Yoneyama Takahiro, Ohyama Chikara, Imai Atsushi, Ishimura Hirofumi, Hagisawa Shigeru, Iwabuchi Ikuya, Mori Kazuyuki, Kamimura Noritaka, Koie Takuya, Yamato Takashi, Suzuki Tadashi
Department of Urology, Hirosaki University of Medicine, Hirosaki, Japan.
Urology. 2008 Jun;71(6):1161-5. doi: 10.1016/j.urology.2007.11.080. Epub 2008 Feb 15.
To evaluate the effectiveness and side effects of prophylactic low-dose bacille Calmette-Guérin (BCG) Tokyo 172 strain.
We conducted a historical cohort study to compare the clinical usefulness of standard-dose versus low-dose BCG Tokyo 172 strain. A total of 156 patients with superficial bladder cancer (Stage Ta-T1) were historically allocated to either 40 or 80 mg of BCG after transurethral resection. Of the 156 patients, 89 had received standard-dose (80 mg) BCG from 1988 to 2000 and 67 had received low-dose (40 mg) BCG from 1996 to 2005. BCG was instilled into the bladder once a week for 6 consecutive weeks. We excluded 6 patients who did not complete the BCG treatment course. The median follow-up period was 66.9 months (range 2 to 176).
Tumor recurrence developed in 21 (32.3%) of 65 patients in the 40-mg group and 29 (34.5%) of 85 patients in the 80-mg group. No significant difference was found in the incidence of tumor recurrence between the two groups (P = 0.6377). Tumor progression was found in 4 (6.2%) of 65 patients in 40-mg group and 9 (10.6%) of 85 patients in the 80-mg group. No significant difference was found in tumor progression between the two groups (P = 0.5010). The overall incidence of side effects and severity of pollakisuria were significantly lower in the 40-mg group than in the 80-mg group (P = 0.012 and P = 0.013, respectively).
The low-dose BCG Tokyo 172 strain achieved identical recurrence-free and progression-free survival as the standard dose with reduced toxicity.
评估预防性低剂量卡介苗（BCG）东京172株的有效性和副作用。
我们进行了一项历史性队列研究，以比较标准剂量与低剂量BCG东京172株的临床效用。共有156例浅表性膀胱癌（Ta-T1期）患者在经尿道切除术后，根据历史数据被分配接受40或80mg的BCG。在这156例患者中，89例在1988年至2000年期间接受了标准剂量（80mg）的BCG，67例在1996年至2005年期间接受了低剂量（40mg）的BCG。BCG每周向膀胱内灌注一次，连续灌注6周。我们排除了6例未完成BCG治疗疗程的患者。中位随访期为66.9个月（范围为2至176个月）。
40mg组65例患者中有21例（32.3%）出现肿瘤复发，80mg组85例患者中有29例（34.5%）出现肿瘤复发。两组之间的肿瘤复发率无显著差异（P = 0.6377）。40mg组65例患者中有4例（6.2%）出现肿瘤进展，80mg组85例患者中有9例（10.6%）出现肿瘤进展。两组之间的肿瘤进展无显著差异（P = 0.5010）。40mg组的副作用总发生率和尿频严重程度均显著低于80mg组（分别为P = 0.012和P = 0.013）。
低剂量BCG东京172株与标准剂量相比，在无复发生存率和无进展生存率相同的情况下，毒性降低。
