Preliminary results from a phase II study of the epidermal growth factor receptor tyrosine kinase inhibitor erlotinib in patients > 70 years of age with previously untreated advanced non-small cell lung carcinoma

Abstract

7080 Background: Chemotherapy for patients ≥ 70 years of age with advanced NSCLC can be associated with greater toxicities than in younger patients. The identification of an efficacious therapy with minimal systemic toxicity would be particularly beneficial to elderly subjects. Erlotinib (Tarceva™) has shown promising activity, and a tolerable side effect profile, in the treatment of patients who have failed prior chemotherapy. We thus chose to conduct a single center phase II trial of erlotinib in patients ≥ 70 with previously untreated advanced NSCLC. Methods: Patients: chemotherapy naïve, IIIB (w/malignant effusion)/IV, PS 0–2; treated with erlotinib, 150 mg p.o. q.d., until evidence of disease progression or toxicity. Primary endpoint: median survival; secondary endpoints: response rate, quality of life (using LCSS), changes in FDG-PET, and analysis of EGFR signaling pathway from pre-treatment tumor specimens. Results: From 3/03 to 12/03, 36 pts were treated; 30 evaluable for toxicity and response; 1 for toxicity only; 5 too early. M/F: 19/17; median age 76 (70–86); PS 0/1/2:6/28/2; Path: adeno, 56%; squamous 14%; adeno w/BAC features, 11%; BAC, 11%; NSCLC unclassified 11%, large cell, 2%. Smoking: current/former/never: 2/30/4. Toxicity: rash 77%(grade 1/2: 92%, grade 3: 8%, grade 4:0%), diarrhea 61% (grade 1/2: 100%, grade3/4:0%). Other ≥ grade 3 toxicities: pneumonitis 2/31 (6.5%) and lacrimation 1/31 (3.2%). One patient died from drug toxicity (pneumonitis); 3/31 (9.6%) were dose reduced; 2/31 (6.5%) discontinued. Response: CR:0; PR: 4 (13.3%; 95% CI 5 - 29%); SD: 14 (46.6%; 95% CI 31–64%); PD:12 (40%). Median duration of response and stable disease: 6.8 (range 3.5–7.5+) and 3.5 months (range 1.5–8.0+), respectively. Survival and FDG-PET imaging are too early to evaluate. Conclusions: Erlotinib appears to be well tolerated and demonstrates encouraging activity in patients ≥ 70 years of age with previously untreated advanced NSCLC. Accrual is continuing to 60 patients and updated response, survival and FDG-PET data will be presented. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Genentech