Jolie Ringash1, John N Waldron2, Lillian L Siu2, Rosemary Martino3, Eric Winquist4, Jim R Wright5, Abdenour Nabid6, John H Hay7, Alex Hammond4, Khalil Sultanem8, Sebastien Hotte5, Carson Leong9, Ali Abdel Halim El-Gayed10, Farah Naz11, Kevin Ramchandar12, Timothy E Owen13, Alexander Montenegro14, Brian O'Sullivan2, Bingshu E Chen14, Wendy R Parulekar14. 1. Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada. Electronic address: jolie.ringash@rmp.uhn.on.ca. 2. Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada. 3. Department of Speech Language Pathology and Krembil Research Institute, University of Toronto, Toronto, ON, Canada. 4. London Health Sciences Centre, London, ON, Canada. 5. Juravinski Cancer Centre, Hamilton, ON, Canada. 6. Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada. 7. British Columbia Cancer Agency, Vancouver, BC, Canada. 8. McGill University Health Centre, Montreal, QC, Canada. 9. British Columbia Cancer Agency - Fraser Valley Centre, Fraser Valley, BC, Canada. 10. Saskatoon Cancer Centre, Saskatoon, SK, Canada. 11. Horizon Health Network - Saint John Regional Hospital, Saint John, NB, Canada. 12. Northwestern Ontario Regional Cancer Care, Thunder Bay, ON, Canada. 13. Northeast Cancer Centre, Sudbury, ON, Canada. 14. Canadian Cancer Trials Group, Kingston, ON, Canada.
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 Tany 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.
RCT Entities:
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.
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