Compassionate use experience with gefitinib in poor performance (PS) patients with advanced non-small-cell lung cancer (NSCLC) treated in an expanded access program (EAP)

Abstract

7082 Background: Advanced NSCLC patients with a PS ≥ 2 have a poor prognosis and often receive less aggressive or no chemotherapy (CT) due to poor tolerance. CALGB study 9730 compared median and 1-year survival in 99 PS 2 NSCLC patients. Median and 1-year survival with paclitaxel was 2.4 mo and 10%, respectively; median and 1-year survival with paclitaxel and carboplatin was 4.7 mo and 18%, respectively. Gefitinib (Iressa), an epidermal growth factor receptor tyrosine kinase inhibitor, has single-agent activity and a favorable tolerability profile in patients with advanced NSCLC. A retrospective review of 533 patients in the US enrolled in an EAP with gefitinib before Jan 2003 identified 117 patients with PS ≥ 2. Methods: Eligible patients had advanced NSCLC, failed standard treatment, or were not suitable for systemic chemotherapy. Patients received oral gefitinib 250 mg once daily for as long as therapy provided clinical benefit without significant toxicity. Results: Of 117 poor PS patients, 84 were PS 2 (71.8%) and 13 (11.1%) were PS 3; the remaining 20 (17.1%) had a PS of 4 (n=1), 2–3 (n=16), or 3–4 (n=3). There were 72 men and 45 women; median age 66.9 y (38.4–87.2 y). Eighteen (15.4%) and 92 (78.6%) patients had stage III and IV NSCLC, respectively. Adenocarcinoma was the predominant histology (53.8%). Most patients had previously received chemotherapy (82.1%) and/or radiation therapy (71.8%). Of 60 patients evaluated for response, 3.3% (95% CI, 0.0–7.9%) had a partial response and 38.3% (95% CI, 26.0–50.6%) had stable disease. The median duration of treatment for all poor PS patients was 1.0 mo (0–29 mo). Median survival was 2.0 mo; estimated 1-year survival was 15.7% (95% CI, 8.4–22.9%). Adverse events consisted primarily of mild skin rash (15.5%/23.1%) and diarrhea (16.7%/23.1%) in PS 2/3 patients, respectively. Conclusions: The median survival rate with gefitinib in PS ≥ 2 patients was comparable to that of single agent CT in PS 2 only patients, whereas the 1-year survival rate with gefitinib in PS ≥ 2 patients was comparable to that of single and double agent CT in newly diagnosed PS 2 only patients. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration AstraZeneca; Lilly AstraZeneca AstraZeneca; Bristol-Myers Squibb; Lilly