426P - Safety of Sputnik V COVID-19 vaccine in cancer patients receiving chemotherapy: An observational study

Background

COVID-2019 had a dramatic impact on cancer care worldwide. There are numerous of vaccines developed or being developed in order to prevent the spread of the disease. A recombinant adenovirus-based vaccine, Gam-COVID-Vac (Sputnik V), has shown a favorable safety profile and efficacy in Phase 3 trial. Nowadays it is a main SARS-CoV-2 vaccine in Russia, but there is lack of information on its safety in cancer patients. We conducted a retrospective trial to assess safety of Sputnik V in adult patients with cancer.

Methods

we screened N.N. Blokhin NMRCO records for 01.2021-05.2022 timeframe and identified adult cancer patients vaccinated against SARS-CoV-2 with Sputnik V vaccine and contacted them to assess the tolerability and safety of the above mentioned vaccine. The patients were asked to report any new adverse events they experienced up to 28 days after the last dose of the vaccine. All the adverse events were recorded in the database and graded according to CTCAE criteria. Patients were specifically asked to report the following: pyrexia, asthenia, nausea, vomiting, local reactions, abdominal pain, muscle or joint pain and to report any other concerning symptoms. Symptoms were graded according to CTCAE4.03 criteria.

Results

we identified 145 patients who received at least 1 dose of vaccine, safety data were available for 141 of them. Median age was 55 years (21-83), 70 (48.9%), 27 (19.2%), 21 (14.9%) and 19 (13.5%) patients had gynecologic, breast, genitourinary, gastrointestinal tumors, respectively; 5 (3.5%) of patients had other types of tumors. Overall, 70 (49.6%) of patients experienced AE of any grade. Most common AEs were injection reactions (40.4%), pyrexia (24.1%), asthenia (22.0%) and arthralgia (13.5%), results are summarized in the table below. Few patients experienced grade 3-4 AEs, however 1 patient developed grade 4 cerebellar ataxia probably related to vaccination. Cancer type and active treatment were not predictors of AEs. Table: 426P

Conclusions

Sputnik V vaccination appears to be safe and tolerable in patients with cancer, however additional studies should be conducted to assess efficacy and safety of the vaccine in cancer setting.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

A. Rumyantsev: Financial Interests, Personal, Invited Speaker: BIOCAD, AstraZeneca, Eisai, Pfizer, Merck, MSD, R-Pharm; Financial Interests, Personal, Stocks/Shares: AstraZeneca, Pfizer, Novartis, MSD. E. Glazkova: Financial Interests, Personal, Invited Speaker: Pfizer, AstraZeneca, MSD, Merck, Novartis, R-Pharm. A. Tryakin: Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb, MSD, Eli Lilly, Merck, Amgen, Biocad; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Astra Zeneca, Biocad; Financial Interests, Personal, Expert Testimony: R-pharm; Financial Interests, Institutional, Invited Speaker: MSD, BMS; Financial Interests, Personal and Institutional, Invited Speaker: Eli Lilly. A. Tyulyandina: Financial Interests, Personal, Funding: AstraZeneca, Roche, MSD, RUSSCO; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Eisai; Financial Interests, Personal, Invited Speaker: Roche, MSD, Pfizer, Tesaro, BIOCAD. All other authors have declared no conflicts of interest.