title: Randomized cross-over trial comparing inpatient and outpatient administration of high-dose cisplatin.
abstract: OBJECTIVE
  Treatment with high-dose cisplatin (HDC) previously required inpatient (IP) admission with overnight hospitalization, but recently practice has shifted to outpatient (OP) therapy. We aimed to determine whether it is preferable to give HDC as an IP or OP using a two-period cross-over trial.
  
  
  METHODS
  Eligible patients were starting chemotherapy with ≥2 cycles of HDC (≥100 mg/dose) and were suitable for OP treatment. All patients received an IP cycle and OP cycle: the order was randomly allocated. Pre-hydration, anti-emetics and chemotherapy were identical for IP and OP. Post-hydration varied by group (3 L normal saline (NS) for IP, 2 L NS for OP). The primary outcome was patient preference for IP versus OP treatment. Secondary outcomes included aspects of health-related quality of life, adverse events (dose delays and reductions, elevated creatinine and unplanned readmissions) and resource use.
  
  
  RESULTS
  Fifty-nine patients were randomized, 53 completed two cycles of HDC. Most patients preferred OP treatment (36 vs 13, P = 0.002). There were no significant differences in patients' ratings of nausea, vomiting, fatigue, anxiety, depression or overall quality of life. Adverse events were few and unrelated to IP versus OP treatment. Nursing time was longer for IP than OP (163 vs 104 min, P < 0.001).
  
  
  CONCLUSIONS
  OP treatment was preferred by most patients, appeared safe and used less resources.
authors.affiliation: Sydney Cancer Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.
authors.forename: K M
authors.initials: KM
authors.lastname: Cox
authors.forename: S
authors.initials: S
authors.lastname: Goel
authors.forename: R L
authors.initials: RL
authors.lastname: O'Connell
authors.forename: M
authors.initials: M
authors.lastname: Boyer
authors.forename: P J
authors.initials: PJ
authors.lastname: Beale
authors.forename: R J
authors.initials: RJ
authors.lastname: Simes
authors.forename: M R
authors.initials: MR
authors.lastname: Stockler
mesh_terms: D000328:Adult; D000553:Ambulatory Care / Q000379:methods*; D002945:Cisplatin / Q000008:administration & dosage*; D018592:Cross-Over Studies; D005260:Female; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy / Q000453:epidemiology; D057240:Patient Preference
chemical_list: D002945:Cisplatin