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). (February 2017)

• Record Type: Journal Article
• Authors: Ringash, Jolie; Waldron, John N.; Siu, Lillian L.; Martino, Rosemary; Winquist, Eric; Wright, Jim R.; Nabid, Abdenour; Hay, John H.; Hammond, Alex; Sultanem, Khalil; Hotte, Sebastien; Leong, Carson; El-Gayed, Ali Abdel Halim; Naz, Farah; Ramchandar, Kevin; Owen, Timothy E.; Montenegro, Alexander; O'Sullivan, Brian; Chen, Bingshu E.; Parulekar, Wendy R.
• Is Part Of: European journal of cancer. Volume 72(2017)
• Page Start: 192
• Page End: 199
• Publication Date: 2017-02
• Subjects: Randomised clinical trial -- Phase III clinical trial -- Head and neck neoplasms -- Intensity-modulated radiation therapy -- Cisplatin -- Concurrent chemoradiotherapy -- Quality of life -- Swallowing -- Patient-reported outcomes; Cancer -- Periodicals; Neoplasms -- Periodicals; Cancer -- Périodiques; Cancer; Tumors; Electronic journals; Periodicals; Electronic journals; 616.994
• DOI: 10.1016/j.ejca.2016.11.008
• Languages: English
• ISSNs: 0959-8049

Abstract

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/m 2 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 . Highlights: Three hundred twenty head and neck cancer patients participated in a phase III randomised trial comparing standard radiotherapy /cisplatin with accelerated radiotherapy/panitumumab. Quality of life (QOL) and swallowing outcomes were compared between arms. No clinically important differences by arm were seen 2–36 months post-treatment. Swallowing and head and neck–specific QOL showed persistent declines in both study arms. These results do not suggest adopting the experimental arm to improve QOL.