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Annals of Oncology 11:757-760, 2000
© 2000 European Society for Medical Oncology

brief-report

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

S. Kakolyris, C. Kouroussis, K. Kalbakis, D. Mavroudis, J. Souglakos, N. Vardakis, S. Kremos and V. Georgoulias

Department of Medical Oncology, School of Medicine, University General Hospital of Heraklion Crete, Greece

Correspondence to: Dr S. Kakolyris, MD, PhD, University Hospital of Heraklion, Department of Medical Oncology, P.O. Box 1352, Heraklion 71110, Crete, Greece. E-mail: georgoul{at}med.uch.gr

Background: A phase II study was conducted in order to determine the toxicity and efficacy of the combination of CPT-11 and cisplatin, as salvage treatment in patients with advanced non-small-cell lung cancer (NSCLC), progressing 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 mg/m2 on day 1 and 110 mg/m2 on day 8; cisplatin was administered at the dose of 80 mg/m2 on day 8, after CPT-11 administration. Treatment was repeated every three weeks.

Results: A total of 110 chemotherapy cycles were administered. In an intention-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-carboplatin combination. The median duration of response was 3 months, the median TTP 8 months and the median survival for the entire group 8 months. Grade 3–4 neutropenia was observed in 16 (52%) patients and in two cases this 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 toxicities were mild.

Conclusions: The combination of CPT-11 and cisplatin has manageable toxicity and interesting activity as salvage treatment of patients with advanced NSCLC, previously treated with a docetaxel-based front-line regimen.

cisplatin, CPT-11, NSCLC, salvage treatment


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