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

被引:80
作者
Dahan, Laetitia [1 ]
Bonnetain, Frank [2 ]
Rougier, Philippe [3 ]
Raoul, Jean-Luc [4 ]
Gamelin, Eric [5 ]
Etienne, Pierre-Luc [6 ]
Cadiot, Guillaume [7 ]
Mitry, Emmanuel
Smith, Denis [8 ]
Cvitkovic, Frederique [9 ]
Coudert, Bruno [10 ]
Ricard, Floriane [1 ]
Bedenne, Laurent [1 ]
Seitz, Jean-Francois [1 ]
机构
[1] Univ Aix Marseille 2, CHU Timone, Hop Timone, Assistance Publ Hop Marseille, F-13385 Marseille 5, France
[2] FFCD, Dijon, France
[3] Hop Ambroise Pare, AP HP, Boulogne, France
[4] Ctr Eugene Marquis, Rennes, France
[5] Ctr Paul Papin, Angers, France
[6] Clin Armoricaine, St Brieuc, France
[7] Hop Robert Debre, Reims, France
[8] CHU Haut Leveque, Pessac, France
[9] Ctr Rene Huguenin, St Cloud, France
[10] Ctr Francois Leclerc, Dijon, France
关键词
COOPERATIVE-ONCOLOGY-GROUP; NEUROENDOCRINE TUMORS; GASTROENTEROPANCREATIC TUMORS; LEUKOCYTE INTERFERON; MANAGEMENT; OCTREOTIDE; FLUOROURACIL; COMBINATION; DOXORUBICIN; THERAPY;
D O I
10.1677/ERC-09-0104
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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. Endocrine-Related Cancer (2009) 16 1351-1361
引用
收藏
页码:1351 / 1361
页数:11
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