Seven-day patient-reported toxicity in patients participating in a prospective study of COVID-19 vaccine response in adults with cancer (SerOzNET).

Abstract

Aims: SerOzNET (ACTRN12621001004853) aims to provide detailed data on outcomes of COVID-19 vaccination, including seroconversion, neutralising antibody titres, T cell response, patient-reported quality of life (QoL) post vaccination and toxicity, for specific cohorts of patients with cancer. This analysis aims to describe acute toxicity post vaccination in patients with cancer. Methods : Cohorts to be enrolled are: current chemotherapy, current immunotherapy, current hormonal or targeted therapy, completed chemotherapy within 6-12 months, haematological malignancy associated with hypogammaglobulinaemia, and patients allergic to PEG or polysorbate-80 containing compounds. Patients have serum and peripheral blood mononuclear cells (PBMC) collected prior to the first dose of vaccine, and at four specified timepoints after vaccination over 6 months. Patients complete baseline QoL and hesitancy surveys; and post vaccination toxicity surveys electronically. Medical staff review patient records for toxicity post vaccination. Results : To date, 102 patients are enrolled. Of these, 35% are on chemotherapy, 20% on immunotherapy, 28% on hormonal or targeted agents, 11% haematological diagnosis, 6% completed chemotherapy previously. From 60 responses to toxicity surveys to date, the most frequently reported adverse events post first dose of vaccine are headache (22%), worsened fatigue (15%), muscle pain (13%), fever (11%) and nausea (7%). Fifty-nine per cent of patients used a medication to treat adverse effects (53% paracetamol, 5% NSAID, 2% other). Two patients had delays in their cancer treatment (1 fever, 1 fatigue) within 7 days of vaccination, and 2 patients saw their GP (1 headache, 1 cough). 1 patient was admitted to hospital (1 fever not attributed to vaccine by treating team). Conclusion(s): COVID-19 vaccines are tolerable in cancer patients. Rates of 7 day patient-reported toxicity are lower than reported in clinical trials of ChAdOx1-S (Astra Zeneca) and BNT162b2 (Pfizer) vaccinations, implying possible reduced immunogenicity. Serological and immunological responses are yet to be analysed and will be informative.