Safety and efficacy of sorafenib in Japanese patients with hepatocellular carcinoma in clinical practice: a subgroup analysis of GIDEONReportar como inadecuado




Safety and efficacy of sorafenib in Japanese patients with hepatocellular carcinoma in clinical practice: a subgroup analysis of GIDEON - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Journal of Gastroenterology

, Volume 51, Issue 12, pp 1150–1160

First Online: 22 April 2016Received: 24 February 2016Accepted: 24 March 2016

Abstract

BackgroundGIDEON was a prospective, global, non-interventional study evaluating the safety of sorafenib in patients with unresectable hepatocellular carcinoma in real-world practice. The aim of this subgroup analysis was to assess the safety and efficacy of sorafenib as used by Japanese patients.

MethodsIn Japan, 508 patients were valid for safety analysis. Efficacy and safety were evaluated by the Child-Pugh score.

ResultsThe number of patients with Child-Pugh A and B was 432 85.0 % and 58 11.4 %, respectively. The median overall survival time and time to progression in patients with Child-Pugh A and Child-Pugh B were 17.4 and 4.9 months, 3.7 and 2.3 months, respectively. The most common drug-related adverse events AEs included hand-foot skin reaction 47.8 %, diarrhea 35.8 % and hypertension 24.2 %. The incidences of all or drug-related AEs were similar between patients with Child-Pugh A and B. However, all or drug-related serious AEs, AEs resulting in permanent discontinuation of sorafenib and deaths were observed more frequently in patients with Child-Pugh B compared with Child-Pugh A. Duration of treatment tended to be shorter as the Child-Pugh score worsened.

ConclusionsSorafenib was well tolerated by Japanese HCC patients in clinical settings. Patients with Child-Pugh B had shorter duration of treatment and higher incidence of SAEs. It is important to carefully evaluate patients’ conditions and assess the benefit and risk before making a decision to treat patients with sorafenib.

KeywordsHepatocellular carcinoma Sorafenib Japanese GIDEON Electronic supplementary materialThe online version of this article doi:10.1007-s00535-016-1204-2 contains supplementary material, which is available to authorized users.

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Autor: Masatoshi Kudo - Masafumi Ikeda - Tadatoshi Takayama - Kazushi Numata - Namiki Izumi - Junji Furuse - Takuji Okusaka - Masu

Fuente: https://link.springer.com/







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