Phase II study of hepatic arterial floxuridine, leucovorin, and dexamethasone for unresectable liver metastases from colorectal carcinoma Journal Article
| Authors: | Kemeny, N.; Conti, J. A.; Cohen, A.; Campana, P.; Huang, Y.; Shi, W. J.; Botet, J.; Pulliam, S.; Bertino, J. R. |
| Article Title: | Phase II study of hepatic arterial floxuridine, leucovorin, and dexamethasone for unresectable liver metastases from colorectal carcinoma |
| Abstract: | Purpose: To determine the toxicity, response rate, and survival of a regimen of hepatic arterial floxuridine (FUDR) with leucovorin (LV) and dexamethasone (Dec) for the treatment of unresectable hepatic metastases from colorectal carcinoma. Patients and Methods: Sixty-two patients with hepatic metastases (33 previously untreated with chemotherapy) were treated with FUDR (0.30 mg/kg/d) and LV (15 mg/m2/d) and Dec (20 mg total dose) as a 14-day hepatic arterial infusion via an implantable pump alternating with 2 weeks of saline. Results: The complete response (CR) plus partial response (PR) rate was 78% in previously untreated patients, with a median survival duration of 24.8 months; 1- and 2-year survival rates were 91% and 57%, respectively. In the previously treated group, the response rate was 52%, with a median survival duration of 13.5 months. Only 3% of patients (two of 62) developed biliary sclerosis; this was significantly lower than the 21% biliary sclerosis rate observed in our previous trial of hepatic arterial FUDR and LV without Dec (P = .002). Conclusion: The addition of Dec to hepatic arterial FUDR and LV reduces biliary toxicity while maintaining an excellent response rate and survival. We recommend that this treatment be studied further. |
| Keywords: | adult; cancer survival; controlled study; aged; major clinical study; clinical trial; controlled clinical trial; phase 2 clinical trial; carcinoembryonic antigen; dexamethasone; colorectal carcinoma; alkaline phosphatase; aspartate aminotransferase; bilirubin; liver metastasis; folinic acid; drug response; intraarterial drug administration; lactate dehydrogenase; liver enzyme; floxuridine; sclerosis; biliary tract disease; human; male; female; priority journal; article |
| Journal Title: | Journal of Clinical Oncology |
| Volume: | 12 |
| Issue: | 11 |
| ISSN: | 0732-183X |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 1994-11-01 |
| Start Page: | 2288 |
| End Page: | 2295 |
| Language: | English |
| DOI: | 10.1200/jco.1994.12.11.2288 |
| PROVIDER: | scopus |
| PUBMED: | 7964942 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
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