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Phase II randomized trial of transoral surgery and low-dose intensity modulated radiation therapy in resectable p16+ locally advanced oropharynx cancer: An ECOG-ACRIN Cancer Research Group Trial (E3311)

Journal of Clinical Oncology Oct 29, 2021

Ferris RL, Flamand Y, Weinstein GS, et al. - In patients with intermediate-risk human papillomavirus–associated (HPV+) oropharynx cancer (OPC), outstanding oncologic outcome and favorable functional outcomes were conferred by primary transoral surgery (TOS) and reduced postoperative radiation therapy (RT).

  • A phase II randomized trial wherein primary TOS and reduced postoperative RT was tested as a deintensification strategy in intermediate-risk HPV+ OPC.

  • The criteria for considering TOS plus 50 Gy promising was: the lower limit of the exact 90% binomial confidence intervals should exceed 85%.

  • TOS was performed for 495 patients, eligible and treated patients (n=359) were allocated to treatment arms.

  • For arm A (observation), arm B (50 Gy), arm C (60 Gy), and arm D (66 Gy plus weekly cisplatin), the 2-year progression-free survival Kaplan-Meier estimate was 96.9%, 94.9%, 96.0%, and 90.7%, respectively.

  • According to exploratory comparison, a trend toward better quality-of-life scores was evident in relation to reduced radiation therapy and chemotherapy.

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