Recommendations for cancer prevention trials using potentially ototoxic test agents

Purpose: Preventive oncology applies pharmacologic agents to reverse, retar d, or halt progression of neoplastic cells to invasive malignancy, a proces s that may require administration of agents over long periods of rime. Alth ough ototoxicity may be a tolerable side effect of anticancer or antimicrob ial therapy, even modest ototoxicity may not be acceptable in agents develo ped for preventive oncology that are routinely administered to subjects who neither are, nor necessarily will become, clinically ill. Materials and Methods: Age-related shifts in hearing may occur over the cou rse of longterm or open-ended therapy; consequently, age-adjusted norms ena ble researchers to better distinguish hearing loss caused by drugs from tha t caused by aging. Norms for hearing sensitivity are derived from the Balti more Longitudinal Study of Aging and are the basis for the proposed audiolo gic monitoring recommendations. Results: Audiologic monitoring recommendations are presented that standardi ze patient selection, adverse event reporting, posttreatment follow up, and audiologic testing for potentially ototoxic investigational agents. Conclusion: These recommendations are applicable to trials of investigation al agents as well as various classes of drugs used in routine clinical care , (C) 2001 by American Society of Clinical Oncology.