Abstract
7571 Background: NEJ002, a phase III trial comparing gefitinib with carboplatin-paclitaxel as the first-line treatment for advanced NSCLC with sensitive EGFR mutations, showed a significant improvement in progression-free survival (PFS) in the gefitinib arm. Although standard schedule of gefitinib was the administration of 250 mg tablet every day, more than half of patients in the gefitinib arm reduced the dose of gefitinib mainly because of toxicities. However, the efficacy of such low-dose (LD) gefitinib has rarely been evaluated. Methods: A post-hoc analysis of the efficacy (response rate and survival) in patients who took gefitinib without any dose reduction during their treatment period and those in patients who received LD gefitinib at any point during the treatment period was performed. Results: Among 114 patients of the first-line gefitinib group in NEJ002, 52 (46%) continued gefitinib without break until their diseases progressed (categorize as group A), and 62 (54%) was reduced their dose of gefitinib (most of them moved into every-2-days schedule) because of some toxicities (same as group B). There was no significant difference of patient characteristics between two groups. Interestingly, PFS of group B seemed to be better than that of group A (median PFS, 301 days in group A versus 351 days in group B; p = 0.450) and overall survival was also similar between the groups (median survival time, 852 days versus 928 days, respectively; p = 0.674). Conclusions: The results suggest that LD gefitinib may be clinically not inferior to standard schedule of gefitinib for NSCLC with sensitive EGFR mutations. Considering the merit in terms of risk-benefit balance, prospective study of LD gefitinib is warranted. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration AstraZeneca AstraZeneca
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