Adjuvant capecitabine prolongs disease-free and overall survivability
Patients with residual invasive carcinoma after preoperative neoadjuvant chemotherapy generally have poor prognoses.
As published in the New England Journal of Medicine , Masakazu Toi of Kyoto University Graduate School of Medicine and his colleagues conducted a randomized trial to improve survivability for these patients through the administration of capecitabine, a common chemotherapy medication used to treat breast cancer.
Under the project name "Capecitabine for Residual Cancer as Adjuvant Therapy (CREATE-X)", an international and multi-center trial was conducted between South Korea and Japan. Professor Soo-Jung Lee of Yeungnam University Hospital in Daegu played a major role. Additionally, The Advanced Clinical Research Organization, Japan Breast Cancer Research Group (JBCRG), Korean Breast Cancer Society, and Korean Cancer Study Group took part.
The trial involved a randomized group of 910 HER2 negative primary breast cancer patients, where each patient had residual invasive disease after standard neoadjuvant chemotherapy. The patients received standard postsurgical treatment with or without capecitabine.
The primary goal of the patients was disease-free survival. Secondary end points included overall survival.
In the final analysis, disease-free survival was significantly longer in the capecitabine group than in the control group after 5-years, where the survival rate was 74.1% versus 67.6% respectively, with a hazard ratio of 0.70 (P = 0.01). The overall survival was also better in the capecitabine group than in the control group, at 89.2% versus 83.6%, with a hazard ratio of 0.59 (P = 0.01).
Among patients with triple negative disease, the disease-free survival rate of the capecitabine group was superior to that of the control group at 69.8% versus 56.1%. Moreover, the overall survival rate was also favorable for the capecitabine group, at 78.8% compared to 70.3%.
The most adverse side effect from capecitabine was hand–foot syndrome, a condition where the hands and feet redden and swell, which occurred in 73.4% of the capecitabine patients.
In HER2-negative breast cancer patients with residual invasive disease on pathological examination after standard chemotherapy, the addition of postoperative adjuvant capecitabine prolonged disease-free survival and overall survival safely.
The researchers hope these results will help to improve breast cancer treatment and therapy.
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 and Masakazu Toi (2017). Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy. New England Journal of Medicine, 376, 2147-2159.