PMID- 25614446
OWN - NLM
STAT- MEDLINE
DCOM- 20160126
LR  - 20220419
IS  - 1557-3265 (Electronic)
IS  - 1078-0432 (Linking)
VI  - 21
IP  - 8
DP  - 2015 Apr 15
TI  - Bevacizumab in Patients with Nonsquamous Non-Small Cell Lung Cancer and 
      Asymptomatic, Untreated Brain Metastases (BRAIN): A Nonrandomized, Phase II 
      Study.
PG  - 1896-903
LID - 10.1158/1078-0432.CCR-14-2082 [doi]
AB  - PURPOSE: The phase II prospective, noncomparative BRAIN study (NCT00800202) 
      investigated efficacy and safety of bevacizumab in chemotherapy-naive or 
      pretreated patients with non-small cell lung cancer (NSCLC) and asymptomatic 
      untreated brain metastases to provide data in this previously unexplored 
      subgroup. EXPERIMENTAL DESIGN: Patients with stage IV nonsquamous NSCLC, Eastern 
      Cooperative Oncology Group performance status 0-1, and untreated, asymptomatic 
      brain metastases received first-line bevacizumab (15 mg/kg) plus carboplatin 
      (area under the curve x6) and paclitaxel (200 mg/m(2)) every 3 weeks (B + CP), or 
      second-line bevacizumab plus erlotinib (150 mg/d; B + E). Six-month 
      progression-free survival (PFS) was the primary endpoint. The trial could be 
      stopped if there were more than three (B + CP) or more than two (B + E) 
      intracranial hemorrhages. RESULTS: In first-line B + CP cohort (n = 67), 6-month 
      PFS rate was 56.5% with a median PFS of 6.7 months [95% confidence interval (CI), 
      5.7-7.1] and median overall survival (OS) of 16.0 months. Investigator-assessed 
      overall response rate (ORR) was 62.7%: 61.2% in intracranial lesions and 64.2% in 
      extracranial lesions. Because of low enrolment (n = 24), efficacy results for the 
      second-line B + E cohort were exploratory only; 6-month PFS rate was 57.2%, 
      median PFS was 6.3 months (95% CI, 3.0-8.4), median OS was 12.0 months, and ORR 
      was 12.5%. Adverse events were comparable with previous trials of bevacizumab. 
      One grade 1 intracranial hemorrhage occurred and resolved without sequelae. 
      CONCLUSIONS: The BRAIN study demonstrates encouraging efficacy and acceptable 
      safety of bevacizumab with first-line paclitaxel and carboplatin in patients with 
      NSCLC and asymptomatic, untreated brain metastases.
CI  - (c)2015 American Association for Cancer Research.
FAU - Besse, Benjamin
AU  - Besse B
AD  - Gustave Roussy, Villejuif France and Paris Sud University, France. 
      benjamin.besse@gustaveroussy.fr.
FAU - Le Moulec, Sylvestre
AU  - Le Moulec S
AD  - Hopital d'Instruction des Armees du Val-de-Grace, Paris, France.
FAU - Mazieres, Julien
AU  - Mazieres J
AD  - CHU Toulouse - Hopital De Larrey, Toulouse, France.
FAU - Senellart, Helene
AU  - Senellart H
AD  - Institut De Cancerologie De l'Ouest, Site Rene Gauducheau, France.
FAU - Barlesi, Fabrice
AU  - Barlesi F
AD  - Aix-Marseille University, Assistance Publique Hopitaux de Marseille, Marseille, 
      France.
FAU - Chouaid, Christos
AU  - Chouaid C
AD  - CHI Cretiel, Cretreil, France.
FAU - Dansin, Eric
AU  - Dansin E
AD  - CLCC Oscar Lambret, Lille, France.
FAU - Berard, Henri
AU  - Berard H
AD  - Hopital d'Instruction des Armees Sainte Anne, France.
FAU - Falchero, Lionel
AU  - Falchero L
AD  - L'Hopital Nord Ouest, Villefranche Sur Saone, France.
FAU - Gervais, Radj
AU  - Gervais R
AD  - Centre Francois Baclesse, Caen, France.
FAU - Robinet, Gilles
AU  - Robinet G
AD  - CHU Morvan, Brest, France.
FAU - Ruppert, Anne-Marie
AU  - Ruppert AM
AD  - Hopital Tenon, APHP, Paris, France.
FAU - Schott, Roland
AU  - Schott R
AD  - Centre Paul Strauss, Strasbourg, France.
FAU - Lena, Herve
AU  - Lena H
AD  - CHU Rennes, Hopital Pontchaillou, Rennes, France.
FAU - Clement-Duchene, Christelle
AU  - Clement-Duchene C
AD  - Hopital de Brabois, Vandoeuvre-les-Nancy, France.
FAU - Quantin, Xavier
AU  - Quantin X
AD  - CHU Montpellier and ICM Val d'Aurelle, Montpellier, France.
FAU - Souquet, Pierre Jean
AU  - Souquet PJ
AD  - Centre Hospitalier de Lyon Sud, Lyon, France.
FAU - Tredaniel, Jean
AU  - Tredaniel J
AD  - Hopital Saint-Joseph, Paris, France.
FAU - Moro-Sibilot, Denis
AU  - Moro-Sibilot D
AD  - CHU De Grenoble, Hopital A. Michalon, La Tronche, France.
FAU - Perol, Maurice
AU  - Perol M
AD  - Centre Leon Berard, Lyon, France.
FAU - Madroszyk, Anne-Catherine
AU  - Madroszyk AC
AD  - Institut Paoli Calmettes, Marseille, France.
FAU - Soria, Jean-Charles
AU  - Soria JC
AD  - Gustave Roussy, Villejuif France and Paris Sud University, France.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150122
PL  - United States
TA  - Clin Cancer Res
JT  - Clinical cancer research : an official journal of the American Association for 
      Cancer Research
JID - 9502500
RN  - 0 (Angiogenesis Inhibitors)
RN  - 0 (Antineoplastic Agents)
RN  - 2S9ZZM9Q9V (Bevacizumab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Angiogenesis Inhibitors/administration & dosage/adverse effects/therapeutic use
MH  - Antineoplastic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Bevacizumab/administration & dosage/adverse effects/*therapeutic use
MH  - Brain Neoplasms/*drug therapy/mortality/*secondary
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality/*pathology
MH  - Female
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Lung Neoplasms/*drug therapy/mortality/*pathology
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Neoplasm Recurrence, Local
MH  - Neoplasm Staging
MH  - Retreatment
MH  - Treatment Outcome
EDAT- 2015/01/24 06:00
MHDA- 2016/01/27 06:00
CRDT- 2015/01/24 06:00
PHST- 2014/08/11 00:00 [received]
PHST- 2015/01/12 00:00 [accepted]
PHST- 2015/01/24 06:00 [entrez]
PHST- 2015/01/24 06:00 [pubmed]
PHST- 2016/01/27 06:00 [medline]
AID - 1078-0432.CCR-14-2082 [pii]
AID - 10.1158/1078-0432.CCR-14-2082 [doi]
PST - ppublish
SO  - Clin Cancer Res. 2015 Apr 15;21(8):1896-903. doi: 10.1158/1078-0432.CCR-14-2082. 
      Epub 2015 Jan 22.