Perry M C, Kardinal C G, Weinberg V, Ginsberg S J, Hughes A, Wood W
J Steroid Biochem. 1985 Dec;23(6B):1135-40. doi: 10.1016/0022-4731(85)90032-9.
Between February 1980 and August 1982, the Cancer and Leukemia Group B (CALGB) performed a randomized study aimed to compare chemotherapy with CAF (Cyclophosphamide, Adriamycin, 5-Fluorouracil) versus the same chemotherapeutic regimen plus tamoxifen (T-CAF) in stage IV breast cancer patients. Patients were stratified on the basis of menopausal status, estrogen receptors (ER) status, dominant site of metastasis and prior adjuvant treatment. Overall 474 patients were entered into the study of whom 433 were assessable for response. 314 patients were postmenopausal, 85 premenopausal and 34 patients were unknown as far menopausal status was concerned. No difference was evident among postmenopausal patients in overall response rate and duration of responses between T-CAF and CAF (52% vs 50% respectively). Similarly no difference was shown among premenopausal patients, response rates being 63% with T-CAF and 60% with CAF. Lack of benefit from adding T to chemotherapy was seen also according to the different strata, including patients with ER positive tumors. The failure for this combination to be synergistic might reflect an effect of T on tumor kinetics interfering with the activity of chemotherapy.
1980年2月至1982年8月期间，癌症与白血病B组（CALGB）开展了一项随机研究，旨在比较IV期乳腺癌患者接受环磷酰胺、阿霉素、5-氟尿嘧啶（CAF）化疗方案与相同化疗方案加他莫昔芬（T-CAF）的疗效。患者根据绝经状态、雌激素受体（ER）状态、主要转移部位及既往辅助治疗情况进行分层。共有474例患者进入该研究，其中433例可评估疗效。就绝经状态而言，314例患者为绝经后，85例为绝经前，34例患者情况不明。在绝经后患者中，T-CAF组与CAF组的总缓解率及缓解持续时间无明显差异（分别为52%和50%）。同样，在绝经前患者中也未显示出差异，T-CAF组缓解率为63%，CAF组为60%。根据不同分层，包括ER阳性肿瘤患者，在化疗中加用T均未显示出益处。这种联合用药缺乏协同作用可能反映了T对肿瘤动力学的影响，干扰了化疗活性。
