Evidence map›Paper›PMID 31089842›Full record

Trial reportInternational journal of clinical oncology2019

Phase II study of S-1 on alternate days plus bevacizumab in patients aged ≥ 75 years with metastatic colorectal cancer (J-SAVER).

Toshikazu Moriwaki, Yoshinori Sakai, Hiroyasu Ishida, Yoshiyuki Yamamoto, Shinji Endo, Hideaki Kuramochi, Mikio Sato, Yukimasa Hatachi, Yoshiaki Bando, Takashi Maeba and 8 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 38% 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, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Trial
  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

18 authors at 15 institutions in 1 country.

Toshikazu MoriwakiDivision of Gastroenterology, Faculty of Medicine, University of Tsukuba, 1-1-1, Tennodai, Tsukuba, 305-8575, Ibaraki, Japan. tmoriwak@gmail.com.ORCID http://orcid.org/0000-0001-7702-122X
Yoshinori SakaiDepartment of Gastroenterology, Tsuchiura Kyodo General Hospital, Tsuchiura City, Ibaraki, Japan.
Hiroyasu IshidaDepartment of Gastroenterology, National Hospital Organization Mito Medical Center, Higashi Ibaraki-Gun, Ibaraki, Japan.
Yoshiyuki YamamotoDivision of Gastroenterology, Faculty of Medicine, University of Tsukuba, 1-1-1, Tennodai, Tsukuba, 305-8575, Ibaraki, Japan.
Shinji EndoDivision of Gastroenterology and Hepatology, Shinmatsudo Central General Hospital, Matsudo City, Chiba, Japan.
Hideaki KuramochiDepartment of Chemotherapy, Yachiyo Medical Center, Tokyo Women's University, Yachiyo City, Chiba, Japan.
Mikio SatoDepartment of Gastroenterology and Hepatology, Ryugasaki Saiseikai Hospital, Ryugasaki City, Ibaraki, Japan.
Yukimasa HatachiDepartment of Medical Oncology, Kobe City Medical Center General Hospital, Kobe City, Hyogo, Japan.
Yoshiaki BandoDepartment of Surgery, Tokushima Prefecture Naruto Hospital, Naruto City, Tokushima, Japan.
Takashi MaebaDepartment of Surgery, Japan Community Health Care Organization Ritsurin Hospital, Takamatsu City, Kagawa, Japan.
Kazuto IkezawaDivision of Gastroenterology, Department of Internal Medicine, Tsukuba Memorial Hospital, Tsukuba City, Ibaraki, Japan.
Mitsuo ShimadaDepartment of Surgery, Tokushima University, Tokushima City, Tokushima, Japan.
Kenji AmagaiDivision of Gastroenterology and G.I. Oncology, Ibaraki Prefectural Central Hospital and Cancer Center, Kasama City, Ibaraki, Japan.
Masamitsu MorimotoDepartment of Surgery, Ehime Medical Center, Toon City, Ehime, Japan.
Kazuma KobayashiDepartment of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki City, Nagasaki, Japan.
Akihito TsujiDepartment of Clinical Oncology, Faculty of Medicine, Kagawa University, Kita-gun, Kagawa, Japan.
Tomohiro NishinaDepartment of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama City, Ehime, Japan.
Ichinosuke HyodoDivision of Gastroenterology, Faculty of Medicine, University of Tsukuba, 1-1-1, Tennodai, Tsukuba, 305-8575, Ibaraki, Japan.
University of Tsukuba · 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 · JPSaiseikai Ibaraki Hospital · JPShikoku Cancer Center · JPShinmatsudo Central General Hospital · JPTokushima University · JPTokyo Women's Medical University · JPTsuchiura Kyodo General Hospital · JPTsukuba Memorial Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlternate-day administration of S-1 is thought to reduce toxicities. This phase II study evaluated S-1 on alternate days combined with bevacizumab as first-line treatment for elderly patients with metastatic colorectal cancer. PATIENTS AND

methodsEligible patients had histologically proven colorectal adenocarcinoma, measurable metastatic lesions, age ≥ 75 years, Eastern Cooperative Oncology Group performance status ≤ 1, no previous chemotherapy, and refused oxaliplatin- or irinotecan-containing regimens. Patients received 40 mg, 50 mg, or 60 mg (body surface area ≤ 1.25 m

resultsOf 54 enrolled patients, 50 patients were evaluated for efficacy and 53 for safety. The median age was 79 years (range 75-88 years). The median progression-free survival was 8.1 months (95% confidence interval (CI) 6.7-9.5 months). The median overall survival was 23.1 months (95% CI 17.4-28.8 months). The response rate was 44% (95% CI 30.2-57.8%), and the disease control rate was 88% (95% CI 79.0-97.0%). Grade 3 or higher hematologic, non-hematologic, and bevacizumab-related adverse events occurred in 9%, 11%, and 25% of patients, respectively. The most common grade 3 and 4 treatment-related adverse events were hypertension (11%), nausea (6%), fatigue (6%), anemia (6%), and proteinuria (6%). Only 6 patients discontinued treatment due to adverse events.

conclusionS-1 on alternate days combined with bevacizumab showed better tolerability and comparable survival compared with the results of similar studies.

Indexed as

AdenocarcinomaAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBevacizumabColorectal NeoplasmsDrug Administration ScheduleDrug CombinationsFemaleHumansMaleNeoplasm MetastasisOxonic AcidPrognosisProspective StudiesSurvival RateBevacizumabDrug CombinationsOxonic AcidS 1 (combination)TegafurBevacizumabColorectal cancerElderlyFluoropyrimidineS-1

Identifiers

PMID31089842
OpenAlexW2945744650

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.