Efficacy and Safety of Gefitinib Plus Pemetrexed/Platinum in Advanced EGFR-Mutated Lung Adenocarcinoma Patients: A Real-World Observational Study

BACKGROUND: Recent clinical trials illustrated that gefitinib plus pemetrexed/platinum regimen improves survival in advanced lung adenocarcinoma patients with EGFR mutation, while data on its efficacy and safety in a real clinical setting are limited. Thus, this real-world observational study aimed to explore this issue. METHODS: Fifty-one advanced lung adenocarcinoma patients with EGFR mutation who received gefitinib plus pemetrexed/platinum (GPP) were enrolled as GPP group, meanwhile 30 patients who only received gefitinib were retrospectively recruited as control group. Progression-free survival (PFS), overall survival (OS), and adverse events were assessed. RESULTS: PFS was prolonged in GPP group compared to control group (P=0.013) (median PFS: 23.0 vs 14.0 months, 1-year PFS rate: 78.4% vs 60.0%, 3-year PFS rate: 19.6% vs 5.3%). Furthermore, OS was longer in GPP group compared to control group (P=0.023) (median PFS: 42.0 vs 28.0 months, 1-year PFS rate: 94.1% vs 86.7%, 3-year PFS rate: 56.9% vs 32.7%). After adjustment by multivariate Cox proportional hazard regression, GPP group vs control group was independent predictive factor of prolonged PFS (P=0.004, hazard ratio (HR)=0.450) and OS (P=0.031, HR=0.462). Moreover, the most common adverse events among patients in GPP group included myelosuppression (66.7%), digestive toxicity (62.7%), renal toxicity (31.4%), and hepatotoxicity (23.5%), and most of them were grade 1–2. CONCLUSION: Gefitinib plus pemetrexed/platinum exhibits favorable efficacy with low occurrence of severe adverse events in advanced lung adenocarcinoma patients with EGFR mutation, suggesting it could be a potential option for these patients.