2106P - Safety and patient reported outcomes of SARS-CoV-2 vaccination in patients with cancer

Background

Vaccination against SARS-CoV-2 reduces morbidity from COVID-19 infection in patients (pts) with cancer. Hesitancy toward vaccination remains in some groups. Ongoing vaccinations are recommended for vulnerable pts. This study provides detailed patient-reported and safety outcomes, providing information for patients and clinicians regarding vaccination safety.

Methods

SerOzNET is a prospective study of pts with cancer who received COVID-19 vaccination (BNT162b2, mRNA1273 or ChadOx1-S) in 2021-22 in 3 cohorts: children (5-11 years(y)), adolescents (12-19y) and adults. From pre-vaccination (to 1 month post dose 3, pts completed serial electronic surveys: Oxford COVID-19 Vaccine Confidence and Complacency Scale, patient reported adverse events (AE), and quality of life (5-19y: PedsQL; 20+:QLQC30). Physicians reported safety, including serious adverse events and thrombosis.

Results

511 pts were enrolled (40 children, 74 adolescents, 397 adults); 499 had one or more patient or medical outcome report completed. Median age was 52 (range 5-85). Pain at injection site was the commonest AE (60-90% of pts). AEs reported in 20-50% of all pts after dose 1, 2 or 3 were fatigue, muscle pain and fever. Headache was more common in adolescents and adults (18-26%) than children (0-11%). Chills were more common in children and adolescents (11-29%) than adults (12-19%). Delays/modifications to cancer treatment from dose 1 to 1 month post dose 2 were reported in 33% of children, 27% of adolescents and 21% of adults; and from dose 3 to 1 month post dose 3 in 10% of children, 18% of adolescents and 12% of adults. None were attributed to vaccine toxicity. Venous thromboembolic events (VTE) were reported in 4/397 adults; there were no arterial events, and no thrombotic events in children or adolescents. No allergic reactions were reported. Mean QLQC30 in adults, and PedsQL in pts <20y was similar pre and post dose 1 (p=n.s. all ages) and 2 (p=n.s. children, adults. Adolescents: 2% improvement, p=0.006).

Conclusions

This large trial dataset demonstrates SARS-CoV-2 vaccination in pts with cancer has manageable toxicity. VTE was low, consistent with background rates. Individuals with cancer can be reassured that SARS-CoV-2 vaccination is safe and will not disrupt their cancer therapy.

Clinical trial identification

ACTRN12621001004853.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Cancer Australia (Australian Government), Victorian Cancer Agency (Victorian Government, Australia), Leukaemia Foundation Australia.

Disclosure

E.S. Ahern: Financial Interests, Institutional, Funding, Research funding: Amgen. All other authors have declared no conflicts of interest.