美国临床肿瘤学会临床实践指南：早期乳腺癌的辅助化疗和靶向疗法
编者按：2016年，美国临床肿瘤学会参考安大略（加拿大经济和人口第一、面积第四大省，首都渥太华所在省，首府多伦多，毗邻美国新英格兰地区）癌症治疗指南，发表了人表皮生长因子受体2（HER2）阳性乳腺癌辅助靶向疗法和HER2阴性乳腺癌最佳辅助化疗方案选择临床实践指南。2年以来，由于CREATE-X、APHINITY、ExteNET等早期乳腺癌辅助疗法III期研究最新结果相继公布，故有必要对该指南进行专项更新。
2018年5月22日，美国临床肿瘤学会《临床肿瘤学杂志》在线发表美国肿瘤专科医师协会、弗吉尼亚癌症专科医师协会、乔治城大学乳腺癌协会、美国临床肿瘤学会、德克萨斯大学MD安德森癌症中心、斯坦福大学医学院、希望之城国家医学中心、萨拉坎农癌症研究所、哈佛大学医学院达纳法伯癌症研究所布列根和波士顿妇女癌症中心、华盛顿大学弗雷德哈钦森癌症研究中心、约翰霍普金斯大学坎摩尔癌症中心、加拿大安大略癌症治疗中心、多伦多大学森尼布鲁克医院奥德特癌症中心的美国临床肿瘤学会临床实践指南专项更新：早期乳腺癌最佳辅助化疗和靶向疗法的选择。
首先，专家组进行有针对性的文献系统回顾，根据渥太华大学提出的定量和定性“信号”法，确定新的、潜在的、正在改变实践、可能转化为修订实践推荐意见的数据。
随后，专家组对以下III期研究进行了评估：
早期HER2阴性乳腺癌患者，术前蒽环类联合紫杉类标准新辅助化疗完成后，手术残余浸润病变的卡培他滨辅助治疗（CREATE-X）
早期HER2阳性乳腺癌患者，术后化疗＋曲妥珠单抗±帕妥珠单抗辅助治疗一年（APHINITY）
早期HER2阳性乳腺癌患者，术后化疗＋曲妥珠单抗联合辅助治疗后，奈拉替尼延长辅助治疗（ExteNET）
最后，专家组推荐意见归纳如下：
对于HER2阴性早期乳腺癌患者，术前接受蒽环类＋紫杉类标准新辅助化疗后，如果手术病理发现残余浸润病变，术后可以接受6～8周的卡培他滨辅助化疗。
对于高风险HER2阳性早期乳腺癌患者，术后辅助化疗＋曲妥珠单抗联合方案可以加入帕妥珠单抗辅助治疗一年。
对于HER2阳性早期乳腺癌患者，曲妥珠单抗辅助治疗后，可以使用奈拉替尼延长辅助治疗；奈拉替尼可以引起明显腹泻，必须使用腹泻预防措施。
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J Clin Oncol. 2018 May 22. [Epub ahead of print]
Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer: ASCO Clinical Practice Guideline Focused Update.
Neelima Denduluri, Mariana Chavez-MacGregor, Melinda L. Telli, Andrea Eisen, Stephanie L. Graff, Michael J. Hassett, Jamie N. Holloway, Arti Hurria, Tari A. King, Gary H. Lyman, Ann H. Partridge, Mark R. Somerfield, Maureen E. Trudeau, Antonio C. Wolff, and Sharon H. Giordano.
The US Oncology Network, Virginia Cancer Specialists; Georgetown Breast Cancer Advocates, Arlington; American Society of Clinical Oncology, Alexandria, VA; University of Texas MD Anderson Cancer Center, Houston, TX; Stanford University School of Medicine, Stanford; City of Hope, Duarte, CA; Sunnybrook Odette Cancer Centre; Cancer Care Ontario, Toronto, Ontario, Canada; Sarah Cannon Cancer Institute HCA Midwest Health, Kansas City, MO; Dana-Farber Cancer Institute; Brigham & Women's Cancer Center, Boston, MA; Fred Hutchinson Cancer Research Center, Seattle, WA; Johns Hopkins Kimmel Cancer Center, Baltimore, MD.
PURPOSE: To update key recommendations of the ASCO guideline adaptation of the Cancer Care Ontario guideline on the selection of optimal adjuvant chemotherapy regimens for early breast cancer and adjuvant targeted therapy for breast cancer.
METHODS: An Expert Panel conducted targeted systematic literature reviews guided by a signals approach to identify new, potentially practice-changing data that might translate to revised practice recommendations.
RESULTS: The Expert Panel reviewed phase III trials that evaluated adjuvant capecitabine after completion of standard preoperative anthracycline- and taxane-based combination chemotherapy by patients with early-stage breast cancer HER2-negative breast cancer with residual invasive disease at surgery; the addition of 1 year of adjuvant pertuzumab to combination chemotherapy and trastuzumab for patients with early-stage, HER2-positive breast cancer; and the use of neratinib as extended adjuvant therapy for patients after combination chemotherapy and trastuzumab-based adjuvant therapy with early-stage, HER2-positive breast cancer.
RECOMMENDATIONS: Patients with early-stage HER2-negative breast cancer with pathologic, invasive residual disease at surgery following standard anthracycline- and taxane-based preoperative therapy may be offered up to six to eight cycles of adjuvant capecitabine. Clinicians may add 1 year of adjuvant pertuzumab to trastuzumab-based combination chemotherapy in patients with high-risk, early-stage, HER2-positive breast cancer. Clinicians may use extended adjuvant therapy with neratinib to follow trastuzumab in patients with early-stage, HER2-positive breast cancer. Neratinib causes substantial diarrhea, and diarrhea prophylaxis must be used.
DOI: 10.1200/JCO.2018.78.8604
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