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R. Chanana
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P3.02b - Poster Session with Presenters Present (ID 494)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02b-007 - Differential Efficacy of Gefitinib in Exon 19 or Exon 21 Mutated Adenocarcinoma Lung (ID 5667)
14:30 - 14:30 | Author(s): R. Chanana
- Abstract
Background:
This study has been designed to evaluate the differential effect of EGFR mutation status (exon 19 versus 21) on PFS and OS in treatment naïve advanced EGFR Mutation positive adenocarcinoma lung treated with Gefitinib as first line agent
Methods:
This was a post hoc analysis of EGFR mutated (exon 19 and 21) advanced-stage (Stage IIIB or IV), chemotherapy-naive NSCLC patients treated with gefitinib as first line in a phase 3 randomized study. Patients were treated with Gefitinib 250 mg daily. Patients underwent axial imaging for response assessment on D42, D84, D126 and subsequently every 2 months till progression. Responding or stable patients were treated until progression or unacceptable toxicity. SPSS was used for statistical analysis. Kaplan Meier method was used for survival estimation and log rank test for comparison. Cox proportion hazard model was used for multivariate analysis.
Results:
141 patients were eligible for analysis of which 78 were males and 63 were females. 127 patients (90.1%) were ECOG 0-1 while 14 patients (9.1%) were ECOG >1. Exon 21 mutation was present in 65 patients (46.1%) and exon 19 mutation in 76 patients (53.9%). 133 of 141 patients were evaluable for response. Response rate of patients having exon 19 mutation was 72.9% (51 patients, n=70) while it was 55.6% in patients having exon 21 mutation (35 patients, n=63) {p=0.046}. Median PFS in exon 19 mutated patients was 9.3 months (95% CI 6.832-11.768) compared to 7.8 months (95% CI 5.543-10.047) in exon 21 mutated patients (p=0.699). The median OS in exon 19 mutated patients was 19.8 months (95 % CI 16.8-22.7) and 16.5 months (95% CI 10.9-22.1) in exon 21 mutated patients (p=0.215).Only female gender had a positive impact on both PFS and OS on multivariate analysis.
Results:
141 patients were eligible for analysis of which 78 were males and 63 were females. 127 patients (90.1%) were ECOG 0-1 while 14 patients (9.1%) were ECOG >1. Exon 21 mutation was present in 65 patients (46.1%) and exon 19 mutation in 76 patients (53.9%). 133 of 141 patients were evaluable for response. Response rate of patients having exon 19 mutation was 72.9% (51 patients, n=70) while it was 55.6% in patients having exon 21 mutation (35 patients, n=63) {p=0.046}. Median PFS in exon 19 mutated patients was 9.3 months (95% CI 6.832-11.768) compared to 7.8 months (95% CI 5.543-10.047) in exon 21 mutated patients (p=0.699). The median OS in exon 19 mutated patients was 19.8 months (95 % CI 16.8-22.7) and 16.5 months (95% CI 10.9-22.1) in exon 21 mutated patients (p=0.215).Only female gender had a positive impact on both PFS and OS on multivariate analysis.
