Sunitinib versus sorafenib in advanced hepatocellular cancer: Results of a randomized phase III trial

Ann Lii Cheng, Yoon Koo Kang, Deng Yn Lin, Joong Won Park, Masatoshi Kudo, Shukui Qin, Hyun Cheol Chung, Xiangqun Song, Jianming Xu, Guido Poggi, Masao Omata, Susan Pitman Lowenthal, Silvana Lanzalone, Liqiang Yang, Maria Jose Lechuga, Eric Raymond

Research output: Contribution to journalArticle

399 Citations (Scopus)

Abstract

Purpose: Open-label, phase III trial evaluating whether sunitinib was superior or equivalent to sorafenib in hepatocellular cancer. Patients and Methods: Patients were stratified and randomly assigned to receive sunitinib 37.5 mg once per day or sorafenib 400 mg twice per day. Primary end point was overall survival (OS). Results: Early trial termination occurred for futility and safety reasons. A total of 1,074 patients were randomly assigned to the study (sunitinib arm, n = 530; sorafenib arm, n = 544). For sunitinib and sorafenib, respectively, median OS was 7.9 versus 10.2 months (hazard ratio [HR], 1.30; one-sided P = .9990; two-sided P = .0014); median progression-free survival (PFS; 3.6 v 3.0 months; HR, 1.13; one-sided P = .8785; two-sided P = .2286) and time to progression (TTP; 4.1 v 3.8 months; HR, 1.13; one-sided P = .8312; two-sided P = .3082) were comparable. Median OS was similar among Asian (7.7 v 8.8 months; HR, 1.21; one-sided P = .9829) and hepatitis B-infected patients (7.6 v 8.0 months; HR, 1.10; one-sided P = .8286), but was shorter with sunitinib in hepatitis C-infected patients (9.2 v 17.6 months; HR, 1.52; one-sided P = .9835). Sunitinib was associated with more frequent and severe adverse events (AEs) than sorafenib. Common grade 3/4 AEs were thrombocytopenia (29.7%) and neutropenia (25.7%) for sunitinib; hand-foot syndrome (21.2%) for sorafenib. Discontinuations owing to AEs were similar (sunitinib, 13.3%; sorafenib, 12.7%). Conclusion: OS with sunitinib was not superior or equivalent but was significantly inferior to sorafenib. OS was comparable in Asian and hepatitis B-infected patients. OS was superior in hepatitis C-infected patients who received sorafenib. Sunitinib-treated patients reported more frequent and severe toxicity.

Original languageEnglish
Pages (from-to)4067-4075
Number of pages9
JournalJournal of Clinical Oncology
Volume31
Issue number32
DOIs
Publication statusPublished - 2013 Nov 10

    Fingerprint

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Cheng, A. L., Kang, Y. K., Lin, D. Y., Park, J. W., Kudo, M., Qin, S., Chung, H. C., Song, X., Xu, J., Poggi, G., Omata, M., Lowenthal, S. P., Lanzalone, S., Yang, L., Lechuga, M. J., & Raymond, E. (2013). Sunitinib versus sorafenib in advanced hepatocellular cancer: Results of a randomized phase III trial. Journal of Clinical Oncology, 31(32), 4067-4075. https://doi.org/10.1200/JCO.2012.45.8372