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• W2968754080 abstract "<h3>Importance</h3> Erlotinib is a standard first-line therapy for patients with epidermal growth factor receptor (<i>EGFR</i>)–mutant non–small cell lung cancer (NSCLC). Median progression-free survival (PFS) with erlotinib is approximately 10 months. <h3>Objective</h3> To determine whether adding bevacizumab to erlotinib treatment results in superior progression-free survival compared with erlotinib alone. <h3>Design, Setting, and Participants</h3> This phase 2 randomized clinical trial compared erlotinib plus bevacizumab with erlotinib alone in<i>EGFR</i>-mutant NSCLC. The trial was conducted in 17 US academic and community medical centers among 88 patients with<i>EGFR</i>exon 19 deletion or exon 21 L858R mutation based on local testing and stage 4 NSCLC who were eligible for bevacizumab. Patients were enrolled between November 2, 2012, and August 22, 2016, and followed up for a median (range) of 33 (0.7-62.5) months. Data were analyzed on August 28, 2018, and included data from November 2, 2012, to August 20, 2018. <h3>Interventions</h3> Patients were randomized with equal allocation to 150 mg of oral erlotinib daily alone or with 15 mg/kg of intravenous bevacizumab every 3 weeks. Study therapy continued until disease progression, unacceptable adverse event, or withdrawal of consent. <h3>Main Outcomes and Measures</h3> The primary outcome was PFS as assessed by the investigator; secondary outcomes were objective response rate (ORR), adverse events, and overall survival (OS). Analysis was designed to detect a hazard ratio (HR) of 0.667 for PFS (an improvement from a median PFS of 10 to 15 months). <h3>Results</h3> Among 88 patients enrolled, the median (range) age was 63 (31-84) years; 62 patients (70%) were female; 75 (85%) were white, 8 (9%) were African American, 3 (3%) were Asian, and for 2 (2%), data on race were not available. Forty-eight patients (55%) were never smokers, 45 patients (51%) were of Eastern Cooperative Oncology Group performance status 1, and 59 patients (67%) had<i>EGFR</i>exon 19 deletion. Compared with erlotinib, the combination did not result in a significant difference in PFS (HR, 0.81; 95% CI, 0.50-1.31;<i>P</i> = .39; median PFS 17.9 [combination] and 13.5 months [erlotinib]), ORR (81% vs 83%;<i>P</i> = .81), and OS (HR, 1.41; 95% CI, 0.71-2.81;<i>P</i> = .33; median OS, 32.4 months [combination] and 50.6 months [erlotinib]). Adverse events of grade 3 or higher observed in 5 or more patients in the combination and erlotinib arms were skin eruption in 11 (26%) vs 7 (16%) patients, diarrhea in 4 (9%) vs 6 (13%) patients, hypertension in 17 (40%) vs 9 (20%) patients, and proteinuria in 5 (12%) vs 0 (0%) patients. <h3>Conclusions and Relevance</h3> Erlotinib plus bevacizumab compared with erlotinib did not result in a significant improvement in PFS in<i>EGFR</i>-mutant NSCLC. <h3>Trial Registration</h3> ClinicalTrials.gov identifier:NCT01532089." @default.
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• W2968754080 date "2019-10-01" @default.
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• W2968754080 title "Effect of Erlotinib Plus Bevacizumab vs Erlotinib Alone on Progression-Free Survival in Patients With Advanced <i>EGFR</i>-Mutant Non–Small Cell Lung Cancer" @default.
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• W2968754080 doi "https://doi.org/10.1001/jamaoncol.2019.1847" @default.
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