卡培他滨用于早期乳腺癌术后辅助治疗:NEJM一锤定音
  • 910例新辅助化疗(含蒽环类或紫杉类,或同时含两者)后残存浸润性病灶HER2阴性乳腺癌患者随机接受术后卡培他滨标准治疗或观察(对照);
  • 与对照组相比,卡培他滨治疗明显延长无病生存期和总体生存期(OD);
  • 5年时患者无复发或无第二原发癌生存率分别为74.1%和 67.6%,5年生存率分别为89.2%和83.6%,三阴性患者,卡培他滨治疗组的无病生存期69.8%,对照组为56.1%,OS分别为78.8%和70.3%;
  • 手足综合征为最常见的不良事件。
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Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy

乳腺癌术前化疗后卡培他滨辅助治疗

10.1056/NEJMoa1612645

2017-06-01, Article

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BACKGROUND Patients who have residual invasive carcinoma after the receipt of neoadjuvant chemotherapy for human epidermal growth factor receptor 2 (HER2)–negative breast cancer have poor prognoses. The benefit of adjuvant chemotherapy in these patients remains unclear. METHODS We randomly assigned 910 patients with HER2-negative residual invasive breast cancer after neoadjuvant chemotherapy (containing anthracycline, taxane, or both) to receive standard postsurgical treatment either with capecitabine or without (control). The primary end point was disease-free survival. Secondary end points included overall survival. RESULTS The result of the prespecified interim analysis met the primary end point, so this trial was terminated early. The final analysis showed that disease-free survival was longer in the capecitabine group than in the control group (74.1% vs. 67.6% of the patients were alive and free from recurrence or second cancer at 5 years; hazard ratio for recurrence, second cancer, or death, 0.70; 95% confidence interval [CI], 0.53 to 0.92; P=0.01). Overall survival was longer in the capecitabine group than in the control group (89.2% vs. 83.6% of the patients were alive at 5 years; hazard ratio for death, 0.59; 95% CI, 0.39 to 0.90; P=0.01). Among patients with triple-negative disease, the rate of disease-free survival was 69.8% in the capecitabine group versus 56.1% in the control group (hazard ratio for recurrence, second cancer, or death, 0.58; 95% CI, 0.39 to 0.87), and the overall survival rate was 78.8% versus 70.3% (hazard ratio for death, 0.52; 95% CI, 0.30 to 0.90). The hand–foot syndrome, the most common adverse reaction to capecitabine, occurred in 73.4% of the patients in the capecitabine group. CONCLUSIONS After standard neoadjuvant chemotherapy containing anthracycline, taxane, or both, the addition of adjuvant capecitabine therapy was safe and effective in prolonging disease-free survival and overall survival among patients with HER2-negative breast cancer who had residual invasive disease on pathological testing. (Funded by the Advanced Clinical Research Organization and the Japan Breast Cancer Research Group; CREATE-X UMIN Clinical Trials Registry number, UMIN000000843.)

First Authors:
Norikazu Masuda

Correspondence Authors:
Norikazu Masuda

All Authors:
Norikazu Masuda,Soo-Jung Lee,Shoichiro Ohtani,Young-Hyuck Im,Eun-Sook Lee,Isao Yokota,Katsumasa Kuroi,Seock-Ah Im,Byeong-Woo Park,Sung-Bae Kim,Yasuhiro Yanagita,Shinji Ohno,Shintaro Takao,Kenjiro Aogi,Hiroji Iwata,Joon Jeong,Aeree Kim,Kyong-Hwa Park,Hironobu Sasano,Yasuo Ohashi,Masakazu Toi

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