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Endocrine-Related Cancer 16 (4) 1351 -1361     DOI: 10.1677/ERC-09-0104
Copyright © 2009 by the Society for Endocrinology
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Phase III trial of chemotherapy using 5-fluorouracil and streptozotocin compared with interferon {alpha} for advanced carcinoid tumors: FNCLCC–FFCD 9710

 Laetitia Dahan1,*, Frank Bonnetain2,*, Philippe Rougier3, Jean-Luc Raoul4, Eric Gamelin5, Pierre-Luc Etienne6, Guillaume Cadiot7, Emmanuel Mitry4, Denis Smith8, Frédérique Cvitkovic9, Bruno Coudert10, Floriane Ricard1, Laurent Bedenne1, Jean-François Seitz1 and for the Fédération Francophone de Cancérologie Digestive (FFCD) and the Digestive Tumors Group of the Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC)

1 Assistance Publique, Hôpitaux de Marseille, Hôpital Timone, Université de la Méditerranée, CHU Timone, 264 rue Saint Pierre, 13385 Marseille Cedex 5, France
2 FFCD, Dijon, France
3 AP-HP, Hôpital Ambroise Paré, Boulogne, France
4 Centre Eugène Marquis, Rennes, France
5 Centre Paul Papin, Angers, France
6 Clinique Armoricaine, Saint Brieuc, France
7 Hopital Robert Debré, Reims, France
8 CHU Haut Leveque, Pessac, France
9 Centre René Huguenin, Saint Cloud, France
10 Centre François Leclerc, Dijon, France

(Correspondence should be addressed to L Dahan; Email: laetitia.dahan{at}mail.ap-hm.fr)

* (L Dahan and F Bonnetain contributed equally to this work)

The aim of this randomized multicenter phase III trial was to compare chemotherapy and interferon (IFN) in patients with metastatic carcinoid tumors. Patients with documented progressive, unresectable, metastatic carcinoid tumors were randomized between 5-fluorouracil plus streptozotocin (day 1–5) and recombinant IFN-{alpha}-2a (3 MUx3 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 IFN (hazard ratio=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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