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A Pilot Study on the Influence of a Corticotropin (4-9) Analogue on Vinca Alkaloid—Induced Neuropathy
Barend van Kooten, MD;
Harriet A. M. van Diemen, MD;
Kees M. Groenhout, MD;
Peter C. Huijgens, MD;
Gert J. Ossenkoppele, MD;
Jos J. P. Nauta, PhD;
Jan J. Heimans, MD
Arch Neurol. 1992;49(10):1027-1031.
Abstract
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• In a randomized, double-blind, placebo-controlled pilot study, we examined the effect of Org 2766—a corticotropin (4-9) analogue—on neurotoxicity in 28 patients with lymphoma who were treated with combination chemotherapy containing Vinca alkaloids (vincristine and vinblastine). The patients received a total dose of 12 mg of vincristine in the case of non-Hodgkin's lymphoma and a total dose of 16 mg of vincristine in the case of Hodgkin's disease. Moreover, the patients with Hodgkin's disease received a mean total dose of 84 mg of vinblastine. Subcutaneous injections of 2 mg of Org 2766 or placebo were administered to patients with non-Hodgkin's lymphoma on days 1 and 10 of each chemotherapy course and to patients with Hodgkin's disease on days 1 and 8 of each chemotherapy course. The first injection was always given before the administration of vincristine. Assessment of neurologic symptoms and signs and measurement of sensory thresholds (vibration sense and temperature sense) were performed on day 1 of the first, fourth, and sixth (or eighth) courses and 6 weeks after cessation of chemotherapy. Thirteen patients (mean age, 44.7 years) received Org 2766 and 15 patients (mean age, 54.7 years) received placebo. More symptoms occurred in the placebo group, but only numbness and autonomic complaints occurred significantly more often in the placebo group. Motor deficit and sensory disturbances were more severe and also occurred significantly more often in the placebo group. There was no difference with respect to reflex examination findings and sensory thresholds. The outcome of this pilot study is promising with regard to an ameliorating effect of Org 2766 on vincristine neurotoxicity, but the results should be interpreted with great care because of a significant age difference between the study groups.
Author Affiliations
From the Departments of Neurology (Drs van Kooten, van Diemen, and Heimans), Hematology (Drs Huijgens and Ossenkoppele), and Epidemiology and Biostatistics (Dr Nauta), Free University Hospital, Amsterdam, and Organon International BV, Oss (Dr Groenhout), the Netherlands.
Footnotes
Accepted for publication May 12, 1992.
Reprint requests to the Department of Neurology, Free University Hospital, PO Box 7057, 1007 MB Amsterdam, the Netherlands (Dr Heimans).
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