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Published on June 4, 2020 by Natalie Silver

AHNS Basic Science/Translational Newsletter Vol 3

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

Anthony C Nichols, Julie Theurer, Eitan Prisman, Nancy Read, Eric Berthelet….David A Palma

From Clinical Trial. The Lancet. Oncology, October 2019; 20(10):1349-1359.

Article Review by Natalie Silver, MD

Background/Hypothesis:

Design: Investigator-initiated, multicenter, international, open label, parallel-group, phase 2, randomized clinical trial comparing T1-T2, N0-2 OPSCC patients randomized to either primary radiotherapy (70Gy, chemotherapy if N1-N2) or TORS plus neck dissection (with/without pathologic based adjuvant chemo/radiotherapy). The primary endpoint was swallowing-related QOL at 1 year as established by the MD Anderson Dysphagia Inventory (MDADI) score, powered to detect a 10 point improvement (a clinically meaningful change).

Summary of results: 68 patients (34 per group) were randomized over a 5 year period (following stratification by p16 status). MDADI total scores at 1 year were: mean 86.9 (SD 11.4) in the radiotherapy (RT) group and 80.1 (SD 13.0) in the TORS plus neck dissection group (p=0.042), which did not meet the prescribed threshold (10 points) for a clinically meaningful difference. Toxicity patterns differed between the two groups with neutropenia, hearing loss and tinnitus being more common in the in the RT group and more cases of trismus in the TORS plus neck dissection group. The most common adverse events in the RT group were dysphagia (n=6), hearing loss (n-6), and mucositis (n=4) and in the TORS plus neck dissection group, dysphagia was the most common adverse event (n=9) and there was one patient death caused by bleeding after TORS. Oncologic outcomes were similar in both groups.

Strengths:

  • Well-designed, prospective randomized clinical trial..
  • Highest level of evidence for a clinical study (Level I evidence).
  • Multi-institutional and international trial.which was not measured in this study.
  • MDADI is a commonly used and validated swallowing QOL assessment tool.

 Weaknesses

  • Modest sample size and was not powered to compare survival outcomes.
  • Institutional differences in criteria for administration of adjuvant therapy may be confounding.
  • Radiotherapy has late side effects, specifically with respect to dysphagia and the swallowing QOL scores may worsen more considerably in the radiotherapy group >1 year after treatment,  which was not measured in this study.

Key Points:

  • While this study did not show clinically meaningful differences in swallowing QOL scores at 1 year, this is the only prospective randomized controlled clinical trial published, to date, to address this concern.
  • Tese findings conflict with previous non-randomized comparisons of radiotherapy with TORS which have found that both modalities achieved similar oncologic outcomes, but that functional outcomes appeared better with TORS (Yeh et al, systematic review 2015).
  • Much of the QOL data (not only swallowing data) in this study favored radiotherapy. The surgical group had a clinically meaningful decline in scores for “Global” (p=0.024) and “Emotional” (p=0.021) subscales. These differences (when compared to retrospective studies) may be due to bias in the retrospective reviews that included advanced T –stage patients not amenable to TORS, or early studies prior to IMRT.
  • In a multidisciplinary setting, it is important for clinicians to understand and counsel our patients in both surgical and non-surgical treatment options, since there are differences in risks and toxicity patterns for the two treatment modalities. Studies, like ORATOR, may be used as a guide, but additional clinical research is needed and discussions about treatment options should be personalized to each individual patient and institution.
  • The results from several more clinical trials will provide high quality evidence for outstanding questions that can help guide us to tailor treatment for OPSCC patients, these include; the QoLATI trial (with similar cohorts and endpoints to ORATOR), ECOG 3311 (NCT01898494) and the ORATOR2 trial (NCT03210103).

From the Basic Science/Translational Service
Jeffrey C. Liu MD Vice Chair
Richard Wong MD Chair

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Natalie Silver

Natalie Silver

Natalie Silver MD, MS, FACS is an Assistant Professor in the Department of Otolaryngology, Head and Neck Surgery, Division of Surgical Oncology, at the University of Florida. She is the UFHealth Cancer Center Head and Neck Cancer Disease Site Group Research Leader. Dr. Silver has an active clinical practice treating head and neck cancer patients. She is also PI of a translational research lab focused on developing therapeutic oral cancer vaccines and investigating the role of the microbiome in the development and progression of oral cancer.
Natalie Silver

Latest posts by Natalie Silver (see all)

  • AHNS Basic Science/Translational Newsletter Vol 3 - June 4, 2020

 

 

Published on June 3, 2020 by Cherie-Ann Nathan

AHNS Endorses ACS Statement on Recent Violence and Protests

Dear AHNS Member,

The American Head and Neck Society (AHNS) strongly endorses the below statement from the American Colleges of Surgeons (ACS) regarding the recent violence and protests. Please join us in supporting the ACS and please stay safe and well. Thank you.

Cherie-Ann Nathan, MD
AHNS President

 

American College of Surgeons Response To Recent Violence and Protests

Recent events across the country have significantly impacted us all, particularly Fellows who are members of Black and Brown communities.

The ACS stands in solidarity against racism, violence, and intolerance. Our mission is to serve all with skill and fidelity, and that extends beyond the operating room.

Racism, brutal attacks, and subsequent violence must end. We will help any injured, and we will use our voice in support of the health and safety of every person.

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Cherie-Ann Nathan

Cherie-Ann Nathan

Dr. Cherie-Ann Nathan is a leading head and neck cancer surgeon. She is Prof. & Chair of the Dept. of Oto/HNS &the Director of Head and Neck Surgical Oncology and Cancer Research, Feist-Weiller Cancer Center Louisiana State University Health - Shreveport (LSU Health Shreveport). The National Cancer Institute has funded her translational research since 2000 and her focus is on targeted therapy for head and neck patients. Dr. Nathan is recognized nationally and internationally for her seminal work on molecular analysis of surgical margins. She has pioneered multi-institutional clinical trials using mTOR inhibitors in HNSCC patients. She has also received NIH funding for chemoprevention of cancer with curcumin and has a patent for a curcumin chewing gum. More recently she also received an NCI grant on cutaneous Squamous cell cancer.  She serves on the NCI head and neck steering committee and the American Cancer Society HPV steering committee. Dr. Nathan has published extensively, has over 180 publications in peer-reviewed journals, and has authored multiple textbooks and encyclopedia chapters. She is married to Dr. Raghu Nathan, a pulmonary and critical eye care specialist with whom she has two boys.
Cherie-Ann Nathan

Latest posts by Cherie-Ann Nathan (see all)

  • AHNS Leadership - July 24, 2020
  • AHNS Endorses ACS Statement on Recent Violence and Protests - June 3, 2020
  • New AHNS COVID-19 Offering on AHNS Web Site - May 7, 2020

Published on May 7, 2020 by Cherie-Ann Nathan

New AHNS COVID-19 Offering on AHNS Web Site

Dear AHNS Members,

The AHNS Education Division has helped create a valuable resource for our members to connect during the pandemic. The AHNS COVID-19 Forum can be accessed through your member account on the AHNS Web Site. Just log onto your account through www.ahns.info and go to the member dashboard to access the AHNS COVID-19 Forum. This was established as a quick way for our members to post questions, comments and suggestions in relation to the COVID-19 pandemic. This forum is only accessible to AHNS members. Posting in any forum subscribes you to that topic and you will receive email notifications of future posts. You may also subscribe to any topic or entire forums by locating the subscribe link.  Clicking your name on any forum page will allow you to modify your personal settings for the forum system. Please note that the views and comments expressed on the forum are views and opinions of those posting and not official AHNS viewpoints.

Please also visit the AHNS COVID-19 Bulletin Board, which serves as a platform on our website where members can share vetted information relevant to dealing with the COVID-19 pandemic. Please visit https://www.ahns.info/covid-19-info/ to view the bulletin board and also submit information. New information has been posted weekly.

And don’t forget to view one of the pieces that was added to the Bulletin Board, the AHNS COVID-19 Practice Patterns.  A direct link can be found here:

https://www.ahns.info/covid-19-info/covid_pp_spreadsheet/

This document is created by a set of head and neck surgeons who will post regular and ‘real-time’ updates about practice patterns, policy changes, and patient care considerations. These will be updated on a weekly basis at minimum, and more frequently if policies and patterns are changing more rapidly.

In addition, aggregate information previously collected from other institutions will be available to view.

We welcome your contributions. We are actively looking for contributors, as well as ideas for additional questions our institutions can help answer. New questions will be added and answered as soon as possible.

Please send any interest or correspondence regarding AHNS COVID-19 Practice Patterns to
[email protected]. 

I continue to be amazed at the great work our members are producing during this difficult time.
Thank you, again, for your service to the society and our specialty!

Cherie-Ann Nathan, MD
AHNS President

  • Bio
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Cherie-Ann Nathan

Cherie-Ann Nathan

Dr. Cherie-Ann Nathan is a leading head and neck cancer surgeon. She is Prof. & Chair of the Dept. of Oto/HNS &the Director of Head and Neck Surgical Oncology and Cancer Research, Feist-Weiller Cancer Center Louisiana State University Health - Shreveport (LSU Health Shreveport). The National Cancer Institute has funded her translational research since 2000 and her focus is on targeted therapy for head and neck patients. Dr. Nathan is recognized nationally and internationally for her seminal work on molecular analysis of surgical margins. She has pioneered multi-institutional clinical trials using mTOR inhibitors in HNSCC patients. She has also received NIH funding for chemoprevention of cancer with curcumin and has a patent for a curcumin chewing gum. More recently she also received an NCI grant on cutaneous Squamous cell cancer.  She serves on the NCI head and neck steering committee and the American Cancer Society HPV steering committee. Dr. Nathan has published extensively, has over 180 publications in peer-reviewed journals, and has authored multiple textbooks and encyclopedia chapters. She is married to Dr. Raghu Nathan, a pulmonary and critical eye care specialist with whom she has two boys.
Cherie-Ann Nathan

Latest posts by Cherie-Ann Nathan (see all)

  • AHNS Leadership - July 24, 2020
  • AHNS Endorses ACS Statement on Recent Violence and Protests - June 3, 2020
  • New AHNS COVID-19 Offering on AHNS Web Site - May 7, 2020

Published on May 4, 2020 by AHNS Office

AHNS Journal Club – May 2020

Volume 31a – May, 2020

The AHNS Journal Club reviews the leading head and neck cancer-related journals, sharing with AHNS members some of the most relevant and important manuscripts, and providing summaries and critiques of the work.

The Journal Club members are: Samer Al-Khudari, MD; Daniel Brickman, MD; Nathan Hales, MD FACS; Jason Kass, MD PhD; Luiz Kowalski, MD PhD; Vikas Mehta, MD MPH FACS; Alirio Mijares Brinez, MD; Alvaro Sanabria, PhD; Mark Varvares, MD; Vivian Wu, MD MPH.

CLICK THE ARTICLES BELOW TO ACCESS THE CURRENT ISSUE

Investigating the Effect of Thyroid Nodule Location on the Risk of Thyroid Cancer
Sina Jasim, Thomas J. Baranski, Sharlene A. Teefey, and William D. Middleton.
from Thyroid, March 2020
****************************************
Comorbidity in head and neck cancer: Is it associated with therapeutic delay, post-treatment mortality and survival in a population-based study?
Sabine Stordeur, Viki Schillemans, Isabelle Savoye, Katrijn Vanschoenbeek, Roos Leroy, Gilles Macq, Leen Verleye, Cindy De Gendt, Sandra Nuyts, Jan Vermorken, Claire Beguin, Vincent Grégoire, Liesbet Van EyckenC
From Oral Oncology, January 2020
****************************************
Impact of routine surveillance imaging on detecting recurrence in human papillomavirus associated oropharyngeal cancer
Joycelin F. Canavan, Bridgett A. Harr, Joanna W. Bodmann, Chandana A. Reddy, Jodi R. Ferrini, Denise I. Ives, Deborah J Chute, Christopher W. Fleming, Neil M. Woody, Jessica L. Geiger, Nikhil P. Joshi, Shlomo A. Koyfman, David J. Adelstein
From Oral Oncology, April 2020
****************************************
Sentinel Lymph Node Biopsy for High-Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck
Wu, M; Sethi, R.; Emerick, K., 2019; 130: 108-114.
From Laryngoscope, January 2020
****************************************
Risk and Rate of Occult Contralateral Nodal Disease in Surgically Treated Patients with Human Papillomavirus-Related Squamous Cell Carcinoma of the Base of the Tongue
Aisling S Last, Patrik Pipkorn, Stephanie Chen, Dorina Kallogjeri, Joseph Zenga, Jason T Rich, Randal Paniello, Jose Zevallos, Rebecca Chernock, Douglas Adkins, Peter Oppelt, Hiram Gay, Mackenzie Daly, Wade Thorstad, Ryan S Jackson
From JAMA Otolaryngology Head & Neck Surgery, November 2019

Published on April 30, 2020 by Wenhua (Diane) Chen

Screening Program for Veterans with HNSCC & HCV – a 2019 AHNS Community Service Award Project

Each year the AHNS Cancer Prevention Service awards Community Service Awards to individuals, departments, organizations or institutions in support of patient and community-oriented projects targeting head & neck cancer awareness and prevention. Drs. Vlad Sandulache and Diane Chen were recipients of this grant in 2019…

There are approximately 3 million people in the U.S. living with hepatitis C (HCV), with 16,000 new cases diagnosed annually. Because patients with HCV demonstrate an increased risk of hepatocellular carcinoma and other malignancies, and since HCV is now often a curable disease, screening for HCV is a US Preventative Services Task Force recommendation. Head and neck squamous cell carcinoma (HNSCC) remains a deadly malignancy, now manifesting an increased incidence secondary to the human papillomavirus (HPV). HNSCC incidence has been shown to correlate with HCV and dually exposed patients generally demonstrate poor survival overall.

Veterans have a disproportionately higher rate of HCV compared to the general population and also a higher risk of HNSCC in part due to increased tobacco consumption, and in part due to higher rates of HPV- associated HNSCC. Based on these data we instituted a cross-educational and screening program for Veterans with HNSCC and HCV at the Michael E. DeBakey Veterans Affairs Medical Center in Houston, Texas. Over the course of 18 months, we instituted an HCV screening program for Veterans with a new diagnosis of HNSCC; HCV screening was incorporated into our multi-disciplinary pre-treatment staging and counseling process. A total of 210 patients underwent screening as part of this effort. Following the introduction of HCV screening for patients with a new diagnosis of HNSCC, we extended the screening program to patients enrolled in the HNSCC Surveillance Clinic (treatment completion — 5 years post-treatment) and the HNSCC Survivorship Clinic (>5 years post-treatment). Currently, this has resulted in a robust screening program accompanied by counseling and education for Veterans with HNSCC regarding risk factors for HCV, basic pathophysiology of the disease and available treatment options. We are currently analyzing the data from the screening program to calculate the number of previously unknown HCV cases which were detected solely as a result of our screening, in order to determine whether this represents a sustainable, cost-effective activity.

Whereas screening HNSCC patients for HCV proved fairly easy to integrate into the normal work-flow associated with HNSCC care, screening and educational activities targeting HNSCC in the general Veteran population have proven somewhat more challenging. Multiple efforts in several countries and different health care delivery systems have failed to identify effective, cost-efficient HNSCC screening strategies, in large part due to the relatively low frequency of the disease in the general population. Given the relatively higher prevalence of HNSCC in the Veteran population, and particularly the Veteran population with HCV, we have instituted an educational program for both Veterans and PrimeCare providers as a first step toward instituting an in-person screening program for HNSCC. We are currently in the process of implementing an intermediate step in this transition, by leveraging the increased telemedicine capabilities of the institution in order to maximize patient outreach without generating unsustainable levels of clinical effort for the providers.

Together, it is our expectation that the cross-educational and screening activities
implemented over the last 18 months will decrease unnecessary morbidity and mortality associated with undetected HCV and HNSCC in the Veteran population.

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Wenhua (Diane) Chen

Wenhua (Diane) Chen

Diane Chen MD is a 5th  year resident at Baylor College of Medicine and hails from Dallas, TX. She will be pursuing her fellowship in Head & Neck Surgery at Indiana University School of Medicine starting July 2020.
Wenhua (Diane) Chen

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  • Screening Program for Veterans with HNSCC & HCV – a 2019 AHNS Community Service Award Project - April 30, 2020
  • Bio
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Vlad Sandulache

Vlad Sandulache

Vlad C. Sandulache MD PhD is a surgeon-scientist with a clinical practice focused on high-risk squamous cell carcinoma at Baylor College of Medicine and the Michael E. DeBakey Veterans Affairs Medical Center. His laboratory is focused on understanding metabolic reprogramming associated with development of treatment resistance.
Vlad Sandulache

Latest posts by Vlad Sandulache (see all)

  • Screening Program for Veterans with HNSCC & HCV – a 2019 AHNS Community Service Award Project - April 30, 2020
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