Evidence map›Paper›PMID 35470391›Full record

Trial reportJapanese journal of clinical oncology2022

Impact of chronological age on efficacy and safety of fluoropyrimidine plus bevacizumab in older non-frail patients with metastatic colorectal cancer: a combined analysis of individual data from two phase II studies of patients aged >75 years.

Toshikazu Moriwaki, Tomohiro Nishina, Yoshinori Sakai, Yoshiyuki Yamamoto, Mitsuo Shimada, Hiroyasu Ishida, Kenji Amagai, Mikio Sato, Shinji Endo, Yuji Negoro and 11 more

Erratum issuedAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Japanese journal of clinical oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 48% 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, 2 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 16 institutions in 1 country.

Toshikazu MoriwakiDepartment of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba City, Japan.ORCID 0000-0001-7702-122X
Tomohiro NishinaDepartment of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama City, Japan.
Yoshinori SakaiDepartment of Gastroenterology, Tsuchiura Kyodo General Hospital, Tsuchiura City, Japan.
Yoshiyuki YamamotoDepartment of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba City, Japan.
Mitsuo ShimadaDepartment of Surgery, Tokushima University, Tokushima City, Japan.
Hiroyasu IshidaDepartment of Gastroenterology, National Hospital Organization Mito Medical Center, Higashi Ibaraki gun, Japan.
Kenji AmagaiDivision of Gastroenterology, Ibaraki Prefectural Central Hospital and Cancer Center, Kasama City, Japan.
Mikio SatoDepartment of Gastroenterology and Hepatology, Ryugasaki Saiseikai Hospital, Ryugasaki City, Japan.
Shinji EndoDepartment of Gastroenterology and Hepatology, Shinmatsudo Central General Hospital, Matsudo City, Japan.
Yuji NegoroDepartment of Oncological Medicine, Kochi Health Sciences Center, Kochi City, Kochi, Japan.
Hidekazu KuramochiDepartment of Chemotherapy and Palliative Care, Tokyo Women's Medical University, Shinjuku-ku, Japan.
Tadamichi DendaDivision of Gastroenterology, Chiba Cancer Center, Chiba City, Japan.
Yukimasa HatachiDepartment of Medical Oncology, Kobe City Medical Center General Hospital, Kobe City, Japan.
Kazuto IkezawaDivision of Gastroenterology, Tsukuba Memorial Hospital, Tsukuba City, Japan.
Go NakajimaDepartment of Chemotherapy and Palliative Care, Tokyo Women's Medical University, Shinjuku-ku, Japan.
Yoshiaki BandoDepartment of Surgery, Tokushima Prefecture Naruto Hospital, Naruto City, Japan.
Akihito TsujiDepartment of Clinical Oncology, Kagawa University Faculty of Medicine, Kita-gun, Japan.
Yuji YamamotoDepartment of Gastrointestinal Surgery and Surgical Oncology, Ehime University Graduate School of Medicine, Toon City, Japan.
Masamitsu MorimotoDepartment of Surgery, National Hospital Organization Ehime Medical Center, Toon City, Japan.
Kazuma KobayashiDepartment of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki City, Japan.ORCID 0000-0002-4249-9933
Ichinosuke HyodoDepartment of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama City, Japan.
University of Tsukuba · JPShikoku Cancer Center · JPTokyo Women's Medical University · JPChiba Cancer Center · JPEhime Medical Center · JPIbaraki Prefectural Central Hospital · JPKagawa University · JPKobe City Medical Center General Hospital · JPNagasaki University · JPNaruto, Tokushima Prefecture hospital · JPNational Hospital Organization Mito Medical Center · JPShinmatsudo Central General Hospital · JPTokushima University · JPTsuchiura Kyodo General Hospital · JPTsukuba Memorial Hospital · JPUniversity of Kochi · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveMany clinical trials for older patients with metastatic colorectal cancer have been conducted, and fluoropyrimidine and bevacizumab are standard treatments. However, the relationship between age and the efficacy and safety of this treatment is unclear in older metastatic colorectal cancer patients.

methodsIndividual data from two phase II studies on older (≥75 years), non-frail patients with metastatic colorectal cancer treated with uracil-tegafur/leucovorin or S-1 combined with bevacizumab were collected. Patient characteristics were evaluated with multiple regression analyses for survival outcomes, using the Cox proportional hazard model and linear regression analyses for the worst grade of adverse events.

resultsWe enrolled 102 patients with a median age of 80 years (range, 75-88 years). Of the 70 patients who died, seven (10%) died of causes unrelated to disease or treatment. The study treatment was discontinued due to adverse events in 19 patients (18.6%), with 63% aged ≥85 years. The adverse event that most commonly resulted in treatment discontinuation was grade 2 fatigue (21%). Chronological age was not associated with progression-free survival (Hazard ratio, 1.03; P = 0.40) or overall survival (Hazard ratio, 1.02; P = 0.65). Age was weakly associated with non-hematologic adverse events (regression coefficient [R], 0.27; P = 0.007), especially fatigue (R, 0.23; P = 0.02) and nausea (R, 0.19; P = 0.06), but not with hematologic (R, 0.05; P = 0.43) or bevacizumab-related (R, -0.06; P = 0.56) adverse events.

conclusionsThe efficacy of fluoropyrimidine plus bevacizumab was age-independent in patients with metastatic colorectal cancer aged ≥75 years, and attention should be paid to non-hematologic adverse events as age increases.

Indexed as

Colonic NeoplasmsColorectal NeoplasmsRectal NeoplasmsAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBevacizumabDisease-Free SurvivalFatigueFluorouracilHumansLeucovorinBevacizumabFluorouracilLeucovorinadverse eventagebevacizumabchemotherapycolon cancerfluoropyrimidineolder patientsrectal cancertoxicityvulnerability

Identifiers

PMID35470391
OpenAlexW4224943009

What OpenQuestion holds

Textmetadata
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.