PMID- 21990397
OWN - NLM
STAT- MEDLINE
DCOM- 20111222
LR  - 20220330
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 29
IP  - 32
DP  - 2011 Nov 10
TI  - RIBBON-2: a randomized, double-blind, placebo-controlled, phase III trial 
      evaluating the efficacy and safety of bevacizumab in combination with 
      chemotherapy for second-line treatment of human epidermal growth factor receptor 
      2-negative metastatic breast cancer.
PG  - 4286-93
LID - 10.1200/JCO.2010.34.1255 [doi]
AB  - PURPOSE: This phase III study compared the efficacy and safety of bevacizumab 
      combined with standard chemotherapy regimens versus chemotherapy alone as 
      second-line treatment of patients with human epidermal growth factor receptor 2 
      (HER2) -negative metastatic breast cancer. PATIENTS AND METHODS: Patients were 
      randomly assigned 2:1 to chemotherapy + bevacizumab or to chemotherapy + placebo. 
      Before random assignment, investigators chose capecitabine, a taxane (paclitaxel, 
      nab-paclitaxel, or docetaxel), gemcitabine, or vinorelbine. Dosing for 
      bevacizumab or placebo was 15 mg/kg every 3 weeks or 10 mg/kg every 2 weeks, 
      depending on chemotherapy regimen. The primary end point was progression-free 
      survival (PFS). Secondary end points included overall survival, PFS by 
      chemotherapy cohort, objective response rate (ORR), duration of objective 
      response, 1-year survival rate, and safety. RESULTS: RIBBON-2 enrolled 684 
      patients (225, chemotherapy + placebo; 459, chemotherapy + bevacizumab). The 
      combination of bevacizumab with chemotherapy demonstrated a statistically 
      significant benefit. Median PFS increased from 5.1 to 7.2 months (stratified 
      hazard ratio for PFS, 0.78; 95% CI, 0.64 to 0.93; P = .0072). The 10% improvement 
      in ORR between the placebo- and bevacizumab-containing arms (39.5% v 29.6%; P = 
      .0193), although not statistically significant, was consistent with previous 
      trials. There was no statistically significant difference in overall survival. 
      The most common grade >/= 3 adverse events (AEs) related to bevacizumab treatment 
      were hypertension (9.0%) and proteinuria (3.1%). There was an increased number of 
      AEs leading to study discontinuation in the chemotherapy + bevacizumab arm 
      compared with the chemotherapy + placebo arm (13.3% v 7.2%). CONCLUSION: The 
      combination of bevacizumab with commonly used chemotherapies improved PFS in the 
      second-line treatment of patients with HER2-negative metastatic breast cancer, 
      with a safety profile comparable with that in prior phase III studies.
FAU - Brufsky, Adam M
AU  - Brufsky AM
AD  - University of Pittsburgh, 300 Halket St, Suite 4628, Pittsburgh, PA 15213, USA. 
      brufskyam@upmc.edu
FAU - Hurvitz, Sara
AU  - Hurvitz S
FAU - Perez, Edith
AU  - Perez E
FAU - Swamy, Raji
AU  - Swamy R
FAU - Valero, Vicente
AU  - Valero V
FAU - O'Neill, Vincent
AU  - O'Neill V
FAU - Rugo, Hope S
AU  - Rugo HS
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20111011
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 (Antibodies, Monoclonal, Humanized)
RN  - 2S9ZZM9Q9V (Bevacizumab)
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
CIN - J Clin Oncol. 2012 Feb 1;30(4):461; author reply 461-2. PMID: 22203773
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal, Humanized/administration & dosage/adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Bevacizumab
MH  - Breast Neoplasms/chemistry/*drug therapy/mortality/pathology
MH  - Disease Progression
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Receptor, ErbB-2/*analysis
EDAT- 2011/10/13 06:00
MHDA- 2011/12/23 06:00
CRDT- 2011/10/13 06:00
PHST- 2011/10/13 06:00 [entrez]
PHST- 2011/10/13 06:00 [pubmed]
PHST- 2011/12/23 06:00 [medline]
AID - JCO.2010.34.1255 [pii]
AID - 10.1200/JCO.2010.34.1255 [doi]
PST - ppublish
SO  - J Clin Oncol. 2011 Nov 10;29(32):4286-93. doi: 10.1200/JCO.2010.34.1255. Epub 
      2011 Oct 11.