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First-Line TKI Use in EGFR Mutation-Positive NSCLC

First-Line TKI Use in EGFR Mutation-Positive NSCLC. Jürgen Wolf, MD Medical Director, Center for Integrated Oncology Köln Department I of Internal Medicine University Hospital of Cologne Bonn, Germany. Pivotal Registration Trials With EGFR TKIs in EGFR Mutation-Positive NSCLC.

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First-Line TKI Use in EGFR Mutation-Positive NSCLC

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  1. First-Line TKI Use in EGFR Mutation-Positive NSCLC Jürgen Wolf, MD Medical Director, Center for Integrated Oncology Köln Department I of Internal Medicine University Hospital of Cologne Bonn, Germany

  2. Pivotal Registration Trials With EGFR TKIs in EGFR Mutation-Positive NSCLC CI = confidence interval; EGFR = epidermal growth factor receptor; HR = hazard ratio; NSCLC = non-small cell lung cancer; OS = overall survival; PFS = progression-free survival; TKI = tyrosine kinase inhibitor a. Fukuoka M, et al. J Clin Oncol. 2011;29(21):2866-2874; b. Rosell R, et al. Lancet Oncol. 2012;13(3):239-246; c. Yang JC, et al. ASCO 2012. Abstract LBA7500.

  3. LUX-Lung 6 Trial: Afatinib vs Chemotherapy in EGFR Mutation-Positive NSCLC • A multicenter, randomized, open-label, phase 3 trial in China, the Republic of Korea, and Thailand • Patients with: • Adenocarcinoma of the lung • Presence of EGFR mutation in the tumor tissue • Stage IIIB/IV • No prior treatment with chemotherapy for advanced/metastatic disease • No prior treatment with EGFR inhibitors • Eastern Cooperative Oncology Group performance status 0 or 1 • N = 364 Randomization 2:1 Cisplatin 75 mg/m2+ gemcitabine 1000 mg/m2IV day 1 + day 8, every 3 weeks Afatinib 40 mg once daily Primary endpoint: PFS Wu YL, et al. ASCO 2013. Abstract 8016.

  4. LUX-Lung 6 Trial: PFS • Median PFS by independent review: • 11.0 months for afatinib arm • 5.6 months for chemotherapy arm • 1-year PFS: • 47% for afatinib arm • 2% for chemotherapy arm Wu YL, et al. ASCO 2013. Abstract 8016.

  5. LUX-Lung 6 Trial: Adverse Events • Most common grade 3 adverse events associated with afatinib: • Rash, 14.2% • Diarrhea, 5.4% • Stomatitis/mucositis, 5.4% • Discontinuation rate due to treatment-related adverse events: • 5.9% of patients on afatinib • 39.8% of patients on chemotherapy • Only 2% of patients on afatinib discontinued due to rash and none due to diarrhea Wu YL, et al. ASCO 2013. Abstract 8016.

  6. LUX-Lung 7 Trial: Afatinib vs Gefitinib (Irreversible TKI vs Reversible TKI) • Patients with • Advanced adenocarcinoma of the lung • Documented common EGFR mutations (del19 or L858R) • First line (no prior treatment) • Global study: 57 sites (currently recruiting) • N = 264 Randomization Gefitinib 250 mg Afatinib40 mg Primary endpoint: PFS and disease control rate at 12 months ClinicalTrials.gov. NCT01466660.

  7. Take-Home Messages • Patients must be tested for the EGFR mutation and, if positive, receive first-line EGFR TKI • Significant improvements in PFS in first-line therapy of patients with EGFR mutation-positive NSCLC with EGFR TKI vs chemotherapy • Significant improvement in quality-of-life parameters with EGFR TKI vs chemotherapy

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