Tubaro A, Velotti F, Stoppacciaro A, Santoni A, Vicentini C, Bossola P C, Galassi P, Pettinato A, Morrone S, Napolitano T
Department of Surgery, L'Aquila University, School of Medicine, Italy.
Cancer. 1991 Jul 1;68(1):56-61. doi: 10.1002/1097-0142(19910701)68:1<56::aid-cncr2820680111>3.0.co;2-z.
Toxicity and clinical effects of intra-arterial (IA) continuous infusion of recombinant interleukin-2 (rIL-2) were evaluated in twelve patients with low-stage transitional cell carcinoma (TCC) of the bladder (T1NOMO; G1 to G2). rIL-2 dosages were escalated from 18 x 10(3) to 18 x 10(6) IU/m2/d in four groups of three patients. After two 5-day courses, separated by a 48-hour interval, evaluation of clinical response and transurethral resection (TUR) were carried out. World Health Organization (WHO) Grade 3 toxicity occurred in 2 of 12 patients (hypotension/mental confusion and fever, respectively); all side effects rapidly disappeared after infusion was abandoned. No laboratory toxicity developed in any patient. Two pathologically proven complete responses (CR) were achieved using 18 x 10(4) IU/m2/d, and three partial responses (PR) were achieved using 18 x 10(5) IU/m2/d in two patients and 18 x 10(6) IU/m2/d in one patient, giving an overall response rate of 42%. All objective responses are still ongoing after a mean follow-up time of 23 months (range, 12 to 32 months). Local relapses occurred 3 months after TUR only in two nonresponders.
对12例低分期膀胱移行细胞癌（TCC）患者（T1N0M0；G1至G2）评估了动脉内（IA）持续输注重组白细胞介素-2（rIL-2）的毒性和临床效果。将12例患者分成四组，每组3例，rIL-2剂量从18×10³IU/m²/d逐步递增至18×10⁶IU/m²/d。在两个5天疗程后，间隔48小时，进行临床反应评估和经尿道切除术（TUR）。12例患者中有2例出现世界卫生组织（WHO）3级毒性反应（分别为低血压/精神错乱和发热）；停止输注后，所有副作用迅速消失。所有患者均未出现实验室毒性反应。使用18×10⁴IU/m²/d剂量时，有2例患者达到病理证实的完全缓解（CR）；使用18×10⁵IU/m²/d剂量时，2例患者达到部分缓解（PR），使用18×10⁶IU/m²/d剂量时，1例患者达到PR，总缓解率为42%。平均随访23个月（范围12至32个月）后，所有客观缓解仍在持续。仅2例无反应者在TUR后3个月出现局部复发。
