Radiotherapy versus transoral robotic surgery and neck dissection for oropharyngeal squamous cell carcinoma (ORATOR): an open-label, phase 2, randomised trial

Nichols, Anthony C.; Theurer, Julie; Prisman, Eitan; Read, Nancy; Berthelet, Eric; Tran, Eric; Fung, Kevin; Almeida, John R. de; Bayley, Andrew; Goldstein, David P.; Hier, Michael P.; Sultanem, Khalil; Richardson, Keith; Mlynarek, Alex; Krishnan, Suren; Le, Hien; Yoo, John; MacNeil, Danielle; Winquist, Eric; Hammond, James R.; Venkatesan, Varagur; Kuruvilla, Sara; Warner, Andrew; Mitchell, Sylvia; Chen, Jeff; Corsten, Martin; Johnson‐Obaseki, Stephanie; Eapen, Libni; Odell, Michael; Parker, Christina; Wehrli, Bret; Kwan, Keith

doi:10.1016/s1470-2045(19)30410-3

Cited by 336 publications

(356 citation statements)

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“…QOL analysis for secondary endpoints will be performed in the same way as the ORATOR trial using linear mixed-effects models [24]. The original ORATOR trial will be used for additional historical controls [12]. A comparison will occur between HPV+ patients in ORATOR (who were treated with more aggressive approaches) and ORATOR2 to assess differences in QOL and time-to-event outcomes.…”

Section: Analysis Planmentioning

confidence: 99%

“…The ORATOR trial is the only trial to examine the question of a primary RT vs. primary TOS approach in a randomized fashion [12]. This phase II trial included 68 patients with OPC regardless of HPV status, and randomized patients to RT (70 Gy, with chemotherapy if N1-2) or TOS plus neck dissection (with or without adjuvant RT/CRT, based on pathology).…”

Section: Introductionmentioning

confidence: 99%

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Treatment de-escalation for HPV-associated oropharyngeal squamous cell carcinoma with radiotherapy vs. trans-oral surgery (ORATOR2): study protocol for a randomized phase II trial

et al. 2020

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Background: Patients with human papillomavirus-positive (HPV+) oropharyngeal squamous cell carcinoma (OPC) have substantially better treatment response and overall survival (OS) than patients with HPV-negative disease. Treatment options for HPV+ OPC can involve either a primary radiotherapy (RT) approach (± concomitant chemotherapy) or a primary surgical approach (± adjuvant radiation) with transoral surgery (TOS). These two treatment paradigms have different spectrums of toxicity. The goals of this study are to assess the OS of two deescalation approaches (primary radiotherapy and primary TOS) compared to historical control, and to compare survival, toxicity and quality of life (QOL) profiles between the two approaches. Methods: This is a multicenter phase II study randomizing one hundred and forty patients with T1-2 N0-2 HPV+ OPC in a 1:1 ratio between de-escalated primary radiotherapy (60 Gy) ± concomitant chemotherapy and TOS ± deescalated adjuvant radiotherapy (50-60 Gy based on risk factors). Patients will be stratified based on smoking status (< 10 vs. ≥ 10 pack-years). The primary endpoint is OS of each arm compared to historical control; we hypothesize that a 2-year OS of 85% or greater will be achieved. Secondary endpoints include progression free survival, QOL and toxicity. Discussion: This study will provide an assessment of two de-escalation approaches to the treatment of HPV+ OPC on oncologic outcomes, QOL and toxicity. Results will inform the design of future definitive phase III trials.

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Section: Analysis Planmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Treatment de-escalation for HPV-associated oropharyngeal squamous cell carcinoma with radiotherapy vs. trans-oral surgery (ORATOR2): study protocol for a randomized phase II trial

et al. 2020

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“…Functional outcomes were not reported in the current study, but data currently are being collected. In what to our knowledge is the only randomized trial comparing TORS versus primary RT and/or chemoradiation for patients with OPSCC, similar survival outcomes were demonstrated but with a superior swallowing quality‐of‐life score at 1 year that favored nonsurgical treatment, although the difference in the score was below the threshold of a clinically meaningful change. The median follow‐up in the current study was >3 years, but it will be prudent to again analyze these data when a longer follow‐up interval exists for all patients because late recurrences are more common in HPV‐positive patients.…”

Section: Discussionmentioning

confidence: 62%

Evaluating the impact of smoking on disease‐specific survival outcomes in patients with human papillomavirus–associated oropharyngeal cancer treated with transoral robotic surgery

Roden

Hobelmann

Vimawala

et al. 2020

Cancer

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BACKGROUND: When treated nonsurgically with definitive chemoradiation, smokers with human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma (OPSCC) have a worse prognosis compared with their nonsmoking counterparts. To the authors' knowledge, the prognostic significance of smoking in surgically treated patients is unknown. METHODS: The current study is a retrospective case series of patients with HPV-positive OPSCC who underwent upfront transoral robotic surgery at a single institution from 2010 through 2017. Exclusion criteria were nonoropharyngeal primary tumors, histology other than SCC, HPV-negative tumors, previous history of head and neck cancer, and/or previous head and neck radiotherapy. Recurrence-free survival (RFS), overall survival, and disease-specific survival were compared using the Kaplan-Meier method and the log-rank test. Smoking history was categorized as never smokers (<1 pack-year), current smokers (smoking at the time of the cancer diagnosis), and former smokers. RESULTS: A total of 258 patients met the study criteria. The average age was 60 years, and approximately 87% of patients were male. A total of 148 patients (57.4%) were smokers whereas 110 (42.6%) reported never smoking. There were 44 active smokers (17.1%) and 104 former smokers (40.3%). The median follow-up was 3.23 years. There were 17 patients of disease recurrence. Smoking pack-year history was not found to be significant for RFS (hazard ratio, 1.01; 95% CI, 0.99-1.03 [P = .45]). There was no significant difference in RFS noted between never and ever smokers (92% vs 89.8%; P = .85) nor was there a difference observed between never, former, and current smokers (92% vs 91.5% vs 86.1%, respectively; P = .69). CONCLUSIONS: A smoking history is common in patients with HPV-positive OPSCC. In the current study, HPV-positive smokers were found to have excellent survival and locoregional control, similar to their nonsmoking counterparts.The results of the current study do not support the exclusion of smokers with early-stage, HPV-positive OPSCC from transoral robotic surgery-based deintensification trials.

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“…Organs at Risk (OAR) de nitions, dose constraints and planning priorities are adapted from the following protocols: RTOG protocols 1016 36 (Arm 1) and RTOG 0920 37 (Arm 2), NCIC-CTG HN6, ORATOR 38,39 and ORATOR2 40 , and are described in Appendix 1.…”

Section: Radiotherapy Planningmentioning

confidence: 99%

Preservation of Swallowing in Resected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): Study Protocol for a Randomized Phase II Trial

Lang

Contreras

Kalman

et al. 2020

Preprint

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Background Patients with resected oral cavity squamous cell carcinoma (OCSCC) are often treated with adjuvant radiation (RT) ± concomitant chemotherapy based on pathological findings. Standard RT volumes include all surgically dissected areas, including the tumour bed and dissected neck. RT has significant acute and long-term toxicities including odynophagia, dysphagia, dermatitis and fibrosis. The goal of this study is to assess the rate of regional failure with omission of radiation to the surgically dissected pathologically node negative (pN0) hemi-neck(s) compared to historical control, and to compare oncologic outcomes, toxicity, and quality of life (QoL) profiles between standard RT volumes and omission of RT to the pN0 neck. Methods This is a multicentre phase II study randomizing ninety patients with T1-4 N0-2 OCSCC with at least one pN0 hemi-neck in a 1:2 ratio between standard RT volumes and omission of RT to the pN0 hemi-neck(s). Patients will be stratified based on overall nodal status (nodal involvement vs. no nodal involvement) and use of concurrent chemotherapy. The primary endpoint is regional failure in the pN0 hemi-neck(s); we hypothesize that a 2-year regional recurrence of 20% or less will be achieved. Secondary endpoints include overall and progression-free survival, local recurrence, rate of salvage therapy, toxicity and QoL. Discussion This study will provide an assessment of omission of RT to the dissected pN0 hemi-neck(s) on oncologic outcomes, QoL and toxicity. Results will inform the design of future definitive phase III trials. Trial Registration: Clinicaltrials.gov identifier: NCT03997643. Date of registration: June 25, 2019, Current version: 2.0 on July 11 2020. URL: https://clinicaltrials.gov/ct2/show/NCT03997643

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Radiotherapy versus transoral robotic surgery and neck dissection for oropharyngeal squamous cell carcinoma (ORATOR): an open-label, phase 2, randomised trial

Cited by 336 publications

References 21 publications

Treatment de-escalation for HPV-associated oropharyngeal squamous cell carcinoma with radiotherapy vs. trans-oral surgery (ORATOR2): study protocol for a randomized phase II trial

Treatment de-escalation for HPV-associated oropharyngeal squamous cell carcinoma with radiotherapy vs. trans-oral surgery (ORATOR2): study protocol for a randomized phase II trial

Evaluating the impact of smoking on disease‐specific survival outcomes in patients with human papillomavirus–associated oropharyngeal cancer treated with transoral robotic surgery

Preservation of Swallowing in Resected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): Study Protocol for a Randomized Phase II Trial

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