Combination of TAS-102 and bevacizumab as third-line treatment for metastatic colorectal cancer: TAS-CC3 study
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ORIGINAL ARTICLE
Combination of TAS‑102 and bevacizumab as third‑line treatment for metastatic colorectal cancer: TAS‑CC3 study Yoichiro Yoshida1 · Takeshi Yamada2 · Hirohiko Kamiyama3 · Chihiro Kosugi4 · Keiichiro Ishibashi5 · Hiroshi Yoshida2 · Hideyuki Ishida5 · Satoru Yamaguchi6 · Hidekazu Kuramochi7 · Atsuko Fukazawa8 · Hiromichi Sonoda9 · Kazuhiko Yoshimatsu10 · Akihisa Matsuda11 · Suguru Hasegawa1 · Kazuhiro Sakamoto3 · Toshiaki Otsuka12 · Keiji Koda4 on behalf of On behalf of the TAS CC3 Study Group. Received: 27 June 2020 / Accepted: 22 September 2020 © Japan Society of Clinical Oncology 2020
Abstract Background 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 thirdline treatment. Our study exclusively examined patients receiving this combination as a third-line treatment to investigate the clinical impact beyond cytotoxic doublets. Methods 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. Results 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 nonhematological adverse events above grade 3 and no treatment-related deaths occurred. Conclusions 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. Keywords Bevacizumab · Chemotherapy · Colorectal cancer · TAS-102 · Neutropenia * Yoichiro Yoshida yyoshida@fukuoka‑u.ac.jp 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
6
Department of Surgical Oncology, Dokkyo Medical University, Tochigi, Japan
7
Department of Chemotherapy, Tokyo Women’s Medical University Yachiyo Medical Center, Chiba, Japan
8
Department of Gastroenterological Surgery, Iwata City Hospital, Shizuoka, Japan
9
Department of Surgery, Shiga University of Medical Science, Shiga, Japan
2
Department of Gastrointes
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