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

By A. Cheng, Yoon-Koo Kang, D. Lin, Joong-Won Park, M. Kudo, S. Qin, H. Chung, Xia Song, Jianming Xu, G. Poggi and 6 more. Journal of Clinical Oncology, 2013

706 citations recorded by the source corpus.

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.

Subfields: Hepatology, Pathology and Forensic Medicine, Pharmacology

View Paper: https://www.semanticscholar.org/paper/a9cc5550a3cf1903ad703cbee1ebbc66dd6fda05

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Citations in the corpus

EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. (2018, background): “A multicentre, open-label sorafenibcontrolled randomised phase III trial was prematurely discontinued for safety issues and futility reasons.(568) This drug is presently not recommended for treatment of HCC.”
Asia–Pacific clinical practice guidelines on the management of hepatocellular carcinoma: a 2017 update (2017, background): “In addition to sorafenib and regorafenib, a variety of molecular targeted agents have been thoroughly investigated, including sunitinib [589], brivanib [590, 591], linifanib [592], ramucirumab (angiogenesis inhibitors) [593], erlotinib (EGFR inhibitor) [594], and everolimus (mTOR inhibitor) [595].”
Assessment of liver function in patients with hepatocellular carcinoma: a new evidence-based approach-the ALBI grade. (2015, methodology): “Patients Entered Onto Clinical Trials We had access to a data set including 1,132 patients receiving sorafenib for unresectable advanced HCC within the control groups of two international clinical trials.(17,18) Of the 1,028 patients with complete data, 96% were classified as C-P grade A.”