PMID- 20339913
OWN - NLM
STAT- MEDLINE
DCOM- 20100713
LR  - 20211020
IS  - 1573-7217 (Electronic)
IS  - 0167-6806 (Print)
IS  - 0167-6806 (Linking)
VI  - 121
IP  - 1
DP  - 2010 May
TI  - Phase III randomized trial of sunitinib versus capecitabine in patients with 
      previously treated HER2-negative advanced breast cancer.
PG  - 121-31
LID - 10.1007/s10549-010-0788-0 [doi]
AB  - This multicenter, randomized, open-label phase III trial (planned enrollment: 700 
      patients) was conducted to test the hypothesis that single-agent sunitinib 
      improves progression-free survival (PFS) compared with capecitabine as treatment 
      for advanced breast cancer (ABC). Patients with HER2-negative ABC that recurred 
      after anthracycline and taxane therapy were randomized (1:1) to sunitinib 37.5 
      mg/day or capecitabine 1,250 mg/m(2) (1,000 mg/m(2) in patients >65 years) BID on 
      days 1-14 q3w. The independent data-monitoring committee (DMC) determined during 
      the first interim analysis (238 patients randomized to sunitinib, 244 to 
      capecitabine) that the trial be terminated due to futility in reaching the 
      primary endpoint. No statistical evidence supported the hypothesis that sunitinib 
      improved PFS compared with capecitabine (one-sided P = 0.999). The data indicated 
      that PFS was shorter with sunitinib than capecitabine (median 2.8 vs. 4.2 months, 
      respectively; HR, 1.47; 95% CI, 1.16-1.87; two-sided P = 0.002). Median overall 
      survival (15.3 vs. 24.6 months; HR, 1.17; two-sided P = 0.350) and objective 
      response rates (11 vs. 16%; odds ratio, 0.65; P = 0.109) were numerically 
      inferior with sunitinib versus capecitabine. While no new or unexpected safety 
      findings were reported, sunitinib treatment was associated with higher 
      frequencies and greater severities of many common adverse events (AEs) compared 
      with capecitabine, resulting in more temporary discontinuations due to AEs with 
      sunitinib (66 vs. 51%). The relative dose intensity was lower with sunitinib than 
      capecitabine (73 vs. 95%). Based on these efficacy and safety results, sunitinib 
      should not be used as monotherapy for patients with ABC.
FAU - Barrios, Carlos H
AU  - Barrios CH
AD  - PUCRS School of Medicine, Centro de Pesquisa em Oncologia, Jardim Botanico, Porto 
      Alegre, RS, 90610-000, Brazil. chbe@via-rs.net
FAU - Liu, Mei-Ching
AU  - Liu MC
FAU - Lee, Soo Chin
AU  - Lee SC
FAU - Vanlemmens, Laurence
AU  - Vanlemmens L
FAU - Ferrero, Jean-Marc
AU  - Ferrero JM
FAU - Tabei, Toshio
AU  - Tabei T
FAU - Pivot, Xavier
AU  - Pivot X
FAU - Iwata, Hiroji
AU  - Iwata H
FAU - Aogi, Kenjiro
AU  - Aogi K
FAU - Lugo-Quintana, Roberto
AU  - Lugo-Quintana R
FAU - Harbeck, Nadia
AU  - Harbeck N
FAU - Brickman, Marla J
AU  - Brickman MJ
FAU - Zhang, Ke
AU  - Zhang K
FAU - Kern, Kenneth A
AU  - Kern KA
FAU - Martin, Miguel
AU  - Martin M
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100326
PL  - Netherlands
TA  - Breast Cancer Res Treat
JT  - Breast cancer research and treatment
JID - 8111104
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Indoles)
RN  - 0 (Pyrroles)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 6804DJ8Z9U (Capecitabine)
RN  - U3P01618RT (Fluorouracil)
RN  - V99T50803M (Sunitinib)
SB  - IM
MH  - Antineoplastic Agents/*therapeutic use
MH  - Breast Neoplasms/*drug therapy/genetics/pathology
MH  - Capecitabine
MH  - Deoxycytidine/*analogs & derivatives/therapeutic use
MH  - Disease-Free Survival
MH  - Female
MH  - Fluorouracil/*analogs & derivatives/therapeutic use
MH  - Genes, erbB-2
MH  - Humans
MH  - Indoles/*therapeutic use
MH  - Kaplan-Meier Estimate
MH  - Pyrroles/*therapeutic use
MH  - Sunitinib
PMC - PMC2855860
EDAT- 2010/03/27 06:00
MHDA- 2010/07/14 06:00
PMCR- 2010/03/26
CRDT- 2010/03/27 06:00
PHST- 2010/02/03 00:00 [received]
PHST- 2010/02/05 00:00 [accepted]
PHST- 2010/03/27 06:00 [entrez]
PHST- 2010/03/27 06:00 [pubmed]
PHST- 2010/07/14 06:00 [medline]
PHST- 2010/03/26 00:00 [pmc-release]
AID - 788 [pii]
AID - 10.1007/s10549-010-0788-0 [doi]
PST - ppublish
SO  - Breast Cancer Res Treat. 2010 May;121(1):121-31. doi: 10.1007/s10549-010-0788-0. 
      Epub 2010 Mar 26.