Lerner H J, Band P R, Israel L, Leung B S
Cancer Treat Rep. 1976 Oct;60(10):1431-5.
Tamoxifen (NSC-180973), a synthetic antiestrogen, was studied for efficacy and toxicity in patients with metastatic breast adenocarcinoma. Two dose levels were used, 10 mg bid and 15 mg/m2 bid, in separate groups. In the 10-mg bid dosage group, 30 of the 31 patients were considered evaluable for efficacy. Five complete and 11 partial responses were recorded, for an overall response rate of 53%. In the 15-mg/m2 bid dosage group, 44 of the 45 patients were considered evaluable for efficacy. Three complete and 16 partial responses were recorded, for an overall response rate of 43%. All 76 patients were evaluated for toxicity. Side effects were generally mild, consisting mostly of hot flushes, transient leukopenia, transient thrombocytopenia, nausea, and fluid retention. A high degree of correlation between response and positive estrogen-receptor assay suggests the value of the test as a means to select patients for tamoxifen treatment. The conclusion from this study is that tamoxifen used as a single agent is an effective drug with minimal toxicity for treatment of metastatic breast adenocarcinoma.
他莫昔芬（NSC - 180973），一种合成抗雌激素药物，在转移性乳腺腺癌患者中进行了疗效和毒性研究。分别对两个剂量组进行了研究，一组为每日两次，每次10毫克；另一组为每日两次，每次15毫克/平方米。在每日两次服用10毫克剂量组中，31例患者中有30例被认为可进行疗效评估。记录到5例完全缓解和11例部分缓解，总缓解率为53%。在每日两次服用15毫克/平方米剂量组中，45例患者中有44例被认为可进行疗效评估。记录到3例完全缓解和16例部分缓解，总缓解率为43%。对所有76例患者进行了毒性评估。副作用一般较轻，主要包括潮热、短暂性白细胞减少、短暂性血小板减少、恶心和液体潴留。反应与雌激素受体检测阳性之间高度相关，表明该检测作为选择他莫昔芬治疗患者的一种手段具有价值。本研究的结论是，他莫昔芬作为单一药物是治疗转移性乳腺腺癌的一种有效且毒性极小的药物。
