Glutamic acid not beneficial for the prevention of vincristine neurotoxicity in children with cancer

TitleGlutamic acid not beneficial for the prevention of vincristine neurotoxicity in children with cancer
Publication TypeJournal Article
Year of Publication2015
AuthorsBradfield, S. M., Sandler E., Geller T., Tamura R. N., & Krischer J. P.
JournalPediatric blood & cancer
Volume62
Issue6
Pagination1004-10
Date Published2015 Jun
ISSN1545-5017
KeywordsAdolescent; Antineoplastic Agents, Phytogenic; chemotherapy neurotoxicities; Child; Child, Preschool; Double-Blind Method; Female; Glutamic Acid; Humans; lymphoblastic leukemia/neurology; Male; Neoplasms; Neurotoxicity Syndromes; pediatric oncology; Quality of Life; support care; Vincristine
Abstract

BACKGROUND: Vincristine causes known side effects of peripheral sensory, motor, autonomic and cranial neuropathies. No preventive interventions are known.
PROCEDURE: We performed a randomized, placebo-controlled, double-blind trial of oral glutamic acid as a preventive agent in pediatric patients with cancer who would be receiving vincristine therapy for at least 9 consecutive weeks (Stratum 1 = Wilms tumor and rhabdomyosarcoma) or 4 consecutive weeks in conjunction with steroids (Stratum 2 = Acute lymphoblastic leukemia and non-Hodgkin lymphoma). At designated time points, a scored neurologic exam using the Modified Balis Pediatric Scale of Peripheral Neuropathies was performed to document neurologic toxicity.
RESULTS: Between 2007 and 2012, 250 patients were enrolled (Stratum 1 = 50, Stratum 2 = 200). The glutamic acid treated group did not have a significantly lower percentage of neurotoxicity compared to placebo treated group either overall or within stratum or age subgroups. The only subgroup which was suggestive of treatment effect was for age. Patients 13 years or older showed a larger benefit in favor of glutamic acid (P = 0.055) compared to patients less than 13 years (P = 1.00). Constipation was the most frequently reported (14%) Grade II or higher neurotoxicity.
CONCLUSION: Vincristine-associated neurotoxicity in pediatric oncology remains a frequent complication of chemotherapy for multiple diagnoses with an approximate 30% of patients affected. Glutamic acid is not effective for prevention in pre-adolescents. There is a suggestion of benefit in patients 13 years or older, but the study was not designed to provide adequate power to test the treatment effect within this age group alone.




DOI10.1002/pbc.25384
Alternate JournalPediatr Blood Cancer
Refereed DesignationRefereed