Abstract
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. 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). 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. ...Continue Reading
References
May 15, 2008·Cancer Science·Hironobu MinamiKeiko Nakajima
May 15, 2008·Journal of the National Cancer Institute·Josep M LlovetUNKNOWN Panel of Experts in HCC-Design Clinical Trials
Jul 25, 2008·The New England Journal of Medicine·Josep M LlovetUNKNOWN SHARP Investigators Study Group
Oct 30, 2008·Journal of the National Cancer Institute·Massimo Di MaioFrancesco Perrone
Dec 5, 2008·The New England Journal of Medicine·Giancarlo Spinzi, Silvia Paggi
Dec 20, 2008·The Lancet Oncology·Ann-Lii ChengZhongzhen Guan
Jul 17, 2010·Hepatology Research : the Official Journal of the Japan Society of Hepatology·Shigeki AriiMasatoshi Kudo
Oct 14, 2011·The New England Journal of Medicine·Hashem B El-Serag
Apr 21, 2012·Cancer·Joanne ChiuThomas Yau
Oct 9, 2012·Annals of Oncology : Official Journal of the European Society for Medical Oncology·T PressianiA Santoro
Nov 14, 2012·Oncology·Masahito NakanoMichio Sata
Mar 5, 2016·Journal of Gastroenterology·Shuichi KanekoKiwamu Okita
Apr 24, 2016·Journal of Gastroenterology·Masatoshi KudoNorihiro Kokudo
Aug 3, 2016·Molecular Therapy : the Journal of the American Society of Gene Therapy·Yoshinari MatsumotoYoshiki Murakami
Dec 10, 2016·Lancet·Jordi BruixUNKNOWN RESORCE Investigators
Feb 1, 2013·Annals of Oncology : Official Journal of the European Society for Medical Oncology·T PressianiA Santoro
Citations
Jun 4, 2020·World Journal of Surgical Oncology·Lei ChenChuansheng Zheng
Nov 20, 2020·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·Robert J Cersosimo
May 10, 2021·Liver International : Official Journal of the International Association for the Study of the Liver·Lorena Carballo-FolgosoMaría Varela
Jul 15, 2021·Japanese Journal of Clinical Oncology·Junji FuruseMasafumi Ikeda