Preliminary safety and efficacy of Sputnik V vaccine in people with genitourinary malignancies

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Created On: 27/12/2021

Preliminary safety and efficacy of Sputnik V vaccine in people with genitourinary malignancies

This retrospective study was carried out to describe the characteristics of the coronavirus infection course as well as the preliminary efficacy and safety of the Gam-COVID-Vac (Sputnik V) vaccine in Russian people having active genitourinary malignancies.

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Key take away

In comparison with the general population, people with active genitourinary malignancies are at an elevated risk of mortality from SARS-CoV-2 infection. Sputnik V vaccination may be safe in people with genitourinary cancer.

Background

Method

The enrolled participants were retrospectively detected at 9 cancer centers in different regions. People were recruited if SARS-CoV-2 infection was diagnosed by RT-PCR. For evaluating safety, collection of data was done from additional people with genitourinary cancers who did not have positive SARS-CoV-2 RT-PCR test prior to vaccination and who were given 2 doses of Sputnik V. Collection of anonymized data was done through an online registry covering outcomes, demographics, and treatments.

Result

The Sputnik V vaccine showed good tolerability. There were no grade 3-5 toxicities noted in 112 vaccinated people with metastatic genitourinary cancer. Asthenia (49%), flu-like illness (68%), and injection site reactions (76%) were the most common grade 1 noxious event (81%). Notably, 3 people had grade 2 fever (2.7%) and 5 people had grade 2 chills (4.5%). With the median follow-up of 6.2 months, 2/112 (1.8%) coronavirus cases were confirmed by RT-PCR test in the vaccine group.

Notably, 88 people with coronavirus disease were incorporated in the assessment with the majority of the participants being male with renal cell carcinoma. Overall, 36 people (41%) exhibited evidence of metastatic disease. Out of these, 22 people were receiving systemic therapy. Hospitalization was needed by more than half of the participants.

In total, 54 people (61%) had complications, 16 people who developed SARS-CoV-2 pneumonia needed mechanical ventilator support, and 16 people (18%) died in a median of 23.5 days following the date of coronavirus diagnosis. The three-month survival rate was noted to be 82%. The clinical and/or radiographic advancement of cancer during SARS-CoV-2 infection or the subsequent three months was noted in 10 people (11.4%).

Conclusion

People with genitourinary malignancies experiencing coronavirus disease have greater mortality linked with the presence of metastatic disease and Eastern Cooperative Oncology Group (ECOG) performance status.