Evidence map›Paper›PMID 35168560›Full record

Trial reportBMC cancer2022

Prospective observational study of the efficacy of oral uracil and tegafur plus leucovorin for stage II colon cancer with risk factors for recurrence using propensity score matching (JFMC46-1201).

Sotaro Sadahiro, Kazuhiro Sakamoto, Takashi Tsuchiya, Takao Takahashi, Hiroki Ohge, Toshihiko Sato, Ken Kondo, Yutaka Ogata, Hideo Baba, Michio Itabashi and 10 more

Open access · goldAbstract readMulticenter StudyObservational StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
2.1field-weighted citation impact, top 11% of its field
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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. Observational
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. 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

20 authors at 19 institutions in 1 country.

Sotaro SadahiroDepartment of Surgery, Tokai University, 143 Shimokasuya, Isehara, Kanagawa, 259-1193, Japan. sadahiro@is.icc.u-tokai.ac.jp.ORCID http://orcid.org/0000-0002-7800-3880
Kazuhiro SakamotoDepartment of Coloproctological Surgery, Juntendo University, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.
Takashi TsuchiyaDepartment of Surgery, Sendai City Medical Center, 5-22-1 Tsurugaya, Miyagino-ku, Sendai, Miyagi, 983-0824, Japan.
Takao TakahashiDepartment of Digestive Surgery, Gifu University Hospital, 1-1 Yanagido, Gifu, 501-1194, Japan.
Hiroki OhgeDepartment of Infectious Diseases, Hiroshima University Hospital, 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, Japan.
Toshihiko SatoDepartment of Surgery, Yamagata Prefectural Central Hospital, 1800 Aoyagi, Yamagata, 990-2292, Japan.
Ken KondoDepartment of Surgery, Nagoya Medical Center, 4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi, 460-0001, Japan.
Yutaka OgataDepartment of Surgery, Kurume University Hospital Cancer Center, 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan.
Hideo BabaDepartment of Gastroenterological Surgery, Kumamoto University, 1-1-1 Honjo, Chuo-ku, Kumamoto, 860-8556, Japan.
Michio ItabashiDepartment of Surgery, Division of Inflammatory Bowel Disease Surgery, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.
Masataka IkedaDepartment of Gastroenterological Surgery, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan.
Madoka HamadaDivision of Gastrointestinal Surgery, Kansai Medical University Hospital, 2-3-1 Shinmachi Hirakata, Osaka, 573-1191, Japan.
Kiyoshi MaedaDepartment of Gastroenterological Surgery, Osaka City General Hospital, 2-13-22 Miyakojimahondori, Miyakojima-ku, Osaka, 534-0021, Japan.
Hiroyuki MasukoDepartment of Surgery, Nikko Memorial Hospital, 1-5-13 Shintomi-cho, Muroran, Hokkaido, 051-8501, Japan.
Keiichi TakahashiTokyo Metropolitan Health and Hospitals Corporation Ohkubo Hospital, 2-44-1 Kabuki-cho, Shinjuku-ku, Tokyo, 160-8488, Japan.
Junichi SakamotoTokai Central Hospital, 4-6-2 Sohara Higashijima-cho, Kakamigahara, Gifu, 504-8601, Japan.
Mitsuo KusanoDepartment of Physical Medicine, Yoichi Hospital, 19-1-1 Kurokawa-cho Yoichi, Hokkaido, 046-0003, Japan.
Ichinosuke HyodoDepartment of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, 160 Kou, Minamiumemoto, Matsuyama, Ehime, 791-0280, Japan.
Masataka TaguriDepartment of Data Science, Yokohama City University, 22-2 Seto, Kanazawa-ku, Yokohama, Kanagawa, 236-0027, Japan.
Satoshi MoritaDepartment of Biomedical Statistics and Bioinformatics, Kyoto University, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan.
Gifu University Hospital · JPHiroshima University Hospital · JPHyogo Medical University · JPJuntendo University · JPKansai Medical University · JPKumamoto University · JPKurume University Hospital · JPKyoto University · JPNagoya Medical Center · JPNikko Memorial Hospital · JPOhkubo Hospital · JPOsaka City General Hospital · JPSendai Medical Center · JPShikoku Cancer Center · JPTokai Central Hospital · JPTokai University · JPTokyo Women's Medical University · JPYamagata Prefectural Central Hospital · JPYokohama City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe efficacy of adjuvant chemotherapy for high-risk stage II colon cancer (CC) has not been well established. We compared the effects of surgery with and without oral uracil and tegafur plus leucovorin (UFT/LV) in patients with high-risk stage II CC, adjusting for potential risk factors.

methodsWe enrolled patients with histologically confirmed stage II colon adenocarcinoma with at least one of the following conditions: T4 disease, perforation/penetration, poorly differentiated adenocarcinoma/mucinous carcinoma, or < 12 dissected lymph nodes. Patients chose to be non-randomized or randomized to undergo surgery alone (NR-Group S or R-Group S) or surgery followed by 6 months of UFT/LV (NR-Group U or R-Group U). The primary endpoint was disease-free survival (DFS) after adjusting for previously reported risk factors using propensity score matching (1:2) and inverse probability of treatment weighting (IPTW) in the non-randomized arm.

resultsOverall, 1,902 (98%) and 36 (2%) patients were enrolled in the non-randomized and randomized arms, respectively. There were too few patients in the randomized arm and these were therefore excluded from the analysis. Of the 1,902 patients, 402 in NR-Group S and 804 in NR-Group U were propensity score-matched. The 3-year DFS rate (95% confidence interval) was significantly higher in NR-Group U (80.9% [77.9%-83.4%]) than in NR-Group S (74.0% [69.3%-78.0%]) (hazard ratio, 0.64 [0.50-0.83]; P = 0.0006). The 3-year overall survival rate was not significantly different between NR-Group S and NR-Group U. Significantly higher 3-year DFS (P = 0.0013) and overall survival (P = 0.0315) rates were observed in NR-Group U compared with NR-Group S using IPTW.

conclusionsAdjuvant chemotherapy with UFT/LV showed a significant survival benefit over surgery alone in patients with high-risk stage II CC characterized by at least one of the following conditions: T4 disease, perforation/penetration, poorly differentiated adenocarcinoma/mucinous carcinoma, or < 12 dissected lymph nodes.

trial registrationJapan Registry of Clinical Trials: jRCTs031180155 (date of registration: 25/02/2019) (UMIN Clinical Trials Registry: UMIN000007783 , date of registration: 18/04/2012).

Indexed as

Administration, OralAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsChemotherapy, AdjuvantColonic NeoplasmsDisease-Free SurvivalFemaleHumansJapanLeucovorinLymph Node ExcisionMaleMiddle AgedNeoplasm Recurrence, LocalLeucovorinTegafurUracilAdjuvant chemotherapyColon cancerHigh-riskInverse probability of treatment weightingLeucovorinPropensity scoreRisk factorStage IITegafurUracil

Identifiers

PMID35168560
PMCPMC8845390
OpenAlexW4213176947

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.