PMID- 23040000
OWN - NLM
STAT- MEDLINE
DCOM- 20130404
LR  - 20221207
IS  - 1938-0666 (Electronic)
IS  - 1526-8209 (Linking)
VI  - 12
IP  - 5
DP  - 2012 Oct
TI  - Phase II study of gemcitabine and bevacizumab as first-line treatment in 
      taxane-pretreated, HER2-negative, locally recurrent or metastatic breast cancer.
PG  - 322-30
LID - S1526-8209(12)00168-1 [pii]
LID - 10.1016/j.clbc.2012.07.004 [doi]
AB  - BACKGROUND: In first-line treatment of metastatic breast cancer, the best use of 
      the available therapeutic agents is unclear. This study evaluated the efficacy 
      and safety of combined therapy with bevacizumab and gemcitabine. PATIENTS: Women 
      who were to undergo first-line treatment for locoregionally recurrent or 
      metastatic breast cancer were eligible. Patients must have received a 
      taxane-containing regimen in the neoadjuvant and/or adjuvant setting with a >/= 
      12-month disease-free interval. METHODS: This was a single-arm, phase II trial. 
      On day 1 of each 14-day cycle, patients received gemcitabine (2500 mg/m(2)) 
      followed by bevacizumab (10 mg/kg). Patients were treated until complete 
      response, progressive disease (PD), or intolerable toxicity. The primary endpoint 
      was progression-free survival (PFS). RESULTS: Fifty-two women were enrolled and 
      treated. The median PFS was 4.8 months (95% confidence interval [CI], 3.4-7.6), 
      the 1-year overall survival rate was 68.7% (95% CI, 54.1%-79.5%), and the 
      response rate was 21.4% (95% CI, 10.3%-36.8%). The clinical benefit rate was 
      35.7%. The median PFS in the triple-negative (n = 19) and non-triple-negative (n 
      = 33) subsets was 3.9 months (95% CI, 2.7-11.7) and 4.9 months (95% CI, 3.4-8.1), 
      respectively. The most common (all grades) drug-related adverse events (AEs) were 
      nausea (51.9%), fatigue (46.2%), decreased appetite (25.0%), and anemia (25.0%). 
      The most common grade 3 or grade 4 drug-related AEs were neutropenia (13.5%), 
      leukopenia (11.5%), and hypertension (7.7%). CONCLUSION: Although the 
      gemcitabine-bevacizumab doublet appears active, the median PFS was lower than 
      expected. There were no unexpected safety signals at this dose and schedule of 
      this combination.
CI  - Copyright (c) 2012 Elsevier Inc. All rights reserved.
FAU - Borson, Rachel
AU  - Borson R
AD  - Mercy Clinic, St. Louis Cancer and Breast Institute, St. Louis, MO, USA.
FAU - Harker, Graydon
AU  - Harker G
FAU - Reeves, James
AU  - Reeves J
FAU - Beck, Thaddeus
AU  - Beck T
FAU - Hager, Steven
AU  - Hager S
FAU - Horvath, William
AU  - Horvath W
FAU - Jones, Michael
AU  - Jones M
FAU - Tillinghast, Guy
AU  - Tillinghast G
FAU - Arrowsmith, Edward
AU  - Arrowsmith E
FAU - Harrer, Grant
AU  - Harrer G
FAU - Kudrik, Fred J
AU  - Kudrik FJ
FAU - Malamud, Stephen C
AU  - Malamud SC
FAU - Bromund, Jane
AU  - Bromund J
FAU - Zeigler, Haoyue
AU  - Zeigler H
FAU - Tai, Datchen Fritz
AU  - Tai DF
FAU - Kornberg, Lori J
AU  - Kornberg LJ
FAU - Obasaju, Coleman
AU  - Obasaju C
FAU - Orlando, Mauro
AU  - Orlando M
FAU - Yardley, Denise A
AU  - Yardley DA
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Breast Cancer
JT  - Clinical breast cancer
JID - 100898731
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Bridged-Ring Compounds)
RN  - 0 (Taxoids)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 1605-68-1 (taxane)
RN  - 2S9ZZM9Q9V (Bevacizumab)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Adenocarcinoma/*drug therapy/mortality/secondary
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal, Humanized/administration & dosage
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Bevacizumab
MH  - Breast Neoplasms/*drug therapy/mortality/pathology
MH  - Bridged-Ring Compounds/administration & dosage
MH  - Deoxycytidine/administration & dosage/analogs & derivatives
MH  - Female
MH  - Humans
MH  - Immunoenzyme Techniques
MH  - In Situ Hybridization, Fluorescence
MH  - Middle Aged
MH  - Neoadjuvant Therapy
MH  - Neoplasm Metastasis
MH  - Neoplasm Recurrence, Local/*drug therapy/mortality/pathology
MH  - Neoplasm Staging
MH  - Prognosis
MH  - Receptor, ErbB-2/genetics/*metabolism
MH  - Survival Rate
MH  - Taxoids/administration & dosage
MH  - Gemcitabine
EDAT- 2012/10/09 06:00
MHDA- 2013/04/05 06:00
CRDT- 2012/10/09 06:00
PHST- 2011/12/13 00:00 [received]
PHST- 2012/06/26 00:00 [revised]
PHST- 2012/07/09 00:00 [accepted]
PHST- 2012/10/09 06:00 [entrez]
PHST- 2012/10/09 06:00 [pubmed]
PHST- 2013/04/05 06:00 [medline]
AID - S1526-8209(12)00168-1 [pii]
AID - 10.1016/j.clbc.2012.07.004 [doi]
PST - ppublish
SO  - Clin Breast Cancer. 2012 Oct;12(5):322-30. doi: 10.1016/j.clbc.2012.07.004.