Abstract
OBJECTIVE: Hearing loss from immune checkpoint inhibitors (ICIs) has been documented in case reports and case series. We present the largest retrospective study investigating the rate of ICI-related ototoxicity in a monitored cohort of platinum-naïve patients. STUDY DESIGN: Retrospective cohort study. SETTING: Tertiary-care center. METHODS: Patients treated with ICI between January 1, 2017, and December 31, 2022, with baseline and post-treatment audiograms, were included. Patients with a history of platinum-based chemotherapy were excluded. Demographics, oncologic diagnosis, ICI treatment details, and temporal bone irradiation (TBRT) were recorded. Audiometric thresholds were compared before and after ICI therapy. The primary outcome measure was a change in hearing as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE). Secondary outcome measures included changes in hearing using the American Speech-Language-Hearing Association (ASHA) and TUNE criteria. RESULTS: Among 15,390 ICI recipients, 29 platinum-naïve patients met the inclusion criteria. Six of 29 patients (20.7%) experienced a CTCAE grade 1 or higher hearing loss. The proportions of hearing loss as defined by ASHA and TUNE criteria were 44.8% and 27.6%, respectively. The length of time between baseline and follow-up audiograms was significantly longer among patients with hearing loss (mean difference [days]: CTCAE: 590.3, P < .01; ASHA: 280.9, P = .05; and TUNE: 122.1, P = .46). No other potential covariates believed to be confounders were significantly associated with the outcome. CONCLUSION: A significant proportion of our monitored platinum-naïve ICI patients met hearing-loss criteria. Prospective studies with standardized audiologic surveillance are needed to further quantify the true incidence of ICI ototoxicity.