Evidence map›Paper›PMID 24281004›Full record

Trial reportBritish journal of cancer2014

Randomised phase II study comparing dose-escalated weekly paclitaxel vs standard-dose weekly paclitaxel for patients with previously treated advanced gastric cancer.

K Shitara, S Yuki, D Tahahari, M Nakamura, C Kondo, T Tsuda, T Kii, Y Tsuji, S Utsunomiya, D Ichikawa and 7 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 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

19 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  16. Second-line chemotherapy for patients with advanced gastric cancer.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2017
    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

17 authors.

K Shitara1] Department of Clinical Oncology, Aichi Cancer Center Hospital, Aichi, Japan [2] Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.
S YukiDepartment of Gastroenterology, Hokkaido University Hospital, Hokkaido, Japan.
D TahahariDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Aichi, Japan.
M NakamuraDepartment of Gastroenterology, Sapporo City General Hospital, Hokkaido, Japan.
C KondoDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Aichi, Japan.
T TsudaDepartment of Clinical Oncology, Saint Marianna University School of Medicine, Kanagawa, Japan.
T KiiCancer Chemotherapy Center, Osaka Medical College, Osaka, Japan.
Y TsujiDepartment of Medical Oncology, KKR Sapporo Medical Center, Tonan Hospital, Hokkaido, Japan.
S UtsunomiyaDepartment of Gastroenterology, Nagoya Kyoritsu Hospital, Aichi, Japan.
D IchikawaDivision of Digestive Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.
A HosokawaDepartment of Gastroenterology and Hematology, University of Toyama, Toyama, Japan.
A IshiguroDepartment of Medical Oncology, Hirosaki University, Aomori, Japan.
D SakaiDepartment of Clinical Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
S HironakaDepartment of Clinical Trial Promotion, Chiba Cancer Center, Chiba, Japan.
I OzeDivision of Epidemiology and Prevention, Aichi Cancer Center Research Institute, Aichi, Japan.
K Matsuo1] Division of Epidemiology and Prevention, Aichi Cancer Center Research Institute, Aichi, Japan [2] Department of Preventive Medicine, Kyushu University Faculty of Medical Sciences, Fukuoka, Japan.
K MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Aichi, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis randomised phase II trial compared dose-escalated weekly paclitaxel (wPTX) vs standard-dose wPTX for patients with previously treated advanced gastric cancer (AGC).

methodsNinety patients were randomised to a standard dose of wPTX (80 mg m(-2)) or an escalated dose of wPTX (80-120 mg m(-2)) to assess the superiority of overall survival (OS) with a one-sided alpha error of 0.3 and a power of 0.8.

resultsThe median OS showed a trend towards longer survival in the dose-escalated arm (11.8 vs 9.6 months; hazard ratio (HR), 0.75; one-sided P=0.12), although it was statistically not significant. The median progression-free survival (PFS) was significantly longer in the dose-escalated arm (4.3 vs 2.5 months, HR, 0.55; P=0.017). Objective response rate was 30.3% with dose escalation and 17.1% with standard dose (P=0.2). The frequency of all grades of neutropenia was significantly higher with dose escalation (88.7% vs 60.0%, P=0.002); however, no significant difference was observed in the proportion of patients experiencing grade 3 or more (40.9% vs 31.1%, P=0.34).

conclusionDose-escalated wPTX in patients with pretreated AGC met our predefined threshold of primary end point, OS (P<0.3); however, it did not show a significantly longer OS. Progression-free survival was significantly better with dose escalation.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Agents, PhytogenicDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansMaleMiddle AgedPaclitaxelStomach NeoplasmsAntineoplastic Agents, PhytogenicPaclitaxel

Identifiers

PMID24281004
PMCPMC3899763

What OpenQuestion holds

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LicenceCC BY-NC-SA
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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.