title: Renal safety of 1-hour pamidronate infusion for breast cancer and multiple myeloma patients: comparison between clinical trials and population-based database.
abstract: OBJECTIVE
  The American Society of Clinical Oncology recommends infusion of pamidronate over 2 hours to avoid renal deterioration, although there are data to suggest that 1-hour infusions may be safe.
  
  
  METHODS
  Prevalence of renal deterioration with 1-hour pamidronate infusions from a population database was compared to renal deterioration with 2-hour pamidronate infusions, in randomised, controlled, trials. A cost-minimisation analysis, comparing the 1- and 2-hour pamidronate infusions, and the 15-minute infusion of zoledronic acid, was performed with a sensitivity analysis that varied the opportunity cost of time in the treatment room.
  
  
  RESULTS
  Renal deterioration occurred in 7.7% of 169 patients with multiple myeloma and metastatic breast cancer. There is no evidence that this differs from the 10% reported in randomised, controlled, trials (one-tailed binomial test, P = 0.3874). A subgroup analysis showed that renal deterioration occurred in 15 and 1.1% of patients with multiple myeloma and metastatic breast cancer, respectively. The median increase in serum creatinine was 13 and 7% in the multiple myeloma and breast cancer groups, respectively. The respective costs/dose (drug/labour/supplies) of pamidronate and zoledronic acid are 325 dollars and 610 dollars. Cost neutrality occurs if the opportunity cost of chair time is 6.33 dollars/minute for pamidronate 1-hour versus zoledronic acid, and 2.71 dollars/minute for pamidronate 2-hour versus zoledronic acid. If a median 4 dollars/minute is used, the respective costs of pamidronate 1-hour, 2-hour, and zoledronic acid infusions are 685 dollars, 925 dollars, and 790 dollars/cycle.
  
  
  CONCLUSIONS
  Prevalence of renal deterioration with 1-hour pamidronate infusions from a population database was not significantly different to 2-hour pamidronate infusions in clinical trials. Our findings suggest further support for the safety of 1-hour pamidronate infusions. Pamidronate via 1-hour infusion is less expensive than zoledronic acid.
authors.affiliation: Provincial Systemic Therapy Program, British Columbia Cancer Agency, Vancouver, BC, Canada. mdelemos@bccancer.bc.ca
authors.forename: Mário L
authors.initials: ML
authors.lastname: de Lemos
authors.forename: Suzanne C
authors.initials: SC
authors.lastname: Taylor
authors.forename: Jeff B
authors.initials: JB
authors.lastname: Barnett
authors.forename: Francis
authors.initials: F
authors.lastname: Hu
authors.forename: Adeera
authors.initials: A
authors.lastname: Levin
authors.forename: Veronika
authors.initials: V
authors.lastname: Moravan
authors.forename: Susan E
authors.initials: SE
authors.lastname: O'Reilly
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000191:economics; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000191:economics; D002986:Clinical Trials as Topic; D003362:Cost-Benefit Analysis; D003404:Creatinine / Q000097:blood; D004164:Diphosphonates / Q000008:administration & dosage / Q000009:adverse effects* / Q000191:economics; D004334:Drug Administration Schedule; D016527:Drug Costs; D005260:Female; D017048:Health Care Costs; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects; D007262:Infusions, Intravenous; D007674:Kidney Diseases / Q000097:blood / Q000139:chemically induced* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000191:economics; D000077268:Pamidronate; D015995:Prevalence; D012042:Registries; D012189:Retrospective Studies; D016896:Treatment Outcome; D000077211:Zoledronic Acid
chemical_list: D000970:Antineoplastic Agents; D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid; D003404:Creatinine; D000077268:Pamidronate