Real-life experience of sorafenib treatment for hepatocellular carcinoma in Korea: From GIDEON data

Do Young Kim, Hye Jin Kim, Kwang Hyub Han, Sang Young Han, Jeong Heo, Hyun Young Woo, Soon-Ho Um, Yeul Hong Kim, Young Oh Kweon, Ho Yeong Lim, Jung Hwan Yoon, Wan Sik Lee, Byung Seok Lee, Han Chu Lee, Baek Yeol Ryoo, Seung Kew Yoon

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16 Citations (Scopus)

Abstract

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).

Original languageEnglish
Pages (from-to)1243-1252
Number of pages10
JournalCancer Research and Treatment
Volume48
Issue number4
DOIs
Publication statusPublished - 2016

Keywords

  • Hepatocellular carcinoma
  • Korea
  • Sorafenib

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Kim, D. Y., Kim, H. J., Han, K. H., Han, S. Y., Heo, J., Woo, H. Y., Um, S-H., Kim, Y. H., Kweon, Y. O., Lim, H. Y., Yoon, J. H., Lee, W. S., Lee, B. S., Lee, H. C., Ryoo, B. Y., & Yoon, S. K. (2016). Real-life experience of sorafenib treatment for hepatocellular carcinoma in Korea: From GIDEON data. Cancer Research and Treatment, 48(4), 1243-1252. https://doi.org/10.4143/crt.2015.278