PMID- 24081937
OWN - NLM
STAT- MEDLINE
DCOM- 20140107
LR  - 20220419
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 31
IP  - 32
DP  - 2013 Nov 10
TI  - Sunitinib versus sorafenib in advanced hepatocellular cancer: results of a 
      randomized phase III trial.
PG  - 4067-75
LID - 10.1200/JCO.2012.45.8372 [doi]
AB  - 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.
FAU - Cheng, Ann-Lii
AU  - Cheng AL
AD  - 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.
FAU - Kang, Yoon-Koo
AU  - Kang YK
FAU - Lin, Deng-Yn
AU  - Lin DY
FAU - Park, Joong-Won
AU  - Park JW
FAU - Kudo, Masatoshi
AU  - Kudo M
FAU - Qin, Shukui
AU  - Qin S
FAU - Chung, Hyun-Cheol
AU  - Chung HC
FAU - Song, Xiangqun
AU  - Song X
FAU - Xu, Jianming
AU  - Xu J
FAU - Poggi, Guido
AU  - Poggi G
FAU - Omata, Masao
AU  - Omata M
FAU - Pitman Lowenthal, Susan
AU  - Pitman Lowenthal S
FAU - Lanzalone, Silvana
AU  - Lanzalone S
FAU - Yang, Liqiang
AU  - Yang L
FAU - Lechuga, Maria Jose
AU  - Lechuga MJ
FAU - Raymond, Eric
AU  - Raymond E
LA  - eng
SI  - ClinicalTrials.gov/NCT00699374
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130930
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Indoles)
RN  - 0 (Phenylurea Compounds)
RN  - 0 (Pyrroles)
RN  - 25X51I8RD4 (Niacinamide)
RN  - 9ZOQ3TZI87 (Sorafenib)
RN  - V99T50803M (Sunitinib)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/*therapeutic use
MH  - Carcinoma, Hepatocellular/*drug therapy/mortality
MH  - Disease-Free Survival
MH  - Female
MH  - Humans
MH  - Indoles/*therapeutic use
MH  - Kaplan-Meier Estimate
MH  - Liver Neoplasms/*drug therapy/mortality
MH  - Male
MH  - Middle Aged
MH  - Niacinamide/*analogs & derivatives/therapeutic use
MH  - Phenylurea Compounds/*therapeutic use
MH  - Proportional Hazards Models
MH  - Pyrroles/*therapeutic use
MH  - Sorafenib
MH  - Sunitinib
MH  - Young Adult
EDAT- 2013/10/02 06:00
MHDA- 2014/01/08 06:00
CRDT- 2013/10/02 06:00
PHST- 2013/10/02 06:00 [entrez]
PHST- 2013/10/02 06:00 [pubmed]
PHST- 2014/01/08 06:00 [medline]
AID - JCO.2012.45.8372 [pii]
AID - 10.1200/JCO.2012.45.8372 [doi]
PST - ppublish
SO  - J Clin Oncol. 2013 Nov 10;31(32):4067-75. doi: 10.1200/JCO.2012.45.8372. Epub 
      2013 Sep 30.