A phase II randomized trial for early-stage squamous cell carcinoma of the oropharynx: Radiotherapy versus trans-oral robotic surgery (ORATOR).

6006 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.

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Modern Treatment Outcomes for Early T-Stage Oropharyngeal Cancer Treated With Intensity-modulated Radiation Therapy at a Tertiary Care Institution

10.21203/rs.3.rs-83234/v1 ◽

2020 ◽

Author(s):

Eric J. Di Gravio ◽

Pencilla Lang ◽

Hugh Andrew Jinwook Kim ◽

Tricia Chinnery ◽

Neil Mundi ◽

...

Keyword(s):

Robotic Surgery ◽

Oropharyngeal Cancer ◽

Early Stage ◽

Tertiary Care ◽

Feeding Tube ◽

The United States ◽

Transoral Robotic Surgery ◽

Transoral Surgery ◽

Severe Toxicity ◽

T Stage

Abstract BackgroundTransoral surgery (TOS), particularly transoral robotic surgery (TORS) has become the preferred modality in the United States for the treatment of early stage oropharyngeal cancer, largely due to assumptions of fewer toxicities and improved quality of life compared to primary radiotherapy (RT). However, these assumptions are based on retrospective analysis, a subset of which utilize primary RT groups not limited to T1-2 stage tumors for which transoral robotic surgery is FDA approved. Thus, there is potential for underestimating survival and overestimating toxicity, including treatment related mortality, in primary RT.MethodsConsecutive cases of early T stage (T1-T2) oropharyngeal cancer presenting to the London Health Sciences Centre between 2014-2018 treated with RT or chemoradiation (CRT) were reviewed. Patient demographics, treatment details, survival outcomes and toxicity were collected. Toxicities were retrospectively graded using the CTCAE criteria.ResultsA total of 198 patients were identified, of which 82% were male and 73% were HPV-positive. Sixty-eight percent of patients experienced a grade 2 toxicity, 48% a grade 3 and 4% a grade 4. The most frequent toxicities were dysphagia, neutropenia and ototoxicity. The rates of gastrostomy tube dependence at 1 and 2 years were 2.5% and 1% respectively. There were no grade 5 (fatal) toxicities. HPV-positive patients experienced improved 5-year overall survival (86% vs 64%, p=0.0026). ConclusionsPrimary RT or CRT provides outstanding survival for early T-stage HPV-positive disease, with low rates of severe toxicity and feeding tube dependence. This study provides a reference for comparison for patients treated with primary transoral surgery.

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Randomized Trial of Radiotherapy Versus Transoral Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma: Long-Term Results of the ORATOR Trial

Journal of Clinical Oncology ◽

10.1200/jco.21.01961 ◽

2022 ◽

Author(s):

Anthony C. Nichols ◽

Julie Theurer ◽

Eitan Prisman ◽

Nancy Read ◽

Eric Berthelet ◽

...

Keyword(s):

Squamous Cell Carcinoma ◽

Robotic Surgery ◽

Cell Carcinoma ◽

Squamous Cell ◽

Transoral Robotic Surgery ◽

Oropharyngeal Squamous Cell Carcinoma ◽

Md Anderson ◽

Anderson Dysphagia Inventory ◽

Over Time

PURPOSE The incidence of oropharyngeal squamous cell carcinoma (OPSCC) has risen rapidly, because of an epidemic of human papillomavirus infection. The optimal management of early-stage OPSCC with surgery or radiation continues to be a clinical controversy. Long-term randomized data comparing these paradigms are lacking. METHODS We randomly assigned patients with T1-T2, N0-2 (≤ 4 cm) OPSCC to radiotherapy (RT) (with chemotherapy if N1-2) versus transoral robotic surgery plus neck dissection (TORS + ND) (with or without adjuvant therapy). The primary end point was swallowing quality of life (QOL) at 1-year using the MD Anderson Dysphagia Inventory. Secondary end points included adverse events, other QOL outcomes, overall survival, and progression-free survival. All analyses were intention-to-treat. Herein, we present long-term outcomes from the trial. RESULTS Sixty-eight patients were randomly assigned (n = 34 per arm) between August 10, 2012, and June 9, 2017. Median follow-up was 45 months. Longitudinal MD Anderson Dysphagia Inventory analyses demonstrated statistical superiority of RT arm over time ( P = .049), although the differences beyond 1 year were of smaller magnitude than at the 1-year timepoint (year 2: 86.0 ± 13.5 in the RT arm v 84.8 ± 12.5 in the TORS + ND arm, P = .74; year 3: 88.9 ± 11.3 v 83.3 ± 13.9, P = .12). These differences did not meet the threshold to qualify as a clinically meaningful change at any timepoint. Certain differences in QOL concerns including more pain and dental concerns in the TORS + ND arm seen at 1 year resolved at 2 and 3 years; however, TORS patients started to use more nutritional supplements at 3 years ( P = .015). Dry mouth scores were higher in RT patients over time ( P = .041). CONCLUSION On longitudinal analysis, the swallowing QOL difference between primary RT and TORS + ND approaches persists but decreases over time. Patients with OPSCC should be informed about the pros and cons of both treatment options (ClinicalTrials.gov identifier: NCT01590355 ).

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Modern treatment outcomes for early T-stage oropharyngeal cancer treated with intensity-modulated radiation therapy at a tertiary care institution

Radiation Oncology ◽

10.1186/s13014-020-01705-1 ◽

2020 ◽

Vol 15 (1) ◽

Author(s):

Eric J. Di Gravio ◽

Pencilla Lang ◽

Hugh Andrew Jinwook Kim ◽

Tricia Chinnery ◽

Neil Mundi ◽

...

Keyword(s):

Robotic Surgery ◽

Oropharyngeal Cancer ◽

Early Stage ◽

Tertiary Care ◽

Feeding Tube ◽

The United States ◽

Transoral Robotic Surgery ◽

Transoral Surgery ◽

Severe Toxicity ◽

T Stage

Abstract Background Transoral surgery (TOS), particularly transoral robotic surgery (TORS) has become the preferred modality in the United States for the treatment of early stage oropharyngeal cancer, largely due to assumptions of fewer toxicities and improved quality of life compared to primary radiotherapy (RT). However, these assumptions are based on retrospective analysis, a subset of which utilize primary RT groups not limited to T1-2 stage tumors for which transoral robotic surgery is FDA approved. Thus, there is potential for underestimating survival and overestimating toxicity, including treatment related mortality, in primary RT. Methods Consecutive cases of early T-stage (T1–T2) oropharyngeal cancer presenting to the London Health Sciences Centre between 2014 and 2018 treated with RT or chemoradiation (CRT) were reviewed. Patient demographics, treatment details, survival outcomes and toxicity were collected. Toxicities were retrospectively graded using the Common Terminology Criteria for Adverse Events criteria. Results A total of 198 patients were identified, of which 82% were male and 73% were HPV-positive. Sixty-eight percent of patients experienced a grade 2 toxicity, 48% a grade 3 and 4% a grade 4. The most frequent toxicities were dysphagia, neutropenia and ototoxicity. The rates of gastrostomy tube dependence at 1 and 2 years were 2.5% and 1% respectively. There were no grade 5 (fatal) toxicities. HPV-positive patients experienced improved 5-year overall survival (86% vs 64%, p = 0.0026). Conclusions Primary RT or CRT provides outstanding survival for early T-stage disease, with low rates of severe toxicity and feeding tube dependence. This study provides a reference for comparison for patients treated with primary transoral surgery.

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Cost-Effectiveness of Radiation Therapy Versus Transoral Robotic Surgery for Early-Stage Oropharyngeal Squamous Cell Carcinoma

International Journal of Radiation Oncology*Biology*Physics ◽

10.1016/j.ijrobp.2015.07.223 ◽

2015 ◽

Vol 93 (3) ◽

pp. S93

Author(s):

D. Rodin ◽

L. Caulley ◽

E. Burger ◽

J. Kim ◽

D.A. Palma ◽

...

Keyword(s):

Squamous Cell Carcinoma ◽

Radiation Therapy ◽

Cost Effectiveness ◽

Robotic Surgery ◽

Cell Carcinoma ◽

Squamous Cell ◽

Early Stage ◽

Transoral Robotic Surgery ◽

Oropharyngeal Squamous Cell Carcinoma

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Functional Outcomes after Transoral Robotic Surgery for Head and Neck Cancer

Otolaryngology ◽

10.1016/j.otohns.2009.05.014 ◽

2009 ◽

Vol 141 (2) ◽

pp. 166-171 ◽

Cited By ~ 146

Author(s):

Tim A. Iseli ◽

Brian D. Kulbersh ◽

Claire E. Iseli ◽

William R. Carroll ◽

Eben L. Rosenthal ◽

...

Keyword(s):

Head And Neck Cancer ◽

Robotic Surgery ◽

Head And Neck ◽

Neck Cancer ◽

Functional Outcomes ◽

Case Series ◽

Feeding Tube ◽

Transoral Robotic Surgery ◽

T Stage ◽

Increased Risk

OBJECTIVE: To evaluate functional outcomes following transoral robotic surgery for head and neck cancer. STUDY DESIGN: Case series with planned data collection. SETTING: Academic hospital. SUBJECTS AND METHODS: Between March 2007 and December 2008, 54 of 62 candidate patients underwent transoral robotic tumor resection. Outcomes include airway management, swallowing (MD Anderson Dysphagia Inventory), and enterogastric feeding. RESULTS: Tumors were most commonly oropharynx (61%) or larynx (22%) and T1 (35%) or T2 (44%). Many received radiotherapy (22% preoperatively, 41% postoperatively) and chemotherapy (31%). Endotracheal intubation was retained (22%) for up to 48 hours, tracheostomy less frequently (9%), and all were decannulated by 14 days. Most commenced oral intake prior to discharge (69%) or within two weeks (83%). A worse postoperative Dysphagia Inventory score was associated with retained feeding tube ( P = 0.020), age >60 ( P = 0.017), higher T stage ( P = 0.009), laryngeal site ( P = 0.017), and complications ( P = 0.035). At a mean 12 months' follow-up, 17 percent retained a feeding tube (9.5% among primary cases). Retained feeding tube was associated with preoperative tube requirement ( P = 0.017), higher T stage ( P = 0.043), oropharyngeal/laryngeal site ( P = 0.034), and recurrent/second primary tumor ( P = 0.008). Complications including airway edema (9%), aspiration (6%), bleeding (6%), and salivary fistula (2%) were managed without major sequelae. CONCLUSION: Transoral robotic surgery provides an emerging alternative for selected primary and salvage head and neck tumors with low morbidity and acceptable functional outcomes. Patients with advanced T stage, laryngeal or oropharyngeal site, and preoperative enterogastric feeding may be at increased risk of enterogastric feeding and poor swallowing outcomes.

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Perioperative Mortality Risk in Patients Undergoing Transoral Robotic Surgery for T1-T2 Oropharyngeal Squamous Cell Carcinoma: A National Cancer Database Study

Frontiers in Oncology ◽

10.3389/fonc.2021.808465 ◽

2022 ◽

Vol 11 ◽

Author(s):

Joel C. Davies ◽

Zain Husain ◽

Terry A. Day ◽

Evan M. Graboyes ◽

Antoine Eskander

Keyword(s):

Squamous Cell Carcinoma ◽

Surgical Treatment ◽

Robotic Surgery ◽

Early Stage ◽

Transoral Robotic Surgery ◽

National Cancer Database ◽

Univariable Analysis ◽

Perioperative Mortality ◽

Risk Of Mortality ◽

American College Of Surgeons

The National Cancer Database is a joint project of the Commission on Cancer of the American College of Surgeons and the American Cancer Society. The American College of Surgeons and the Commission on Cancer have not verified and are not responsible for the analytic or statistical methods used or for the conclusions drawn from these data by the investigators.IntroductionTransoral robotic surgery (TORS) is well established as initial definitive treatment for early-stage oropharyngeal squamous cell carcinoma (OPSCC) as an alternative to radiation therapy with similar survival rates. While proponents of TORS focus on the reduced morbidity of treatment compared to open procedures, shortened hospital admissions and equivalent survival outcomes to non-surgical treatment, there remain concerns over the risk of mortality within the acute perioperative period. Therefore, we sought to determine the 30-day and 90-day perioperative mortality risk using the National Cancer Database.MethodsA retrospective cohort analysis was performed for patients diagnosed with pathologic T1/2 OPSCC between January 1, 2010, and December 31, 2016 that underwent primary surgical treatment with TORS and was not restricted by HPV status. The primary outcome was 30-day perioperative mortality. The secondary outcome was 90-day perioperative mortality. Univariable analysis was used to identify variables associated with 30-day perioperative mortality.ResultsIn total, 4,127 patients (mean [SD; range] age, 59 [9.5; 22-90] years; 3,476 [84%] men and 651 [16%] women) met inclusion criteria. The number of patients with pT1-2 OPSCC undergoing TORS increased three-fold between 2010 (279/4,127; 7%) to 2016 (852/4,127; 21%). The overall 30-day and 90-day perioperative mortality rate for TORS during the study period was 0.6% (23/4,127) and 0.9% (38/4,127), respectively. On univariable analysis (UVA), age≥65 was the only predictor of 30-day perioperative mortality (OR 3.41; 95% CI 1.49-7.81).ConclusionThe overall risk of all cause mortality following TORS for early-stage OPSCC remains low. The risk of mortality is higher in elderly patients and should be considered, in addition to previously established risk factors, during patient selection and counselling.

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Transoral Robotic Surgery for Cancer of the Soft Palate Posterior Surface

Ear Nose & Throat Journal ◽

10.1177/0145561320977463 ◽

2020 ◽

pp. 014556132097746

Author(s):

Emilien Chebib ◽

Jérôme R. Lechien ◽

Younes Chekkoury ◽

Stéphane Hans

Keyword(s):

Squamous Cell Carcinoma ◽

Surgical Treatment ◽

Robotic Surgery ◽

Soft Palate ◽

Functional Outcomes ◽

Early Stage ◽

Tumor Resection ◽

Transoral Robotic Surgery ◽

Posterior Surface ◽

Papilloma Virus

The surgical treatment of oropharyngeal squamous cell carcinoma (OSCC) has undergone a considerable evolution, with, among others, transoral robotic surgery (TORS). However, TORS is rarely used for the surgery of soft palate. A 73-year-old man presented a human papilloma virus OSCC of the posterior soft palate. The tumor was resected using TORS. This report describes the surgical technique step by step of the tumor resection. The resection of early stage OSCC of the posterior surface of soft palate is possible through TORS. The procedure is noninvasive, rapid, and seems to be associated with excellent functional outcomes.

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