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Accepted Preprint first posted online on 2 September 2009
Endocrine-Related Cancer (2009) In press
DOI: 10.1677/ERC-09-0104
Copyright © 2009 by the Society for Endocrinology.
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RESEARCH

Phase III trial of chemotherapy using 5-fluorouracil (5-FU) and streptozotocin (STZ) compared with alpha interferon (IFN) for advanced carcinoid tumors: FNCLCC-FFCD 9710

 Laetitia Dahan, Franck Bonnetain, Philippe Rougier, Jean-Luc Raoul, Eric Gamelin, Pierre-Luc Etienne, Guillaume Cadiot, Emmanuel Mitry, Denis Smith, Frederic Cvitkovic, Bruno Coudert, Floriane Ricard, Laurent Bedenne and Jean-Francois Seitz

L Dahan, Digestive Oncology, CHU Timone, Marseille, 13005, France
F Bonnetain, FFCD, Dijon, France
P Rougier, Digestive Oncology, Hopital Ambroise Paré, Boulogne, France
J Raoul, Oncology, Centre Eugène Marquis, Rennes, France
E Gamelin, Oncology, Centre Paul Papin, Angers, France
P Etienne, Oncology, Clinique Armoricaine, Saint Brieuc, France
G Cadiot, Digestive Oncology, Hopital Robert Debré, Reims, France
E Mitry, Digestive Oncology, Hopital Ambroise Paré, Boulogne, France
D Smith, Oncology, CHU Haut Leveque, Pessac, France
F Cvitkovic, Oncology, Centre René Huguenin, Saint Cloud, France
B Coudert, Oncology, Centre Francois Leclerc, Dijon, France
F Ricard, FFCD, Dijon, France
L Bedenne, FFCD, Dijon, France
J Seitz, Digestive Oncology, CHU Timone, Marseille, France

Correspondence: Laetitia Dahan, Email: laetitia.dahan{at}mail.ap-hm.fr

Abstract

The aim of this randomized multicenter phase III trial was to compare chemotherapy and interferon in patients with metastatic carcinoid tumors. Patients with documented progressive, unresectable, metastatic carcinoid tumors were randomized between 5FU plus streptozotocin (day1 to day5) and recombinant interferon alpha 2a (3MU x 3 per week). Primary endpoint was progression-free survival (PFS). From February 1998 to June 2004, 64 patients were included. The two arms were well matched for median age, sex ratio, PS 0-1, previous chemotherapy, surgery or radiotherapy. The median PFS for chemotherapy was 5.5 months versus 14.1 for interferon (HR = 0.75 [0.41-1.36]). Overall survival (OS), tolerance and effects on carcinoid symptoms were not significantly different. Despite a trend in favor of IFN there was no difference in PFS and OS in advanced metastatic carcinoid tumors and therapeutic effect of both treatments was mild.






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