Ferlazzo G, Magno C, Lupo G, Rizzo M, Iemmo R, Semino C, Melioli G
Sezione Decentrata di Tecnologie Biomediche, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy.
Am J Clin Oncol. 1995 Apr;18(2):100-4. doi: 10.1097/00000421-199504000-00002.
A Phase I study was started to evaluate the locoregional and/or systemic toxic effects of the continuous perfusion of recombinant interleukin-2 (rIL-2) in superficial bladder cancer. Three different dose levels were used: 3 x 10(6) IU/day (3 patients), 9 x 10(6) IU/day (3 patients) and 27 x 10(6) IU/day (3 patients). Two patients (one treated with 3 x 10(6) and another with 27 x 10(6) IU/day of rIL-2) had hematuria after the end of the treatment, one patient had fever (grade I) and 7 of 9 patients experienced hypotension (grade I-II). All effects were not dose related. Routine laboratory tests indicated that no significant variations of biochemical parameters occurred. A phenotypic analysis of white blood cells detectable in the bladder, showed an evident locoregional activation of lymphoid cells. In particular, T lymphocytes expressed activation antigens (such as CD25 and HLA-DR) following treatment with rIL-2. A 6- to 12-month clinical follow-up, showed that all patients but one (which recurred after 5 months) are alive and disease-free. This therefore indicates that the locoregional perfusion of rIL-2 is safe and gives clinical results similar to those obtained using Calmette-Guérin bacillus locoregional instillation, in patients who underwent a transurethral resection of superficial bladder cancer.
开展了一项I期研究，以评估重组白细胞介素-2（rIL-2）持续灌注治疗浅表性膀胱癌的局部和/或全身毒性作用。使用了三种不同剂量水平：3×10⁶IU/天（3例患者）、9×10⁶IU/天（3例患者）和27×10⁶IU/天（3例患者）。两名患者（一名接受3×10⁶IU/天rIL-2治疗，另一名接受27×10⁶IU/天rIL-2治疗）在治疗结束后出现血尿，一名患者发热（I级），9例患者中有7例出现低血压（I-II级）。所有这些影响均与剂量无关。常规实验室检查表明生化参数无显著变化。对膀胱中可检测到的白细胞进行的表型分析显示，淋巴细胞有明显的局部激活。特别是，用rIL-2治疗后，T淋巴细胞表达了激活抗原（如CD25和HLA-DR）。6至12个月的临床随访表明，除1例患者（5个月后复发）外，所有患者均存活且无疾病。因此，这表明在接受经尿道浅表性膀胱癌切除术的患者中，rIL-2局部灌注是安全的，其临床结果与使用卡介苗局部灌注相似。
