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.

The psychological impact of the SARS-CoV-2 outbreack and associated factors to adjustment to the context of life and of care in Italian cancer patients

Introduction: The purpose of this study is to investigate the psychological impact of the SARS-CoV-2 and the effects on functional adaptation to the context of life and care in Italian cancer patients. Methods: We adopted a cross-sectional survey design to assess the psychosocial impact in cancer patients during the COVID-19 outbreack. To assess the behavior of patients in this stressful situation, we developed the 31-item self-assessment questionnaire “ImpACT”. Results: 445 patients from 17 Italian regions participated in the study (79.8% women, average age 58 y). 85.9% received satisfactory responses from oncologists, 81.0% from nurses, 72.1% from psychologists, 66.3% from GPs and 58.3% in Emergency rooms;59.8% reported feeling very safe in their oncology unit. 87.7% of pts reported perceiving changes in their lives compared to before the pandemic;89.9% reported feeling worried, 97.1% said they pay attention to possible signs of physical discomfort attributable to the coronavirus, 97.6% say they strictly follow the rules provided by the government and doctors. Patients who reported being anxious were more likely to be afraid medical staff may get sick (OR = 3.01;95% CI = 1.49-6.30), or not to sleep because of worries (OR = 2.42;95% CI = 1.23-4.83), to use medicines to manage anxiety (OR = 4.04;95% CI = 1.43-13.34) or to think that faith might help them (OR = 3.47;95% CI = 1.62-7.69). Who reported being angry were more likely to feel lonely (OR = 3.58;95% CI = 1.98-6.63), but less likely to report not thinking about the coronavirus (OR = 0.34;95% CI = 0.13-0.82). The patients who reported to be calm, showed less fear for the future (OR = 0.20;95% CI = 0.09-0.43), less insomnia due to worries (OR = 0.46;95%) CI = 0.25- 0.83), less risk of suicidal thoughts (OR = 0.10;95% CI = 0.00-0.63) and were less likely to think that faith would help them (OR = 0.47;95% CI = 0.24-0.91). Men were more likely to reported being calm than women (OR = 2.60;95% CI = 1.27-5.43). Conclusions: The results suggest that the majority of cancer patients have faced the situation related to the SARSCoV- 2 pandemic, with concern of being infected, and the consequences on their health and on the anticancer treatments. How healthcare professionals respond to patients' needs can facilitate understanding of information and emotionally support patients.

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.

A prospective cohort study to identify biomarkers predicting the regression of grade 2 Cervical Intraepithelial Neoplasia. Study protocol

Objective: The detection and treatment of high-grade cervical lesions prevent the development of invasive cervical cancer. Excisional procedures can pose a risk for subsequent pregnancies, thus conservative management of Cervical Intraepithelial Neoplasia grade 2 (CIN2) lesions should be adopted in young women. The aim of our study is to evaluate the ability of viral and cellular biomarkers in predicting regression/progression of CIN2. Methods: Women aged 25 to 45 years, participating to population-based organised cervical cancer screening programmes in the Veneto Region (Italy), diagnosed with a CIN2 lesion and fitting predefined inclusion/exclusion criteria, are invited to take part in a multicentre observational longitudinal cohort study with a follow-up of 24 months. Upon signing an informed consent, women are enrolled in the study and cervical cell samples collected. Treatment is delayed and subsequently performed in the case of lesion progression, or persistence for >12 months. HPV genotyping, p16(INK4A)/ki67 expression and methylation status for L1 viral sequences and FAM19A4/miR124-2 cellular genes are determined at baseline and during follow-up, and evaluated in relation to the clinical outcome. Results: The study, registered on Clinical Trials.gov (ID: NCTo4687267), is currently ongoing. Enrolment of women aged 25-45 years started in 2019, and will continue up to the end of 2021. Discussion: Since February 2020, the Veneto Region has been hit by the COVID-19 pandemic. The enrolment of women in the study was interrupted during an initial two-month lockdown, and slowed down during the subsequent months. The12-month extension of the study period will partially counterbalance this delay.

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.

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.