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Safety and effectiveness of sorafenib in Japanese patients with hepatocellular carcinoma in daily medical practice: interim analysis of a prospective postmarketing all-patient surveillance study

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ABSTRACT

Background: Sorafenib was approved for treatment of unresectable hepatocellular carcinoma (HCC) in Japan in 2009. A prospective postmarketing all-patient surveillance (PMS) study was requested by Japanese authorities to confirm safety and effectiveness of sorafenib in Japanese HCC population.

Methods: Patients with unresectable HCC treated with sorafenib were followed up for 12 months. Data on patient demographic characteristics, treatment status, clinical outcome, and adverse events (AEs) were collected.

Results: This interim analysis included 1109 and 1065 patients evaluable for safety and effectiveness, respectively. Most patients (83.4 %) received the recommended initial dose of 400 mg twice daily. After a follow-up of 12-months, 89.8 % had discontinued treatment, most because of AEs (44.5 %) or progression (33.8 %). The most common drug-related adverse events (DRAE) were hand-foot skin reaction (51.4 %), liver dysfunction (26.4 %), diarrhea (25.1 %), and hypertension (21.6 %). The median overall survival (OS) was 348 days [95 % confidence interval (CI) 299–389 days], and the median duration of treatment was 87 days (95 % CI 78–98 days). Multivariate analyses identified baseline prognostic factors for longer OS, including female sex, low Child-Pugh score, Eastern Cooperative Oncology Group performance status 0, tumor stage I/II/III, low aspartate aminotransferase level, high hemoglobin level, hepatitis C and history of surgical resection.

Conclusions: In general, the safety and effectiveness findings in this PMS were consistent with findings from previous clinical studies. Sorafenib was well tolerated and clinically useful for Japanese patients.

Conclusions: Clinical trial registration number: NCT01411436

Electronic supplementary material: The online version of this article (doi:10.1007/s00535-016-1173-5) contains supplementary material, which is available to authorized users.

No MeSH data available.


Related in: MedlinePlus

Overall survival of patient subgroups according to baseline prognostic factors. Evaluated 887 patients (83.3 %) available for this analysis in the effectiveness-analysis set of 1065 patients. *Median value. CI confidence interval, ECOG PS Eastern Cooperative Oncology Group performance status, AST aspartate aminotransferase
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Fig3: Overall survival of patient subgroups according to baseline prognostic factors. Evaluated 887 patients (83.3 %) available for this analysis in the effectiveness-analysis set of 1065 patients. *Median value. CI confidence interval, ECOG PS Eastern Cooperative Oncology Group performance status, AST aspartate aminotransferase

Mentions: The multivariate analyses evaluated 887 patients available in the effectiveness-analysis set and identified baseline characteristics that were correlated with longer OS: female sex, Child-Pugh A5, ECOG PS score of 0, tumor stage I/II/III, AST level (below median) and Hb (at or above median), hepatitis C, and history of surgical resection (Fig. 3).Fig. 3


Safety and effectiveness of sorafenib in Japanese patients with hepatocellular carcinoma in daily medical practice: interim analysis of a prospective postmarketing all-patient surveillance study
Overall survival of patient subgroups according to baseline prognostic factors. Evaluated 887 patients (83.3 %) available for this analysis in the effectiveness-analysis set of 1065 patients. *Median value. CI confidence interval, ECOG PS Eastern Cooperative Oncology Group performance status, AST aspartate aminotransferase
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5037148&req=5

Fig3: Overall survival of patient subgroups according to baseline prognostic factors. Evaluated 887 patients (83.3 %) available for this analysis in the effectiveness-analysis set of 1065 patients. *Median value. CI confidence interval, ECOG PS Eastern Cooperative Oncology Group performance status, AST aspartate aminotransferase
Mentions: The multivariate analyses evaluated 887 patients available in the effectiveness-analysis set and identified baseline characteristics that were correlated with longer OS: female sex, Child-Pugh A5, ECOG PS score of 0, tumor stage I/II/III, AST level (below median) and Hb (at or above median), hepatitis C, and history of surgical resection (Fig. 3).Fig. 3

View Article: PubMed Central - PubMed

ABSTRACT

Background: Sorafenib was approved for treatment of unresectable hepatocellular carcinoma (HCC) in Japan in 2009. A prospective postmarketing all-patient surveillance (PMS) study was requested by Japanese authorities to confirm safety and effectiveness of sorafenib in Japanese HCC population.

Methods: Patients with unresectable HCC treated with sorafenib were followed up for 12 months. Data on patient demographic characteristics, treatment status, clinical outcome, and adverse events (AEs) were collected.

Results: This interim analysis included 1109 and 1065 patients evaluable for safety and effectiveness, respectively. Most patients (83.4 %) received the recommended initial dose of 400 mg twice daily. After a follow-up of 12-months, 89.8 % had discontinued treatment, most because of AEs (44.5 %) or progression (33.8 %). The most common drug-related adverse events (DRAE) were hand-foot skin reaction (51.4 %), liver dysfunction (26.4 %), diarrhea (25.1 %), and hypertension (21.6 %). The median overall survival (OS) was 348 days [95 % confidence interval (CI) 299–389 days], and the median duration of treatment was 87 days (95 % CI 78–98 days). Multivariate analyses identified baseline prognostic factors for longer OS, including female sex, low Child-Pugh score, Eastern Cooperative Oncology Group performance status 0, tumor stage I/II/III, low aspartate aminotransferase level, high hemoglobin level, hepatitis C and history of surgical resection.

Conclusions: In general, the safety and effectiveness findings in this PMS were consistent with findings from previous clinical studies. Sorafenib was well tolerated and clinically useful for Japanese patients.

Conclusions: Clinical trial registration number: NCT01411436

Electronic supplementary material: The online version of this article (doi:10.1007/s00535-016-1173-5) contains supplementary material, which is available to authorized users.

No MeSH data available.


Related in: MedlinePlus