Real-life experience of sorafenib treatment for hepatocellular carcinoma in Korea

From GIDEON data

doyoung kim, Hye Jin Kim, KwangHyub 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

Research output: Contribution to journalArticle

13 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 Jan 1

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Korea
Hepatocellular Carcinoma
Therapeutics
Safety
Survival
sorafenib
Life Change Events
Drug-Related Side Effects and Adverse Reactions
Observational Studies
Foot
Diarrhea
Hand
Prospective Studies
Skin
Incidence

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

kim, doyoung ; Kim, Hye Jin ; Han, KwangHyub ; Han, Sang Young ; Heo, Jeong ; Woo, Hyun Young ; Um, Soon Ho ; Kim, Yeul Hong ; Kweon, Young Oh ; Lim, Ho Yeong ; Yoon, Jung Hwan ; Lee, Wan Sik ; Lee, Byung Seok ; Lee, Han Chu ; Ryoo, Baek Yeol ; Yoon, Seung Kew. / Real-life experience of sorafenib treatment for hepatocellular carcinoma in Korea : From GIDEON data. In: Cancer Research and Treatment. 2016 ; Vol. 48, No. 4. pp. 1243-1252.
@article{db52b90086a64b3c91e03a6e31b53f18,
title = "Real-life experience of sorafenib treatment for hepatocellular carcinoma in Korea: From GIDEON data",
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).",
author = "doyoung kim and Kim, {Hye Jin} and KwangHyub Han and Han, {Sang Young} and Jeong Heo and Woo, {Hyun Young} and Um, {Soon Ho} and Kim, {Yeul Hong} and Kweon, {Young Oh} and Lim, {Ho Yeong} and Yoon, {Jung Hwan} and Lee, {Wan Sik} and Lee, {Byung Seok} and Lee, {Han Chu} and Ryoo, {Baek Yeol} and Yoon, {Seung Kew}",
year = "2016",
month = "1",
day = "1",
doi = "10.4143/crt.2015.278",
language = "English",
volume = "48",
pages = "1243--1252",
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publisher = "Korean Cancer Association",
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kim, D, Kim, HJ, Han, K, Han, SY, Heo, J, Woo, HY, Um, SH, Kim, YH, Kweon, YO, Lim, HY, Yoon, JH, Lee, WS, Lee, BS, Lee, HC, Ryoo, BY & Yoon, SK 2016, 'Real-life experience of sorafenib treatment for hepatocellular carcinoma in Korea: From GIDEON data', Cancer Research and Treatment, vol. 48, no. 4, pp. 1243-1252. https://doi.org/10.4143/crt.2015.278

Real-life experience of sorafenib treatment for hepatocellular carcinoma in Korea : From GIDEON data. / kim, doyoung; Kim, Hye Jin; Han, KwangHyub; Han, Sang Young; Heo, Jeong; Woo, Hyun Young; Um, Soon Ho; Kim, Yeul Hong; Kweon, Young Oh; Lim, Ho Yeong; Yoon, Jung Hwan; Lee, Wan Sik; Lee, Byung Seok; Lee, Han Chu; Ryoo, Baek Yeol; Yoon, Seung Kew.

In: Cancer Research and Treatment, Vol. 48, No. 4, 01.01.2016, p. 1243-1252.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Real-life experience of sorafenib treatment for hepatocellular carcinoma in Korea

T2 - From GIDEON data

AU - kim, doyoung

AU - Kim, Hye Jin

AU - Han, KwangHyub

AU - Han, Sang Young

AU - Heo, Jeong

AU - Woo, Hyun Young

AU - Um, Soon Ho

AU - Kim, Yeul Hong

AU - Kweon, Young Oh

AU - Lim, Ho Yeong

AU - Yoon, Jung Hwan

AU - Lee, Wan Sik

AU - Lee, Byung Seok

AU - Lee, Han Chu

AU - Ryoo, Baek Yeol

AU - Yoon, Seung Kew

PY - 2016/1/1

Y1 - 2016/1/1

N2 - 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).

AB - 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).

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DO - 10.4143/crt.2015.278

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