Evaluation of COVID-19 impact on DELAYing diagnostic-therapeutic pathways of lung cancer patients in Italy (COVID-DELAY study): fewer cases and higher stages from a real-world scenario.

INTRODUCTION: COVID-19 has disrupted the global health care system since March 2020. Lung cancer (LC) patients (pts) represent a vulnerable population highly affected by the pandemic. This multicenter Italian study aimed to evaluate whether the COVID-19 outbreak had an impact on access to cancer diagnosis and treatment of LC pts compared with pre-pandemic time. METHODS: Consecutive newly diagnosed LC pts referred to 25 Italian Oncology Departments between March and December 2020 were included. Access rate and temporal intervals between date of symptoms onset and diagnostic and therapeutic services were compared with the same period in 2019. Differences between the 2 years were analyzed using the chi-square test for categorical variables and the Mann-Whitney U test for continuous variables. RESULTS: A slight reduction (-6.9%) in newly diagnosed LC cases was observed in 2020 compared with 2019 (1523 versus 1637, P = 0.09). Newly diagnosed LC pts in 2020 were more likely to be diagnosed with stage IV disease (P < 0.01) and to be current smokers (someone who has smoked more than 100 cigarettes, including hand-rolled cigarettes, cigars, cigarillos, in their lifetime and has smoked in the last 28 days) (P < 0.01). The drop in terms of new diagnoses was greater in the lockdown period (percentage drop -12% versus -3.2%) compared with the other months included. More LC pts were referred to a low/medium volume hospital in 2020 compared with 2019 (P = 0.01). No differences emerged in terms of interval between symptoms onset and radiological diagnosis (P = 0.94), symptoms onset and cytohistological diagnosis (P = 0.92), symptoms onset and treatment start (P = 0.40), and treatment start and first radiological revaluation (P = 0.36). CONCLUSIONS: Our study pointed out a reduction of new diagnoses with a shift towards higher stage at diagnosis for LC pts in 2020. Despite this, the measures adopted by Italian Oncology Departments ensured the maintenance of the diagnostic-therapeutic pathways of LC pts.

Fewer early stage breast cancer diagnoses after COVID-19 outbreak: Preliminary report from the Italian COVID-DELAY study

Background: The coronavirus disease (COVID-19) has imposed an unprecedented challenge on the Health Care System. With the reallocation of crucial health resources to effectively exit the crisis, the pandemic has profoundly affected cancer patients' (pts) management. Breast cancer (BC) diagnosis results, especially in the early stage, from screening programs temporarily paused during COVID-19 outbreak. The aim of our multicenter study is to investigate the impact of COVID-19 on the likelihood of receiving timely diagnosis, staging and treatment for BC pts compared to pre-pandemic period. Material (patients) and methods: Medical records of all consecutive newly diagnosed BC pts referred to 4 Italian Oncology Departments between March and December 2020 were assessed. Monthly access rate and temporal intervals between date of symptoms onset, radiological, cytohistological diagnosis and treatment start were analyzed and compared with those of the same period in 2019. Differences between the two years were analyzed using Fisher's exact or chi-square test for categorical variables and unpaired Student t test, or the Mann-Whitney U test for continuous variables. Results: A significant reduction (23%) in newly diagnosed BC pts was seen when compared with 2019 (552 vs 719). Newly BC pts in 2020 were less likely to be diagnosed with early stage (stage I-II) BC (77% vs 84%, p < 0.01), had a worsened ECOG PS (19% had PS > 0 in 2020 vs 16% in 2019, p = 0.15) and were more symptomatic at diagnosis (43% vs 23%, p < 0.01). Other clinical and tumor characteristics (such as histotype [p = 0.23] and molecular subtype [p = 0.71]) were similar regardless of the year. Looking at pts management, time intervals between symptom onset and radiological diagnosis (median 17 days in 2020 vs 21 in 2019, p = 0.04), symptom onset and cytohistological diagnosis (26 vs 35 days, p = 0.06), cytohistological diagnosis and treatment start (median 62 vs 76 days, p < 0.01) were maintained or even improved. However, less BC cases were discussed in multidisciplinary tumor meetings during the 2020 (52% vs 69%, p < 0.01). Conclusions: While the COVID-19 effects on cancer care will be likely felt for years to come, our data indicate a sharp decline in BC detection in 2020 with major impact on early stage diagnosis. Despite the upheaval generated by this global Health Care crisis, our study proves the effectiveness of the actions taken by Oncology Departments to guarantee diagnostic-therapeutic pathways.

COVID-19 impact on colorectal cancer care in 2020: Preliminary data from the Italian COVID-DELAY study

Background: Since March 2020, Coronavirus disease 2019 (COVID-19) has rapidly spread worldwide causing a massive Health Care crisis with Italy among the most affected countries. Oncology care has been widely derailed and cancer screening programs halted to effectively face the pandemic. Aim of our multicenter study is to assess how COVID-19 has impacted on the likelihood of receiving timely diagnosis, staging and treatment for colorectal cancer (CRC) patients (pts) during the 2020 compared to pre-pandemic period. Material (patients) and methods: All consecutive medical records of newly diagnosed CRC pts referred to 4 Italian Oncology Departments between March and December 2020 were evaluated. Monthly access rate and temporal intervals between date of symptoms onset, radiological and cytohistological diagnosis, treatment start and first radiological evaluation were analyzed and compared with the same months of 2019. Differences between the two years were evaluated using Fisher's exact or chisquare test for categorical variables and unpaired Student t test, or the Mann-Whitney U test for continuous variables. Results: A considerable drop (20%) in newly diagnosed CRC cases emerged compared to 2019 (214 vs 268). The lockdown period was more impacted by such decrease compared to the other months (percentage drop 40% vs 12%). New CRC diagnoses in 2020 were less likely to be diagnosed with early stage (stage I-II-III) CRC (67% vs 72%). Other clinical and tumor characteristics such as age, gender, sidedness and mutational status were similar regardless of the year. Looking at pts management, no differences were seen in terms of interval between symptom onset and radiological diagnosis (median 19 days in 2020 vs 28 days in 2019, p=0.88), symptom onset and cytohistological diagnosis (25 vs 36 days, p=0.27), symptom onset and treatment start (median 86 vs 100 days, p=0.79). However, less CRC were discussed in multidisciplinary tumor meetings during the 2020 (45% vs 54%, p=0.07). Conclusions: While COVID-19 effects on cancer pts' outcome might unfold in the years to come, our preliminary data show a remarkable drop in early stage CRC diagnoses throughout 2020. The Italian Oncology Departments managed to optimally tackle the quality care issue ensuring prompt diagnosis and treatment despite the pandemic evolving scenario. Further investigation, including larger case series, are warranted to offer a more exhaustive picture of the impact of COVID-19 emergency on cancer care.

Evaluation of COVID-19 impact on DELAYing diagnostic-therapeutic pathways of lung cancer patients in Italy: Real-world evidence from the COVID-DELAY study

Background: The coronavirus disease 2019 (COVID-19) had an unprecedent impact on the global health care system since March 2020. Lung cancer (LC) patients (pts) represent a vulnerable population, and diagnostic/therapeutic delays might affect the years to come. Aim of the multicenter, real-world, Italian COVID-DELAY study was to evaluate how the 2020 COVID-19 pandemic impacted on LC pts' access to diagnosis and treatment compared to pre-pandemic time. Patients and methods: All consecutive newly diagnosed LC pts referred to 25 Italian Oncology Departments between March and December 2020 were reviewed. Monthly access rate and temporal intervals between date of symptom onset, diagnosis and treatment start were analyzed and compared to the same period of 2019. Differences between the two years were analyzed using Fisher's exact test or chi-square test for categorical variables and unpaired Student t test, or the Mann-Whitney U test for continuous variables. Results: Less LC cases (1523 vs 1637, -6.9%) were diagnosed during the 2020 pandemic compared to 2019. LC pts in 2020 were more likely to be diagnosed with stage IV disease (p < 0.01) and to be current smokers (p < 0.01). A major drop of new LC cases was seen during the lockdown period (percentage drop -13.2% vs -5.1%) compared to the other months included. Moreover, a geographic migration was observed with more LC patients referring to low/ medium volume hospital in 2020 compared to 2019 (p = 0.01). Looking at pts management, no differences emerged in terms of interval between symptom onset and radiological diagnosis (p = 0.94), symptom onset and cytohistological diagnosis (p = 0.92), symptoms onset and treatment start (p = 0.40), treatment start and first radiological revaluation (p = 0.36). However, less LC patients were treated in the context of clinical trials during 2020 (5% vs 7%, p = 0.07). Conclusions: Our study pointed out a decrease of new LC cases and a shift towards a higher stage at diagnosis in 2020. Despite this, the efforts put in place by the Italian Oncology Departments ensured the maintenance of the diagnostic-therapeutic pathways of LC patients.

Drop in early-stage colorectal cancer diagnoses after COVID-19: Preliminary report from the COVID-DELAY study

Background: By the end of 2020, coronavirus disease 2019 (COVID-19) would have indelibly marked the cancer care setting. With Italy at the forefront of pandemic, unprecedented measures were adopted to tackle the quality care issue. As a result of pausing screening programs, diagnostic delays might affect the years to come. Aim of our multicenter Italian study is to evaluate whether the COVID-19 outbreak has impacted on likelihood of receiving timely diagnosis, staging and treatment for colorectal cancer (CRC) patients (pts) after March 2020 compared to pre-pandemic time. Methods: Medical records of all consecutive newly diagnosed CRC pts referred to 4 Italian Oncology Departments between March and December 2020 were examined. Access rate (number of pts/days) and temporal intervals between date of symptoms onset, radiological and cytohistological diagnosis, treatment start and first radiological evaluation were analyzed and compared with the same months of 2019. Differences between the two years were evaluated using Fisher’s exact test or chi-square test for categorical variables and unpaired Student t test, or the Mann-Whitney U test for continuous variables. Results: A reduction (20%) in newly diagnosed CRC cases was seen when compared with 2019 (214 vs 268). The decline was greater in the lockdown period compared to the other months (percentage drop 40 % vs 12%). Newly CRC pts in 2020 were less likely to be diagnosed with early stage (stage I-II-III) CRC (67% vs 72%). Other clinical and tumor characteristics were similar regardless of the year. Looking at pts management, no differences emerged in terms of interval between symptom onset and radiological diagnosis (median 19 days in 2020 vs 28 days in 2019, p = 0.88), symptom onset and cytohistological diagnosis (25 vs 36 days, p = 0.27), symptom onset and treatment start (median 86 vs 100 days, p = 0.79). However, less CRC were discussed in multidisciplinary tumor meetings during the 2020 (45% vs 54%, p = 0.07). Conclusions: While COVID-19 repercussions will be likely felt for decades to come, our data suggest an alarming drop in early-stage CRC diagnoses during the first pandemic year. Conversely, our study draws the attention on the efforts made to ensure diagnostic-therapeutic pathways proper operation. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.

Epidemiology and clinical course of SARS-CoV-2 infection in cancer patients in the Veneto Oncology Network during the first and second pandemic waves

Background: Since the beginning of the COVID19 outbreak, the Veneto Oncology Network ROV licensed dedicated guidelines for cancer patients care during the pandemic, and developed a regional registry (ROVID) aimed at describing epidemiology and clinical course of SARS-CoV-2 infection in cancer patients. Preliminary data on 170 patients mainly diagnosed during the first pandemic wave have been published (Guarneri V, Eur J Cancer 2021). Here we report the data of additional 270 patients, comparing clinical data and outcomes between first (W1) and second (W2) pandemic waves. Methods: All patients with cancer diagnosis and documented SARS-CoV-2 infection are eligible. Data on diagnosis, comorbidities, anticancer treatments, details on SARS-CoV-infection including source of contagion, clinical presentation, hospitalization, treatments and fate of the infection are recorded. Results: 440 patients have been enrolled, 196 diagnosed during W1 (until September 2020) and 244 during W2. The most common cancer type was breast cancer (n = 116). Significant differences in clinical characteristics between W1 and W2 were the followings: ECOG PS 0 (34% vs 58%), presence of cardiac comorbidities (30% vs 13%), presence of any co-morbidities (81% vs 62%), smoking habits (23% vs 13%). Patients diagnosed in W1 were less likely on active anticancer therapy (54% vs 73%) at the time of SARS-CoV-2 infection. Distribution per stage, presence of lung metastases, disease setting (curative vs palliative), active treatment discontinuation due to infection were similar between W1 and W2. Patients diagnosed in W1 were more likely symptomatic for SARS-CoV-2 infection (80% vs 67%), and reported more frequently an inhospital contact as potential source of infection (44% vs 9%). Significantly more patients diagnosed in W1 were hospitalized (76% vs 25%). All-cause mortality rates were 30.6% for patients diagnosed in W1 vs 12% for patients diagnosed in W2 (p < 0.001). However, deaths due to SARS-CoV-2 infection were more frequent in patients diagnosed in W2 (86% vs 54%, odds ratio 3.22;95% CI 1.97-5.279). Conclusions: Differences in clinical characteristics between W1 and W2 reflect different pattern of virus circulation. The dramatic reduction of in-hospital contact as a source of infection reflects the efforts put in place to protect this vulnerable population from in-hospital exposure. The lower all-cause mortality rate observed in W2 is in line with the observed less frail population. However, the higher relative risk of death due to SARS-CoV-2 infection observed in W2 reinforces the need to adopt protective measures including vaccination in cancer patients, irrespectively of age, stage, and comorbidities.

COVID-19 infection in cancer patients: what has been the contribution of Associazione Italiana Oncologia Medica (AIOM) to oncological care since the beginning of the first pandemic wave?

High mortality rates in elderly patients or in those with underlying chronic illnesses and/or a compromised immune system is a peculiar feature of COVID-19 infection. The possible coexistence of a cancer and COVID-19 infection in the same individual prompted concerns regarding their synergistic effect on prognosis. In order to balance patients' needs with the risks related to the infection, the question oncologists have asked from the beginning of the first wave of the pandemic has been: 'how can we deal with COVID-19 infection in cancer patients?' In pursuing its mission, the Associazione Italiana Oncologia Medica (AIOM) has made every possible effort to support cancer patients, health care professionals and institutions in the decision-making processes the pandemic has engendered within this scenario. The relevant documents as well as the educational and institutional initiatives the AIOM has taken are reported in this article.

Epidemiology and clinical course of SARS-CoV-2 infection in cancer patients in the veneto oncology network: The ROVID study

Background: COVID-19 pandemic started in Italy with clusters identified in Northern Italy. Since the beginning, the Veneto region started a proactive approach, including testing for SARS-CoV-2 part of the asymptomatic population and healthcare providers. The Veneto Oncology Network ROV licensed a dedicated PDTA to ensure proper care minimizing the risk of infection in cancer patient (pts). At the same time, a regional registry (ROVID) has been set up, to describe epidemiology and clinical course of SARS-CoV-2 infection in cancer pts. Materials and methods: All pts with cancer diagnosis and documented SARS-CoV-2 infection are eligible. The following information are recorded: age, cancer diagnosis, stage, tumor biology, comorbidities, presence of COVID- 19 symptoms, anticancer treatment at the time infection (type, aim, line of therapy, discontinuation, recovery), other medical treatments, hospitalization, treatments for SARS-CoV-2 infection, fate of the infection. Results: 144 pts from 18 centers have been enrolled. Mean age at the time infection: 69 yrs (25 to 95 yrs). The 5 most common cancer types were breast cancer (n=26), colorectal, prostate, lung cancer (n=16 each), melanoma (n=10). Distribution by stage was as follows: I 19%, II 9%, III 13%, IV 59%. Lung metastases were documented in 15% of the cases. 77% of the pts had at least one comorbidity. COVID-19 symptoms were reported in 78% of the pts. Active anticancer therapy at the time of the infection was reported for 71 pts (chemotherapy n=37, targeted therapy n=14, hormonal therapy n=13, immunotherapy n=6). Treatment was discontinued because of infection in 44 case. 101 pts were hospitalized;45 received low flow oxygen support and 26 received non-invasive mechanical ventilation, high flow nasal cannula or endotracheal intubation. The fate of infection is available for 95 cases so far: 44 infection resolution with confirmed negative swab, 16 with clinical resolution discharged with positive swab, and 35 deaths. Among cases with fatal exitus, 22 were attributable to COVID-19. Conclusions: Data collection is still ongoing, including further follow up and results of serological tests, where available. The mortality rate reported in this study is in line with other registry of cancer patients, confirming the frailty of this population. These data reinforce the need to protect cancer patients from SARS-CoV2 infection.

Social distress among medical oncologists and other healthcare professionals during the first wave of COVID-19 pandemic in Italy.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has rapidly spread to every country around the world taking on pandemic proportions. Since 8 March 2020, the Italian government ordered a nationwide lockdown with unavoidable social isolation. Healthcare professionals (HCPs) represent the most physically and emotionally involved category. The aim of this study is to assess the social distress among HCPs in Italy. PATIENTS AND METHODS: In this online, totally anonymous survey, 24 multiple choice questions were posed to medical staff employed in the Italian Healthcare System during the COVID-19 pandemic. Data collection was performed from 30 March to 24 April 2020. RESULTS: A total of 600 HCPs completed the questionnaire. The majority of respondents expressed the fear of being at higher risk of contagion than the general population (83.3%) and the weighty concern of infecting their families (72.5%). An insufficient supply of personal protective equipment (PPE; P = 0.0003) and inadequate training about procedures to follow (P = 0.0092) were seen to significantly coincide with these worries. More than two-thirds declared a change in family organisation, which showed a significant correlation with the concern of infecting their relatives (P < 0.0001). CONCLUSIONS: This is the first Italian survey on social distress among HCPs during the COVID-19 pandemic. The unavailability of PPE, screening procedures and adequate training strongly affected HCPs' emotional status. Although there was a predominance of oncologists (especially from the North of Italy), which impairs the generalisation of our findings, this survey underlined the social impact that this health emergency has had on HCPs.

COVID-19 pandemic in Italy: Socialdistress and gender imbalance among health careprofessionals

Introduction: During the last months coronavirus disease 2019 (COVID-19) has spread abruptly to nearly everycountry, taking on pandemic proportions. The Italian government ordered a nationwide lockdown to hinder thespread of the contagion with unavoidable social isolation and substantial changes in lifestyle habits. Therefore, COVID-19 affected not only physical but also psychological health and well-being. Health care professionals fightingthe epidemic represent the most involved category, resulting in more physical and emotional involvement. The aimof this study is to assess the social stress level of health care workers in Italy. Materials and Methods: In this online, totally anonymous survey, 24 multiple-choice questions were broadcast tomedical staffs employed in the Italian health care system during COVID-19 pandemic. Data collection wasperformed from 30th March to 24th April 2020. Descriptive statistics have been applied to describe and summarizeour findings and the correlation analyses between categorical variables were performed using Pearson's Chi-Square. Results: A total of 600 health care professionals completed the questionnaire with a prevalence of young (32.3%between 36 and 45 years old), female (74.0%) oncologists (58.8%). Participants mainly belong to Lombardy (31.3%)and Marche (30.3%), two of the most affected regions, but almost all the Italian regions contributed to the survey. The majority of respondents expressed the fear of being at higher risk of contagion than the general population(83.3%) and the weighty concern of infecting their own families (72.5%). An insufficient supply of personal protectiveequipment (p = 0.0003) and inadequate training about procedures to follow (p = 0.0092) significantly correlated withthese worries. Furthermore, more than two thirds declared a change in family organization and daily life, showing asignificant correlation with worry about infecting their own relatives (p < 0.0001). Discussion: This is the first Italian survey on social distress among health care professionals during the COVID-19pandemic. The unavailability of personal protective equipment, periodic screening procedures, adequate training, and the correct spread of information strongly conditioned health care professionals' emotional status, familyorganization, and daily life. With this survey we underlined the social impact that this health emergency has onhealth care workers, especially on women, who deal with “caring” in the hospital as well as at home, juggling to fulfillmultiples roles of professionals, mothers, wives, and caregivers for elderly parents. We wish that institutions couldinvolve themselves concretely to guarantee that health care professionals safely perform their work in a contextappropriate to proper professional skills and with the adequate social and psychological support. Reducing workers'fear of contagion and psychological distress will certainly bring significant positive repercussions for the nationalhealth system.