Postchemotherapy adjuvant tamoxifen therapy beyond five years in patients with lymph node-positive breast cancer. Eastern Cooperative Oncology Group.
Postchemotherapy adjuvant tamoxifen therapy beyond five years in patients with lymph node-positive breast cancer. Eastern Cooperative Oncology Group.
复制标题
DOI：
10.1093/jnci/88.24.1828
复制
发表时间：
1996-12
期刊：
影响因子：
--
通讯作者：
D. Tormey;R. Gray;H. Falkson
中科院分区：
文献类型：
--
作者：
D. Tormey;R. Gray;H. Falkson
1984年发表的一项初步研究的数据表明，在乳腺癌初次手术后给予他莫昔芬（作为辅助激素治疗）5年以上可能有治疗效果。目的：进行了一项随机试验，以评估在手术后化疗1年和他莫昔芬治疗5年的腋窝淋巴结阳性乳腺癌患者维持他莫昔芬治疗5年以上的疗效。方法194名女性（绝经后87名，绝经前107名）同时参加了两项东方肿瘤合作组辅助试验（绝经后患者E4181，绝经前患者E5181），随机分配到继续他莫昔芬治疗或观察组。193名妇女（87名绝经后妇女和106名绝经前妇女）的数据可供分析。5年随机化后中位随访5.6年，最长随访8.0年。主要的分析测量了从随机化到复发或死亡的事件；其中包括复发时间分析，将新的对侧乳腺癌算作治疗失败，以及生存分析。使用Kaplan-Meier法和logrank检验对两个治疗组的妇女进行复发时间比较和生存比较。报告的P值是双面的。结果：随机化5年后，继续接受他莫昔芬治疗的妇女与接受观察的妇女在复发时间和生存时间上没有统计学上的显著差异。85%接受他莫昔芬治疗的女性在此期间无疾病，而观察组的这一比例为73% (P = .10)；继续接受他莫昔芬治疗的患者生存率为86%，观察组生存率为89% （P = 0.52）。绝经前和绝经后两组患者的复发时间和生存期差异也无统计学意义（绝经前和绝经后患者的复发时间分别为P = 0.38和P = 0.16；绝经前和绝经后患者的生存期分别为P = 0.18和P = 0.72）。有迹象表明，雌激素受体阳性肿瘤的女性继续他莫昔芬治疗可能会经历更长的复发时间（P = 0.014）；然而，该亚组的生存差异无统计学意义（P = 0.81）。两个治疗组的毒性模式相似。结论和意义我们的研究结果表明，进一步评估在腋窝淋巴结阳性、雌激素受体阳性的乳腺癌患者同时接受辅助化疗的5年以上辅助他莫昔芬治疗是合适的。
BACKGROUND Data from a pilot study published in 1984 suggested that tamoxifen administration (as adjuvant hormonal therapy) for more than 5 years after initial breast cancer surgery might have therapeutic benefit. PURPOSE A randomized trial was performed to assess the efficacy of maintaining tamoxifen therapy beyond 5 years in women with axillary lymph node-positive breast cancer who had been treated with surgery followed by 1 year of chemotherapy and 5 years of tamoxifen. METHODS One hundred ninety-four women (87 postmenopausal and 107 premenopasual) enrolled in two concurrent Eastern Cooperative Oncology Group adjuvant trials (E4181 for postmenopausal patients and E5181 for premenopausal patients) were randomly assigned to continued tamoxifen therapy or observation. Data for 193 women (87 postmenopausal and 106 premenopausal) were available for analysis. Median follow-up is 5.6 years since the randomization at 5 years, with the longest follow-up being 8.0 years. The major analyses measured events from the time of randomization until relapse or death; these included time-to-relapse analyses, with new opposite-breast cancers counted as treatment failures, and survival analyses. Time-to-relapse comparisons and survival comparisons for women in the two treatment groups were made by use of the Kaplan-Meier method and the logrank test. Reported P values are two-sided. RESULTS Five years after the randomization, no statistically significant differences were noted in either time to relapse or survival between women continuing to receive tamoxifen and those on observation. Eight-five percent of the women receiving tamoxifen were disease free at this time compared with 73% of those on observation (P = .10); survival was 86% for those continuing to receive tamoxifen and 89% for those on observation (P = .52). Differences in the time to relapse and survival between premenopausal and postmenopausal women assigned to the two treatment groups were also not statistically significant (time to relapse: P = .38 and P = .16 for premenopausal and postmenopausal patients, respectively; survival; P = .18 and P = .72 for premenopausal and postmenopausal patients, respectively). There was an indication that women with estrogen receptor-positive tumors may experience a longer time to relapse with continued tamoxifen therapy (P = .014); however, the survival difference for this subgroup was not statistically significant (P = .81). The toxicity patterns in the two treatment groups were similar. CONCLUSIONS AND IMPLICATIONS Our results suggest that further evaluation of adjuvant tamoxifen therapy beyond 5 years in women with axillary lymph node-positive, estrogen receptor-positive breast cancer who have also been treated with adjuvant chemotherapy would be appropriate.