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International Journal of Colorectal Disease
Published in: International Journal of Colorectal Disease 12/2021

01-12-2021 | Maintenance Therapy | Original Article

Multicenter phase II clinical study of the efficiency and safety of capecitabine plus intermittent oxaliplatin with bevacizumab as first-line therapy in patients with metastatic colorectal cancer (VOICE trial)

Authors: Chihiro Kosugi, Keiji Koda, Tadamichi Denda, Keiichiro Ishibashi, Hideyuki Ishida, Kazuhiro Seike, Haruhito Sakata, Shinji Yanagisawa, Akinari Miyazaki, Wataru Takayama, Naoto Koike, Hiroaki Shimizu, Hisahiro Matsubara

Published in: International Journal of Colorectal Disease | Issue 12/2021

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Abstract

Purpose

The aim of this phase II study was to evaluate the efficacy and safety of combination therapy with five-cycle CAPOX (capecitabine plus oxaliplatin) plus bevacizumab, followed by five-cycle maintenance therapy with capecitabine plus bevacizumab and reintroduction of CAPOX plus bevacizumab for five cycles, with a preplanned intermittent oxaliplatin strategy in metastatic colorectal cancer (mCRC).

Methods

Patients with untreated mCRC were administered CAPOX (130 mg/m2 oxaliplatin on day 1, 2000 mg/m2/day capecitabine on days 1–14, every 21 days) + bevacizumab (7.5 mg/kg) every 3 weeks for five cycles, maintenance treatment without oxaliplatin for five cycles, and CAPOX + bevacizumab reintroduction for five cycles or upon tumor progression. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were the time to treatment failure (TTF), overall survival, response rate (RR), and safety.

Results

Forty-seven patients who fulfilled the inclusion criteria were enrolled in the evaluation of efficacy and safety. Median PFS was 14.1 months (95% confidence interval [CI], 8.6–19.5), and median TTF was 12.3 months (95% CI, 10.3–14.3). The objective RRs were 51.1% (24/47) during induction therapy, 58.3% (21/36) during maintenance therapy, and 63.6% (14/22) during reintroduction therapy. The frequency of patients with neutropenia, diarrhea, peripheral sensory neuropathy, venous thromboembolism, or grade ≥ 3 allergic reactions was 2.1%.

Conclusion

CAPOX plus bevacizumab therapy with a preplanned intermittent oxaliplatin strategy consisting of brief five-cycle induction therapy, five-cycle maintenance therapy with capecitabine plus bevacizumab, and five-cycle reintroduction therapy consisting of CAPOX plus bevacizumab is safe and effective for mCRC patients.

Trial registration

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Metadata
Title
Multicenter phase II clinical study of the efficiency and safety of capecitabine plus intermittent oxaliplatin with bevacizumab as first-line therapy in patients with metastatic colorectal cancer (VOICE trial)
Authors
Chihiro Kosugi
Keiji Koda
Tadamichi Denda
Keiichiro Ishibashi
Hideyuki Ishida
Kazuhiro Seike
Haruhito Sakata
Shinji Yanagisawa
Akinari Miyazaki
Wataru Takayama
Naoto Koike
Hiroaki Shimizu
Hisahiro Matsubara
Publication date
01-12-2021
Publisher
Springer Berlin Heidelberg
Published in
International Journal of Colorectal Disease / Issue 12/2021
Print ISSN: 0179-1958
Electronic ISSN: 1432-1262
DOI
https://doi.org/10.1007/s00384-021-03995-7

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