Department of Urology, Dr. Ram Manohar Lohia Hospital, New Delhi, India.
Serum Institute of India Pvt. Ltd., Pune, India.
Urol Oncol. 2020 May;38(5):433-439. doi: 10.1016/j.urolonc.2020.01.002. Epub 2020 Feb 7.
Bacillus Calmette-Guerin (BCG) is widely used as an immunotherapeutic agent and recommended in management of non-muscle-invasive bladder cancer (NMIBC). There is no consensus on the optimal dose of the BCG. However, dose reduction has been assessed to decrease the side effects following instillation of BCG. This study compared the efficacy and safety of 80 and 120 mg doses of Sii Onco BCG (Moscow I, Russian strain) in patients with NMIBC.
Patients with histologically confirmed, completely resected solitary or multiple Ta or T1 (with or without carcinoma in situ), grade 1 to 3 urothelial carcinoma of the bladder were included. After transurethral resection of the tumor, repeated intravesical instillations with Sii Onco BCG (80 or 120 mg) were administered, following the induction and 3 weekly maintenance schedule (at 3, 6, 9, 15, 21, 27, and 33 months). Recurrence and progression of the tumor were monitored at scheduled time intervals using cystoscopy.
A total of 104 eligible patients were enrolled to receive 80 mg (n = 51) dose or 120 mg dose (n = 53) of Sii Onco BCG. On completion of 3 years follow-up, recurrence-free survival rate of 84.31% and 86.79% and progression-free survival rate of 84.31% and 94.34% were observed for 80 and 120 mg groups, respectively; difference being statistically nonsignificant.
Both, 80 and 120 mg doses of Sii Onco BCG are effective and safe for prophylaxis and management of NMIBC.
卡介苗（BCG）被广泛用作免疫治疗剂，并被推荐用于治疗非肌肉浸润性膀胱癌（NMIBC）。然而，目前对于 BCG 的最佳剂量尚未达成共识。但是，为了减少 BCG 灌注后的副作用，已经评估了剂量减少。本研究比较了 Sii Onco BCG（莫斯科 I 型，俄罗斯株）80 和 120 mg 剂量在 NMIBC 患者中的疗效和安全性。
纳入组织学证实、完全切除的单发或多发 Ta 或 T1（伴或不伴原位癌）、1 级至 3 级膀胱尿路上皮癌的患者。在肿瘤经尿道切除后，按照诱导和 3 周维持方案（在 3、6、9、15、21、27 和 33 个月时），重复进行 Sii Onco BCG（80 或 120 mg）膀胱内灌注。通过定期膀胱镜检查监测肿瘤的复发和进展情况。
共纳入 104 例符合条件的患者，分别接受 Sii Onco BCG 80 mg（n=51）剂量或 120 mg（n=53）剂量。在完成 3 年随访时，80 和 120 mg 组的无复发生存率分别为 84.31%和 86.79%，无进展生存率分别为 84.31%和 94.34%；差异无统计学意义。
Sii Onco BCG 的 80 和 120 mg 剂量对 NMIBC 的预防和治疗均有效且安全。
