PMID- 23073758
OWN - NLM
STAT- MEDLINE
DCOM- 20130611
LR  - 20181202
IS  - 1573-7217 (Electronic)
IS  - 0167-6806 (Linking)
VI  - 136
IP  - 3
DP  - 2012 Dec
TI  - Phase II open-label study of sunitinib in patients with advanced breast cancer.
PG  - 759-67
LID - 10.1007/s10549-012-2285-0 [doi]
AB  - This multicenter, open-label phase II study was conducted to evaluate sunitinib 
      monotherapy in patients with either metastatic or locoregionally recurrent 
      advanced breast cancer. Patients received sunitinib 37.5 mg on a continuous daily 
      dosing schedule. The primary endpoint was objective response rate (ORR); the 
      predefined target ORR was 25 %. All 83 patients enrolled into the study received 
      study treatment. The majority of patients (90 %) had metastatic disease; 92 % had 
      received prior systemic therapies, and 60 % had received two or more regimens for 
      early and/or advanced disease. The ORR was 8 % (95 % exact CI, 4-17), comprising 
      seven partial responses. In patients with superficial lesions (defined as 
      cutaneous or palpable chest wall lesions), the ORR was 20 % (three of 15 
      evaluable patients), which was higher than that in patients with non-superficial 
      disease (9 %; six of 64 patients). Median progression-free survival in the 
      overall population was 3.6 months (95 % CI, 2.4-3.9); median overall survival was 
      15.6 months (95 % CI, 14.0-22.7). No new or unexpected safety findings were 
      reported. The most commonly reported adverse events (AEs) were fatigue (60 %), 
      diarrhea (54 %), and nausea (49 %). The most commonly reported grade 3/4 AEs were 
      fatigue (17 %), neutropenia (16 %), and thrombocytopenia (11 %). Four patients (5 
      %) had a dose reduction due to an AE, and 39 patients (47 %) had temporary 
      discontinuations of therapy due to AEs. Two on-study deaths were reported, one 
      due to a pulmonary embolism (considered related to treatment) and one attributed 
      to dyspnea and a myocardial infarction (considered unrelated to treatment). 
      Patient-reported outcomes suggested that sunitinib treatment did not have a 
      negative impact overall on patients' functional domains or the majority of 
      symptom scales. The trial did not meet its prespecified primary endpoint, and in 
      view of the negative results obtained in several other trials, sunitinib will not 
      be developed further for this indication.
FAU - Yardley, Denise A
AU  - Yardley DA
AD  - The Sarah Cannon Research Institute and Tennessee Oncology, Suite 110, 250 25th 
      Ave. North, Nashville, TN 37203, USA. dyardley@tnonc.com
FAU - Dees, E Claire
AU  - Dees EC
FAU - Myers, Stephen D
AU  - Myers SD
FAU - Li, Sherry
AU  - Li S
FAU - Healey, Paul
AU  - Healey P
FAU - Wang, Zhixiao
AU  - Wang Z
FAU - Brickman, Marla J
AU  - Brickman MJ
FAU - Paolini, Jolanda
AU  - Paolini J
FAU - Kern, Kenneth A
AU  - Kern KA
FAU - Citrin, Dennis L
AU  - Citrin DL
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20121017
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  - V99T50803M (Sunitinib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/adverse effects/*therapeutic use
MH  - Breast Neoplasms/*drug therapy/mortality/*pathology
MH  - Diarrhea/chemically induced
MH  - Disease-Free Survival
MH  - Fatigue/chemically induced
MH  - Female
MH  - Humans
MH  - Indoles/adverse effects/*therapeutic use
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - Pyrroles/adverse effects/*therapeutic use
MH  - Sunitinib
MH  - Thrombocytopenia/chemically induced
MH  - Treatment Outcome
EDAT- 2012/10/18 06:00
MHDA- 2013/06/12 06:00
CRDT- 2012/10/18 06:00
PHST- 2012/04/30 00:00 [received]
PHST- 2012/10/01 00:00 [accepted]
PHST- 2012/10/18 06:00 [entrez]
PHST- 2012/10/18 06:00 [pubmed]
PHST- 2013/06/12 06:00 [medline]
AID - 10.1007/s10549-012-2285-0 [doi]
PST - ppublish
SO  - Breast Cancer Res Treat. 2012 Dec;136(3):759-67. doi: 10.1007/s10549-012-2285-0. 
      Epub 2012 Oct 17.