TY - JOUR
T1 - Bevacizumab in patients with nonsquamous non-small cell lung cancer and asymptomatic, untreated brain metastases (BRAIN)
T2 - A nonrandomized, phase II study
AU - Besse, Benjamin
AU - Le Moulec, Sylvestre
AU - Mazières, Julien
AU - Senellart, Hélène
AU - Barlesi, Fabrice
AU - Chouaid, Christos
AU - Dansin, Eric
AU - Bérard, Henri
AU - Falchero, Lionel
AU - Gervais, Radj
AU - Robinet, Gilles
AU - Ruppert, Anne Marie
AU - Schott, Roland
AU - Léna, Hervé
AU - Clément-Duchêne, Christelle
AU - Quantin, Xavier
AU - Souquet, Pierre Jean
AU - Trédaniel, Jean
AU - Moro-Sibilot, Denis
AU - Pérol, Maurice
AU - Madroszyk, Anne Catherine
AU - Soria, Jean Charles
N1 - Publisher Copyright:
©2015 AACR.
PY - 2015/4/15
Y1 - 2015/4/15
N2 - Purpose: The phase II prospective, noncomparative BRAIN study (NCT00800202) investigated efficacy and safety of bevacizumab in chemotherapy-naïve 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 fi rst-line bevacizumab (15 mg/kg) plus carboplatin (area under the curve x6) and paclitaxel (200 mg/m2) 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, andORR 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.
AB - Purpose: The phase II prospective, noncomparative BRAIN study (NCT00800202) investigated efficacy and safety of bevacizumab in chemotherapy-naïve 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 fi rst-line bevacizumab (15 mg/kg) plus carboplatin (area under the curve x6) and paclitaxel (200 mg/m2) 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, andORR 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.
UR - http://www.scopus.com/inward/record.url?scp=84927655714&partnerID=8YFLogxK
U2 - 10.1158/1078-0432.CCR-14-2082
DO - 10.1158/1078-0432.CCR-14-2082
M3 - Article
C2 - 25614446
AN - SCOPUS:84927655714
SN - 1078-0432
VL - 21
SP - 1896
EP - 1903
JO - Clinical Cancer Research
JF - Clinical Cancer Research
IS - 8
ER -