Masuda, Norikazu; Lee, Soo-Jung; Ohtani, Shoichiro; Im, Young-Hyuck; Lee, Eun-Sook; Yokota, Isao; Kuroi, Katsumasa; Im, Seock-Ah; Park, Byeong-Woo; Kim, Sung-Bae; Yanagita, Yasuhiro; Ohno, Shinji; Takao, Shintaro; Aogi, Kenjiro; Iwata, Hiroji; Jeong, Joon; Kim, Aeree; Park, Kyong-Hwa; Sasano, Hironobu; Ohashi, Yasuo; Toi, Masakazu
The New England journal of medicine
2017Jun ; 376 ( 22 ) :2147-2159.
PMID : 28564564
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Masuda, Norikazu -
Lee, Soo-Jung -
Ohtani, Shoichiro -
Im, Young-Hyuck -
Lee, Eun-Sook -
Yokota, Isao -
Kuroi, Katsumasa -
Im, Seock-Ah -
Park, Byeong-Woo -
Kim, Sung-Bae -
Yanagita, Yasuhiro -
Ohno, Shinji -
Takao, Shintaro -
Aogi, Kenjiro -
Iwata, Hiroji -
Jeong, Joon -
Kim, Aeree -
Park, Kyong-Hwa -
Sasano, Hironobu -
Ohashi, Yasuo -
Toi, Masakazu -
ABSTRACT
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 .).
Adult; Aged; Antimetabolites, Antineoplastic/adverse effects/*therapeutic use; Breast Neoplasms/*drug therapy/mortality/surgery; Capecitabine/adverse effects/*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/mortality
MESH
Adult, Aged, Antimetabolites, Antineoplastic/adverse effects/*therapeutic use, Breast Neoplasms/*drug therapy/mortality/surgery, Capecitabine/adverse effects/*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/mortality
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