Nursing Management of Frail Patients with Hematologic Malignancies during COVID-19 Pandemia in the Viterbo Domiciliary Care Unit: Data Analysis from March 2020 to March 2021

Introduction In the Viterbo province (3612 Km 2 divided into 60 municipalities) is operative a Domiciliary Hematologic Care Unit (DHCU) for clinical assistance to frail patients (pts) with hemopathies: DHCU nursing activity is done by 4 units who were employed during Covid-19 pandemia to avoid as possible risks of viral contagium due to hospital admissions of our pts. Aims To evaluate the entity and type of nursing management for frail pts followed by DHCU during the first year of Covid-19 pandemia. Methods All nursing activities from 3/2020 to 3/2021 in the lockdown framework were analysed. On the whole, 107 pts in 43 municipalities of Viterbo province were followed by DHCU nurses in the study period. Results Main features of the pts at baseline of domiciliary assistance are reported in the Table. At beginning of the study period (08/03/2020), 37 pts (34.5%) were already followed by DHCU, while 70 pts (65.5%) entered domiciliary assistance during the year of study. Median distance from DHCU central site to pts house was 25 Km [Interquartile range (IQR) 16 - 34]: distance from DHCU was < 20 Km in 32 cases (29.9%), ≥ 20 < 40 Km in 57 (53.2%) and ≥ 40 Km in 18 (16.9%). A total number of 2609 nursing accesses was done in the whole period. According to different procedures, 1152 blood samples were performed, with a median number of 7 (IQR 3 - 15) for each pts: in addition, there were 1040 accesses for chemotherapy (CHT) administration (108 cycles of azacytidine in 15 pts, 87 bortezomib-based cycles in 30 pts, 16 administrations of other CHTs in 2 pts) and 417 accesses for other procedures (260 venous catheter medications, 125 therapy other than CHT, 32 nursing assistances of transfusions or marrow aspirates). Finally, 20 pts were vaccinated at home with respective caregivers. During the entire study period, 2 pts (1.8%) developed Covid-19 infection while in home care. At the last follow-up (31/03/2021), 59 pts (55.1%) were alive and still followed by DHCU, 20 pts (18.6%) were alive and returned to sDay-Hospital (DH) setting due to improvement of clinical conditions and 28 pts (26.3%) died while in domiciliary assistance. Conclusions Domiciliary nurse assistance during Covid-19 pandemia allowed to follow in a safer way compared to standard DH/ordinary admission settings > 100 frail pts with hemopathies, most of them in 1 st or subsequent active lines of therapy, in a wide geographic area. In our opinion, this approach should represent the best type of assistance for a high rate of hematologic pts even beyond Covid-19 period of pandemia. [Formula presented] Disclosures: Stagno: Novartis: Consultancy, Honoraria, Other: Support for attending meetings and/or travel, Research Funding;Pfizer: Consultancy, Honoraria, Other: Support for attending meetings and/or travel;InCyte: Consultancy, Honoraria. Latagliata: BMS Cellgene: Honoraria;Pfizer: Honoraria;Novartis: Honoraria.

Antineoplastic treatment class modulates COVID-19 mRNA-BNT162b2 vaccine immunogenicity in cancer patients: a secondary analysis of the prospective Vax-On study.

BACKGROUND: Preliminary analysis from the Vax-On study did not find a correlation between cancer treatment type and antibody response to COVID-19 vaccination. We carried out a secondary subgroup analysis to verify the effects of comprehensive cancer treatment classification on vaccine immunogenicity. METHODS: The Vax-On study prospectively enrolled patients who started a two-dose messenger RNA-BNT162b2 vaccine schedule from 9 March 2021 to 12 April 2021 (timepoint-1). Those on active treatment within the previous 28 days accounted for the exposed cases. Patients who had discontinued such treatment by at least 28 days or received intravesical therapy represented the control cases. Quantification of immunoglobulin G (IgG) antibodies against the receptor binding domain of the S1 subunit of the SARS-CoV-2 spike protein was carried out before the second dose (timepoint-2) and 8 weeks thereafter (timepoint-3). Seroconversion response was defined at ≥50 arbitrary units/ml IgG titer. Classification of antineoplastic agents was based on their pharmacodynamic properties. RESULTS: Three hundred and sixty-six patients were enrolled (86 and 260 as control and exposed cases, respectively). Univariate analysis revealed a significantly lower IgG titer after both doses of vaccine in subgroups treated with tyrosine kinase inhibitors (TKIs), multiple cytotoxic agents, alkylating agents, and topoisomerase inhibitors. At timepoint-3, seroconversion response was significantly impaired in the topoisomerase inhibitors and mechanistic target of rapamycin (mTOR) inhibitors subgroups. After multivariate testing, treatment with alkylating agents and TKIs was significantly associated with a reduced change in IgG titer at timepoint-2. Treatment with mTOR inhibitors resulted in a similar interaction at each timepoint. Cyclin-dependent kinase 4/6 inhibitor treatment was independently correlated with an incremental variation in IgG titer at timepoint-3. Specific subgroups (TKIs, antimetabolites, alkylating agents, and multiple-agent chemotherapy) predicted lack of seroconversion at timepoint-2, but their effect was not retained at timepoint-3. Eastern Cooperative Oncology Group performance status 2, immunosuppressive corticosteroid dosing, and granulocyte colony-stimulating factor use were independently linked to lower IgG titer after either dose of vaccine. CONCLUSIONS: Drugs interfering with DNA synthesis, multiple-agent cytotoxic chemotherapy, TKIs, mTOR and cyclin-dependent kinase 4/6 inhibitors differentially modulate humoral response to messenger RNA-BNT162b2 vaccine.