Hepatic arterial infusion of Floxuridine and dexamethasone plus high-dose Mitomycin C for patients with unresectable hepatic metastases from colorectal carcinoma Journal Article


Authors: Kemeny, N.; Eid, A.; Stockman, J.; Gonen, M.; Schwartz, L.; Tetzlaff, E.; Paty, P.
Article Title: Hepatic arterial infusion of Floxuridine and dexamethasone plus high-dose Mitomycin C for patients with unresectable hepatic metastases from colorectal carcinoma
Abstract: Background: In vitro data suggest increased cytotoxicity with Mitomycin C (Mit-C) and Floxuridine (FUDR). Based on these data, we performed a phase II trial of hepatic arterial infusion (HAI) of FUDR and Dexamethasone (Dex) plus high-dose Mit-C for patients with unresectable hepatic metastases from colorectal carcinoma. Methods: High-dose Mit-C (15 mg/m 2) was added via the pump sideport to HAI FUDR and Dex for 14 days of a 28-day cycle. Mit-C was given on days 1 and 29, and FUDR was given indefinitely until disease progression or discontinuation of therapy due to toxicity. Results: Sixty-three patients with unresectable liver metastases were entered. The chemotherapy-naïve group (n = 26) and those previously treated (n = 37) had similar response and median survival: 73% and 70%, and 23 and 20 months, respectively. The major toxicities were liver bilomas (7.9%), elevation in bilirubin level >3 (22%), and biliary sclerosis (9.5%). Hematologic and gastrointestinal toxicity was less than 2%. Conclusion: The addition of high-dose Mit-C to HAIFUDR and Dex produced a high response rate even in previously treated patients. The median survival was 21 months even though half the patients were previously treated with chemotherapy. Biliary toxicity was higher than expected; therefore, alternatives to high dose Mit-C should be investigated when exploring additions to HAI therapy with FUDR and Dex. © 2005 Wiley-Liss, Inc.
Keywords: adult; cancer survival; controlled study; aged; middle aged; survival rate; major clinical study; clinical trial; fatigue; fluorouracil; cancer growth; diarrhea; liver neoplasms; drug megadose; controlled clinical trial; phase 2 clinical trial; blood toxicity; leukopenia; thrombocytopenia; antineoplastic combined chemotherapy protocols; drug administration schedule; colonic neoplasms; dexamethasone; dose-response relationship, drug; irinotecan; abdominal pain; backache; colorectal carcinoma; bilirubin; gastrointestinal toxicity; liver metastasis; folinic acid; infusions, intra-arterial; mitomycin c; mitomycin; oxaliplatin; floxuridine; rectal neoplasms; hepatic metastases; bilirubin blood level; hepatic artery; sclerosis; epigastric pain; duodenum ulcer; hepatic arterial infusion; infusion pumps, implantable; gastroenteritis; myopathy; gastritis; biloma; fudr
Journal Title: Journal of Surgical Oncology
Volume: 91
Issue: 2
ISSN: 0022-4790
Publisher: Wiley Blackwell  
Date Published: 2005-08-01
Start Page: 97
End Page: 101
Language: English
DOI: 10.1002/jso.20286
PUBMED: 16028279
PROVIDER: scopus
DOI/URL:
Notes: --- - "Cited By (since 1996): 29" - "Export Date: 24 October 2012" - "CODEN: JSONA" - "Source: Scopus"
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  1. Philip B Paty
    499 Paty
  2. Mithat Gonen
    1029 Gonen
  3. Lawrence H Schwartz
    307 Schwartz
  4. Nancy Kemeny
    543 Kemeny