Lack of neuroprotection by an ACTH (4-9) analogue. A randomized trial in patients treated with vincristine for Hodgkin's or non-Hodgkin's lymphoma.
OBJECTIVE
This randomized, double-blind, placebo-controlled study evaluates the effect of the corticotropin (4-9) analogue Org 2766 on the neuropathy-free interval in patients receiving vincristine (VCR) containing chemotherapy for Hodgkin's or non-Hodgkin's lymphoma.


METHODS
In a longitudinal design, 150 patients were evaluated by interview, neurological examination, and neurophysiological techniques. Patients with an expected cumulative VCR dose of at least 8 mg received a single dose of Org 2766 or placebo before and after each intravenous VCR injection and 3-4 weeks after cessation of VCR. The final patient assessment was performed 1 month after discontinuation of study medication. The neuropathy-free interval as the major end point of this study was defined as the first occurrence of bilateral paresthesias and expressed as the administered cumulative VCR dose. This bi-center study represents the largest cohort of patients monitored for the effect of an ACTH-analogue on VCR neurotoxicity.


RESULTS
A total of 147 patients were included in the final analysis. No significant differences were observed between the placebo and actively treated group for the major and secondary endpoints.


CONCLUSIONS
Contrary to a single previous pilot study in patients receiving VCR-based chemotherapy, in our study the ACTH (4-9) analogue Org 2766 did not provide protection from VCR-induced neuropathy.
Koeppen
S
S
Department of Neurology, University of Essen, Hufelandstrasse 55, 45122 Essen, Germany. susanne.koeppen@uni-essen.de
Verstappen
C C P
CC
Körte
R
R
Scheulen
M E
ME
Strumberg
D
D
Postma
T J
TJ
Heimans
J J
JJ
Huijgens
P C
PC
Kiburg
B
B
Renzing-Köhler
K
K
Diener
H C
HC
D000324:Adrenocorticotropic Hormone / Q000031:analogs & derivatives* / Q000494:pharmacology*; D000328:Adult; D000368:Aged; D000927:Anticonvulsants / Q000494:pharmacology*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D015331:Cohort Studies; D004311:Double-Blind Method; D005260:Female; D006689:Hodgkin Disease / Q000188:drug therapy*; D006801:Humans; D007407:Interviews as Topic; D008137:Longitudinal Studies; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009422:Nervous System Diseases / Q000139:chemically induced*; D010446:Peptide Fragments / Q000494:pharmacology*; D010919:Placebos; D014750:Vincristine / Q000008:administration & dosage
D000927:Anticonvulsants; D010446:Peptide Fragments; D010919:Placebos; C013765:Org 2766; D014750:Vincristine; D000324:Adrenocorticotropic Hormone