Evidence map›Paper›PMID 19238628›Full record

Trial reportBritish journal of cancer2008

Gemcitabine and oxaliplatin in advanced biliary tract carcinoma: a phase II study.

T André, J M Reyes-Vidal, L Fartoux, P Ross, M Leslie, O Rosmorduc, M R Clemens, C Louvet, N Perez, F Mehmud and 1 more

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

Trial report in British journal of cancer, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01383746 (Efficacy and Tolerance of RADIOEMBOLIZATION for Patients With Unresectable Intrahepatic Cholangiocarcinoma With Tumor Progression After First-line Therapy), which is not on this map. Cited by 68 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 1 pooled it
10.7field-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.

NCT01383746 phase1 / phase2terminatednot on this mapstarted 2011, after this paper: background citation

Efficacy and Tolerance of RADIOEMBOLIZATION for Patients With Unresectable Intrahepatic Cholangiocarcinoma With Tumor Progression After First-line Therapy

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2011 to 2012Enrolled5ConditionsCholestasis, Progressive Familial Intrahepatic 3ArmsYttrium microsphere injection
3 · Its place in the literature

Who cites it

68 citing papers in PubMed, 1 synthesis or guideline pooled it, 173 citations in OpenAlex.

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8 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

11 authors at 8 institutions in 5 countries.

T AndréDepartment of Medical Oncology, Hôpital Tenon, Université Paris 06, Paris 75020, France. thierry.andre@psl.aphp.fr
J M Reyes-Vidal
L Fartoux
P Ross
M Leslie
O Rosmorduc
M R Clemens
C Louvet
N Perez
F Mehmud
W Scheithauer
Hôpital Saint-Antoine · FRSorbonne Université · FRSt Thomas' Hospital · GBClínica Las Condes · CLComprehensive Cancer Center Vienna · ATHôpital Tenon · FRKlinikum Mutterhaus der Borromäerinnen · DESanofi (France) · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Advanced biliary tract carcinomas (BTCs) are often diagnosed at an advanced/metastatic stage and have a poor prognosis. The combination of gemcitabine and oxaliplatin (GEMOX) has shown promising activity in this setting. This international phase II study evaluated the efficacy and safety of GEMOX as first-line therapy in patients with advanced BTCs. Eligible patients with previously untreated locally advanced or metastatic BTC received gemcitabine 1000 mg m(-2) (day 1) and oxaliplatin 100 mg m-2 (day 2), every 2 weeks. Seventy patients were enroled; 72.9% had metastatic disease. Sixty-seven patients were treated. There were 10 confirmed partial responses (14.9%; 95% confidence interval (CI), 7.4-25.7%) in the treated population (RECIST). Twenty-four patients (35.8%) had stable disease. The objective response rate was 20.5% in patients with non-gallbladder cancers (9/44 patients) and 4.3% in patients with gallbladder cancers (1/23). Median overall survival for the intent-to-treat population was 8.8 months (95% CI, 6.9-11.1%) and progression-free survival was 3.4 months (95% CI, 2.5-4.6%). Grade 3/4 toxicities included thrombocytopenia (14.9% of patients), alanine aminotransferase elevation (13.4%), anaemia (10.4%), neutropenia (11.9%) and pain (1 1.9%). In this study, GEMOX demonstrated activity in non-gallbladder carcinoma, but poor activity in gallbladder carcinoma. GEMOX is well tolerated in advanced BTCs.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsDeoxycytidineDisease-Free SurvivalFemaleHumansInternational AgenciesMaleMiddle AgedNeoplasm StagingOrganoplatinum CompoundsSurvival RateTime FactorsDeoxycytidineOrganoplatinum Compounds

Identifiers

PMID19238628
PMCPMC2538748
OpenAlexW2094501197

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.