Phase II trial of first-line gefitinib in patients unsuitable for chemotherapy with stage III/IV non-small-cell lung cancer

Abstract

7256 Background: The median age of patients (pts) presenting with non-small-cell lung cancer (NSCLC) is now >70 years and the role of chemotherapy in elderly pts with performance status (PS) 2 is contentious. The epidermal growth factor receptor tyrosine kinase inhibitor gefitinib (IRESSA) was effective and well tolerated in a small study of pretreated elderly pts with NSCLC. There are few data in the first-line setting. Methods: A Phase II clinical trial enrolled chemonaïve PS 0–2 pts with NSCLC who were unfit for or declined chemotherapy. Pts received gefitinib (250 mg/day) until progression or toxicity. Response was assessed using RECIST 1 month after starting treatment and at 2-monthly intervals thereafter. Adverse events (AEs) were assessed using NCI-CTC (version 2.0). Results: 45 pts consented (unfit for/declined chemotherapy, 25/20; male/female, 29/16; median age, 76 years (range 59–85); PS 0/1/2/3, 2/15/27/1; stage III/IV, 19/26; smoking history: 19 current, 15 ex, 9 never, 2 unknown; histology: 17 squamous, 15 adenocarcinoma, 6 unclassifiable, 3 bronchioalveolar, 3 undifferentiated, 1 adenosquamous). Of these, 41 pts received gefitinib at least once and were evaluable for response and toxicity. Partial response was achieved in 4 (9.8%) pts (median duration [range], 168 [107–170] days), 15 (36.6%) had stable disease (35 [0–112] days) and 22 (53.4%) progressed. Disease control rate was 46.4% at 1 month. Median progression-free survival was 32 days and median overall survival was 82 days; 2 pts remain alive. No association was seen between response and histology, smoking history or gender. Drug-related AEs were mild: grade 2 AEs included rash (5 pts) and diarrhoea (2). Grade 3 AEs were rash (2 pts, 1 due to penicillin allergy) and diarrhoea (1). Grade 3 interstitial pneumonitis was a serious AE in 1 pt who withdrew. No other pt withdrew due to AEs. No grade 4 AEs were reported. Conclusions: Antitumour activity was observed with gefitinib 250 mg/day in this small study of chemonaïve pts (median age, 76 years; median PS 2) who were unfit for or declined chemotherapy. Further investigation of first-line gefitinib monotherapy is warranted. IRESSA is a trademark of the AstraZeneca group of companies Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration AstraZeneca AstraZeneca AstraZeneca AstraZeneca