Evidence map›Paper›PMID 29948358›Full record

Trial reportInvestigational new drugs2018

Survival and tolerance to sorafenib in Child-Pugh B patients with hepatocellular carcinoma: a prospective study.

Cassia Regina Guedes Leal, Cristiane Magalhães, Daniel Barbosa, Diogo Aquino, Bernardo Carvalho, Elizabeth Balbi, Lucio Pacheco, Renata Perez, Paulo de Tarso Pinto, Sérgio Setubal

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 27% 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.

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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Review
  6. Review
  7. Saudi Association for the Study of Liver diseases and Transplantation practice guidelines on the diagnosis and management of hepatocellular carcinoma.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2020
    Article
  8. Review
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

10 authors at 5 institutions in 1 country.

Cassia Regina Guedes LealHospital Federal dos Servidores do Estado, Rua Sacadura Cabral, 178, Saúde, Rio de Janeiro, RJ, 20221-903, Brazil. cassia.r.g.leal@gmail.com.ORCID http://orcid.org/0000-0002-9653-8088
Cristiane MagalhãesInstituto Nacional do Cancer (INCA), Rio de Janeiro, Brazil.
Daniel BarbosaHospital Federal dos Servidores do Estado, Rua Sacadura Cabral, 178, Saúde, Rio de Janeiro, RJ, 20221-903, Brazil.
Diogo AquinoHospital Federal dos Servidores do Estado, Rua Sacadura Cabral, 178, Saúde, Rio de Janeiro, RJ, 20221-903, Brazil.
Bernardo CarvalhoHospital Federal dos Servidores do Estado, Rua Sacadura Cabral, 178, Saúde, Rio de Janeiro, RJ, 20221-903, Brazil.
Elizabeth BalbiHospital Quinta D'Or, Rio de Janeiro, Brazil.
Lucio PachecoHospital Quinta D'Or, Rio de Janeiro, Brazil.
Renata PerezUniversidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.
Paulo de Tarso PintoHospital Federal dos Servidores do Estado, Rua Sacadura Cabral, 178, Saúde, Rio de Janeiro, RJ, 20221-903, Brazil.
Sérgio SetubalUniversidade Federal Fluminense, Niterói, Brazil.
Hospital Federal dos Servidores do Estado · BRD’Or Institute for Research and Education · BRUniversidade Federal Fluminense · BRInstituto Nacional de Câncer - INCA · BRUniversidade Federal do Rio de Janeiro · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Sorafenib has been widely used to treat unresectable hepatocellular carcinoma (HCC) but most studies have been done in Child-Pugh A (CP-A) patients with well-preserved liver function. We evaluated the overall survival (OS) and tolerance to sorafenib in a large cohort of Child-Pugh B (CP-B) HCC patients as compared to CP-A HCC patients. We prospectively studied 130 patients with advanced HCC who started sorafenib between January 2011 and December 2015. Patients were classified as CP-A (n = 65) or CP-B (n = 65). The average OS for all 130 patients was 10 months. CP-A patients had a median survival rate significantly longer than CP-B patients: 12 months vs. 6 months. The OS found in our group of CP-B patients was 6.5 months, which is higher than that found in most studies done so far. When stratified, our CP-B patients had better OS than ever reported. The dose of the drug was interrupted due to adverse events (AEs) in 38 (29%) of the patients, of whom 20 (30%) were CP-A patients and 18 (28%) were CP-B patients. This real-life cohort of CP-B HCC patients treated with sorafenib had a higher survival than that described in the literature, with a satisfactory safety profile. Despite the high prevalence of severe AEs in CP-B patients, there were fewer treatment interruptions in this group, indicating that Child-Pugh B patients can tolerate treatment and may benefit from sorafenib.

Indexed as

Agedalpha-FetoproteinsAntineoplastic AgentsCarcinoma, HepatocellularFemaleHumansLiver NeoplasmsMaleMiddle AgedProtein Kinase InhibitorsSorafenibSurvival Analysisalpha-FetoproteinsAntineoplastic AgentsProtein Kinase InhibitorsSorafenibChild-Pugh AChild-Pugh BHepatocellular carcinomaSorafenib

Identifiers

PMID29948358
OpenAlexW2808480731

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.