Sorafenib for the treatment of unresectable hepatocellular carcinoma

The Oncologist
Robert C KaneRichard Pazdur

Abstract

To describe the U.S. Food and Drug Administration (FDA) review and approval of sorafenib (Nexavar; Bayer Pharmaceuticals Corp., Montville, NJ, and Onyx Pharmaceuticals Corp., Emeryville, CA), an oral kinase inhibitor, for the treatment of patients with unresectable hepatocellular carcinoma (HCC). The FDA independently analyzed an international, double-blind, placebo-controlled trial comparing the effect of best supportive care plus sorafenib or matching placebo on overall survival. Eligible patients had unresectable, biopsy-proven HCC and had not received prior systemic therapy. Among the 602 randomized patients (placebo, 303; sorafenib, 299), baseline characteristics were well balanced, and 97% were Child-Pugh score A. HCC was "advanced" in 70% overall, as defined by extrahepatic metastases or by tumor radiographically visible in venous structures outside the liver. Underlying liver diseases included hepatitis B (18%), hepatitis C (28%), and alcohol-related (26%). The trial was stopped following a prespecified second interim analysis showing a statistically significant survival advantage for sorafenib [median, 10.7 vs 7.9 months; hazard ratio, 0.69 (95% confidence interval, (0.55, 0.87)), p = 0.00058]. Adverse events in sorafe...Continue Reading

References

Mar 1, 2002·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Jordi Bruix, Josep M Llovet
Dec 26, 2006·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Robert C KaneRichard Pazdur

❮ Previous
Next ❯

Citations

Nov 17, 2009·Cardiovascular Toxicology·Brian B Hasinoff, Daywin Patel
Aug 27, 2009·Nature Reviews. Clinical Oncology·Massimo Di MaioFrancesco Perrone
Oct 13, 2012·Nature Reviews. Drug Discovery·Gideon BollagPeter Hirth
Sep 3, 2010·Cancer Research·Steven WhittakerCaroline J Springer
Nov 12, 2009·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·David S HongRazelle Kurzrock
Aug 4, 2010·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Melanie B ThomasAlan Venook
Mar 1, 2012·World Journal of Gastroenterology : WJG·Catherine Frenette, Robert Gish
Sep 23, 2011·Bioinformation·Mohammad Amin ElgamacyDalal Abd El Rahman Abou-El-Ella
Aug 1, 2013·Indian Journal of Pharmaceutical Sciences·R R Somani, U V Bhanushali
Feb 22, 2014·Experimental & Molecular Medicine·Young Ki LeeSeung Kew Yoon
Jan 6, 2011·Acta Crystallographica. Section C, Crystal Structure Communications·K RavikumarM Pulla Reddy
Feb 1, 2014·The American Journal of Pathology·Xin Chen, Diego F Calvisi
Aug 22, 2013·Breast Cancer Research and Treatment·Claudia FumarolaMara A Bonelli
Jan 8, 2010·Breast Cancer Research and Treatment·Mara A BonelliPier Giorgio Petronini
Feb 22, 2011·Expert Opinion on Therapeutic Targets·Yanhua WuLong Yu
Jan 14, 2011·Expert Opinion on Pharmacotherapy·Yong-Song Guan, Qing He
Sep 10, 2013·Current Medical Research and Opinion·Rajiv MallickJenifer Wogen
Jun 13, 2012·Pancreatology : Official Journal of the International Association of Pancreatology (IAP) ... [et Al.]·Ann H RosendahlRoland Andersson
Apr 24, 2012·Hematology/oncology Clinics of North America·Behrouz ZandAnil K Sood
Sep 7, 2011·Gastroenterology Clinics of North America·Robert WongRobert Gish
May 5, 2012·Pediatric Transplantation·Sukru EmreManuel Rodriguez-Davalos
Nov 22, 2011·Liver International : Official Journal of the International Association for the Study of the Liver·Alisan KahramanAli Canbay
Dec 17, 2014·Basic & Clinical Pharmacology & Toxicology·Ye LiXian-Jun Qu
Feb 11, 2014·International Journal of Cancer. Journal International Du Cancer·Mario ScartozziStefano Cascinu
Sep 1, 2015·ACS Applied Materials & Interfaces·Raj Kumar ThapaJong Oh Kim
Mar 15, 2015·Journal of Gastroenterology and Hepatology·Yu-Hung SuTse-Ching Chen
Jun 1, 2015·International Journal of Surgery·Zong-ming ZhangXiao-ping Chen
Mar 13, 2014·International Journal of Pharmaceutics·Emanuela F CraparoGennara Cavallaro
Sep 18, 2013·Critical Reviews in Oncology/hematology·Audrey Thomas-SchoemannFrançois Goldwasser

❮ Previous
Next ❯

Related Concepts

Related Feeds

Carcinoma, Hepatocellular

Hepatocellular Carcinoma is a malignant cancer in liver epithelial cells. Discover the latest research on Hepatocellular Carcinoma here.

Related Papers

The New England Journal of Medicine
Giancarlo Spinzi, Silvia Paggi
The New England Journal of Medicine
Josep M LlovetSHARP Investigators Study Group
Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
Robert C KaneRichard Pazdur
Hepatology : Official Journal of the American Association for the Study of Liver Diseases
Jordi BruixAmerican Association for the Study of Liver Diseases
© 2021 Meta ULC. All rights reserved