Author of

• 18374

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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
  • Moderators:
  • Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 18432

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    P3.02b-058 - Second-Line Therapy in EGFR Activating Mutation Positive Advanced NSCLC: Analysis from a Randomized Phase III First-Line Trial (ID 5591)

    14:30 - 14:30  |  Author(s): N. Pande
    • Abstract
    • Slides

    Background:
    To evaluate the efficacy of second line therapy in patients progressing on either a Pemetrexed-Platinum doublet or Gefitinib in an epidermal growth factor receptor (EGFR) activating mutation positive Stage IIIB/IV non small cohort in the setting of a phase III clinical trial evaluating Pemetrexed-Platinum doublet versus Gefitinib as first line therapy
    
    Methods:
    Patients were part of a randomized Phase III open label parallel group study comparing Gefitinib with Pemetrexed- Platinum doublet in the upfront setting in an EGFR mutation positive Stage IIIB/IV lung cancer population. On progression on first-line therapy, patients were started on second line therapy, if Eastern Cooperative Oncology Group (ECOG) performance status (PS) was 0-2 and baseline clinical and biochemical parameters were within acceptable limits. Patients who received Pemetrexed-Platinum in the first line were offered Gefitinib in the second-line while patients progressing on first-line Gefitinib were considered for Pemetrexed-Platinum doublet as second-line therapy.
    
    Results:
    187 patients were included for analysis.Out of these 157 patients were evaluable for response. 113 patients had received gefitinib as second line ,while 74 patients had received other I.V second line chemotherapy. The response rate was 60.6% in Gefitinib cohort (60, n=99) and 31% in non -Gefitinib cohort (18, n=58), {p=0.30}. The median PFS was 7.4 months (95% CI:5.4-9.4) in gefitinib cohort, whereas it was 4.4 months in non -gefitinib cohort (95% CI:3.7 -5.2). Median OS in gefitinib cohort was 14 months (95% CI:10.8-17.2), while it was 9.8 months in non -gefitinib cohort (95% CI:7.8-11.7){p-0.007}
    
    Conclusion:
    Patients started on gefitinib post progression on pemetrexed therapy had significant benefit, whereas it was limited in patients who received I.V chemotherapy post Gefitinib.
    
    

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  • 18464

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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): N. Pande
    • 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.