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\begin{document}

\title{Penn Medicine Head and Neck Cancer Service Line COVID-19
Management Guidelines}



\author[1]{Gregory S. Weinstein, M.D.}%
\affil[1]{University of Pennsylvania}%


\vspace{-1em}



  
  \date{March 14, 2025}


\begingroup
\let\center\flushleft
\let\endcenter\endflushleft
\maketitle
\endgroup





\selectlanguage{english}
\begin{abstract}
Introduction: The COVID-19 pandemic caused by the SARS-CoV-2 virus has
altered the healthcare environment for the management of head and neck
cancers. ~The purpose of these guidelines is to provide direction during
the pandemic for rational Head and Neck Cancer management in order to
achieve a medically and ethically appropriate balance of risks and
benefits.

Methods: Creation of consensus document.

Results: The process yielded a consensus statement among a wide range of
practitioners involved in the management of head and neck cancer
patients in a multi-hospital tertiary care health system.~

Conclusions: These guidelines support an ethical approach for the
management of head and neck cancers during the COVID-19 epidemic
consistent with both the local standard of care as well as the head and
neck oncological literature.~%
\end{abstract}%



\sloppy


\subsection*{\texorpdfstring{Gregory S. Weinstein, MD\textsuperscript{1},
Roger Cohen, MD\textsuperscript{2}, Alexander Lin,
MD\textsuperscript{3}, ~Bert W. O'Malley, Jr, MD\textsuperscript{1},
John Lukens, MD\textsuperscript{3}, Samuel Swisher-McClure,
MD\textsuperscript{3},~ Rabie M. Shanti, DMD, MD\textsuperscript{1,4},
Jason G. Newman, MD\textsuperscript{1} Harman S. Parhar, MD,
MPH\textsuperscript{1}, Kendall Tasche, MD\textsuperscript{1}, Robert M.
Brody, MD\textsuperscript{1}, Ara Chalian, MD \textsuperscript{1},
Steven Cannady, MD\textsuperscript{1}, James N. Palmer,
MD\textsuperscript{1}, Nithin D. Adappa, MD\textsuperscript{1}, Michael
A. Kohanski, MD\textsuperscript{1}, Joshua Bauml, MD\textsuperscript{2},
Charu Aggrawal, MD\textsuperscript{2}, Kathleen Montone,
MD\textsuperscript{5}, Virginia Livolsi, MD\textsuperscript{5}, Zubair
W. Baloch, MD, PhD\textsuperscript{5} , Jalal B Jalaly, MBBS,
MS\textsuperscript{5}, Kumarasen Cooper, MBChB, DPhil, FRCPath, Karthik
Rajaskeran, MD\textsuperscript{1} Laurie Loevner, MD\textsuperscript{6},
Christopher Rassekh,
MD\textsuperscript{1}}{Gregory S. Weinstein, MD1, Roger Cohen, MD2, Alexander Lin, MD3, ~Bert W. O'Malley, Jr, MD1, John Lukens, MD3, Samuel Swisher-McClure, MD3,~ Rabie M. Shanti, DMD, MD1,4, Jason G. Newman, MD1 Harman S. Parhar, MD, MPH1, Kendall Tasche, MD1, Robert M. Brody, MD1, Ara Chalian, MD 1, Steven Cannady, MD1, James N. Palmer, MD1, Nithin D. Adappa, MD1, Michael A. Kohanski, MD1, Joshua Bauml, MD2, Charu Aggrawal, MD2, Kathleen Montone, MD5, Virginia Livolsi, MD5, Zubair W. Baloch, MD, PhD5 , Jalal B Jalaly, MBBS, MS5, Kumarasen Cooper, MBChB, DPhil, FRCPath, Karthik Rajaskeran, MD1 Laurie Loevner, MD6, Christopher Rassekh, MD1}}

{\label{330350}}\par\null

1. Department of Otorhinolaryngology -- Head \& Neck Surgery, University
of Pennsylvania, Philadelphia, PA

2. Division of Medical Oncology, Department of Medicine, University of
Pennsylvania, Philadelphia, PA

3. Department of Radiation Oncology, University of Pennsylvania,
Philadelphia, PA

4. Department of Oral and Maxillofacial Surgery, University of
Pennsylvania, Philadelphia, PA

5. Department of Pathology, University of Pennsylvania, Philadelphia, PA

~

Corresponding Author

Gregory S. Weinstein, M.D.

Professor and Vice Chair

Department of Otorhinolaryngology -- Head \& Neck Surgery, University of
Pennsylvania

Director, PENN Center for Head and Neck Cancer

Director, Penn Medicine Head and Neck Cancer Service Line{}

3400 Spruce Street, 5 Ravdin, Philadelphia, PA, 19104 {}

E-mail: {gregory.weinstein@uphs.upenn.edu} {}

~

Disclosures{}

This work has never been published or presented anywhere. The authors
have no financial or industry relationships to disclose. There are no
sources of funding to disclose.

~

Running Title{}

Management Guidelines -- COVID 19 Head and Neck Cancer

~

Keywords{}

SARS-CoV-2, COVID-19, Coronavirus, Head and Neck Cancer

~

Abstract

\emph{Introduction:} The COVID-19 pandemic caused by the SARS-CoV-2
virus has altered the healthcare environment for the management of head
and neck cancers. ~The purpose of these guidelines is to provide
direction during the pandemic for rational Head and Neck Cancer
management in order to achieve a medically and ethically appropriate
balance of risks and benefits.{}

~

\emph{Methods:} Creation of consensus document.

~

\emph{Results:} The process yielded a consensus statement among a wide
range of practitioners involved in the management of head and neck
cancer patients in a multi-hospital tertiary care health system.~

~

\emph{Conclusions:} These guidelines support an ethical approach for the
management of head and neck cancers during the COVID-19 epidemic
consistent with both the local standard of care as well as the head and
neck oncological literature.~

\par\null

\emph{Introduction}

The individual cancer service lines at the Abramson Cancer Center at
Penn Medicine were delegated the responsibility of creating treatment
guidelines for the entire health system during the COVID-19 pandemic.
The purpose of these guidelines is to provide direction during the
pandemic for rational Head and Neck Cancer management and achieve a
medically and ethically appropriate balance of risks and benefits. Our
goal in sharing the guidelines are three-fold. First, it may be useful
to share the process of developing the guidelines and achieving
consensus in a multi-hospital tertiary care system. Second, we would
like to share our fundamental principles governing the guideline
development process. Lastly, the guidelines themselves may be useful for
Head and Neck Oncology services at other institutions to consider as
they develop their own approaches.

\emph{Methods}

A core committee was created by the Director of the Head and Neck Cancer
Service Line (GSW) including senior leadership from the surgical,
medical oncology and radiation oncology services. The first draft was
created by the core committee. All physicians and critical ancillary
staff were sent a copy of the first draft of the guidelines via email
and asked to review the document and make changes in track changes mode.
In order to ensure an orderly process, the document was initially sent
``Bcc'' to the group to expedite individual responses that would then be
trackable and avoid the ensuing cross chatter that occurs in groups when
documents such as this are sent ``Cc'' and individuals send their
response ``Reply to All''. The entire group was assured that every
recommended change would be reviewed by the core committee and their
changes would either be adopted and if not there would be an explanation
from the Director of the Head and Neck Service Line as to why their
change was not included. This process allowed for an effective,
efficient and timely turnaround in the development algorithm that was
inclusive to all stakeholders.

\textbf{Fundamental Principles Governing the Development of these
Recommendations}

\begin{enumerate}
\tightlist
\item
  Alignment to the extent possible with our established
  multi-disciplinary practice approaches.
\item
  Adhere to the standard of care, and when this is not possible given
  the current health crisis, then supported to the extent possible by
  the existing medical literature.
\item
  Favor modalities and approaches that minimize the number of visits to
  PENN Medicine, while not compromising the opportunity for cure.
\item
  Favor modalities that minimize immune compromise during and after
  treatment.
\item
  Compliance with the evolving Center for Medicare Services (CMS)
  recommendations on medical and surgical triage during the COVID-19
  pandemic.\textsuperscript{1}
\item
  Avoid surgical treatment if patient is immunocompromised unless the
  risk of the cancer progressing outweighs the risk posed by their
  immunocompromised state.\textsuperscript{2}
\item
  COVID 19 Thyroid Cancer Guidelines as well Skin Cancer Guidelines were
  created by separate respective Cancer Service Line and are not
  included in the Head and Neck Cancer COVID 19 guidelines reported
  herein.
\item
  COVID-19 Testing Principles for Patients with Head and Neck Tumors
\item
  All patients should undergo standard COVID-19 history taking by team
  members for possible active infection or exposure and referred for
  testing per hospital guidelines. The COVID -9 history should be taken
  at the time of the initial encounter and again the day before
  treatment begins and on the day of treatment.
\item
  Depending on availability, SARS-CoV-2 testing should be done
  preoperatively and prior to chemotherapy or radiation. It is
  recommended that this testing be done within 24 hours of starting
  cancer treatment during the surge and apogee of the COVID-19 curve and
  72 hours prior to treatment initiation later in the disease pandemic
  curve.
\item
  Patients that have tested positive for SARS-CoV-2 or are a Patient
  Under Investigation (PUI) should, in general, have all treatment
  deferred until the patient is no longer ill or contagious confirmed by
  two negative tests a
\item
  Some patients that have tested positive for SARS-CoV-2 or are a PUI
  may start/continue radiation treatment; this recommendation is
  modality specific and has been defined in the general workflow created
  by the Department of Radiation Oncology for patients undergoing
  radiation therapy during the COVID-19 pandemic.
\item
  For patients who are COVID-19 positive, PUI or unable to determine and
  present with acute emergencies in need of immediate surgical
  intervention (e.g., bleeding or airway emergencies), the surgical team
  should don appropriate Personal Protective Equipment, which in our
  institution is an N95 face mask, goggles, double gown and gloves or a
  full Powered Air-Purifying Respirator (PAPR) if for that individual
  the N95 mask is ill fitting.\textsuperscript{3,4}
\item
  For patients who are neither COVID-19 positive or PUI the surgical
  team should don N95 masks, face shields, surgical gowns and gloves
  during patient assessment and treatment.
\end{enumerate}

\emph{Results}

\emph{Penn Medicine Head and Neck Cancer Service Line COVID-19
Guidelines}

\textbf{Primary Treatment}

\textbf{Surgical Treatment}

Principles Concerning Operating Room Availability

\begin{itemize}
\tightlist
\item
  If there is a temporary inability to access operating rooms due to the
  COVID-19 pandemic, defer surgical treatment until a point in time when
  the operating rooms are re-opened.
\item
  If treatment is delayed because of operating room capacity issues due
  to the pandemic, perform monthly CT or MRI scans to monitor growth of
  the tumor and consider primary radiation or chemoradiation for tumors
  with continued growth.
\end{itemize}

Masses and Lesions of Uncertain Behavior

\begin{itemize}
\tightlist
\item
  Needle biopsy for masses or biopsy of mucosal or skin lesions to rule
  out cancer can be done in the outpatient setting.
\item
  If excision is thought to be the best way to determine the nature of
  the lesion, then perform incisional or excisional biopsy. We suggest
  the biopsy be done in the operating room with a justification of
  ``rule out cancer''.
\end{itemize}

Definitively Benign Tumors and Masses Based on Biopsy Results.

Defer treatment until after the COVID-19 pandemic.

Salivary Malignancy

\begin{itemize}
\tightlist
\item
  Resect all high and intermediate grade cancers.\textsuperscript{5}
\item
  Defer treatment of low-grade carcinomas (e.g., low grade
  mucoepidermoid carcinoma, acinic cell carcinoma or polymorphous
  low-grade adenocarcinoma) until after the COVID-19 pandemic, per
  clinical judgement of the surgeon. In the interim, perform serial MRI
  or CT scans with contrast every two months to monitor growth of the
  tumor.
\end{itemize}

Asymptomatic Leukoplakia

\begin{itemize}
\tightlist
\item
  If this is the first patient visit for leukoplakia with no history of
  prior biopsy and no histologic diagnosis, we recommend the patient
  send pictures of the suspicious area(s) via our secure patient portal
  followed by a telehealth video visit\textsuperscript{6} To avoid
  missing cancer, perform either incisional or excisional biopsy within
  1 -6 weeks depending on the surgeon's index of suspicion based on the
  pictures. The biopsy can be done in the outpatient setting or in the
  operating room depending on the preference of the clinician.
\item
  If this is a long-standing patient with history of leukoplakia or a
  recent biopsy that shows premalignancy then have the patient submit a
  photo to your team and perform a telehealth video visit. If the lesion
  on the photo does not have high-risk features, then defer treatment
  until after the COVID-19 pandemic. If the lesion has high-risk
  features in the photo, then to avoid missing a cancer perform either
  incisional or excisional biopsy within 1 - 6 weeks depending on the
  surgeon's index of suspicion based on the picture. The biopsy can be
  done in the outpatient setting or in the operating room depending on
  the preference of the clinician.
\end{itemize}

Mucosal Squamous Cell Carcinoma: p16 + and p16 -

\begin{itemize}
\tightlist
\item
  Perform surgery on all surgically resectable squamous cell carcinomas
  as soon as possible.
\item
  The rationale is based on the following:
\item
  Studies from Italy indicate delays in care may lead to increased cost
  of care and loss of life during the pandemic.\textsuperscript{7}
\item
  The literature indicates that treatment delays in the 19-46 day range
  increase the risk of mortality.\textsuperscript{8,9}
\item
  Treatment delays can result in upstaging of
  cancers.\textsuperscript{10}
\end{itemize}

\begin{enumerate}
\tightlist
\item
  Choice of reconstructive approach should be based upon the defect as
  well as the preference of the reconstructive surgeon. We recommend the
  surgeon factor in time in the operating room and minimization of
  complications.\textsuperscript{11}
\item
  Prior to all transoral approaches, it is recommended that the nose and
  pharynx be irrigated with 1:4 solution of povidone iodine which has
  been shown to be virucidal for coronaviruses.\textsuperscript{12}
\end{enumerate}

Skull Base Malignancy

\begin{itemize}
\tightlist
\item
  Due to the potentially high COVID-19 viral load in the nasal mucosa,
  we suggest the guidelines in the section below for Office Procedures
  ``Fiberoptic Laryngoscopy,~Nasal Endoscopy, Transoral and Transnasal
  biopsies.''
\item
  Unlike mucosal squamous cell carcinoma in which the recommendation is
  to perform surgery in all resectable cases as soon as possible, given
  the diverse biology of skull base tumors we recommend following the
  ICAR-Skull Base Tumors guideline to determine therapy after definitive
  biopsy is performed.\textsuperscript{13}
\item
  If a transnasal endoscopic surgery is needed, it is highly recommended
  that high speed drills be avoided and that the entire surgical,
  perioperative and anesthesia teams wear N95 masks, goggles and face
  shields for these cases for the duration of the COVID-19
  pandemic.\textsuperscript{14,15}
\end{itemize}

\textbf{Adjuvant Radiation and Chemoradiation}

\begin{enumerate}
\tightlist
\item
  All patients for which there are standard indications for
  postoperative radiation alone should proceed with treatment as per
  normal, without intentional delay.
\item
  Guidance for the use of Chemoradiation
\end{enumerate}

\begin{itemize}
\tightlist
\item
  Tier 1 -- Patients over 70 years of age were underrepresented in the
  trials supporting the use of chemoradiotherapy. There is some evidence
  from meta-analyses that the addition of chemotherapy to radiation for
  patients over the age of 70 may confer minimal benefit or may even be
  detrimental.\textsuperscript{16} Therefore, it is strongly encouraged
  that during the COVID19 pandemic, medical oncologists consider the
  omission of chemotherapy from the adjuvant treatment regimens for
  patients over 70.
\item
  Tier 2 -- For pathological findings of microscopic extranodal
  extension (ENE) (\textless{} 1mm ENE) in patients with p16 + cancer
  there is retrospective evidence to support omitting chemotherapy
  without compromising oncologic outcomes. It is therefore reasonable to
  consider omitting chemotherapy with radiation during the COVID 19
  pandemic.\textsuperscript{17,18}
\item
  Tier 3 -- In the following cases the recommendation is to proceed with
  chemoradiation with the caveat that there should be shared informed
  decision making between the clinician and the patient of the risks
  versus the benefits of adding cytotoxic chemotherapy to the treatment
  regimen during the COVID19 pandemic.
\item
  All p16- cancers with positive margins or any amount of ENE.
\item
  All p16 + cancers with positive margins or macroscopic
  (\textgreater{}1mm) ENE.
\end{itemize}

\textbf{Primary Chemoradiation}

\begin{enumerate}
\tightlist
\item
  Fundamental Principle is that all patients who are surgical candidates
  should undergo primary surgical resection as outlined above.
\item
  p16 Positive Squamous Cell Carcinoma of the Oropharynx
\end{enumerate}

The recommendation is to proceed with standard cisplatin-based
chemoradiation with the caveat that there should be shared informed
decision-making between the clinician and the patient of the risks
versus the benefits of adding cytotoxic chemotherapy to the treatment
regimen during the COVID-19 pandemic.

p16 Negative Squamous Cell Carcinoma

The recommendation is to consider systemic-therapy sensitized radiation.
Registry data indicate that cetuximab is inferior to cisplatin
regardless of primary site, but this needs to be weighed against the
desire to minimize the immunosuppression associated with cytotoxic
chemotherapy.\textsuperscript{19} There should thus be shared informed
decision-making between the clinician and the patient of the risks
versus the benefits of substituting cetuximab for cisplatin in the
treatment regimen during the COVID-19 pandemic.

\begin{enumerate}
\tightlist
\item
  When Possible Avoid : TPF (docetaxel, cisplatin, and 5-fluorouracil)
  regimens for induction therapy, as they are associated with high rates
  of neutropenic fever and subsequent hospitalization.
\item
  When Possible Avoid : For chemoradiation patients, try to avoid
  high-dose cisplatin, which can result in higher rates of
  hospitalization and renal dysfunction. Instead, substitute weekly
  cisplatin at 40 mg/m\textsuperscript{2}.\textsuperscript{20}
\end{enumerate}

Outpatient Care

\textbf{General Principles}

\begin{enumerate}
\tightlist
\item
  All patients will be advised prior to their visits that they must wear
  a mask at all times while in a Penn Medicine facility and if they do
  not have a mask one will be provided.
\item
  Patients will complete a COVID-19 questionnaire and undergo have their
  temperature and oximetry documented in the electronic medical record.
  All patients who qualify by Penn Medicine criteria will be instructed
  to go for immediate testing. Patients that have a minimum of one
  positive response on the questionnaire or an elevated temperature or
  decreased oxygenation will be escorted to a designated COVID 19 clinic
  room and be evaluated by a physician in consultation with infection
  control. This minimizes risk of exposure and maximizes safety for both
  patients and staff.
\item
  Known COVID-19 positive patients or PUI who are asymptomatic from the
  perspective of their Head and Neck Cancer should have follow-up visits
  delayed until they test negative for Sars-CoV-2.
\item
  During the surge leading up to and at the apogee of the COVID-19
  incidence curve it is strongly encouraged that routine follow-up
  visits or visits for treatment-related symptoms be done via telehealth
  video visits whenever possible.
\item
  During the surge leading up to and at the apogee of the COVID-19
  disease curve suspicious symptoms or radiologic evidence of mucosal
  disease should be assessed in the operating room under general
  anesthesia in order to optimize control of potentially infectious
  aerosolized secretions.
\item
  Known COVID-19 positive patients, or PUI with new head and neck
  symptoms that are potentially life threatening (e.g., bleeding,
  shortness of breath) should be seen in the emergency room by staff
  donning full protection, including PAPR.\textsuperscript{3}
\item
  Later in the COVID-19 disease curve when routine office visits have
  resumed it is suggested that physicians wear N95 masks, goggles and
  gloves routinely given their proximity to patients and the potential
  exposure risks of aerosolizing procedures (e.g., fiberoptic
  laryngoscopy, nasal endoscopy, tracheostomy change). Support staff
  should not be in the patient examining room during aerosolizing
  procedures and therefore should only require and wear standard masks,
  goggles and gloves.\textsuperscript{21}
\item
  Anesthetizing the nasal cavity with spray systems prior to scoping
  should be avoided until the COVID-19 pandemic is over.
\item
  It is recommended that throughout the COVID-19 pandemic that all
  outpatients have their temperature taken and have a COVID-19 history
  taken before they are seen and that all patients with either elevated
  temperatures or affirmative responses to the COVID-19 history be
  escorted to designated COVID-19 clinic rooms for further evaluation by
  providers and consultation with infection control for next steps.
\item
  Each department will create a phased plan to incrementally increase
  clinic volumes during this period with the goal of both avoiding
  exposure of staff, physicians and other patients to COVID-19 positive
  patients and creating a waiting room environment conducive with Social
  Distancing.
\end{enumerate}

\textbf{Cancer Follow-up}

\begin{enumerate}
\tightlist
\item
  During the surge leading up to and at the apogee of the COVID-19
  incidence curve:
\item
  Routine follow-ups in asymptomatic patients should be delayed,
  including routine follow-up imaging.
\item
  Radiologic surveillance for patients who are cancer-free but are at
  risk for developing a cancer in the future should be delayed unless
  symptoms or signs are concerning.
\item
  Follow-up later in the COVID-19 pandemic when routine office visits
  have resumed:
\item
  Resume routine follow-ups in asymptomatic patients, including routine
  follow-up imaging
\item
  Since a third of asymptomatic COVID-19 patients have characteristic
  chest CT findings, all patients that undergo CT of the chest or total
  body PET/CT as part of their routine follow-imaging for their cancer
  and who have radiographic evidence suggesting viral infection should
  undergo SAR-CoV-2 testing.\textsuperscript{22}
\end{enumerate}

\textbf{Postoperative Visits during the surge leading up to and at the
apogee of COVID 19 disease incidence curve:}

When clinically appropriate it is recommended that all drains,
tracheostomies and nasogastric tubes be removed during the hospital stay
to allow for the maximum amount of postoperative care to be done via
telehealth video visits. Visiting nurses in our community have also
agreed to remove nasogastric tubes and drains to minimize visits to the
medical center for removal.

\textbf{Postoperative Visits later in the COVID 19 disease incidence
curve when routine office visits have resumed}

\begin{enumerate}
\tightlist
\item
  Examine practices that were implemented during the COVID19 surge
  regarding hospital-based drain, tracheostomy and nasogastric tube
  removal and retain practices found to be safe and effective.
\item
  When removing nasogastric and tracheostomy tubes in the inpatient or
  outpatient setting it is recommended that N95 mask, goggles, gown and
  gloves be worn.
\end{enumerate}

\textbf{Office Procedures}

\begin{enumerate}
\tightlist
\item
  Fiberoptic Laryngoscopy, Nasal Endoscopy, Transoral and Transnasal
  biopsies.
\item
  During the surge leading up to and the apogee of the COVID-19 Disease
  Incidence Curve
\item
  If a staging laryngoscopy under anesthesia is planned and there is a
  question about the safety of standard intubation, it is suggested that
  the Fiberoptic Laryngoscopy be deferred and be done with the patient
  in the operating room just prior to anesthesia so that the surgical
  and anesthesia team can formulate an appropriate plan concerning safe
  intubation. For the duration of the COVID-19 pandemic we do not
  recommend screening bronchoscopy be performed at the time of staging
  endoscopy.
\item
  Later in the COVID-19 Disease Incidence Curve when Routine Office
  Visits have Resumed
\item
  Fiberoptic laryngoscopy and nasal endoscopy can be done at the
  discretion of the attending physician.
\item
  No anesthetizing the nasal or oral cavity with sprays.
\item
  Topical application of pledgets impregnated with Afrin and lidocaine
  may be used, instead.
\item
  Local anesthetic injection may be performed for transoral or
  transnasal biopsies.
\item
  The use of N95 mask, goggles, gloves and gown is required for all
  patients.
\item
  When testing is available, it is recommended that all patients
  undergoing potentially aerosol generating procedures (e.g. Fiberoptic
  laryngoscopy and Nasal Endoscopy) undergo COVID-19 testing within 72
  hours of the procedure.
\end{enumerate}

\begin{enumerate}
\tightlist
\item
  Fine Needle Aspiration
\item
  Standard garb including mask, goggles and gloves is suggested.
\end{enumerate}

\textbf{Palliative and End of Life Care}

\begin{itemize}
\tightlist
\item
  Patients with incurable disease undergoing palliative treatment such
  as chemotherapy or immunotherapy should be treated when significant
  extension of life (\textgreater{}6 months) and reduction of symptoms
  are reasonable expectations.~ Consideration should be given to
  alterations in treatment plans to reduce number and frequency of
  visits, including reduced frequency of imaging to re-assess disease if
  the state of disease can be assessed by other means.
\item
  Consider a 4-6-week schedule for pembrolizumab for those patients who
  are clinically and radiographically stable or responding after 3-6
  months of immunotherapy
\item
  Consider discontinuation of immunotherapy for patients that are well
  into a complete response beyond one year.
\item
  End of life patients should receive necessary care, much or all of
  which can be delivered at home via telehealth visits.~ Palliative care
  consultations at Penn Medicine are now being done entirely via
  telehealth visits.~ Goals of care (serious illness) conversations
  should occur early on to facilitate this approach.\textsuperscript{23}
\end{itemize}

\textbf{Management of Complications}

Patients with complications of care such as surgical site complications,
neutropenic fever, etc., should be managed so as not to put the patient
at increased risk for further complications or mortality, taking into
consideration risk of COVID-19 infection with hospital visits.~ Low risk
fever and neutropenia, for example, might be managed as an outpatient at
home, for example, with appropriate monitoring by telehealth visits.

\emph{Discussion}

Our goal was to create effective and ethical cancer guidelines in an
expeditious fashion to allow quick deployment during the COVID-19
epidemic. While a group consensus was both desired and required, time to
completion was an important consideration which obligated the leadership
to seek consensus individually rather than in a virtual group session.
The result was a document agreed to by all which was completed within
two weeks.

Our entire team agreed, that the primary treatment of choice during the
COVID-19 epidemic was surgery in all surgically and medically resectable
cases. Non-surgical options do exist utilizing radiation alone or
chemoradiation. However, these options are fraught with increasing risks
during this pandemic. In some cases, surgery results in a single day
treatment that allows the patient with or without hospitalization to
return home and avoid returning to the hospital. Radiation requires
daily trips to the hospital for several weeks which puts both the
patient and the radiation teams at risk of spread of SARS-CoV-2.
Chemotherapy, when required, further immunocompromises the patient which
makes them more susceptible to SARS-CoV-2 infection. Adjuvant radiation
and chemotherapy can be done several weeks after surgery, safely and
according to standard of care, and for many this will be after the peak
of the virus spread in our community and when testing may be more
readily available for screening patients.

A primary surgical approach for resectable cancers was seen as the
safest pathway in cases where the pathology indicated that surgery was a
standard of care option for a given anatomic site in the head and neck.
For squamous cell carcinoma we made a distinction between P16+ and P16--
cancers given how common oropharyngeal cancer is in our setting.
Oropharyngeal cancers, in particular those which are P16+ and Human
Papilloma Virus (HPV) associated, accounts for a significant percentage
of the patients presenting to Head and Neck Surgeons in 2020. It has
been estimated that by 2030 half of all head and neck cancers will be
HPV related.\textsuperscript{24} The Center for Disease Control (CDC)
website notes that 70\% of all oropharyngeal cancers are caused by HPV
and account for 13,500 cases annually, making this the most common HPV
related cancer in the United States, exceeding cervical cancer by almost
3000 cases.\textsuperscript{25} Transoral Robotic Surgery (TORS) which
was invented in 2005 and FDA cleared in 2009 has emerged as the most
common surgical treatment of HPV related oropharyngeal
cancer.\textsuperscript{26,27} The most frequent alternative
non-surgical treatment for the management of HPV related oropharyngeal
cancer is cisplatin-based chemoradiation which is associated with
significant acute and chronic toxicity, including acute compromise of
the immune system and significant acute and late risk of treatment
related death and gastrostomy tube dependence.\textsuperscript{28} The
standard of care for the treatment of oral cavity cancer worldwide is
primary surgery with or without adjuvant radiation or
chemoradiation.\textsuperscript{29} The standard of care requires that
many laryngeal cancers be offered the option of surgery as the primary
modality for organ preservation.\textsuperscript{30}

The major concerns for Head and Neck Surgeons for the safety of all
members of the surgical, perioperative and anesthesia teams are related
to numerous factors. It is well established that large viral load of
SARS-CoV-2 reside in nasal cavity and all levels of the mucosa between
the nasopharynx and trachea. In addition, histological evaluation, in
the primate model, of the SARS-CoV-1, a similar corona virus, indicates
large viral load with the cells of the head and neck
mucosa.\textsuperscript{31,32} Experimental evidence from the University
of Pennsylvania indicates that appropriate surgical masks, even when
virus is present in the electrocautery plume, do prevent passage of
viral particles in electrocautery plume to the
wearer.\textsuperscript{33} The aerosolized virus particles from
SARS-CoV-2 remain viable for at least 3 hours.\textsuperscript{34} An
article in Science estimates that 86\% of SARS-CoV-2 infections in China
were undocumented prior to the January 23, 2020 travel ban and that
undocumented infections were likely responsible for spreading the
disease to 79\% of documented cases.\textsuperscript{35} Initially in
the COVID-19 pandemic Personal Protective Equipment (PPE) and patient
testing were in short supply or unavailable. Early on in the pandemic
our team successfully negotiated with our hospital executives to ensure
that for all head and neck cancer cases involving transection of mucosa
the entire staff in the operating room would be issued N95 masks and all
patients would undergo SARS-CoV-2 testing within 24 hours of the
procedure. The fundamental premise of our negotiations were based on the
idea that ``the goal is to flatten the disease curve, not the personnel
curve.''\textsuperscript{36}

Preoperative testing of patients for SARS-CoV-2 may be critical for
patient and staff safety. Xia et al. published a paper in which
asymptomatic patients underwent a variety of surgical procedures
throughout the body, including one laryngeal surgery. Thirty-four
patients developed COVID-19 during the postoperative period and the
mortality rate for this group was 20.5\%. We recommend based on this
study that asymptomatic patients who test SARS-CoV-2 positive prior to
any treatment delay such treatment until they have had two negative
tests within 24 hours.\textsuperscript{37}

Our guidelines include a discussion of the management of routine cancer
follow-up during the apogee of the COVID-19 disease incidence curve as
well as during the reopening process of face-to face visits in the
outpatient clinics. The pillars upon which our plan is built are: (1)
multilevel triage approach to minimize the risk of COVID-19 PUI or
positive patients encountering multiple personnel, (2)~special
precautions when performing potentially aerosolizing procedures (e.g.,
fiberoptic laryngoscopy and nasal endoscopy) in clinic, (3) appropriate
workflow and PPE ~use by staff, physicians and patients so that if an
unexpected exposure to COVID-19 does occur the need for quarantine of
staff or physicians is either minimized or non-existent, (4)~added
cleaning measures to sanitize patient exam and treatment rooms and (5)
plan for clinic re-opening that ensures appropriate social distancing in
the waiting room.\textsuperscript{38}

\emph{Conclusions}

The COVID-19 pandemic has created significant constraints within the
healthcare environment and it is important that each cancer management
team work together to create efficient and ethical care guidelines to
which all team members agree. It is important to consider the concerns
of all subspecialties involved in patient care while also moving forward
with publishing guidelines in a timely fashion. Given the rapid changes
in our knowledge about this novel corona virus it is understood by all
involved that these guidelines are in a state of constant revision to
allow for adaptability in a quickly changing environment. Our goal was
to share process, fundamental principles and our internal guidelines
with the intent of information sharing for other institutions that are
in the process of creating their own management algorithms during this
pandemic.

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