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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.

Author(s): Dahan L, Bonnetain F, Rougier P, Raoul JL, Gamelin E, Etienne PL, Cadiot G, Mitry E, Smith D, Cvitkovic F, Coudert B, Ricard F, Bedenne L, Seitz JF, Federation Francophone de Cancerologie Digestive (FFCD), Digestive Tumors Group of the Federation Nationale des Centres de Lutte Contre le Cancer (FNCLCC)

Affiliation(s): Assistance Publique, Hopitaux de Marseille, Hopital Timone, Universite de la Mediterranee, CHU Timone, Marseille Cedex 5, France. laetitia.dahan@mail.ap-hm.fr

Publication date & source: 2009-12, Endocr Relat Cancer., 16(4):1351-61. Epub 2009 Sep 2.

Publication type: Clinical Trial, Phase III; Comparative Study; Multicenter Study; Randomized Controlled Trial

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 MU 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 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.

Page last updated: 2010-10-05

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