Background: We aimed to evaluate the efficacy and safety of irinotecan monotherapy as a third- or fourth-line treatment for advanced non-small cell lung cancer (NSCLC) patients. Methods: Patients with advanced NSCLC refractory to 2 or more previous regimens were treated with 80mg/m2 irinotecan on days 1, 8, and 15, every 4 weeks. The primary endpoint was the overall response rate (ORR), whereas secondary endpoints included progression-free survival (PFS), overall survival (OS), and toxicity profiles. Results: From December 2007 to April 2009, 32 patients (median age, 60 years) were enrolled. Most of the patients (75.0%) were male, and 18.8% had a performance status of 2. Six partial responses to irinotecan monotherapy were observed (ORR, 18.8%: 95% confidence interval, 5.3%-32.3%). The disease control rate (DCR) was 78.1%, median PFS was 4.0 months, and median survival time (MST) was 10.4 months. Grade 3-4 neutropenia was observed in 22% of patients, but other toxic effects were moderate. No cases of grade 3-4 diarrhea or treatment-related death were noted. Of the 15 patients for whom progressive disease represented the best response to previous treatment regimens, 2 exhibited a partial response and 9 showed stable disease after irinotecan monotherapy, with a DCR of 73.3%, median PFS of 4.4 months, and MST of 8.2 months. Conclusions: Irinotecan monotherapy is effective for advanced NSCLC patients who have previously failed 2 or more treatment regimens.
- Non-small cell lung cancer
- Third-line therapy
ASJC Scopus subject areas
- Pulmonary and Respiratory Medicine