PMID- 23591401
OWN - NLM
STAT- MEDLINE
DCOM- 20130819
LR  - 20181203
IS  - 1095-6859 (Electronic)
IS  - 0090-8258 (Linking)
VI  - 130
IP  - 1
DP  - 2013 Jul
TI  - A randomized phase II trial of maintenance therapy with Sorafenib in front-line 
      ovarian carcinoma.
PG  - 25-30
LID - S0090-8258(13)00231-X [pii]
LID - 10.1016/j.ygyno.2013.04.011 [doi]
AB  - OBJECTIVES: Sorafenib, an oral multikinase inhibitor of the 
      VEGFR/PDGFR/Raf/MEK/ERK pathway, has shown potential activity in patients with 
      recurrent ovarian cancer (OC). One strategy to prolong disease control and 
      survival in patients with OC is maintenance therapy after achieving a complete 
      response. A double-blind, randomized, placebo-controlled, phase II study to 
      assess the efficacy and safety of maintenance therapy with sorafenib in the 
      treatment of OC is presented. METHODS: Patients with epithelial OC or primary 
      peritoneal cancer in complete remission were randomized to sorafenib 400mg BID or 
      matching placebo. The primary endpoint was progression-free survival (PFS). 
      RESULTS: Of 246 randomized patients, 93% had OC; baseline characteristics were 
      balanced between treatment arms. There was no significant difference between 
      sorafenib and placebo arms for PFS (median 12.7 vs 15.7 months; hazard ratio 
      1.09; 95% CI 0.72-1.63), although there was a notable imbalance in early 
      censoring. The most common >/= grade 3 adverse events (AEs) were hand-foot skin 
      reaction (39.0% vs 0.8%) and rash (14.6% vs 0%). More patients receiving 
      sorafenib versus placebo required dose reductions (67.5% vs 30.1%), resulting in 
      a lower than planned median daily dose (median 584.6 vs 800.0mg). Treatment with 
      sorafenib was of shorter duration (median 17.6 vs 51.9 weeks) with more frequent 
      discontinuations due to AEs (37.4% vs 6.5%). CONCLUSIONS: Sorafenib 400mg BID 
      cannot be recommended as maintenance therapy for patients with OC in complete 
      remission. Assessment of efficacy was limited by the high rate of dose reductions 
      and early discontinuations.
CI  - Copyright (c) 2013 Elsevier Inc. All rights reserved.
FAU - Herzog, Thomas J
AU  - Herzog TJ
AD  - Columbia University & NY Presbyterian Hospital, New York, NY 10032, USA. 
      th2135@columbia.edu
FAU - Scambia, Giovanni
AU  - Scambia G
FAU - Kim, Byoung-Gie
AU  - Kim BG
FAU - Lhomme, Catherine
AU  - Lhomme C
FAU - Markowska, Janina
AU  - Markowska J
FAU - Ray-Coquard, Isabelle
AU  - Ray-Coquard I
FAU - Sehouli, Jalid
AU  - Sehouli J
FAU - Colombo, Nicoletta
AU  - Colombo N
FAU - Shan, Minghua
AU  - Shan M
FAU - Petrenciuc, Oana
AU  - Petrenciuc O
FAU - Oza, Amit
AU  - Oza A
LA  - eng
SI  - ClinicalTrials.gov/NCT00791778
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130413
PL  - United States
TA  - Gynecol Oncol
JT  - Gynecologic oncology
JID - 0365304
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Phenylurea Compounds)
RN  - 0 (Placebos)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 25X51I8RD4 (Niacinamide)
RN  - 9ZOQ3TZI87 (Sorafenib)
SB  - IM
MH  - Aged
MH  - Antineoplastic Agents/adverse effects/therapeutic use
MH  - Combined Modality Therapy
MH  - Disease-Free Survival
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Middle Aged
MH  - Niacinamide/adverse effects/*analogs & derivatives/therapeutic use
MH  - Ovarian Neoplasms/*drug therapy/surgery
MH  - Phenylurea Compounds/adverse effects/*therapeutic use
MH  - Placebos
MH  - Protein Kinase Inhibitors/adverse effects/therapeutic use
MH  - Sorafenib
EDAT- 2013/04/18 06:00
MHDA- 2013/08/21 06:00
CRDT- 2013/04/18 06:00
PHST- 2013/01/31 00:00 [received]
PHST- 2013/03/26 00:00 [revised]
PHST- 2013/04/06 00:00 [accepted]
PHST- 2013/04/18 06:00 [entrez]
PHST- 2013/04/18 06:00 [pubmed]
PHST- 2013/08/21 06:00 [medline]
AID - S0090-8258(13)00231-X [pii]
AID - 10.1016/j.ygyno.2013.04.011 [doi]
PST - ppublish
SO  - Gynecol Oncol. 2013 Jul;130(1):25-30. doi: 10.1016/j.ygyno.2013.04.011. Epub 2013 
      Apr 13.