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Combination of TAS-102 and bevacizumab as third-line treatment for metastatic colorectal cancer: TAS-CC3 study.

  • Yoshida, Yoichiro1
  • Yamada, Takeshi2
  • Kamiyama, Hirohiko3
  • Kosugi, Chihiro4
  • Ishibashi, Keiichiro5
  • Yoshida, Hiroshi2
  • Ishida, Hideyuki5
  • Yamaguchi, Satoru6
  • Kuramochi, Hidekazu7
  • Fukazawa, Atsuko8
  • Sonoda, Hiromichi9
  • Yoshimatsu, Kazuhiko10
  • Matsuda, Akihisa11
  • Hasegawa, Suguru12
  • Sakamoto, Kazuhiro3
  • Otsuka, Toshiaki13
  • Koda, Keiji4
  • 1 Department of Gastroenterological Surgery, Faculty of Medicine, Fukuoka University, Fukuoka University School of Medicine, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan. [email protected] , (Japan)
  • 2 Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Nippon Medical School, Tokyo, Japan. , (Japan)
  • 3 Department of Coloproctological Surgery, Faculty of Medicine, Juntendo University, Tokyo, Japan. , (Japan)
  • 4 Department of Surgery, Teikyo University Chiba Medical Center, Chiba, Japan. , (Japan)
  • 5 Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan. , (Japan)
  • 6 Department of Surgical Oncology, Dokkyo Medical University, Tochigi, Japan. , (Japan)
  • 7 Department of Chemotherapy, Tokyo Women's Medical University Yachiyo Medical Center, Chiba, Japan. , (Japan)
  • 8 Department of Gastroenterological Surgery, Iwata City Hospital, Shizuoka, Japan. , (Japan)
  • 9 Department of Surgery, Shiga University of Medical Science, Shiga, Japan. , (Japan)
  • 10 Department of Surgery, Saiseikai Kurihashi Hospital, Saitama, Japan. , (Japan)
  • 11 Department of Surgery, Nippon Medical School Chiba Hokuso Hospital, Chiba, Japan. , (Japan)
  • 12 Department of Gastroenterological Surgery, Faculty of Medicine, Fukuoka University, Fukuoka University School of Medicine, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180, Japan. , (Japan)
  • 13 Dept of Hygiene and Public Health, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan. , (Japan)
Published Article
International journal of clinical oncology
Publication Date
Jan 01, 2021
DOI: 10.1007/s10147-020-01794-8
PMID: 33083913


TAS-102 improved the overall survival of metastatic colorectal cancer (CRC) patients with a median progression-free survival (PFS) in the RECOURSE trial. Subsequently, the combination of TAS-102 and bevacizumab was shown to extend the median PFS (C-TASK FORCE study). However, the study included patients who received second- and third-line treatment. Our study exclusively examined patients receiving this combination as a third-line treatment to investigate the clinical impact beyond cytotoxic doublets. This investigator-initiated, open-label, single-arm, multi-centered phase II study was conducted in Japan. Eligible CRC patients were refractory or intolerant to fluoropyrimidine, irinotecan, and oxaliplatin in first- and second-line therapy. TAS-102 (35 mg/m2) was given orally twice daily on days 1-5 and 8-12 in a 4-week cycle, and bevacizumab (5 mg/kg) was administered by intravenous infusion every 2 weeks. The primary endpoint was PFS and the secondary endpoints were time-to-treatment failure, response rate, overall survival (OS), and safety. Between June 2016 and August 2017, 32 patients were enrolled. All patients previously received bevacizumab. The median PFS was 4.5 months; the median overall survival was 9.3 months. Partial response was observed in two patients. The most common adverse events above grade 3 were neutropenia followed by thrombocytopenia. There were no non-hematological adverse events above grade 3 and no treatment-related deaths occurred. This study met its primary endpoint of PFS, which is comparable to the results of the C-TASK FORCE study. The TAS-102 and bevacizumab combination has the potential to be a therapeutic option for third-line treatment of metastatic CRC.

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