2019 ASCO Annual Meeting!
Session: Head and Neck Cancer
Type: Oral Abstract Session
Time: Friday May 31, 2:45 PM to 5:45 PM
A phase II randomized trial for early-stage squamous cell carcinoma of the oropharynx: Radiotherapy versus trans-oral robotic surgery (ORATOR).
Head and Neck Cancer
2019 ASCO Annual Meeting
J Clin Oncol 37, 2019 (suppl; abstr 6006)
Author(s): Anthony Charles Nichols, Julie Theurer, Eitan Prisman, Nancy E Read, Eric Berthelet, Eric Tran, Fung Kevin, John R. de Almeida, Andrew Hope, David Paul Goldstein, Michael Hier, Khalil Sultanem, John Yoo, S. Danielle Macneil, Eric Winquist, Alex Hammond, Varagur Venkatesan, Sara Kuruvilla, Libni Eapen, David A. Palma; Western University and London Health Sciences Centre, London, ON, Canada; University of Western Ontario, London, ON, Canada; University of British Columbia, Vancouver, BC, Canada; University of Western Ontario, London Regional Cancer Center, London, ON, Canada; British Columbia Cancer Agency, Vancouver, BC, Canada; Department of Otolaryngology-Head & Neck Surgery/Surgical Oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada; Department of Radiation Oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada; McGill University, Montreal, QC, Canada; Jewish General Hospital Room G-002 3755 Côte Ste. Catherine Road, Montreal, QC, Canada; Western University, London, ON, Canada; London Health Sciences Centre, London, ON, Canada; London Regional Cancer Program, London, ON, Canada; The Ottawa Hospital, Ottawa, ON, Canada
Background: The incidence of OPSCC has risen rapidly, due to an epidemic of human papillomavirus (HPV) infection. Radiation therapy (RT) has historically been the standard treatment, but transoral robotic surgery (TORS) has surpassed RT in the US as the most common approach, based on assumptions of reduced toxicity or improved quality of life (QOL). No randomized trials have previously compared these treatments. Methods: The ORATOR trial (NCT01590355) enrolled patients with T1-T2 N0-2(≤4 cm) OPSCC amenable to TORS. We randomly assigned patients, stratified by p16 status, to RT (70 Gy/35 fractions, with chemotherapy if N1-2) vs. TORS (± adjuvant [chemo]RT based on pathology). The primary endpoint was a definitive comparison of swallowing QOL at 1-year using the MD Anderson Dysphagia Inventory (MDADI), powered to detect a 10-point improvement (a clinically-meaningful change [CMC]) in the TORS arm. Secondary endpoints included adverse events (AEs), other QOL outcomes [including EORTC scales, the Voice Handicap Index-10, Neck Dissection Impairment Index, and Patient Neurotoxicity Questionnaire], overall- and progression-free survival (OS, PFS). All analyses were pre-specified and intention-to-treat. Results: Between 2012 and 2017, 68 patients were randomized (n = 34 in each arm), in Canada and Australia. Median age was 59 years; 87% were male. Primary tumor sites were palatine tonsil (74%) or base of tongue (26%). Arms were well-balanced for baseline factors, including p16 status (88% in each arm). Median follow-up was 27 months. MDADI scores at 1-year were statistically superior in the RT arm (mean ± SD: 86.9 ± 11.4 vs. 80.1 ± 13.0 in the TORS arm; p = 0.042), but not meeting the definition of a CMC. For the other QOL metrics, outcomes were similar at 1-year. Feeding tube rates at 1-year were 3% (n = 1) vs. 0% respectively. Rates of treatment-related grade ≥2 AEs were similar (91% vs. 100%, p = 0.24), with more neutropenia, constipation and tinnitus in the RT arm and more trismus in the TORS arm (all p < 0.05). There was one TORS bleeding-related death. OS and PFS were similar. Conclusions: RT had superior swallowing QOL scores at 1 year compared to TORS, but the difference was not a CMC. Toxicities differed between the arms. This study provides the first level 1 evidence to inform patients of the QOL impact of both approaches. Clinical trial information: NCT01590355