The efficacy and safety of CapeOX plus bevacizumab therapy followed by capecitabine plus bevacizumab maintenance therapy in patients with metastatic colorectal cancer: a multi-center, single-arm, phase II study (CCOG-0902)

BMC Cancer

Yuichi Ando¹  Hiroshi Kojima²  Masamichi Hayashi³  Yasuhiro Kodera³  Mitsuro Kanda³  Goro Nakayama³  Daisuke Kobayashi³  Norifumi Hattori³  Chie Tanaka³  Suguru Yamada³  Tsutomu Fujii³  Masahiko Koike³  Hiroyuki Sugimoto³  Nao Takano³  Michitaka Fujiwara³  Hiroyuki Yokoyama⁴  Kiyoshi Ishigure⁵  Akiharu Ishiyama⁶  Naomi Hayashi⁷  Keisuke Uehara⁸  Kenta Murotani⁹ 

[1] Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital;Department of Gastroenterological Surgery, Aichi Cancer Center Aichi Hospital;Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine;Department of Surgery, Komaki City Hospital;Department of Surgery, Konan Kosei Hospital;Department of Surgery, Okazaki City Hospital;Department of Surgery, Tosei Hospital;Department of Surgical Oncology, Nagoya University Graduate School of Medicine;Division of Biostatistics, Clinical Research Center, Aichi Medical University Hospital;

关键词: Metastatic colorectal cancer;    Reintroduction of oxaliplatin;    Maintenance therapy;    Capecitabin;    Bevacizumab;    Peripheral sensory neuropathy;   

DOI  :  10.1186/s12885-017-3245-1

来源: DOAJ

【 摘 要 】

Abstract Background The aim of this study was to evaluate the efficacy and safety of CapeOX plus bevacizumab with a planned oxaliplatin stop-and-go strategy in Japanese patients with metastatic colorectal cancer (mCRC). Methods Patients with untreated mCRC were treated with 4 cycles of CapeOX plus bevacizumab therapy, followed by capecitabine plus bevacizumab maintenance therapy. Reintroduction of oxaliplatin was scheduled after 8 cycles of maintenance therapy or upon tumor progression. The primary endpoint was progression-free survival (PFS), and secondary end points included overall survival (OS), objective response rate to each treatment, reintroduction rate of oxaliplatin, frequency of peripheral sensory neuropathy (PSN), and safety. Results The 52 patients who received the protocol treatment were included in the evaluation of efficacy and safety. Median PFS and OS were 12.4 months (95% confidence interval [CI], 10.0–14.8) and 30.6 months (95% CI, 27.6–33.5), respectively. The objective response rates were 55.8% for the initial CapeOX plus bevacizumab therapy, 17.8% for capecitabine plus bevacizumab maintenance therapy, and 31.0% for reintroduced CapeOX plus bevacizumab therapy. The frequency of PSN was 63.5%, including 3.8% of patients with grade 3 PSN. No patients required treatment discontinuation because of PSN during the induction or maintenance therapy. Conclusions CapeOX plus bevacizumab therapy with a planned oxaliplatin stop-and-go strategy is a feasible first-line treatment for Japanese patients with mCRC. Trial registration This trial is registered with the University Hospital Medical Information Network in 15 March 2010 ( UMIN000006478 ).

【 授权许可】

Unknown