Quality of life and swallowing with standard chemoradiotherapy versus accelerated radiotherapy and panitumumab in locoregionally advanced carcinoma of the head and neck: A phase III randomised trial from the Canadian Cancer Trials Group (HN.6)

Abstract Aim To compare quality of life (QOL) between standard (SFX) chemoradiotherapy (arm A) and altered fractionation radiotherapy (AFX) with panitumumab (PMab; arm B). Methods Patients with T any N + M0 or T3-4N0M0 squamous cell head-neck carcinoma were randomised to SFX (70 Gy/35/7 wks) plus cisplatin (100 mg/m2 IV × 3) versus AFX (70 Gy/35/6 wks) plus PMab (9 mg/kg IV × 3). QOL was collected at baseline, end of radiation therapy (RT) and 2, 4, 6, 12, 24 and 36 months post-RT using the Functional Assessment of Cancer Therapy Head and Neck (FACT-H&N), MD Anderson Dysphagia Index (MDADI) and SWAL-QOL. We hypothesised a 6-point more favourable change in FACT-H&N score from baseline to 1 year in arm B over arm A. Results Among 320 patients, median follow-up was 46 (range: 0.1–64.3) months, median age 56, 84% male, Eastern Cooperative Oncology Group PS 0 (71%), 1 (29%). Primary site was oropharynx in 81% (p16+ 68%, p16− 16%, missing 16%). Baseline scores did not differ by arm (A/B): FACT-H&N 116.5/115, MDADI Global 83/77, SWAL-QOL General 67/68. At 1 year, no difference was seen between arms in FACT-H&N change from baseline: A −1.70, B −4.81, p = 0.194. Subscale change scores by arm were (A/B): last week RT, FACT-Physical (−11.6, −10, p = 0.049), MDADI Physical (−40.4, −33.9, p = 0.045), and SWAL-QOL Eating Duration (−61.2, −51.2, p = 0.02), Eating Desire (−53.3, −43.9, p = 0.031) and Mental Health (−42, −32.6, p = 0.009); 4 months, HN subscale (−7.7, −10, p = 0.014). No clinically important differences by arm were seen post-treatment. Conclusions PMab with AFX did not durably improve QOL or swallowing as compared with SFX with cisplatin. Trial registration ClinicalTrials.gov: NCT00820248.