A phase II study of irinotecan in children with relapsed or refractory neuroblastoma: a European cooperation of the Société Française d'Oncologie Pédiatrique (SFOP) and the United Kingdom Children Cancer Study Group (UKCCSG).
OBJECTIVE
To evaluate the efficacy and safety of irinotecan in paediatric recurrent or refractory neuroblastoma.


METHODS
Thirty seven patients aged between 6 months and < or = 20 years, with relapsed or refractory neuroblastoma, received irinotecan at 600 mg/m(2) administered as a 60-min infusion, every 3 weeks. Tumour response was evaluated by conventional radiological and mIBG scans every two cycles.


RESULTS
No objective response was observed during the study. Stable disease was observed in 13% of evaluable patients. Median times to progression and survival were 1.4 months (range, 1.2-1.5 months) and 8.8 months (range, 6.7-11.3 months), respectively. One forty two cycles were administered, with a median of two cycles per patient (range, 1-17 cycles). The most common grade 3-4 toxicities were neutropenia (65% of patients), anaemia (43%), thrombocytopenia (38%), vomiting (14%), abdominal pain or cramping (8%), and nausea (5%).


CONCLUSIONS
Irinotecan administered intravenously as a single agent every 3 weeks induced no objective response in relapsed or refractory neuroblastoma.
Vassal
Gilles
G
Department of Paediatrics, Institute Gustave Roussy, Villejuif, France. gvassal@igr.fr
Giammarile
Francesco
F
Brooks
Mariel
M
Geoerger
Birgit
B
Couanet
Dominique
D
Michon
Jean
J
Stockdale
Elizabeth
E
Schell
Matthias
M
Geoffray
Anne
A
Gentet
Jean-Claude
JC
Pichon
Fabienne
F
Rubie
Hervé
H
Cisar
Laura
L
Assadourian
Sylvie
S
Morland
Bruce
B
D000008:Abdominal Neoplasms / Q000188:drug therapy*; D000293:Adolescent; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D002648:Child; D002675:Child, Preschool; D019008:Drug Resistance, Neoplasm; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D007223:Infant; D007275:Injections, Intravenous; D000077146:Irinotecan; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control; D009447:Neuroblastoma / Q000188:drug therapy*; D011446:Prospective Studies; D013899:Thoracic Neoplasms / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
D000972:Antineoplastic Agents, Phytogenic; D000077146:Irinotecan; D002166:Camptothecin