2014年，美国临床肿瘤学会（ASCO）首次发布HER2阳性晚期乳腺癌患者全身治疗临床实践指南，并于2018年对该循证指南推荐意见进行更新，至今又隔4年。
2022年5月31日，ASCO《临床肿瘤学杂志》在线发表德克萨斯大学MD安德森癌症中心、德克萨斯肿瘤医院、ASCO、杜克大学、纽约纪念医院斯隆凯特林癌症中心、纽约州中部血液病与肿瘤医院、西雅图癌症医疗联盟、华盛顿大学弗雷德哈钦森癌症研究中心、哈佛大学达纳法伯癌症研究所、密歇根大学、安娜堡患者权益基金会、佛罗里达大学奥兰多医院癌症中心、法国古斯塔夫·鲁西研究所联合起草的HER2阳性晚期乳腺癌全身治疗：ASCO指南更新。
为了更新来自临床证据的指南推荐意见供临床肿瘤科医师对HER2阳性晚期乳腺癌患者进行全身治疗，专家组针对全身治疗±中枢神经系统转移截至2021年发表的文献进行系统回顾，确定545篇文献，关注的结局包括有效性和安全性。
结果，从545篇文献筛选出14篇作为指南推荐意见的证据基础，主要推荐意见如下：
一、HER2靶向治疗被推荐用于HER2阳性晚期乳腺癌患者，除了临床充血性心力衰竭或左心室射血分数显著降低的患者应该根据具体情况进行评估。
二、推荐曲妥珠单抗＋帕妥珠单抗＋紫杉类用于一线治疗、德喜曲妥珠单抗用于二线治疗。
三、对于三线治疗，临床医师应提供其他HER2靶向治疗组合。由于缺乏头对头试验，故没有足够证据推荐一种方案优于另一种方案。患者与临床医师决策时应该对治疗方案、途径、毒性等差异进行讨论。选项包括图卡替尼、恩美曲妥珠单抗、德喜曲妥珠单抗（如果既往未用过）、奈拉替尼、拉帕替尼、化疗、马吉妥昔单抗、激素治疗、阿贝西利＋曲妥珠单抗＋氟维司群，如果患者既往未接受过帕妥珠单抗，也可采用。
四、化疗的最佳疗程至少4～6个月或直至最大程度缓解，取决于毒性低且未进展。
五、HER2靶向治疗可以持续至疾病进展或毒性无法耐受时。
六、对于HER2阳性且雌激素受体阳性或孕激素受体阳性乳腺癌患者，临床医师可以推荐标准一线治疗，或者对于经过筛选的患者可以推荐内分泌治疗±HER2靶向治疗。
相关链接
J Clin Oncol. 2022 May 31. Online ahead of print.
Systemic Therapy for Advanced Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: ASCO Guideline Update.
Giordano SH, Franzoi MAB, Temin S, Anders CK, Chandarlapaty S, Crews JR, Kirshner JJ, Krop IE, Lin NU, Morikawa A, Patt DA, Perlmutter J, Ramakrishna N, Davidson NE.
University of Texas MD Anderson, Houston, TX; Texas Oncology, Austin, TX; American Society of Clinical Oncology, Alexandria, VA; Duke University, Durham, NC; Memorial Sloan Kettering Cancer Center, New York, NY; Hematology/Oncology Associates of Central New York, East Syracuse, NY; Seattle Cancer Care Alliance, Seattle, WA; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, WA; Dana-Farber Cancer Institute, Boston, MA; University of Michigan, Ann Arbor, MI; Patient Advocate, Ann Arbor, MI; University of Florida Health Cancer Center at Orlando Health, Orlando, FL; Institute Gustave Roussy, Villejuif, France.
PURPOSE: To update evidence-based guideline recommendations to practicing oncologists and others on systemic therapy for patients with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer.
METHODS: An Expert Panel conducted a targeted systematic literature review (for both systemic treatment and CNS metastases) and identified 545 articles. Outcomes of interest included efficacy and safety.
RESULTS: Of the 545 publications identified and reviewed, 14 were identified to form the evidentiary basis for the guideline recommendations.
RECOMMENDATIONS: HER2-targeted therapy is recommended for patients with HER2-positive advanced breast cancer, except for those with clinical congestive heart failure or significantly compromised left ventricular ejection fraction, who should be evaluated on a case-by-case basis. Trastuzumab, pertuzumab, and taxane for first-line treatment and trastuzumab deruxtecan for second-line treatment are recommended. In the third-line setting, clinicians should offer other HER2-targeted therapy combinations. There is a lack of head-to-head trials; therefore, there is insufficient evidence to recommend one regimen over another. The patient and the clinician should discuss differences in treatment schedule, route, toxicities, etc during the decision-making process. Options include regimens with tucatinib, trastuzumab emtansine, trastuzumab deruxtecan (if either not previously administered), neratinib, lapatinib, chemotherapy, margetuximab, hormonal therapy, and abemaciclib plus trastuzumab plus fulvestrant, and may offer pertuzumab if the patient has not previously received it. Optimal duration of chemotherapy is at least 4-6 months or until maximum response, depending on toxicity and in the absence of progression. HER2-targeted therapy can continue until time of progression or unacceptable toxicities. For patients with HER2-positive and estrogen receptor-positive or progesterone receptor-positive breast cancer, clinicians may recommend either standard first-line therapy or, for selected patients, endocrine therapy plus HER2-targeted therapy or endocrine therapy alone.
PMID: 35640077
DOI: 10.1200/JCO.22.00519
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