Phase II study of irinotecan based fourth-line chemotherapy for gefitinib therapy-failed non-small cell lung cancer (NSCLC)

Abstract

18164 Background: Despite the undoubted gains from EGFR TK inhibitor therapy as 2nd or 3rd line chemotherapy, most of them will relapse during treatment. Among these patients, they might be young, with good performance status, and their disease is expressed with only minor symptoms. The objectives of this study were to evaluate the antitumor efficacy and safety of irinotecan based regimen as 4th line therapy for refractory or recurrent to gefitinib treatment. We report our experience with irinotecan-based 4th line chemotherapy. Methods: Eligibility required proven NSCLC refractory or recurrent after 3rd line chemotherapy(gefitinib), measurable lesions by RECIST, and ECOG PS 0–1. Irinotecan (60mg/m2, day 1,8,15) and/or cisplatin (60 mg/m2, day 1) were administered every four week for at least 2 course. We analyzed for time to tumor progression (TTP) for first, response rates and toxicities. Results: Since June 2004, 17 patients (consisting of 9 with squamous cell, 7 with adeno-, and 1 with NSCLC not further specified) with a median age of 61 years were enrolled, with 1 drop out during treatment. Chemotherapy was administered for a median 2 courses (range 2–6). Median TTP was 91 (range 35–210) days. Two pts achieved a PR and 5 pts a SD. Disease control rate was 41.2%. Response rate was 11.8%. Toxicity of grade 3 or 4 consisted of neutropenia (35.3%), anemia (29.4%), thrombocytopenia (17.7%), nausea (17.6%), and diarrhea (23.5%). There were no treatment related deaths. Conclusions: This irinotecan based chemotherapy for EGFR TK inhinbitor therapy failed NSCLC patients showed promising efficacy with tolerable toxicity. Irinotecan based chemotherapy may be considered a potential therapeutic option for 4th line chemotherapy in well selected patients. No significant financial relationships to disclose.