Hearing Outcomes in Cisplatin or Cetuximab Combined with Radiation for Patients with HPV-Associated Oropharyngeal Cancer in NRG/RTOG 1016

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Conference Proceeding

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Int J Radiat Oncol Biol Phys


Purpose/Objective(s): NRG/RTOG 1016 was a noninferiority phase 3 trial comparing the efficacy of radiation with either cisplatin (RT+Cisp) or cetuximab (RT+Cetux) for patients with 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+Cisp compared to RT+Cetux. Materials/Methods: Perceived hearing handicap was measured at baseline, end of treatment, 3, 6, and 12-months post-treatment 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. Total HHIA-S scores range from 0 to 40; higher total score indicates more severe perceived hearing handicap. Hearing handicap categories (none, mild/moderate, and severe) were also analyzed. Mixed ordinal logistic models were used to analyze the raw HHIA-S scores and handicap categories (2-sided alpha 0.05). Results: Participation in the PRO assessments was optional, with 368 patients participating in the hearing PRO. No significant differences in patient/tumor characteristics were found between PRO participants/non-participants. Pre-treatment (mean [SD]) HHIA-S scores were not different for RT+Cisp (3.23 [6.28]) and RT+Cetux (4.77 [8.14]) groups. Post-treatment HHIA-S scores increased for RT+Cisp, and remained stable at the later follow-up time points. RT+Cetux scores remained stable from baseline. Change score from pre- to post-treatment was higher for RT+Cisp (4.32, 95% CI = [2.57, 6.07]) than RT+Cetux (0.08, 95% CI = [-1.15, 1.31]; p < 0.001). For hearing handicap category, post-treatment RT+Cisp had a significantly higher percentage of mild/moderate and severe cases (32%) compared to RT+Cetux (20%). From pre- to post-treatment, worsening of hearing handicap category from normal to mild/moderate or severe was greater for RT+Cisp (24%) than for RT+Cetux (9%). The conditional odds of being in a higher self-perceived hearing handicap category in the RT+Cisp arm were 3.57 (95% CI [2.04, 6.25]) times that in the RT+Cetux arm. Averaging over patients, the marginal odds ratio was 2.46 (95% CI [1.65, 3.66]). Conclusion: Patients receiving concurrent RT+Cisp for HPV-associated OPC have significantly higher odds of worsening self-perceived hearing handicap after treatment than with RT+Cetux. This was consistent across time through one-year post-treatment. These findings inform hearing-related outcomes for patients with HPV-associated OPC.





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