Evidence map›Paper›PMID 16773074›Full record

Trial reportBritish journal of cancer2006

Phase I/II study of docetaxel and S-1 in patients with advanced gastric cancer.

K Yamaguchi, T Shimamura, I Hyodo, W Koizumi, T Doi, H Narahara, Y Komatsu, T Kato, S Saitoh, T Akiya and 8 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00525005 (A Phase II Study of Docetaxel, Oxaliplatin and S-1), which is not on this map. Cited by 32 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 2 pooled it
7.8field-weighted citation impact, top 2% 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.

NCT00525005 phase2completednot on this mapstarted 2007, after this paper: background citation

A Phase II Study of Docetaxel, Oxaliplatin and S-1 (DOS) in Patients With Advanced Gastric Cancer

TypeinterventionalSponsorHallym University Medical CenterRan2007 to 2010Enrolled44ConditionsStomach NeoplasmsArmsDOS (Docetaxel, Oxaliplatin and S-1)
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 2 syntheses or guidelines pooled it, 68 citations in OpenAlex.

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  19. The use of lentinan for treating gastric cancer.Anti-cancer agents in medicinal chemistry · 2013
    Review
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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 16 institutions in 1 country.

K YamaguchiDepartment of Gastroenterology, Saitama Cancer Centre, Ina-machi, Kitaadachi-gun, Japan. k-yamaguchi@cancer-c.pref.saitama.jp
T Shimamura
I Hyodo
W Koizumi
T Doi
H Narahara
Y Komatsu
T Kato
S Saitoh
T Akiya
M Munakata
Y Miyata
Y Maeda
H Takiuchi
S Nakano
T Esaki
F Kinjo
Y Sakata
Misawa City Hospital · JPSaitama Cancer Center · JPAomori Prefectural Central Hospital · JPGunma Prefectural Cardiovascular Center · JPHiroshima University · JPHokkaido University · JPKitasato University East Hospital · JPKyushu University · JPNational Cancer Centre Japan · JPNational Hospital Organization Kyushu Cancer Center · JPNiigata Cancer Center Hospital · JPOsaka Medical and Pharmaceutical University · JPSaku Central Hospital · JPTokyo Metropolitan Komagome Hospital · JPUniversity of the Ryukyus · JPUniversity of Tsukuba · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aims of this phase I/II study of docetaxel and S-1 were to determine the dose-limiting toxicity (DLT), maximum-tolerated dose (MTD), and recommended dose (RD) in the phase I part and to explore the tumour response, survival and safety in the phase II part. Patients with histologically- or cytologically confirmed unresectable or recurrent gastric cancer were eligible. Treatment consisted of intravenous docetaxel on day 1 (starting dose 50 mg m(-2)) and oral S-1 at a fixed dose of 40 mg m(-2) twice daily on days 1-14, every 4 weeks up to six cycles. Nine patients took part in the phase I portion of the study. The MTD of docetaxel was determined to be 50 mg m(-2), with the DLTs of grade 3 infection associated with grade 3 neutropenia and grade 4 neutropenia during S-1 administration. The RD of docetaxel was 40 mg m(-2) in combination with S-1 40 mg m(-2) b.i.d. The efficacy and safety of this regimen was therefore assessed in 46 patients with at least one measurable lesion. The overall response rate and estimated median overall survival were 46% (95% CI, 31-61%) and 14.0 months (8.3-17.3 months), respectively. The most common grade 3/4 toxicity was neutropenia (67% of patients), which was predictable and manageable. This regimen showed promising activity with moderate toxicities in advanced gastric cancer.

Indexed as

AdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsDocetaxelDose-Response Relationship, DrugDrug CombinationsFemaleHumansMaleMaximum Tolerated DoseOxonic AcidStomach NeoplasmsSurvival AnalysisSurvival RateTaxoidsTegafurTreatment OutcomeDocetaxelDrug CombinationsOxonic AcidS 1 (combination)TaxoidsTegafur

Identifiers

PMID16773074
PMCPMC2361339
OpenAlexW2158387151

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.