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MINI 32 - Topics in Localized Lung Cancer (ID 166)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Treatment of Localized Disease - NSCLC
- Presentations: 1
MINI32.12 - Randomized Adjuvant Chemotherapy of EGFR-Mutated Non-Small Cell Lung Cancer Patients with or without Icotinib Consolidation Therapy (ID 2219)
18:30 - 20:00 | Author(s): H. Wang
Epidermal growth factor receptor (EGFR) mutations occur in up to 50% of Asian patients with non-small cell lung cancer (NSCLC). Treatment of advanced NSCLC patients with EGFR-tyrosine kinase inhibitors (EGFR-TKI) confers a significant survival benefit. This study assessed the efficacy and safety of chemotherapy with or without icotinib in patients undergoing resection of stage IB to IIIA EGFR-mutated NSCLC.
Patients with surgically resected stage IB (with high risk factors) to IIIA EGFR-mutated NSCLC were randomly assigned (1:1) to one of two treatment plans. One group received four cycles of platinum-based doublet chemotherapy every three weeks, and the other received platinum-based chemotherapy supplemented by a consolidation therapy of orally administered icotinib (125 mg thrice daily) two weeks after chemotherapy for four to eight months, or until the occurrence of disease relapse, metastasis or unacceptable icotinib or chemotherapy toxicity. The primary endpoint was disease free survival (DFS).
39 patients were enrolled between February 2011 and December 2012. 21 patients were assigned to the combined chemotherapy plus icotinib treatment group, while 18 patients received chemotherapy only. DFS at 12 months was 100% for icotinib-treated patients and 88.9% for chemotherapy-only patients (p = 0. 122). At 18 months DFS for icotinib-treated vs. chemotherapy-only patients was 95.2% vs. 83.3% (p = 0. 225), respectively, and at 24 months DFS was 90.5% vs. 66.7% (p = 0. 066). In the Cox proportional hazards model, the treatment groups and pTNM stage showed a statistically significant, the HR was 0.136 (95%CI: 0.022-0.829, p = 0.030) and 5.498 (95%CI: 1.333-22.673, p = 0.018) respectively. Adverse chemotherapy effects predominantly presented as gastrointestinal reactions and marrow suppression, and there was no significant difference between the two treatment groups. Patients in the chemotherapy plus icotinib treatment group showed favorable tolerance to oral icotinib.Figure 1
The results suggest that, firstly, chemotherapy plus orally icotinib displayed a longer DFS compared with chemotherapy only, and secondly, patients receiving extra orally icotinib showed favorable tolerance without severe side effects. Nonetheless, our results are promising and future trials with larger sample sizes could confirm our current data.