Evidence map›Paper›PMID 24045669›Full record

Trial reportBritish journal of cancer2013

Randomised phase II study of S-1/cisplatin plus TSU-68 vs S-1/cisplatin in patients with advanced gastric cancer.

W Koizumi, K Yamaguchi, H Hosaka, Y Takinishi, N Nakayama, T Hara, K Muro, H Baba, Y Sasaki, T Nishina and 5 more

Erratum issuedAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2013. 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 18 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 10 pooled it
–field-weighted citation impact
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

18 citing papers in PubMed, 10 syntheses or guidelines pooled it.

  1. Pooled it
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  7. Molecular-targeted first-line therapy for advanced gastric cancer.The Cochrane database of systematic reviews · 2016
    Pooled it
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  10. The role of anti-VEGF agents in the treatment of advanced gastric cancer: a meta-analysis of randomized controlled trials.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2014
    Pooled it
  11. Trial
  12. Article
  13. Review
  14. Review
  15. Review
  16. Article
  17. New drug developments in metastatic gastric cancer.Therapeutic advances in gastroenterology · 2018
    Review
  18. Article
4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

15 authors.

W KoizumiDepartment of Gastroenterology, Kitasato University East Hospital, Sagamihara 228-8520, Japan.
K Yamaguchi
H Hosaka
Y Takinishi
N Nakayama
T Hara
K Muro
H Baba
Y Sasaki
T Nishina
N Fuse
T Esaki
M Takagi
M Gotoh
T Sasaki

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study aimed to determine whether combination S-1 plus cisplatin (CDDP) therapy, the most widely used therapy for Japanese patients with advanced gastric cancer, and the novel oral antiangiogenic agent TSU-68 could contribute to gastric cancer treatment.

methodsNinety-three patients with chemotherapy-naïve unresectable or recurrent advanced gastric cancers were randomised into two groups: TSU-68 plus S-1/CDDP (group A) and S-1/CDDP (group B) groups. Both patient groups received identical S-1 and CDDP dosages. TSU-68 was orally administered for 35 consecutive days. Group B patients received S-1 orally twice daily for three consecutive weeks, followed by intravenous CDDP on day 8. The primary endpoint was progression-free survival (PFS).

resultsMedian PFS periods were 208 and 213 days in groups A and B, respectively (P=0.427). Median survival periods for groups A and B were 497.0 and 463.5 days, respectively (P=0.219). No statistically significant differences were noted for PFS, survival or the adverse event (AE) incidence rate. All AEs were expected according to previous reports for TSU-68, TS-1, and CDDP.

conclusionCombination therapy involving TSU-68, S-1, and CDDP was safe and well tolerated in patients with chemotherapy-naïve unresectable or recurrent advanced gastric cancers. However, factors related to therapeutic efficacy should be investigated further.

Indexed as

AgedAngiogenesis InhibitorsAntineoplastic Combined Chemotherapy ProtocolsCisplatinDisease-Free SurvivalDrug CombinationsFemaleHumansIndolesMaleMiddle AgedOxindolesOxonic AcidPropionatesPyrrolesStomach NeoplasmsAngiogenesis InhibitorsCisplatinDrug CombinationsIndolesorantinibOxindolesOxonic AcidPropionatesPyrrolesS 1 (combination)Tegafur

Identifiers

PMID24045669
PMCPMC3798959

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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.