T. Chu

1281PCOMBINATION OF CHEMOTHERAPY AND GEFITINIB AS FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED LUNG ADENOCARCINOMA AND SENSITIVE EGFR MUTATIONS: A RANDOMISED CONTROLLED TRIAL

ABSTRACT Aim: The results of fastact2 show that chemotherapy plus erlotinib significantly prolonged PFS and OS of patients with NSCLC. However, outcome of the combination therapy are similar to those reported in several trials of single-agent EGFR TKIs. So which is the optimal first-line treatment for patients who harbored a sensitive EGFR mutation? We need a head-to-head study to reply. Methods: 61 untreated patients with advanced lung adenocarcinoma who harbored sensitive EGFR mutations, and with ECOG PS 0-1, were randomly assigned to 3 groups. 20 patients were allocated to the combination therapy group (group A), received pemetrexed (500 mg/m(2) on day 1) plus carboplatin (AUC 5 on day 1) combined with gefitinib (250 mg/day on days 5-21) and repeated every 4 weeks for up to six cycles, then continued to receive pemetrexed combined with gefitinib every 4 weeks. 20 patients allocated to the chemotherapy group (group B), received the same chemotherapy regimen alone every 4 weeks for up to six cycles, then continued to receive pemetrexed alone every 4 weeks. 21 patients allocated to the gefitinib group (group C), and received gefitinib alone. All therapies of 3 groups were continued until progression or unacceptable toxicity or death. The primary endpoint was 6-month PFS. Analyses were done on an ITT basis. Results: 6-month PFS was 95.0% (19 of 20) in the group A, 40.0% (8 of 20) in the group B, and 66.7% (14 of 21) in the group C. ORR was 75.0% in the group A, 30.0% in the group B, and 66.7% in the group C. The most common grade 3-4 adverse events were neutropenia (3 [15.0%] of patients in the group A vs 4 [20.0%] in the group B vs 0 [0.0%] in the group C ), fatigue (2 [10.0%] of patients in the group A vs 2 [10.0%] in the group B vs 0 [0.0%] in the group C ), and liver dysfunction (3 [15.0%] of patients in the group A vs 0 [0.0%] in the group B vs 1 [4.8%] in the group C ). Conclusions: Patients with lung adenocarcinoma who harbored a sensitive EGFR mutation have longer PFS if they are treated with pemetrexed plus carboplatin combined with gefitinib. Disclosure: All authors have declared no conflicts of interest.