Quality of Life in Patients With p16+ Oropharyngeal Cancer Receiving Accelerated Radiation Therapy With Either Cisplatin or Cetuximab in the NRG/RTOG 1016 Randomized Controlled Trial.

In 30 seconds

This phase III randomized controlled trial examined quality of life (QOL) in patients with p16-positive oropharyngeal cancer receiving accelerated intensity-modulated radiation therapy (70 Gy/6 weeks) with either cisplatin or cetuximab. The QOL substudy included 375 patients, who completed questionnaires from baseline through 12 months. At 6 months, there was no significant between-arm difference in change from baseline in any QOL domain, including global health status and swallowing. Both groups experienced broad worsening at treatment completion; dry mouth, sticky saliva, and sensory problems remained impaired over follow-up.

Key findings

• Analyzable QOL data were available for 375 patients; questionnaire completion across five timepoints was similar between treatment arms.
• At 6 months, no significant between-arm difference was found in change from baseline for any QOL domain.
• At 6 months, declines greater than 10 points persisted for senses, social eating, opening the mouth, dry mouth, and sticky saliva.
• At 12 months, persistent declines greater than 10 points included senses, social eating, opening the mouth, dry mouth, sticky saliva, pain killers, and weight gain.

Why it matters

The findings describe the QOL burden associated with accelerated radiation and concurrent systemic therapy, while showing no measured 6-month QOL advantage for cetuximab over cisplatin. Persistent problems with dry mouth, sticky saliva, and sensory function may be important when discussing expected treatment effects and monitoring recovery. The study also supports the responsiveness of the EORTC QLQ-C30/H&N35 in this setting.

What to keep in mind

The QOL analysis was a secondary endpoint and included patients from the first 400 entered into the trial; follow-up questionnaires were reported only through 12 months.