Fisher B, Redmond C, Legault-Poisson S, Dimitrov N V, Brown A M, Wickerham D L, Wolmark N, Margolese R G, Bowman D, Glass A G
National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA 15261.
J Clin Oncol. 1990 Jun;8(6):1005-18. doi: 10.1200/JCO.1990.8.6.1005.
The National Surgical Adjuvant Breast and Bowel Project (NSABP) conducted a randomized clinical trial to determine whether tamoxifen (TAM) plus chemotherapy is more effective than TAM alone in improving disease-free survival (DFS), distant disease-free survival (DDFS), and survival (S) of positive-node, TAM-responsive patients aged greater than or equal to 50 years. Women were randomized among three treatment groups: (1) TAM alone, (2) Adriamycin (doxorubicin; Adria Laboratories, Columbus, OH), cyclophosphamide, and TAM (ACT), or (3) melphalan (L-PAM), fluorouracil (5-FU), and TAM (PFT). The PFT arm was later modified so that new patients also received Adriamycin (PAFT). Findings from 1,124 eligible patients through 3 years of follow-up indicated a significantly better DFS for ACT-treated patients than for those receiving TAM alone (84% v 67%; P = .0004). An advantage in DDFS and S was also observed after ACT therapy (83% v 73% [P = .04 in the former] and 93% v 85% [P = .04 in the latter]). Both the DFS and DDFS of PAFT-treated patients were better than in those treated by TAM alone (83% v 66%, P = .0002 and 85% v 73%, P = .003). PFT patients also fared better in DFS and DDFS than TAM patients (81% v 72%, P = .07 and 85% v 74%, P = .02). Odds ratios consistently favored the three TAM-plus-chemotherapy groups. No significant S advantage is as yet evident in favor of the PAFT or PFT groups. Of importance is the failure of these studies to demonstrate an unfavorable interaction between the drug regimens used and the TAM, which was administered simultaneously. The findings related to the use of PAFT and PFT are of more biologic than clinical significance since L-PAM is rarely used in the treatment of breast cancer. The major conclusion from this study is the observance of a better outcome in positive-node breast cancer patients aged greater than or equal to 50 years from the use of postoperative prolonged TAM and short-course AC therapy (completed in 63 days) than from prolonged TAM therapy alone.
国家乳腺与肠道外科辅助治疗项目（NSABP）开展了一项随机临床试验，以确定他莫昔芬（TAM）联合化疗在改善年龄大于或等于50岁、淋巴结阳性且对TAM有反应的患者的无病生存期（DFS）、远处无病生存期（DDFS）和总生存期（S）方面是否比单独使用TAM更有效。女性被随机分为三个治疗组：（1）单独使用TAM；（2）阿霉素（多柔比星；阿德里亚实验室，俄亥俄州哥伦布市）、环磷酰胺和TAM（ACT）；或（3）美法仑（L-PAM）、氟尿嘧啶（5-FU）和TAM（PFT）。PFT组后来进行了修改，新患者也接受阿霉素（PAFT）。对1124例符合条件的患者进行3年随访的结果表明，ACT治疗的患者的DFS显著优于单独接受TAM治疗的患者（84%对67%；P = 0.0004）。ACT治疗后在DDFS和S方面也观察到优势（83%对73%[前者P = 0.04]和93%对85%[后者P = 0.04]）。PAFT治疗的患者的DFS和DDFS均优于单独接受TAM治疗的患者（83%对66%，P = 0.0002和85%对73%，P = 0.003）。PFT组患者在DFS和DDFS方面也比TAM组患者表现更好（81%对72%，P = 0.07和85%对74%，P = 0.02）。优势比一直有利于三个TAM加化疗组。目前尚未明显看出PAFT或PFT组在S方面有显著优势。重要的是，这些研究未能证明所使用的药物方案与同时给予的TAM之间存在不利的相互作用。与使用PAFT和PFT相关的研究结果更多地具有生物学意义而非临床意义，因为L-PAM很少用于乳腺癌的治疗。这项研究的主要结论是，年龄大于或等于50岁的淋巴结阳性乳腺癌患者，术后长期使用TAM和短期AC疗法（63天内完成）比单独长期使用TAM疗法的效果更好。
