Evidence map›Paper›PMID 34318389›Full record

ArticleInternational journal of clinical oncology2021

Tolerability and safety of adjuvant chemoradiotherapy with S-1 after limited surgery for T1 or T2 lower rectal cancer.

Mitsuyoshi Tei, Shingo Noura, Masayuki Ohue, Masatoshi Kitakaze, Hidekazu Takahashi, Norikatsu Miyoshi, Mamoru Uemura, Tsunekazu Mizushima, Kohei Murata, Yuichiro Doki and 1 more

Abstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in International journal of clinical oncology, 2021. 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
0.1field-weighted citation impact, top 54% 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

1 citing paper in PubMed, 1 citations in OpenAlex.

  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

11 authors at 5 institutions in 1 country.

Mitsuyoshi TeiDepartment of Surgery, Osaka Rosai Hospital, 1179-3 Nagasonecho, Kita-ku, Sakai, 591-8025, Japan. mtei@live.jp.ORCID http://orcid.org/0000-0003-0236-3641
Shingo NouraDepartment of Surgery, Toyonaka Municipal Hospital, Toyonaka, Japan.
Masayuki OhueDepartment of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.
Masatoshi KitakazeDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Japan.
Hidekazu TakahashiDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Japan.
Norikatsu MiyoshiDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Japan.
Mamoru UemuraDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Japan.
Tsunekazu MizushimaDepartment of Surgery, Osaka Rosai Hospital, 1179-3 Nagasonecho, Kita-ku, Sakai, 591-8025, Japan.
Kohei MurataDepartment of Surgery, Kansai Rosai Hospital, Amagasaki, Japan.
Yuichiro DokiDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Japan.
Hidetoshi EguchiDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Japan.
The University of Osaka · JPOsaka Rosai Hospital · JPKansai Rosai Hospital · JPOsaka International Cancer Institute · JPToyonaka Municipal Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChemo-radiotherapy (CRT) after local excision for pT1 with high-risk features or pT2 rectal cancer is recommended as an optional treatment to achieve both curability and maintenance of quality of life. The aim of this study was to evaluate the short-term safety of combining limited surgery with adjuvant CRT for T1 or T2 lower rectal cancer.

methodsThis was a multicenter, single-arm, prospective phase II trial. Patients diagnosed with lower rectal or anal canal cancer (clinical T1 or T2 with a maximum diameter of 30 mm and N0 and M0) underwent local excision or endoscopic resection. Patients received CRT with S-1 (tegafur/gimeracil/oteracil) after confirmation of well- or moderately differentiated adenocarcinoma, and negative margins, and/or depth of submucosal invasion ≥ 1000 µm or muscularis propria, and/or positive lymphovascular invasion, and/or tumor budding grade of 2/3. The primary endpoint was relapse-free survival. Secondary endpoints included overall and local relapse-free survival, safety, anal sphincter preservation rate, and anal function.

resultsPathological diagnosis was T1 in 36 patients and T2 in 16 patients. Serious complications after surgery were not reported. The CRT completion rate per protocol was 86.5% (45/52). Thirty-two patients developed 54 events of CRT-related adverse events, including only one patient with a grade 3 event (stomatitis). The most common CRT-related adverse event was diarrhea (n = 14). No patients showed deterioration of anal function at 3 years postoperatively.

conclusionCRT with S-1 after limited surgery for T1 or T2 lower rectal cancer resulted in a low incidence of toxicities and maintenance of anal function.

Indexed as

Chemoradiotherapy, AdjuvantRectal NeoplasmsHumansNeoplasm Recurrence, LocalOxonic AcidProspective StudiesPyridinesQuality of LifeTegafurgimeracilOxonic AcidPyridinesTegafurAdjuvant chemo-radiotherapyEarly rectal cancerLocal excision

Identifiers

PMID34318389
OpenAlexW3186846388

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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.