DOXORUBICIN-CONTAINING REGIMENS FOR THE TREATMENT OF STAGE-II BREAST-CANCER - THE NATIONAL SURGICAL ADJUVANT BREAST AND BOWEL PROJECT EXPERIENCE
DOXORUBICIN-CONTAINING REGIMENS FOR THE TREATMENT OF STAGE-II BREAST-CANCER - THE NATIONAL SURGICAL ADJUVANT BREAST AND BOWEL PROJECT EXPERIENCE
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DOI：
10.1200/jco.1989.7.5.572
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发表时间：
1989-05-01
影响因子：
45.3
通讯作者：
SUTHERLAND, CM
中科院分区：
文献类型：
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作者：
FISHER, B;REDMOND, C;SUTHERLAND, CM
尽管使用阿霉素（阿霉素[A]；阿德里亚实验室，哥伦布，俄亥俄州）对原发性乳腺癌和腋窝淋巴结阳性患者进行术后治疗后获得的研究结果有大量报告，但关于其在这种情况下使用的价值尚未达成明确的共识。 1981 年 6 月，国家乳腺和肠道辅助手术项目 (NSABP) 实施了两项随机临床试验，旨在评估阿霉素与美法仑 (L-PAM) 和氟尿嘧啶 (5-FU) (PF) 联合用药的价值。之前的一项 NSABP 研究确定了一些患者在与化疗一起使用时没有从他莫昔芬（TAM，T）中获益。该信息被用于本研究的设计。被认为对 TAM 有反应的女性 (1,106) 被随机分配到 PFT 和 PAFT 之间，而那些对 TAM 无反应的女性 (707) 被随机分配到 PF 和 PAF 之间。 6 年随访结果（研究的平均潜在时间分别为 64 个月和 63 个月）表明，接受 PAF 的无 TAM 反应患者的无病生存 (DFS) (P = .003) 和生存 (P = .05) 明显优于接受 PF 的患者。相比之下，PFT 和 PAFT 治疗的患者之间的 DFS (P = .6) 或生存率 (P = .7) 没有显着差异。所接受的药物量没有差异，无论是与中位量还是与剂量强度有关，都不能解释研究之间的结果差异。除了脱发和呕吐之外，含有阿霉素的方案的毒性与不含阿霉素的方案相似。心肌病并不是一个重要的发现；没有人因心脏毒性死亡。接受 TAM 的患者动脉和静脉并发症的发生率低于其他报道。
Despite numerous reports of findings obtained following the use of doxorubicin (Adriamycin [A]; Adria Laboratories, Columbus, OH) for the postoperative treatment of patients with primary breast cancer and positive axillary nodes, no clear consensus exists regarding its worth when used in that setting. In June 1981, the National Surgical Adjuvant Breast and Bowel Project (NSABP) implemented two randomized clinical trials aimed at evaluating the worth of doxorubicin when administered in conjunction with melphalan (L-PAM) and fluorouracil (5-FU) (PF). A prior NSABP study identified cohorts of patients who did not did not benefit from tamoxifen (TAM, T) when used with chemotherapy. That information was employed in the design of the present studies. Women considered responsive to TAM (1,106) were randomized between PFT and PAFT, and those nonresponsive to TAM (707) were randomized between PF and PAF. Findings through 6 years of follow-up (mean duration of potential time on study, 64 months and 63 months, respectively)indicate that non-TAM-responsive patients who received PAF had a significantly better disease-free survival (DFS) (P = .003) and survival (P = .05) than did those receiving PF. By contrast, there was no significant difference in DFS (P = .6) or survival (P = .7) between PFT- and PAFT-treated patients. No disparity in the amount of drug received, whether related to the median amount or to dose-intensity, is present to account for the difference in findings between the studies. Aside from alopecia and emesis, the toxicity from the doxorubicin-containing regimens was similar to those in which doxorubucin was omitted. Cardiomyopathy was not a significant finding; there were no deaths from cardiac toxicity. The incidence of arterial and venous complications in patients receiving TAM was less than reported by others.