Evidence map›Paper›PMID 29293874›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2018

S-1 and irinotecan plus bevacizumab versus mFOLFOX6 or CapeOX plus bevacizumab as first-line treatment in patients with metastatic colorectal cancer (TRICOLORE): a randomized, open-label, phase III, noninferiority trial.

Y Yamada, T Denda, M Gamoh, I Iwanaga, S Yuki, H Shimodaira, M Nakamura, T Yamaguchi, H Ohori, K Kobayashi and 10 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 62 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 6 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

62 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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  18. The Current Role of Antiangiogenics in Colorectal Cancer.International journal of molecular sciences · 2025
    Review
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2 more citing papers are in PubMed but not listed here.

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

20 authors.

Y YamadaGastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.
T DendaDivision of Gastroenterology, Chiba Cancer Center, Chiba, Japan.
M GamohDepartment of Medical Oncology, Osaki Citizen Hospital, Miyagi, Japan.
I IwanagaDepartment of Medical Oncology, Japanese Red Cross Kitami Hospital, Hokkaido, Japan.
S YukiDepartment of Gastroenterology and Hepatology, Hokkaido University Hospital, Hokkaido, Japan.
H ShimodairaDepartment of Medical Oncology, Tohoku University Hospital, Miyagi, Japan.
M NakamuraComprehensive Cancer Center, Aizawa Hospital, Nagano, Japan.
T YamaguchiDepartment of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
H OhoriClinical Oncology, Japanese Red Cross Ishinomaki Hospital, Miyagi, Japan.
K KobayashiDivision of Medical Oncology, Showa University Northern Yokohama Hospital, Kanagawa, Japan.
M TsudaDepartment of Gastroenterological Oncology, Hyogo Cancer Center, Hyogo, Japan.
Y KobayashiDepartment of Internal Medicine, Kushiro Rosai Hospital, Hokkaido, Japan.
Y MiyamotoDepartment of Gastroenterological Surgery, Kumamoto University, Kumamoto, Japan.
M KotakeDepartment of Surgery, Kouseiren Takaoka Hospital, Toyama, Japan.
K ShimadaDepartment of Internal Medicine, Showa University Koto Toyosu Hospital, Tokyo, Japan.
A SatoDepartment of Medical Oncology, Hirosaki University Graduate School of Medicine, Aomori, Japan.
S MoritaDepartment of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
S TakahashiDepartment of Medical Oncology, Tohoku University Hospital, Miyagi, Japan.
Y KomatsuDepartment of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Hokkaido, Japan. Electronic address: ykomatsu@ac.cyberhome.ne.jp.
C IshiokaDepartment of Medical Oncology, Tohoku University Hospital, Miyagi, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Combination therapy with oral fluoropyrimidine and irinotecan has not yet been established as first-line treatment of metastatic colorectal cancer (mCRC). We carried out a randomized, open-label, phase III trial to determine whether S-1 and irinotecan plus bevacizumab is noninferior to mFOLFOX6 or CapeOX plus bevacizumab in terms of progression-free survival (PFS). Patients and methods: Patients from 53 institutions who had previously untreated mCRC were randomly assigned (1 : 1) to receive either mFOLFOX6 or CapeOX plus bevacizumab (control group) or S-1 and irinotecan plus bevacizumab (experimental group; a 3-week regimen: intravenous infusions of irinotecan 150 mg/m2 and bevacizumab 7.5 mg/kg on day 1, oral S-1 80 mg/m2 twice daily for 2 weeks, followed by a 1-week rest; or a 4-week regimen: irinotecan 100 mg/m2 and bevacizumab 5 mg/kg on days 1 and 15, S-1 80 mg/m2 twice daily for 2 weeks, followed by a 2-week rest). The primary end point was PFS. The noninferiority margin was 1.25; noninferiority would be established if the upper limit of the 95% confidence interval (CI) for the hazard ratio (HR) of the control group versus the experimental group was less than this margin. Result: Between June 2012 and September 2014, 487 patients underwent randomization. Two hundred and forty-three patients assigned to the control group and 241 assigned to the experimental group were included in the primary analysis. Median PFS was 10.8 months (95% CI 9.6-11.6) in the control group and 14.0 months (95% CI 12.4-15.5) in the experimental group (HR 0.84, 95% CI 0.70-1.02; P < 0.0001 for noninferiority, P = 0.0815 for superiority). One hundred and fifty-seven patients (64.9%) in the control group and 140 (58.6%) in the experimental group had adverse events of grade 3 or higher. Conclusion: S-1 and irinotecan plus bevacizumab is noninferior to mFOLFOX6 or CapeOX plus bevacizumab with respect to PFS as first-line treatment of mCRC and could be a new standard treatment. Clinical trials number: UMIN000007834.

Indexed as

AdenocarcinomaAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCapecitabineColorectal NeoplasmsDisease-Free SurvivalDrug CombinationsFemaleFluorouracilHumansIrinotecanKaplan-Meier EstimateLeucovorinBevacizumabCapecitabineDrug CombinationsFluorouracilIrinotecanLeucovorinOrganoplatinum CompoundsOxaliplatinOxonic AcidS 1 (combination)Tegafur

Identifiers

PMID29293874
PMCPMC5889030

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Registered trials

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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.