Real-Life Experience of Sorafenib Treatment for Hepatocellular Carcinoma in Korea: From GIDEON Data
| Autor: | Ho Yeong Lim, Sang Young Han, Wan Sik Lee, Yeul Hong Kim, Baek Yeol Ryoo, Byung Seok Lee, Hye Jin Kim, Jung Hwan Yoon, Soon Ho Um, Hyun Young Woo, Seung Kew Yoon, Jeong Heo, Young Oh Kweon, Kwang Hyub Han, Do Young Kim, Han Chu Lee |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Male Niacinamide Oncology Sorafenib Cancer Research medicine.medical_specialty Carcinoma Hepatocellular Drug-Related Side Effects and Adverse Reactions Hepatocellular carcinoma Sorafenib treatment Disease-Free Survival 03 medical and health sciences 0302 clinical medicine Internal medicine Republic of Korea medicine Humans Adverse effect Protein Kinase Inhibitors Aged Korea business.industry Phenylurea Compounds Incidence (epidemiology) Liver Neoplasms Middle Aged medicine.disease digestive system diseases Diarrhea Safety profile Treatment Outcome 030220 oncology & carcinogenesis Female Original Article 030211 gastroenterology & hepatology Observational study medicine.symptom business medicine.drug |
| Zdroj: | Cancer Research and Treatment : Official Journal of Korean Cancer Association |
| ISSN: | 2005-9256 1598-2998 |
| Popis: | Purpose The purpose of this study is to report real life experiences of sorafenib therapy for hepatocellular carcinoma (HCC) in Korea, using a subset of data from GIDEON (Global Investigation of Therapeutic Decisions in HCC and of Its Treatment with Sorafenib; a large, prospective, observational study). Materials and methods Between January 2009 and April 2012, a total of 497 patients were enrolled from 11 sites in Korea. Of these, 482 patients were evaluable for safety analyses. Case report forms of paper or electronic version were used to record safety and efficacy data from all patients. Results More patients of Child-Pugh A received sorafenib for > 8 weeks than did patients of Child-Pugh B (55.5% vs. 34.3%). Child-Pugh score did not appear to influence the starting dose of sorafenib, and approximately 70% of patients both in Child-Pugh A and B groups received the recommended initial daily dose of 800 mg (69.0% and 69.5%, respectively). The median overall survival (OS) and time to progression (TTP) were 8.5 months and 2.5 months. In Child-Pugh A patients, the median OS and TTP were 10.2 months and 2.5 months. The most frequent treatment-emergent drug-related adverse event was hand-foot skin reaction (31.7%), followed by diarrhea (18.0%). The incidence of treatment-emergent adverse events was similar in both Child-Pugh A (85.4%) and Child-Pugh B (84.8%) patients. Conclusion Sorafenib was well tolerated by Korean HCC patients in clinical settings, and the safety profile did not appear to differ by Child-Pugh status. Survival benefit in Korean patients was in line with that of a previous pivotal phase III trial (SHARP). |
| Databáze: | OpenAIRE |
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