Randomized Trial of Radiotherapy Versus Transoral Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma: Long-Term Results of the ORATOR Trial

DOI Web Site 被引用文献1件
  • Anthony C. Nichols
    Department of Otolaryngology—Head and Neck Surgery, Western University, London, Ontario, Canada
  • Julie Theurer
    School of Communication Sciences and Disorders, Western University, London, Ontario, Canada
  • Eitan Prisman
    Department of Otolaryngology, University of British Columbia, Vancouver, British Columbia, Canada
  • Nancy Read
    Department of Radiation Oncology, Western University, London, Ontario, Canada
  • Eric Berthelet
    Department of Radiation Oncology, University of British Columbia, Vancouver, British Columbia, Canada
  • Eric Tran
    Department of Radiation Oncology, University of British Columbia, Vancouver, British Columbia, Canada
  • Kevin Fung
    Department of Otolaryngology—Head and Neck Surgery, Western University, London, Ontario, Canada
  • John R. de Almeida
    Department of Otolaryngology—Head and Neck Surgery, University Health Network, University of Toronto, Toronto, Ontario, Canada
  • Andrew Bayley
    Department of Radiation Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada
  • David P. Goldstein
    Department of Otolaryngology—Head and Neck Surgery, University Health Network, University of Toronto, Toronto, Ontario, Canada
  • Michael Hier
    Department of Otolaryngology—Head and Neck Surgery, McGill University, Montreal, Quebec, Canada
  • Khalil Sultanem
    Department of Radiation Oncology, McGill University, Montreal, Quebec, Canada
  • Keith Richardson
    Department of Otolaryngology—Head and Neck Surgery, McGill University, Montreal, Quebec, Canada
  • Alex Mlynarek
    Department of Otolaryngology—Head and Neck Surgery, McGill University, Montreal, Quebec, Canada
  • Suren Krishnan
    Department of Otolaryngology—Head and Neck Surgery, Royal Adelaide Hospital, Adelaide, Australia
  • Hien Le
    Department of Radiation Oncology, Royal Adelaide Hospital, Adelaide, Australia
  • John Yoo
    Department of Otolaryngology—Head and Neck Surgery, Western University, London, Ontario, Canada
  • S. Danielle MacNeil
    Department of Otolaryngology—Head and Neck Surgery, Western University, London, Ontario, Canada
  • Eric Winquist
    Department of Medical Oncology, Western University, London, Ontario, Canada
  • J. Alex Hammond
    Department of Radiation Oncology, Western University, London, Ontario, Canada
  • Varagur Venkatesan
    Department of Radiation Oncology, Western University, London, Ontario, Canada
  • Sara Kuruvilla
    Department of Medical Oncology, Western University, London, Ontario, Canada
  • Andrew Warner
    Department of Radiation Oncology, Western University, London, Ontario, Canada
  • Sylvia Mitchell
    Department of Radiation Oncology, Western University, London, Ontario, Canada
  • Jeff Chen
    Department of Radiation Oncology, Western University, London, Ontario, Canada
  • Martin Corsten
    Department of Otolaryngology—Head and Neck Surgery, University of Ottawa, Ottawa, Ontario, Canada
  • Stephanie Johnson-Obaseki
    Department of Otolaryngology—Head and Neck Surgery, University of Ottawa, Ottawa, Ontario, Canada
  • Michael Odell
    Department of Otolaryngology—Head and Neck Surgery, University of Ottawa, Ottawa, Ontario, Canada
  • Christina Parker
    Department of Audiology, London Health Sciences Centre, London, Ontario, Canada
  • Bret Wehrli
    Department of Pathology, Western University, London, Ontario, Canada
  • Keith Kwan
    Department of Pathology, Western University, London, Ontario, Canada
  • David A. Palma
    Department of Radiation Oncology, Western University, London, Ontario, Canada

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<jats:sec><jats:title>PURPOSE</jats:title><jats:p> The incidence of oropharyngeal squamous cell carcinoma (OPSCC) has risen rapidly, because of an epidemic of human papillomavirus infection. The optimal management of early-stage OPSCC with surgery or radiation continues to be a clinical controversy. Long-term randomized data comparing these paradigms are lacking. </jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p> We randomly assigned patients with T1-T2, N0-2 (≤ 4 cm) OPSCC to radiotherapy (RT) (with chemotherapy if N1-2) versus transoral robotic surgery plus neck dissection (TORS + ND) (with or without adjuvant therapy). The primary end point was swallowing quality of life (QOL) at 1-year using the MD Anderson Dysphagia Inventory. Secondary end points included adverse events, other QOL outcomes, overall survival, and progression-free survival. All analyses were intention-to-treat. Herein, we present long-term outcomes from the trial. </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> Sixty-eight patients were randomly assigned (n = 34 per arm) between August 10, 2012, and June 9, 2017. Median follow-up was 45 months. Longitudinal MD Anderson Dysphagia Inventory analyses demonstrated statistical superiority of RT arm over time ( P = .049), although the differences beyond 1 year were of smaller magnitude than at the 1-year timepoint (year 2: 86.0 ± 13.5 in the RT arm v 84.8 ± 12.5 in the TORS + ND arm, P = .74; year 3: 88.9 ± 11.3 v 83.3 ± 13.9, P = .12). These differences did not meet the threshold to qualify as a clinically meaningful change at any timepoint. Certain differences in QOL concerns including more pain and dental concerns in the TORS + ND arm seen at 1 year resolved at 2 and 3 years; however, TORS patients started to use more nutritional supplements at 3 years ( P = .015). Dry mouth scores were higher in RT patients over time ( P = .041). </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> On longitudinal analysis, the swallowing QOL difference between primary RT and TORS + ND approaches persists but decreases over time. Patients with OPSCC should be informed about the pros and cons of both treatment options (ClinicalTrials.gov identifier: NCT01590355 ). </jats:p></jats:sec>

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