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.
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.
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.
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.
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%).
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.
Journal of Hematology and Oncology
Safety and preliminary efficacy of the Gam-COVID-Vac vaccine and outcomes of SARS-CoV-2 infection in Russian patients with genitourinary malignancies
Ilya Tsimafeyeu et al.
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