• Home
  • Search Results
  • Sunitinib versus sorafenib in advanced hepatocellular cancer: results of a randomized phase III trial.

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

Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2013-10-02)
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
ABSTRACT

Open-label, phase III trial evaluating whether sunitinib was superior or equivalent to sorafenib in hepatocellular cancer. 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). 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%). 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.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Nicotinamide, BioReagent, suitable for cell culture, suitable for insect cell culture
Sigma-Aldrich
Nicotinamide, ≥99.5% (HPLC)
Supelco
Niacinamide, Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
Nicotinamide, ≥98% (HPLC), powder
Supelco
Nicotinamide (Niacinamide), analytical standard
Sigma-Aldrich
Niacinamide, meets USP testing specifications
Supelco
Nicotinamide (Vitamin B3) solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material, Cerilliant®
Sigma-Aldrich
Nicotinamide, ≥98.5% (HPLC)
Nicotinamide, European Pharmacopoeia (EP) Reference Standard