术前化疗后乳腺癌的卡培他滨辅助治疗 - NEJM医学前沿
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Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy

Norikazu Masuda ... 肿瘤 • 2017.06.01
• 铂类化疗可否用于BRCA相关三阴性乳腺癌 • 卡培他滨用于术后残留乳腺癌的治疗 • 贝伐单抗联合新辅助化疗治疗乳腺癌









预先设定的中期分析结果达到了主要终点,所以本试验被提前终止。最终分析显示卡培他滨组的无病生存期比对照组长(5年时仍存活,并且没有癌症再发或患第二种癌的患者比例,74.1%对67.6%;再发、患第二种癌或死亡的风险比为0.70;95%置信区间[CI],0.53~0.92;P=0.01)。卡培他滨组的总生存期比对照组长(5年时仍存活的患者比例,89.2%对83.5%;死亡风险比为0.59;95% CI,0.39~0.90;P=0.01)。在三阴性乳腺癌患者中,卡培他滨组的无病生存率为69.8%,而对照组为56.1%(再发、患第二种癌或死亡的风险比为0.58;95% CI,0.39~0.87);而总生存率为78.8%对70.3%(死亡风险比为0.52;95% CI,0.30~0.90)。卡培他滨的最常见不良反应手足综合征发生于卡培他滨组73.4%的患者。



接受包括蒽环类抗生素、紫杉烷或两者兼有的标准新辅助化疗后,在病理学检查中有残余浸润性癌的HER2阴性乳腺癌患者中,加用卡培他滨辅助治疗是安全的,并且对于延长无病生存期和总生存期有效(由高级临床研究机构[Advanced Clinical Research Organization]和日本乳腺癌研究组[Japan Breast Cancer Research Group]资助;CREATE-X UMIN临床试验注册号,UMIN000000843)。


Norikazu Masuda, M.D., Ph.D., Soo-Jung Lee, M.D., Ph.D., Shoichiro Ohtani, M.D., Ph.D., Young-Hyuck Im, M.D., Ph.D., Eun-Sook Lee, M.D., Ph.D., Isao Yokota, Ph.D., Katsumasa Kuroi, M.D., Ph.D., Seock-Ah Im, M.D., Ph.D., Byeong-Woo Park, M.D., Ph.D., Sung-Bae Kim, M.D., Ph.D., Yasuhiro Yanagita, M.D., Ph.D., Shinji Ohno, M.D., Ph.D., Shintaro Takao, M.D., Ph.D., Kenjiro Aogi, M.D., Ph.D., Hiroji Iwata, M.D., Ph.D., Joon Jeong, M.D., Ph.D., Aeree Kim, M.D., Ph.D., Kyong-Hwa Park, M.D., Ph.D., Hironobu Sasano, M.D., Ph.D., Yasuo Ohashi, Ph.D., and Masakazu Toi, M.D., Ph.D.
From the National Hospital Organization Osaka National Hospital, Osaka (N.M.), Hiroshima City Hiroshima Citizens Hospital, Hiroshima (S. Ohtani), Kyoto Prefectural University of Medicine (I.Y.), and Graduate School of Medicine, Kyoto University (M.T.), Kyoto, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital (K.K.), and Chuo University (Y.O.), Tokyo, Gunma Prefectural Cancer Center, Ota (Y.Y.), National Hospital Organization Kyushu Cancer Center, Fukuoka (S. Ohno), Hyogo Cancer Center, Akashi (S.T.), National Hospital Organization Shikoku Cancer Center, Matsuyama (K.A.), Aichi Cancer Center Hospital, Nagoya (H.I.), and Tohoku University, Sendai (H.S.) — all in Japan; and Yeungnam University Hospital, Daegu (S.-J.L.), Samsung Medical Center, Sungkyunkwan University School of Medicine (Y.-H.I.), Cancer Research Institute, Seoul National University Hospital, Seoul National University College of Medicine (S.-A.I.), Severance Hospital (B.-W.P.) and Gangnam Severance Hospital (J.J.), Yonsei University College of Medicine, Asan Medical Center, University of Ulsan College of Medicine (S.-B.K.), Korea University Guro Hospital (A.K.), and Korea University Anam Hospital (K.-H.P.), Seoul, and National Cancer Center, Goyang-si (E.-S.L.) — all in South Korea. Address reprint requests to Dr. Toi at the Breast Cancer Unit, Kyoto University Hospital, Breast Surgery, Graduate School of Medicine, Kyoto University, 54 Shogoin-Kawaracho, Sakyo-ku, Kyoto 606-8507, Japan, or at toi@kuhp.kyoto-u.ac.jp. A complete list of the investigators in the Capecitabine for Residual Cancer as Adjuvant Therapy (CREATE-X) trial is provided in the Supplementary Appendix, available at NEJM.org.



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