A phase II study of irinotecan and infusional cisplatin with recombinant human granulocyte colony-stimulating factor support for advanced non-small-cell lung cancer

Purpose: We administered chemotherapy consisting of a combination of 5-day continuous infusion of cisplatin (20 mg/m(2) per day) plus irinotecan (160 mg/m(2) per day, as a bolus, on day 1) with recombinant human granulocyte c olony-stimulating factor (rG-CSF) support to previously untreated advanced non-small-cell lung cancer (NSCLC) patients, and evaluated the effectivenes s and safety of this therapy. Patients: Enrolled in the study were 41 NSCLC patients. Results: Of the 41 patients, 24 achieved a partial response. The response rate was 58.5% (95% confidence interval, 42.2% to 74.8%), with a median response duration of 32.1 weeks. The median survival time was 44.8 w eeks and the 1-year survival rate was 44%. A total of 100 courses of therap y were given. The major toxic effects were grade 3 or 4 diarrhea (23%), gra nulocytopenia (20%), thrombocytopenia (15%) and anemia (15%). There were no treatment-related deaths. Conclusions: Combination chemotherapy with irino tecan plus infusional cisplatin with rG-CSF support was well tolerated and effective in patients with advanced NSCLC.