PMID- 18160686
OWN - NLM
STAT- MEDLINE
DCOM- 20080104
LR  - 20231024
IS  - 1533-4406 (Electronic)
IS  - 0028-4793 (Linking)
VI  - 357
IP  - 26
DP  - 2007 Dec 27
TI  - Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer.
PG  - 2666-76
AB  - BACKGROUND: In an open-label, randomized, phase 3 trial, we compared the efficacy 
      and safety of paclitaxel with that of paclitaxel plus bevacizumab, a monoclonal 
      antibody against vascular endothelial growth factor, as initial treatment for 
      metastatic breast cancer. METHODS: We randomly assigned patients to receive 90 mg 
      of paclitaxel per square meter of body-surface area on days 1, 8, and 15 every 4 
      weeks, either alone or with 10 mg of bevacizumab per kilogram of body weight on 
      days 1 and 15. The primary end point was progression-free survival; overall 
      survival was a secondary end point. RESULTS: From December 2001 through May 2004, 
      a total of 722 patients were enrolled. Paclitaxel plus bevacizumab significantly 
      prolonged progression-free survival as compared with paclitaxel alone (median, 
      11.8 vs. 5.9 months; hazard ratio for progression, 0.60; P<0.001) and increased 
      the objective response rate (36.9% vs. 21.2%, P<0.001). The overall survival 
      rate, however, was similar in the two groups (median, 26.7 vs. 25.2 months; 
      hazard ratio, 0.88; P=0.16). Grade 3 or 4 hypertension (14.8% vs. 0.0%, P<0.001), 
      proteinuria (3.6% vs. 0.0%, P<0.001), headache (2.2% vs. 0.0%, P=0.008), and 
      cerebrovascular ischemia (1.9% vs. 0.0%, P=0.02) were more frequent in patients 
      receiving paclitaxel plus bevacizumab. Infection was more common in patients 
      receiving paclitaxel plus bevacizumab (9.3% vs. 2.9%, P<0.001), but febrile 
      neutropenia was uncommon (<1% overall). CONCLUSIONS: Initial therapy of 
      metastatic breast cancer with paclitaxel plus bevacizumab prolongs 
      progression-free survival, but not overall survival, as compared with paclitaxel 
      alone. (ClinicalTrials.gov number, NCT00028990 [ClinicalTrials.gov].).
CI  - Copyright 2007 Massachusetts Medical Society.
FAU - Miller, Kathy
AU  - Miller K
AD  - Indiana University Cancer Center, Indianapolis, USA. kathmill@iupui.edu
FAU - Wang, Molin
AU  - Wang M
FAU - Gralow, Julie
AU  - Gralow J
FAU - Dickler, Maura
AU  - Dickler M
FAU - Cobleigh, Melody
AU  - Cobleigh M
FAU - Perez, Edith A
AU  - Perez EA
FAU - Shenkier, Tamara
AU  - Shenkier T
FAU - Cella, David
AU  - Cella D
FAU - Davidson, Nancy E
AU  - Davidson NE
LA  - eng
SI  - ClinicalTrials.gov/NCT00028990
GR  - CA16116/CA/NCI NIH HHS/United States
GR  - CA21115/CA/NCI NIH HHS/United States
GR  - CA23318/CA/NCI NIH HHS/United States
GR  - CA49883/CA/NCI NIH HHS/United States
GR  - CA66636/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - N Engl J Med
JT  - The New England journal of medicine
JID - 0255562
RN  - 0 (Angiogenesis Inhibitors)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antineoplastic Agents, Phytogenic)
RN  - 2S9ZZM9Q9V (Bevacizumab)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - P88XT4IS4D (Paclitaxel)
SB  - IM
CIN - N Engl J Med. 2008 Apr 10;358(15):1637; author reply 1637-8. PMID: 18403775
CIN - N Engl J Med. 2008 Apr 10;358(15):1637; author reply 1637-8. PMID: 18411431
CIN - Curr Oncol Rep. 2009 Jan;11(1):5-6. PMID: 19080734
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Angiogenesis Inhibitors/therapeutic use
MH  - Antibodies, Monoclonal/adverse effects/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Antineoplastic Agents, Phytogenic/*therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Bevacizumab
MH  - Breast Neoplasms/*drug therapy/mortality/pathology
MH  - Disease Progression
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Neoplasm Metastasis/drug therapy
MH  - Paclitaxel/adverse effects/*therapeutic use
MH  - Proportional Hazards Models
MH  - Quality of Life
MH  - Receptor, ErbB-2/analysis
MH  - Survival Analysis
EDAT- 2007/12/28 09:00
MHDA- 2008/01/05 09:00
CRDT- 2007/12/28 09:00
PHST- 2007/12/28 09:00 [pubmed]
PHST- 2008/01/05 09:00 [medline]
PHST- 2007/12/28 09:00 [entrez]
AID - 357/26/2666 [pii]
AID - 10.1056/NEJMoa072113 [doi]
PST - ppublish
SO  - N Engl J Med. 2007 Dec 27;357(26):2666-76. doi: 10.1056/NEJMoa072113.