Your browser doesn't support javascript.
Safety and preliminary efficacy of the Gam-COVID-Vac vaccine and outcomes of SARS-CoV-2 infection in Russian patients with genitourinary malignancies.
Tsimafeyeu, Ilya; Volkova, Maria; Alekseeva, Galina; Berkut, Maria; Nosov, Alexander; Myslevtsev, Igor; Andrianov, Andrey; Semenov, Andrey; Borisov, Pavel; Zukov, Ruslan; Goutnik, Vadim; Savchuk, Sergey; Dengina, Natalia; Mitin, Timur.
  • Tsimafeyeu I; Kidney Cancer Research Bureau, Mayakovskogo pereulok 2, Moscow, 109147, Russia. tsimafeyeu@gmail.com.
  • Volkova M; N.N. Blokhin National Medical Research Center of Oncology, Moscow, Russia.
  • Alekseeva G; Pacific State Medical University, Vladivostok, Russia.
  • Berkut M; N.N. Petrov National Medical Research Center of Oncology, St. Petersburg, Russia.
  • Nosov A; N.N. Petrov National Medical Research Center of Oncology, St. Petersburg, Russia.
  • Myslevtsev I; St. Alexei Central Clinical Hospital, Moscow, Russia.
  • Andrianov A; St. Alexei Central Clinical Hospital, Moscow, Russia.
  • Semenov A; Ivanovo Regional Oncology Dispensary, Ivanovo, Russia.
  • Borisov P; N.N. Petrov National Medical Research Center of Oncology, St. Petersburg, Russia.
  • Zukov R; V.F. Voyno-Yasenetsky Krasnoyarsk State Medical University, Krasnoyarsk, Russia.
  • Goutnik V; Medicine 24/7 Clinic, Moscow, Russia.
  • Savchuk S; Saint-Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological), St. Petersburg, Russia.
  • Dengina N; Ulyanovsk Regional Cancer Center, Ulyanovsk, Russia.
  • Mitin T; Knight Cancer Institute, Oregon Health and Science University, Portland, OR, USA.
J Hematol Oncol ; 14(1): 192, 2021 11 13.
Article in English | MEDLINE | ID: covidwho-1515448
ABSTRACT

BACKGROUND:

To our knowledge, there is no clinical data pertaining to COVID-19 outcomes and safety of COVID-19 vaccination in Russian patients with genitourinary (GU) malignancies. Aim of our analysis was to describe the characteristics of the COVID-19 infection course as well as preliminary safety and efficacy of Gam-COVID-Vac vaccine in patients with active GU malignancies.

METHODS:

Patients were retrospectively identified at nine cancer centers in different regions. Patients were included if COVID-19 was diagnosed by a polymerase chain reaction. Data from additional patients with GU cancers who had no positive SARS-CoV-2 RT-PCR test before vaccination and who received two doses of Gam-COVID-Vac (Sputnik V) between 11 February and 31 August 2021 were collected for safety assessment. Anonymized data were collected through an online registry covering demographics, treatments, and outcomes.

RESULTS:

The Gam-COVID-Vac vaccine was well tolerated; no grade 3-5 toxicities were reported in 112 vaccinated metastatic GU cancer patients. The most common grade 1 adverse events (81%) were injection site reactions (76%), flu-like illness (68%), and asthenia (49%). Five patients experienced grade 2 chills (4.5%) and 3 patients had grade 2 fever (2.7%). With median follow-up of 6.2 months, two COVID-19 cases were confirmed by RT-PCR test in the vaccine group (of 112 participants; 1.8%). Eighty-eight patients with COVID-19 disease were included in the analysis. The average age as of the study enrollment was 66 (range 39-81) and the majority of patients were male with renal cell carcinoma (RCC). Thirty-six patients (41%) had evidence of metastatic disease, of these 22 patients were receiving systemic therapy. More than half of patients required hospitalization. Fifty-four patients (61%) experienced complications. Sixteen patients who developed COVID-19 pneumonia required mechanical ventilator support. Sixteen patients (18%) died in a median of 23.5 days after the date of COVID-19 diagnosis was established. The 3-month survival rate was 82%. Clinical and/or radiographic progression of cancer during COVID-19 infection or the subsequent 3 months was observed in 10 patients (11.4%).

CONCLUSION:

Patients with GU malignancies are at increased risk of mortality from COVID-19 infection when compared to the general population. Vaccination could be safe in GU cancer patients. TRIAL REGISTRATION retrospectively registered.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Urogenital Neoplasms / COVID-19 Vaccines / COVID-19 Type of study: Controlled clinical trial / Diagnostic study / Observational study / Prognostic study / Randomized controlled trials / Risk factors Limits: Adult / Aged / Female / Humans / Male / Middle aged Country/Region as subject: Asia / Europa Language: English Journal: J Hematol Oncol Journal subject: Hematology / Neoplasms Year: 2021 Document Type: Article Affiliation country: S13045-021-01205-z

Full text: Available Collection: International databases Database: MEDLINE Main subject: Urogenital Neoplasms / COVID-19 Vaccines / COVID-19 Type of study: Controlled clinical trial / Diagnostic study / Observational study / Prognostic study / Randomized controlled trials / Risk factors Limits: Adult / Aged / Female / Humans / Male / Middle aged Country/Region as subject: Asia / Europa Language: English Journal: J Hematol Oncol Journal subject: Hematology / Neoplasms Year: 2021 Document Type: Article Affiliation country: S13045-021-01205-z