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" |