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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
PHASE II STUDIES

Summary

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.

Keywords

Child-Pugh B Hepatocellular carcinoma Sorafenib Child-Pugh A 

Notes

Compliance with ethical standards

Conflict of interest

All authors declare that they have no conflicts of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

The study protocol was approved by the local Ethics Committee and all patients signed a consent form.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  • Cassia Regina Guedes Leal
    • 1
    • 2
  • Cristiane Magalhães
    • 3
  • Daniel Barbosa
    • 1
  • Diogo Aquino
    • 1
  • Bernardo Carvalho
    • 1
  • Elizabeth Balbi
    • 4
  • Lucio Pacheco
    • 4
  • Renata Perez
    • 5
    • 6
  • Paulo de Tarso Pinto
    • 1
  • Sérgio Setubal
    • 2
  1. 1.Hospital Federal dos Servidores do EstadoRio de JaneiroBrazil
  2. 2.Universidade Federal FluminenseNiteróiBrazil
  3. 3.Instituto Nacional do Cancer (INCA)Rio de JaneiroBrazil
  4. 4.Hospital Quinta D’OrRio de JaneiroBrazil
  5. 5.Universidade Federal do Rio de JaneiroRio de JaneiroBrazil
  6. 6.Instituto D’Or de Pesquisa e EnsinoRio de JaneiroBrazil

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