J Cancer 2014; 5(7):499-509. doi:10.7150/jca.9257
Sorafenib Therapy for BCLC Stage B/C Hepatocellular Carcinoma; Clinical Outcome and Safety in Aged Patients: A Multicenter Study in Japan
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.
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.
Nishikawa H, Takeda H, Tsuchiya K, Joko K, Ogawa C, Taniguchi H, Orito E, Uchida Y, Osaki Y, Izumi N,