Sufficient prophylactic efficacy with minor adverse effects by intravesical instillation of low-dose bacillus Calmette-Guerin for superficial bladder cancer recurrence
Sufficient prophylactic efficacy with minor adverse effects by intravesical instillation of low-dose bacillus Calmette-Guerin for superficial bladder cancer recurrence
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DOI：
10.1046/j.0919-8172.2003.00607.x
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发表时间：
2003-04-01
影响因子：
2.6
通讯作者：
Baba, S
中科院分区：
文献类型：
--
作者：
Irie, A;Uchida, T;Baba, S
背景：膀胱内滴注卡介苗（BCG）是预防浅表性膀胱癌复发的最有效策略。卡介苗的不良反应是主要障碍，但减少卡介苗剂量可以最大限度地减少这些影响。前瞻性评估半剂量（40 mg）卡介苗（东京 172 株）的疗效和不良反应。 方法：共有 93 名浅表性膀胱癌（pTa 或 pT1）患者在经尿道切除术后依次接受 40 或 80 mg 卡介苗治疗。术后每周注射一次 BCG，持续 6 周。对80名BCG治疗后观察时间超过12个月的患者（41、40 mg组；39、80 mg组）进行了分析。结果：71名患者完成了BCG治疗疗程。 40 mg 组 40 名患者中有 11 名出现肿瘤复发，80 mg 组 31 名患者中有 5 名出现肿瘤复发。两组肿瘤复发率无显着差异（P=0.547）。由于 BCG 相关不良反应，40 mg 组中有 1 名患者和 80 mg 组有 8 名患者停止了 BCG 治疗。 80mg组卡介苗相关毒性发生率明显较高。结论：半剂量卡介苗东京172株与标准剂量相比具有相似的疗效，且毒性明显降低。因此，该菌株的半剂量可能适合预防膀胱癌复发，至少对于初始卡介苗治疗而言是这样。需要进一步研究来阐明低剂量滴注对高危患者的疗效。
Background: Intravesical instillation of bacillus Calmette-Guerin (BCG) is the most efficient strategy for prophylaxis of superficial bladder cancer recurrence. Adverse effects of BCG are major obstacles, but the reduction of BCG dose could minimize these effects. The efficacy and adverse effects of half-dose (40 mg) BCG, Tokyo 172 strain, were prospectively evaluated.Methods: A total of 93 patients with superficial bladder cancer (pTa or pT1) were sequentially assigned to receive either 40 or 80 mg of BCG after transurethral resection. BCG was administered weekly for 6 weeks postoperatively. Eighty patients observed longer than 12 months after BCG therapy (41, 40 mg group; 39, 80 mg group) were analyzed.Results: BCG therapy course was completed in 71 patients. Tumor recurrence was recognized in 11 of 40 patients in the 40 mg group and in 5 of 31 patients in the 80 mg group. There was no significant difference in tumor recurrence rate between the two groups (P = 0.547). BCG therapy was withdrawn in 1 patient in the 40 mg group and in 8 patients in the 80 mg-group because of BCG-related adverse effects. The morbidity of BCG-related toxicity was significantly higher in the 80 mg group.Conclusion: Half-dose of BCG Tokyo 172 strain had a similar efficacy and its toxicity was signi-ficantly lower compared to the standard dose. Thus, half-dose of this strain might be suitable, at least for initial BCG therapy, for the prophylaxis of bladder cancer recurrence. Further study would be necessary to clarify the efficacy of low-dose instillation in high-risk patients.