Author of

• 30446

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  P1.01 - Advanced NSCLC (ID 158)

  • Event: WCLC 2019
  • Type: Poster Viewing in the Exhibit Hall
  • Track: Advanced NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall

  • 30547

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    P1.01-88 - PS 2 Patients with Advanced EGFR Mutant NSCLC: Subset Analysis of a Phase III Randomized Trial Comparing Gefitinib to Gefitinib with Chemotherapy (ID 3022)

    09:45 - 18:00  |  Author(s): Vijay Maruti Patil
    • Abstract

    Background
    

    Background: Performance status is an important prognostic indicator in lung cancer. Most landmark trials excluded PS 2 patients; however, many patients we see in the clinic are PS 2, hence management of these patients is an extrapolation of the data from trials done in fitter patients.

    Method
    

    Methods: We had conducted a Phase III randomized trial in patients with advanced NSCLC harboring EGFR sensitizing mutation, ECOG PS 0 to 2 planned for first-line palliative therapy. Performance status was a stratification factor, thus there was an equal proportion of PS 2 patients in the two arms. Randomization was 1:1 to gefitinib 250 mg orally daily (gef) or pemetrexed 500 mg/m² and carboplatin AUC 5 IV 3-weekly for 4 cycles, followed by maintenance pemetrexed with gefitinib from day 1 (gef+C). Primary end-point was progression-free survival (PFS); secondary end-points included overall survival (OS), response rate and toxicity. We present the subset analysis of the PS 2 patients in the trial.

    Result
    

    Results: Between 2016 and 2018, 75 PS 2 patients were randomly assigned to gef (n=39) and gef+C (n=36). The median age was 56 years, 63% were females, 23% had brain metastases and 50% had comorbidities. Median follow-up was 20 months (range, 7 to 28). Radiologic response rates were 83% and 67% in gef+C and gef arms respectively, P=0.117. Estimated median PFS was significantly longer with gef+C than gef [15 months, (95% CI, 10.6 to 19.4) versus 6 months (95% CI, 4.3 to 7.7); hazard ratio for disease progression or death, 0.57; 95% CI, 0.33 to 0.98; P=0.031] (Fig 2). Data for OS are immature. Clinically relevant > grade 3 toxicities occurred in 58% and 28% of patients in gef+C and gef arms respectively, P=0.008.

    Conclusion
    

    Conclusion: In EGFR mutant PS 2 patients, combining pemetrexed and carboplatin chemotherapy with gefitinib led to a significant PFS prolongation, with an increase in clinically relevant severe toxicities. PS 2 patients with driver mutations appear to benefit from treatment intensification.

• 30601

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  P2.01 - Advanced NSCLC (ID 159)

  • Event: WCLC 2019
  • Type: Poster Viewing in the Exhibit Hall
  • Track: Advanced NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall

  • 30716

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    P2.01-102 - Outcome of Patients with EGFR Exon 19 Mutation in a Phase III Randomized Trial Comparing Gefitinib to Gefitinib with Chemotherapy (ID 3027)

    10:15 - 18:15  |  Author(s): Vijay Maruti Patil
    • Abstract

    Background
    

    In patients with EGFR sensitizing mutations, the subtype of the EGFR mutation impacts the clinical outcome and carries both prognostic and predictive value.

    Method
    

    We had conducted a Phase III randomized trial in patients with advanced NSCLC harboring EGFR sensitizing mutation, ECOG PS 0 to 2 planned for first-line palliative therapy. The type of sensitizing EGFR mutation (exon 19 versus others) was a stratification factor. Randomization was 1:1 to gefitinib 250 mg orally daily (gef) or pemetrexed 500 mg/m² and carboplatin AUC 5 IV 3-weekly for 4 cycles, followed by maintenance pemetrexed with gefitinib from day 1 (gef+C). The primary end-point was progression-free survival (PFS); secondary end-points included overall survival (OS), response rate and toxicity. We present the subset analysis of the patients with exon 19 in-frame deletion.

    Result
    

    Between 2016 and 2018, 216 patients with EGFR exon 19 mutation were randomly assigned to gef (n=109) and gef+C (n=107). The median age was 54 years, 51% were males, 20% were PS 2 and 21% had brain metastases. Median follow-up was 17 months (range, 7 to 30). Radiologic response rates were 81% and 75% in gef+C and gef arms respectively, P=0.29. Estimated median PFS was significantly longer with gef+C than gef [17 months, (95% CI, 12.4 to 21.6) versus 8 months (95% CI, 6.8 to 9.3); hazard ratio for disease progression or death, 0.49; 95% CI, 0.35 to 0.69; P<0.001]. Data for OS are immature. Clinically relevant > grade 3 toxicities occurred in 55% and 23% of patients in gef+C and gef arms respectively, P<0.001.

    Conclusion
    

    In patients with exon 19 in-frame deletion, combining pemetrexed and carboplatin chemotherapy with gefitinib led to a significant PFS prolongation, with an increase in clinically relevant severe toxicities.