Evidence map›Paper›PMID 34368890›Full record

Trial reportInternational journal of colorectal disease2021

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).

Chihiro Kosugi, Keiji Koda, Tadamichi Denda, Keiichiro Ishibashi, Hideyuki Ishida, Kazuhiro Seike, Haruhito Sakata, Shinji Yanagisawa, Akinari Miyazaki, Wataru Takayama and 3 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in International journal of colorectal disease, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Chihiro KosugiDepartment of Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan. ckosugi0126@yahoo.co.jp.ORCID http://orcid.org/0000-0003-3719-6425
Keiji KodaDepartment of Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan.
Tadamichi DendaDivision of Gastroenterology, Chiba Cancer Center, Chiba, Japan.
Keiichiro IshibashiDepartment of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Kawagoe, Saitama, Japan.
Hideyuki IshidaDepartment of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Kawagoe, Saitama, Japan.
Kazuhiro SeikeDepartment of Surgery, Odawara Municipal Hospital, Odawara, Kanagawa, Japan.
Haruhito SakataDepartment of Surgery, Saisei Hospital, Hanamigawa, Chiba, Japan.
Shinji YanagisawaDepartment of Surgery, Kimitsu Chuo Hospital, Kisarazu, Chiba, Japan.
Akinari MiyazakiDepartment of Surgery, Funabashi Municipal Medical Center, Funabashi, Chiba, Japan.
Wataru TakayamaDepartment of Surgery, Chiba Prefectural Sawara Hospital, Sakura, Chiba, Japan.
Naoto KoikeDepartment of Surgery, Seirei Sakura Citizen Hospital, Sakura, Chiba, Japan.
Hiroaki ShimizuDepartment of Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan.
Hisahiro MatsubaraDepartment of Frontier Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe 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).

methodsPatients with untreated mCRC were administered CAPOX (130 mg/m

resultsForty-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%.

conclusionCAPOX 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 registrationUMIN ID: 000,005,732, date of registration: June 7, 2011.  https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000006695.

Indexed as

Colorectal NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCapecitabineDisease-Free SurvivalFluorouracilHumansOrganoplatinum CompoundsOxaliplatinTreatment OutcomeBevacizumabCapecitabineFluorouracilOrganoplatinum CompoundsOxaliplatinCAPOXMetastatic colorectal cancer stop-and-go strategyPeripheral sensory neuropathyReintroduction of oxaliplatin

Identifiers

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.