However, due to the small quantity of individuals, they were grouped into 3 major treatment types so an analysis of the specific effects of each drug and mixtures could not be performed. or with additional therapy; 55 (16.9%) were treated with immune checkpoint inhibitors and 38 (11.7%) with targeted therapy alone; 28 (8.6%) received other mixtures. The vaccine SBI-0206965 was well tolerated, and no severe side effects were reported. Among individuals with malignancy, 39 (11.9%) were seronegative compared with 5 (3.0%) of the control group (test (numerical variables) and the 2 2 test (categorical variables). The Kruskal-Wallis test was used to evaluate variations in numerical variables (eg, age and SARS-CoV-2 S AU IgG titer) among different malignancy types and treatment types (eg, chemotherapy vs immunotherapy vs targeted therapy). Multiple comparisons of numerical variables were performed using the Mann-Whitney test with Bonferroni correction. A multivariable logistic regression model was used to evaluate the association between being a cancer patient and anti-SARS-CoV-2 S IgG antibodies modified for age and sex, and to evaluate the effect of age, metastatic disease, time from second vaccination to IgG test, treatment type (chemotherapy vs no chemotherapy), and malignancy type on seronegativity or positivity. All statistical checks were 2-sided, and a value less than .05 was considered statistically significant. Statistical analysis was carried out using SPSS software. Transforming data to logs and plots formation were performed using GraphPad Prism version SBI-0206965 9.0.1 for Windows. Results Patient Characteristics Between March 15 and April 30, 2021, 326 out Rabbit Polyclonal to HUNK of 1383 (23.6%) actively treated individuals with malignancy agreed to participate in the study. Their characteristics are offered in Table?1. The median age was 66 years, most (n?=?203, 62.3%) were ladies, and the most common tumor types were gastrointestinal (n?=?84, 25.8%) followed by breast (n?=?82, 25.2%) and lung (n?=?45, 13.8%) malignancy. Most individuals (n?=?205, 62.9%) were treated with chemotherapy either alone (n?=?101 patients) or in combination with additional therapy (ICI, targeted therapy, radiation, and hormonal therapy; 104 individuals): 55 (16.9%) were treated with ICI, 38 (11.6%) with targeted therapy alone, and 28 (8.6%) received other treatments (eg, radiation alone or in combination with ICI or targeted therapy). Most individuals (n?=?230, 70.6%) had metastatic disease. As expected from the study design, the median time from second vaccine dose to antibody screening was 78?days (range = 21-115?days). Table 1. Clinical characteristics of study participants values derived from the nonparametric Mann-Whitney test, 2-sided. Ab = antibody; CNS = central nervous system; NA = not relevant; NSCLC = non-small cell lung malignancy. values derived from the parametric 2, 2-sided. The control group included 164 individuals. Their median age was statistically significantly younger than the malignancy individuals cohort (54 vs 64?years, respectively, ideals derived from the nonparametric Mann-Whitney test, 2-sided. Assessment of median IgG Ab between malignancy individuals and control group was modified for age and sex using a logistic regression model including these variables. Ab = antibody; IgG = immunoglobulin G. ideals derived from the parametric 2, 2-sided. To identify additional factors contributing for reduced response to the BNT162b2 vaccine, we also compared characteristics of the 39 individuals with bad antibody titer (<50?AU/mL) with the 287 individuals with positive antibody titers (Table?3). Although no statistically significant variations were found between the 2 organizations in age, sex, metastatic disease status, time to IgG test, or treatment type (chemotherapy-based vs no-chemotherapy-based treatment), the analysis is considered exploratory because of the relatively small number of individuals who remained seronegative. Moreover, there was no statistically significant association between malignancy type and immunogenicity status (values derived from the nonparametric Mann-Whitney test, 2-sided. Ab = antibody; IgG = immunoglobulin G; NSCLC = non-small cell lung malignancy. values derived from the parametric 2 test, 2-sided. value derived from 2 test, 2-sided. Similarly, multivariable logistic regression models (generated separately for men and women because they differ by unique cancer analysis) did not display any statistically significant association between seropositivity in individuals with malignancy and age, sex, or malignancy type variables (data not demonstrated). Finally, we analyzed the association between either antibody titers or immunogenicity and treatment given (Table?4). Because of the heterogeneity of chemotherapy-based mixtures, the analysis was restricted to individuals receiving only a single type of systemic therapy: SBI-0206965 chemotherapy alone (n?=?101), ICI alone (n?=?55), or targeted therapy alone (n?=?38). Seronegativity proportions were higher in the chemotherapy-treated group (18.8%) compared with 9.1% in the ICI-treated individuals and 2.6% in those treated with targeted therapy (values derived from the.