Assessment of Toxic Effects and Survival in Treatment Deescalation With Radiotherapy vs Transoral Surgery for HPV-Associated Oropharyngeal Squamous Cell Carcinoma

作者：David A. Palma, Eitan Prisman, Eric Berthelet, Eric M. Tran, Sarah Nicole Hamilton, Jonn Wu, Antoine E. Eskander, Kevin McLughlin Higgins, Irene Karam, Ian Poon, Zain Ali Husain, Danny Enepekides, Michael Hier, Khalil Sultanem, Keith Richardson, Alex Mlynarek, Stephanie Johnson‐Obaseki, Michael L O'Dell, Andrew Bayley, Samuel A. Dowthwaite, James E. Jackson, Marcin Radoslaw Dzienis, John O’Neil, Shamir P. Chandarana, Robyn N. Banerjee, Robert D. Hart, Jeffson Chung, Todd Tenenholtz, Suren Krishnan, Hien V. Le, John J. Yoo, Adrian Mendez, Eric Winquist, Sara Kuruvilla, Paul Stewart, Andrew Warner, Sylvia Mitchell, Jeff Chen, Christina Narelle Parker, Bret Michael Wehrli, Keith F. Kwan, Julie Theurer, Jinka Sathya, J. Alex Hammond, Nancy E. Read, Varagur Venkatesan, S. Danielle MacNeil, Kevin K. Fung, Anthony Charles Nichols · 发表于：JAMA Oncology · 年份：2022 · DOI：10.1001/jamaoncol.2022.0615 · 被引用次数：110 · 研究领域：Head and Neck Cancer Studies、Head and Neck Surgical Oncology、Esophageal Cancer Research and Treatment

Importance: The optimal approach for treatment deescalation in human papillomavirus (HPV)-related oropharyngeal squamous cell carcinomas (OPSCCs) is unknown. Objective: To assess a primary radiotherapy (RT) approach vs a primary transoral surgical (TOS) approach in treatment deescalation for HPV-related OPSCC. Design, Setting, and Participants: This international, multicenter, open-label parallel-group phase 2 randomized clinical trial was conducted at 9 tertiary academic cancer centers in Canada and Australia and enrolled patients with T1-T2N0-2 p16-positive OPSCC between February 13, 2018, and November 17, 2020. Patients had up to 3 years of follow-up. Interventions: Primary RT (consisting of 60 Gy of RT with concurrent weekly cisplatin in node-positive patients) vs TOS and neck dissection (ND) (with adjuvant reduced-dose RT depending on pathologic findings). Main Outcomes and Measures: The primary end point was overall survival (OS) compared with a historical control. Secondary end points included progression-free survival (PFS), quality of life, and toxic effects. Results: Overall, 61 patients were randomized (30 [49.2%] in the RT arm and 31 [50.8%] in the TOS and ND arm; median [IQR] age, 61.9 [57.2-67.9] years; 8 women [13.6%] and 51 men [86.4%]; 31 [50.8%] never smoked). The trial began in February 2018, and accrual was halted in November 2020 because of excessive toxic effects in the TOS and ND arm. Median follow-up was 17 months (IQR, 15-20 months). For the OS end po...