J Cancer 2014; 5(7):499-509. doi:10.7150/jca.9257

Research Paper

Sorafenib Therapy for BCLC Stage B/C Hepatocellular Carcinoma; Clinical Outcome and Safety in Aged Patients: A Multicenter Study in Japan

Hiroki Nishikawa1✉*, Haruhiko Takeda1*, Kaoru Tsuchiya2, Kouji Joko3, Chikara Ogawa4, Hiroyoshi Taniguchi5, Etsuro Orito6, Yasushi Uchida7, Yukio Osaki1, Namiki Izumi2, Japanese Red Cross Liver Study Group

1. Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital;
2. Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital;
3. Center for Liver-Biliary-Pancreatic Diseases, Matsuyama Red Cross Hospital;
4. Department of Gastroenterology, Takamatsu Red Cross Hospital;
5. Department of Gastroenterology, Japanese Red Cross Medical Center;
6. Department of Gastroenterology and Hepatology Nagoya Daini Red Cross Hospital;
7. Department of Gastroenterology, Matsue Red Cross Hospital.
* Hiroki Nishikawa and Haruhiko Takeda equally contributed to this work.

Abstract

Background and aims: We aimed to compare clinical outcomes and safety after sorafenib therapy between patients with Barcelona Clinic Liver Cancer (BCLC) stage B or C hepatocellular carcinoma (HCC) aged ≥75 years (aged group, n=179) and those with BCLC stage B or C HCC aged <75 years (control group, n=279).

Patients and methods: We compared overall survival (OS), progression free survival (PFS), best treatment response and sorafenib related serious adverse events (SAEs) of grade 3 or more in the two groups. Furthermore, for reducing the selection bias, we compared clinical outcome of these two groups using propensity score matching analysis.

Results: The median OS and PFS intervals were 9.7 and 3.8 months in the aged group and 8.2 and 3.3 months in the control group (P=0.641 for OS and P=0.068 for PFS). Disease control rates were 49.2% (88/179) in the aged group and 49.1% (137/279) in the control group (P>0.999). Objective response rates were 15.1% (27/179) in the aged group and 14.3% (40/279) in the control group (P=0.892). Treatment related SAEs of grade 3 or more were observed in 51 patients (28.5%) in the aged group and in 69 patients (24.7%) in the control group (P=0.385). In the propensity score matched cohort (132 pairs), no significant difference in the two groups was observed in terms of OS (P=0.898) and PFS (P=0.407).

Conclusion: In BCLC stage B or C HCC patients treated with sorafenib, life expectancy, disease progression, treatment efficacy and SAEs are unaffected by age over 75 years.

Keywords: Hepatocellular carcinoma, Sorafenib, Aged patients, Clinical outcome, Safety.

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How to cite this article:
Nishikawa H, Takeda H, Tsuchiya K, Joko K, Ogawa C, Taniguchi H, Orito E, Uchida Y, Osaki Y, Izumi N, Japanese Red Cross Liver Study Group. Sorafenib Therapy for BCLC Stage B/C Hepatocellular Carcinoma; Clinical Outcome and Safety in Aged Patients: A Multicenter Study in Japan. J Cancer 2014; 5(7):499-509. doi:10.7150/jca.9257. Available from http://www.jcancer.org/v05p0499.htm