2023 World Conference on Lung Cancer (Posters)-P2.09. Gefitinib Maintenance After Definitive CCRT in EGFR mutant Stage III NSCLC: Single Arm, Open Label, Multicenter Phase 2 Trial

P2.09. Gefitinib Maintenance After Definitive CCRT in EGFR mutant Stage III NSCLC: Single Arm, Open Label, Multicenter Phase 2 Trial - PDF(Abstract)

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A study was conducted to evaluate the effect of gefitinib maintenance after concurrent chemoradiotherapy (CCRT) in patients with stage III non-small cell lung cancer (NSCLC) who had epidermal growth factor receptor (EGFR) mutations. The study was an open-label, single-arm, multicenter Phase II trial and included 15 patients with sensitizing EGFR mutations and stage III NSCLC. The patients were treated with gefitinib (250mg daily) for up to 12 months. The primary endpoint was progression-free survival (PFS), and secondary outcomes were overall survival (OS) and safety. <br /><br />The results showed that the median PFS was 26.5 months and the median OS was not reached. The overall response rate was 66.7% and the disease control rate was 93.3%. The most common adverse events were skin rash and diarrhea, but no grade 3 or 4 toxicities were observed. <br /><br />Based on these findings, the study concludes that gefitinib maintenance after definitive CCRT demonstrated excellent PFS and OS in patients with EGFR mutant stage III NSCLC without any new unexpected toxicity. However, further large-scale prospective randomized controlled trials are needed to validate these results.<br /><br />The baseline characteristics of the study population showed that the median age was 64, and the majority of patients were never-smokers and had adenocarcinoma. The primary EGFR mutation types were 19del and L858R. The patients had stage IIIA or IIIB NSCLC, and the Eastern Cooperative Oncology Group performance status was 1 for all patients.

Asset Subtitle

Yoonsil Jang

Meta Tag

Speaker Yoonsil Jang

Topic Metastatic NSCLC: Targeted Therapy - EGFR/HER2

Keywords

gefitinib maintenance

concurrent chemoradiotherapy

stage III non-small cell lung cancer

epidermal growth factor receptor mutations

open-label

single-arm

multicenter Phase II trial

progression-free survival

overall survival

safety