ABSTRACT
Background: Real world studies on the immunogenicity of BNT162b2 and mRNA-1273 in patients (pts) with cancer showed a reduced seroconversion. The aim of the study is to evaluate the immunogenicity and clinical efficacy of two doses of mRNA vaccines in cancer pts, during or after active treatment. Patients and Methods: This is a single institution, prospective, observational study, conducted at Luigi Sacco Hospital in Milan, IT. Seric antibody levels were measured in solid cancer pts and in healthy controls before the 1st dose (T0) and 30 days after the 2nd one (T1) by a fluorescence bead-based assay. Seroconversion (SR) was defined as anti-S and anti-RBD > 700 MFI (Median Fluorescence Intensity). Previous exposure was defined as anti-N >700 MFI (E-group: exposed;nonE-group: non exposed). Clinical efficacy was defined as the percentage of subjects who did not develop COVID-19 six months after the second dose. Result(s): 195 cancer pts: median age 64.1 y (Q1-Q3 53.8- 72.0);female 138 (70.8%);E-group (12.6%);active therapy 144 (86.7%);advanced stage of disease 131 (67.2%);breast cancer 100 (51.3%);chemotherapy 65 (33.3%), targeted therapy 69 (35.4%);multiple comorbidities 44 (22.6%);prophylaxis with G-CSF 15 (7.7%). 20 healthy subjects were enrolled as controls: median age 28.5 y (Q1-Q3 25.0-42.0), female 11 (55.0%). SR in nonEgroup was lower than in healthy controls (66.7% vs 95.0%, p=0.0085). Conversely, SR in E-group was comparable to healthy controls (93.3%, p=0.0020). In cancer pts, multiple comorbidities (p=0.0274) and the use of G-CSF (p=0.0151) negatively correlated with SR;mRNA-1273 induced a higher SR (p<0.0001). Clinical efficacy in pts was 97.4%. 7 pts were diagnosed for SARS-CoV-2 infection and confirmed by a RNA test. 5 pts developed COVID-19: 3 of them did not seroconvert at T1. COVID-19 disease was mild and managed at home. Only 1 hospitalization was recorded, but no ventilation or no intensive care admission was required. Conclusion(s): In our study, cancer pts with a previous SARS-CoV-2 infection showed a higher SR, similar to the one observed in healthy people. Besides, the presence of comorbidities and the use of G-CSF negatively affected the SR, while mRNA-1273 induced a higher SR. Interestingly, no COVID-19 serious complication or death were observed in all subgroups. Finally, as the third dose is the actual standard, identification of persistent non-responder pts is critical in order to select who could benefit of new treatments as monoclonal antibodies.
ABSTRACT
Background: Due to immunosuppression, influenza virus and S. pneumoniae infections in cancer patients (pts) are responsible of a 4 times higher morbidity and mortality rates. Inadequate data are available about efficacy, safety, timing and immunogenicity of influenza (I) and pneumococcal (P) vaccine (vax) in pts undergoing active oncologic treatment. Nevertheless, the main Oncology societies recommend I and P vax in cancer pts and their family members (FMs). Materials and Methods: This is a single institution prospective study conducted at L. Sacco Hospital (Milan) between Sept 20 and Apr 21. The aim was to evaluate efficacy and safety of vax. Pts with diagnosis of tumor, age>18ys, in active antineoplastic treatment and FMs age>18ys were included. Each pt received I+P vax on the same day of therapy. Pts were compared with a control group of FMs, with age- and gender-adjusted logistic regression. Monthly monitoring was scheduled to register any Adverse Events (AEs) after injection (local and systemic AEs), episode of Influenza Like Illness (ILI), pneumococcal infection, access to Emergency department (ED) or Hospital admission (HA) and delay of treatment (DT). Results: 194 pts (63y median age, 67.5% female) and 140 FMs (59y median age, 49% female) were enrolled. CANCER: 92% solid and 8% hematological malignancy, 69% metastatic stage. TREATMENTS: 54% =1 previous line of therapy;38% chemotherapy, 31% target, 17% chemo+target, 14% hormone therapy. VAX: 47% pts and 72% FMs received I-vax for first time. I+P-vax were administered in 100% pts and 49% FMs. LOCAL AEs: I-vax: 34% pts and 19.6% FMs (p=0.01), P-vax: 35.7% pts and 20.7% FMs (p=0.11). The most common was pain in site of injection. SISTEMIC AEs: 19.6% pts and 8.5% FMs (p=0.11);the most frequent was fatigue. EFFICACY: ILI were recorded in 8.8% pts (3 had a HA and 1 a DT) and 3.6% FMs (p=0.04). No PI was recorded. Type of therapy, previous treatment and the use of steroid don't significantly impact on vax safety and efficacy. Conclusions: Despite the atypical season, I+P vax are safe and effective in cancer pts. The limited number of ILI events observed could be referred to vax but also to COVID-19 risk prevention and mitigation measures. No differences in efficacy and safety were observed between the 2 groups, except for local I-vax AEs. Moreover, the vax administration in the Oncology department, a wide vaccination coverage was achieved (>70% of cancer pts), reducing the pressure on territorial healthcare system.
ABSTRACT
Background: Influenza virus and S. pneumoniae infections in cancer patients (pts) are responsible of a higher morbidity and mortality rates. Limited data are available about safety, efficacy, immunogenicity and timing of influenza (I) and pneumococcal (P) vaccine (vax) in pts receiving active treatment. However, I and P vax in cancer pts and their family members (FMs) are reccomended. Methods: This is a single institution prospective study conducted at L. Sacco Hospital (Milan, Italy) between Sept 20 and Apr 21. The aim was to assess efficacy and safety of vax. Cancer pts, age>18yo, in active antineoplastic treatment and FMs age>18yo were included. Each pt received I+P vax on the same day of therapy. Any local and systemic Adverse Event (AE), episode of Influenza Like Illness (ILI), pneumococcal infection (PI), access to Emergency Department (ED) or Hospital admission (HA) and delay of therapy (DoT) were recorded. The frequency of AEs, ILI episodes and PI among pts and age- and gender- matching FMs were compared. Results: 194 pts (63y median age, 67.5% female) and 140 FMs (59y median age, 49% female) were enrolled. CANCER: 92% solid and 8% hematological malignancy, 69% metastatic stage. TREATMENTS: 54% ≥1 previous line of therapy;38% chemotherapy, 31% target, 17% chemo+target, 14% hormone therapy. VAX: I-vax received for first time in 47% pts and 72% FMs. 100% pts and 49% FMs received I+P-vax. LOCAL AEs: I-vax: 34% pts and 19.6% FMs (p=0.01). P-vax: 35.7% pts and 20.7% FMs (p=0.11). The most common was pain in site of injection. SISTEMIC AEs: 19.6% pts and 8.5% FMs (p=0.11);the most frequent was fatigue. EFFICACY: ILI were recorded in 8.8% pts (3 had a HA and 1 a DoT) and 3.6% FMs (p=0.04). No PI was recorded. In a logistic regression analysis type of therapy, previous treatment and the use of steroid don’t significantly impact on vax safety and efficacy. Conclusions: Few ILI events were observed due to vax and probably to all measures adopted to prevent SARS-CoV-2 virus spread. Except for local I-vax AEs, no differences were observed in efficacy and safety between the 2 groups. During the observation time, >70% of cancer pts in active treatment received I and P vax, so the vaccination coverage was achieved, reducing the pressure on territorial healthcare system. Clinical trial identification: Trial protocol n. 2020/ST/433 release by Local Ethic Committee. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: N.M. La Verde: Financial Interests, Personal, Advisory Board: Novartis;Financial Interests, Personal, Advisory Board: Pfizer;Financial Interests, Personal, Advisory Board: Roche;Financial Interests, Personal, Advisory Board: MSD;Financial Interests, Personal, Speaker’s Bureau: Gentili;Financial Interests, Institutional, Funding: EISA. D. Dalu: Financial Interests, Personal, Invited Speaker: Gentili;Financial Interests, Personal, Other: MSD. A. Riva: Financial Interests, Personal, Other: MSD,;Financial Interests, Personal, Other: ViiV;Financial Interests, Personal, Other: Gilead;Financial Interests, Personal, Other: Janseen;Financial Interests, Personal, Other: Cilag. S. Antinori: Financial Interests, Personal, Other: Pfizer;Financial Interests, Personal, Other: Merck. M. Galli: Financial Interests, Personal, Other: ViiV;Financial Interests, Personal, Other: BMS;Financial Interests, Personal, Other: MSD;Financial Interests, Personal, Other: AbbVie;Financial Interests, Personal, Other: Gilead;Financial Interests, Personal, Other: Janssen;Financial Interests, Personal, Other: Roche. All other authors have declared no conflicts of interest.
ABSTRACT
Background: COVID-19 pandemic led to a reorganization of Health Care System for cancer pts, also because of the application of containment measures. The aim of our study was to investigate the emotional discomfort of pts and their CGs who needed to access the day-hospital to receive treatment during pandemic. Methods: This is a single-institution, prospective, cross-sectional study. From 5th May to 5thJune 2020 a survey was conducted at a Department of Oncology in the midst of the Italian outbreak. We compared the points of view of both the 'players' through 2 different multiple-choice questionnaires enquiring demographic characteristics, changes in emotional status, interpersonal relationships with health professionals (HCPs) and self-perception of treatment outcomes. Results: 625 pts and 254 CGs were enrolled. Female were prevalent (pts:65%, CGs:56%). Pts were generally older than CGs (pts:70% > 60 y, CGs:50.4% 41-60 y;p < 0.001). 50.5% pts had a low education level (EL) while 67.5% CGs had a higher degree. About half of pts (52.8%) reached the hospital with their own CG who lived together in the 58.3% of cases. 52.5% of pts felt more vulnerable to COVID-19 compared to CGs. Differently, CGs did not feel more exposed to infection, although they were involved in taking care or lived together with pts. The EL influenced the risk contagion perception: people with a lower EL were less worried about being infected with SARS-CoV-2. Regardless of the perceived contagion risk, study participants considered the containment measures a valid support to avoid the spread of infection (pts:92%, CGs:89%;p = 0.163) without an excessive loss of time (pts:78%, CGs:88.6%;p = 0.003). A personal emotional change caused by waiting and performing visits/treatments alone was reported more by CGs (66%) than by pts (32.7%;p < 0.001). Specifically, CGs had greater anxiety (58.8%) and fear of not properly managing pts at home (19.8%). The majority of pts (73%) and CGs (62%) thought that the pandemic didn't influence treatment outcomes. The relationship with HCPs was not negatively affected for both pts (79.6%) and CGs (95%), but about a quarter of pts (25%) and CGs (29%) thought that the attention of HCPs was more focused on COVID-19 than on cancer treatment. Conclusions: The majority of pts felt at higher risk of COVID-19 infection and therefore approved the application of safety standards to help them feel more protected. Good relationships with HCPs contributed to receive treatments without experiencing additional distress. For CGs the main troubles are limitations which don't allow to fully share the pts' care route and the perceive an impairment in HCPs relationship. Starting from these data, we can better understand the current psychological distress of pts and their families in order to develop potential strategies to support them in this strenuous period of crisis.