In the NEJ002 study, compared with first-line gefitinib and standard-chemotherapy for advanced NSCLC patients harboring sensitive EGFR mutations, progression-free survival was significantly longer in the gefitinib group than in standard chemotherapy. However, the overall survival was similar between the two groups. The 2-year survival rate of both groups in the NEJ002 was considerably good as about 50%. 95% of the patients in whom first-line carboplatin-paclitaxel failed crossed over to gefitinib therapy in the NEJ002. To identify prognostic factors that impact overall survival of NSCLC patients with mutated EGFR, we evaluated the relation between demographic characteristics and overall survival outcome in 230 patients who entered onto the NEJ002.Methods
Two hundred and twenty-six patients who received EGFR-tyrosine kinase inhibitors (TKI) and had survival confirmation were analyzed. Fourteen factors were evaluated by univariate analysis using the Kaplan–Meier method. Multivariate analyses were conducted using Cox's proportional hazard model.Results
Five prognostic factors were identified by univariate analysis: sex, smoking status, performance status (PS), response to standard-chemotherapy and EGFR-TKI. There were no significant differences among age, histologic type, clinical stage, EGFR mutation type and the first-line treatment. Two independent prognostic factors were identified by multivariate analysis: PS 0 [hazard ratio (HR) 0.35] and response to standard chemotherapy CR + PR [HR 0.42]. Thirty-five patients survived 3 years or more. This long-survived population had a median age of 67 years and was primarily made up of female (77%), non-smoker (71%), PS 0 (66%) and EGFR major mutation (97%).Conclusion
Base line PS was the most important prognostic factor among those who were analyzed in this study on the prognosis of NSCLC patients with sensitive EGFR mutations.