Phase III trial of chemotherapy using 5-fluorouracil and streptozotocin compared with interferon alpha for advanced carcinoid tumors: FNCLCC-FFCD 9710.
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.
Dahan
Laetitia
L
Assistance Publique, Hôpitaux de Marseille, Hôpital Timone, Université de la Méditerranée, CHU Timone, Marseille Cedex 5, France. laetitia.dahan@mail.ap-hm.fr
Bonnetain
Frank
F
Rougier
Philippe
P
Raoul
Jean-Luc
JL
Gamelin
Eric
E
Etienne
Pierre-Luc
PL
Cadiot
Guillaume
G
Mitry
Emmanuel
E
Smith
Denis
D
Cvitkovic
Frédérique
F
Coudert
Bruno
B
Ricard
Floriane
F
Bedenne
Laurent
L
Seitz
Jean-François
JF
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002276:Carcinoid Tumor / Q000188:drug therapy* / Q000556:secondary; D018450:Disease Progression; D004701:Endocrine Gland Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011994:Recombinant Proteins; D013311:Streptozocin / Q000008:administration & dosage; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome
D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D013311:Streptozocin; D005472:Fluorouracil