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.

Abstract

PURPOSE:

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.

PATIENTS AND 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.

CONCLUSION:

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.

• Authors: S Koeppen, C C P Verstappen, R Körte, M E Scheulen, D Strumberg, T J Postma, J J Heimans, P C Huijgens, B Kiburg, K Renzing-Köhler, H C Diener
• Journal: Journal of cancer research and clinical oncology (J Cancer Res Clin Oncol) Vol. 130 Issue 3 Pg. 153-60 (Mar 2004) ISSN: 0171-5216 [Print] Germany
• PMID: 14727106 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anticonvulsants
• Peptide Fragments
• Placebos
• Org 2766
• Vincristine
• Adrenocorticotropic Hormone

Topics

• Adrenocorticotropic Hormone (analogs & derivatives, pharmacology)
• Adult
• Aged
• Anticonvulsants (pharmacology)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)
• Cohort Studies
• Double-Blind Method
• Female
• Hodgkin Disease (drug therapy)
• Humans
• Interviews as Topic
• Longitudinal Studies
• Lymphoma, Non-Hodgkin (drug therapy)
• Male
• Middle Aged
• Nervous System Diseases (chemically induced)
• Peptide Fragments (pharmacology)
• Placebos
• Vincristine (administration & dosage)