Abstract
7059 Background: Gefitinib is active for recurrent NSCLC after platinum-based chemotherapy (Fukuoka M, et al. J Clin Oncol 21:2237, 2003. Kris MG, et al. JAMA 290:2149, 2003). However, efficacy of gefitinib as first-line chemotherapy remains unknown. We conducted a phase II study of single agent of gefitinib in chemonaïve pts with advanced NSCLC. Methods: Eligibility criteria: stage IIIB (malignant pleural or pericardial effusion and/or metastasis in the same lobe) or IV NSCLC without previous chemotherapy, measurable lesion, 20≤age≤74, ECOG PS 0 or 1, PaO2≥60 torr, and adequate bone marrow, renal, and hepatic functions. Patients with interstitial pneumonia, pulmonary fibrosis, paralytic ileus, symptomatic brain metastases, or infection, were excluded. Treatment: Pts received 250mg doses of gefitinib every day. Administration of gefitinib was terminated, if partial response was not achieved within eight weeks or no tumor reduction was observed within four weeks. In these cases, platinum-based doublet chemotherapy was performed as salvage. Results: Forty-two pts were enrolled between March and November 2003, and 40 of them were eligible. To date, thirty-seven pts were evaluable. Patient characteristics: male/female = 24/13, median age = 61 (range 44–74), ECOG PS 0/1 = 14/23, stage IIIB/IV = 3/34, and adenocarcinoma / squamous / large cell = 27/3/7. Ten pts achieved partial response. The response rate was 27% (95% CI: 18–44%). The most common toxicity included grade 1 or 2 acne-like eruption (46%) and grade 1 diarrhea (19%). Grade 2 hepatic toxicity was observed in 3%. Four pts developed grade 5 interstitial lung disease (ILD). Conclusions: Single agent of gefitinib is active in chemonaïve pts with advanced NSCLC, but produces unacceptable frequnet ILD. No significant financial relationships to disclose.
Published Version
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