背景:尽管经尿道切除了膀胱肿瘤(TURBT),然后进行了膀胱内芽孢杆菌-卡介苗(BCG),高危非肌层浸润性膀胱癌(HR-NMIBC)与高复发率和进展率相关.免疫检查点抑制剂可以提高膀胱癌的抗肿瘤活性,但HR-NMIBC的相关证据有限。因此,我们评估了基于tislelizumab的联合方案在HR-NMIBC中的疗效和安全性.
方法:一项回顾性研究包括2020年7月至2022年9月期间诊断为HR-NMIBC的21例患者。所有患者均接受TURBT,然后进行tislelizumab加BCG联合或不联合吉西他滨/顺铂(GC)化疗。关于人口统计学和特征的临床数据,治疗信息,结果,和安全性进行了收集和分析。
结果:在21例HR-NMIBC患者中,中位年龄为63岁(范围39-85岁),大多数患者为T1期(16/21,76.19%)。tislelizumab的中位治疗为5个周期(范围1-12),BCG滴注的中位次数为12次(范围2-19)。在21名患者中,15人(71.43%)接受GC联合化疗,中位治疗2个周期(范围0-7);其他没有。总的来说,中位随访25个月(范围7-31)后,估计的2年无膀胱复发生存率为78.64%(95%置信区间[CI],50.79-91.83%),2年无膀胱切除术生存率为83.00%(95%CI53.53-94.59%),2年无病生存率为73.39%(95%CI46.14~88.36%)。16例T1期患者2年无远处转移生存率为95.45%(95%CI71.87-99.34%)。14例(66.67%)患者经历了至少一种治疗相关的AE(TRAEs),3-4级的9.52%(2/21)。≥3级的TRAEs分别为垂体炎(1/21,4.76%)和肌无力(1/21,4.76%)。没有观察到治疗相关的死亡。
结论:该研究显示了基于tislelizumab的联合方案作为HR-NMIBC的膀胱保留治疗的有希望的临床益处和可控制的安全性。
BACKGROUND: Despite adequate transurethral resection of the bladder tumor (TURBT) followed by intravesical bacillus-calmette guérin (BCG), high-risk non-muscle-invasive bladder cancer (HR-NMIBC) is associated with high rates of recurrence and progression. Immune checkpoint inhibitors can improve antitumor activity in bladder cancer, but relevant evidence in HR-NMIBC is limited. Thus, we evaluated the efficacy and safety of the
tislelizumab-based combination regimen in HR-NMIBC.
METHODS: A retrospective study included 21 patients diagnosed with HR-NMIBC between July 2020 and September 2022. All patients underwent TURBT followed by combination regimens of
tislelizumab plus BCG with or without gemcitabine/cisplatin (GC) chemotherapy. Clinical Data on demographics and characteristics, treatment information, outcomes, and safety were collected and analyzed.
RESULTS: Among the 21 patients with HR-NMIBC, the median age was 63 years (range 39-85), with the majority of patients with stage T1 (16/21, 76.19%). The median treatment of
tislelizumab was 5 cycles (range 1-12) and the median number of BCG instillations was 12 times (range 2-19). Of the 21 patients, 15 (71.43%) received combination chemotherapy with GC, with a median treatment of 2 cycles (range 0-7); others did not. Overall, after the median follow-up of 25 months (range 7-31), the estimated 2-year bladder recurrence-free survival rate was 78.64% (95% confidence intervals [CIs], 50.79-91.83%), 2-year cystectomy-free survival rate was 83.00% (95% CI 53.53-94.59%), and 2-year disease-free survival rate was 73.39% (95% CI 46.14-88.36%). Sixteen stage T1 patients achieved a distant metastasis-free survival rate of 95.45% (95% CI 71.87-99.34%) at 2 years. Fourteen (66.67%) patients experienced at least one treatment related-AEs (TRAEs), with 9.52% (2/21) of grade 3-4. Grade ≥ 3 TRAEs were hypophysitis (1/21, 4.76%) and myasthenia (1/21, 4.76%). No treatment-related deaths were observed.
CONCLUSIONS: The study demonstrated promising clinical benefits and a manageable safety profile of
tislelizumab-based combination regimen as a bladder-sparing treatment of HR-NMIBC.