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).

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 ).

• Authors: Goro Nakayama, Kiyoshi Ishigure, Hiroyuki Yokoyama, Keisuke Uehara, Hiroshi Kojima, Akiharu Ishiyama, Naomi Hayashi, Nao Takano, Norifumi Hattori, Daisuke Kobayashi, Chie Tanaka, Masamichi Hayashi, Mitsuro Kanda, Suguru Yamada, Hiroyuki Sugimoto, Masahiko Koike, Michitaka Fujiwara, Tsutomu Fujii, Kenta Murotani, Yuichi Ando, Yasuhiro Kodera
• Journal: BMC cancer (BMC Cancer) Vol. 17 Issue 1 Pg. 243 (04 04 2017) ISSN: 1471-2407 [Electronic] England
• PMID: 28376737 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Organoplatinum Compounds
• Oxaliplatin
• Bevacizumab
• Capecitabine

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols
• Bevacizumab (administration & dosage)
• Capecitabine (administration & dosage)
• Colorectal Neoplasms (drug therapy, pathology)
• Disease-Free Survival
• Female
• Humans
• Male
• Middle Aged
• Neoplasm Metastasis
• Organoplatinum Compounds (administration & dosage)
• Oxaliplatin