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Quality of life in patients with p16+ oropharyngeal cancer receiving accelerated radiotherapy with either cisplatin or cetuximab in the NRG/RTOG 1016 randomized controlled trial.

Quality of life in patients with p16+ oropharyngeal cancer receiving accelerated radiotherapy with either cisplatin or cetuximab in the NRG/RTOG 1016 randomized controlled trial. International journal of radiation oncology, biology, physics Ringash, J., Torres-Saavedra, P. A., Gillison, M. L., Caudell, J. J., Adelstein, D. J., Harari, P. M., Sturgis, E. M., Basch, E., Koyfman, S. A., Krempl, G. A., Blakaj, D. M., Bates, J. E., Galloway, T. J., Jones, C. U., Beadle, B. M., Harris, J., Le, Q., Yom, S. S., Movsas, B. 2026

Abstract

BACKGROUND: NRG/RTOG 1016 was a phase III randomized non-inferiority de-escalation trial comparing cetuximab vs cisplatin, concurrent with accelerated radiation (RT) 70 Gy/6 weeks, in p16+ oropharyngeal cancer (OPC). Quality of life (QOL) was a secondary endpoint.METHODS: Eligible/consenting patients among the first 400 entered completed the EORTC QLQ-C30/H&N35 at baseline, end of treatment, 3, 6, and 12 months post-treatment, to provide 90% power to detect an effect size of 0.5 in the between-arm change in QOL scores from baseline to 6 months. We report completion, responsiveness, and patterns over time across domains between arms, considering a difference of > 10 points as clinically significant.RESULTS: Consent to the QOL substudy was 91%, with analyzable data in 375 patients. No significant differences in patient/tumor characteristics were found by QOL participation status. Completion at the 5 timepoints did not differ by arm (IMRT+cisplatin/cetuximab) and was: 92/94%, 74/77%, 76/81%, 76/81%, and 73/74%. No significant difference was observed between arms for the 6-month change from baseline on any domain. At the end of treatment, all domains showed statistically and clinically significant mean worsening across both arms except Emotional Functioning, Dyspnea, Financial Difficulties, Diarrhea, and Teeth. By 6 months, drops > 10 points remained for: Senses, Social Eating, Opening Mouth, Dry Mouth, Sticky Saliva; and at 12 months for Senses, Trouble with Social Eating, Opening Mouth, Dry Mouth, Sticky Saliva, Pain Killers, and Weight Gain. Pain Killer reduced at both 6 and 12 months.CONCLUSION: Although replacing concurrent IMRT+cisplatin with IMRT+cetuximab did not improve global health status or swallowing at 6 months, this study supports the responsiveness of the EORTC QLQ-C30/H&N35 to the effects of IMRT+systemic therapy for OPC. Dry Mouth, Sticky Saliva, and Senses showed large, significant, and persistent impairment, whereas domains related to eating (Swallowing, Appetite, Nutritional Supplements, Social Eating, and Weight Loss) did not show sustained significant impairment in this study.

View details for DOI 10.1016/j.ijrobp.2026.02.242

View details for PubMedID 41825810