Evidence map›Paper›PMID 38833114›Full record

ArticleInternational journal of clinical oncology2024

Final analyses of the prospective controlled trial on the efficacy of uracil and tegafur/leucovorin as an adjuvant treatment for stage II colon cancer with risk factors for recurrence using propensity score-based methods (JFMC46-1201).

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

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of clinical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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.

Yutaka OgataDepartment of Surgery, Kurume University School of Medicine, 67 Asahi-Machi, Kurume, Fukuoka, 830-0011, Japan. yogata147@gmail.com.ORCID http://orcid.org/0009-0007-5883-8681
Sotaro SadahiroDepartment of Surgery, Tokai University, 143 Shimokasuya, Isehara, Kanagawa, 259-1193, Japan.
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.
Hideo BabaDepartment of Gastroen- Terological 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, Division of Lower GI, Hyogo Medical University, 1-1 Mukogawa-Cho, Nishinomiya, Hyogo, 663-8501, Japan.
Madoka HamadaDepartment of Gastrointestinal Surgery, Kansai Medical University Hospital, 2-3-1 Shinmachi Hirakata, Osaka, 573-1191, Japan.
Kiyoshi MaedaDepartment of Gastroenterological Surgery, Osaka Metropolitan University, 1-4-3 Asahimachi, Abeno-Ku, Osaka, 545-8585, 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.
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.
Junichi SakamotoTokai Central Hospital, 4-6-2 Sohara Higashijima-Cho, Kakamigahara, Gifu, 504-8601, Japan.
Masataka TaguriDepartment of Health Data Science, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku-Ku, Tokyo, 160-8402, Japan.
Satoshi MoritaDepartment of Biomedical Statistics and Bioinformatics, Kyoto University, 54 Kawahara-Cho, Shogoin, Sakyo-Ku, Kyoto, 606-8507, Japan.

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. Using propensity score matching, we previously reported that the 3-year disease-free survival (DFS) rate was significantly higher in patients treated with uracil and tegafur plus leucovorin (UFT/LV) against surgery alone. We report the final results, including updated 5-year overall survival (OS) rates and risk factor analysis outcomes.

methodsIn total, 1902 high-risk stage II CC patients with T4, perforation/penetration, poorly differentiated adenocarcinoma/mucinous carcinoma, and/or < 12 dissected lymph nodes were enrolled in this prospective, non-randomized controlled study based on their self-selected treatment. Oral UFT/LV therapy was administered for six months after surgery.

resultsOf the 1880 eligible patients, 402 in Group A (surgery alone) and 804 in Group B (UFT/LV) were propensity score-matched. The 5-year DFS rate was significantly higher in Group B than in Group A (P = 0.0008). The 5-year OS rates were not significantly different between groups. The inverse probability of treatment weighting revealed significantly higher 5-year DFS (P = 0.0006) and 5-year OS (P = 0.0122) rates in group B than in group A. Multivariate analyses revealed that male sex, age ≥ 70 years, T4, < 12 dissected lymph nodes, and no adjuvant chemotherapy were significant risk factors for DFS and/or OS.

conclusionThe follow-up data from our prospective non-randomized controlled study revealed a considerable survival advantage in DFS offered by adjuvant chemotherapy with UFT/LV administered for six months over surgery alone in individuals with high-risk stage II CC.

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

Antineoplastic Combined Chemotherapy ProtocolsColonic NeoplasmsLeucovorinNeoplasm Recurrence, LocalNeoplasm StagingPropensity ScoreTegafurUracilAdultAgedAged, 80 and overChemotherapy, AdjuvantDisease-Free SurvivalFemaleHumansMaleLeucovorinTegafurUracilAdjuvant chemotherapyColon cancerHigh-risk stage IIInverse probability of treatment-weightingLeucovorinPropensity scoreRisk factorTegafurUracil

Identifiers

PMID38833114
PMCPMC11347494

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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.