Sunitinib versus sorafenib in advanced hepatocellular cancer: Results of a randomized phase III trial
Journal
Journal of Clinical Oncology
Journal Volume
31
Journal Issue
32
Pages
4067-4075
Date Issued
2013
Author(s)
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.
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. ? 2013 by American Society of Clinical Oncology.
SDGs
Other Subjects
aspartate aminotransferase; sorafenib; sunitinib; antineoplastic agent; carbanilamide derivative; indole derivative; nicotinamide; pyrrole derivative; sorafenib; sunitinib; abdominal distension; abdominal pain; adult; advanced cancer; aged; alopecia; anemia; Article; ascites; Asian; aspartate aminotransferase blood level; asthenia; cancer chemotherapy; cancer survival; cause of death; constipation; controlled study; decreased appetite; diarrhea; drug dose reduction; drug efficacy; drug safety; drug withdrawal; fatality; fatigue; female; fever; hand foot syndrome; hepatitis B; hepatitis C; human; hypertension; interactive voice response system; leukopenia; liver cell carcinoma; major clinical study; male; morning dosage; multiple cycle treatment; nausea; neutropenia; outcome assessment; overall survival; phase 3 clinical trial; priority journal; progression free survival; randomized controlled trial; rash; side effect; stomatitis; thrombocytopenia; vomiting; weight reduction; adolescent; analogs and derivatives; Carcinoma, Hepatocellular; clinical trial; disease free survival; Kaplan Meier method; Liver Neoplasms; middle aged; mortality; multicenter study; proportional hazards model; very elderly; young adult; Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Carcinoma, Hepatocellular; Disease-Free Survival; Female; Humans; Indoles; Kaplan-Meier Estimate; Liver Neoplasms; Male; Middle Aged; Niacinamide; Phenylurea Compounds; Proportional Hazards Models; Pyrroles; Young Adult
Publisher
American Society of Clinical Oncology
Type
journal article