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. 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. 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%). 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.

中文翻译：

---

Gam-COVID-Vac 疫苗的安全性和初步疗效以及俄罗斯泌尿生殖系统恶性肿瘤患者感染 SARS-CoV-2 的结果

据我们所知，没有关于俄罗斯泌尿生殖系统 (GU) 恶性肿瘤患者 COVID-19 结果和 COVID-19 疫苗接种安全性的临床数据。我们分析的目的是描述 COVID-19 感染过程的特征以及 Gam-COVID-Vac 疫苗在活动性 GU 恶性肿瘤患者中的初步安全性和有效性。在不同地区的九个癌症中心对患者进行回顾性鉴定。如果通过聚合酶链反应诊断出 COVID-19，则包括患者。收集了其他 GU 癌症患者的数据，这些患者在接种疫苗前没有 SARS-CoV-2 RT-PCR 检测呈阳性，并且在 2021 年 2 月 11 日至 8 月 31 日期间接受了两剂 Gam-COVID-Vac（人造卫星 V），用于安全评估。匿名数据是通过涵盖人口统计数据的在线注册表收集的，治疗方法和结果。Gam-COVID-Vac 疫苗耐受性良好；在 112 名接种疫苗的转移性 GU 癌症患者中未报告 3-5 级毒性。最常见的 1 级不良事件 (81%) 是注射部位反应 (76%)、流感样疾病 (68%) 和虚弱 (49%)。5 名患者出现 2 级寒战 (4.5%)，3 名患者出现 2 级发热 (2.7%)。中位随访时间为 6.2 个月，通过 RT-PCR 测试在疫苗组（112 名参与者；1.8%）中确认了 2 例 COVID-19 病例。88 名 COVID-19 患者被纳入分析。研究登记时的平均年龄为 66 岁（范围 39-81），大多数患者为男性肾细胞癌 (RCC)。36 名患者 (41%) 有转移性疾病的证据，其中 22 名患者正在接受全身治疗。超过一半的患者需要住院治疗。54 名患者 (61%) 出现并发症。16 名发生 COVID-19 肺炎的患者需要机械呼吸机支持。在确定 COVID-19 诊断日期后的中位时间为 23.5 天，16 名患者 (18%) 死亡。3个月的生存率为82%。10 名患者 (11.4%) 在 COVID-19 感染期间或随后的 3 个月内观察到癌症的临床和/或放射学进展。与普通人群相比，患有 GU 恶性肿瘤的患者因 COVID-19 感染而死亡的风险更高。接种疫苗对 GU 癌症患者可能是安全的。试注册：追溯注册。16 名发生 COVID-19 肺炎的患者需要机械呼吸机支持。在确定 COVID-19 诊断日期后的中位时间为 23.5 天，16 名患者 (18%) 死亡。3个月的生存率为82%。10 名患者 (11.4%) 在 COVID-19 感染期间或随后的 3 个月内观察到癌症的临床和/或放射学进展。与普通人群相比，患有 GU 恶性肿瘤的患者因 COVID-19 感染而死亡的风险更高。接种疫苗对 GU 癌症患者可能是安全的。试注册：追溯注册。16 名发生 COVID-19 肺炎的患者需要机械呼吸机支持。在确定 COVID-19 诊断日期后的中位时间为 23.5 天，16 名患者 (18%) 死亡。3个月的生存率为82%。10 名患者 (11.4%) 在 COVID-19 感染期间或随后的 3 个月内观察到癌症的临床和/或放射学进展。与普通人群相比，患有 GU 恶性肿瘤的患者因 COVID-19 感染而死亡的风险更高。接种疫苗对 GU 癌症患者可能是安全的。试注册：追溯注册。10 名患者 (11.4%) 在 COVID-19 感染期间或随后的 3 个月内观察到癌症的临床和/或放射学进展。与普通人群相比，患有 GU 恶性肿瘤的患者因 COVID-19 感染而死亡的风险更高。接种疫苗对 GU 癌症患者可能是安全的。试注册：追溯注册。10 名患者 (11.4%) 在 COVID-19 感染期间或随后的 3 个月内观察到癌症的临床和/或放射学进展。与普通人群相比，患有 GU 恶性肿瘤的患者因 COVID-19 感染而死亡的风险更高。接种疫苗对 GU 癌症患者可能是安全的。试注册：追溯注册。