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J Clin Oncol. 2013 Nov 10;31(32):4067-75. doi: 10.1200/JCO.2012.45.8372. Epub 2013 Sep 30.

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

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Ann-Lii Cheng, National Taiwan University Hospital, Taipei; Deng-Yn Lin, Chang Gung Memorial Hospital, Chang Gung University, Guishan Township, Taiwan, Republic of China; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Hyun-Cheol Chung, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul; Joong-Won Park, National Cancer Center, Goyang, Republic of Korea; Masatoshi Kudo, Kinki University Hospital, Osaka; Masao Omata, Yamanashi Prefecture Central Hospital, Kofu, Yamanashi, Japan; Shukui Qin, Nanjing Bayi Hospital, Nanjing; Xiangqun Song, Tumor Hospital of Guangxi Zhuang Autonomous Region, Nanning; Jianming Xu, Beijing 307 Hospital Cancer Centre, Beijing, People's Republic of China; Guido Poggi, Istituto di Ricovero e Cura a Carattere Scientifico Fondazione Maugeri, Pavia; Silvana Lanzalone, Maria Jose Lechuga, Pfizer Italia Srl, Milan, Italy; Susan Pitman Lowenthal, Pfizer Oncology, New York, NY; Liqiang Yang, Pfizer Oncology, La Jolla, CA; Eric Raymond, Service Inter Hospitalier de Cancerologie Bichat-Beaujon, Clichy, France.



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.


[Indexed for MEDLINE]

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