Effect of P16 status on the quality of life experience during chemoradiation for locally advanced oropharyngeal cancer: A sub-study of randomized trial TROG 02.02 (HeadSTART)

Abstract Purpose Human papillomavirus-associated OPC has a favorable prognosis. Current research de-escalates treatment, aiming to improve QOL. Understanding the QOL experience with current standard treatment (chemoradiotherapy) provides context for emerging data. We report the impact of p16 status on QOL for patients with stage III or IV OPC undergoing chemoradiotherapy in an international phase III trial (TROG 02.02/HeadSTART ). Methods and Materials A subgroup analysis by p16 status was conducted in patients with OPC treated on a phase III randomized trial. The study sub-set with OPC and known p16 status was mainly from Australasia, western Europe, and North America. Of 861 participants, 200 had OPC, known p16 status, and baseline QOL; 82 were p16-, 118 p16+. Radiotherapy (70 Gy/7 weeks) was given concurrently with 3 cycles of either cisplatin (100mg/m2) or cisplatin (75 mg/m2) plus tirapazamine. QOL was measured with the FACT-H&N at baseline, 2,6,12, 23 and 38 months. As no significant difference in QOL score was observed between arms, results by p16 status are reported with arms combined. Results P16+ patients were younger, had better ECOG PS, and were less often current smokers. Our primary hypothesis that the change in FACT-H&N score from baseline to 6 months would be more favorable in the p16+ cohort was not met (p16+ -6.3, p16-, -1.8; p=0.14). Baseline mean FACT-H&N score was statistically and clinically significantly better in p16+ patients (111 vs. 102, p