Self-Perceived Hearing Outcomes With Radiation and Cisplatin or Radiation and Cetuximab for Patients With Human Papilloma Virus (HPV)-Positive Oropharyngeal Cancer-Results From NRG Oncology RTOG 1016.

Abstract

RTOG 1016 was a noninferiority phase III trial comparing the efficacy of radiation with either cisplatin (RT + Cis) or cetuximab (RT + Cetux) for patients with Humman Papillomavirus (HPV)+ oropharyngeal cancer (OPC). Perceived hearing handicap was included as a patient-reported outcome (PRO) secondary endpoint. The primary hypothesis was that perceived hearing handicap would be greater for patients receiving RT + Cis compared with RT + Cetux. Perceived hearing handicap was measured at baseline, end of treatment, and 3, 6, and 12 months posttreatment using the Hearing Handicap Inventory for Adults Screening Version (HHIA-S), a 10-item self-assessment questionnaire designed to measure patients' reactions to their hearing loss. Mixed ordinal logistic models were used to determine the treatment effect on HHIA-S scores and handicap categories (2-sided α = 0.05). The PRO substudy included 375 eligible patients. No significant differences in patient/tumor characteristics were found between patients who participated in the HHIA-S study versus those excluded. For total HHIA-S scores and social and emotional subscales, RT + Cetux had significantly lower (ie, better) scores from end of treatment. Change score from baseline to end of treatment for RT + Cis (4.32; 95% confidence interval [CI], 2.57-6.07]) was greater than RT + Cetux (0.08; 95% CI, -1.15 to 1.31). For hearing handicap category, RT + Cis had a significantly higher percentage of mild/moderate and severe cases at the end of treatment (32%) compared with RT + Cetux (20%) (P < .0001). Adjusted conditional odds of higher self-perceived hearing handicap category for RT + Cis compared with RT + Cetux was 3.73 (95% CI, 2.10-6.62). Patients have significantly worse self-perceived hearing handicap after receiving RT + Cis treatment than with RT + Cetux. This was consistent across time through 1 year posttreatment. These findings inform hearing-related outcomes for patients with HPV-associated OPC and indicate the need for ototoxicity monitoring with RT + Cis treatment.