Vaccination for seasonal influenza, pneumococcal infection and SARS-CoV-2 in patients with solid tumors: recommendations of the Associazione Italiana di Oncologia Medica (AIOM).

Patients with cancer have a well-known and higher risk of vaccine-preventable diseases (VPDs). VPDs may cause severe complications in this setting due to immune system impairment, malnutrition and oncological treatments. Despite this evidence, vaccination rates are inadequate. The Italian Association of Medical Oncology [Associazione Italiana di Oncologia Medica (AIOM)] has been involved in vaccination awareness since 2014. Based on a careful review of the available data about the immunogenicity, effectiveness and safety of flu, pneumococcal and anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines, we report the recommendations of the AIOM about these vaccinations in adult patients with solid tumors. The AIOM recommends comprehensive education on the issue of VPDs. We believe that a multidisciplinary care model may improve the vaccination coverage in immunocompromised patients. Continued surveillance, implementation of preventive practices and future well-designed immunological prospective studies are essential for better management of our patients with cancer.

Six-Month Humoral and Cellular Immune Response to the Bnt162b2 Mrna Covid-19 Vaccine Booster in the Patients with Solid Tumors on Active Treatment: Focus on Variants of Concern (Vocs)

Background: The role and the durability of immunogenicity of the 3rd dose of vaccine against COVID-19 variants of concern (VOCs) in cancer patients remains to be elucidated. The aim of this study is to evaluate the immunogenicity of the 3rd dose of the SARS-CoV-2 BNT162b2 mRNA vaccine in triggering both the humoral and the cell-mediated immune response in the patients with solid tumors undergoing active treatment 6 months after booster Methods: We have prospectively evaluated kinetics of humoral and cellular immune response elicited by booster BNT162b2 anti-SARS-CoV-2 vaccine dose up to 6 months. Samples were collected at the enrollment (T0), 21 days after the booster (T1) and 6 months after (T2). Sera were tested for Spike trimeric IgG (cut off 33.8 BAU/mL) and SARS-CoV-2 neutralizing antibodies (NT Abs;cut off 1:10), T-cell response against Spike protein was detected by IFNgamma release assay (IGRA from Euroimmun). Result(s): One-hundred patients (36F/50M;median age 65, range 26-89) were included in the study. In 9 subjects, a COVID-19 infection was reported before the administration of the 1st dose of vaccine. Preliminary analyses were performed in a cohort of 79 previously unexposed subjects. The 3rd dose was administered at median 176 days (range 91-281) after the 1st dose. At T0 anti-S IgG response was median 170 (IQR 67.8-421.4) BAU/mL and it increased to median 2080 (IQR 2080-2080) BAU/mL at T1;a decrease of response was observed at T2 (median 1605 IQR 822-2080 BAU/mL). Overall, 11/79 (13.9%) patients were negative at baseline and 10/11 reached positive level of response at T1. Only 2 subjects were negative for serological response at T2. A similar trend was observed for SARS-CoV-2 NTAbs. In 65 patients we compared NT Abs levels reached against wild type (WT) strain, Delta and Omicron variants at T2. Median response against WT strain was 1:320 (IQR 1:40-1:640) while it decreased to 1:80 (IQR 1:20-1:320) and 1:10 (IQR <1:10-1:40) against Delta and Omicron variants (p value 0.08 and <0.001, respectively). Overall, 4/65 (6.2%) patients were negative for WT SARS-CoV-2 NT Abs while 6/65 (9.2%) and 17/65 (26.2%) were negative for Delta and Omicron SARSCoV- 2 NT Abs, respectively. Conclusion(s): Preliminary data suggest an enhanced immunogenicity elicited by booster in cancer patients, also against variant strains, even if a decrease NT Abs level was observed against Omicron. T-cellular response and multivariable analysis on demographic/clinical data will be presented at the meeting.

Sars-Cov-2 Omicron (B11529) Variant Infection Leads to High Morbidity and Mortality in Unvaccinated Patients with Cancer

Background: The Omicron (B.1.1.529) SARS-CoV-2 variant is highly transmissible and escapes vaccinal immunity. Evidence is lacking as to the impact of Omicron in oncological patients. Method(s): Capitalizing on OnCovid study data (NCT04393974), we analysed COVID-19 morbidity and case fatality rate at 28 days (CFR28) of unvaccinated patients across 3 phases defined following the evolution of the pandemic in Europe, according to date of COVID-19 diagnosis: "Pre-vaccination" phase (27/02/2020-30/11/2020), "Alpha- Delta variant" phase (01/12/2020-14/12/2021), "Omicron variant" phase (15/12/2021-31/01/2022). Finding(s): By the data lock of 04/02/2022, 3820 patients from 37 institutions across 6 countries were entered. Out of 3473 eligible patients, 2033 (58.6%), 1075 (30.9%) and 365 (10.5%) were diagnosed during the Pre-vaccination, Alpha-Delta and Omicron phases. In total 659 (61.3%) and 42 (11.5%) were unvaccinated in the Alpha-Delta and Omicron. Unvaccinated patients across the Omicron, Alpha-Delta and Pre-vaccination phases experienced similar CFR28 (27.5%, 28%, 29%, respectively). Following propensity score matching, 42 unvaccinated Omicron patients were matched with 122 and 121 patients from the Pre-vaccination and Alpha-Delta phases respectively, based on country of origin, sex, age, comorbidity burden, primary tumour, cancer stage and status, and the receipt of systemic anticancer therapy at COVID-19. Unvaccinated Omicron patients experienced improved COVID-19 outcomes in comparison to patients diagnosed during the Prevaccination phase. Morbidity and mortality were comparable to those of unvaccinated patients diagnosed during the Alpha-Delta phase. Interpretation(s): Despite time-dependent improvements in outcomes reported in the Omicron phase, patients with cancer remain highly vulnerable to SARS-CoV-2 in absence of vaccinal protection. This study provides unequivocal evidence in support of universal vaccination of patients with cancer as a protective measure against morbidity and mortality from COVID-19.

Six-month humoral and cellular immune response to the third dose of BNT162b2 anti-SARS-CoV-2 vaccine in patients with solid tumors: a longitudinal cohort study with a focus on the variants of concern.

BACKGROUND: The role and the durability of the immunogenicity of the third dose of vaccine against COVID-19 variants of concern in cancer patients have to be elucidated. PATIENTS AND METHODS: We have prospectively evaluated the immunogenicity of the third dose of the SARS-CoV-2 BNT162b2 messenger RNA vaccine in triggering both humoral and cell-mediated immune response in patients with solid tumors undergoing active treatment 6 months after the booster. Neutralizing antibody (NT Ab) titers and total anti-spike immunoglobulin G concentrations were measured in serum. Heparinized whole blood samples were used for the SARS-CoV-2 interferon-γ release assay (IGRA). RESULTS: Six months after the third dose only two patients (2.4%) showed negative spike-specific immunoglobulin G antibody levels (<33.8 BAU/ml). The median level of SARS-CoV-2 NT Abs decreased and only 39/83 (47%) subjects showed maximum levels of NT Abs. T-cellular positive response was observed in 38/61 (62.3%) patients; the highest median level of response was observed 21 days after the third dose (354 mIU/ml, interquartile range 83.3-846.3 mIU/ml). The lowest median level of NT Ab response was observed against the Omicron variant (1 : 10, interquartile range 1 : 10-1 : 40) with a significant reduced rate of responder subjects with respect to the wild-type strain (77.5% versus 95%; P = 0.0022) and Delta variant (77.5% versus 93.7%; P = 0.0053). During the follow-up period, seven patients (8%) had a confirmed post-vaccination infection, but none of them required hospitalization or oxygen therapy. CONCLUSIONS: Our work highlights a significant humoral and cellular immune response among patients with solid tumors 6 months after the third BNT162b2 vaccine dose, although a reduction in neutralizing activity against Omicron was observed.

Clinical effectiveness of SARS-CoV-2 vaccines and booster doses in patients with cancer: An analysis from the European OnCovid registry

Background: Immunogenicity and safety of SARS-CoV-2 vaccines have been widely investigated in patients (pts) with cancer. However, their effectiveness against Coronavirus disease 2019 (COVID-19) and the additional protective effect of a booster dose in this population are yet to be defined. Methods: Using OnCovid study data (NCT04393974), a European registry enrolling consecutive pts with cancer and COVID-19, we evaluated morbidity and 14 days case fatality rates (CFR14) from COVID-19 in pts who were unvaccinated, vaccinated (either partially/full vaccinated but not boosted) and those who had received a third dose. Analyses were restricted to pts diagnosed between 17/11/2021 (first breakthrough infection in a boosted pt) and the 31/01/2022. Pts with unknown vaccination status were excluded. Results: By the data lock of 22/02/2022, out of 3820 consecutive pts from 36 institutions, 415 pts from 3 countries (UK, Spain, Italy) were eligible for analysis. Among them, 51 (12.3%) were unvaccinated, 178 (42.9%) were vaccinated and 186 (44.8%) were boosted. Among vaccinated pts, 26 (14.6%) were partially vaccinated (1 dose). Pts with haematological malignancies had more likely received a booster dose prior to infection (25.4% vs 13.6% and 11.8%, p = 0.02). We found no other associations between vaccination status and pts' characteristics including sex, age, comorbidities, smoking history, tumour stage, tumour status and receipt of systemic anticancer therapy. Compared to unvaccinated pts, boosted and vaccinated pts achieved improved CFR14 (6.8% and 7.0% vs 22.4%, p = 0.01), COVID-19-related hospitalization rates (26.1% and 20.6% vs 41.2%, p = 0.01) and COVID-19-related complications rates (14.5% and 15.7% vs 31.4%). Using multivariable Inverse Probability of Treatment Weighting (IPTW) models adjusted for sex, comorbidities, tumour status and country of origin we confirmed that boosted (OR 0.21, 95%CI: 0.05-0.89) and vaccinated pts (OR 0.19, 95%CI: 0.04-0.81) achieved improved CFR14 compared to unvaccinated pts, whilst a significantly reduced risk of COVID-19 complications (OR 0.26, 95%CI: 0.07-0.93) was reported for vaccinated pts only. Conclusions: SARS-CoV-2 vaccines protect from COVID-19 morbidity and mortality in pts with cancer. Accounting for the enrichment of haematologic pts in the boosted group, the observation of comparable mortality outcomes between boosted and vaccinated pts is reassuring and suggests boosting to be associated with reduced mortality in more vulnerable subjects, despite evidence of adverse features in this group.

Humoral and cell-mediated immune response to the third dose of BNT162b2 anti- SARS-CoV-2 vaccine in patients with cancer on active treatment: Focus on wild type, Delta and Omicron strains

Background: Although a full course of COVID-19 vaccine is effective in cancer patients, the duration of the protection and the efficacy of a booster dose against the new variants remain unknown. We prospectively evaluated the immunogenicity of the third dose of the SARS-CoV-2 BNT162b2 mRNA vaccine in cancer patients undergoing active treatment. Methods: Patients with solid cancer, vaccinated with a booster dose during active treatment, were prospectively enrolled in this study. Patients were classified in SARS-CoV-2 naïve (without previous COVID-19 infection) and SARS-CoV-2 experienced (with previous COVID-19 infection). Neutralizing antibody (NT Abs) titer and total anti-Spike IgG concentration were quantified in serum. Heparinized whole blood samples were used for SARS-CoV-2 Interferon Gamma Release Assay (IGRA). The primary endpoint was to assess the increase of IgG antibody level between baseline (T0) and 3 weeks after the booster (T1). Results: 142 consecutive patients were recruited. In SARS-CoV-2 naïve subjects, median level of IgG was 157 BAU/mL (interquartile range (IQR) 62-423) at T0 and reached median of 2080 (IQR 2080-2080) at three weeks after booster administration (T1;p < 0.0001). A median 16-fold increase of SARS-CoV-2 NT Abs titre (IQR 4-32) was observed in naïve subjects (from median 20 IQR 10-40 to median 640 IQR 160-640;p < 0.0001). Median IFN-γ level at T1 was significantly higher than that measured at T0 in SARS-CoV- 2 naïve subjects (p = 0.0049) but not in SARS-CoV-2 experienced patients. No difference was observed in terms of median response between patients treated with immunotherapy and chemotherapy (p > 0.05). A stronger correlation between SARS-CoV-2 NT Abs and total IgG level was observed at T0 (r = 0.76;p < 0.0001) compared to T1 (r = 0.27, p = 0.0081). No correlation as regards the number of days was observed from the first to the third vaccination and SARS-CoV-2 NT Abs/total IgG. The median level of SARS-CoV-2 NT Abs was 32-fold lower against Omicron compared to wild type strain (p = 0.0004) and 12-fold lower compared to Delta strain (p = 0.0110). Conclusions: The third dose is able to trigger both the humoral and the cell-mediated immune response in cancer patients on active treatment. Our preliminary data about the neutralization of the SARS-CoV-2 vaccine against variants of concern (VOCs) seem to confirm the vaccine lower activity. (Table Presented).

Immunogenicity and safety after the third dose of BNT162b2 anti-SARS-CoV-2 vaccine in patients with solid tumors on active treatment: a prospective cohort study.

BACKGROUND: Although a full course of coronavirus disease 2019 (COVID-19) vaccine is effective in cancer patients, the duration of the protection and the efficacy of a booster dose against the new variants remain unknown. We prospectively evaluated the immunogenicity of the third dose of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) BNT162b2 messenger RNA vaccine in cancer patients undergoing active treatment. PATIENTS AND METHODS: Patients with solid cancer, vaccinated with a booster dose during active treatment, were enrolled in this study. Patients were classified into SARS-CoV-2 naïve (without previous COVID-19 infection) and SARS-CoV-2 experienced (with previous COVID-19 infection). Neutralizing antibody (NT Ab) titer and total anti-Spike immunoglobulin G (IgG) concentration were quantified in serum. Heparinized whole blood samples were used for SARS-CoV-2 Interferon Gamma Release Assay (IGRA). The primary endpoint was to assess the increase of IgG antibody level between baseline and 3 weeks after the booster. RESULTS: One hundred and forty-two consecutive patients were recruited. In SARS-CoV-2-naïve subjects, the median level of IgG was 157 BAU/ml [interquartile range (IQR) 62-423 BAU/ml] at T0 and reached a median of 2080 BAU/ml (IQR 2080-2080 BAU/ml) at 3 weeks after booster administration (T1; P < 0.0001). A median 16-fold increase of SARS-CoV-2 NT Ab titer (IQR 4-32) was observed in naïve subjects (from median 20, IQR 10-40, to median 640, IQR 160-640; P < 0.0001). Median interferon-γ level at T1 was significantly higher than that measured at T0 in SARS-CoV-2-naïve subjects (P = 0.0049) but not in SARS-CoV-2-experienced patients. The median level of SARS-CoV-2 NT Abs was 32-fold lower against Omicron compared to the wild-type strain (P = 0.0004) and 12-fold lower compared to the Delta strain (P = 0.0110). CONCLUSIONS: The third dose is able to trigger both the humoral and the cell-mediated immune response in cancer patients on active treatment. Our preliminary data about the neutralization of the SARS-CoV-2 vaccine against variants of concern seem to confirm the lower vaccine activity.

The immunogenity, efficacy and safety of BNT162b2 anti-SARSCoV- 2 vaccine in cancer patients treated with PD-1/PD-L1 inhibitors: An observational ambispective multicenter study

Background and Aim: Cancer patients are underrepresented in ongoing phase 3 clinical trials of COVID-19 vaccines. The aim of this study is to evaluate the magnitude of the T- and B-cell response in these patients treated with Immune Checkpoint Inhibitors (ICIs) and receiving the BNT162b2 vaccine. A group of vaccinated healthy subjects has been used as a validation control Methods: Consecutive cancer patients in ICIs were enrolled from the beginning of the vaccination campaign for frail patients. Samples were collected before vaccination (T0), at time of the 2nd dose (T1) and 21days after complete vaccination schedule (T2). Sera were tested for S1/S2 IgG (cut off 15 AU/mL) and SARS-CoV-2 neutralizing antibodies (NT Abs;cut off 1:10), while peripheral blood mononuclear cells (PBMC) were isolated and used for Spike specific ELISpot assay (cut off 10 net spots/million PBMC) Results: Preliminary results on 65 patients (18 females and 47 males;median age 67) were obtained. At T0,8/65 (12.3%) were positive for S1/S2 IgG since they had experienced COVID-19 disease (median 61 IQR 27.5-133.5 AU/mL). All subjects developed a sustained humoral response at T1 in terms of both S1/S2 IgG (median 2735 IQR 2220-3768 AU/mL) and SARS-CoV-2 NT Abs. 35/57 patients (61.4%) were still seronegative at T1 since they showed a S1/S2 IgG level lower than 15 AU/mL. The level of humoral response at T1 was significantly reduced compared to the level observed in healthy subjects (p=0.0187). Spike-specific T-cell response was analyzed in 26 subjects at T0 (median 5 IQR 0-16.5 net spots/million PBMC). Response increased significantly from T1 to T2 (median 22.5 IQR 5-95 and 180 IQR 92.5-380 net spots/million PBMC). The most common side-effects were pain at the injection site (6%, 4/65) and fever (5%, 3/65). One patient presented 2 immune-related sideeffects (hepatitis and colitis G3) 10 days after the 1st dose of vaccine: she received high-dose steroid therapy, with clinical remission Conclusions: BNT162b2 mRNA vaccine elicited a humoral response after the 1st dose in about 40% of the patients. Differences with healthy subjects may depend on the older age and time gap between start of ICIs and vaccine administration. Additional data, including long term analysis (+6months), T-cellular response and multivariable analysis on demographic/clinical data, will be presented at the meeting. Overall, our preliminary data suggest a reassuring safety profile of vaccination in cancer patients undergoing ICIs.

A one-year survey on cancer patients affected by SARSCoV-2 infection: Clinical characteristics and disease evolution in a single Institution experience

Background: Patients affected by cancer are considered particularly susceptible to SARS-CoV-2 infection complications. We aimed to study the effect of COVID on patients with solid tumors at our Oncology Unit at Policlinico San Matteo of Pavia. Material and methods: Data of patients affected by solid tumors and COVID-19 were extracted from medical records between February 21, 2020 and May 15, 2021. COVID diagnosis was confirmed by RT-PCR on nasal swab. Associations between demographic, clinical characteristics and outcomes were measured with HR with 95%CI using Cox regression. Results: Seventy-five patients affected by solid tumors with COVID diagnosis were included in the analysis. The incidence of SARS-CoV-2 infection in our cancer patients was similar to that observed in the global Italian population (5.8 vs 6.2%), but lower compared to the local population of Lombardia (8.2%) and Pavia (7.9%). In 34 patients (45.9%) COVID diagnosis was obtained through screening, in 40 patients (54.1%) because of symptoms or radiologic findings. Median age was 64.4 years (25th-75th 56-75);the majority had an ECOG PS of 0-1 (89.2%), was affected by breast, lung or gastro-intestinal cancer (28.0, 26.7 and 21.3% respectively), had stage IV disease (72.2%) and was on therapy at the time of COVID (76.0%);26 patients (36.1%) were hospitalized;21 patients (28.0%) died, 13 of them (17.3%) for COVID complications. COVID determined a median delay of the oncologic treatment of 14.0 days (25th-75th 0-25). Mortality rate was higher in our cancer population than that observed in the global Italian population (3.0%), in local population of Lombardia (4.0%) and Pavia (5.9%). In the univariable analysis, being older than 66 years (HR: 2.64, 95%CI 1.06-6.55, p=0.029), with ECOG PS ≥ 2 (HR: 5.81, 95%CI 2.18-15.49, p=0.002), >1 comorbidities (HR: 2.72, 95%CI 1.14-6.48, p=0.023), having dyspnea at the time of COVID diagnosis (HR: 6.10, 95%CI 2.37-15.68, p=0.0001), and being hospitalized (HR: 6.75, 95%CI 3.06-36.89, p<0.001) were associated with increased risk of death. In multivariable analysis, ECOG PS ≥ 2, dyspnea, hospitalization and days of treatment delay were associated with increased risk of death. Conclusions: The incidence of SARS-CoV-2 infection in our cancer patients was lower than that observed in the local population of Lombardia and Pavia, while mortality rate was higher. Predictive factors of death in cancer population correlate consistently with those alrealy published about global population.

Analysis of the humoral and cellular immune response after a full course of BNT162b2 anti-SARS-CoV-2 vaccine in cancer patients treated with PD-1/PD-L1 inhibitors with or without chemotherapy: an update after 6 months of follow-up.

BACKGROUND: The durability of immunogenicity of SARS-CoV-2 vaccination in cancer patients remains to be elucidated. We prospectively evaluated the immunogenicity of the vaccine in triggering both the humoral and the cell-mediated immune response in cancer patients treated with anti-programmed cell death protein 1/programmed death-ligand 1 with or without chemotherapy 6 months after BNT162b2 vaccine. PATIENTS AND METHODS: In the previous study, 88 patients were enrolled, whereas the analyses below refer to the 60 patients still on immunotherapy at the time of the follow-up. According to previous SARS-CoV-2 exposure, patients were classified as SARS-CoV-2-naive (without previous SARS-CoV-2 exposure) and SARS-CoV-2-experienced (with previous SARS-CoV-2 infection). Neutralizing antibody (NT Ab) titer against the B.1.1 strain and total anti-spike immunoglobulin G concentration were quantified in serum samples. The enzyme-linked immunosorbent spot assay was used for quantification of anti-spike interferon-γ (IFN-γ)-producing cells/106 peripheral blood mononuclear cells. Fifty patients (83.0%) were on immunotherapy alone, whereas 10 patients (7%) were on chemo-immunotherapy. We analyzed separately patients on immunotherapy and patients on chemo-immunotherapy. RESULTS: The median T-cell response at 6 months was significantly lower than that measured at 3 weeks after vaccination [50 interquartile range (IQR) 20-118.8 versus 175 IQR 67.5-371.3 IFN-γ-producing cells/106 peripheral blood mononuclear cells; P < 0.0001]. The median reduction of immunoglobulin G concentration was 88% in SARS-CoV-2-naive subjects and 2.1% in SARS-CoV-2-experienced subjects. SARS-CoV-2 NT Ab titer was maintained in SARS-CoV-2-experienced subjects, whereas a significant decrease was observed in SARS-CoV-2-naive subjects (from median 1 : 160, IQR 1 : 40-1 : 640 to median 1 : 20, IQR 1 : 10-1 : 40; P < 0.0001). A weak correlation was observed between SARS-CoV-2 NT Ab titer and spike-specific IFN-γ-producing cells at both 6 months and 3 weeks after vaccination (r = 0.467; P = 0.0002 and r = 0.428; P = 0.0006, respectively). CONCLUSIONS: Our work highlights a reduction in the immune response in cancer patients, particularly in SARS-CoV-2-naive subjects. Our data support administering a third dose of COVID-19 vaccine to cancer patients treated with programmed cell death protein 1/programmed death-ligand 1 inhibitors.

A snapshot of the immunogenicity, efficacy and safety of a full course of BNT162b2 anti-SARS-CoV-2 vaccine in cancer patients treated with PD-1/PD-L1 inhibitors: a longitudinal cohort study.

BACKGROUND: Very few cancer patients were enrolled in coronavirus disease-2019 vaccine studies. In order to address this gap of knowledge, real-world studies are mandatory. The aim of this study was to assess both humoral and cellular response after a messenger RNA vaccination schedule. PATIENTS AND METHODS: Eighty-eight consecutive cancer patients treated with programmed cell death protein 1/programmed death-ligand 1 inhibitors were enrolled from the beginning of the vaccination campaign for frail patients. Blood samples for humoral and cell-mediated immune response evaluation were obtained before vaccination (T0), before the second administration (T1) and 21 days after the second dose (T2). The primary endpoint was the evaluation of the percentage of participants showing a significant increase in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific T cells, measured by an enzyme-linked immunospot assay, after the second dose of BNT162b2 vaccine. The proportion of patients who reached the primary endpoint is computed together with its exact binomial 95% confidence interval. RESULTS: In SARS-CoV-2-naïve subjects, spike-specific T-cell response was almost undetectable at T0 [median 0.0 interferon-γ (IFN-γ) spot forming units (SFU)/million peripheral blood mononuclear cell (PBMC) interquartile range (IQR) 0-7.5] and significantly increased at T1 and T2 (median 15.0 IFN-γ SFU/million PBMC, 25th-75th 0-40 versus 90 IFN-γ SFU/million PBMC, 25th-75th 32.5-224, respectively) (P < 0.001). Focusing on naïve and experienced SARS-CoV-2 subjects, no differences were reported both in terms of CD4- and CD8-specific T-cell response, suggesting that BNT162b2 is able to elicit both adaptive responses after complete vaccination schedule, regardless of previous SARS-CoV-2 exposure. The level of SARS-CoV-2 neutralizing antibodies was low at T1 in SARS-CoV-2-naïve subjects [median 1 : 5 (IQR 1 : 5-1 : 20)] but reached a significantly higher median of 1 : 80 (25th-75th 1 : 20-1 : 160) at T2 (P < 0.0001). Moreover, no COVID-19 cases were documented throughout the period of study. CONCLUSIONS: Our data have demonstrated that the administration of a full course of BNT162b2 vaccine elicited a sustained immune response against SARS-CoV-2 regardless of the type of cancer and/or the type of immune checkpoint inhibitors.

Resilience in cancer care at the time of covid-19: Practical approach to the management of cancer patients during the covid-19 emergency in a large Italian community hospital

Background: The Fondazione IRCCS Policlinico San Matteo, the largest academic Hospital in the south-west part of Lombardy has been involved in the management of the COVID-19 outbreak since its inception. The Oncology Unit had to face with the challenge of to keep on active oncological treatments without compromising the safety of our pts and healthcare personnel both in the inpatients, as well as in the outpatients. Patients and methods: From the very beginning of the emergency, the inpatient ward and the outpatient clinic were moved to the main building of the Hospital as their original locations become COVID-19 wards. From Feb. 24th, we reorganized our Unit, with the introduction of a double-step triage strategy for cancer pts under treatment in order to identify pts at risk from COVID-19, and to avoid their admission to Hospital.-First step: a phone call the day before active therapy or admission (virtual swab);-Second step: a clinical evaluation upon entry the outpatient and inpatient wards. Results: From February 24 to April 7, 2020, 819 phone calls were performed, leading to the authorization of 788 accesses to the outpatient clinic for active treatments. 26 pts (8.3%) with symptoms were kept at home and managed by repeated telephone calls in collaboration with the family doctor;of these subjects, 3 were hospitalized for suspected COVID, while 23 were managed at home with symptomatic treatments and antibiotics. At the second triage level, 5 pts were hospitalized and proved positive for SARS-CoV-2 by nasal swab. In the same period, 177 pts were admitted to the inpatient ward: none has been found to be COVID-19-suspected or swab-positive. Both outpatient and inpatient areas were still COVID-19 free. No healthcare workers resulted infected by SARS-CoV-2, including 2 physicians who had fever during this period, but resulted SARS-CoV-2 negative by 2 sequential nasal swabs, performed 14 days apart. Conclusions: During the emergency phase of the COVID-19 outbreak the behavior of health care workers had to be arranged to appropriately manage it, according to risk management strategies particularly to that defined as 'resilience'. Our screening strategy, which requested neither human nor economic extra resources, put successfully into practice the capacity to adapt the management to a global health emergency as we could maintain the pre-COVID approach to cancer care, while protecting pts and healthcare workers from COVID-19 infection.

Practical approach to the management of clinical studies during the covid-19 emergency in a large academic hospital

Background: The Fondazione IRCCS Policlinico San Matteo, the largest academic Hospital in the south-west part of Lombardy has been involved in the management of the COVID-19 outbreak since its inception. The emergency required a deep reorganization of our Oncology/ Hematology Clinical trial office (CTO-OH) in order to avoid significant disruption to usual practice, while facilitating clinical trials of the Infectous Disease Unit. Materials and Methods: The activity of the CTO-OH included 141 profit and no profit clinical studies before the COVID outbreak. In addition to conducting already active clinical studies, several clinical trials with active drugs and procedure towards Covid-19 have been activated through the fast track procedure. For all these studies, Sponsor companies and regulatory agencies requested the insertion of data, as the progress of the patients, was monitored in real time to assess their effectiveness, but also any potential damage through the communication of SAE. Results: Since February 21st, 2 studies have not been activated at our Institution while 4 were activated through a remote SIV. The screening of new patients was reduced and in 2 studies it was temporarily suspended. Remote monitoring visits were carried out. At the same time the CTO-OH supported the Infectious disease dept. and the whole hospital in conducting clinical studies for COVID-19 pts. Within a month and half about 100 pts were enrolled, monitored;data were collected and entered. A major problem was the management of COVID patients enrolled in the various operative units used for infected patients in which patients were hospitalized or moved following the worsening/ improvement of their conditions. We were able to ensure that the staff involved was correctly towed and updated. Conclusions: The preparation and experience of the CTO-OH team and the motivation of all the hospital staff involved (physicians, nurses and lab personnel) allowed the success of the COVID-19 studies while almost fully preserving the ordinary Oncology-Hematology activity.

Providing nutritional care to cancer patients during the COVID-19 pandemic: An Italian perspective

Background: The emergence of 2019 novel coronavirus disease (COVID-19) has caused a global public health emergency. Italy was the first European country where the disease widespread and Lombardy is the principal cluster. In the most affected areas, a rapid and thorough reorganization of hospital clinical procedures has taken place: all non-essential clinical activity has been suspended, while the ordinary activity continues for whom diagnostic procedures and treatments cannot be delayed. It is the case of cancer patients undergoing treatments with curative intent;in this situation of deep distress for the health care system, the inability to satisfy cancer patients' needs is an additional concern. In the light of the above, during the current COVID-19 pandemic it is likely to see a dramatic worsening of cancer patients' nutritional status, due to possible delayed clinical assistance and difficulties in procuring nutritionally adequate quality food as lock-down's repercussion. The consequences are reasonably foreseeable and will have a severe negative impact after the emergency. Hence, it is essential to carry on, as far as possible, the activity of clinical nutrition in oncology, which can be safely provided only by a thorough setting and approach to patients rearrangement. Methods: For this purpose, the Clinical Nutrition and Dietetics Unit and the Medical Oncology Unit of our hospital have reorganized the clinical routine activity in strict collaboration, to better face up to the challenge, while preserving cancer patients' needs. Results: Several general actions have been taken to protect both patients and healthcare professionals;remote capabilities have been implemented to minimize interactions, efforts are being done to secure medical resources and supplies. This allowed the regular provision of nutritional counseling and nutritional support in both inpatients and outpatients, in line with the recommended hygienic measures to protect both patients and healthcare professionals. Nutritional follow- up has been planned by regular telephone counseling and laboratory exams have been checked by email. Conclusions: Implementing appropriate nutritional care in oncology during this unprecedented emergency is a hard challenge. However, any effort should be done to guarantee, along with active treatment, adequate nutritional support to cancer patients, in order to prevent the deleterious consequences of malnutrition on clinical outcomes and quality of life.