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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

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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.

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Acknowledgment

Organon International provided an unrestricted grant to perform the study and also supplied the study medication. The authors thank B. Adler, Department of Neurology, University of Essen, Germany, for ty** the manuscript

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Authors and Affiliations

  1. Department of Neurology, University of Essen, Hufelandstrasse 55, 45122 , Essen, Germany

    S. Koeppen, R. Körte & H. C. Diener

  2. Department of Internal Medicine (Cancer Research), University of Essen, Essen, Germany

    M. E. Scheulen & D. Strumberg

  3. Department of Neurology, Vrije Universiteit Medical Center , Amsterdam, The Netherlands

    C. C. P. Verstappen, T. J. Postma, J. J. Heimans & B. Kiburg

  4. Department of Haematology, Vrije Universiteit Medical Center , Amsterdam, The Netherlands

    P. C. Huijgens

  5. Institute for Medical Informatics, Biometry and Epidemiology, University of Essen, Essen, Germany

    K. Renzing-Köhler

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  1. S. Koeppen
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Correspondence to S. Koeppen.

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Koeppen, S., Verstappen, C.C.P., Körte, R. et al. 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. J Cancer Res Clin Oncol 130, 153–160 (2004). https://doi.org/10.1007/s00432-003-0524-9

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