PMID- 24606768
OWN - NLM
STAT- MEDLINE
DCOM- 20141228
LR  - 20211021
IS  - 1471-2407 (Electronic)
IS  - 1471-2407 (Linking)
VI  - 14
DP  - 2014 Mar 7
TI  - Sunitinib in combination with trastuzumab for the treatment of advanced breast 
      cancer: activity and safety results from a phase II study.
PG  - 166
LID - 10.1186/1471-2407-14-166 [doi]
AB  - BACKGROUND: This phase II study evaluated the efficacy and safety/tolerability of 
      sunitinib plus trastuzumab in patients with HER2-positive advanced breast cancer 
      (ABC). METHODS: Eligible patients received sunitinib 37.5 mg/day and trastuzumab 
      administered either weekly (loading, 4 mg/kg; then weekly 2 mg/kg) or 3-weekly 
      (loading, 8 mg/kg; then 3-weekly 6 mg/kg). Prior trastuzumab and/or lapatinib 
      treatment were permitted. The primary endpoint was objective response rate (ORR). 
      RESULTS: Sixty patients were enrolled and evaluable for safety; 57 were evaluable 
      for efficacy. The majority of patients (58%) had received no prior chemotherapy 
      in the metastatic setting. The ORR was 37%; the clinical benefit rate (CBR; 
      percent objective response plus stable disease >/= 24 weeks) was 56%. Among 
      patients who were treatment-naive or had received only adjuvant therapy, the ORR 
      was 44% and the CBR was 59%. Overall, median overall survival had not been 
      reached and the 1-year survival rate was 91%. The majority of adverse events 
      (AEs) were mild to moderate in severity. Forty percent of patients experienced 
      AEs related to measured left ventricular ejection fraction (LVEF) declines, which 
      occurred more frequently in patients who had received prior anthracycline 
      treatment. Ten percent of patients exhibited symptoms related to LVEF declines. 
      One patient died on study from cardiogenic shock. Antitumor response and several 
      safety parameters appeared to correlate with sunitinib exposure. CONCLUSIONS: 
      Sunitinib plus trastuzumab demonstrated antitumor activity in patients with 
      HER2-positive ABC, particularly those who were treatment-naive or had only 
      received prior adjuvant treatment. Sunitinib plus trastuzumab had acceptable 
      safety and tolerability in patients with HER2-positive ABC who had not received 
      prior anthracycline therapy. TRIAL REGISTRATION: NCT00243503.
FAU - Bachelot, Thomas
AU  - Bachelot T
FAU - Garcia-Saenz, Jose A
AU  - Garcia-Saenz JA
FAU - Verma, Sunil
AU  - Verma S
FAU - Gutierrez, Maya
AU  - Gutierrez M
FAU - Pivot, Xavier
AU  - Pivot X
FAU - Kozloff, Mark F
AU  - Kozloff MF
FAU - Prady, Catherine
AU  - Prady C
FAU - Huang, Xin
AU  - Huang X
FAU - Khosravan, Reza
AU  - Khosravan R
FAU - Wang, Zhixiao
AU  - Wang Z
FAU - Cesari, Rossano
AU  - Cesari R
FAU - Tassell, Vanessa
AU  - Tassell V
FAU - Kern, Kenneth A
AU  - Kern KA
FAU - Blay, Jean-Yves
AU  - Blay JY
AD  - EORTC, Soft Tissue and Bone Sarcoma Group, Centre Leon-Berard and Universite 
      Claude Bernard, Lyon, France. jean-yves.blay@lyon.unicancer.fr.
FAU - Lluch, Ana
AU  - Lluch A
LA  - eng
SI  - ClinicalTrials.gov/NCT00243503
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20140307
PL  - England
TA  - BMC Cancer
JT  - BMC cancer
JID - 100967800
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Indoles)
RN  - 0 (Pyrroles)
RN  - P188ANX8CK (Trastuzumab)
RN  - V99T50803M (Sunitinib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal, Humanized/administration & dosage
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Breast Neoplasms/*drug therapy/*pathology
MH  - Female
MH  - Humans
MH  - Indoles/administration & dosage
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Neoplasm Staging
MH  - Pyrroles/administration & dosage
MH  - Sunitinib
MH  - Trastuzumab
MH  - Treatment Outcome
PMC - PMC3995914
EDAT- 2014/03/13 06:00
MHDA- 2014/12/30 06:00
PMCR- 2014/03/07
CRDT- 2014/03/11 06:00
PHST- 2013/12/09 00:00 [received]
PHST- 2014/02/20 00:00 [accepted]
PHST- 2014/03/11 06:00 [entrez]
PHST- 2014/03/13 06:00 [pubmed]
PHST- 2014/12/30 06:00 [medline]
PHST- 2014/03/07 00:00 [pmc-release]
AID - 1471-2407-14-166 [pii]
AID - 10.1186/1471-2407-14-166 [doi]
PST - epublish
SO  - BMC Cancer. 2014 Mar 7;14:166. doi: 10.1186/1471-2407-14-166.