Department of Maternal-Infant and Urological Sciences, Policlinico Umberto I Hospital, "Sapienza" University of Rome, Viale del Policlinico 155, 00161, Rome, Italy.
Department of Urology, Stanford Medical Center, Stanford, CA, USA.
J Cancer Res Clin Oncol. 2021 Oct;147(10):3073-3080. doi: 10.1007/s00432-021-03571-0. Epub 2021 Mar 6.
(I) To evaluate the clinical efficacy of three different BCG strains in patients with intermediate-/high-risk non-muscle-invasive bladder cancer (NMIBC). (II) To determine the importance of performing routine secondary resection (re-TUR) in the setting of BCG maintenance protocol for the three strains.
NMIBCs who received an adjuvant induction followed by a maintenance schedule of intravesical immunotherapy with BCG Connaught, TICE and RIVM. Only BCG-naïve and those treated with the same strain over the course of follow-up were included. Cox proportional hazards model was developed according to prognostic factors by the Spanish Urological Oncology Group (CUETO) as well as by adjusting for the implementation of re-TUR.
n = 422 Ta-T1 patients (Connaught, n = 146; TICE, n = 112 and RIVM, n = 164) with a median (IQR) follow-up of 72 (60-85) were reviewed. Re-TUR was associated with improved recurrence and progression outcomes (HR: 0.63; 95% CI 0.46-0.86; HR: 0.55; 95% CI 0.31-0.86). Adjusting for CUETO risk factors and re-TUR, BGC TICE and RIVM provided longer RFS compared to Connaught (HR: 0.58, 95% CI 0.39-0.86; HR: 0.61, 95% CI 0.42-0.87) while no differences were identified between strains for PFS and CSS. Sub-analysis of only re-TUR cases (n = 190, 45%) showed TICE the sole to achieve longer RFS compared to both Connaught and RIVM.
Re-TUR was confirmed to ensure longer RFS and PFS in intermediate-/high-risk NMIBCs but did not influence the relative single BCG strain efficacy. When routinely performing re-TUR followed by a maintenance BCG schedule, TICE was superior to the other strains for RFS outcomes.
(一)评估三种不同卡介苗菌株在中高危非肌肉浸润性膀胱癌(NMIBC)患者中的临床疗效。(二)确定在卡介苗维持方案中常规进行二次切除(再 TUR)对三种菌株的重要性。
接受辅助诱导后,采用卡介苗康诺特、TICE 和 RIVM 进行膀胱内免疫治疗维持方案的 NMIBC 患者。仅包括卡介苗初治患者和在随访过程中接受相同菌株治疗的患者。根据西班牙泌尿外科肿瘤学组(CUETO)的预后因素以及调整再 TUR 实施情况,建立 Cox 比例风险模型。
共纳入 422 例 Ta-T1 患者(康诺特组 n=146,TICE 组 n=112,RIVM 组 n=164),中位(IQR)随访时间为 72(60-85)。再 TUR 与复发和进展结局的改善相关(HR:0.63;95%CI 0.46-0.86;HR:0.55;95%CI 0.31-0.86)。调整 CUETO 危险因素和再 TUR 后,与康诺特组相比,BGC TICE 和 RIVM 提供了更长的 RFS(HR:0.58,95%CI 0.39-0.86;HR:0.61,95%CI 0.42-0.87),而 PFS 和 CSS 方面三种菌株之间没有差异。仅再 TUR 病例(n=190,45%)的亚组分析显示,TICE 是唯一与康诺特和 RIVM 相比能够实现更长 RFS 的菌株。
在中高危 NMIBC 中,再次 TUR 被证实可确保更长的 RFS 和 PFS,但对单一 BCG 菌株疗效的相对影响不大。当常规进行再 TUR 并随后进行卡介苗维持方案时,TICE 在 RFS 结局方面优于其他菌株。