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\begin{document}

\title{Head and neck cancer radiotherapy amid COVID-19 pandemic:~Report from
Milan, Italy~~~~~~~~~~~~}



\author[1]{Stefania Volpe MD }%
\affil[1]{European Institute of Oncology IRCCS}%


\vspace{-1em}



  
  \date{May 17, 2024}


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





\selectlanguage{english}
\begin{abstract}
Background: Management of head and neck cancers (HNC) in Radiation
Oncology in the COVID-19 era is challenging. Aim of our work is to
report organization strategies at a Radiation Therapy (RT) Department in
the first European area experiencing the COVID-19 pandemic. Methods: We
focused on 1) dedicated procedures for HNC, 2) radiation treatment
scheduling and 3) healthcare professionals' protection applied during
the Covid-19 breakdown (from 1st March to 30th April 2020). Results:
Applied procedures are reported and discussed. Forty-three pts were
treated. Image-guided, Intensity Modulated RT was performed in all
cases. Median overall treatment time (OTT) was 50 (IQR: 47-54.25) days.
RT was interrupted/delayed in seven pts (16\%) for suspected COVID-19
infection. Two health professionals managing HNC pts were proven as
COVID-19 positive. Conclusion: Adequate and well-timed organization
allowed for the optimization of HNC pts balancing at the best of our
possibilities pts' care and personnel's safety.%
\end{abstract}%



\sloppy


\subsection*{\texorpdfstring{Daniela Alterio*\textsuperscript{1},
Stefania Volpe*\textsuperscript{?1,2}, Giulia
Marvaso\textsuperscript{1,2}, Irene Turturici\textsuperscript{1},
Annamaria Ferrari\textsuperscript{1}, Maria Cristina
Leonardi\textsuperscript{1}, Roberta Lazzari\textsuperscript{1}, Massimo
Sarra Fiore\textsuperscript{1}, Giammaria Bufi\textsuperscript{1},
Federica Cattani\textsuperscript{3}, Camilla
Arrobbio\textsuperscript{1,2}, Filippo Patti\textsuperscript{1,2},
Alessia Casbarra\textsuperscript{1,2}, Iacopo
Cavallo\textsuperscript{1,2}, Fabrizio Mastrilli\textsuperscript{4},
Roberto Orecchia\textsuperscript{5}, Barbara Alicja
Jereczek-Fossa\textsuperscript{1,2}}{Daniela Alterio*1, Stefania Volpe*?1,2, Giulia Marvaso1,2, Irene Turturici1, Annamaria Ferrari1, Maria Cristina Leonardi1, Roberta Lazzari1, Massimo Sarra Fiore1, Giammaria Bufi1, Federica Cattani3, Camilla Arrobbio1,2, Filippo Patti1,2, Alessia Casbarra1,2, Iacopo Cavallo1,2, Fabrizio Mastrilli4, Roberto Orecchia5, Barbara Alicja Jereczek-Fossa1,2}}\selectlanguage{english}

{\label{179398}}\par\null

1. Division of Radiation Oncology, IEO, European Institute of Oncology
IRCCS, Milan, Italy

2. Department of Oncology and Hemato-Oncology, University of Milan,
Milan, Italy

3. Medical Physics Unit, IEO, European Institute of Oncology IRCCS,
Milan, Italy

4. Medical Administration, CMO, IEO, European Institute of Oncology,
IRCCS, Milan, Italy

5. Scientific Direction, IEO, European Institute of Oncology IRCCS,
Milan, Italy

~

* Daniela Alterio MD and Stefania Volpe MD equally contributed to the
present work, and should be considered as co-first authors

\textbf{~}

\textbf{Corresponding Author:}

Stefania Volpe MD

E-mail address: {stefania.volpe@ieo.it}

Orcid ID https://orcid.org/0000-0003-0498-2964

~

\textbf{Conflicts of Interest:} The authors declare that the research
was conducted in the absence of any commercial or financial
relationships that could be construed as a potential conflict of
interest.

\textbf{Funding statement and Acknowledgements:} This study was
partially supported by the Italian Ministry of Health with ``Progetto di
Eccellenza''. Stefania Volpe MD is a PhD student within the European
School of Molecular Medicine (SEMM). \textbf{}

~

\textbf{ABSTRACT}

\textbf{Background:} Management of head and neck cancers (HNC) in
Radiation Oncology in the COVID-19 era is challenging. Aim of our work
is to report organization strategies at a Radiation Therapy (RT)
Department in the first European area experiencing the COVID-19
pandemic. \textbf{Methods:} We focused on 1) dedicated procedures for
HNC, 2) radiation treatment scheduling and 3) healthcare professionals'
protection applied during the Covid-19 breakdown (from 1st March to 30th
April 2020). \textbf{Results}: Applied procedures are reported and
discussed. Forty-three pts were treated. Image-guided, Intensity
Modulated RT was performed in all cases. Median overall treatment time
(OTT) was 50 (IQR: 47-54.25) days. RT was interrupted/delayed in seven
pts (16\%) for suspected COVID-19 infection. Two health professionals
managing HNC pts were proven as COVID-19 positive. \textbf{Conclusion:}
Adequate and well-timed organization allowed for the optimization of HNC
pts balancing at the best of our possibilities pts' care and personnel's
safety.

\par\null

\textbf{1. INTRODUCTION}

Since the 20th February 2020, Italy is experiencing one of the most
severe 2019 coronavirus-19 disease (COVID-19) outbreak worldwide, with
the region of Lombardy being the first area in Europe hit by the
pandemic. At present, Lombardy is the most affected areas in Italy, with
15.116 deaths and 82.904 cases as of 12\textsuperscript{th} May 2020. Of
these, 21.632 were diagnosed in the Milan area. Therefore, health care
services across the Region are still facing and unprecedented challenges
in limiting transmission rates in order to guarantee the continuity of
care\textsuperscript{1}.

Cancer patients are often frail and immunocompromised, and therefore at
risk of being more severely affected by COVID-19
infection\textsuperscript{2,3}. Following the Regional resolution
XI-2906 approved on the 8\textsuperscript{th} March 2020, selected
centers were designated as oncological hubs, meaning that they were
called to host patients from hospitals in the frontline for COVID-19
emergency. Since our Institution was included among Lombardy oncological
hubs, a set of procedures were implemented in order to guarantee a safe
care and working environment.

Several reports and recommendations have been published on the
management of head a neck cancer (HNC) from both an ethical and surgical
perspective\textsuperscript{4--6}. Moreover, a recent consensus by the
American and European Societies of Radiation Oncology (ASTRO and ESTRO,
respectively) was published to provide guidelines on optimal radiation
treatment (RT) strategies during the pandemic \textsuperscript{7}.
Nevertheless, issues related to the management of HNC patients during RT
have not been reported yet. Hence, aim of the current work is to report
on technical aspects and the organization strategies applied in a
Radiation Oncology facility operating in the first European area hit by
the COVID-19 pandemic. As the 4th May represent the end of the lockdown
phase in Italy, we wish to share our experience, and to provide some
highlights on how everyday activities were re-organized to face an
evolving epidemiological scenario, together with the short-term results
of our efforts.Daniela Alterio*\textsuperscript{1}, Stefania
Volpe*\textsuperscript{?1,2}\selectlanguage{english}, Giulia Marvaso\textsuperscript{1,2}, Irene
Turturici\textsuperscript{1}, Annamaria Ferrari\textsuperscript{1},
Maria Cristina Leonardi\textsuperscript{1}, Roberta
Lazzari\textsuperscript{1}, Massimo Sarra Fiore\textsuperscript{1},
Giammaria Bufi\textsuperscript{1}, Federica Cattani\textsuperscript{3},
Camilla Arrobbio\textsuperscript{1,2}, Filippo
Patti\textsuperscript{1,2}, Alessia Casbarra\textsuperscript{1,2},
Iacopo Cavallo\textsuperscript{1,2}, Fabrizio
Mastrilli\textsuperscript{4}, Roberto Orecchia\textsuperscript{5},
Barbara Alicja Jereczek-Fossa\textsuperscript{1,2}

1. Division of Radiation Oncology, IEO, European Institute of Oncology
IRCCS, Milan, Italy

2. Department of Oncology and Hemato-Oncology, University of Milan,
Milan, Italy

3. Medical Physics Unit, IEO, European Institute of Oncology IRCCS,
Milan, Italy

4. Medical Administration, CMO, IEO, European Institute of Oncology,
IRCCS, Milan, Italy

5. Scientific Direction, IEO, European Institute of Oncology IRCCS,
Milan, Italy

~

* Daniela Alterio MD and Stefania Volpe MD equally contributed to the
present work, and should be considered as co-first authors

\textbf{~}

\textbf{Corresponding Author:}

Stefania Volpe MD

E-mail address: {stefania.volpe@ieo.it}

Orcid ID https://orcid.org/0000-0003-0498-2964

~

\textbf{Conflicts of Interest:} The authors declare that the research
was conducted in the absence of any commercial or financial
relationships that could be construed as a potential conflict of
interest.

\textbf{Funding statement and Acknowledgements:} This study was
partially supported by the Italian Ministry of Health with ``Progetto di
Eccellenza''. Stefania Volpe MD is a PhD student within the European
School of Molecular Medicine (SEMM). \textbf{}

~

\textbf{ABSTRACT}

\textbf{Background:} Management of head and neck cancers (HNC) in
Radiation Oncology in the COVID-19 era is challenging. Aim of our work
is to report organization strategies at a Radiation Therapy (RT)
Department in the first European area experiencing the COVID-19
pandemic. \textbf{Methods:} We focused on 1) dedicated procedures for
HNC, 2) radiation treatment scheduling and 3) healthcare professionals'
protection applied during the Covid-19 breakdown (from 1st March to 30th
April 2020). \textbf{Results}: Applied procedures are reported and
discussed. Forty-three pts were treated. Image-guided, Intensity
Modulated RT was performed in all cases. Median overall treatment time
(OTT) was 50 (IQR: 47-54.25) days. RT was interrupted/delayed in seven
pts (16\%) for suspected COVID-19 infection. Two health professionals
managing HNC pts were proven as COVID-19 positive. \textbf{Conclusion:}
Adequate and well-timed organization allowed for the optimization of HNC
pts balancing at the best of our possibilities pts' care and personnel's
safety.

\par\null

\textbf{1. INTRODUCTION}

Since the 20th February 2020, Italy is experiencing one of the most
severe 2019 coronavirus-19 disease (COVID-19) outbreak worldwide, with
the region of Lombardy being the first area in Europe hit by the
pandemic. At present, Lombardy is the most affected areas in Italy, with
15.116 deaths and 82.904 cases as of 12\textsuperscript{th} May 2020. Of
these, 21.632 were diagnosed in the Milan area. Therefore, health care
services across the Region are still facing and unprecedented challenges
in limiting transmission rates in order to guarantee the continuity of
care\textsuperscript{1}.

Cancer patients are often frail and immunocompromised, and therefore at
risk of being more severely affected by COVID-19
infection\textsuperscript{2,3}. Following the Regional resolution
XI-2906 approved on the 8\textsuperscript{th} March 2020, selected
centers were designated as oncological hubs, meaning that they were
called to host patients from hospitals in the frontline for COVID-19
emergency. Since our Institution was included among Lombardy oncological
hubs, a set of procedures were implemented in order to guarantee a safe
care and working environment.

Several reports and recommendations have been published on the
management of head a neck cancer (HNC) from both an ethical and surgical
perspective\textsuperscript{4--6}. Moreover, a recent consensus by the
American and European Societies of Radiation Oncology (ASTRO and ESTRO,
respectively) was published to provide guidelines on optimal radiation
treatment (RT) strategies during the pandemic \textsuperscript{7}.
Nevertheless, issues related to the management of HNC patients during RT
have not been reported yet. Hence, aim of the current work is to report
on technical aspects and the organization strategies applied in a
Radiation Oncology facility operating in the first European area hit by
the COVID-19 pandemic. As the 4th May represent the end of the lockdown
phase in Italy, we wish to share our experience, and to provide some
highlights on how everyday activities were re-organized to face an
evolving epidemiological scenario, together with the short-term results
of our efforts.

\textbf{1.1 Peculiarities of HNC clinical management}

With a number of incident and prevalent cases in Lombardy of 1583 and
2687 in 2019, respectively, HNCs can be considered as relatively rare.
Nevertheless, a recent national Italian survey among Radiation Oncology
facilities has shown that the majority of COVID-19 positive oncological
patients had a diagnosis of either lung or HN cancers and had their
domicile in Lombardy\textsuperscript{1}.

For the Radiation Oncologist HNC patients in the
COVID-era\textsuperscript{8} the following peculiarities should be
considered: 1) HNC are non-deferrable treatments\textsuperscript{9,10},
2) increase in overall treatment time (OTT) negatively affects survival
in curative-intent treatments\textsuperscript{5,6} , 3) patients are
generally elderly, heavy smokers as well as affected by several
comorbidities \textsuperscript{11--13} 4) as curative-intent RT is
administrated in 25-35 fractions, patients are required to perform
multiple hospital accesses, which may increases their risk of
contagion\textsuperscript{7}, 5) the need of removing patient's surgical
masks in different phases of RT favors environmental dissemination of
droplets\textsuperscript{5}, 5) the frequent presence of a tracheostomy
represents a further mean of viral spreading\textsuperscript{14}, 6)
abundant mucous secretions with cough secondary to tumor- and
treatment-related distress might further favor cross-infections, 7) high
risk of developing ab-ingestis pneumonitis as a consequence of tumor
and/or treatment-related swallowing impairment could make patients prone
to pulmonary distress syndromes\textsuperscript{15}, and 8) the combined
effect of RT and concomitant systemic treatments (mainly platinum-based
chemotherapy) could result in myelosuppression, thus favoring infectious
disease \textsuperscript{16} .

\textbf{2. MATERIALS AND METHODS}

Data of HNC patients treated with RT at the Radiation Oncology
Department of the European Institute of Oncology IRCSS (Milan, Italy)
were reviewed. The considered time frame encompassed the early phase of
COVID-19 pandemic in Lombardy (1\textsuperscript{st} March to
30\textsuperscript{th} April 2020). The impact of the pandemic was
analyzed as: 1) dedicated Departmental procedures for HNC, 2) treatment
scheduling (i.e.: delays, interruptions), and 3) healthcare
professionals' protection was analyzed. As the current report focuses on
outpatients treated with external beam RT, hospitalization and
brachytherapy-related procedures are not described. Medical records from
HNC patients were retrieved from electronic medical charts. This work
was approved by the Ethical Committee of the~European Institute of
Oncology IRCSS (notification number IEO726). All patients signed a
written informed consent for clinical research purposes.

\textbf{3. RESULTS}

\textbf{3.1 Radiation Oncology Department- General organization}

Eighteen Radiation Oncologists, 15 Radiation Oncology Residents, 11
Medical Physicists, 25 Radiation Therapists and 6 Nurses are currently
working at our Department. On average, the number of outpatient
treatments is approximatively 900 per week. In this time of emergency,
and given the role of oncological hub, our efforts were directed towards
maintaining an efficient clinical routine.

For this reason, the entire workflow was re-organized to minimize
COVID-19 transmission among both the personnel and the patients. All
measures were coordinated by a COVID-19 emergency team composed by the
Chief of the Department, three Senior Radiation Oncologists, the
Radiation Therapists Coordinator, the Nursing Coordinator and the Chief
of the Medical Physics Unit, in compliance with the Institutional
Recommendations.

The healthcare personnel was assigned a COVID-19 exposure risk class.
Personal protective equipment (PPE) was provided accordingly: 1)
low-risk of COVID-19 exposure (surgical mask, disposable gloves), 2)
intermediate risk of COVID-19 exposure (surgical masks, disposable
gloves, disposable gowns, medical caps) and 3) high risk of COVID-19
exposure (filtering facepieces- FFP2/KN95 and FFP3 masks, disposable
gloves, disposable gowns, medical caps, goggles or face shield, aprons).
The administrative staff and the medical physicists were assigned to the
first group, the healthcare professionals (namely, physicians, Radiation
Therapists and Nurses) without contacts with HNC patients to the second
group, and the healthcare professionals with contacts with HNC patients
to the third group. All staff members were required to use PPE for the
whole working day, regardless of whether their activity encompassed any
direct contact with patients.

A full list of the policies for the whole department is provided
in\textbf{Supplementary Materials} .

\textbf{3.2 Departmental COVID-19 dedicated procedures}

Treatment scheduling was not modified and was followed our Institutional
clinical practice: 6 weeks after surgery, 4 weeks after the last cycle
of induction chemotherapy, within 4 weeks for exclusive radiation or
concurrent chemoradiation).

The whole care path for HNC patients was re-planned according to
temporal and special criteria, with the aim to maintain a safe working
and treating environment. As previously detailed, patients were required
to wear a surgical mask unless otherwise instructed by the personnel. A
second surgical mask was provided to cover tracheotomies, if needed. A
summary of dedicated procedures for HNC patients is provided
in\textbf{Table 1} .

Time management in the COVID-19 pandemic encompassed scheduling all
computed-tomography (CT) simulation scans and RT delivery in dedicated
slots. The rationale beyond these measures was to optimize room
sanitization and to easily provide all involved healthcare professionals
with PPE.

All treatments are performed with mouthpiece-assisted head and shoulder
thermoplastics masks (FirmFit Thermoplastics Masks CIVCO Radiotherapy
Corporate Office 2303, Iowa, United States of America), to minimize
intra- and inter-fraction movements during treatment delivery. Due to
our immobilization device of choice, it was not possible for patients to
keep surgical masks during irradiation. For safety reasons, patients
were instructed to wear their surgical mask until they were correctly
positioned on treatment couch. Subsequently, they were invited to remove
the surgical mask and to insert their personalized mouth bites. The
thermoplastic mask could therefore be applied by the Radiation
Therapist, who performed the standard set-up procedures. The temporary
removal of surgical masks by the Radiation Therapist managing HNC
patients' set-up procedures were considered as a potential source of
contamination, and an adequate PPE was provided accordingly
(\textbf{Figure 1} ).

Similarly, patients' surgical masks were removed at least once per week
during medical consultations for oral cavity examination and toxicity
assessment. A consultation room was reserved exclusively for HNC
patients, and sanitized at the end of every working day. Clinical
evaluations during the RT treatment were regularly performed. Follow-up
consultations were organized according to the general Department
procedures detailed in \textbf{Supplementary Materials} . In detail,
follow-up evaluations for HNC patients were organized in the form of
telehealth surveillances, except for those requiring a physical and
radiologic assessment of their gross tumor volume response following a
curative-intent RT. In order to limit the accesses to our Institute,
patients with no evidence of disease and good performance status were
invited to stay at home and to reschedule their consultations.

All the above-mentioned procedures were progressively implemented
according to pandemic development and in accordance with World Health
Organization (WHO), National and recommendations and availability of
Institutional resources\textsuperscript{17} While COVID-19 phase II
started in Italy on May 4\textsuperscript{th} 2020, these procedures are
still applied in our Department while this work is being written
(10\textsuperscript{th} March).

\textbf{3.3 Impact of COVD-pandemic on HNC patients}

Forty-three patients were included in the analysis. During the first two
months of the COVID19 pandemic a slightly higher number of patients were
treated at our Department as compared with the same period of 2019 (44
vs 36, respectively, +22\%). This could be probably explained by the
fact that as a hub center, some patients were referred from other
Institutions. All patients received image-guided Intensity Modulated
Volumetric Arch Therapy (VMAT). Two patients maintained their
tracheostomy positioned at time of surgery. Patients' and treatment
characteristics are provided in \textbf{Table 2} .

Postoperative RT was started after a median time of 58 (IQR 53-69) days
for the 17 patients treated with surgery. Exclusive RT was initiated
after a median time of 29 (IQR 20-42) days following the first clinical
examination performed by the Radiation Oncologist (22 patients). For the
4 patients who had undergone induction chemotherapy, a median time to RT
start was 24 (IQR 14-30) days from the last cycle.

Median OTT was 50 (IQR: 47-54.25) days. Overall, RT was
interrupted/delayed in seven patients (16\%) as a consequence of a
suspected COVID-19 infection. Specifically:

- One patient presenting with fever was diagnosed with COVID-19- related
pneumonia on March 4\textsuperscript{th} after receiving 18 Gy out of
the prescription dose of 70 Gy for cT1cN2M0 HPV-positive oropharyngeal
cancer, TNM 8th edition\textsuperscript{18}. The patient required
hospitalization for intensive respiratory distress of COVID-19 related
pneumonitis and was treated at an intensive care unit of a dedicated
COVID-19 hospital. After a quarantine period the patient was proven
negative at two consecutive nasal swabs (7\textsuperscript{th} April).
Due to a prolonged interruption of 57 days, after multidisciplinary
discussion, a salvage surgery \selectlanguage{ngerman}± post-operative RT according to pathology
specimen findings was proposed.

- Four patients had their RT interrupted following the onset fever.
Nasal swabs tests were negative in all cases. RT breaks was 2 days for
all patients.

- One patient interrupted curative RT for 23 days due to the quarantine
measurements of her residence area. Treatment was interrupted at the
dose of 62 Gy. OTT time was 105 days (further interruptions were needed
for severe skin RT-induced toxicity).

- One patient with oral cavity cancer is experiencing a delay in the
beginning of his adjuvant therapy. Following surgery, he subsequently
developed COVID-19 pneumonia. Despite two consecutive swabs detected no
sign of infection, the third one proved to be positive. Further two
consecutive swabs performed recently demonstrated absence of COVID-19
infection. The patients is actually scheduled to start postoperative RT
which will be performed after 71 days from surgery.

Overall, follow-up consultations were regularly performed until April
19\textsuperscript{th} 2020\textbf{.} Telehealth surveillance
subsequently performed for 21 patients. Among these three patients who
had completed their RT course, were scheduled for a short-term
consultation for a more comprehensive assessment (tracheostomy removal,
toxicity evaluation and physical assessment of gross tumor response,
respectively).

\textbf{3.4 Impact on Health professionals}

Overall, two health care professionals involved in the management of HNC
patients (a Radiation Therapist and a Radiation Oncology Resident, 51
and 33 years old, respectively) were found to be COVID-19 positive at
nasal swabs. Both of them had been in contact with the patient diagnosed
with COVID-19- related pneumonia. They have no comorbidities and
clinical presentation of COVID-19 infection was mild in both cases
(anosmia, diarrhea, fatigue and fever). No respiratory symptoms were
reported and hospitalization was therefore not needed. In compliance
with safety measurements, both of them were re-admitted to work after
two consecutive negative nasal swabs.

Since pregnancy, has been recognized as a risk factor for developing a
COVID-19 related severe acute respiratory distress
syndrome\textsuperscript{19}, a Radiation Oncology resident in her
seventh month of pregnancy was suspended from clinical practice and was
assigned research works she could manage from home.

\textbf{DISCUSSION}

Radiation treatment management of HNC patients in the COVID-19 era is
challenging. As Lombardy was the first European area affected form
COVID-19 pandemic, guidelines and recommendation for RT in HNC patients
were very limited at that time. Therefore, our Department approved
extra-caution measurements to maintain adequate safety standards for
both patients and healthcare personnel to minimize the risk of
transmission. Our experience has shown that the designation as an
oncological hub, together with internal procedures, allowed to preserve
our standard of care while protecting health professionals treating HNC
patients.

As COVID-19 likely binds to epithelial cells in the nasal cavities and
the oropharynx\textsuperscript{20}, aerosolized droplets from infected
patients determine a high risk of transmission during the whole HNC
clinical workflow, from diagnosis (i.e. physical examination, trans-oral
endoscopy) to treatment delivery (i.e. surgery, RT± systemic
therapy)\textsuperscript{5}. During the emergency, it was difficult to
identify a clear cut between our duty to provide optimal care and the
one to protect healthcare professional and their families from
infection\textsuperscript{5}. Specifically, contamination reduction had
to be balanced with the need of guaranteeing access to the best
treatment options, as per national and international
guidelines\textsuperscript{6}. If an absolute solution to this ethical
question is probably impossible to be found, the issue has been debated
by some authors. Shuman et al advocate for a deliberate effort towards
balancing exposure and maintaining moral and professional integrity in
patient care\textsuperscript{21}.

An additional concern for HNC patients who undergo RT is the
counterbalance between the benefit of a timely delivered treatment and
the risk of contracting COVID-19 infection during the 7 weeks of an
average curative-intent irradiation. In this regard, Bhattacharjee et al
developed a multistate and hazard model to simulate the risk of death
from disease progression vs the risk of death from COVID-19 infection in
patients diagnosed with stage IV cancer of the oral
cavity\textsuperscript{22}. Given the risks of hospital admission, the
authors suggest to defer treatment in this subset of HNC patients and to
make efforts to minimize the chance of infection. While statistical
models can provide reasonable solution to practical and ethical problems
in the COVID-19 era, there was an unmet need for practice
recommendations encompassing different clinical scenarios (i.e. curative
vs adjuvant treatments, high-risk vs low-risk adjuvant settings). To
this aim, a joint effort by the ASTRO and ESTRO has produced an expert
consensus statement for five common cases of HN
carcinoma\textsuperscript{7}. While the reader is invited to refer to
the full recommendations, we would like to focus on the need of
adequately prioritizing treatment at the time of limited resources. Of
note, as the authors claim, all measurements and recommendations need to
be weighted according to the extent and duration of the pandemic across
nations and regions, which are hardly predictable and constantly
evolving\textsuperscript{7}. As hospitals represent critical areas in
the epidemiology of the disease: it is therefore straightforward to
understand how critical it is to keep transmission rates as low as
possible in all healthcare facilities. The rationale of oncological hubs
instituted in March 2020 is to provide the best treatment options to the
highest number of safely eligible patients, in order to preserve
oncological outcomes of these populations. Our experience shows that
these measures were effective in limiting cross infections for
candidates to curative-intent RT for HNC. Overall, we did not experience
a significant reduction in the number of treated patients, while
maintaining high quality standards for delivered treatments.

In the context of HNCs, IMRT has proven to be superior to 3-dimensional
conformal radiotherapy in reducing both acute and long-term
treatment-related side effects (i.e. xerostomia, dysphagia) without
jeopardizing oncological outcomes\textsuperscript{23--25}. Coherent with
these results, we decided not to modify our planning strategies and to
prioritize the maintenance of high-quality treatment standards for our
patients. To this aim, set-up accuracy is an essential condition to
ensure a safe and effective treatment delivery. Therefore, in order to
assure an accurate set-up, our immobilization device is provided with a
mouthpiece-assisted bite for every curative-intent treatment. A previous
study from our Department showed that using this device maintain the
set-up error within 5 mm in all directions\textsuperscript{26}. As we
did not test the outcomes of patients' positioning without a
mouthpiece-assisted bite, we favored to maintain our standard
immobilization procedures despite they could not allow patients to wear
surgical masks. Accordingly, all Radiation Therapists managing HNC
patients were considered at high risk of COVID-19 infection and equipped
with personnel protection accordingly. Therefore, they were instructed
to safely use PPE, as well as to adequately sanitize treatment rooms and
any equipment in contact with patients. Results of our report highlight
that to maintain a high quality standard of care, RT for HNC patients
requires adequate personal protection as well as a department
re-organization to optimize the room sanitization.

Considering that a percentage of individuals ranging from 13\% to 30\%
were found to be COVID-19 asymptomatic, all HNC patients were considered
as potentially COVID-19 carriers\textsuperscript{6,27}. One of the
limitations in our management was the impossibility to perform a
swabs-based screening to all patients prior to the beginning of RT. A
Chinese respective cohort study has underlined that the correct use of
PPE prevented all 41 healthcare workers included in the analysis from
being infected following the contact with COVID-19-positive
patients\textsuperscript{28,29}. Despite higher probability of contact
with COVID-19 infected patients, Lombardy centers received, less PPE
than the Italian average, most probably due to insufficient supply at
the beginning of the outbreak. As an example, FFP2 and FFP3 provisions
to the healthcare personnel were approximately 2 and 3 times lower in
Lombardy than other regions, respectively\textsuperscript{1}. Therefore,
at our Department during the first weeks of the outbreak, priority for
PPE assignment was given to those managing HNC patients. Arguably, this
strategy probably contributed to reduce cross-infections between
potentially COVID-19 positive HNC patients and health care providers.
The relatively limited number of COVID-19 cases among health
professionals in our Department could therefore be explained by contacts
with asymptomatic carriers before rigorous self-protection measurements
were introduced. Encouragingly, no other cases were diagnosed among our
Colleagues recently. This might suggest that the high risk of
cross-infection of HNC patients management was mitigated by the use of
adequate PPE.

We are well aware that further protective measurements could have been
taken. Possibly, the risk of viral dissemination could have been further
reduced by defining two separate working shifts for health care
professionals, as well as by creating separate areas for patients at
higher risk for COVID-19 infection. Serological screenings for the whole
staff have been executed only in a minority of swab-proven cases, while
a systematic testing is programmed for the upcoming weeks. However, at
the time of the outbreak available guidelines and/or recommendation were
scares and admittedly, the pandemic urged us to quickly address
unprecedented issues and to balance patients' and personnel's safety and
oncological indications.

Overall, the peculiarities of our experience derive from our designation
as an oncological hub in an area of severe COVID-19 outbreak, from the
patients' volume and from the need (especially in the early phases of
the emergency) of optimizing the use PPE. However, our aim is far from
being either educational or didactic. The current work should in fact be
considered as an early report of our management for HNC patients at the
time of an unprecedented global health crisis. Nevertheless, we believe
that it could be useful to provide our Fellow Radiation Oncologists with
a set of indication covering Department organization in providing
patients' and health professionals protection.

\textbf{Conclusion:} We presented the first report analyzing the
beginning of COVID-19 pandemic in Europe with a dedicated focus on HNC
patients candidate to curative radiation treatments. Results of the
present work show that an adequate and well-timed organization (both in
terms of national/regional and Institutional rules) permitted us to
maintain a high quality radiation therapy standards of care, balancing
the best clinical practice with healthcare personnel's safety.

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