Salvage treatment of advanced non-small-cell lung cancer previously treated with docetaxel-based front-line chemotherapy with irinotecan (CPT-11) in combination with cisplatin

Background: A phase II study was conducted in order to determine the toxici ty and efficacy of the combination of CPT-11 and cisplatin, as salvage trea tment in patients with advanced non-small-cell lung cancer (NSCLC), progres sing after a docetaxel-based front-line regimen. Patients and methods: Thirty-one patients (median age 61 years) with NSCLC, were enrolled. Twenty-six (84%) patients were male, twenty-five (81%) had disease stage IV, and twenty-eight (90%) had a performance status (WHO) 0-1 . CPT-11 was administered as a 60-minute i.v. infusion at the dose of 100 m g/m(2) on day 1 and 110 mg/m(2) on day 8; cisplatin was administered at the dose of 80 mg/m(2) on day 8, after CPT-11 administration. Treatment was re peated every three weeks. Results: A total of 110 chemotherapy cycles were administered. In an intent ion-to-treat analysis 7 patients (23%; 95% confidence interval (95% CI): 8% -37%) achieved a partial response, 6 (19%) had stable disease, and 18 (58%) progressive disease. Three of responders had failed a previous docetaxel-c arboplatin combination. The median duration of response was 3 months, the m edian TTP 8 months and the median survival for the entire group 8 months. G rade 3-4 neutropenia was observed in 16 (52%) patients and in two cases thi s was febrile. Grade 3 and 4 thrombocytopenia occurred in two (7%) patients , respectively. Grade 3 and 4 diarrhea was seen in 10 (33%) patients, grade 2-3 neurotoxicity in 2 (6%), and fatigue grade 2-3 in 12 (39%). Other toxi cities were mild. Conclusions: The combination of CPT-11 and cisplatin has manageable toxicit y and interesting activity as salvage treatment of patients with advanced N SCLC, previously treated with a docetaxel-based front-line regimen.