Evidence map›Paper›PMID 21340666›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2011

Randomized phase III study comparing the efficacy and safety of irinotecan plus S-1 with S-1 alone as first-line treatment for advanced gastric cancer (study GC0301/TOP-002).

Hiroyuki Narahara, Hiroyasu Iishi, Hiroshi Imamura, Akira Tsuburaya, Keisho Chin, Haruhiko Imamoto, Taito Esaki, Hiroshi Furukawa, Chikuma Hamada, Yuh Sakata

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

Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 74 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 10 pooled it
17.2field-weighted citation impact, top 1% 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

74 citing papers in PubMed, 10 syntheses or guidelines pooled it, 160 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Chemotherapy for advanced gastric cancer.The Cochrane database of systematic reviews · 2017
    Pooled it
  4. Japanese gastric cancer treatment guidelines 2014 (ver. 4).Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2017
    Guideline
  5. Pooled it
  6. The efficacy and safety of S-1-based regimens in the first-line treatment of advanced gastric cancer: a systematic review and meta-analysis.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2016
    Pooled it
  7. Pooled it
  8. S-1-based therapy versus S-1 monotherapy in advanced gastric cancer: a meta-analysis.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2014
    Pooled it
  9. Pooled it
  10. Japanese gastric cancer treatment guidelines 2010 (ver. 3).Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2011
    Guideline
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
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  18. Stratified phase II trial to establish the usefulness of the collagen gel droplet embedded culture-drug sensitivity test (CD-DST) for advanced gastric cancer.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2014
    Trial
  19. Trial
  20. A randomized phase II study comparing S-1 plus weekly split-dose cisplatin with S-1 plus standard-dose cisplatin as first-line chemotherapy for advanced gastric cancer.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2014
    Trial

14 more citing papers are in PubMed but not listed here.

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

10 authors at 9 institutions in 1 country.

Hiroyuki NaraharaDivision of Clinical Oncology, Hiroshima University Graduate School of Biomedical Sciences, Hiroshima, 734-8551, Japan. narahara@hiroshima-u.ac.jp
Hiroyasu Iishi
Hiroshi Imamura
Akira Tsuburaya
Keisho Chin
Haruhiko Imamoto
Taito Esaki
Hiroshi Furukawa
Chikuma Hamada
Yuh Sakata
Sakai Municipal Hospital · JPHiroshima University · JPKanagawa Cancer CenterKindai University · JPMisawa City Hospital · JPNational Hospital Organization Kyushu Cancer Center · JPOsaka Medical Center for Cancer and Cardiovascular Diseases · JPThe Cancer Institute Hospital · JPTokyo University of Science · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIrinotecan hydrochloride and S-1, an oral fluoropyrimidine, have shown antitumor activity against advanced gastric cancer as single agents in phase I/II studies. The combination of irinotecan and S-1 (IRI-S) is also active against advanced gastric cancer. This study was conducted to compare the efficacy and safety of IRI-S versus S-1 monotherapy in patients with advanced or recurrent gastric cancer.

methodsPatients were randomly assigned to oral S-1 (80 mg/m² daily for 28 days every 6 weeks) or oral S-1 (80 mg/m² daily for 21 days every 5 weeks) plus irinotecan (80 mg/m² by intravenous infusion on days 1 and 15 every 5 weeks) (IRI-S). The primary endpoint was overall survival. Secondary endpoints included the time to treatment failure, 1- and 2-year survival rates, response rate, and safety.

resultsThe median survival time with IRI-S versus S-1 monotherapy was 12.8 versus 10.5 months (P = 0.233), time to treatment failure was 4.5 versus 3.6 months (P = 0.157), and the 1-year survival rate was 52.0 versus 44.9%, respectively. The response rate was significantly higher for IRI-S than for S-1 monotherapy (41.5 vs. 26.9%, P = 0.035). Neutropenia and diarrhea occurred more frequently with IRI-S, but were manageable. Patients treated with IRI-S received more courses of therapy at a relative dose intensity similar to that of S-1 monotherapy.

conclusionsAlthough IRI-S achieved longer median survival than S-1 monotherapy and was well tolerated, it did not show significant superiority in this study.

Indexed as

AdultAgedAntimetabolites, AntineoplasticAntineoplastic Agents, PhytogenicAntineoplastic Combined Chemotherapy ProtocolsCamptothecinDisease ProgressionDrug CombinationsFemaleFollow-Up StudiesHumansIrinotecanMaleMiddle AgedNeoplasm Recurrence, LocalOxonic AcidAntimetabolites, AntineoplasticAntineoplastic Agents, PhytogenicCamptothecinDrug CombinationsIrinotecanOxonic AcidS 1 (combination)Tegafur

Identifiers

PMID21340666
PMCPMC3056989
OpenAlexW2053144686

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.