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A multicenter Phase II study of sorafenib in Japanese patients with advanced hepatocellular carcinoma and Child Pugh A and B class

Japanese journal of clinical oncology, 2018-04, Vol.48 (4), p.317-321 [Peer Reviewed Journal]

The Author(s) 2018. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. 2018 ;ISSN: 1465-3621 ;EISSN: 1465-3621 ;DOI: 10.1093/jjco/hyy010 ;PMID: 29474553

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Title:
A multicenter Phase II study of sorafenib in Japanese patients with advanced hepatocellular carcinoma and Child Pugh A and B class
Author: Suzuki, Eiichiro ; Kaneko, Shuichi ; Okusaka, Takuji ; Ikeda, Masafumi ; Yamaguchi, Kensei ; Sugimoto, Rie ; Aramaki, Takeshi ; Asagi, Akinori ; Yasui, Kohichiroh ; Sano, Keiji ; Hosokawa, Ayumu ; Kato, Naoya ; Ishii, Hiroshi ; Sato, Tosiya ; Furuse, Junji
Subjects: Aged ; Asians ; Carcinoma, Hepatocellular - drug therapy ; Carcinoma, Hepatocellular - pathology ; Disease Progression ; Female ; Humans ; Liver Neoplasms - drug therapy ; Liver Neoplasms - pathology ; Male ; Middle Aged ; Neoplasm Staging ; Niacinamide - adverse effects ; Niacinamide - analogs & derivatives ; Niacinamide - therapeutic use ; Phenylurea Compounds - adverse effects ; Phenylurea Compounds - therapeutic use ; Sorafenib ; Survival Analysis ; Time Factors ; Treatment Outcome
Is Part Of: Japanese journal of clinical oncology, 2018-04, Vol.48 (4), p.317-321
Description: To evaluate prospectively the efficacy and safety of sorafenib, which has been the first-line treatment for advanced hepatocellular carcinoma (HCC), in Japanese HCC patients (pts) with not only Child-Pugh (C-P) A class but also C-P B class. Abstract Objective To evaluate prospectively the efficacy and safety of sorafenib, which has been the first-line treatment for advanced hepatocellular carcinoma (HCC), in Japanese HCC patients (pts) with not only Child-Pugh (C-P) A class but also C-P B class. Methods Sorafenib was administered orally at the dose of 400 mg twice daily for pts with HCC and liver function of C-P score of 5–8. Administration was continued until the detection of disease progression or appearance of unacceptable toxicity. The primary endpoint was time to progression (TTP), and toxicity and the secondary endpoints included objective response, overall survival (OS). Results Forty C-P A pts and 12 C-P B pts were enrolled. The median TTP in the C-P A pts and C-P B pts was 3.3 months and 3.2 months, respectively. Among the pts with C-P A, complete response, partial response, and stable disease were achieved for 2.5%, 7.5% and 47.5%. Among the pts with C-P B, there were no treatment responses, 66.7% of pts had stable disease. The median OS in the C-P A pts and C-P B pts was 13.4 months and 7.4 months, respectively. With regard to toxicities, fewer C-P A pts experienced Grade 3/4 toxicities than C-P B pts (77.5% vs. 91.6%). There were no treatment-related deaths in either group of patients. Conclusions This study shows sorafenib has similar effectiveness in the recent post-approval studies and is well-tolerated in Japanese pts with HCC and Child Pugh A class. Sorafenib should be used with great care for Child Pugh class B pts.
Publisher: England: Oxford University Press
Language: English
Identifier: ISSN: 1465-3621
EISSN: 1465-3621
DOI: 10.1093/jjco/hyy010
PMID: 29474553
Source: GFMER Free Medical Journals
MEDLINE
Alma/SFX Local Collection

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A multicenter Phase II study of sorafenib in Japanese patients with advanced hepatocellular carcinoma and Child Pugh A and B class

The Author(s) 2018. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. 2018 ;ISSN: 1465-3621 ;EISSN: 1465-3621 ;DOI: 10.1093/jjco/hyy010 ;PMID: 29474553

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