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

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ABSTRACT

Background: GIDEON 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.

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

Results: The 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.

Conclusions: Sorafenib 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.

Electronic supplementary material: The online version of this article (doi:10.1007/s00535-016-1204-2) contains supplementary material, which is available to authorized users.

No MeSH data available.


Related in: MedlinePlus

Kaplan-Meier curve of OS and TTP (intent-to-treat population): a OS by baseline Child-Pugh status; b TTP by baseline Child-Pugh status. OS overall survival, TTP time to progression
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Fig1: Kaplan-Meier curve of OS and TTP (intent-to-treat population): a OS by baseline Child-Pugh status; b TTP by baseline Child-Pugh status. OS overall survival, TTP time to progression

Mentions: A total of 500 patients were analyzed for efficacy in the ITT analysis. The difference between the safety and ITT population was due to reasons such as exclusion of patients who had a history of sorafenib treatment. OS and TTP by Child-Pugh score and BCLC stage per Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 are shown in Figs. 1 and 2.Fig. 1


Safety and efficacy of sorafenib in Japanese patients with hepatocellular carcinoma in clinical practice: a subgroup analysis of GIDEON
Kaplan-Meier curve of OS and TTP (intent-to-treat population): a OS by baseline Child-Pugh status; b TTP by baseline Child-Pugh status. OS overall survival, TTP time to progression
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5121182&req=5

Fig1: Kaplan-Meier curve of OS and TTP (intent-to-treat population): a OS by baseline Child-Pugh status; b TTP by baseline Child-Pugh status. OS overall survival, TTP time to progression
Mentions: A total of 500 patients were analyzed for efficacy in the ITT analysis. The difference between the safety and ITT population was due to reasons such as exclusion of patients who had a history of sorafenib treatment. OS and TTP by Child-Pugh score and BCLC stage per Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 are shown in Figs. 1 and 2.Fig. 1

View Article: PubMed Central - PubMed

ABSTRACT

Background: GIDEON 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.

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

Results: The 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.

Conclusions: Sorafenib 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.

Electronic supplementary material: The online version of this article (doi:10.1007/s00535-016-1204-2) contains supplementary material, which is available to authorized users.

No MeSH data available.


Related in: MedlinePlus