Evidence map›Paper›PMID 33604941›Full record

Trial reportThe oncologist2021

Administration Method of Adjuvant Tegafur-Uracil and Leucovorin Calcium in Patients with Resected Colorectal Cancer: A Phase III Study.

Taishi Hata, Kiyotaka Hagihara, Anna Tsutsui, Hiroki Akamatsu, Masayuki Ohue, Tatsushi Shingai, Mitsuyoshi Tei, Masakazu Ikenaga, Ho Min Kim, Hideki Osawa and 9 more

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The oncologist, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.5field-weighted citation impact, top 33% 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

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Review
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

19 authors at 11 institutions in 1 country.

Taishi HataDepartment of Gastroenterological Surgery, Kansai Rosai Hospital, Hyogo, Japan.ORCID 0000-0003-1680-724X
Kiyotaka HagiharaDepartment of Surgery, Kawanishi City Hospital, Kawanishi, Japan.
Anna TsutsuiDepartment of Mathematical Health Science, Graduate School of Medicine, Osaka University, Osaka, Japan.
Hiroki AkamatsuDepartment of Surgery, Osaka Police Hospital, Osaka, Japan.
Masayuki OhueDepartment of Surgery, Osaka Police Hospital, Osaka, Japan.
Tatsushi ShingaiDepartment of Surgery, Saiseikai Senri Hospital, Osaka, Japan.
Mitsuyoshi TeiDepartment of Gastroenterological Surgery, Osaka Rosai Hospital, Osaka, Japan.
Masakazu IkenagaDepartment of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.
Ho Min KimDepartment of Surgery, Rinku General Medical Center, Izumisano Municipal Hospital, Osaka, Japan.
Hideki OsawaDepartment of Surgery, Japan Community Health Care Organization Osaka Hospital, Osaka, Japan.
Hiroyoshi TakemotoDepartment of Surgery, Kinki Central Hospital, Hyogo, Japan.
Ken Konishi
Mamoru UemuraDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.
Chu MatsudaDepartment of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.
Tsunekazu MizushimaDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.
Kohei MurataDepartment of Gastroenterological Surgery, Kansai Rosai Hospital, Hyogo, Japan.
Yuko OhnoDepartment of Mathematical Health Science, Graduate School of Medicine, Osaka University, Osaka, Japan.
Yuichiro DokiDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.
Hidetoshi EguchiDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.
Osaka University · JPKansai Rosai Hospital · JPOsaka Health Science University · JPOsaka Police Hospital · JPKinki Central Hospital · JPKishiwada City Hospital · JPOsaka Hospital · JPOsaka Medical Center for Cancer and Cardiovascular Diseases · JPOsaka National Hospital · JPOsaka Rosai Hospital · JPSaiseikaisenri Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

lessons learnedThe 3-year disease-free survival rate of the twice-daily regimen was not inferior to that of the conventional three-times-daily regimen, and the twice-daily regimen did not lead to an increase in adverse events. The effectiveness of the twice-daily regimen highlights an increased number of treatment options for patients. This will facilitate personalized medicine, particularly for elderly or frail patients who may experience more severe side effects from the combination therapy.

backgroundTegafur-uracil (UFT)/leucovorin calcium (LV) is an adjuvant chemotherapy treatment for colorectal cancer. We conducted a multicenter randomized trial to assess the noninferiority of a twice-daily compared with a three-times-daily UFT/LV regimen for stage II/III colorectal cancer in an adjuvant setting.

methodsPatients were randomly assigned to group A (three doses of UFT [300 mg/m

resultsIn total, 386 patients were enrolled between July 28, 2011, and September 27, 2013. The 3-year disease-free survival rates of group A (n = 194) and B (n = 192) were 79.4% and 81.4% (95% confidence interval, 72.6-84.4-74.5-85.9), respectively. The most common grade 3/4 adverse events in group A and B were diarrhea (3.9% vs. 7.3%), neutropenia (2.9% vs. 1.6%), increase in aspartate aminotransferase (4.0% vs. 3.9%), increase in alanine aminotransferase (6.2% vs. 6.8%), nausea (1.7% vs. 3.4%), and fatigue (1.1% vs. 2.3%).

conclusionGroup B outcomes were not inferior to group A outcomes, and adverse events did not increase.

Indexed as

Colorectal NeoplasmsTegafurAdministration, OralAgedAntineoplastic Combined Chemotherapy ProtocolsCalciumChemotherapy, AdjuvantHumansLeucovorinUracilCalciumLeucovorinTegafurUracilColorectal cancerLeucovorin calciumPhase IIITegafur-uracil

Identifiers

PMID33604941
PMCPMC8100551
OpenAlexW3133255100

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.