Phase I trial of dose-escalated stereotactic radiosurgery (SRS) boost for unfavorable locally advanced oropharyngeal can

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Phase I trial of dose‑escalated stereotactic radiosurgery (SRS) boost for unfavorable locally advanced oropharyngeal cancer Prashant Vempati1,2, Aditya N. Halthore1,2, Sewit Teckie1,2, Zaker Rana1,2, Emile Gogineni1,2, Jeffrey Antone1, Honglai Zhang1, Mihaela Marrero1, Kristin Beadle2, Douglas K. Frank2,3, Mohamed Aziz2, Doru Paul2,4 and Maged Ghaly1,2*

Abstract  Background and purpose:  Patients with locally advanced oropharynx squamous cell carcinoma have suboptimal outcomes with standard chemoradiation. Here, we evaluated toxicity and oncologic outcomes of dose escalation using radiosurgical boost for patients with unfavorable oropharynx squamous cell carcinoma. Materials and methods:  Between 2010–2017, Thirty four patients with intermediate- or high-risk oropharynx squamous cell carcinoma were enrolled onto this prospective phase I trial. Each patient received concurrent cisplatin and fractionated radiotherapy totaling 60 Gy or 66 Gy followed by radiosurgery boost to areas of residual gross tumor: single fraction of 8 Gy or 10 Gy, or two fractions of 5 Gy each. Primary endpoint was treatment toxicity. Secondary endpoints were local, regional, and distant disease control. Results:  Eleven, sixteen and seven patients received radiosurgery boost with 8 Gy in 1 fraction, 10 Gy in 1 fraction, and 10 Gy in 2 fractions respectively. Acute toxicities include 4 patients with tumor necrosis causing grade 3 dysphagia, of which 3 developed grade 4 pharyngeal hemorrhage requiring surgical intervention. At 24 months after treatment, 7%, 9%, and 15% had grade 2 dysgeusia, xerostomia, and dysphagia, respectively, and two patients remained feeding tube dependent. No grade 5 toxicities occurred secondary to treatment. Local, regional, and distant control at a median follow up of 4.2 years were 85.3%, 85.3% and 88.2%, respectively. Five patients died resulting in overall survival of 85.3%. Conclusions:  This study is the first to report the use of radiosurgery boost dose escalation in patients with unfavorable oropharynx squamous cell carcinoma. Longer follow-up, larger cohorts, and further refinement of boost methodology are needed prior to implementation in routine clinical practice. Trial Registration: Northwell Health Protocol #09-309A (NCT02703493) (https​://clini​caltr​ials.gov/ct2/show/NCT02​70349​ 3) Keywords:  Radiosurgery, SRS, Dose escalation, Oropharynx, Head-and-neck

*Correspondence: [email protected] 1 Department of Radiation Medicine, Northwell Health, Zucker School of Medicine at Hofstra/Northwell, 450 Lakeville Road, Lake Success, NY 11040, USA Full list of author information is available at the end of the article

Introduction Locoregional control rates after curative radiation therapy for patients with oropharynx (OP) squamous cell carcinoma (SCC) unassociated with human papilloma virus (HPV) or those with prolonged tobacco exposure are significantly lower than the 80% local control rates

© The Author(s) 2020. Open Access This article is licensed under a Creative Commons Attribution