A phase II study of irinotecan, high-dose 24-h continuous intravenous infusion of floxuridine and leucovorin (IFLUX) for advanced, previously untreated colorectal cancer

Bach Ardalan, Olga Kozyreva, Kao Tai Tsai, Edgardo Santos, Dido Franceschi, Alan Livingstone, Mayra Lima

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Our objectives were to determine response rate, time to progression, overall survival and tolerability of novel combination chemotherapy, consisting of irinotecan, high-dose 24-h continuous intravenous infusion of floxuridine and leucovorin in advanced previously untreated colorectal cancer. Thirty-eight patients with advanced colorectal cancer were treated at Sylvester Comprehensive Cancer Center, University of Miami, from 2000 to 2004, and received weekly intravenous infusion of irinotecan at 110 mg/m with a combination of 120 mg/kg floxuridine and 500 mg/m leucovorin administered as a 24-h continuous intravenous infusion. The treatment cycle consisted of 4 weeks of consecutive therapy followed by 2 weeks of rest. Five (13%) patients achieved complete response, 10 (26%) patients achieved partial response, 17 (45%) patients attained stable disease and six (16%) patients progressed. The overall response rate was 39% in this study. This chemotherapy regiment was well tolerated; the most common grade 3 toxicities were neutropenia (16%), anemia (16%), vomiting (24%), diarrhea (16%), and hand-and-foot syndrome (26%). The median time to progression was 11.5 months (347.5 days) with 95% confidence intervals of 6.8-12.9 months (206-389 days). The time to progression ranged from 1.8 to 34 months. The median survival of the patients in this trial was 31.28 months (952 days) with a confidence interval of 20.9-38.0 months (629-1141 days). Intravenous infusion of floxuridine and leucovorin is beneficial as first-line therapy in advanced colorectal cancer, demonstrating a prolonged time to progression and overall survival with acceptable tolerability and manageable toxicity profile.

Original languageEnglish
Pages (from-to)955-961
Number of pages7
JournalAnti-Cancer Drugs
Volume18
Issue number8
DOIs
StatePublished - Sep 1 2007

Fingerprint

irinotecan
Floxuridine
Leucovorin
Intravenous Infusions
Colorectal Neoplasms
Survival
Hand-Foot Syndrome
Confidence Intervals
Combination Drug Therapy
Neutropenia
Vomiting
Anemia
Diarrhea
Therapeutics

Keywords

  • Advanced colorectal cancer
  • Chemotherapy
  • Toxicity profiles

ASJC Scopus subject areas

  • Pharmacology
  • Cancer Research
  • Oncology

Cite this

A phase II study of irinotecan, high-dose 24-h continuous intravenous infusion of floxuridine and leucovorin (IFLUX) for advanced, previously untreated colorectal cancer. / Ardalan, Bach; Kozyreva, Olga; Tsai, Kao Tai; Santos, Edgardo; Franceschi, Dido; Livingstone, Alan; Lima, Mayra.

In: Anti-Cancer Drugs, Vol. 18, No. 8, 01.09.2007, p. 955-961.

Research output: Contribution to journalArticle

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abstract = "Our objectives were to determine response rate, time to progression, overall survival and tolerability of novel combination chemotherapy, consisting of irinotecan, high-dose 24-h continuous intravenous infusion of floxuridine and leucovorin in advanced previously untreated colorectal cancer. Thirty-eight patients with advanced colorectal cancer were treated at Sylvester Comprehensive Cancer Center, University of Miami, from 2000 to 2004, and received weekly intravenous infusion of irinotecan at 110 mg/m with a combination of 120 mg/kg floxuridine and 500 mg/m leucovorin administered as a 24-h continuous intravenous infusion. The treatment cycle consisted of 4 weeks of consecutive therapy followed by 2 weeks of rest. Five (13{\%}) patients achieved complete response, 10 (26{\%}) patients achieved partial response, 17 (45{\%}) patients attained stable disease and six (16{\%}) patients progressed. The overall response rate was 39{\%} in this study. This chemotherapy regiment was well tolerated; the most common grade 3 toxicities were neutropenia (16{\%}), anemia (16{\%}), vomiting (24{\%}), diarrhea (16{\%}), and hand-and-foot syndrome (26{\%}). The median time to progression was 11.5 months (347.5 days) with 95{\%} confidence intervals of 6.8-12.9 months (206-389 days). The time to progression ranged from 1.8 to 34 months. The median survival of the patients in this trial was 31.28 months (952 days) with a confidence interval of 20.9-38.0 months (629-1141 days). Intravenous infusion of floxuridine and leucovorin is beneficial as first-line therapy in advanced colorectal cancer, demonstrating a prolonged time to progression and overall survival with acceptable tolerability and manageable toxicity profile.",
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