Efficacy and safety of gefitinib in chemo-naive patients with non-small cell lung cancer (NSCLC) in an expanded access program (EAP)

Abstract

7094 Background: Patients (pts) with advanced NSCLC who cannot tolerate or refuse chemotherapy (CT) have few or no treatment options. The EGFR-TKI gefitinib (Iressa) has antitumor activity and favorable tolerability in pts with recurrent advanced NSCLC. A global EAP made gefitinib available to >37,000 pts with NSCLC who had failed standard treatment or were ineligible for or refused cytotoxic CT. Methods: Retrospective chart review of 1671 pts enrolled at 11 sites in the US EAP identified 198 pts (89 men, 109 women, median age 72.7 y [range 37.8–89.9 y]) who had not received prior CT for advanced NSCLC. Pts received 250 mg/d gefitinib until treatment failure or undue toxicity. Outcomes analyzed included clinical response, survival, and adverse events (AEs). Results: Reasons for enrollment were disease progression (57.6%), CT intolerance (22.2%), significant comorbidity (21.7%), and CT refusal (21%). Predominant (66%) histology was adenocarcinoma, 16.2% with bronchioloalveolar subtype: 186 pts (93.9%) had stage III/IV disease, 3 (1.5%) were stage I/II, and 9 (4.5%) had no staging data recorded. Fifty-six (28.3%) patients had ECOG performance status (PS) ≥2. Although PS was not recorded for 69 (34.8%) pts, at enrollment 60% were nonambulatory, 15.2% required oxygen, and 4% were in a hospice. Median survival was 6 months (95% CI, 5–8 mo); estimated 1-year survival rate was 29.7% (95% CI, 22.1–37.3%). In 142 (72.2%) pts with ≥1 imaging study postenrollment, complete, partial, and stable response rates were 0.7%, 5.6%, and 40.6%, respectively. Most common AEs were diarrhea (31.3%), rash (31.3%), asthenia (15.7%), anorexia (11.6%), and nausea (11.1%). Mean treatment duration was 4.7 months (range 0.1–26 mo). Post-EAP treatment data were available for 157 (79.3%) pts: 36 (22.9%) of this group went on to further treatment, 25 received CT, and 11 received radiation therapy. Conclusions: Oral gefitinib was well tolerated and effective in this unselected population of chemo-naive pts with NSCLC who were unsuitable for or refused CT. Median and 1-year survival were significantly better than with best supportive care alone and similar to CT, with substantially less toxicity. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration AstraZeneca AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Genentech, Ligand Amgen, AstraZeneca, Aventis, Bristol-Myers Squibb, Eli Lilly, Genentech, Merck, Pfizer Amgen, AstraZeneca, Aventis, Bristol-Myers Squibb, Eli Lilly, Genentech, Genta, Ligand, Pfizer AstraZeneca Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly