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\begin{document}

\title{Clinical and surgical management of Head and Neck cancer
patients}



\author[1]{Laura Tricarico, MD}%
\affil[1]{Università Cattolica del Sacro Cuore, Largo}%


\vspace{-1em}



  
  \date{May 27, 2024}


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\selectlanguage{english}
\begin{abstract}
\textbf{Introduction~}For the ENT surgeon there are many challenges that
show-up in the clinical management of a patient affected by a Head and
Neck cancer during COVID-19 pandemic, especially in the postoperative
period.~\textbf{Methods~}During the acute COVID-19 emergency phase in
Italy, we analysed the management of a patient affected by a Head and
Neck cancer. We reported several clinical data about the hospitalization
period, pointing out the difficulties encountered both from clinical and
management point of view.~\textbf{Results~}During pandemic, we admitted
27 oncological patients at our ENT department. Delays in surgical
procedures, complications of hospitalizations, need for radiological
studies and possible transfer to other hospital ward, due to suspect
Sars-CoV-2 infection, were registered.~\textbf{Conclusions~}The changes
in the whole health care system during the COVID-19 pandemic have
impacted the management of head and neck cancer patients, generating
several clinical challenges for the ENT surgeon.%
\end{abstract}%



\sloppy




Jacopo Galli\textsuperscript{1,2} MD, Stefano
Settimi\textsuperscript{2}MD, Laura Tricarico\textsuperscript{2} MD,
Giovanni Almadori\textsuperscript{1,2} MD, Gaetano
Paludetti\textsuperscript{1,2}MD

\textbf{Short title}

Head and neck oncology issues during COVID-19 pandemic

\textbf{Affiliation}

\textsuperscript{1} Otorhinolaryngology and Head \& Neck Surgery Unit,
Fondazione Policlinico Universitario ``A.Gemelli'' IRCCS, Rome, Italy

\textsuperscript{2} Universit\selectlanguage{ngerman}à Cattolica del Sacro Cuore, Rome, Italy

\textbf{Corresponding author}

Dr. Laura Tricarico, Head and Neck Department, Università Cattolica del
Sacro Cuore, Largo F. Vito 1, 00168 - Rome, Italy. Tel. +393888981885.
E-mail: lauratricarico90bis@gmail.com.

\textbf{ABSTRACT}

\textbf{Introduction}

For the ENT surgeon there are many challenges that show-up in the
clinical management of a patient affected by a Head and Neck cancer
during COVID-19 pandemic, especially in the postoperative period.

\textbf{Methods}

During the acute COVID-19 emergency phase in Italy, we analysed the
management of a patient affected by a Head and Neck cancer. We reported
several clinical data about the hospitalization period, pointing out the
difficulties encountered both from clinical and management point of
view.

\textbf{Results}

During pandemic, we admitted 27 oncological patients at our ENT
department. Delays in surgical procedures, complications of
hospitalizations, need for radiological studies and possible transfer to
other hospital ward, due to suspect Sars-CoV-2 infection, were
registered.

\textbf{Conclusions}

The changes in the whole health care system during the COVID-19 pandemic
have impacted the management of head and neck cancer patients,
generating several clinical challenges for the ENT surgeon.

\textbf{INTRODUCTION}

The COVID-19 pandemic in Italy has affected the entire national health
service, by imposing the clinicians to adopt new security measures for
out- and inpatients, and a re-organization of the clinical and surgical
procedures in almost all the hospitals. The ENT surgeon represents one
of the most exposed figures of the pandemic scenario, due to its field
of action that includes the upper aerodigestive tract with high-risk
procedures for COVID-19 transmission, such as endoscopic examination or
aerodigestive surgery, including tracheostomy \textsuperscript{1,2}. At
our Institution, ``A. Gemelli'' Hospital Foundation -- IRCCS, immediate
measures have been taken to reduce transmission of virus and to protect
patients and providers. A neighboring building affiliated to our
Institution was primarily dedicated to COVID patients care but it
quickly got full, thus requiring more resources to our Foundation. All
the outpatient clinics were therefore closed, reducing the activities to
those strictly necessary, such as emergencies and indispensable
admissions only for oncologic patients. In this setting, health care
providers take part to the first cohort of infected patients and the
equilibrium between the clinician mission to care for patients and the
duty to protect them is fragile. Moreover, ethical issues are hard
testing the efficacy of this revised system of health care in the
distribution of resources among the needs of populations and the needs
of individuals, leading to unavoidably treatment delays, sometimes
dangerous especially for cancer patients \textsuperscript{3}. Alongside
these fundamental issues, for the ENT surgeon there are other challenges
that show-up in the clinical management of a patient affected by a Head
and Neck cancer, once admitted in the Clinic. This kind of patients, in
fact, usually presents old age and several comorbidities, including
cardiac disease, chronic pulmonary disease, peripheral vascular disease,
diabetes, previous cancer history and other factors that could be
confounding in the era of coronavirus pneumonia \textsuperscript{4,5}.
Moreover, in several surgical oncologic procedures, a new permanent or
temporary tracheostomy is required, increasing the risk of very
dangerous aerosol generating condition in case of unexpected concomitant
coronavirus infection.

\textsuperscript{6,7}. The post-operative period management of these
patients, already rich of pitfalls for the clinician, could be
characterized also by cardiovascular and respiratory complications, thus
requiring complex differential diagnosis with COVID-related conditions,
in a setting of poor resources in the field of radiology and pneumology.
With this manuscript, our aim was to highlight the challenges
encountered during the hospitalization of oncologic patients at our ENT
Clinic, both from clinical and management point of view, during the
pandemic in a COVID-19 dedicated center.

\textbf{METHODS}

\emph{Setting and population}

During the most acute COVID-19 emergency phase, from 8 March 2020 to 20
April 2020, we prospectively collected data from patients admitted to
ENT department of Fondazione Policlinico Universitario ``A. Gemelli'',
in Rome (Italy). As a result of new restrictions imposed by the health
emergency and infectious risk, hospitalization at ENT department was
permitted strictly for patients suffering from head-neck cancer,
assessed by a multidisciplinary team (MDT) and candidate for an
appropriate surgical therapy. The MDT in our practice is composed by
several specialists \textsuperscript{8}: head and neck surgeon,
radiation oncologist, medical oncologist, neuroradiologist, supportive
and palliative care specialist, speech language pathologist,
nutritionist, dentist, who during COVID-19 pandemic, can meet only in a
virtual conference room with an associated tele-conference line. Remote
participants were able to join via on-line platform, observing eventual
imaging reproduced during the conference and discussing the
post-operative care. For non-emergency patients or patients with benign
head and neck tumors, the in-hospital treatment was postponed according
to national and regional authorities' indications.

\emph{Admission during COVID-19 pandemic}

Before the hospitalization, each patient underwent a pre-operative
anesthesiological evaluation, consisting of global medical history
collection, patient's parameters observation including body temperature,
complete blood count, ECG and chest x-ray examination or chest CT scan
when it was necessary. Although asymptomatic, each patient underwent the
COVID-19 RT-PCR swab test, a real-time reverse transcription polymerase
chain reaction (rRT-PCR) test for the qualitative detection of nucleic
acid from SARS-CoV-2, through nasopharyngeal (NP) and oropharyngeal (OP)
swab \textsuperscript{9}. Only in case of negative result to the
COVID-19 test and confirmed eligibility for surgery at the
anesthesiological evaluation, patients were admitted to the head and
neck inpatient clinic. Body temperature was screened again at the
entrance by the nurses, who used secondary protective measures by means
of personal protective equipment (PPE) for routine patient evaluation.
We defined ``appropriate PPE'' as the use of standard-of-care
procedure-specific PPE for patients who are confirmed to be negative for
COVID-19. Otherwise, in case of positive result to the COVID-19 test,
the institutional guidelines stated that surgery should be performed in
a dedicated operatory room and the post-operative hospitalization should
continue in COVID-reserved Department. Only one visitor for patient was
allowed in the time interval between 06.00 and 07.00 pm and, in any
case, with due regard for safety distances and wearing PPE. The purpose
of these measures was to control population flow in the department area
and to reduce the number of cross-infections.

\emph{Post-operative procedures}

Before the epidemic of new coronavirus infection, once the surgical and
anesthesiological procedure was over, the patients were usually
transferred to the recovery room to continue the post-operative
assistance. To avoid overcrowding of multiple patients, during the
COVID-19 emergency phase, the single patient was monitored in the
post-operative period in a reserved room adjacent to the operating room,
under the supervision of the anesthesiology specialist and then was
transferred at the ENT inpatient clinic. During the post-operative stay,
all patients were assisted at ENT department using special precaution
for patients with temporary or permanent tracheostomy, considering the
heightened risk of viral transmission \textsuperscript{10}. On the basis
of the definitive histological examination, all oncological clinical
cases were newly discussed by the weekly virtual multidisciplinary tumor
board to define the eventual adjuvant therapy plan and the follow up
procedures.

\emph{Data collection and clinical management}

We prospectively collected data from oncologic patients admitted at our
ENT department during COVID-19 pandemic, and in particular:
demographics, oncologic diagnosis, comorbidities, number of NP and OP
swab test performed, surgical procedures performed, presence of
tracheostomy, length of hospitalization, complications of surgery and
hospitalization, radiological studies, possible transfer to other
hospital ward.

\textbf{RESULTS}

\emph{Cancer statistics}

During pandemic, we admitted 27 oncological patients at our ENT
department, who all underwent head and neck surgery. Mean age was 67,2
and M:F= 3,3:1. Most frequent comorbidities were: chronic obstructive
pulmonary disease (18.5\%), idiopathic hypertension (77.7\%), type 2
diabetes (25.9\%), heart failure (Class. NYHA II -- III) (14.8\%),
chronic kidney disease (11.1\%) and Gastro-Esophageal Reflux Disease
(62.9\%). All the patients were negative at the first COVID-19 swab.
About the oncological diagnosis and procedures: 4/27 patients (14.8\%)
were affected by oral cavity cancer and underwent surgical resection of
the tumor; in three cases we performed an immediate reconstructive
surgery with local or microvascular free flap. Five out of 27 patients
(18.5\%) were affected by laryngeal cancer and underwent laser type IV
Cordectomy (1/5) and Total Laryngectomy (TL) with elective bilateral
neck dissection (4/5); in two cases of salvage TL an internal mammary
artery perforator (IMAP) flap was used for tracheostoma reconstruction.
A parotid malignant tumor (previously diagnosed with fine needle
aspiration biopsy, FNAB) was found in 5/27 patients (18,5\%), all who
underwent total parotidectomy and selective ipsilateral neck dissection.
Three out of 27 patients (11.1\%) affected by hypopharyngeal carcinoma
underwent biopsy and were addressed to radiation therapy. Paranasal
sinus and nasal cancer were diagnosed in 6/27 patients (22,2\%); 5/6
patients were suitable for endoscopic resection of tumor and one patient
with cancer of nasal vestibule underwent local excision and
brachytherapy. Finally, 1/27 patient underwent total thyroidectomy, 2/27
patients underwent unilateral super-selective neck dissection to confirm
a suspected diagnosis of lymphoma and 1/27 patient was admitted to our
department in emergency for a neck mass then revealed as large
submandibular abscess. Mean hospital stay for all the patients admitted
at our ENT department during pandemic was 10,3 days. Tracheostomy was
performed in 8/27 patients (29.6\%)

\emph{Post-operative management and issues}

Post-operative period was even more complex. In one older patient
affected by chronic pulmonary disease, we observed on the fourth day
after surgery the onset of fever, dyspnea and desaturation during
wide-spectrum antibiotic therapy; for this reason, he underwent
chest-TC, which showed sign of interstitial involvement by an
inflammatory process. The infectious disease specialist, was then asked
to evaluate the patient and decided to move him from our inpatient
clinic to a ward dedicated to COVID-19 positive patients, waiting for
the result of NP and OP swabs. All the swabs resulted negative for
infection and were repeated after 24h for a confirmation. However, the
patient remained in the COVID-19 unit until the resolution of pulmonary
infection, thus prolonging his overall hospital stay. In another case,
we had a delay in the scheduled operatory session, due to the presence
of suspect radiologic findings in an asymptomatic patient with
ground-glass opacities and interstitial inflammation, emerged with a
staging chest-CT and not evident at the routine pre-admission chest-RX.
In a dialysis patient, the onset of fever and dyspnea on the second
postoperative day required a new COVID-19 test; due to the waiting of
the result (about 24 hours), the dialysis session was postponed by one
day, without systemic consequences. Finally, we report the case of a
female patient admitted to intensive care unit for dyspnoea, underwent
emergency orotracheal intubation for acute respiratory failure and the
case was considered suspect for SARS-CoV-2 infection; because of the
improvement of the clinical conditions, she was extubated, transferred
to medicine department and a COVID-19 swab resulted negative. Due to the
onset of dysphonia following orotracheal intubation, she performed ENT
evaluation with diagnosis of left vocal cord impaired mobility in
malignant laryngeal tumor.

\textbf{DISCUSSION}

It's clear that our lives have changed with this pandemic and will
continue to change in the next months, when the worst phase will be
over. One of the most upset participants at this battle will definitely
be our health care system. Modification in the attribution of priorities
of care, reduction of non-COVID-19-related health care, redistribution
of human and economic resources, are just some of the new challenges
that will revolutionize our health care system. Clinicians and health
providers are experiencing several technical, clinical, managing and
ethical issues that are burdening their everyday activity. In our
experience, as one of the most involved countries by the pandemic, our
Institution has tried to guarantee a high-level standard of care for
non-COVID oncologic patients and for emergencies. However, it was not
simple to face up with the consequences of a huge re-organization in a
hospital assigned to be one of the few COVID-centers of a European
capital, as Rome is.

One of the hardest challenges was to guarantee the safety both for
patient in admission and those already hospitalized in our clinic. We
noticed that, during this pandemic, there was a general propensity, by
radiologists, to highlight even minimal signs of interstitial and
peri-bronchial lung inflammation, thus suggesting an adequate
continuation of clinical studies and so overestimating COVID diagnosis.
This represents one of the costs that we will have to pay for a safe way
to prevent the loss of any possible infected patient, who could
represent a high risk of infection for the community. However, this
particular attention could slightly slow down the usual clinical
activity in a Head and Neck oncologic department. Moreover, those
patients with respiratory comorbidities, old age and fever represent
another challenging issue in the post-operative period. Fever could be
present is a frequent sign in the immediate post-operative
period\textsuperscript{11}, as well as cough, increased C-reactive
protein level and elevated lactate dehydrogenase \textsuperscript{12},
but when they occurred in a patient with dyspnea, oxygen desaturation
and tracheostomy, chest-CT and evaluation by the infectious disease
specialist are mandatory. We found several findings suggestive of novel
coronavirus pneumonia, such as ground-glass opacities (GGO), multilobe
and posterior involvement, bilateral pneumonia, and subsegmental vessel
enlargement \textsuperscript{13}, so the patients was transferred to a
COVID-dedicated ward, waiting for NP and OP swab results. Obviously,
technical difficulties showed-up immediately after the transfer, due to
the limited number of clinical evaluation possible in a day by the ENT
surgeon, and the difficult management of surgical dressings. This
patient never become positive to both NP and OP swabs, repeated three
times due to the persistence of fever, dyspnea and radiologic findings
suggestive of novel coronavirus pneumonia and was finally addressed to
our attention after antibiotic treatment. In conclusion, the changes in
the whole health system that have been put in place during the COVID-19
pandemic have impacted our daily clinical practice and the management of
head and neck cancer patients, which are the only patients, along with
those in emergency situations, suitable of surgical treatment in our
COVID-dedicated Institution. The guidelines in Italy are constantly
evolving and more efforts are needed to assess the future impact of
COVID-19 on oncology patients. Only a large multicenter study could help
the head and neck surgeons' community to better standardize future
guidelines to optimize the management of our patients.

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\textbf{Conflicts of Interest and Source of Funding}

The authors have no funding, financial relationships, or conflicts of
interest to disclose

\textbf{Authorship}

Galli J: substantial contributions to conception and design, acquisition
of data, analysis and interpretation of data; involved in drafting the
manuscript and revising it critically for important intellectual
content; gave final approval of this manuscript version to be published

Settimi S, Tricarico L, Almadori G, Paludetti G: acquisition of data,
analysis and interpretation of data; involved in drafting the manuscript
and revising it critically for important intellectual content; gave
final approval of this manuscript version to be published

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