Francesco Bassi P, Milani C, Meneghini A, Maruzzi D, Garbeglio A, Aragona F, Tejerizo J C, Pagano F
Instituto de Urología de la Universidad de Padua, Italia.
Arch Esp Urol. 1990 Jun;43(5):503-7.
The preliminary results of a randomized ongoing study performed in order to evaluate the efficacy and the relative toxicity of a low dose (75 mg). BCG regimen in the treatment of superficial bladder cancer were considered. Ninety-eight patients (58 patients for prophylaxis of the recurrences of Ta-T1 papillary tumors; 40 patients for therapy of carcinoma in situ) received a 6-weeks course of 75 mg. BCG Pasteur vaccine. An additional course was given to non-responders. A maintenance therapy was administered in complete responders monthly for the first year and quarterly for the second. The prophylaxis group (TUR + BCG) was randomized vs TUR alone (40 patients = control group). Complete response in evaluated patients of the prophylaxis, control and therapy groups achieved 86%, 17% and 78%, respectively, after 18 months; 5%, 20% and 9% of patients, respectively, experienced tumor progression. As regards the toxicity, irritative disturbances (27%) and fever (16%) appeared significantly decreased in comparison with those reported in the literature. No major complications were experienced. In conclusion, the low dose (75 mg.) Pasteur BCG regimen used in our trial was effective as a prophylaxis against recurrent superficial papillary tumors and as a treatment of carcinoma in situ, with a significant decrease in toxicity.
为评估低剂量（75毫克）卡介苗（BCG）方案治疗浅表性膀胱癌的疗效和相对毒性，开展了一项正在进行的随机研究，现将初步结果予以报道。98例患者（58例用于预防Ta-T1乳头状肿瘤复发；40例用于原位癌治疗）接受了为期6周的75毫克卡介苗巴斯德疫苗疗程。对无反应者给予额外疗程。对完全反应者在第一年每月进行一次维持治疗，第二年每季度进行一次。预防组（经尿道膀胱肿瘤切除术+卡介苗）与单纯经尿道膀胱肿瘤切除术（40例患者=对照组）进行随机分组。18个月后，预防组、对照组和治疗组评估患者的完全缓解率分别为86%、17%和78%；分别有5%、20%和9%的患者出现肿瘤进展。在毒性方面，与文献报道相比，刺激性干扰（27%）和发热（16%）明显减少。未出现重大并发症。总之，我们试验中使用的低剂量（75毫克）卡介苗巴斯德方案作为预防复发性浅表乳头状肿瘤和治疗原位癌有效，且毒性显著降低。
