PMID- 22331954
OWN - NLM
STAT- MEDLINE
DCOM- 20120508
LR  - 20220311
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 30
IP  - 9
DP  - 2012 Mar 20
TI  - First-line treatment of advanced breast cancer with sunitinib in combination with 
      docetaxel versus docetaxel alone: results of a prospective, randomized phase III 
      study.
PG  - 921-9
LID - 10.1200/JCO.2011.35.7376 [doi]
AB  - PURPOSE: To investigate whether sunitinib plus docetaxel improves clinical 
      outcomes for patients with human epidermal growth factor receptor 2 
      (HER2)/neu-negative advanced breast cancer (ABC) versus docetaxel alone. PATIENTS 
      AND METHODS: In this phase III study, patients were randomly assigned to 
      open-label combination therapy (sunitinib 37.5 mg/d, days 2 to 15 every 3 weeks; 
      and docetaxel 75 mg/m(2), day 1 every 3 weeks) or monotherapy (docetaxel 100 
      mg/m(2) every 3 weeks). Progression-free survival (PFS) was the primary end 
      point. RESULTS: Two hundred ninety-six patients were randomly assigned to 
      combination therapy, and 297 patients were assigned to monotherapy. Median PFS 
      times were 8.6 and 8.3 months with combination therapy and monotherapy, 
      respectively (hazard ratio, 0.92; one-sided P = .265). The objective response 
      rate (ORR) was significantly higher with the combination (55%) than with 
      monotherapy (42%; one-sided P = .001). Duration of response was similar in both 
      arms (7.5 months with the combination v 7.2 months with monotherapy). Median 
      overall survival (OS) times were 24.8 and 25.5 months with combination therapy 
      and monotherapy, respectively (one-sided P = .904). There were 107 deaths with 
      the combination and 91 deaths with monotherapy. The frequency of common adverse 
      events (AEs) was higher with the combination, as were treatment discontinuations 
      caused by AEs. CONCLUSION: The combination of sunitinib plus docetaxel improved 
      ORR but did not prolong either PFS or OS compared with docetaxel alone when given 
      to an unselected HER2/neu-negative cohort as first-line treatment for ABC. 
      Sunitinib combination therapy may also have resulted in AEs that yield an 
      unfavorable risk-benefit ratio. The sunitinib-docetaxel regimen evaluated in this 
      study is not recommended for further use in ABC.
FAU - Bergh, Jonas
AU  - Bergh J
AD  - Karolinska Institutet and University Hospital, 171 76 Stockholm, Sweden. 
      jonas.bergh@ki.se
FAU - Bondarenko, Igor M
AU  - Bondarenko IM
FAU - Lichinitser, Mikhail R
AU  - Lichinitser MR
FAU - Liljegren, Annelie
AU  - Liljegren A
FAU - Greil, Richard
AU  - Greil R
FAU - Voytko, Nataliya L
AU  - Voytko NL
FAU - Makhson, Anatoly N
AU  - Makhson AN
FAU - Cortes, Javier
AU  - Cortes J
FAU - Lortholary, Alain
AU  - Lortholary A
FAU - Bischoff, Joachim
AU  - Bischoff J
FAU - Chan, Arlene
AU  - Chan A
FAU - Delaloge, Suzette
AU  - Delaloge S
FAU - Huang, Xin
AU  - Huang X
FAU - Kern, Kenneth A
AU  - Kern KA
FAU - Giorgetti, Carla
AU  - Giorgetti C
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 - 20120213
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 (Indoles)
RN  - 0 (Pyrroles)
RN  - 0 (Taxoids)
RN  - 15H5577CQD (Docetaxel)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - V99T50803M (Sunitinib)
SB  - IM
CIN - J Clin Oncol. 2012 Mar 20;30(9):898-901. PMID: 22331930
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Breast Neoplasms/*drug therapy/mortality/pathology
MH  - Carcinoma, Ductal, Breast/*drug therapy/mortality/secondary
MH  - Carcinoma, Lobular/*drug therapy/mortality/secondary
MH  - Docetaxel
MH  - Female
MH  - Humans
MH  - Indoles/administration & dosage
MH  - International Agencies
MH  - Middle Aged
MH  - Prospective Studies
MH  - Pyrroles/administration & dosage
MH  - Receptor, ErbB-2/metabolism
MH  - Sunitinib
MH  - Survival Rate
MH  - Taxoids/administration & dosage
MH  - Treatment Outcome
EDAT- 2012/02/15 06:00
MHDA- 2012/05/09 06:00
CRDT- 2012/02/15 06:00
PHST- 2012/02/15 06:00 [entrez]
PHST- 2012/02/15 06:00 [pubmed]
PHST- 2012/05/09 06:00 [medline]
AID - JCO.2011.35.7376 [pii]
AID - 10.1200/JCO.2011.35.7376 [doi]
PST - ppublish
SO  - J Clin Oncol. 2012 Mar 20;30(9):921-9. doi: 10.1200/JCO.2011.35.7376. Epub 2012 
      Feb 13.