Annals of Oncology 14:1537-1542, 2003
© 2003 European Society for Medical Oncology
Original Paper |
Multimodal therapy with intravenous biweekly leucovorin, 5-fluorouracil and irinotecan combined with hepatic arterial infusion pirarubicin in non-resectable hepatic metastases from colorectal cancer (a European Association for Research in Oncology trial)
1 Department of Oncology, 3 Department of Surgery, 6 Department of Radiology and Department of Hepato-Gastroenterology, CHU Henri-Mondor, Assistance Publique-Hôpitaux de Paris, Créteil; 2 Department of Oncology and Department of Radiology, Centre Claudius Régaud, Toulouse; 4 Centre Jean Bernard, Le Mans; 5 Department of Surgery, Hôpital Lariboisière, Assistance Publique-Hôpitaux de Paris, Paris, France; 7 International Drug Development Institute, Brussels, Belgium
Received 25 February 2003; revised 16 May 2003; accepted 4 June 2003
Background:
The purpose of this study was to evaluate the tolerance and efficacy of combining i.v. irinotecan, 5-fluorouracil (5-FU) and leucovorin (LV) with hepatic arterial infusion (HAI) of pirarubicin in non-resectable liver metastases from colorectal cancer.
Patients and methods:
Thirty-one patients were included in a phase II trial with i.v. irinotecan/5-FU/LV administered every 2 weeks, combined with HAI pirarubicin 60 mg/m2 on day 1 every 4 weeks. In most cases HAI was administered via a percutaneous catheter.
Results:
The main grade 3/4 toxicity was neutropenia, encountered in 78% of the patients. When all patients were considered in the analysis, tumour response rate was 15 out of 31 [48%; 95% confidence interval (CI) 32% to 65%]. Liver resection was made possible in 11 patients (35%; 95% CI 21% to 53%). There were no toxic death. Median overall survival was 20.5 months, and median progression-free survival was 9.1 months. In patients with completely resected metastases, median overall survival was not reached and median progression-free survival was 20.2 months.
Conclusion:
The multimodality approach used in the present study was well-tolerated and yielded dramatic responses. An aggressive approach combining i.v. and HAI chemotherapy deserves further investigation.
Key words: colorectal cancer, hepatic artery infusion, irinotecan, liver resection, pirarubicin
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