Kidney Cancer Research Bureau, Mayakovskogo pereulok 2, Moscow, 109147, Russia.
N.N. Blokhin National Medical Research Center of Oncology, Moscow, Russia.
J Hematol Oncol. 2021 Nov 13;14(1):192. doi: 10.1186/s13045-021-01205-z.
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.
retrospectively registered.
据我们所知，目前尚无关于俄罗斯泌尿生殖系统（GU）恶性肿瘤患者 COVID-19 结局和 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。
在不同地区的九家癌症中心回顾性地确定患者。如果 COVID-19 通过聚合酶链反应（PCR）诊断，则纳入患者。收集了另外一些 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 日期间接种了两剂 Gam-COVID-Vac（Sputnik V），用于安全性评估。通过涵盖人口统计学、治疗和结局的在线登记册收集了匿名数据。
Gam-COVID-Vac 疫苗耐受性良好；112 名转移性 GU 癌症接种疫苗的患者中没有报告 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%）和乏力（49%）。5 例患者出现 2 级寒战（4.5%），3 例患者出现 2 级发热（2.7%）。中位随访 6.2 个月时，疫苗组有 2 例 COVID-19 病例通过 RT-PCR 检测确诊（112 名参与者中占 1.8%）。88 例 COVID-19 疾病患者纳入分析。研究入组时的平均年龄为 66 岁（范围 39-81 岁），大多数患者为男性，患有肾细胞癌（RCC）。36 例患者（41%）有转移疾病证据，其中 22 例患者正在接受全身治疗。超过一半的患者需要住院治疗。54 例患者（61%）发生并发症。16 例发生 COVID-19 肺炎的患者需要机械通气支持。16 例患者（18%）在 COVID-19 诊断确立后平均 23.5 天死亡。3 个月生存率为 82%。在 COVID-19 感染期间或随后的 3 个月内，观察到 10 例（11.4%）癌症出现临床和/或影像学进展。
与一般人群相比，GU 恶性肿瘤患者因 COVID-19 感染而死亡的风险增加。在 GU 癌症患者中，疫苗接种可能是安全的。
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