ABSTRACT
Background: Despite of the administration of multiple doses of vaccines (vax), cancer patients (pts) are a group at high risk of COVID-19 complications. The aim of this study is to evaluate the factors associated with the humoral response to the 3rd dose (D) of mRNA-based vax in cancer pts during or after active treatment. Patients and Methods: Single institution, prospective study conducted at the L. Sacco Hospital, Milan, between 5/2021-4/2022. 30 days after the 2nd and 30 days after the 3rdD of BNT162b2 or mRNA-1273 (selected based on local pharmacy availability), seric levels of 3 antibodies (Ab) were measured in solid tumors pts during or after the active treatment, by a fluorescence bead-based assay. Anti-S and anti-RBD IgG to determine the humoral response to vax, anti-N IgG to identify a previous exposure to SARS-Cov-2. Primary objective: to assess the seroconversion (SC) rate and the Ab titres after 3rdD. Secondary Objectives: to detect any relation between the 3rdD response and pre-defined pts variables;to evaluate the humoral response to 3rdD in pts not responding to the 2ndD. Result(s): 99 of 110 pts were evaluated: 67.7% female, median age 63 ys, 49.5% breast cancer, 67.7% advanced stage. Active treatment: 40.4% biologic agent, 23% chemotherapy (alone or combination), 11.1% hormone. 3rdD vax type: 74.8% BNT162b2, 25.2% mRNA-1273. SC after 3rdD was obtained in 99% of pts. The use of GCSF was associated with a lower amount of anti-RBD IgG (p=0.03). A 6 vs 5 months interval between 2nd and 3rdD was correlated with higher anti-S IgG level (p<0.001). The heterologous vax regimen was associated with higher rate of anti-S IgG (p=0.04), especially the sequence mRNA- 1273 x 2 -> BNT162b2 (p=0.001). No significant correlation at the multivariate analyses was found between Ab levels and the other variables tested (age, BMI, cancer type, tumor stage, use of steroids, previous exposure to SARS-CoV-2, anti-cancer therapy, neutropenic potential of the therapy). 21/22 pts not responding to the 2ndD obtained SC after 3rdD. Conclusion(s): 3rdD of anti-COVID-19 vax is effective in cancer pts with solid tumors undergoing or after recent treatment. In this group the 3rdD oversteps all the negative influence of the factors related to the 2ndD vax failure, achieving the same response of the healthy population and demonstrating efficacy in not previously responders, too. The better performance of the heterologous vax regimen could be due to an exposition to a wider range of epitopes.
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.