Literature DB >> 34995124

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

Anthony C Nichols1, Julie Theurer2, Eitan Prisman3, Nancy Read4, Eric Berthelet5, Eric Tran5, Kevin Fung1, John R de Almeida6, Andrew Bayley7, David P Goldstein6, Michael Hier8, Khalil Sultanem9, Keith Richardson8, Alex Mlynarek8, Suren Krishnan10, Hien Le11, John Yoo1, S Danielle MacNeil1, Eric Winquist12, J Alex Hammond4, Varagur Venkatesan4, Sara Kuruvilla12, Andrew Warner4, Sylvia Mitchell4, Jeff Chen4, Martin Corsten13, Stephanie Johnson-Obaseki13, Michael Odell13, Christina Parker14, Bret Wehrli15, Keith Kwan15, David A Palma4.   

Abstract

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).

Entities:  

Mesh:

Year:  2022        PMID: 34995124     DOI: 10.1200/JCO.21.01961

Source DB:  PubMed          Journal:  J Clin Oncol        ISSN: 0732-183X            Impact factor:   44.544


  7 in total

1.  [ORATOR2 trial: randomized comparison of primary surgery vs. primary radiotherapy for HPV-associated oropharyngeal cancer in the context of de-escalated therapy].

Authors:  Alexander Fabian; Nils H Nicolay; David Krug
Journal:  Strahlenther Onkol       Date:  2022-08-01       Impact factor: 4.033

2.  [The ORATOR trials-an update : Primary surgery or radiotherapy for HPV-associated oropharyngeal cancer].

Authors:  Thomas K Hoffmann
Journal:  HNO       Date:  2022-06-21       Impact factor: 1.330

Review 3.  De-Escalation Strategies for Human Papillomavirus-Associated Oropharyngeal Squamous Cell Carcinoma-Where Are We Now?

Authors:  Jennifer A Silver; Sena Turkdogan; Catherine F Roy; Thavakumar Subramaniam; Melissa Henry; Nader Sadeghi
Journal:  Curr Oncol       Date:  2022-05-18       Impact factor: 3.109

4.  The effect of human papillomavirus status on prognosis and local treatment strategies of T1-2N0 oropharyngeal squamous cell cancer.

Authors:  Ping Zhou; Deng-Lin Chen; Chen-Lu Lian; San-Gang Wu; Shi-Yang Zhang
Journal:  Front Public Health       Date:  2022-07-25

Review 5.  Current indications and patient selection for transoral robotic surgery in head and neck cancer - a brief review.

Authors:  Patryk Niewinski; Wojciech Jerzy Golusiński
Journal:  Contemp Oncol (Pozn)       Date:  2022-07-08

6.  The Sinai Robotic Surgery Trial in HPV-related oropharyngeal squamous cell carcinoma (SIRS 2.0 trial) - study protocol for a phase II non-randomized non-inferiority trial.

Authors:  Raymond L Chai; Rocco M Ferrandino; Christine Barron; Kianoush Donboli; Scott A Roof; Mohemmed N Khan; Marita S Teng; Marshall R Posner; Richard L Bakst; Eric M Genden
Journal:  Front Oncol       Date:  2022-08-25       Impact factor: 5.738

7.  18F-Fluorodeoxyglucose Positron Emission Tomography of Head and Neck Cancer: Location and HPV Specific Parameters for Potential Treatment Individualization.

Authors:  Sebastian Zschaeck; Julian Weingärtner; Elia Lombardo; Sebastian Marschner; Marina Hajiyianni; Marcus Beck; Daniel Zips; Yimin Li; Qin Lin; Holger Amthauer; Esther G C Troost; Jörg van den Hoff; Volker Budach; Jörg Kotzerke; Konstantinos Ferentinos; Efstratios Karagiannis; David Kaul; Vincent Gregoire; Adrien Holzgreve; Nathalie L Albert; Pavel Nikulin; Michael Bachmann; Klaus Kopka; Mechthild Krause; Michael Baumann; Joanna Kazmierska; Paulina Cegla; Witold Cholewinski; Iosif Strouthos; Klaus Zöphel; Ewa Majchrzak; Guillaume Landry; Claus Belka; Carmen Stromberger; Frank Hofheinz
Journal:  Front Oncol       Date:  2022-06-08       Impact factor: 5.738

  7 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.