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R. Kaushal



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    P3.02b - Poster Session with Presenters Present (ID 494)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 2
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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. Kaushal

      • Abstract
      • Slides

      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.

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      P3.02b-090 - Pemetrexed versus Gefitinib in EGFR Mutation Positive Lung Cancer: Results of a Phase 3 Study from India (ID 5416)

      14:30 - 14:30  |  Author(s): R. Kaushal

      • Abstract

      Background:
      This study has been designed to confirm the efficacy of gefitinib Platinum and Pemetrexed combination chemotherapy as first-line treatment for advanced EGFR Mutation positive adenocarcinoma lung.

      Methods:
      This was an open label, randomised, parallel group study comparing Gefitinib ( 250 mg OD daily) with Platinum ( either Cisplatin 75 mg/m2 or Carboplatin AUC-5 ) and Pemetrexed ( 500 mg/m2 ) doublet intravenous chemotherapy regimen ( Induction of 4-6 cycles followed by maintenance) in patients with stage IIIB or stage IV adenocarcinoma lung who have confirmed to be EGFR activating mutation-positive in the first line setting. The primary endpoint for the study is progression free survival (PFS). Patients underwent axial imaging for response assessment on D42, D84, D126 and subsequently every 2 months till progression. Patients were followed up till death. For an estimated 50% improvement in progression free survival, with 80 % power and 5% type one error, number of patients required will be 260. We expect a 5% dropout rate, which required 290 patients to be randomized.

      Results:
      The median PFS in gefitinib arm was 8.433 months ( 95% CI 6.332-10.535) while it was 5.6 months ( 95% CI 4.207-6.993) in pemetrexed arm ( p value-0.000 , log rank test). The adjusted hazard ratio was 0.661 (95% CI 0.513- 0.852) . The impact of gefitinib on PFS was seen across all subgroups Table 1. There was no statistically significant difference in overall survival between the 2 arms .

      Variable Subgroup HR 95%CI HR P value
      Age Below 65 years 0.66 0.50-0.86 0.003
      Above 65 years 0.35 0.18-0.68 0.002
      Gender Male 0.66 0.47-0.92 0.014
      Female 0.66 0.45-0.97 0.037
      Smoking Smoker 0.60 0.34-1.04 0.071
      Non smoker 0.60 0.45-0.79 0.000
      Oral tobacco use Yes 0.62 0.41-0.92 0.018
      No 0.57 0.41-0.79 0.001
      ECOG PS PS0-1 0.62 0.48-0.82 0.001
      PS2 0.51 0.23-1.10 0.087
      Presence of liver metastasis Yes 0.55 0.33-0.91 0.020
      No 0.63 0.48-0.85 0.002
      Presence of brain metastasis Yes 0.56 0.30-1.06 0.073
      No 0.61 0.46-0.80 0.000
      Table 1 : Impact of gefitinib on progression free survival in different subgroups.

      Conclusion:
      The study confirms superiority of gefitinib against the the most active chemotherapy regimen of pemetrexed platinum in EGFR mutated NSCLC patients.