Madarnas Yolanda, Trudeau Maureen, Franek Jacob A, McCready David, Pritchard Kathleen I, Messersmith Hans
Cancer Centre of Southeastern Ontario, Kingston General Hospital, 25 King Street West, Kingston, ON, Canada K7L 5P9.
Cancer Treat Rev. 2008 Oct;34(6):539-57. doi: 10.1016/j.ctrv.2008.03.013. Epub 2008 May 27.
A systematic review was undertaken to evaluate the evidence for the use of trastuzumab as (neo)adjuvant therapy for women with HER-2/neu-positive breast cancer and to develop and support recommendations pertaining to its use across five domains: as a single-agent therapy, in combination with chemotherapy, methods to identify women who will benefit from it, adverse events associated with it, and optimal dose, schedule, and duration.
MEDLINE, EMBASE, the American Society of Clinical Oncology, the San Antonio Breast Cancer Symposia proceedings, and the Cochrane Library were searched through May 2007 for reports of randomized controlled trials that met the inclusion criteria.
Eight randomized trials, described across 23 citations, were identified. All six trials of adjuvant trastuzumab reported significantly improved disease-free survival (DFS) while 4 of 6 adjuvant trials showed significant improvement in overall survival (OS) for patients treated with trastuzumab over those that were not. Two trials of trastuzumab in the neoadjuvant setting reported significantly better pathological complete response (pCR) in patients treated with trastuzumab although both studies were limited by small sample size, and longer follow-up is needed.
Although the optimal duration, schedule, and timing of adjuvant trastuzumab remains undefined, the bulk of the available evidence supports that adjuvant trastuzumab be offered for 1 year to all patients with HER-2-positive and node-positive or high-risk node-negative (tumour >or= 1cm in size) primary breast cancer who are receiving or have received (neo)adjuvant chemotherapy.
进行了一项系统评价，以评估使用曲妥珠单抗作为HER-2/neu阳性乳腺癌女性的（新）辅助治疗的证据，并制定和支持在五个领域使用曲妥珠单抗的建议：作为单药治疗、与化疗联合使用、识别将从其治疗中获益的女性的方法、与之相关的不良事件，以及最佳剂量、给药方案和疗程。
检索MEDLINE、EMBASE、美国临床肿瘤学会、圣安东尼奥乳腺癌研讨会论文集以及Cochrane图书馆，检索截至2007年5月符合纳入标准的随机对照试验报告。
共识别出八项随机试验，分布在23篇文献中。所有六项辅助性曲妥珠单抗试验均报告无病生存期（DFS）显著改善，而六项辅助试验中有四项显示，接受曲妥珠单抗治疗的患者总生存期（OS）比未接受治疗的患者有显著改善。两项新辅助治疗曲妥珠单抗试验报告称，接受曲妥珠单抗治疗的患者病理完全缓解（pCR）显著更好，不过两项研究均受样本量小的限制，需要更长时间的随访。
尽管辅助性曲妥珠单抗的最佳疗程、给药方案和时机仍不明确，但现有大部分证据支持，对于所有接受或已接受（新）辅助化疗的HER-2阳性且淋巴结阳性或高危淋巴结阴性（肿瘤大小≥1cm）的原发性乳腺癌患者，给予1年的辅助性曲妥珠单抗治疗。
