Objectives: This phase II study was conducted to investigate the efficacy and safety of irinotecan (CPT-11) and ifosfamide as first-line chemotherapy for advanced non-small cell lung cancer (NSCLC). Methods: Eligibility criteria included histologically or cytologically confirmed NSCLC (stage IIIb or IV), no prior treatment, and measurable or evaluable disease. CPT-11 (80 mg/m2) was administered intravenously on days 1, 8, and 15, while ifosfamide (1.5 g/m2) was given on days 1 through 3 every 4 weeks. Results: Forty-four patients (31 men) with a median age of 65 years (range 43–75) and a median ECOG performance status of 1 (range 0–2) were enrolled. The response rate was 29.5% [95% CI: 16.7–45.2%], with 13 partial responses. The median survival was 12.5 months, the median time to progression was 5.3 months, and the 1 and 2-year survival rates were 52.3 and 11.3%, respectively. Toxicity was generally mild; WHO grade 3–4 neutropenia was recorded in 38.6% of the patients, grade 3 diarrhea in 6.8%, and grade 3–4 nausea/vomiting in 0%. Conclusions: CPT-11 combined with ifosfamide demonstrated anti-tumor activity in advanced NSCLC, with response and survival rates similar to those of cisplatin-based chemotherapy but with a more favorable toxicity profile.

Keywords:
Chemotherapy, Non-small cell lung cancer, Irinotecan, Ifosfamide, Phase II study
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