Bevacizumab in Patients with Non-Squamous Non-Small-Cell Lung Cancer and Asymptomatic, Untreated Brain Metastases (BRAIN): a Non-Randomised, Phase II Study.
Fiche publication
Date publication
janvier 2015
Auteurs
Membres identifiés du Cancéropôle Est :
Dr CLEMENT-DUCHENE Christelle, Dr SCHOTT Roland
Tous les auteurs :
Besse B, Le Moulec S, Maazieres J, Senellart H, Barlesi F, Chouaid C, Dansin E, Berard H, Falchero L, Gervais R, Robinet G, Ruppert AM, Schott R, Lena H, Clement-Duchene C, Quantin X, Souquet PJ, Tredaniel J, Moro-Sibilot D, Perol M, Madroszyk AC, Soria JC
Lien Pubmed
Résumé
Purpose: The phase II prospective, non-comparative 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 non-squamous 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/m2) every 3 weeks (B+CP), or second-line bevacizumab plus erlotinib (150 mg/day) (B+E) until unacceptable toxicity or disease progression. Primary endpoint: 6-month progression-free survival (PFS). 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% 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.
Référence
Clin Cancer Res. 2015 Jan 22. pii: clincanres.2082.2014.