ABSTRACT
Background: Concerns about safety and treatment interference are known barriers to COVID-19 vaccination in cancer patients. Data on safety and tolerability in this population remain scarce. One of the objectives of this study is to describe COVID-19 vaccination safety in cancer patients. Methods: Patients diagnosed with a malignancy requiring systemic treatment in the last 12 months and undergoing COVID-19 vaccination were prospectively enrolled in this single-center study. Validated questionnaires to assess vaccine-related adverse events (VRAEs) were collected;chart review identified baseline characteristics and treatments received. Descriptive statistics and logistic regressions were performed. Results: 253 questionnaires were collected from 171 patients, enrolled between May and September 2021. 130 patients were survey-eligible after the 1st dose (D1) and 185 after 2nd dose (D2). 91 questionnaires were collected after D1 (Questionnaire 1: Q1) and 162 after D2 (Questionnaire 2: Q2). Surveys couldn't be collected due to interval > 1 month between D1 / enrollment, patients' unavailability, withdrawal of study or death. Median age was 55 (24-87) and 62.8% were female. 58.5% had solid tumors, treated with chemotherapy (49%) or checkpoint inhibitors only (9.5%);19.4% malignancies were treated with targeted therapies and 22.1% had hematological malignancies. Most frequent solid tumors were breast (31.3%), lung (15.9%) and gastro-intestinal (GI) (14.3%). Patients received 45.6% Pfizer/BioNTech, 52.8% Moderna and 1.6% Oxford/AstraZeneca. A combination of 2 different vaccines was administered to 11.9%. Interval between D1 and D2 was ≤30 days in 53.1%, 31-90 days in 42.6%, and 91-180 days in 4.3%. Among all patients, 84.1% developed VRAEs after a median of 2 days post-vaccine for a median of 4 days. 74.5% had local symptoms (Sx) (pain, sensitivity and/or redness at injection site and/or arm) and 65.8% had systemic Sx. Most frequent systemic Sx were fatigue, chills or myalgia (39.4%), GI (6.3%) and fever (2.9%). Most patients (90.7%) described their Sx as having no / minimal impact (Gr 1), 7.8% reported seeking medical consultation (Gr 2), and 1.5% lead to hospitalization (Gr 3) (1 cardiovascular event, 1 infection;causality with concurrent systemic treatment not excluded and 1 due to malignancy). Gr 2, but not Gr 3, VRAEs were more common after D2 (11.4% vs 2.5%, p = 0.03). 41.7% considered their Sx as a new health problem. On multivariate analysis, younger age and female sex were significantly associated with the development of any Sx (OR 1.08, p = 0.01;OR 2.92, p = 0.02, respectively) and local Sx (OR 1.04, p = 0.04;OR 2.19, p = 0.04), but not systemic Sx or new health problem. Conclusions: Patients experienced mostly minor and transient symptoms post-vaccination;few perceived these as a new health problem. COVID-19 vaccination is overall safe and well-tolerated among cancer patients.
ABSTRACT
Background: Studies suggest that patients with cancer are more likely to experience severe outcomes fromCOVID-19. Therefore, cancer centers have undertaken efforts to care for patients with cancer in COVID-free zones.Nevertheless, nosocomial transmission of COVID-19 in patients with cancer likely occurs, but the frequency andrelevance of these events remain unknown. The goal of this study was to determine the incidence and impact ofhospital-acquired COVID-19 in this population and identify prognostic factors for COVID-19 severity in patients withcancer. Methods: Patients with cancer and a laboratory-confirmed or presumed diagnosis of COVID-19 were prospectivelyidentified using provincial registries and hospital databases between March 3rd and May 23rd, 2020, in theprovinces of Quebec and British Columbia. Patients' baseline characteristics including age, sex, comorbidities, cancer type, and type of anticancer treatment were collected. The primary outcome was incidence of hospital-acquired infection defined by diagnosis of SARS-CoV-2 5 days after hospital admission for COVID-unrelated cause. Co-primary outcomes were death or composite outcomes of severe illness from COVID-19 such as hospitalization, supplemental oxygen, intensive-care unit (ICU) admission, and/or mechanical ventilation. Results: A total of 253 patients (N=250 adult and N=3 pediatric) with COVID-19 and cancer were identified, and themajority were residents of Quebec (N=236). Ninety patients (35.6%) received active anticancer treatment in the last3 months prior to COVID-19 diagnosis. During a median follow-up of 23 days, 209 (82.6%) required hospitalization,38 (15%) required admission to ICU, and 71 (28%) died. Forty-seven (19%) had a diagnosis of hospital-acquiredCOVID-19. Median overall survival was shorter in those with hospital-acquired infection, compared to acontemporary community-acquired population (27 days vs. 71 days, HR 2.2, 95% CI 1.2-4.0, p=0.002). Multivariateanalysis demonstrated that hospital-acquired COVID-19, age, ECOG status, and advanced stage of cancer wereindependently associated with death. Conclusion: Our study demonstrates a high rate of nosocomial transmission of COVID-19, associated withincreased mortality in both univariate and multivariate analysis in the cancer population, reinforcing the importanceof treating patients with cancer in COVID-free zones. We also validated that age, poor ECOG, and advanced cancer were negative prognostic factors for COVID-19 in patients with cancer.