Tubaro A, Stoppacciaro A, Velotti F, Bossola P C, Cusumano G, Vicentini C, De Carli P, Ruco L, Santoni A, Cancrini A
Department of Surgery, L'Aquila University School of Medicine, L'Aquila, Italy.
Eur Urol. 1995;28(4):297-303. doi: 10.1159/000475070.
Local immunotherapy of superficial bladder cancer by endovesical administration of recombinant interleukin-2 (rIL-2) was investigated in a phase I-II study. Twenty-five patients with Ta-T1, N0, M0, G1-G2 transitional cell carcinoma of the bladder received an induction course of rIL-2 (10 daily instillations) with the tumor in place using an interpatient dose escalation scheme from 3 to 18 x 10(6) IU/day. Seven to fourteen days after the end of the induction course, the objective clinical response was evaluated and transurethral resection of the bladder tumor was carried out. Four maintenance courses (10 daily instillations) were started 1 month after surgery and carried out every 4 months at a dose of 6 x 10(6) IU/day in all patients. Follow-up visits were scheduled bimonthly during treatment and then every 6 months. No evidence of laboratory, local or systemic toxicity was observed even at the highest rIL-2 dosages. Induction of a local inflammatory response could be demonstrated at the tumor site after intravesical rIL-2 treatment. The significant reduction in tumor diameters observed in some patients may be interpreted as a sign of the biological activity of this rIL-2 regimen. Further exploratory work is required to evaluate the clinical efficacy of this immunotherapeutic approach.
在一项I-II期研究中，对通过膀胱内给予重组白细胞介素-2（rIL-2）进行浅表性膀胱癌局部免疫治疗进行了研究。25例Ta-T1、N0、M0、G1-G2级膀胱移行细胞癌患者接受了rIL-2诱导疗程（每日灌注10次），肿瘤原位使用患者间剂量递增方案，从3×10⁶IU/天增至18×10⁶IU/天。诱导疗程结束后7至14天，评估客观临床反应并进行膀胱肿瘤经尿道切除术。术后1个月开始4个维持疗程（每日灌注10次），所有患者每4个月进行一次，剂量为6×10⁶IU/天。治疗期间每两个月安排一次随访，之后每6个月随访一次。即使在最高rIL-2剂量下，也未观察到实验室、局部或全身毒性的证据。膀胱内rIL-2治疗后，可在肿瘤部位证实局部炎症反应的诱导。在一些患者中观察到肿瘤直径显著减小，这可解释为该rIL-2方案具有生物活性的迹象。需要进一步的探索性工作来评估这种免疫治疗方法的临床疗效。
