Hurle Rodolfo, Soria Francesco, Contieri Roberto, Avolio Pier Paolo, Mancon Stefano, Lazzeri Massimo, Bernasconi Valentina, Mazzoli Simone, Pizzuto Giuseppe, De Bellis Matteo, Rosazza Matteo, Livoti Simone, Lupia Tommaso, Corcione Silvia, Lillaz Beatrice, De Rosa Francesco Giuseppe, Buffi Nicolò Maria, Kamat Ashish M, Gontero Paolo, Casale Paolo
Department of Urology, IRCCS Humanitas Research Hospital, Via Manzoni 56, 20089 Rozzano, Italy.
Division of Urology, Department of Surgical Sciences, San Giovanni Battista Hospital, Torino School of Medicine, 10126 Turin, Italy.
Cancers (Basel). 2023 Mar 6;15(5):1618. doi: 10.3390/cancers15051618.
We aim to evaluate the potential protective role of intravesical Bacillus Calmette-Guerin (BCG) against SARS-CoV-2 in patients with non-muscle invasive bladder cancer (NMIBC). Patients treated with intravesical adjuvant therapy for NMIBC between January 2018 and December 2019 at two Italian referral centers were divided into two groups based on the received intravesical treatment regimen (BCG vs. chemotherapy). The study's primary endpoint was evaluating SARS-CoV-2 disease incidence and severity among patients treated with intravesical BCG compared to the control group. The study's secondary endpoint was the evaluation of SARS-CoV-2 infection (estimated with serology testing) in the study groups. Overall, 340 patients treated with BCG and 166 treated with intravesical chemotherapy were included in the study. Among patients treated with BCG, 165 (49%) experienced BCG-related adverse events, and serious adverse events occurred in 33 (10%) patients. Receiving BCG or experiencing systemic BCG-related adverse events were not associated with symptomatic proven SARS-CoV-2 infection ( = 0.9) nor with a positive serology test ( = 0.5). The main limitations are related to the retrospective nature of the study. In this multicenter observational trial, a protective role of intravesical BCG against SARS-CoV-2 could not be demonstrated. These results may be used for decision-making regarding ongoing and future trials.
我们旨在评估膀胱内灌注卡介苗（BCG）对非肌层浸润性膀胱癌（NMIBC）患者感染严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的潜在保护作用。2018年1月至2019年12月期间，在意大利的两家转诊中心接受膀胱内辅助治疗的NMIBC患者，根据所接受的膀胱内治疗方案（卡介苗与化疗）分为两组。该研究的主要终点是评估与对照组相比，接受膀胱内卡介苗治疗的患者中SARS-CoV-2疾病的发病率和严重程度。该研究的次要终点是评估研究组中的SARS-CoV-2感染情况（通过血清学检测估计）。总体而言，340例接受卡介苗治疗的患者和166例接受膀胱内化疗的患者纳入了该研究。在接受卡介苗治疗的患者中，165例（49%）出现了与卡介苗相关的不良事件，33例（10%）患者发生了严重不良事件。接受卡介苗治疗或出现全身性卡介苗相关不良事件与经症状证实的SARS-CoV-2感染（P=0.9）或血清学检测阳性（P=0.5）均无关。主要局限性与该研究的回顾性性质有关。在这项多中心观察性试验中，无法证明膀胱内卡介苗对SARS-CoV-2有保护作用。这些结果可用于正在进行的和未来试验的决策。
