TY - JOUR
T1 - 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
AU - Runge, Christina L
AU - Lyness, Jessica A
AU - Gillison, Maura L
AU - Adelstein, David J
AU - Harari, Paul M
AU - Ringash, Jolie
AU - Geiger, Jessica L
AU - Krempl, Greg A
AU - Blakaj, Dukagjin M
AU - Bates, James Edward
AU - Galloway, Thomas J
AU - Jones, Christopher U
AU - Gensheimer, Michael F
AU - Dunlap, Neal E
AU - Phan, Jack
AU - Caudell, Jimmy J
AU - Pennington, J Daniel
AU - Torres-Saavedra, Pedro A
AU - Yom, Sue S
AU - Le, Quynh-Thu
AU - Movsas, Benjamin
N1 - Copyright © 2025 Elsevier Inc. All rights reserved.
PY - 2025/8/18
Y1 - 2025/8/18
N2 - PURPOSE: RTOG 1016 was a noninferiority phase 3 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.METHODS AND MATERIALS: 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).RESULTS: 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).CONCLUSION: 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.
AB - PURPOSE: RTOG 1016 was a noninferiority phase 3 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.METHODS AND MATERIALS: 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).RESULTS: 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).CONCLUSION: 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.
UR - https://www.scopus.com/pages/publications/105016757398
U2 - 10.1016/j.ijrobp.2025.08.021
DO - 10.1016/j.ijrobp.2025.08.021
M3 - Article
C2 - 40829719
SN - 0360-3016
JO - International Journal of Radiation Oncology Biology Physics
JF - International Journal of Radiation Oncology Biology Physics
ER -
