the same chemotherapy plus tamoxifen; CMF plus T). Patients on treatment A had T added to CMF at the time of progression or relapse (second-line CMF plus T). One hundred thirty-three cases were evaluable. Considering response rate to first-line treatment, CMF plus T appeared to be significantly superior to CMF alone (74 versus 51%, respectively; P less than 0.01). Median time to failure to first-line treatments, considering all patients, was longer in CMF plus T than in CMF arm (48 and 24 weeks, respectively; P = 0.06). Considering patients showing objective remission, median duration of response to CMF was similar to that of CMF plus T (47 and 51 weeks, respectively). Twelve of 39 evaluable women treated with second-line CMF plus T showed objective responses (31%). Median time to failure to treatment procedures scheduled in arm A (CMF leads to CMF + T) was longer than that to treatment in arm B (CMF plus T) (56 and 48 weeks, respectively; P = 0.08). Median survival was longer in patients randomized to treatment A (111 weeks) than in patients randomized to treatment B (78 weeks), but this difference was not statistically significant (P = 0.25). It can be concluded from this study that a combination of endocrine therapy and chemotherapy is significantly more active than chemotherapy alone in inducing an objective remission. This strategy of treatment is advisable in situations urgently requiring a clinical response. However, as a sequence of chemical and endocrine therapy induced a longer time to development of progressive disease and a better survival, sequential therapy is advisable for common clinical use.
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols; D001943:Breast Neoplasms / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D003520:Cyclophosphamide / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008727:Methotrexate / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011379:Prognosis; D011446:Prospective Studies; D011897:Random Allocation; D013629:Tamoxifen / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D013629:Tamoxifen; D003520:Cyclophosphamide; D005472:Fluorouracil; D008727:Methotrexate