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Phase III trial of chemotherapy using 5-fluorouracil and streptozotocin compared with interferon α for advanced carcinoid tumors: FNCLCC–FFCD 9710

Laetitia Dahan, Frank Bonnetain, Philippe Rougier, Jean-Luc Raoul, Eric Gamelin, Pierre-Luc Etienne, Guillaume Cadiot, Emmanuel Mitry, Denis Smith, Frédérique Cvitkovic, Bruno Coudert, Floriane Ricard, Laurent Bedenne, Jean-François Seitz, 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)

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-α-2a (3 MU×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.