PMID- 17167137
OWN - NLM
STAT- MEDLINE
DCOM- 20061221
LR  - 20250214
IS  - 1533-4406 (Electronic)
IS  - 0028-4793 (Linking)
VI  - 355
IP  - 24
DP  - 2006 Dec 14
TI  - Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer.
PG  - 2542-50
AB  - BACKGROUND: Bevacizumab, a monoclonal antibody against vascular endothelial 
      growth factor, has been shown to benefit patients with a variety of cancers. 
      METHODS: Between July 2001 and April 2004, the Eastern Cooperative Oncology Group 
      (ECOG) conducted a randomized study in which 878 patients with recurrent or 
      advanced non-small-cell lung cancer (stage IIIB or IV) were assigned to 
      chemotherapy with paclitaxel and carboplatin alone (444) or paclitaxel and 
      carboplatin plus bevacizumab (434). Chemotherapy was administered every 3 weeks 
      for six cycles, and bevacizumab was administered every 3 weeks until disease 
      progression was evident or toxic effects were intolerable. Patients with 
      squamous-cell tumors, brain metastases, clinically significant hemoptysis, or 
      inadequate organ function or performance status (ECOG performance status, >1) 
      were excluded. The primary end point was overall survival. RESULTS: The median 
      survival was 12.3 months in the group assigned to chemotherapy plus bevacizumab, 
      as compared with 10.3 months in the chemotherapy-alone group (hazard ratio for 
      death, 0.79; P=0.003). The median progression-free survival in the two groups was 
      6.2 and 4.5 months, respectively (hazard ratio for disease progression, 0.66; 
      P<0.001), with corresponding response rates of 35% and 15% (P<0.001). Rates of 
      clinically significant bleeding were 4.4% and 0.7%, respectively (P<0.001). There 
      were 15 treatment-related deaths in the chemotherapy-plus-bevacizumab group, 
      including 5 from pulmonary hemorrhage. CONCLUSIONS: The addition of bevacizumab 
      to paclitaxel plus carboplatin in the treatment of selected patients with 
      non-small-cell lung cancer has a significant survival benefit with the risk of 
      increased treatment-related deaths. (ClinicalTrials.gov number, NCT00021060.)
CI  - 2006 Massachusetts Medical Society
FAU - Sandler, Alan
AU  - Sandler A
AD  - Vanderbilt University, Nashville, TN, USA. sandler@vanderbilt.edu
FAU - Gray, Robert
AU  - Gray R
FAU - Perry, Michael C
AU  - Perry MC
FAU - Brahmer, Julie
AU  - Brahmer J
FAU - Schiller, Joan H
AU  - Schiller JH
FAU - Dowlati, Afshin
AU  - Dowlati A
FAU - Lilenbaum, Rogerio
AU  - Lilenbaum R
FAU - Johnson, David H
AU  - Johnson DH
LA  - eng
SI  - ClinicalTrials.gov/NCT00021060
GR  - CA12046/CA/NCI NIH HHS/United States
GR  - CA14548/CA/NCI NIH HHS/United States
GR  - CA16116/CA/NCI NIH HHS/United States
GR  - CA21076/CA/NCI NIH HHS/United States
GR  - CA21115/CA/NCI NIH HHS/United States
GR  - CA23318/CA/NCI NIH HHS/United States
GR  - CA31946/CA/NCI NIH HHS/United States
GR  - CA49957/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
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 (Vascular Endothelial Growth Factor A)
RN  - 2S9ZZM9Q9V (Bevacizumab)
RN  - BG3F62OND5 (Carboplatin)
RN  - P88XT4IS4D (Paclitaxel)
SB  - IM
EIN - N Engl J Med. 2007 Jan 18;356(3):318
CIN - N Engl J Med. 2007 Mar 29;356(13):1373; author reply 1374-5. doi: 
      10.1056/NEJMc070042. PMID: 17392310
CIN - N Engl J Med. 2007 Mar 29;356(13):1374; author reply 1374-5. PMID: 17396304
CIN - N Engl J Med. 2007 Mar 29;356(13):1373; author reply 1374-5. PMID: 17396305
CIN - N Engl J Med. 2007 Mar 29;356(13):1373-4; author reply 1374-5. PMID: 17396306
MH  - Aged
MH  - Angiogenesis Inhibitors/*administration & dosage/adverse effects
MH  - Antibodies, Monoclonal/*administration & dosage/adverse effects
MH  - Antibodies, Monoclonal, Humanized
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Bevacizumab
MH  - Carboplatin/administration & dosage/adverse effects
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality
MH  - Disease-Free Survival
MH  - Female
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Lung Neoplasms/*drug therapy/mortality
MH  - Male
MH  - Middle Aged
MH  - Paclitaxel/administration & dosage/adverse effects
MH  - Vascular Endothelial Growth Factor A/blood
EDAT- 2006/12/15 09:00
MHDA- 2006/12/22 09:00
CRDT- 2006/12/15 09:00
PHST- 2006/12/15 09:00 [pubmed]
PHST- 2006/12/22 09:00 [medline]
PHST- 2006/12/15 09:00 [entrez]
AID - 355/24/2542 [pii]
AID - 10.1056/NEJMoa061884 [doi]
PST - ppublish
SO  - N Engl J Med. 2006 Dec 14;355(24):2542-50. doi: 10.1056/NEJMoa061884.