Eiichiro Suzuki1, Shuichi Kaneko2, Takuji Okusaka3, Masafumi Ikeda4, Kensei Yamaguchi5, Rie Sugimoto6, Takeshi Aramaki7, Akinori Asagi8, Kohichiroh Yasui9, Keiji Sano10, Ayumu Hosokawa11, Naoya Kato1, Hiroshi Ishii12, Tosiya Sato13, Junji Furuse14. 1. Department of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba. 2. Department of Gastroenterology, Kanazawa University School of Medical Science, Kanazawa. 3. Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo. 4. Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Tokyo. 5. Division of Gastroenterology, Saitama Cancer Center, Saitama. 6. Department of Hepato-Biliary-Pancreatology, National Hospital Organization, Kyushu Cancer Center, Fukuoka. 7. Division of Interventional Radiology, Shizuoka Cancer Center, Sunto-gun. 8. Department of Gastroenterology, Shikoku Cancer Center, Sunto-gun. 9. Department of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto. 10. Department of Surgery, Teikyo University School of Medicine, Tokyo. 11. Department of Gastroenterology and Hematology, Faculty of Medicine University of Toyama, Toyama. 12. Department of Gastroenterology, Clinical Research Center, National Hospital Organization, Shikoku Cancer Center, Matsuyama. 13. Department of Biostatistics, Kyoto University School of Public Health, Kyoto. 14. Department of Medical Oncology, Kyorin University School of Medicine, Tokyo, Japan.
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.
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.