Trial reportInternational journal of clinical oncology2025
Phase II study of afatinib for advanced non-small cell lung cancer with uncommon epidermal growth factor receptor mutations, including compound mutations detected by next-generation sequencing.
Trial report in International journal of clinical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
11 authors.
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Abstract
backgroundThere are no prospective clinical data on the efficacy of afatinib in patients with non-small cell lung cancer (NSCLC) harboring various uncommon epidermal growth factor receptor (EGFR) mutations detected using next-generation sequencing. We aimed to report the efficacy and safety of afatinib in patients with NSCLC harboring uncommon EGFR mutations detected using next-generation sequencing.
methodsThis was a prospective single-center single-arm phase II study. Patients with histologically confirmed metastatic or recurrent NSCLC harboring uncommon EGFR mutations, excluding exon 20 insertion and T790M mutations detected using next-generation sequencing, were eligible. Patients received oral afatinib (40 mg once daily). The primary endpoint was the objective response rate. The secondary endpoints were progression-free survival, overall survival, and safety.
resultsBetween August 2019 and September 2022, 17 patients were enrolled. The median age was 71 years (range, 59-80 years; 9 males). The uncommon mutations identified were G719X (n = 4; 24%), S768I (n = 3; 17.6%), and L861Q (n = 6; 35%), and 13 other rare EGFR mutations were detected in 10 patients. These mutations were identified as single or compound mutations. The objective response rate for all patients was 82.4%, median progression-free survival was 11.3 months, and median overall survival was 27.8 months. Grade 3 or higher adverse events were diarrhea (n = 5; 29%), paronychia (n = 2; 12%), and decreased appetite (n = 2; 12%). All adverse events were manageable, and there were no treatment-related deaths.
conclusionsAfatinib demonstrated favorable activity with manageable toxicity in patients with NSCLC harboring uncommon EGFR mutations.
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