Skin rash and good performance status (PS) predict improved survival with gefitinib for patients with advanced non-small cell lung cancer (NSCLC)

Abstract

7097 Background: Gefitinib (Iressa®) is active as a single agent for the treatment of advanced NSCLC patients who have failed prior chemotherapy. For optimal utilization of gefitinib, effective methods to identify sub-sets of patients likely to benefit from treatment are necessary. We analyzed patients treated with gefitinib on an Expanded Access Program at our institutions to detect possible predictive factors for patient selection to future studies. Methods: Patients (N=178) with advanced NSCLC were treated with gefitinib (250 mg PO QD) upon progression from chemotherapy. Patients with ECOG PS of ≤ 2, adequate bone marrow, hepatic and renal function were eligible. Results: Baseline patient characteristics were: Median age: 68 years (range 29–100); males - 56%; Adenocarcinoma –49%, squamous –21%, bronchioloalveolar-6%, other –24%. Objective partial responses were noted in 4 (2.4%) and disease stabilization in 28 (17%) patients. The median survival (MS) was 6.1 months (95% CI 4.42–7.21) and median time to progression was 3 months (95% CI 2.0–3.0). The predictive factors analyzed were gender, skin rash, diarrhea and PS. Patients who developed a skin rash (any grade) had a MS of 11 months compared to 4.5 months for patients without a rash (P < 0.0001, log rank test). Patients with PS 0/1 and 2 had a MS of 5.8 months and 2.9 months respectively (P < 0.0001). Other factors did not impact survival. Conclusions: Occurence of skin rash and baseline PS of 0/1were associated with significantly improved survival for advanced NSCLC patients who failed prior chemotherapy, upon treatment with gefitinib. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration AstraZeneca AstraZeneca