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• W3119146950 abstract "<h3>Importance</h3> Although treatment with first-generation epidermal growth factor receptor (EGFR)–tyrosine kinase inhibitor (TKI) plus antiangiogenic inhibitor has shown promising efficacies in patients with<i>EGFR-</i>mutated lung adenocarcinoma, recent single-arm studies have suggested that osimertinib plus antiangiogenic inhibitor might not work synergistically. <h3>Objective</h3> To explore the efficacy and safety of osimertinib plus bevacizumab compared with osimertinib alone in patients with lung adenocarcinoma with<i>EGFR</i>T790M mutation. <h3>Design, Setting, and Participants</h3> Patients with advanced lung adenocarcinoma that progressed with prior EGFR-TKI treatment (other than third-generation TKI) and acquired<i>EGFR </i>T790M mutation were enrolled. This study comprises a lead-in part with 6 patients and a subsequent phase 2 part. In phase 2, patients were randomized to osimertinib plus bevacizumab or osimertinib alone in a 1:1 ratio. <h3>Interventions</h3> The combination arm received oral osimertinib (80 mg, every day) plus intravenous bevacizumab (15 mg/kg, every 3 weeks) until progression or unacceptable toxic effects. The control arm received osimertinib monotherapy. <h3>Main Outcomes and Measures</h3> The primary end point was progression-free survival (PFS) assessed by investigators. Secondary end points consisted of overall response rate, time to treatment failure, overall survival, and safety. <h3>Results</h3> From August 2017 through September 2018, a total of 87 patients were registered (6 in the lead-in part and 81 in the phase 2 part [intention-to-treat population]). Among those randomized, the median (range) age was 68 (41-82) years; 33 (41%) were male; 37 (46%) had an Eastern Cooperative Oncology Group performance status of 0; and 21 (26%) had brain metastasis. Although the overall response rate was better with osimertinib plus bevacizumab than osimertinib alone (68% vs 54%), median PFS was not longer with osimertinib plus bevacizumab (9.4 months vs 13.5 months; adjusted hazard ratio, 1.44; 80% CI, 1.00 to 2.08;<i>P</i> = .20). Median time to treatment failure was also shorter in the combination arm vs the osimertinib arm (8.4 months vs 11.2 months;<i>P</i> = .12). Median overall survival was not different in the combination arm vs osimertinib arm (not reached vs 22.1 months;<i>P</i> = .96). In the combination arm, common adverse events of grade 3 or higher were proteinuria (n = 9; 23%), hypertension (n = 8; 20%). <h3>Conclusions and Relevance</h3> In this randomized clinical trial comparing osimertinib plus bevacizumab vs osimertinib alone, the combination arm failed to show prolongation of PFS in patients with advanced lung adenocarcinoma with<i>EGFR </i>T790M mutation. <h3>Trial Registration</h3> UMIN Clinical Trials Registry Identifier:UMIN000023761" @default.
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• W3119146950 date "2021-03-01" @default.
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• W3119146950 title "Efficacy of Osimertinib Plus Bevacizumab vs Osimertinib in Patients With <i>EGFR</i> T790M–Mutated Non–Small Cell Lung Cancer Previously Treated With Epidermal Growth Factor Receptor–Tyrosine Kinase Inhibitor" @default.
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• W3119146950 doi "https://doi.org/10.1001/jamaoncol.2020.6758" @default.
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