Evidence map›Paper›PMID 19935794›Full record

Trial reportBritish journal of cancer2010

Sorafenib in patients with advanced biliary tract carcinoma: a phase II trial.

C Bengala, F Bertolini, N Malavasi, C Boni, E Aitini, C Dealis, S Zironi, R Depenni, A Fontana, C Del Giovane and 2 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 97 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
97citing papers in PubMed, 5 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

97 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Biomarkers for the Diagnosis of Cholangiocarcinoma: A Systematic Review.The American journal of tropical medicine and hygiene · 2018
    Pooled it
  2. Efficacy and safety of chemotherapy with or without targeted therapy in biliary tract cancer: A meta-analysis of 7 randomized controlled trials.Journal of Huazhong University of Science and Technology. Medical sciences = Hua zhong ke ji da xue xue bao. Yi xue Ying De wen ban = Huazhong keji daxue xuebao. Yixue Yingdewen ban · 2017
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37 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.

C BengalaDivision of Medical Oncology, University Hospital, University of Modena and Reggio Emilia, 41100 Modena, Italy. carmelo.bengala@unimore.it
F Bertolini
N Malavasi
C Boni
E Aitini
C Dealis
S Zironi
R Depenni
A Fontana
C Del Giovane
G Luppi
P Conte

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdvanced biliary tract carcinoma has a very poor prognosis, with chemotherapy being the mainstay of treatment. Sorafenib, a multikinase inhibitor of VEGFR-2/-3, PDGFR-beta, B-Raf, and C-Raf, has shown to be active in preclinical models of cholangiocarcinoma.

methodsWe conducted a phase II trial of single-agent sorafenib in patients with advanced biliary tract carcinoma. Sorafenib was administered at a dose of 400 mg twice a day. The primary end point was the disease control rate at 12 weeks.

resultsA total of 46 patients were treated. In all, 26 (56%) had received chemotherapy earlier, and 36 patients completed at least 45 days of treatment. In intention-to-treat analysis, the objective response was 2% and the disease control rate at 12 weeks was 32.6%. Progression-free survival (PFS) was 2.3 months (range: 0-12 months), and the median overall survival was 4.4 months (range: 0-22 months). Performance status was significantly related to PFS: median PFS values for ECOG 0 and 1 were 5.7 and 2.1 months, respectively (P=0.0002). The most common toxicities were skin rash (35%) and fatigue (33%), requiring a dose reduction in 22% of patients.

conclusionsSorafenib as a single agent has a low activity in cholangiocarcinoma. Patients having a good performance status have a better PFS. The toxicity profile is manageable.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsBenzenesulfonatesBile Duct NeoplasmsBiliary Tract NeoplasmsCarcinomaCholangiocarcinomaDisease-Free SurvivalDrug EruptionsFatigueFemaleGallbladder NeoplasmsHumansKaplan-Meier EstimateAntineoplastic AgentsBenzenesulfonatesNiacinamidePhenylurea CompoundsProtein Kinase InhibitorsPyridinesSorafenib

Identifiers

PMID19935794
PMCPMC2813746

What OpenQuestion holds

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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.