title: A prospective randomized evaluation of the prophylactic use of low-dose dopamine in cancer patients receiving interleukin-2.
abstract: The administration of high-dose interleukin-2 (IL-2) causes tumor regression in 17-25% of patients with metastatic melanoma or renal cell carcinoma. Renal dysfunction is a common dose-limiting toxicity of IL-2 administration, limiting 26% of treatment cycles. We have conducted a prospective randomized trial to evaluate whether the prophylactic administration of low-dose dopamine (2 mg/kg/min) can minimize renal toxicity and thus affect the amount of IL-2 administered. Forty-two patients were randomly assigned to receive systemic high-dose IL-2 with standard supportive measures (group A = 21 patients) or with the addition of prophylactic dopamine (group B = 21 patients) at 2 mg/kg/min. For patients in group B, dopamine was instituted 1 h before the initiation of IL-2 administration and was discontinued 6-12 h after the maximum number of doses of IL-2 were given. There was no difference in the amount of IL-2 administered for each course of therapy for groups A and B. Despite differences in urine flow (milliliters per kilogram per day), fluid balance (liters per day), and overall weight gain, prophylactic low-dose dopamine did not significantly alter maximum plasma urea or creatinine levels in group B when compared with the control group (group A). The overall toxicity profile considering all grade 3 and 4 toxicities for patients in groups A and B was comparable. Thus, there is no evidence to support the routine use of prophylactic low-dose dopamine in patients receiving high-dose IL-2.
authors.affiliation: Surgery Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892, USA.
authors.forename: J N
authors.initials: JN
authors.lastname: Cormier
authors.forename: R
authors.initials: R
authors.lastname: Hurst
authors.forename: J
authors.initials: J
authors.lastname: Vasselli
authors.forename: D
authors.initials: D
authors.lastname: Lee
authors.forename: C J
authors.initials: CJ
authors.lastname: Kim
authors.forename: M
authors.initials: M
authors.lastname: McKee
authors.forename: D
authors.initials: D
authors.lastname: Venzon
authors.forename: D
authors.initials: D
authors.lastname: White
authors.forename: F M
authors.initials: FM
authors.lastname: Marincola
authors.forename: S A
authors.initials: SA
authors.lastname: Rosenberg
mesh_terms: D000328:Adult; D000368:Aged; D002292:Carcinoma, Renal Cell / Q000628:therapy*; D004298:Dopamine / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007376:Interleukin-2 / Q000009:adverse effects*; D007668:Kidney / Q000187:drug effects*; D007680:Kidney Neoplasms / Q000628:therapy*; D008297:Male; D008545:Melanoma / Q000628:therapy*; D008875:Middle Aged; D009846:Oliguria / Q000517:prevention & control; D011446:Prospective Studies
chemical_list: D007376:Interleukin-2; D004298:Dopamine