Evidence map›Paper›PMID 30833647›Full record

Trial reportBritish journal of cancer2019

Phase III randomised trial comparing 6 vs. 12-month of capecitabine as adjuvant chemotherapy for patients with stage III colon cancer: final results of the JFMC37-0801 study.

Naohiro Tomita, Katsuyuki Kunieda, Atsuyuki Maeda, Chikuma Hamada, Takeharu Yamanaka, Toshihiko Sato, Kazuhiro Yoshida, Narikazu Boku, Riichiro Nezu, Shigeki Yamaguchi and 7 more

Abstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
–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

15 citing papers in PubMed.

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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

17 authors.

Naohiro TomitaDepartment of Surgery, Division of Lower Gastrointestinal Surgery, Hyogo College of Medicine, Hyogo, Japan. ntomita@hyo-med.ac.jp.
Katsuyuki KuniedaDepartment of Surgery, Gifu Prefectural General Medical Center, Gifu, Japan.
Atsuyuki MaedaDepartment of Surgery, Ogaki Municipal Hospital, Gifu, Japan.
Chikuma HamadaGraduate School of Engineering, Tokyo University of Science, Tokyo, Japan.
Takeharu YamanakaDepartment of Biostatistics, Yokohama City University School of Medicine, Kanagawa, Japan.
Toshihiko SatoYamagata Prefectural Central Hospital, Yamagata, Japan.
Kazuhiro YoshidaDepartment of Surgical Oncology, Gifu University, Graduate School of Medicine, Gifu, Japan.
Narikazu BokuNational Cancer Center Hospital, Tokyo, Japan.
Riichiro NezuNishinomiya Municipal Central Hospital, Hyogo, Japan.
Shigeki YamaguchiDepartment of Gastroenterological Surgery, Saitama Medical University International Medical Center, Saitama, Japan.
Hideyuki MishimaCancer Center, Aichi Medical University, Aichi, Japan.
Sotaro SadahiroDepartment of Surgery, Tokai University School of Medicine, Kanagawa, Japan.
Kei MuroAichi Cancer Center, Aichi, Japan.
Megumi IshiguroDepartment of Translational Oncology, Tokyo Medical and Dental University Graduate School, Tokyo, Japan.
Junichi SakamotoJapanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan.
Shigetoyo SajiJapanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan.
Yoshihiko MaeharaJapanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUp to 6-months oxaliplatin-containing regimen is now widely accepted as a standard adjuvant chemotherapy for stage III colorectal cancer (CRC). However, oral fluoropyrimidine monotherapy is used for some part of patients, especially in Asian countries including Japan, and its optimal duration is yet to be fully investigated.

methodsA total of 1306 patients with curatively-resected stage III CRC were randomly assigned to receive capecitabine (2500 mg/m

resultsThe 3- and 5-year DFS were 70.0% and 65.3% in the 6M group and 75.3% and 68.7% in the 12M group, respectively (p = 0.0549, HR = 0.858, 90% CI: 0.732-1.004). The 5-year RFS was 69.3% and 74.1% in the 6M and 12M groups, respectively (p = 0.0143, HR = 0.796, 90% CI: 0.670-0.945). The 5-year OS was 83.2% and 87.6%, respectively (p = 0.0124, HR = 0.727, 90% CI: 0.575-0.919). The incidence of overall grade 3-4 adverse events was almost comparable in both groups.

conclusionsAlthough 12-month adjuvant capecitabine did not demonstrate superior DFS to that of 6-month, the observed better RFS and OS in the 12-month treatment period could be of value in selected cases.

Indexed as

AdenocarcinomaAgedAntimetabolites, AntineoplasticCapecitabineChemotherapy, AdjuvantColorectal NeoplasmsDisease-Free SurvivalDuration of TherapyFemaleHumansMaleNeoplasm StagingProportional Hazards ModelsAntimetabolites, AntineoplasticCapecitabine

Identifiers

PMID30833647
PMCPMC6461756

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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.