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Combination of gefitinib and olaparib vs gefitinib alone in EGFR mutant non-small-cell lung cancer (NSCLC): A multicenter, randomized phase II study (GOAL)

Lung Cancer Oct 07, 2020

Garcia-Campelo R, Arrieta O, Massuti B, et al. - In EGFR (epidermal growth factor receptor)-mutant advanced non-small-cell lung cancer (NSCLC), researchers assessed if adding olaparib to gefitinib could improve outcomes via a multicenter, randomized phase IB/II study (GOAL). Eligibility criteria for inclusion were age 18 years or older, treatment-naïve, and pathologically verified stage IV NSCLC with centrally verified EGFR mutations and measurable disease. Patients were randomized 1:1 to receive gefitinib 250 mg daily or gefitinib 250 mg daily plus olaparib 200 mg three times daily in 28-day cycles. Progression-free survival (primary endpoint) as well as overall survival, response rate, safety and tolerability (secondary endpoints) were evaluated. No significant benefit was seen with gefitinib plus olaparib in combination vs gefitinib alone in this study. Hematological and gastrointestinal toxicity was higher in relation to treatment with gefitinib plus olaparib combination vs gefitinib alone, however, they noted no relevant adverse events.

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