Multicentre phase II study of bifractionated CPT-11 with bimonthly leucovorin and 5-fluorouracil in patients with metastatic colorectal cancer pretreated with FOLFOX
| Autor: | A Cesta, Silvio Rea, Francesco Recchia, L Di Lullo, Antonio Nuzzo, Gaetano Saggio, A Lalli |
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| Rok vydání: | 2004 |
| Předmět: |
Male
Cancer Research Organoplatinum Compounds Colorectal cancer medicine.medical_treatment Leucovorin Phases of clinical research Thymidylate synthase Gastroenterology Metastasis FOLFOX CPT-11 Antineoplastic Combined Chemotherapy Protocols 5-fluorouracil heterocyclic compounds Infusions Intravenous second-line chemotherapy biology Middle Aged metastatic Oxaliplatin Treatment Outcome Oncology Fluorouracil Female Colorectal Neoplasms medicine.drug Adult medicine.medical_specialty medicine.drug_class colorectal cancer Folfox Irinotecan Antimetabolite Disease-Free Survival Clinical Internal medicine medicine Humans neoplasms Aged Salvage Therapy Chemotherapy business.industry medicine.disease digestive system diseases Surgery biology.protein Camptothecin business |
| Zdroj: | British Journal of Cancer |
| ISSN: | 1532-1827 0007-0920 |
| Popis: | This multicentre phase II study was designed to evaluate the antitumour activity and toxicity of bifractionated camptothecin (CPT-11) and 5-fluorouracil/ leucovorin (5-FU/LV) in the treatment of patients with metastatic colorectal cancer (MCC) who had been pretreated with 5-FU/LV-oxaliplatin (FOLFOX regimen). In all, 35 patients were enrolled in a two-stage trial. Treatment consisted of two daily doses of CPT-11, 90 mg m2 administered over 90 min, followed by LV, 200 mg m2 administered over 2 h plus 5-FU 400 mg m2 as a bolus and 600 mg m2 as a 22-h continuous infusion administered with disposable pumps as outpatient therapy. Toxicity was closely monitored. Response was evaluated by computed tomography scans every 8 weeks. All 35 patients were assessable for toxicity and response to treatment. Seven patients had a partial response, giving an overall response rate of 20%; 11 patients had stable disease (31.4%) and 17 progressed (48.5%). The median progression-free survival was 7.1 months and median survival was 14 months. A total of 10 patients (30%) experienced grade 3-4 toxicity, including nausea (15%), diarrhoea (12%) and neutropenia (15%), while seven patients (21%) had grade 2 alopecia. The bifractionated bimonthly schedule of CPT-11 plus 5-FU/LV showed substantial antitumour activity and was well tolerated in this group of patients with a poor prognosis, pretreated with the FOLFOX regimen. |
| Databáze: | OpenAIRE |
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