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Clinical Trial
. 2009 Nov 3:9:388.
doi: 10.1186/1471-2407-9-388.

Continuous 5-fluorouracil infusion plus long acting octreotide in advanced well-differentiated neuroendocrine carcinomas. A phase II trial of the Piemonte oncology network

Maria P Brizzi  1 , Alfredo Berruti, Anna Ferrero, Enrica Milanesi, Marco Volante, Federico Castiglione, Nadia Birocco, Sebastiano Bombaci, Davide Perroni, Benedetta Ferretti, Oscar Alabiso, Libero Ciuffreda, Oscar Bertetto, Mauro Papotti, Luigi Dogliotti
Affiliations
Clinical Trial

Continuous 5-fluorouracil infusion plus long acting octreotide in advanced well-differentiated neuroendocrine carcinomas. A phase II trial of the Piemonte oncology network

Maria P Brizzi et al. BMC Cancer. .

Abstract

Background: Well-differentiated neuroendocrine carcinomas are highly vascularized and may be sensitive to drugs administered on a metronomic schedule that has shown antiangiogenic properties. A phase II study was designed to test the activity of protracted 5-fluorouracil (5FU) infusion plus long-acting release (LAR) octreotide in patients with neuroendocrine carcinoma.

Methods: Twenty-nine patients with metastatic or locally advanced well-differentiated neuroendocrine carcinoma were treated with protracted 5FU intravenous infusion (200 mg/m2 daily) plus LAR octreotide (20 mg monthly). Patients were followed for toxicity, objective response, symptomatic and biochemical response, time to progression and survival.

Results: Assessment by Response Evaluation Criteria in Solid Tumors (RECIST) criteria showed partial response in 7 (24.1%), stable disease in 20 (69.0%), and disease progression in 2 patients. Response did not significantly differ when patients were stratified by primary tumor site and proliferative activity. A biochemical (chromogranin A) response was observed in 12/25 assessable patients (48.0%); symptom relief was obtained in 9/15 symptomatic patients (60.0%). There was non significant decrease in circulating vascular epithelial growth factor (VEGF) over time. Median time to progression was 22.6 months (range, 2.7-68.5); median overall survival was not reached yet. Toxicity was mild and manageable.

Conclusion: Continuous/metronomic 5FU infusion plus LAR octreotide is well tolerated and shows activity in patients with well-differentiated neuroendocrine carcinoma. The potential synergism between metronomic chemotherapy and antiangiogenic drugs provides a rationale for exploring this association in the future.

Trial registration: NCT00953394.

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Figures

Figure 1
Figure 1
Time to progression (1a and 1b) and overall survival (1c and 1d) according to Ki67 expression at the cutoff of 2% positive cells and mitosis count.
See this image and copyright information in PMC

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