title: Continuous intra-arterial administration of recombinant interleukin-2 in low-stage bladder cancer. A phase IB study.
abstract: 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.
authors.affiliation: Department of Surgery, L'Aquila University, School of Medicine, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Tubaro
authors.forename: F
authors.initials: F
authors.lastname: Velotti
authors.forename: A
authors.initials: A
authors.lastname: Stoppacciaro
authors.forename: A
authors.initials: A
authors.lastname: Santoni
authors.forename: C
authors.initials: C
authors.lastname: Vicentini
authors.forename: P C
authors.initials: PC
authors.lastname: Bossola
authors.forename: P
authors.initials: P
authors.lastname: Galassi
authors.forename: A
authors.initials: A
authors.lastname: Pettinato
authors.forename: S
authors.initials: S
authors.lastname: Morrone
authors.forename: T
authors.initials: T
authors.lastname: Napolitano
mesh_terms: D000328:Adult; D000368:Aged; D002295:Carcinoma, Transitional Cell / Q000473:pathology / Q000628:therapy*; D004341:Drug Evaluation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007261:Infusions, Intra-Arterial; D007376:Interleukin-2 / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D011379:Prognosis; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D001749:Urinary Bladder Neoplasms / Q000473:pathology / Q000628:therapy*
chemical_list: D007376:Interleukin-2; D011994:Recombinant Proteins