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