Norikazu Masuda1, Soo-Jung Lee1, Shoichiro Ohtani1, Young-Hyuck Im1, Eun-Sook Lee1, Isao Yokota1, Katsumasa Kuroi1, Seock-Ah Im1, Byeong-Woo Park1, Sung-Bae Kim1, Yasuhiro Yanagita1, Shinji Ohno1, Shintaro Takao1, Kenjiro Aogi1, Hiroji Iwata1, Joon Jeong1, Aeree Kim1, Kyong-Hwa Park1, Hironobu Sasano1, Yasuo Ohashi1, Masakazu Toi1. 1. 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.
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 afterneoadjuvant 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 .).
RCT Entities:
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 .).
Authors: Laura L Michel; Laura Sommer; Rosa González Silos; Justo Lorenzo Bermejo; Alexandra von Au; Julia Seitz; André Hennigs; Katharina Smetanay; Michael Golatta; Jörg Heil; Florian Schütz; Christof Sohn; Andreas Schneeweiss; Frederik Marmé Journal: Breast Cancer Res Treat Date: 2019-06-24 Impact factor: 4.872
Authors: Guillaume S Chevrollier; Danica N Giugliano; Francesco Palazzo; Scott W Keith; Ernest L Rosato; Nathaniel R Evans Iii; Adam C Berger Journal: J Gastrointest Surg Date: 2019-02-26 Impact factor: 3.452
Authors: Jennifer Y Sheng; Cesar A Santa-Maria; Neha Mangini; Haval Norman; Rima Couzi; Raquel Nunes; Mary Wilkinson; Kala Visvanathan; Roisin M Connolly; Evanthia T Roussos Torres; John H Fetting; Deborah K Armstrong; Jessica J Tao; Lisa Jacobs; Jean L Wright; Elissa D Thorner; Christine Hodgdon; Samantha Horn; Antonio C Wolff; Vered Stearns; Karen L Smith Journal: JCO Oncol Pract Date: 2020-06-30