UCSF

Purpose

NRG/RTOG 1016 was a phase III randomized noninferiority de-escalation trial comparing cetuximab versus cisplatin, concurrent with accelerated radiation 70 Gy/6 weeks, in p16+ oropharyngeal cancer. Quality of life (QOL) was a secondary endpoint.

Methods and materials

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 posttreatment, 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 (intensity modulated radiation therapy [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.

Conclusions

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 oropharyngeal cancer. 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.