Presentation on theme: "First-Line TKI Use in EGFR Mutation-Positive NSCLC"— Presentation transcript:
1 First-Line TKI Use in EGFR Mutation-Positive NSCLC Jürgen Wolf, MDMedical Director,Center for Integrated Oncology KölnDepartment I of Internal MedicineUniversity Hospital of CologneBonn, Germany
2 del19/L858R “common” mutations Pivotal Registration Trials With EGFR TKIs in EGFR Mutation-Positive NSCLCStudyTreatment RegimenAll EGFR mutationsdel19/L858R “common” mutationsMedian PFSMedian OSIPASS[a] Asians with subgroup of EGFR mutationsGefitinib vs carboplatin + paclitaxel9.5 vs 6.3(HR, 0.48; 95% CI, )21.6 vs 21.9(HR, 1.00; 95% CI, )EURTAC[b] European with all EGFR mutationsErlotinib vs cisplatin + docetaxel or gemcitabine9.7 vs 5.2(HR, 0.37; 95% CI, )19.3 vs (HR, 1.04; 95% CI, )LUX-Lung 3[c]International with all EGFR mutationsAfatinib vs cisplatin + pemetrexed11.1 vs 6.9(HR, 0.58; 95% CI, )Not yet available13.6 vs 6.9 (HR, 0.47; 95% CI, )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 inhibitora. Fukuoka M, et al. J Clin Oncol. 2011;29(21): ; b. Rosell R, et al. Lancet Oncol.2012;13(3): ; c. Yang JC, et al. ASCO 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 ThailandPatients with:Adenocarcinoma of the lungPresence of EGFR mutation in the tumor tissueStage IIIB/IVNo prior treatment with chemotherapy for advanced/metastatic diseaseNo prior treatment with EGFR inhibitorsEastern Cooperative Oncology Group performance status 0 or 1N = 364Randomization 2:1Afatinib40 mg once dailyCisplatin 75 mg/m2 + gemcitabine 1000 mg/m2 IV day 1 + day 8, every 3 weeksPrimary endpoint: PFSWu YL, et al. ASCO Abstract 8016.
4 LUX-Lung 6 Trial: PFS Median PFS by independent review: 1-year PFS: 11.0 months for afatinib arm5.6 months for chemotherapy arm1-year PFS:47% for afatinib arm2% for chemotherapy armWu YL, et al. ASCO 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 afatinib39.8% of patients on chemotherapyOnly 2% of patients on afatinib discontinued due to rash and none due to diarrheaWu YL, et al. ASCO Abstract 8016.
6 Primary endpoint: PFS and disease control rate at 12 months LUX-Lung 7 Trial: Afatinib vs Gefitinib (Irreversible TKI vs Reversible TKI)Patients withAdvanced adenocarcinoma of the lungDocumented common EGFR mutations (del19 or L858R)First line (no prior treatment)Global study: 57 sites (currently recruiting)N = 264RandomizationAfatinib 40 mgGefitinib 250 mgPrimary endpoint: PFS and disease control rate at 12 monthsClinicalTrials.gov. NCT
7 Take-Home MessagesPatients must be tested for the EGFR mutation and, if positive, receive first-line EGFR TKISignificant improvements in PFS in first-line therapy of patients with EGFR mutation-positive NSCLC with EGFR TKI vs chemotherapySignificant improvement in quality-of-life parameters with EGFR TKI vs chemotherapy
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