Objectives: We conducted a phase II study of combination chemotherapy with paclitaxel (Pac) and irinotrecan (CPT) to determine the qualitative and quantitative toxicities and efficacy of the combination against advanced nonsmall cell lung cancer (NSCLC).
Patients and methods: Patients with stage IIIB or IV NSCLC were treated with CPT at 60 mg/m and Pac at 160 mg/m2 every 2 weeks.
Results: Between May 2002 and July 2004, 39 of registered 46 patients received 4 to 6 cycles of chemotherapy, and 7 patients discontinued treatment because of disease progression in 5 patients and grade 2 pneumonitis in 2 patients. Grade 3 anemia, leukopenia, neutropenia, and elevation of bilirubin occurred in 4.0%, 0.5%, 1.0%, and 0.5%, respectively. Twenty-one patients responded, and the overall response rate was 45.6%. The median survival time was 355 days and the 1-year survival rate was 47.8%.
Conclusion: Pac plus CPT was efficacious and safe in NSCLC.