Kazutaka Narui1, Takashi Ishikawa2, Daisuke Shimizu3, Akimitsu Yamada4, Mikiko Tanabe5, Takeshi Sasaki6, Mari S Oba7, Satoshi Morita8, Shuichi Nawata9, Kumiko Kida10, Masatoshi Mogaki11, Takako Doi12, Koichiro Tsugawa13, Haruki Ogata14, Tomohiko Ota15, Yoshimasa Kosaka16, Norihiko Sengoku17, Masaru Kuranami18, Naoki Niikura19, Yuki Saito20, Yasuhiro Suzuki21, Akihiko Suto22, Hitoshi Arioka23, Takashi Chishima24, Yasushi Ichikawa25, Itaru Endo26, Yutaka Tokuda27. 1. Department of Breast and Thyroid Surgery, Yokohama City University Medical Center, Yokohama, Japan. Electronic address: nr1@gc5.so-net.ne.jp. 2. Department of Breast and Thyroid Surgery, Yokohama City University Medical Center, Yokohama, Japan; Department of Breast Oncology and Surgery, Tokyo Medical University, Tokyo, Japan. Electronic address: tishik55@gmail.com. 3. Department of Breast and Thyroid Surgery, Yokohama City University Medical Center, Yokohama, Japan. Electronic address: d-shimizu.surg@yokohama.jrc.or.jp. 4. Department of Breast and Thyroid Surgery, Yokohama City University Medical Center, Yokohama, Japan. Electronic address: yakimitsu@gmail.com. 5. Division of Diagnostic Pathology, Yokohama City University Medical Center, Yokohama, Japan. Electronic address: betana.m@gmail.com. 6. Division of Diagnostic Pathology, Yokohama City University Medical Center, Yokohama, Japan. Electronic address: takesasa@m.u-tokyo.ac.jp. 7. Department of Biostatistics and Epidemiology, Yokohama City University Medical Center, Yokohama, Japan. Electronic address: mari.oba@med.toho-u.ac.jp. 8. Department of Biostatistics and Epidemiology, Yokohama City University Medical Center, Yokohama, Japan. Electronic address: smorita@kuhp.kyoto-u.ac.jp. 9. Pharmaceutical Department, Yokohama City University Medical Center, Yokohama, Japan. Electronic address: nawa_shu@cmed.showa-u.ac.jp. 10. Department of Breast and Thyroid Surgery, Yokohama City University Medical Center, Yokohama, Japan. Electronic address: kidakumiko117@gmail.com. 11. Department of Surgery, Yokosuka Kyosai Hospital, Yokosuka, Japan. Electronic address: moga@yg.so-net.ne.jp. 12. Kamakura Breast Cancer Center, Shonan Memorial Hospital, Kamakura, Japan. Electronic address: doi@syonankinenhp.or.jp. 13. Department of Breast and Endocrine Surgery, St. Marianna University School of Medicine, Kawasaki, Japan. Electronic address: koitsuga@marianna-u.ac.jp. 14. Department of Breast and Endocrine Surgery, St. Marianna University School of Medicine, Kawasaki, Japan. Electronic address: hogata@tth-japanpost.jp. 15. Department of Translational Oncology, St. Marianna University School of Medicine, Kawasaki, Japan. Electronic address: to1@marianna-u.ac.jp. 16. Department of Breast and Endocrine Surgery, Kitasato University Hospital, Sagamihara, Japan. Electronic address: y-kosaka@med.kitasato-u.ac.jp. 17. Department of Breast and Endocrine Surgery, Kitasato University Hospital, Sagamihara, Japan. Electronic address: sengoku@med.kitasato-u.ac.jp. 18. Department of Breast and Endocrine Surgery, Kitasato University Hospital, Sagamihara, Japan. Electronic address: masaru.kuranami@yamatocity-hosp.jp. 19. Department of Breast and Endocrine Surgery, Tokai University School of Medicine, Isehara, Japan. Electronic address: niikura@is.icc.u-tokai.ac.jp. 20. Department of Breast and Endocrine Surgery, Tokai University School of Medicine, Isehara, Japan. Electronic address: yu-ki@is.icc.u-tokai.ac.jp. 21. Department of Breast and Endocrine Surgery, Tokai University School of Medicine, Isehara, Japan. Electronic address: luke-szk@is.icc.u-tokai.ac.jp. 22. Department of Breast and Endocrine Surgery, St. Marianna University School of Medicine, Kawasaki, Japan. Electronic address: khksuto@marianna-u.ac.jp. 23. Department of Medical Oncology, Yokohama Rosai Hospital, Yokohama, Japan. Electronic address: arioka@yokohamah.rofuku.go.jp. 24. Department of Oncology, Yokohama City University, Yokohama, Japan. Electronic address: chissy@nifty.com. 25. Department of Oncology, Yokohama City University, Yokohama, Japan. Electronic address: yasu0514@med.yokohama-rcu.ac.jp. 26. Department of Gastroenterological Surgery, Yokohama City University, Yokohama, Japan. Electronic address: endoit@med.yokohama-cu.ac.jp. 27. Department of Translational Oncology, St. Marianna University School of Medicine, Kawasaki, Japan. Electronic address: tokuda@is.icc.u-tokai.ac.jp.
Abstract
BACKGROUND: It is important to determine whether anthracycline-containing regimens or taxane-containing regimens are more effective in individual patients. The present study compared the efficacy of six cycles of docetaxel and cyclophosphamide (TC6) with that of three cycles of 5-fluorouracil, epirubicin and cyclophosphamide followed by docetaxel (FEC-D) in Japanese patients with hormone receptor (HR)-negative breast cancer (BC) to identify subtypes requiring anthracycline treatment. METHODS: The study included 103 patients with operable HR-negative BC. Of these patients 53 received FEC-D and 50 received TC6. The primary endpoint was pathological complete response (pCR). The secondary endpoints were safety, breast-conserving surgery, disease-free survival (DFS) and overall survival (OS). The predictive factors for each regimen were evaluated. RESULTS: Of the 103 patients, 97 completed the study (FEC-D, 50 patients; TC6, 47 patients). The pCR rate was higher with FEC-D (36%) than with TC6 (25.5%); however, the difference was not significant (P = 0.265). TC6 was safer than FEC-D, as the adverse events with docetaxel in the FEC-D regimen were similar to those with the TC6 regimen. Among patients with basal BC, the pCR rate was significantly higher with FEC-D (42.9%) than with TC6 (13.6%; P = 0.033). Among patients with triple-negative breast cancer (TNBC), the DFS and OS were significantly better with FEC-D than with TC6 (P = 0.016 and P = 0.034, respectively). CONCLUSION:TC6 was not as effective as FEC-D for treating HR-negative BC, as TC6 was not sufficient to treat TNBC, particularly the basal subtype. Our findings suggest that anthracyclines are better treatment options than taxanes for basal BC.
RCT Entities:
BACKGROUND: It is important to determine whether anthracycline-containing regimens or taxane-containing regimens are more effective in individual patients. The present study compared the efficacy of six cycles of docetaxel and cyclophosphamide (TC6) with that of three cycles of 5-fluorouracil, epirubicin and cyclophosphamide followed by docetaxel (FEC-D) in Japanese patients with hormone receptor (HR)-negative breast cancer (BC) to identify subtypes requiring anthracycline treatment. METHODS: The study included 103 patients with operable HR-negative BC. Of these patients 53 received FEC-D and 50 received TC6. The primary endpoint was pathological complete response (pCR). The secondary endpoints were safety, breast-conserving surgery, disease-free survival (DFS) and overall survival (OS). The predictive factors for each regimen were evaluated. RESULTS: Of the 103 patients, 97 completed the study (FEC-D, 50 patients; TC6, 47 patients). The pCR rate was higher with FEC-D (36%) than with TC6 (25.5%); however, the difference was not significant (P = 0.265). TC6 was safer than FEC-D, as the adverse events with docetaxel in the FEC-D regimen were similar to those with the TC6 regimen. Among patients with basal BC, the pCR rate was significantly higher with FEC-D (42.9%) than with TC6 (13.6%; P = 0.033). Among patients with triple-negative breast cancer (TNBC), the DFS and OS were significantly better with FEC-D than with TC6 (P = 0.016 and P = 0.034, respectively). CONCLUSION:TC6 was not as effective as FEC-D for treating HR-negative BC, as TC6 was not sufficient to treat TNBC, particularly the basal subtype. Our findings suggest that anthracyclines are better treatment options than taxanes for basal BC.