Single agent gefitinib in poor performance status patients with previously untreated advanced non-small cell lung cancer: A Minnie Pearl Cancer Research Network phase II trial

Abstract

7086 Background: Gefitinib has single agent activity and excellent tolerability in patients (pts) with refractory non-small cell lung cancer (NSCLC) and may be of benefit to previously untreated poor performance status (PS) pts. Methods: The objectives were to evaluate the feasibility/toxicity, response rate, and symptom response (SR) of gefitinib in a total of 60 poor PS untreated pts. Eligible pts had no prior systemic therapy; ECOG PS 2, 3; stage IV or IIIB NSCLC; adequate organ function. Gefitinib 250 mg/day was given orally until disease progression, with initial evaluation at 8 weeks. Symptoms were evaluated at baseline and SR weekly using the Lung Cancer Subscale (LCS) of the FACT-L. Results: Twenty-five pts of the required 60 pts have enrolled to date (male/female 17/8); median age 64 (range 58–84); ECOG PS 2/3 20/5; stage IIIB/IV 7/18; bronchioalveolar/adenocarcinoma/squamous/large cell/or other 2/8/8/6/1. The median treatment duration was 3 months (range 1–7) and duration of follow-up 1.2 months (range 0.5–6 months). Grade 3/4 toxicities included: rash (1/10), diarrhea (0/0), elevated liver function test (0/0), dry skin/pruritis (0/0), and stomatitis (0/0). Eighteen pts are now evaluable for response. No partial responses have been seen. Eleven pts (61%) had stable disease and 8 of these 11 pts remain on study. Seven pts (39%) had progressive disease. Six of the 11 pts with stable disease had improved SR. Of the 25 pts enrolled, 8 have expired. Conclusions: Gefitinib is safe, well-tolerated and useful for symptom improvement as first-line therapy for some pts with poor PS. Further follow-up and additional evaluable pts will be provided. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration AstraZeneca