Abstract |
PURPOSE Prior trials have shown that surgery followed by hepatic artery infusion (HAI) of floxuridine ( FUDR) alternating with systemic fluorouracil improves survival rates. Oxaliplatin combined with capecitabine has demonstrated activity in advanced colorectal cancer. Based on this observation a trial was conducted to assess the potential benefit of systemic oxaliplatin and capecitabine alternating with HAI of FUDR. The primary end point was 2-year survival. PATIENTS AND METHODS Patients with liver-only metastases from colorectal cancer amenable to resection or cryoablation were eligible. HAI and systemic therapy was initiated after metastasectomy. Alternating courses of HAI consisted of 0.2 mg/m(2)/d FUDR and dexamethasone, day 1 through 14 weeks 1 and 2. Systemic therapy included oxaliplatin 130 mg/m(2) day 1 with capecitabine at 1,000 mg/m(2) twice daily, days 1 through 14, weeks 4 and 5. Two additional 3-week courses of systemic therapy were given. Capecitabine was reduced to 850 mg/m(2) twice daily after interim review of toxicity. Results Fifty-five of 76 eligible patients were able to initiate protocol-directed therapy and completed median of six cycles (range, one to six). Three postoperative or treatment-related deaths were reported. Overall, 88% of evaluable patients were alive at 2 years. With a median follow-up of 4.8 years, a total of 30 patients have had disease recurrence, 11 involving the liver. Median disease-free survival was 32.7 months. CONCLUSION Alternating HAI of FUDR and systemic capecitabine and oxaliplatin met the prespecified end point of higher than 85% survival at 2 years and was clinically tolerable. However, the merits of this approach need to be established with a phase III trial.
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Authors | Steven R Alberts, Mark S Roh, Michelle R Mahoney, Michael J O'Connell, David M Nagorney, Lawrence Wagman, Thomas C Smyrk, Timothy L Weiland, Lily Lau Lai, Roderich E Schwarz, Roy Molina, Todor Dentchev, John S Bolton |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 28
Issue 5
Pg. 853-8
(Feb 10 2010)
ISSN: 1527-7755 [Electronic] United States |
PMID | 20048179
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural)
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Chemical References |
- Organoplatinum Compounds
- Floxuridine
- Oxaliplatin
- Deoxycytidine
- Capecitabine
- Dexamethasone
- Fluorouracil
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Topics |
- Administration, Oral
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage, adverse effects)
- Capecitabine
- Catheter Ablation
- Chemotherapy, Adjuvant
- Colorectal Neoplasms
(pathology)
- Cryosurgery
- Deoxycytidine
(administration & dosage, analogs & derivatives)
- Dexamethasone
(administration & dosage)
- Drug Administration Schedule
- Feasibility Studies
- Female
- Floxuridine
(administration & dosage)
- Fluorouracil
(administration & dosage, analogs & derivatives)
- Hepatectomy
- Hepatic Artery
- Humans
- Infusions, Intra-Arterial
- Infusions, Intravenous
- Kaplan-Meier Estimate
- Liver Neoplasms
(drug therapy, mortality, secondary, surgery)
- Male
- Middle Aged
- Organoplatinum Compounds
(administration & dosage)
- Oxaliplatin
- Proportional Hazards Models
- Risk Assessment
- Time Factors
- Treatment Outcome
- United States
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