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Annals of Oncology Advance Access originally published online on February 20, 2009
Annals of Oncology 2009 20(7):1236-1241; doi:10.1093/annonc/mdn769
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

gastrointestinal tumors

Phase I trial of adjuvant hepatic arterial infusion (HAI) with floxuridine (FUDR) and dexamethasone plus systemic oxaliplatin, 5-fluorouracil and leucovorin in patients with resected liver metastases from colorectal cancer

N. Kemeny*, M. Capanu, M. D'Angelica, W. Jarnagin, D. Haviland, R. Dematteo and Y. Fong

Memorial Sloan-Kettering Cancer Center (MSKCC), New York, USA

* Correspondence to: Dr N. Kemeny, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, USA Tel: +1-212-639-8068; Fax: +1-212-794-7186; E-mail: kemenyn{at}mskcc.org.

Background: The purpose of the study was to determine the maximum tolerated dose of systemic oxaliplatin (oxal), 5-fluorouracil (5-FU) and leucovorin (LV) that could be administered with hepatic arterial infusion (HAI) of floxuridine (FUDR) and dexamethasone (Dex) in the adjuvant setting after hepatic resection.

Methods: Thirty-five patients with resected liver metastases were entered into a phase I trial using HAI FUDR/Dex with escalating doses of oxal and 5-FU.

Results: The initial dose of HAI FUDR was fixed at 0.12 mg/kg x pump volume divided by pump flow rate plus Dex infused over the first 2 weeks of a 5-week cycle. Systemic chemotherapy was delivered on days 15 and 29 with the doses of oxal escalated from 85 to 100 mg/m2 and the 5-FU 48-h continuous infusion doses from 1000 to 2000 mg/m2. The LV dose was fixed at 400 mg/m2. Dose-limiting toxic effects were diarrhea, 8.5%, and elevated bilirubin, 8.5%. With a median follow-up of 43 months, the 4-year survival and progression-free survival were 88% and 50%, respectively.

Conclusions: Adjuvant therapy after liver resection with HAI FUDR/Dex plus systemic oxal at 85 mg/m2 and 5-FU by continuous infusion at 2000 g/m2 with LV at 400 mg/m2 is feasible and appears effective. Randomized studies comparing this regimen to systemic FOLFOX are suggested.

Key words: adjuvant HAI FUDR, oxaliplatin/FU/LV, liver resection, colorectal cancer

Received for publication October 8, 2008. Revision received December 2, 2008. Accepted for publication December 3, 2008.


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