Home Venous Access Device Insertion during Covid-19 Pandemic, from an Emergency Response to a Daily Work Practice

Background: Reliable venous access device(VAD) is essential in providing effective care for many cancer patients. VAD are placed by a specialized team using ultrasound guidance in a dedicated room of the hospital, however, during the pandemic COVID-19, many not autonomous or bedridden cancer patients were unable to reach the hospital for VAD insertion, due to unavailability of ambulance for the transport. For this reason the specialized team organized a modality of positioning VAD at patients' homes. Material (patients) and methods: In January 2012, a VADs-team was established by the health authority in the oncology-hematology department at the hospital of Piacenza, it initially served the care of cancer patients in the oncology and hematology department of the Piacenza hospital;subsequently, during the COVID-19 pandemic, the team was able to reach patients at home to positioning VAD for people unable to go to the hospital. The positioning of the VAD was performed under ultrasound guidance, according to the same modalities used in the hospital. In the present study we retrospectively analyzed data of patient who positioned a VAD. Result(s): Between March 2020 to December 2020 and January 2021 to December 2021, VADs were positioned in 28 and 31 cancer patients respectively, in both groups there were patients with advanced cancer. The VAD utilized was the Midline for each patients. The mean age of the patients was 88 years, the majority were female (>60%). VADs allowed the planned treatment in 94% of the patients. The complications were low: VAD dislocation (<1%), thrombosis (<2%). No infections were registered. Conclusion(s): During COVID-19 pandemic the VAD-team demonstrated the feasibility of VADs home positioning, in for cancer patients, subsequently, the VAD-team served also non-cancer patients who need home Vad positioning. The results of our study allowed this procedure to become routine practice for not autonomous or bedridden cancer patients with a need for VADs who are unable to reach the hospital for the insertion.

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.

Differences in Mrna-1273 (Moderna) and Bnt162b2 (Pfizer-Biontech) Sarscov- 2 Vaccine Antibody Responses in Cancer Patients

Background: Severe acute respiratory syndrome coronovirus- 2 (SARS-CoV-2) is the cause of the coronavirus disease 2019 (COVID-19) pandemic. Vaccination is considered the core approach to containing the pandemic, but differences in immunogenicity between mRNA SARSCoV- 2 vaccines have not been reported in patients with cancer. Material (patients) and methods: We conducted a retrospective monocentric study on oncological patients, treated at the Piacenza hospital, who received the BNT162b2 or mRNA-1273 SARS-CoV-2 vaccines. The aim was to investigate the humoral response determining IgG antibody levels against the SARS-CoV-2 receptor-binding domain developed according to the type of vaccine. To reduce the possibility of selection bias and make the baseline characteristics of the two groups more comparable we conducted propensity score matching (1:1 nearest-neighbor without replacement). Serum samples were evaluated for SARS-COV-2 antibodies prior vaccinations and 2-6 weeks after the administration of the second vaccine dose, data about age, gender, anticancer treatment, type and stage of cancer were collected. Result(s): Between 20 March 2021 and 12 June 2021, 293 consecutive patients with solid tumor underwent a program of COVID-19 vaccinations and 257 were evaluable;after propensity score matching 76 were included in each group. The IgG antibody levels were different among the two groups: median 319.5 AU/ml [IQR 76.15-401] mRNA- 1273 vs 53.55 AU/ml [IQR 5.83-152] BNT162b2, p<0.001. Conclusion(s): We found greater antibody response with the mRNA-1273 vaccine than the BNT162b2 vaccine in patients with cancer and the other factor that has the greatest impact on the intensity of the vaccine response, regardless of its type, was the active anticancer treatment. These two factors should be taken into consideration when choosing the type of vaccine and the timing of administration based on the oncologic-hematologic treatment.

Narrative Medicine in Oncology Department of Piacenza: Tell the Change of Helping Relationship with the Use of Personal Protective Equipment (Ppe)

Background: After Covid-19 emergency, operators always had to work with approved and safe Personal Protective Equipment (PPE) for patients and professionals, but which limited communication, the approach to assistance and the helping relationship. Those who practice professional health care practices as they are exposed to the suffering of others should be aware of the need for themselves to equip themselves adequately to face difficult situations through suitable narrative practices of selfcare. This study has a dual purpose: to investigate the experience of the health care personnel of the Piacenza's Oncology Department through narrative medicine following the use of PPE and to help operators become aware of it through creative writing. Material(s) and Method(s): We conducted a qualitative study, the data collection tool is creative writing, consisting of write unconditionally by first reading a preface consisting of sequential questions. The sample selection has been voluntary based subject to prior informed consent signature. 14 texts writed by nurses and oss were collected. The data analysis took place with analysis of the thematic content. Qualitative analysis involves the fragmentation of data into simpler units and the subsequent recomposition in new ways. Result(s): The results of creative writing were divided into four macrocodes: PPE Data Changes, Strategies, PPE Negative Side, PPE Positive Side, in turn divided into several microcodes. Emerge the difficulties of the health care personnel in using PPE in the care approach and the strategies that were introduced in the face of these difficulties. Conclusion(s): From the analysis emerged all the changes that the PPE have involved: the impossibility of approaching, seeing and touching each other, in particular not being able to show the face and to be recognized and to smile. Through examples of everyday life, the disadvantages of the use of PPE have been highlighted but at the same time it is evident that the use of protective devices has made it possible to re-elaborate the approach to the patient, reminding professionals of the need for empathy and listening, devising creative ways to deal with these difficulties such as the use of video calls, gazes. They noticed a greater humanization thanks to the use of PPE: less abrupt and frenetic ways have been introduced during the satisfaction of needs and a greater willingness to stay "here and now" in the care relationship to limit the shortcomings.

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.

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.

Anti-SARS-CoV2 vaccine project in Onco-haematological patients in Piacenza

Background: Onco-haematological patients are considered a vulnerable group with early access to SARS-CoV-2 vaccination. The Onco-Hematological Department of Piacenza has activated a dedicated vaccination program, with appropriate timing. We selected patients on active injection therapy with extreme immune fragility or undergoing haematopoietic stem cell transplantation. The project has created a path for access to vaccination, with reservations on a dedicated agenda and departmental vaccination point, has allowed patients to be vaccinated before starting therapies, start a clinical study of immunological surveillance, feed a departmental database by recording the number of vaccinated patients and any adverse events, favor vaccination in a known, familiar, comfortable context. Materials and methods: The staff underwent training on the preparation, administration, registration of the vaccine, observation and management of any adverse events. On the basis of the identified criteria, the patients who had to carry out the vaccination were selected. The programming was carried out by the referring physician who delivered the informed consent and who checked the medical history. During the vaccination sessions, the patients were managed by the Department team who took care of all the planned vaccination phases. The data were recorded on a regional IT platform. Each vaccination session was coordinated by a nurse and a vaccinating doctor. Results: The vaccination sessions were organized from 20/03/2021 for a total of 13 vax days. 426 patients were vaccinated, 230 F (53.99%) and 196 M (46.01%), mean age 63.38 ± 11.35, range 20-86, of these 415 (97.42%) completed the two scheduled vaccination doses, 11 patients (2.58%) did not receive the second administration due to worsening of the clinical picture. To evaluate the perceived quality and make suggestions, 10 posts were published on the FB page, totaling 2217 likes, 93 comments and 97 shares. The comments were positive, in particular the family environment, the presence of the treating team and the adequate waiting times were appreciated. Conclusions: Experience has made it possible to vaccinate the category of vulnerable patients ensuring safety, appropriateness, effectiveness, efficiency, satisfaction and user loyalty, without delaying or interrumpting oncological treatment.

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.

Efficacy and safety of COVID-19 vaccine in cancer patients

Background: Cancer patients are presumed a frail group at high risk of contracting coronavirus disease (COVID- 19), and vaccination represents a cornerstone in addressing the COVID-19 pandemic. However, data on COVID-19 vaccination in cancer patients are fragmentary and poor. Material (patients) and methods: An observational study was conducted to evaluate the seropositivity rate and safety of a two-dose regimen of the BNT162b2 or mRNA-1273 vaccine in adult patients with solid cancer undergoing active anticancer treatment or whose treatment had been terminated within 6 months of the start of study. The control group was composed of healthy volunteers. Serum samples were evaluated for SARS-COV-2 antibodies prior vaccinations and 2-6 weeks after the administration of the second vaccine dose. Primary endpoint: seropositivity rate. Secondary endpoints: safety, factors influencing seroconversion, IgG titers of patients versus healthy volunteers, COVID-19 infection. Results: Between 20 March 2021 and 12 June 2021, 293 consecutive cancer patients with solid tumors underwent a program of COVID-19 vaccinations: of these, 2 patients refused vaccination, 13 did not receive the second dose of the vaccine due to cancer progression and 21 had COVID-19 antibodies at baseline and were excluded. The 257 evaluable patients had a median age of 65 years (range 28 - 86), 66.15% with metastatic disease. Primary endpoint: seropositivity rate in patients was 75.88%, versus 100% in the control group. Secondary endpoints: no grade 3 - 4 side effects, no COVID-19 infections were reported. Patients median IgG titer was significantly lower than in the control group, male sex and active anticancer therapy influenced negatively seroconversion. Conclusions: BNT162b2 or mRNA-1273 vaccines were immunogenic in cancer patients, showing good safety profile.

COVID-19 vaccine in hematologic patients: Preliminary safety and effectiveness results

Background: From March to May of the current year, the Department of onco-hematology of “Guglielmo da Saliceto” hospital of Piacenza vaccinated 108 haematological patients with a m-RNA vaccine, either Pfizer- BionNTech or Moderna. The aim of this study is to investigate the efficacy and safety of COVID-19 vaccine Materials and methods: This is an observational study. We analyzed the humoral immune response by antibody titer (IgG) at baseline (T0) and 4-6 weeks after the first dose of vaccine (T1). We evaluated whether age, sex, hematologic disease, previous bone marrow transplant, past COVID-19 infection and antitumor treatments interfere with the development of the humoral immune response evaluated with an anti-SARS-CoV-2 IgG ChemiLuminescent ImmunoAssay (LIAISON SARS-CoV2 S1/S2 IgGDIASORIN Inc.) measured in AU/ml. An antibody level 315 AU/ml was considered relevant. Results: From the 108 patients enrolled, 87 patients with median age of 65 years (IQR 58-71) have T1 IgG determination available of which 51 patients (58,62%) seroconverted, with IgG median value of 254 AU/ml (IQR 98,1-385 AU/ml), whereas 36 patients (41,38%) did not, with IgG median value of 3.8 AU/ml (IQR 3.8-4,5 AU/ml). Being on active anticancer treatment at the time of vaccination (p 0,03), especially on anti-CD20 monoclonal therapy (p 0.001), showed a statistically significant effect on seroconversion in univariate analysis, while age over 60 years and sex (male vs female) are near to be significant (respectively p 0.05 and p 0.06). Hematologic disease and previous bone marrow transplant (without differentiate between allo-HSCT and auto-HSCT) seem not to influence the immune response. In multivariate analysis, only anti-CD20 monoclonal therapy deeply reduces the probability of seroconversion (99,97%, p 0.003). The latter does not seem to be influenced by age, sex and active therapy (including all the remaining immunomodulant or immunosuppressor treatments). None of the patients had adverse reactions to vaccine, neither allergic nor immunological. Conclusions: More than half of the patients seroconverted. Active antitumor therapy, especially anti-CD20 monoclonal antibody, seems to have a negative effect on seroconversion. We are actually testing the cell-mediated immune response to prove the efficacy of COVID vaccination also in those immunocompromised subjects who did not seroconverted. The m-RNA vaccines seem to be safe in patients with immune deficiency.

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.

COVID-19 infection in cancer patients receiving antitumor treatment at medical oncology hospital units in Italy. A CIPOMO observational study (CIPOMO ONCO COVID-19)

Background: Cancer patients are more susceptible to infections and potentially at higher risk to develop COVID-19. Tumor type and antitumor treatment may also affect both the susceptibility and the severity of SARS COV-2. Material and methods: To analyze the distribution of patients who developed COVID-19 during active antineoplastic therapy and the related clinical course by tumor type, stage and class of oncologic treatment (chemo, immune, biologic therapy and other) a multicenter, retroprospective, observational study was proposed to the Hospital Medical Oncologic Units of the National Health Service in Italy (168 centers of the Collegio Italiano dei Primari Oncologi Medici Ospedalieri-CIPOMO). The data were collected on demographics, tumor characteristics, treatment setting, type of ongoing anti-cancer therapy and COVID-19 clinical course (phenotype, hospitalization, therapy, duration and outcome). Eligibility required a positive COVID-19 molecular test before May 4th, 2020 and at least 1 course of antitumor therapy delivered after January 15th . Results: At present analysis data are available from 116 of 168 centers (7 declined, 28 pending, 17 data awaited). 64 of 116 centers (55%) had COVID-19 positive cases (cases/ center: median 3, range 1-40). At these 64 centers, 283 positive cases (males 158, 55.9%, females 125, 44.1%;median age 67 years, range 28-89) were observed among a total population of 40.894 patients receiving active treatment between January 15th and May 4th 2020. 65 of 283 (23%) had cardiovascular comorbidities and 7 (2%) preexistent pulmonary disease. 239/283 patients (84.4%) were receiving treatment for metastatic disease and 44 (15.6%) were in the adjuvant setting. Breast, lung, colon and prostate cancer were the main tumor types accounting for 61% of cases. Conclusions: The occurrence of COVID-19 among cancer patients receiving active antitumor treatment appears to reflect tumor epidemiology. Full analysis of the distribution of COVID-19 occurrence and clinical course by tumor type, stage and oncologic treatment will be presented.

Tha case manager at the time of the covid19

Background: In Piacenza it all started on 21 February 2020.The local hospital that the gravity of the situation was perceived more clearly, and the actions that were needed to reorganise happened quickly. Among the various interventions that were rapidly approved, was the creation of a team capable of bringing care home to home. Case managers work to meet patient needs through assessment, coordination, and planning, and by evaluating the available. The nursing directors wanted the presence of a case manager within the team made up of the nursing coordinator and the medical manager. Materials and methods: The need to give quick answers to a tragic situation has highlighted how telephone contact can be used to integrate take-up interventions aimed at preventing hospitalizations and early treatment. The telephone is an important communication tool and can be used to provide information to the patient, to control it remotely, to prevent it from going to the clinic. In the period between 12 March and 30 April, 240 phone calls were made by the case manager in patients suffering from symptoms attributable to the covid who requested, leaving a message to a dedicated number, a service. Each visit was preceded by a phone call in which the case manager monitored with the aid of a specially designed card the comorbid symptoms, the presence of symptoms, the therapy taken. The telephone interview lasted an average 5 minutes. The completed forms were evaluated by the team that established the priority of access to the home based on the data collected. The evaluation was carried out by the team daily and determined the choice of patients to visit on the following day Home visits were 220 while 20 patients were managed with only telephone contact. It was 20 people who reported a temperature not exceeding 37.5 degrees and no other symptoms. These 20 patients were indicated the drug therapy to be taken by the team's medical contact and given as an indication if there was a worsening recall. For these 20 patients it was decided to make a follow-up call after 10 days. Results: 20 patients followed by telephone, 15 reported an improvement in symptoms, 5 had the need to be visited. Everyone reported feeling taken care of and reducing anxiety. Conclusions: The choice of the presence of the case manager allowed, through the intervention of the phone call, to reduce access to the emergency room and the visits n charge. No less important is the reduction of anxiety.

Moral distress in healthcare personnel during Covid-19 pandemic: Experience from Piacenza Oncology Department

Background: Italy has been one of the countries most affected by Covid-19 emergency, in particular Piacenza has reached the record for the number of victims caused by the virus and is still facing a copious number of infections. The healthcare staff of Piacenza Hospital faced this emergency demonstrating a strong spirit of adaptation, alleviating suffering, loneliness and leading many patients infected with the virus towards healing. Moral distress is a common reaction in morally difficult situations, and includes feelings of frustration and lack of power when healthcare professionals are prevented from acting in accordance with their values and ideals (Gustavsson et al, 2019). Morally demanding choices add a greater burden to working in an already stressful environment. The Covid-19 emergency as a pandemic can be considered a real catastrophe, characterized by health needs that exceed existing capacities and so often health professionals have had to make difficult decisions, quickly choose who to treat and how to use optimal limited resources available. The study aims to investigate the Moral Distress of oncologic operators of Piacenza Oncology during Covid-19 emergency period. Material and methods: We conducted an observational qualitative study, the data collection tool is a semi-structured interview, consisting of sequential and standardized questions. 26 operators were interviewed (8 doctors, 13 nurses and 5 OSS) who worked in the Medical Oncology Unit of Piacenza hospital during the emergency period. The data analysis took place with analysis of the thematic content. Qualitative analysis involves the fragmentation of data into simpler units and the subsequent recomposition in new ways. Results: The results of the interviews were divided into four macrocodes: Sensations associated with Moral Distress, Negative episodes, Changes, Positive episodes, in turn divided into several microcodes. The Moral Distress therefore emerges that this pandemic has evoked in operators despite their professionalism and preparation for end of life. Conclusions: Moral Distress is a usual condition for Oncology operators who are used to being in contact with suffering and death, caused by the high psychological and physical contact that is established with the sick person, but the results of our work highlighted how the pandemic has changed the care and perception of operators, intensifying this feeling of psychological imbalance.

The safety of oncology care at the time of Covid19

Background: The U.O. of Oncology DH / DSA of the Piacenza Hospital provides life-saving and indifferent services that could not be postponed or suspended even during the maximum spread of Coronavirus infection in the city of Piacenza. In order to ensure continuity of care and containment of the transmission of infected cases between patients, visitors and health professionals, the organization of the service was planned and changed. Materials and methods: All patients were invited to wash their hands with hydroalcoholic gel, to wear the surgical mask and their temperature was detected. All patients were accepted after triage performed by a nurse who, through the use of a questionnaire, ascertained the health conditions, the geographical origin and epidemiological criteria at risk. Patients who tested positive for screening were isolated and managed in a specific area identified within the service and assisted by dedicated staff. Access was allowed only to the person who was to receive the service;the presence of Caregiver was allowed for people who are not independent, if linguisticcultural mediation was required or in specific cases agreed with the staff and the oncologist. The patient paths inside the structure ware redesigned in order to guarantee the safety distance required by current legislation and the ventilation of the locations. Patient appointments were spaced apart to avoid gatherings in common areas. The patients were instructed to contact their oncologist on the day before the appointment if they had symptoms such as dyspnea temperature, gastrointestinal symptoms, dysgeusia. The use of telephone conversation as a tool for active patient surveillance was implemented. All the processes for sanitizing environments, disinfecting surfaces, equipment and care devices ware revised. Specific procedures ware written for the wearing of operators and the use of DPI based on the risk of exposure to Covid19. Results: In the period from 21/02/2020 to 30/04/2020 there were 2935 DSA accesses with an average value of 60 daily accesses in five daily opening days of the service. During this period, 2 patients, during the first cancer visit were found positive post-nasopharyngeal swab, while no new infections were found in the patients already in charge. Conclusions: The reorganization of the service has made it possible to provide safe and secure care to cancer patients.

Cancer patients' perceptions, opinions and feelings during the covid epidemic in the most affected Italian areas: Serial cross-sectional study

Background: Risks associated with COVID outbreak and consequent restrictive measures taken by the Government, can cause concern and anxiety. The impact on cancer patients (pts) may be even greater. We investigated the influence of COVID pandemic on pts' perceptions, opinions and feelings during the peak of the epidemic and after the loosening of the Government restrictions. Methods: Multicenter, serial cross-sectional study conducted in 11 cancer centers located in the hardest hit Italian areas. The study is composed by 2 surveys administered to unselected adult pts receiving onsite oncologic treatments: the first during the enforcement of containment measures against COVID spread;the second upon the loosening of Government restrictions. A self-administered questionnaire composed by 11 closed questions (only 1 answer) was used. At least 1000 pts per each survey were deemed necessary. Multivariable logistic regression models will be used to identify factors associated to recorded perceptions and opinions. Main outcomes are: 1) perception of the pandemic effect on feelings 2) perception of changes in the relationship with the medical team 3) opinions on healthcare reorganization and on the information campaign. Results: The first survey was conducted between March 16th and April 30th. 1027 questionnaires were collected. Mean age was 64 years (SD 11.7), 58% were women, 49% had low educational level. 80% and 20% received i.v. and oral treatment, respectively. As for pts feelings, 45.5% indicated that their fears related to cancer had increased because hope in recovery had diminished (23%). Courage of coping with tumor was increased in 26%, unchanged in 64%;95% perceived a high availability of healthcare facilities and 97.6% declared confidence in the treating team's handling of the epidemic, while 65.3% stated that the information received from the Government and local bodies was confusing. Conclusions: Although half of the pts had more fears and concerns about the epidemic, they feel reassured, maintain trust in healthcare facilities and a good communication with doctors and nurses. Due to the epidemic's course, the second survey could not yet be performed and data will be available by June.

Cancer patients’ perceptions, opinions and feelings during the COVID-19 epidemic in the most affected Italian areas: Serial cross-sectional study

Background: Risks associated with COVID outbreak and consequent restrictive measures taken by the Government can cause concern and anxiety. The impact on cancer patients (pts) may be even greater. We investigated the influence of COVID pandemic on pts’ perceptions, opinions and feelings during the peak of the epidemic and after the loosening of the Government restrictions. Methods: Multicenter, serial cross-sectional study conducted in 11 cancer centers located in the hardest hit Italian areas. The study is composed by 2 surveys administered to unselected adult pts receiving onsite oncologic treatments: the first during the enforcement of containment measures against COVID spread;the second upon the loosening of Government restrictions. A self-administered questionnaire composed by 11 closed questions (only 1 answer) was used. At least 1000 pts per each survey were deemed necessary. Multivariable logistic regression models will be used to identify factors associated to recorded perceptions and opinions. Main outcomes are: 1) perception of the pandemic effect on feelings 2) perception of changes in the relationship with the medical team 3) opinions on healthcare reorganization and on the information campaign This study has been approved by all Ethical Commettees of the centers. Results: The first survey was conducted between March 16th and April 30th. 1027 questionnaires were collected. Mean age was 64 yrs (SD 11.7), 58% were women, 49% had low educational level. 80% and 20% received i.v. and oral treatment, respectively. As for pts feelings, 45.5% indicated that their fears related to cancer increased because hope in recovery diminished (23%). Courage of coping with tumor was increased in 26%, unchanged in 64%;95% perceived a high availability of healthcare facilities and 97.6% declared confidence in the treating teams, while 65.3% stated that the information received from the Government and local bodies was confusing. Conclusions: Although half of the pts had more fears and concerns about the epidemic, they feel reassured, maintain trust in healthcare facilities and a good communication with doctors and nurses. Due to the epidemic course, the second survey could not yet be performed and data will be available by June. Legal entity responsible for the study: Azienda Istituti Ospitalieri di Cremona, Italy. Funding: MEDEA, Medicina e Arte, Onlus, Cremona. Disclosure: All authors have declared no conflicts of interest.