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N Engl J Med. 2017 Jun 1;376(22):2147-2159. doi: 10.1056/NEJMoa1612645.

Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy.

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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.



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.


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.


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.


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 .).

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