Cancer Res Treat.  2016 Oct;48(4):1243-1252. 10.4143/crt.2015.278.

Real-Life Experience of Sorafenib Treatment for Hepatocellular Carcinoma in Korea: From GIDEON Data

• Kim DY
• Kim HJ
• Han KH
• 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

• KMID: 2356226
• DOI: http://doi.org/10.4143/crt.2015.278

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).

Keyword

Hepatocellular carcinoma; Sorafenib; Korea

MeSH Terms

Carcinoma, Hepatocellular*
Diarrhea
Humans
Incidence
Korea*
Life Change Events
Prospective Studies
Skin

Figure

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  Fig. 1. The median overall survival (OS) (A) and time to progression (TTP) (B) in the entire study population was 8.5 months and 2.5 months, respectively. The response was estimated based on Response Evaluation Criteria in Solid Tumors ver. 1.0.

Reference

References

1. Kim DY, Han KH. Epidemiology and surveillance of hepatocellular carcinoma. Liver Cancer. 2012; 1:2–14.

2. Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010; 127:2893–917.

3. Bolondi L, Burroughs A, Dufour JF, Galle PR, Mazzaferro V, Piscaglia F, et al. Heterogeneity of patients with intermediate (BCLC B) hepatocellular carcinoma: proposal for a subclassification to facilitate treatment decisions. Semin Liver Dis. 2012; 32:348–59.

4. Jeng KS, Chang CF, Jeng WJ, Sheen IS, Jeng CJ. Heterogeneity of hepatocellular carcinoma contributes to cancer progression. Crit Rev Oncol Hematol. 2015; 94:337–47.

5. Han KH, Kim DY, Park JY, Ahn SH, Kim J, Kim SU, et al. Survival of hepatocellular carcinoma patients may be impro-ved in surveillance interval not more than 6 months compared with more than 6 months: a 15-year prospective study. J Clin Gastroenterol. 2013; 47:538–44.

6. Santi V, Buccione D, Di Micoli A, Fatti G, Frigerio M, Farinati F, et al. The changing scenario of hepatocellular carcinoma over the last two decades in Italy. J Hepatol. 2012; 56:397–405.

7. European Association For The Study Of The Liver; European Organisation For Research And Treatment Of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2012; 56:908–43.

8. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: hepatobiliary cancers (version 2.2013) [Internet]. Fort Washington, PA: National Comprehensive Cancer Network;2012. [cited 2014 Jun 1]. Available from: http://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf.

9. Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, et al. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008; 359:378–90.

10. Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, et al. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009; 10:25–34.

11. Lencioni R, Kudo M, Ye SL, Bronowicki JP, Chen XP, Dagher L, et al. GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib): second interim analysis. Int J Clin Pract. 2014; 68:609–17.

12. Lencioni R, Marrero J, Venook A, Ye SL, Kudo M. Design and rationale for the non-interventional Global Investigation of Therapeutic DEcisions in Hepatocellular Carcinoma and Of its Treatment with Sorafenib (GIDEON) study. Int J Clin Pract. 2010; 64:1034–41.

13. Marrero JA, Lencioni R, Ye SL, Kudo M, Bronowicki JP, Chen XP, et al. Final analysis of GIDEON (global investigation of therapeutic decisions in hepatocellular carcinoma [HCC] and of its treatment with sorafenib [Sor]) in > 3000 Sor-treated patients (pts): clinical findings in pts with liver dysfunction. J Clin Oncol. 2013; 31:Abstr.

14. Abou-Alfa GK, Schwartz L, Ricci S, Amadori D, Santoro A, Figer A, et al. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J Clin Oncol. 2006; 24:4293–300.

15. Marrero JA, Venook A, Kudo M, Ye SL, Nakajima K, Cihon F, et al. Second interim analysis of GIDEON (global investigation of therapeutic decisions in unresectable carcinoma [uHCC] and of its treatment with sorafenib): subgroup analysis by initial sorafenib (Sor) dose. Hepatology. 2011; 54:1389A.

16. Bruix J, Sherman M; American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma: an update. Hepatology. 2011; 53:1020–2.