Lay Summary: I review suitability of Xeloda for adjuvant therapy of breast cancer.
The proven efficacy of capecitabine (Xeloda(R)) in the metastatic setting, its association with minimal myelosuppression and alopecia, and the lack of increased toxicity when added to taxotere all point to an increasingly important role for capecitabine for early breast cancer, according to an overview of recent, ongoing and future trials.
Adjuvant capecitabine improves outcomes in women with HER2-negative breast cancer who still have invasive disease after neoadjuvant chemotherapy, according to findings of the CREATE-X trial reported at the 2015 San Antonio Breast Cancer Symposium.
The phase III trial was conducted among 910 patients with early breast cancer in Japan and Korea who still had positive nodes or didn’t achieve a pathologic complete response after receipt of neoadjuvant chemotherapy that included an anthracycline, a taxane, or both. The CREATE-X (Capecitabine for Residual Cancer as Adjuvant Therapy) trial involved 900 Korean and Japanese women with HER2-negative breast cancer who did not have a pathologic complete response (pCR) or who had node-positive disease despite having undergone neoadjuvant chemotherapy with an anthracycline and/or taxane followed by surgery. They were randomized to open-label adjuvant capecitabine (Xeloda) or no capecitabine, in addition to standard therapy.
Results of a preplanned 2-year interim analysis, reported in a session and related press briefing, showed that the risk of disease-free survival events was 30% lower and the risk of death was 40% lower among women given capecitabine than among counterparts not given the drug, prompting early stopping of the trial. This is different from previous negative studies, which, however, were quite diferently designed. In those negative studies, patients either received capecitabine with other chemotherapy or as a single agent.
Lee S-J, Toi M, Lee ES, et al: A phase III trial of adjuvant capecitabine in breast cancer patients with HER2-negative pathologic residual invasive disease after neoadjuvant chemotherapy (CREATE-X, JBCRG-04). 2015 San Antonio Breast Cancer Symposium. Abstract S1-07. Presented December 9, 2015.
2. von Minckwitz G, Reimer T, Potenberg J, et al: The phase III ICE study: Adjuvant ibandronate with or without capecitabine in elderly patients with moderate or high risk early breast cancer. 2014 San Antonio Breast Cancer Symposium. Abstract S3-04. Presented December 11, 2014.
3. Norikazu Masuda, M.D., Ph.D., Soo-Jung Lee, M.D., Ph.D., Shoichiro Ohtani, M.D., Ph.D., Young-Hyuck Im, M.D., Ph.D., Eun-Sook Lee, M.D., Ph.D., Isao Yokota, Ph.D., Katsumasa Kuroi, M.D., Ph.D., Seock-Ah Im, M.D., Ph.D., Byeong-Woo Park, M.D., Ph.D., Sung-Bae Kim, M.D., Ph.D., Yasuhiro Yanagita, M.D., Ph.D., Shinji Ohno, M.D., Ph.D., Shintaro Takao, M.D., Ph.D., Kenjiro Aogi, M.D., Ph.D., Hiroji Iwata, M.D., Ph.D., Joon Jeong, M.D., Ph.D., Aeree Kim, M.D., Ph.D., Kyong-Hwa Park, M.D., Ph.D., Hironobu Sasano, M.D., Ph.D., Yasuo Ohashi, Ph.D., and Masakazu Toi, M.D., Ph.D.Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy. N Engl J Med 2017; 376:2147-2159 June 1, 20