亚洲晚期乳腺癌奈拉替尼疗效汇总
2019年8月21日，英国未来医学旗下《未来肿瘤学》在线发表中国医学科学院北京协和医学院附属肿瘤医院徐兵河、韩国蔚山大学首尔峨山医院金成裴、日本埼玉癌症中心井上贤一、美国洛杉矶美洲狮生物技术张波和理查德·布莱斯、中国香港仁康医疗乳腺综合诊治中心周永昌等学者的研究报告，汇总分析了奈拉替尼治疗亚洲HER2阳性晚期乳腺癌患者的安全性和有效性。
作者对奈拉替尼单药或联合（化疗药物或曲妥珠单抗）治疗晚期实体瘤患者的7项前瞻多中心非盲早期研究进行了汇总分析，其中I/II期研究4项、II期研究1项、随机对照II期研究2项。
结果，共计793例HER2阳性转移性乳腺癌患者被纳入疗效分析，其中亚洲患者271例、其他地区患者522例。亚洲患者客观缓解180例、总缓解率66.4%，中位无进展生存55.6周。亚洲患者发生率最高的不良事件为腹泻，其中各级腹泻：96.3%、3级腹泻：27.4%。
因此，该研究结果表明，奈拉替尼治疗对于亚洲HER2阳性转移性乳腺癌患者安全有效。
Future Oncol. 2019 Aug 21. [Epub ahead of print]
Neratinib-based therapy in patients with metastatic HER2-positive breast cancer from Asia.
Xu B, Kim SB, Inoue K, Lee J, Zhang B, Bryce R, Chow LW.
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea; Saitama Cancer Center, Saitama, Japan; Puma Biotechnology Inc., Los Angeles, CA, USA; Unimed Medical Institute, Wan Chai, Hong Kong.
AIM: To evaluate the safety and efficacy of neratinib-based therapy in Asian patients with HER2-positive metastatic breast cancer (MBC).
PATIENTS & METHODS: We performed a pooled analysis of seven early-phase studies of neratinib given either as monotherapy or in combination with chemotherapeutic agents or trastuzumab in patients with advanced solid tumors.
RESULTS: A total of 793 patients with HER2-positive MBC were included in the efficacy analysis (Asia: 271 patients; other regions: 522 patients). The overall response rate in patients from Asia was 66.4% (180/271) and the median progression-free survival was 55.6 weeks. The most common adverse event in patients from Asia was diarrhea (all-grade: 96.3%; grade 3: 27.4%).
CONCLUSION: Neratinib-based therapy is safe and effective in patients with HER2-positive MBC from Asia.
KEYWORDS: Asia; HER2; efficacy; metastatic breast cancer; neratinib; pooled analysis; safety; tyrosine kinase inhibitor
PMID: 31432689
DOI: 10.2217/fon-2019-0222
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