Evidence map›Paper›PMID 23263829›Full record

Trial reportMedical oncology (Northwood, London, England)2013

Sorafenib in hepatocellular carcinoma: prospective study on adverse events, quality of life, and related feasibility under daily conditions.

Paola Rita Brunocilla, Franco Brunello, Patrizia Carucci, Silvia Gaia, Emanuela Rolle, Alessandro Cantamessa, Anna Castiglione, Giovannino Ciccone, Mario Rizzetto

Registry-linked trialAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Medical oncology (Northwood, London, England), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03277716 (Effectivity and Safety of Microwave Ablation Combined With Transcatheter Arterial Chemoembolization), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 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.

NCT03277716 naunknown statusnot on this mapstarted 2017, after this paper: background citation

Effectivity and Safety of Microwave Ablation Combined With Transcatheter Arterial Chemoembolization(TACE) for Huge Unresectable Hepatocellular Carcinoma: a Multicenter Analysis

TypeinterventionalSponsorFan WeijunRan2017 to 2021Enrolled100ConditionsHepatocellular Carcinoma Non-resectable, Transarterial Chemoembolization, Microwave AblationArmsTACE, MWA, MWA system, Chemoembolization
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Health-related quality of life in primary hepatic cancer: a systematic review assessing the methodological properties of instruments and a meta-analysis comparing treatment strategies.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2021
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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

9 authors.

Paola Rita BrunocillaDivision of Gastroenterology and Hepatology, AO San Giovanni Battista, Turin, Italy. paolabrunocilla@gmail.com
Franco Brunello
Patrizia Carucci
Silvia Gaia
Emanuela Rolle
Alessandro Cantamessa
Anna Castiglione
Giovannino Ciccone
Mario Rizzetto

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Sorafenib is an oral multikinase inhibitor approved for the treatment of hepatocellular carcinoma (HCC). In two randomized trials, sorafenib was reported to be safe without a significant impact on quality of life (QoL). The aim of this study was to evaluate the occurrence of adverse events, QoL variations, and treatment discontinuations in HCC patients treated with sorafenib. Between November 2009 and March 2011, all patients evaluated as suitable for sorafenib treatment were enrolled. Every patient was invited to complete the Functional Assessment of Cancer Therapy-Hepatobiliary Questionnaire before starting therapy, at week 1, and at months 1 and 2. QoL scores were analyzed by the Wilcoxon matched-pairs test. Side effects were classified according to the Common Terminology Criteria for Adverse Events v.3.0. Thirty-six patients were enrolled. The cumulative incidence of therapy discontinuation for drug-related adverse events was 33 % (95 % confidence interval, 20.2-49.7). The most common adverse event was fatigue (66.7 %). The worst score decrease was detected from baseline to week 1 in physical well-being, with a median reduction of -8.3 (range -60.1 to 17.9; P = 0.0003). Treatment withdrawal from adverse events was higher than previously reported, significant QoL decrease occurred, and estimated feasibility was 66.7 %.

Indexed as

Quality of LifeAdultAgedAged, 80 and overAntineoplastic AgentsCarcinoma, HepatocellularFemaleHumansLiver NeoplasmsMaleMiddle AgedNiacinamidePhenylurea CompoundsSorafenibSurveys and QuestionnairesAntineoplastic AgentsNiacinamidePhenylurea CompoundsSorafenib

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.