Treatment of operable breast cancer in the elderly: a randomised clinical trial EORTC 10851 comparing tamoxifen alone with modified radical mastectomy

Treatment of operable breast cancer in the elderly: a randomised clinical trial EORTC 10851 comparing tamoxifen alone with modified radical mastectomy
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DOI:
10.1016/s0959-8049(02)00673-1
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发表时间:
2003-02-01
影响因子:
8.4
通讯作者:
Therasse, P
Therasse, P
中科院分区:
医学1区
文献类型:
--
作者:
Fentiman, IS;Christiaens, MR;Therasse, P

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对于老年妇女早期乳腺癌的治疗,从随机试验中获得的证据很少。我们进行了一项随机试验,比较了164例年龄大于或等于70岁的可手术乳腺癌患者改良根治性乳房切除术(MRM)和他莫昔芬(TAM)作为唯一初始治疗。MRM治疗82例,TAM治疗82例。使用Kaplan-Meier法估计生存曲线;使用Cox比例风险模型进行多变量分析。终点包括生存期、首次复发或进展时间、局部区域进展时间、远处进展时间和无进展生存期。经过大约10年的中位随访,TAM组的进展时间明显缩短(logrank P < 0.0001), TAM组的局部进展时间明显缩短(logrank P < 0.0001)。两组的总生存率相似。结果表明,单独使用他莫昔芬会导致不可接受的高局部进展或复发率。2003爱思唯尔科学有限公司版权所有。
For treatment of early breast cancer in older women, little evidence is available from randomised trials. We conducted a randomised trial comparing modified radical mastectomy (MRM) with tamoxifen (TAM) as the sole initial therapy in 164 patients aged greater than or equal to70 years with operable breast cancer. 82 were treated by MRM and 82 with TAM. Survival curves were estimated using the Kaplan-Meier method: multivariate analyses were performed using the Cox's proportional hazards model. Endpoints included survival, time to first relapse or progression, loco-regional progression, time to distant progression and progression-free survival. After a median follow-up of approximately 10 years, there was a significantly decreased time to progression in the TAM only group (logrank P < 0.0001) and significantly shorter time to local progression within the TAM group (logrank P < 0.0001). Overall survival of the two groups was similar. The results indicate that tamoxifen alone leads to an unacceptably high rate of local progression or relapse. (C) 2003 Elsevier Science Ltd. All rights reserved.