1256P - Long-Term Survivors in Non-Small Cell Lung Cancer (NSCLC) Patients with Epidermal Growth Factor Receptor (EGFR) Mutations: Data from a Randomized Phase III Study Comparing GEFITINIB with Carboplatin Plus Paclitaxel (NEJ002)

Abstract

ABSTRACT Background In the NEJ002 study comparing first-line gefitinib to a standard-chemotherapy of carboplatin plus paclitaxel for advanced NSCLC patients with tumors harboring sensitive EGFR mutations, progression-free survival was significantly longer in the gefitinib group compared with the standard-chemotherapy group. However, as 98% of the patients in whom first-line carboplatin-paclitaxel failed crossed over to gefitinib therapy, the overall survival was similar between the two groups. The 2.5-year survival rate of both groups in NEJ002 were very good at about 50%. In order to clarify the factors which contribute to the long-term survival of NSCLC patients with mutated EGFR, we evaluated any correlation between demographic factors and overall survival outcome in 230 patients enrolled in NEJ002. Methods The analysis was performed independently from our previous reports. A total of 226 patients who received EGFR-tyrosine kinase inhibitors (TKI) and had survival confirmation were analyzed. Fourteen factors were evaluated using the cause-specific survival, and uni- and multi-variate analyses were conducted by Cox's proportional hazard model. Results Four prognostic factors were identified by univariate analysis: base-line performance status (PS), existence of the distant metastasis, response to standard-chemotherapy and EGFR-TKI (P Conclusion Base-line PS, responses to standard chemotherapy and response to EGFR-TKI were significant factors on the prognosis of NSCLC with sensitive EGFR mutations. Using updated survival data, a logistic regression analysis for long survivors (more than 3 years) will be presented. Disclosure A. Inoue: I was paid lecture fees from AstraZeneca. S. Oizumi: I was paid an honorarium (AstraZeneca). K. Hagiwara: I was paid honoraria from AstraZeneca. A. Gemma: I (my department) received grant for basic research by AstraZeneca as a chief of department. All other authors have declared no conflicts of interest.