Masahito Kotaka1, Shigeyoshi Iwamoto2, Hironaga Satake3, Daisuke Sakai4, Toshihiro Kudo5, Mutsumi Fukunaga6, Ken Konishi6, Yoshihito Ide7, Taro Ikumoto8, Akihito Tsuji9, Yasushi Sano10, Takeshi Kato11, Naotoshi Sugimoto5, Taroh Satoh4, Akiyoshi Kanazawa12, Takayasu Kurata13, Takeharu Yamanaka14, Naohiro Tomita15. 1. Gastrointestinal Cancer Center, Sano Hospital, 2-5-1, Shimizugaoka, Tarumi-ku, Kobe, 655-0031, Japan. tomomakotaka6410@yahoo.co.jp. 2. Cancer Center, Aichi Medical University, Aichi, Japan. 3. Cancer Treatment Center, Kansai Medical University Hospital, Osaka, Japan. 4. Department of Frontier Science for Cancer and Chemotherapy, Graduate School of Medicine, Osaka University, Osaka, Japan. 5. Department of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan. 6. Department of Surgery, Hyogo Prefectural Nishinomiya Hospital, Hyogo, Japan. 7. Department of Surgery, Yao Municipal Hospital, Osaka, Japan. 8. Gastrointestinal Cancer Center, Sano Hospital, 2-5-1, Shimizugaoka, Tarumi-ku, Kobe, 655-0031, Japan. 9. Department of Clinical Oncology, Faculty of Medicine, Kagawa University, Kagawa, Japan. 10. Gastrointestinal Center, Sano Hospital, Hyogo, Japan. 11. Department of Surgery, National Hospital Organization, Osaka National Hospital, Osaka, Japan. 12. Department of Surgery, Shimane Prefectural Central Hospital, Shimane, Japan. 13. Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka, Japan. 14. Department of Biostatistics, Yokohama City University School of Medicine, Kanagawa, Japan. 15. Division of Lower GI Surgery, Department of Surgery, Hyogo College of Medicine, Hyogo, Japan.
Abstract
BACKGROUND: Chemotherapy in relapsed colorectal cancer patients treated with oxaliplatin as adjuvant chemotherapy is under debate. REACT study aimed to investigate the efficacy of reintroducing modified FOLFOX6 (mFOLFOX6) or CAPOX with or without bevacizumab in recurrent colorectal cancer patients after oxaliplatin adjuvant chemotherapy. METHODS: Patients that participated in this trial had a medical history of adjuvant chemotherapy, including oxaliplatin with a cumulative dose greater than 400 mg/m2, and recurrence that was diagnosed more six months post adjuvant chemotherapy. Primary endpoints were response rate (RR) and disease control rate (DCR), while key secondary endpoints were time to treatment failure (TTF), progression-free survival (PFS), overall survival (OS), and safety. RESULTS: A total of 31 patients were enrolled between October 2012 and October 2016. Of the 29 eligible patients, 7 received mFOLFOX6 and 22 received CAPOX. The RR was 62.1% (95% confidence interval 42.3-79.3) and the DCR was 82.8% (95% confidence interval 64.2-94.2). The RR for oxaliplatin-free interval was 100.0% in months 6-12 and 56.0% after 12 months. Median TTF, PFS, and OS were 6.3, 10.8, and 28.7 months, respectively. Grade 3 or worse peripheral sensory neuropathy developed in 6.5%. Allergic reactions occurred in 12.9% of the patients, with one (3.2%) grade 3 episode. There were no other severe treatment-related adverse events. CONCLUSION: Reintroduction of oxaliplatin was feasible and achieved high RR or DCR in patients after more than 6 months post oxaliplatin adjuvant chemotherapy.
BACKGROUND: Chemotherapy in relapsed colorectal cancerpatients treated with oxaliplatin as adjuvant chemotherapy is under debate. REACT study aimed to investigate the efficacy of reintroducing modified FOLFOX6 (mFOLFOX6) or CAPOX with or without bevacizumab in recurrent colorectal cancerpatients after oxaliplatin adjuvant chemotherapy. METHODS:Patients that participated in this trial had a medical history of adjuvant chemotherapy, including oxaliplatin with a cumulative dose greater than 400 mg/m2, and recurrence that was diagnosed more six months post adjuvant chemotherapy. Primary endpoints were response rate (RR) and disease control rate (DCR), while key secondary endpoints were time to treatment failure (TTF), progression-free survival (PFS), overall survival (OS), and safety. RESULTS: A total of 31 patients were enrolled between October 2012 and October 2016. Of the 29 eligible patients, 7 received mFOLFOX6 and 22 received CAPOX. The RR was 62.1% (95% confidence interval 42.3-79.3) and the DCR was 82.8% (95% confidence interval 64.2-94.2). The RR for oxaliplatin-free interval was 100.0% in months 6-12 and 56.0% after 12 months. Median TTF, PFS, and OS were 6.3, 10.8, and 28.7 months, respectively. Grade 3 or worse peripheral sensory neuropathy developed in 6.5%. Allergic reactions occurred in 12.9% of the patients, with one (3.2%) grade 3 episode. There were no other severe treatment-related adverse events. CONCLUSION: Reintroduction of oxaliplatin was feasible and achieved high RR or DCR in patients after more than 6 months post oxaliplatin adjuvant chemotherapy.