The AIRO community has quickly faced the emergency by producing - PowerPoint Presentation

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The AIRO community has quickly faced the emergency by producing

a public guidance document for the Radiation Oncology Departments

indicating how to manage the emergency.

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Italy experienced one of the world’s deadliest COVID-19 outbreaks and healthcare systems had to instantly reorganise activity.

The Italian Radiation Oncology Departments adapted numerous solutions

to minimize the disruptions.

Information technologies, treatment prioritization,

implementation of hypofractionation and protection procedures allowed balancing between cancer patient care and patient/healthcare workers safety. Radiotherapy and Oncology 149 (2020) 89–93

12 May 2020

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Considering

that RT treatments are indicated in about 50% of cancer

patients, Italian Radiation Oncology Departments had to fully

reorganise their activity trying to find an hypothetical trade-offbetween the risk of cancer progression in case of RT interruptionand the likelihood of SARS-CoV-2 infection

in case of RT initiation or continuation.

The present study, based on a digital survey administered to the Directors of the Italian Radiation Oncology Departments

through the AIRO mailing list,

is aimed at identifying the strategies that the Italian RT facilities

have implemented to face this unprecedented emergency.

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An online questionnaire (32 multiple-choice questions) based on the first COVID-19 reports and on the former investigation carried out in Lombardy was administered to the 176 Directors of Italian Radiation Oncology Departments, members of the AIRO,

between the 6th and 16

th

april

2020.

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PART 1: GENERAL INFORMATION

20% of responders worked in Lombardy, the most populated Italian region

Approximately 80% of RT facilities are active in hospitals equipped with an emergency department

Within few weeks from the outbreak, 85 structures (68%) became COVID-19 centres, requiring immediate reorganisation of the entire facility.

PART 2: MANAGEMENT OF CLINICAL AND OUTPATIENT ACTIVITIESThe management of the emergency was mainly (88.8%)

coordinated by the Director of the department.Most centres were compelled to

reorganise their therapeutic and outpatient activities: one of the most widely implemented strategies included the extensive use of hypofractionated

regimens (92, 73.6%)

. This approach was most frequently adopted by large centres (>500 pts/year) compared to smaller institutions (75.9% vs 58.8%), regardless of their academic profile.

Rescheduling of the patients waiting lists

(prioritization)

was also carried out in 78 facilities (62.4%) but did not affect first out-patient consultations, which continued to be ensured almost everywhere.

On the other hand, virtually all responders had to

cancel routine

follow-up

examinations

and maintain only those with high priority (high risk of recurrence, acute RT-induced toxicity): in 78 centres (62.4%) telematic consultations were activated.

Even though

no centres closed

, the emergency inevitably brought some repercussions on the overall clinical activity volumes of the interviewed centres, as 38 (30.4%) reduced their

workload

by 10–30% and 11 (8.8%) by 30–50%.

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PART

3

: PATIENTS

MANAGEMENT

AND CLINICAL PRACTICE

The first-line screening

, consisting in phone interviews, was adopted in 61 centres (48.8%); the second-line control, consisting in a checkpoint at the main hospital entrance, was available in 68 facilities (54.4%) and was mainly carried out by nurses; approximately 75% responders also opted for a further level of triage at the entrance of their Radiation Oncology Department.

The patients allowed to access the Radiation Oncology Department had to follow strict

measures.:

wear a surgical mask (98.4%), respect inter-personal distance (94.4%) and could not be accompanied (76%).

Interestingly, 76 centres (62.3%) had

no confirmed COVID-19 positive patients

during ongoing treatment, and 32 centres (26.2%) had three or less.

Only a minority (5 centres on 136) declared their intention not to treat at all the COVID-19 positive patients with RT.

Positive patients

were mostly affected by

lung or head and neck cancers

.

In case of positive patients, approximately two out of three centres opted for suspending the treatment.

In a positive patient who resulted negative after two consecutive swabs, about half centres stated they would start or continue the suspended treatment immediately; other responders were more cautious and would wait for additional 14 or even 30 days.

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PART 4: MANAGEMENT OF PERSONNEL

In virtually all facilities, some basic

protections

, such as surgical masks and gloves, were provided indiscriminately

to any type of personnel, while more sophisticated personal protective equipment (PPE), such as protection class 2 filtering facepieces (FFP2), was a prerogative of personnel in close contact with patients, such as physicians, nurses and RT technicians. As far as meetings are concerned, only minorities decided to keep or, conversely, to cancel all of them (4 vs 16, 3.2% vs 12.8%, respectively) and about half responders opted for virtual solutions.To limit

overcrowding, working from home solutions were permitted to a large proportion of personnel not in direct contact with patients (61 centres, 48.8%); only few centres extended this modality also to sanitary staff (14, 11.2%), preferring turnover (64, 51.2%) or recovery of hours or holidays (44, 35.1%). Of note, in one centre, the risk of infection between operators and patients was reduced by defining two working teams who never meet each other and by extending the working time. These measures had some impact on the

linac quality assurance procedures, as in 13 centres (10.4%), some changes occurred

45% of centres had one or more staff persons in

quarantine

(any COVID-19 related absence), Physicians and RT technicians were most frequently infected, followed by nurses, medical physicists and other personnel.

In 20 centres (16.0%), mostly located in Northern Italy, the medical staff was deployed elsewhere to cope with the

emergency,

requiring a daily effort in the large majority of cases.

Considering the possible psychological and emotive repercussions brought by the emergency, in approximately half of the centres

psychological

support for personnel and/or staff was activated.

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We mentioned before the increasing number of

national and international guidelines, that

during months have been joined by many

detailed disease-oriented recommendations, as those presented here.

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1. Which patients can have in-person clinic visits

safel

delayed

or converted to telehealth visits?

2. Which patients can safely avoid treatment or have treatment deferred, and for how long? 3. Which patients can have radiation therapy safely deferred with the initiation of ADT, and for how long?

4. For patients undergoing treatment, what are the preferred modalities and fractionation by disease risk?

In generating these recommendations, the following assumptions were made:

(1) the pandemic will last for multiple months, often occurring in multiple waves with variable severity;

(2) during the pandemic, a significant proportion of staff will not be available to work ;

(3) capacity of hospital services will be exceeded and stress the hospital system;

The combined effect is that resources will be stressed and normal workflow will not be possible

Importantly, these recommendations apply only to patients not infected with COVID-19.

The goal of this rapid review was to synthesize knowledge to provide a framework

for clinical practice and management of prostate cancer during the COVID-19 pandemic, answering to these key questions:

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1) REMOTE VISITS: all visits should be transitioned to telehealth visits. Very few patients require an in-person visit during a pandemic, and the minimal value of a digital rectal examination is less important than the risk of COVID-19 exposure.

2) AVOIDANCE OF RADIATION THERAPY:

for very low-, low-, and

favorable

intermediate-risk disease, treatment deferral until after pandemic restrictions have been lifted is thought to be safe.3) DEFERRAL OF RADIATION THERAPY: patients with unfavorable intermediate-risk, high-risk, very high-risk, post-prostatectomy, clinical node-positive, oligometastatic, and low-volume M1 can variably delay in-person new patient consultations and return visits. After these patients have initiated treatment, ADT can allow for further deferral of radiation therapy as necessary.).

Significant prolongation of ADT beyond standard of care should be avoided given the potential for increased morbidity and other-cause mortality.

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4) SHORTENING OF RADIATION THERAPY: if treatment is deemed necessary and safe, the shortest fractionation schedule that has evidence of safety and efficacy should be adopted.

For localized prostate cancer,

5- to 7-fraction SBRT/

ultrahypofractionation

should be used, which is in accordance with the 2020 National Comprehensive Cancer Network guidelines as an acceptable regimen for intermediate- and high-risk prostate cancer. For centers without the ability to perform image guidance (CBCT with or without fiducial markers), a 20-fraction regimen can be used to 60 to 62

Gy.

For low-volume M1 disease, either SBRT or 6 Gy 6 fractions is safe and acceptable.

Non-essential procedures that do not have evidence to support their impact on overall survival rates, such as a prostate MRI, fiducial markers, and/or rectal spacers,

should be used very selectively

given they require either prolonged or extra patient visits.

There was unanimous consensus that if treatment needs to be performed during the peak of the pandemic,

brachytherapy is not

recommended given its reliance on

anesthesia

staff and PPE.

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Given that breast RT accounts for 30 per cent of delivered RT fractions, the following recommendations require particularly urgent consideration.

By adopting these recommendations where RT is minimised

and targeted to those with the highest risk of relevant breast recurrence,

we aim to protect our patients and health care professionals

from potential exposure to COVID-19

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Omit RT for patients 65 years and over (or younger with relevant co-morbidities) with invasive breast cancer that are up to 30mm with clear margins, grade 1-2, ER positive, HER2 negative and node negative who are planned for treatment with endocrine therapy.

Deliver RT in 5 fractions

for all patients requiring RT with node negative tumours that do not require a boost.

Options include 28-30Gy in once weekly fractions over 5 weeks or 26Gy in 5 daily fractions over 1 week as per the FAST and FAST Forward trials, respectively

. Partial breast RT using 28.5-6Gy in 5 fractions over 1-2 weeks can also be considered for selected patients if resources are available for increased complexity and/or to avoid deep inspiration breath hold (DIBH) for left sided tumours in the upper half of the breast (if DIBH impacts on treatment time).

Boost RT should be omitted to reduce fractions and/or complexity in the vast majority of patients unless they 40 years old and under, or over 40 years with significant risk factors for local relapse (i.e. involved resection margins where further surgery is not possible). Boost RT has no proven survival advantage so risks and benefits during the COVID-19 pandemic need to be re-evaluated.

Nodal RT

can be omitted in post-menopausal women

requiring whole breast RT following sentinel lymph node biopsy and primary surgery for T1, ER positive, HER2 negative G1-2 tumours with 1-2

macrometastases

.

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For curative-intent treatments, there are parallel and specific

challenges facing the head and neck (HN) oncologist:

(1)

operating r

oom closures, with increased requirement for nonsurgical treatments; (2) an altered risk-benefit ratio of

chemotherapy and radiation therapy as a result of increased susceptibility for SARS-CoV-2 infection; (3) a need to suppress coronavirus spread by

minimizing travel of patients for daily treatments and the exposure of hospital and radiation therapy staff; (4

) a shortage of radiation therapy

resources because of staff sickness or leave for family care, entailing allocation of resources and triage of patients.

The use of

hypofractionated

radiation therapy could help address the latter 2 concerns, but these regimens may be unfamiliar to many radiation oncologists,

and there is a risk of inappropriate application if these fall outside current international guidelines

The pandemic has strained cancer services, with routine outpatient appointments cancelled,

elective surgeries postponed,

and resources diverted to the front line.

For the oncology clinician wishing to offer palliative therapies, there is a Hobson’s choice: a high symptom burden from cancer without treatment or an increased risk of

more imminent death from SARS-CoV-2 infection resulting from the exposure and stress of therapy.

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Management of head and neck cancer (HNC) during the COVID-19 outbreak is challenging. Not only patients diagnosed with HNC are often comorbid and frail but may have specific features increasing their risk of being more severely affected by COVID-19 infection.

Treatment-related sequelae, including but not limited to the presence of tracheostomy and the myelosuppressive action of chemo- and radiotherapy, further increase

the threat of the pandemic on these patients’ health. RT represents a mainstay in HNC, both in the definitive and in the post-operative setting .

While the unprecedented COVID- 19 emergency is requiring health care professionals to redefine treatment paradigms, there is a general agreement on three basic principles for HNC management in Radiation Oncology: (1)

curative-intent RT should be considered as non-deferrable

(2) treatment

breaks

should be minimized to preserve patients’ outcomes

(3) Maintenance of adequate

quality

standards should be guaranteed, especially when highly conformal techniques are used.

As for surgical treatments, patients undergoing RT may be required to remove their medical masks for either physical examination or set-up procedures (e.g. thermoplastic mask positioning), thus requiring additional cautions by healthcare providers.

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Given the different distribution of COVID-19 incidence and prevalence across the country, the panel was required to evaluate the issue of

patients’ relocation in another region

for RT delivery. While responders generally agreed on the possibility of recommending treating facilities close to the patient’s domicile, a strong degree of consensus was not reached. Specifically, responders suggested

considering high-volume centers whenever possible, as both RT technique and treating Radiation Oncologist’s experience have been associated with better oncological outcomes.

Overall, the panel underlined that multidisciplinary team meetings should be maintained to discuss individual indication to RT.

T

he possibility of offering alternative

treatment strategies was discussed and approved for early-stage

tumors

, such as mini-invasive surgery for T1–T2 cancers of the glottis.

A

lthough

hypofractionated

schemes may be proposed,

20 is the lowest currently accepted number of fractions for curative-intent treatments.

Therefore,

the choice to address to mini-invasive surgery would have the advantage to prevent patients from multiple accesses to the hospital and therefore limit the risk of cross contamination

.

To this aim, caregivers’ access to the Radiation Oncology Department should be discouraged.

However, the

panel recognized that a caregiver could attend medical consultations in selected cases

(i.e. senior individuals, speech impairment, and linguistic barriers). As the

reduction of psychological distress

has been correlated with increased compliance to treatment and better oncological outcomes, caution in balancing strict safety policies and support from the caregivers is advised for this subset of patients.

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In this setting of the COVID-19 pandemic, hypofractionation is an attractive treatment option, one that is actively being discussed within the radiotherapy community on social media platforms.

On the other end of the spectrum

, adoption of appropriate hypofractionation might be low if that practice is outside of international guidelines and not endorsed by recognized experts and professional societies,

yet such guidelines often take many months to develop.

In this practice recommendation, which is endorsed by the ESTRO and ASTRO, an international group of experts in lung cancer RT aims to rapidly provide guidance about the potential need to adapt the practice and fractionation for lung cancer in the current COVID-19 pandemic.

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There are 3 potential strategies to reduce the demand for RT during the pandemic:

omitting, delaying, and shortening the RT course.

To decide on the most appropriate action in patients with hematologic malignancies, clinicians need to carefully assess disease factors (indication for radiotherapy, expected benefit, and natural history of disease) and patients’ individual risk in case of COVID-19 infection (age, comorbidities, and expected case-fatality rate)

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OMITTING RT: When the risk of severe outcomes from COVID-19 infection

(for those aged > 60 years and/or with serious underlying health conditions)

outweighs the benefit of RT

, omitting RT is to be considered in the following situations:

in a palliative setting, where alternatives can be offered (eg, optimizing pain control); for localized low-grade lymphomas if completely excised (eg, follicular lymphoma, marginal zone lymphoma, cutaneous B-cell lymphoma);for localized nodular lymphocyte-predominant Hodgkin lymphoma if completely excised;

in consolidation RT for diffuse large B-cell lymphoma/ aggressive non-Hodgkin lymphoma (NHL) in patients who have completed a full chemotherapy course and achieved a complete remission.

Multidisciplinary discussion of each individual case is important.

DELAYING RT:

When there is no or little expected adverse effect on outcome

from the delay

, delaying RT is to be considered in the following situations:

for asymptomatic localized low-grade lymphomas;

for localized nodular lymphocyte-predominant Hodgkin lymphoma;

in a palliative setting for low-grade lymphomas in stable patients;

for patients who develop COVID-19 infection prior to commencing RT, until the infection is clear, provided the malignancy is not progressing.

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SHORTENING RT: Using alternative hypofractionation RT regimens when RT cannot be omitted or delayed is to be considered with the aim of maintaining high cure/palliation rates without undue toxicity.

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Despite the severity of the pandemic in the so-called Italian phase (P) 1 (18th March–3rd May 2020), RT facilities in the country managed to efficiently reorganised themselves to maintain a high standard of care while minimising the risk of contagion for patients and staff.

The authorities introduced, on the 3rd May 2020, the so-called P2 (4th May2020–today).

The present study, which represents the natural evolution of a previous investigation conducted in the middle of P1

aims to query the directors of Italian RT centres, through an online questionnaire, about the approach and measures undertaken during P2 of the COVID-19 pandemic to restore the normal workload and revert to a new normality.

The survey was sent to 177 Directors of RT facilities, members of AIRO,

between June the 10th and

July the

13th of 2020.

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Thanks to all the adopted measures to limit contagion among staff and patients, the pandemic effect on the Italian RT centres during P1 was, ultimately, modest

, with most centres (55, 61.8%)

reporting no reduction

or a decrease in clinical activity not higher than 10%.

Therefore, the average reduction of clinical activities in Italy turned out to be much less marked than that of Europe (38% centres reporting a reduction <80%) and US (84% centres reporting a reduction <80%).This was reflected by the proportion of centres registering positive cases which

dropped down from 43.8% in P1 to 10.1% in P2, and in the maximum reported number of positive staff cases per centre, which decreased from 18 to 2.

On the contrary, with the advent of P2, RT Directors globally reported a progressive

realignment

with the pre COVID-19 era workload for both outpatient and clinical activities.

Therefore, the present survey demonstrated how the planned progressive return to a novel routine during P2 has been attained by most Italian RT centres, maintaining high safety standards against a possible new spread of the infection and registering a lower number of positives cases among both patients and health professionals despite the resumption of a pre COVID-19 era workload.

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