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OA 16 - Treatment Strategies and Follow Up (ID 686)
- Event: WCLC 2017
- Type: Oral
- Track: Early Stage NSCLC
- Presentations: 1
OA 16.04 - Efficacy and Safety of Erlotinib vs Vinorelbine/Cisplatin as Adjuvant Therapy for Stage IIIA EGFR Mutant NSCLC Patients (ID 8717)
14:30 - 16:15 | Author(s): Q. Wang
Adjuvant chemotherapy remains the most important treatment for stage IIIA non-small cell lung cancer (NSCLC) after radical operation, but its benefits has reached plateau and high risk of recurrence. Previous studies SELECT and RADIANT have suggested a trend of improving DFS of erlotinib as adjuvant therapy for patients with activating mutations. This study is designed as prospective, open-label, randomized, multicenter phase II trial to investigate the efficacy and safety of erlotinib (E) as adjuvant therapy in comparison with vinorelbine/cisplatin (NP) chemotherapy in completely resected stage IIIA EGFR mutant patients.
Patients aged between 18 – 75 with ECOG PS 0–1, stage IIIA, EGFR-activating mutation (exon 19 or exon 21 L858R), reached R0 resection NSCLC were eligible. And patients were randomized(1:1) into either erlotinib (orally 150mg/day for 2 years, util relapse or unacceptable toxicity) or NP (vinorelbine 25mg/m i.v. day 1, 8 and cisplatin 75mg/m i.v. day 1, every 3 weeks for 4 cycles) group. Random assignment was stratified by EGFR mutation type (exon 19 vs exon 21), histology (adenocarcinoma vs non- ) and smoking status (smoker vs non-). The primary endpoint was 2-year disease free survival rate (DFSR), secondary endpoints include disease free survival (DFS), overall survival (OS), safety (NCI CTCAE 4.0) and quality of life (QoL), and exploratory biomarker analysis.
From Sep, 2012 to May, 2015, in total 102 patients from 16 centers across China were randomized to receive E (N=51) or NP (N=51). Median follow-up time was 33 months for E and 28 months for NP. Baseline characteristics of age, sex, PS, histology, smoking status, EGFR mutation subtypes were well balanced in each arm. Two-year DFSR was 81.35% (95%CI: 69.63-93.08) in E arm and 44.62% (95%CI: 26.86-62.38) in NP arm respectively (P<0.001) in ITT population. DFS was significantly prolonged with E vs NP (median, 42.41 vs 20.96 months, HR 0.271, 95% CI: 0.137-0.535; P<0.001). OS data from our trial are still immature. In current, the number of death events were 2 (E) and 13 (NP) arm. Safety profile was similar to previous studies of each agent in NSCLC, no new unexpected AE were observed in each arms.
As compared with NP, E showed superior efficacy and should be considered therapeutic option for patients with R0 resected stage IIIA NSCLC with EGFR-activating mutation. (EVAN, NCT01683175).