Bolus vs. continuous hepatic arterial infusion of cisplatin plus intravenous 5-fluorouracil chemotherapy for unresectable colorectal metastases
Autor: | V. Casaldi, L. Capussotti, Diana Giannarelli, A. Padovani, P. P. Da Pian, P. Di Tora, G. B. Morandi, A. Callopoli, Dario Civalleri, Enrico Cortesi, Ernesto Mannella, Maurizio Cosimelli |
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Rok vydání: | 1994 |
Předmět: |
Male
medicine.medical_specialty medicine.medical_treatment Phases of clinical research Gastroenterology Bolus (medicine) Hepatic arterial infusion Hepatic Artery Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Infusions Intra-Arterial Infusions Intravenous Survival rate Cisplatin Chemotherapy business.industry Liver Neoplasms General Medicine Middle Aged Survival Rate Injections Intra-Arterial Fluorouracil Anesthesia Toxicity Female business Colorectal Neoplasms medicine.drug |
Zdroj: | Diseases of the colon and rectum. 37 |
ISSN: | 0012-3706 |
Popis: | A multicenter, randomized Phase 2 study that compared patients, affected by colorectal liver metastases, who received intrahepatic arterial infusion with two different schedules of cisplatin, bolusvs. continuous infusion, and systemic 5-fluorouracil. PURPOSE: The aim of this study was to validate results of a previous Phase 2 trial on bolus cisplatin intrahepatic arterial infusion, which reported a 47 percent response rate and a 32 percent 4-year survival rate for Gennari's Stage 2 patients, with a high rate of neurologic, gastrointestinal, and hematologic toxicity. METHODS: One hundred nine patients were randomized in a Phase 2 study to receive cisplatin intrahepatic arterial infusion (24 mg/m2/day, 1→5, bolusvs. continuous infusion) and systemic intravenous 5-fluorouracil (250, 375, or 500 mg/m2/day, 1→5; escalating doses, respectively, at cycles I, II, III, and VI). To avoid neurotoxicity a maximum of six cycles was administered. RESULTS: Preliminary results for the 78 evaluable patients are similar to those of the previous study: response rate 46 percent and at a median follow-up of 16.5 months, the overall survival was 16.5 months, with 45 percent of the patients who received more than 3 cycles alive at 3 years. Toxicity, evaluable in 99 patients, showed a decreased incidence of neurotoxicity and a tolerable gastrointestinal and hematologic toxicity, lower in the cisplatin continuous infusion arm. CONCLUSION: This study clearly shows that cisplatin intrahepatic arterial infusion is able to provide a good palliative effect with a tolerable toxicity. |
Databáze: | OpenAIRE |
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