title: 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: To compare quality of life (QOL) between standard (SFX) chemoradiotherapy (arm A) and altered fractionation radiotherapy (AFX) with panitumumab (PMab; arm B).
  
  
  
  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/m2IV × 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.
  
  
  
  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.
  
  
  
  PMab with AFX did not durably improve QOL or swallowing as compared with SFX with cisplatin.
  
  
  
  ClinicalTrials.gov: NCT00820248.
authors.affiliation: Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada. Electronic address: jolie.ringash@rmp.uhn.on.ca.
authors.forename: Jolie
authors.initials: J
authors.lastname: Ringash
authors.affiliation: Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
authors.forename: John N
authors.initials: JN
authors.lastname: Waldron
authors.affiliation: Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
authors.forename: Lillian L
authors.initials: LL
authors.lastname: Siu
authors.affiliation: Department of Speech Language Pathology and Krembil Research Institute, University of Toronto, Toronto, ON, Canada.
authors.forename: Rosemary
authors.initials: R
authors.lastname: Martino
authors.affiliation: London Health Sciences Centre, London, ON, Canada.
authors.forename: Eric
authors.initials: E
authors.lastname: Winquist
authors.affiliation: Juravinski Cancer Centre, Hamilton, ON, Canada.
authors.forename: Jim R
authors.initials: JR
authors.lastname: Wright
authors.affiliation: Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada.
authors.forename: Abdenour
authors.initials: A
authors.lastname: Nabid
authors.affiliation: British Columbia Cancer Agency, Vancouver, BC, Canada.
authors.forename: John H
authors.initials: JH
authors.lastname: Hay
authors.affiliation: London Health Sciences Centre, London, ON, Canada.
authors.forename: Alex
authors.initials: A
authors.lastname: Hammond
authors.affiliation: McGill University Health Centre, Montreal, QC, Canada.
authors.forename: Khalil
authors.initials: K
authors.lastname: Sultanem
authors.affiliation: Juravinski Cancer Centre, Hamilton, ON, Canada.
authors.forename: Sebastien
authors.initials: S
authors.lastname: Hotte
authors.affiliation: British Columbia Cancer Agency - Fraser Valley Centre, Fraser Valley, BC, Canada.
authors.forename: Carson
authors.initials: C
authors.lastname: Leong
authors.affiliation: Saskatoon Cancer Centre, Saskatoon, SK, Canada.
authors.forename: Ali Abdel Halim
authors.initials: AA
authors.lastname: El-Gayed
authors.affiliation: Horizon Health Network - Saint John Regional Hospital, Saint John, NB, Canada.
authors.forename: Farah
authors.initials: F
authors.lastname: Naz
authors.affiliation: Northwestern Ontario Regional Cancer Care, Thunder Bay, ON, Canada.
authors.forename: Kevin
authors.initials: K
authors.lastname: Ramchandar
authors.affiliation: Northeast Cancer Centre, Sudbury, ON, Canada.
authors.forename: Timothy E
authors.initials: TE
authors.lastname: Owen
authors.affiliation: Canadian Cancer Trials Group, Kingston, ON, Canada.
authors.forename: Alexander
authors.initials: A
authors.lastname: Montenegro
authors.affiliation: Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
authors.forename: Brian
authors.initials: B
authors.lastname: O'Sullivan
authors.affiliation: Canadian Cancer Trials Group, Kingston, ON, Canada.
authors.forename: Bingshu E
authors.initials: BE
authors.lastname: Chen
authors.affiliation: Canadian Cancer Trials Group, Kingston, ON, Canada.
authors.forename: Wendy R
authors.initials: WR
authors.lastname: Parulekar
mesh_terms: D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002170:Canada; D002277:Carcinoma / Q000150:complications / Q000188:drug therapy* / Q000628:therapy*; D059248:Chemoradiotherapy / Q000379:methods*; D002945:Cisplatin / Q000627:therapeutic use; D003679:Deglutition; D003680:Deglutition Disorders / Q000209:etiology*; D005260:Female; D006258:Head and Neck Neoplasms / Q000150:complications / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077544:Panitumumab; D011788:Quality of Life; D011878:Radiotherapy / Q000379:methods
chemical_list: D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D000077544:Panitumumab; D002945:Cisplatin
keywords: Cisplatin; Concurrent chemoradiotherapy; Head and neck neoplasms; Intensity-modulated radiation therapy; Patient-reported outcomes; Phase III clinical trial; Quality of life; Randomised clinical trial; Swallowing