医学
贝伐单抗
肺癌
内科学
埃罗替尼
临床终点
肿瘤科
无症状的
卡铂
外科
胃肠病学
化疗
癌症
随机对照试验
表皮生长因子受体
顺铂
作者
Benjamin Besse,Sylvestre Le Moulec,Julien Mazières,Hélène Senellart,Fabrice Barlési,C. Chouaïd,Ivan Bièche,H. Bérard,L. Falchero,Radj Gervais,G. Robinet,Anne-Marie Ruppert,Roland Schött,H. Léna,Christelle Clément-Duchêne,Xavier Quantin,Pierre Jean Souquet,Jean Trédaniel,Denis Moro‐Sibilot,M. Pérol,Anne-Catherine Madroszyk,Jean‐Charles Soria
标识
DOI:10.1158/1078-0432.ccr-14-2082
摘要
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.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 ×6) 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.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.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.
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