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Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy

 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 
 NEW ENGLAND JOURNAL OF MEDICINE, Vol.376(22) : 2147-2159, 2017 
Journal Title
Issue Date
Adult ; Aged ; Antimetabolites, Antineoplastic/adverse effects ; Antimetabolites, Antineoplastic/therapeutic use ; Breast Neoplasms/drug therapy ; Breast Neoplasms/mortality ; Breast Neoplasms/surgery ; Capecitabine/adverse effects ; Capecitabine/therapeutic use ; Chemotherapy, Adjuvant/adverse effects ; Female ; Hand-Foot Syndrome/etiology ; Humans ; Middle Aged ; Neoadjuvant Therapy ; Neoplasm Staging ; Preoperative Care ; Receptor, ErbB-2 ; Survival Analysis ; Triple Negative Breast Neoplasms/drug therapy ; Triple Negative Breast Neoplasms/mortality

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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1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Park, Byeong Woo(박병우) ORCID logo https://orcid.org/0000-0003-1353-2607
Jeong, Joon(정준) ORCID logo https://orcid.org/0000-0003-0397-0005
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