The efficacy and safety of first-line therapy for the epidermal growth factor receptor mutant non-small cell lung cancer in older versus younger patients: A pooled analysis of two randomized controlled trials

Background: There is a scarcity of data to guide the management of older patients with cancer. We therefore conducted this study to compare the outcomes and toxicities in older versus younger patients with an epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer (NSCLC). Patients and Methods: For this pooled analysis, we utilized the individual patient databases of two prospective, first-line Phase III randomized controlled trials in patients with EGFR-mutant advanced NSCLC. The therapies in the two trials included gefitinib alone, pemetrexed/carboplatin, followed by maintenance pemetrexed and the combination of gefitinib with pemetrexed/carboplatin chemotherapy. We evaluated the progression-free survival (PFS) and overall survival (OS) of older patients (=/> 60 years) as compared to younger patients. Grade 3 or worse adverse events were also compared. Results: A total of 640 patients were included in this analysis, of which 156 (24.3%) were 60 years or older. The median PFS with first-line therapy was 8.5 months (95% confidence interval [CI], 7.8–9.2) in younger versus 9 months (95% CI, 6.7–11.4) in older patients (hazard ratio [HR], 2.3; 95% CI, 0.8–6.7; P = 0.575). The median OS of younger patients was 23.2 months (95% CI, 20.6–25.6) compared to 19 months (95% CI, 14.2–23.7) in older patients (HR, 1.18; 95 CI, 0.89–1.54, P = 0.234). On comparing older with younger patients for various known prognostic factors, there was no difference in OS based on any of the factors. On comparing the toxicities between the younger and older patients in the combination group, there was no difference in Grade 3 or 4 toxicities between younger and older patients except higher incidence of diarrhea in older patients (24.4% versus 9.3%, P = 0.010). Conclusions: In patients with EGFR-mutated NSCLC, similar survival and toxicities were found in patients aged 60 years or older as compared to younger patients with Eastern Cooperative Oncology Group Performance Status of 0–2, except for a higher incidence of diarrhea in older patients.