key: cord-0807699-cy01gyze
authors: Gianluca, Milanese; Federica, Sabia; Stefano, Sestini; Eufrasia, Ledda Roberta; Luigi, Rolli; Paola, Suatoni; Nicola, Sverzellati; Gabriella, Sozzi; Giovanni, Apolone; Vittorio, Marchianò Alfonso; Ugo, Pastorino
title: FEASIBILITY AND SAFETY OF LUNG CANCER SCREENING AND PREVENTION PROGRAM DURING THE COVID-19 PANDEMIC
date: 2021-03-18
journal: Chest
DOI: 10.1016/j.chest.2021.02.072
sha: 1df36d9d2df57494409d944d4720fdd74350cf23
doc_id: 807699
cord_uid: cy01gyze

nan

Since the outbreak of Coronavirus disease-2019 (COVID-19) pandemic, health care systems have focused on its containment 1, 2 , facing critical issues in managing patients with medical disorders other than COVID-19, such as cancer and cardiovascular diseases 2 .

During the first wave of the COVID-19 pandemic, an international panel of lung cancer (LC) experts recommended to delay both baseline LC screening (LCS) rounds and any further evaluation of screendetected pulmonary nodules with low probability of being malignant or likely representing indolent cancers 2 . While screening programs dropped down in the hospitals' priorities, a significant decline in the incidence of the six most frequent cancers was registered in the United States, including LC 3 . Delayed diagnosis and treatment of all LCs are well known to lead to worse outcomes (e.g., a surgical delay of 12 weeks is associated with a slightly decreased overall survival) 4 , requiring LC timely diagnosis and management to be ensured during the COVID-19 pandemic.

The SMILE trial (ClinicalTrials.gov Identifier: NCT03654105) is an ongoing LCS trial including multiple smoking cessation and anti-inflammatory interventions, performed at the Fondazione IRCCS Istituto Nazionale dei Tumori of Milan (INTM) in Lombardy, Italy, and offered to subjects from the whole country.

The baseline round enrolled 978 heavy current or former smokers, starting in July 2019, and allowed the diagnosis of ten LCs (1.0%; stage I disease: 7; 70%) to be treated with curative surgery. Enrolment was interrupted in early March 2020, when the first wave of the COVID-19 pandemic severely affected Northern Italy, and mainly Lombardy. To safely allow short-term and annual screening rounds, we expanded the INTM protocol developed for all cancer patients, by adding to the workflow a rapid severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) screening test (BIOCREDIT COVID-19 Ag, Republic of Korea). The designed COVID-19 SMILE algorithm was implemented following institutional review board and Ethics Committee approval (INT129/17, 28/09/2020) 5 .

Screenees were contacted by phone for preliminary anamnestic evaluation. Subjects who reported no COVID-19 symptoms over the previous two weeks were invited to reach Milan by private transport, to allow those testing positives to return home avoiding physical contact with other people. If public transport was needed, we requested screenees to undergo viral screening tests before the scheduled appointment to safely travel to and from INTM. Out of the 845 contacted subjects, 534 (63.2%, 221 females, 41.4%; mean age 62.1 ± 5.4 years) agreed to participate and attended one of the 13 sessions scheduled between 17/10/2020 and 30/01/2021, whereas 277 (32.7%) requested to either postpone the appointment or withdraw from the project, similarly to other reports 6, 7 (Table 1) . Participating subjects were evaluated J o u r n a l P r e -p r o o f with a median of only one-month delay, as compared to their theoretical annual round. Unsurprisingly, long distance travel to be covered by public transport reduced the adherence to the program, increasing the rate of rescheduled appointments from 16.7% for subjects living in Lombardy (median distance to cover of 17.6 km) to 89% for those from Southern Italy (median distance of 823.4 km).

LCS feasibility during COVID-19 pandemic was provided by an ad-hoc multi-step framework including detailed preliminary anamnestic evaluation for symptoms of COVID-19 and rapid antigenic testing. All LCS and prevention interventions-related costs were charged to the INTM, including the rapid antigenic test, which increased costs of about 10€ per screenee, whereas volunteers had to cover only travel expenses. We evaluated an average of 41 screenees per sessions, during which screenees had to first fill in a health questionnaire and to undergo a rapid antigenic naso-pharyngeal swab test. Those who tested negative underwent carbon monoxide (CO) test, smoking cessation and/or inflammatory status reduction intervention, with anti-tobacco and anti-inflammatory drugs, and an ultra-low-dose CT (ULDCT) scan (SOMATOM Force, Siemens Healthineers), within an average hospital stay of 97 minutes (Figure 1 ). Safety of our approach is supported by the lack of COVID-19 cases among hospital staff and, to the best of our knowledge, screenees after the appointment. Only one asymptomatic subject (0.2%) was identified as positive by the rapid antigenic swab. The screenee was instructed to return home and contact the referring general practitioner and the positivity was then confirmed at the reverse transcriptasepolymerase chain reaction test. We performed a strict selection of subjects, admitting to the complete set of the SMILE trial activities only screenees with no COVID-19-related symptoms over the previous two weeks, and testing negatives at the rapid antigenic swab. During the whole stay within INTM, subjects had to maintain social distancing and use personal protective equipment. Furthermore, the SMILE staffclinicians, nurses, biologists, and radiographers -was tested by rapid antigenic swab within 24 hours before the appointment. An on-call cleaning service was available for disinfection of rooms and equipment within 20 minutes after contact with potentially infected individuals. We also installed Ultraviolet-C lamps to provide additional and fast disinfection of the CT scanner. J o u r n a l P r e -p r o o f FIGURE LEGEND Figure 1 . Workflow of the COVID-19 SMILE algorithm: asymptomatic and apyretic screenees had to fill in a health questionnaire and to undergo rapid antigen naso-pharyngeal swabbing and blood test. Those testing negatives at the rapid antigenic swab were admitted completing the lung cancer screening and prevention program interventions of the designed algorithm (carbon monoxide (CO) test, administration of antitobacco and anti-inflammatory drugs, and ULDCT scan). ULDCT scans were immediately reviewed to ruleout COVID-19 pneumonia-related findings.

J o u r n a l P r e -p r o o f J o u r n a l P r e -p r o o f

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