Bevacizumab in patients with nonsquamous non-small cell lung cancer and asymptomatic, untreated brain metastases (BRAIN): A nonrandomized, phase II study

Benjamin Besse, Sylvestre Le Moulec, Julien Mazières, Hélène Senellart, Fabrice Barlesi, Christos Chouaid, Eric Dansin, Henri Bérard, Lionel Falchero, Radj Gervais, Gilles Robinet, Anne Marie Ruppert, Roland Schott, Hervé Léna, Christelle Clément-Duchêne, Xavier Quantin, Pierre Jean Souquet, Jean Trédaniel, Denis Moro-Sibilot, Maurice PérolAnne Catherine Madroszyk, Jean Charles Soria

Résultats de recherche: Contribution à un journalArticleRevue par des pairs

202 Citations (Scopus)

Résumé

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.

langue originaleAnglais
Pages (de - à)1896-1903
Nombre de pages8
journalClinical Cancer Research
Volume21
Numéro de publication8
Les DOIs
étatPublié - 15 avr. 2015
Modification externeOui

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