Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer
Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer
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DOI：
10.1056/nejmoa052122
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发表时间：
2005-10-20
影响因子：
158.5
通讯作者：
Wolmark, N
中科院分区：
文献类型：
--
作者：
Romond, EH;Perez, EA;Wolmark, N
背景：我们目前的综合结果的两个试验，比较辅助化疗与或不同时曲妥珠单抗在妇女手术切除HER 2阳性breastcancer.METHODS：国家外科辅助乳腺和肠道项目试验B-31比较阿霉素和环磷酰胺，然后紫杉醇每3周（组1）与相同的方案加52周曲妥珠单抗开始的第一剂紫杉醇（组2）。北中央癌症治疗组试验N9831比较了三种方案：多柔比星和环磷酰胺，随后每周一次紫杉醇（A组），相同方案，随后紫杉醇后曲妥珠单抗52周（B组），以及相同方案加52周曲妥珠单抗与紫杉醇同时启动（C组）。对研究进行了修订，以纳入比较组1和A（对照组）与组2和C（曲妥珠单抗组）的联合分析。B组被排除在外，因为曲妥珠单抗没有同时给予paclitaxel.Results：到2005年3月15日，394起事件（复发，第二原发癌，或复发前死亡）已被报告，触发第一次预定的中期分析。其中，曲妥珠单抗组133例，对照组261例（风险比，0.48; P
BACKGROUND:We present the combined results of two trials that compared adjuvant chemotherapy with or without concurrent trastuzumab in women with surgically removed HER2-positive breast cancer.METHODS:The National Surgical Adjuvant Breast and Bowel Project trial B-31 compared doxorubicin and cyclophosphamide followed by paclitaxel every 3 weeks (group 1) with the same regimen plus 52 weeks of trastuzumab beginning with the first dose of paclitaxel (group 2). The North Central Cancer Treatment Group trial N9831 compared three regimens: doxorubicin and cyclophosphamide followed by weekly paclitaxel (group A), the same regimen followed by 52 weeks of trastuzumab after paclitaxel (group B), and the same regimen plus 52 weeks of trastuzumab initiated concomitantly with paclitaxel (group C). The studies were amended to include a joint analysis comparing groups 1 and A (the control group) with groups 2 and C (the trastuzumab group). Group B was excluded because trastuzumab was not given concurrently with paclitaxel.RESULTS:By March 15, 2005, 394 events (recurrent, second primary cancer, or death before recurrence) had been reported, triggering the first scheduled interim analysis. Of these, 133 were in the trastuzumab group and 261 in the control group (hazard ratio, 0.48; P