Evidence map›Paper›PMID 19690548›Full record

Trial reportBritish journal of cancer2009

A randomised phase III trial comparing gemcitabine with surgery-only in patients with resected pancreatic cancer: Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer.

H Ueno, T Kosuge, Y Matsuyama, J Yamamoto, A Nakao, S Egawa, R Doi, M Monden, T Hatori, M Tanaka and 2 more

Abstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in British journal of cancer, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 157 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
157citing papers in PubMed, 11 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

157 citing papers in PubMed, 11 syntheses or guidelines pooled it.

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  11. Extended pancreaticoduodenectomy with vascular resection for pancreatic cancer: a systematic review.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2010
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97 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

12 authors.

H UenoHepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Tokyo, Japan. hiueno@ncc.go.jp
T Kosuge
Y Matsuyama
J Yamamoto
A Nakao
S Egawa
R Doi
M Monden
T Hatori
M Tanaka
M Shimada
K Kanemitsu

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis multicentre randomised phase III trial was designed to determine whether adjuvant chemotherapy with gemcitabine improves the outcomes of patients with resected pancreatic cancer.

methodsEligibility criteria included macroscopically curative resection of invasive ductal carcinoma of the pancreas and no earlier radiation or chemotherapy. Patients were randomly assigned at a 1 : 1 ratio to either the gemcitabine group or the surgery-only group. Patients assigned to the gemcitabine group received gemcitabine at a dose of 1000 mg m(-2) over 30 min on days 1, 8 and 15, every 4 weeks for 3 cycles.

resultsBetween April 2002 and March 2005, 119 patients were enrolled in this study. Among them, 118 were eligible and analysable (58 in the gemcitabine group and 60 in the surgery-only group). Both groups were well balanced in terms of baseline characteristics. Although heamatological toxicity was frequently observed in the gemcitabine group, most toxicities were transient, and grade 3 or 4 non-heamatological toxicity was rare. Patients in the gemcitabine group showed significantly longer disease-free survival (DFS) than those in the surgery-only group (median DFS, 11.4 versus 5.0 months; hazard ratio=0.60 (95% confidence interval (CI): 0.40-0.89); P=0.01), although overall survival did not differ significantly between the gemcitabine and surgery-only groups (median overall survival, 22.3 versus 18.4 months; hazard ratio=0.77 (95% CI: 0.51-1.14); P=0.19).

conclusionThe current results suggest that adjuvant gemcitabine contributes to prolonged DFS in patients undergoing macroscopically curative resection of pancreatic cancer.

Indexed as

AdultAgedAntimetabolites, AntineoplasticDeoxycytidineDisease-Free SurvivalFemaleGemcitabineHumansMaleMiddle AgedPancreatic NeoplasmsSurvival RateAntimetabolites, AntineoplasticDeoxycytidineGemcitabine

Identifiers

PMID19690548
PMCPMC2743365

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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.