Pagano F, Bassi P, Milani C, Meneghini A, Maruzzi D, Garbeglio A
Department of Urology, University of Padova, Italy.
J Urol. 1991 Jul;146(1):32-5. doi: 10.1016/s0022-5347(17)37707-8.
Bacillus Calmette-Guerin (BCG) intravesical therapy represents a major advance in the treatment of superficial transitional cell carcinoma of the bladder. To date, however, the optimal treatment schedule must be defined and the toxicity related to the treatment is significant. The preliminary results of a randomized ongoing study performed to evaluate the effectiveness and relative toxicity of a low dose (75 mg.) BCG regimen in the treatment of superficial bladder cancer therapy are reported. A total of 126 patients (70 for prophylaxis of recurrent stages Ta and T1 papillary tumors and 56 for treatment of carcinoma in situ or with microinfiltration of the subepithelial connective tissue) underwent a 6-week course of 75 mg. BCG (Pasteur vaccine). An additional course was given in patients who failed to respond to the induction course. Maintenance therapy was administered in complete responders monthly for 1 year and then quarterly for 1 year. The prophylaxis group (transurethral resection plus BCG) was randomized versus transurethral resection alone (63 patients, control group). A complete response in the prophylaxis, control and therapy groups was observed in 74, 17 and 57% of the patients, respectively, while 4, 17 and 12.5%, respectively, experienced tumor progression. The additional course of therapy increased the response rate. On the contrary, previous unsuccessful intravesical chemotherapy did not affect the response rate. In regard to toxicity, irritative disturbances (27%) and fever (17%) appeared to be significantly decreased compared with the rates reported in the literature. No major complications were experienced. In conclusion, a low dose (75 mg.) Pasteur strain BCG regimen was effective as prophylaxis against recurrent superficial papillary tumors and as treatment of carcinoma in situ or with microinfiltration of the subepithelial connective tissue. Toxicity related to the treatment appeared to be low.
卡介苗（BCG）膀胱内灌注治疗是膀胱浅表性移行细胞癌治疗的一项重大进展。然而，迄今为止，最佳治疗方案仍有待确定，且该治疗相关的毒性较为显著。本文报告了一项正在进行的随机研究的初步结果，该研究旨在评估低剂量（75毫克）BCG方案治疗浅表性膀胱癌的有效性和相对毒性。共有126例患者（70例用于预防Ta和T1期乳头状肿瘤复发，56例用于治疗原位癌或伴有上皮下结缔组织微浸润的癌）接受了为期6周的75毫克BCG（巴斯德疫苗）治疗。对诱导疗程无反应的患者给予额外疗程治疗。完全缓解的患者每月进行1年的维持治疗，然后每季度进行1年的维持治疗。预防组（经尿道切除术加BCG）与单纯经尿道切除术（63例患者，对照组）进行随机对照。预防组、对照组和治疗组的完全缓解率分别为74%、17%和57%，而肿瘤进展率分别为4%、17%和12.5%。额外的治疗疗程提高了缓解率。相反，既往膀胱内化疗失败并不影响缓解率。关于毒性，与文献报道的发生率相比，刺激性症状（27%）和发热（17%）的发生率似乎显著降低。未发生重大并发症。总之，低剂量（75毫克）巴斯德菌株BCG方案作为预防浅表性乳头状肿瘤复发以及治疗原位癌或伴有上皮下结缔组织微浸润的癌有效。该治疗相关的毒性似乎较低。
