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Recommendations for cancer prevention trials using potentially ototoxic test agents
L I Shotland1, F G Ondrey, K A Mayo
1Hearing Section, Neuro-Otology Branch, National Institute on Deafness and Other Communication Disorders, National Institutes of Health, Bethesda, MD 20892, USA.
Summary
Preventive oncology agents require careful monitoring for hearing loss. New audiologic recommendations help distinguish drug-induced ototoxicity from age-related hearing changes.
Area of Science:
- Oncology
- Audiology
- Pharmacology
Background:
- Preventive oncology uses long-term pharmacologic agents to halt cancer progression.
- Ototoxicity is a potential side effect, but may be unacceptable in preventive therapies for asymptomatic individuals.
Purpose of the Study:
- To establish audiologic monitoring recommendations for potentially ototoxic agents in preventive oncology.
- To differentiate drug-induced hearing loss from age-related hearing shifts during long-term therapy.
Main Methods:
- Utilized age-adjusted hearing norms from the Baltimore Longitudinal Study of Aging.
- Developed recommendations for standardizing patient selection, adverse event reporting, and audiologic testing.
Main Results:
- Presented standardized audiologic monitoring recommendations for investigational agents.
- Recommendations cover patient selection, adverse event reporting, posttreatment follow-up, and testing protocols.
Conclusions:
- The recommendations are applicable to clinical trials of new agents.
- These guidelines also apply to drugs used in routine clinical practice for ototoxicity monitoring.
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