Randomized cross-over trial comparing inpatient and outpatient administration of high-dose cisplatin

Background/Aims: 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...

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Bibliographic Details
Published in:Internal medicine journal 2011-02, Vol.41 (2), p.172-178
Main Authors: Cox, K. M., Goel, S., O'Connell, R. L., Boyer, M., Beale, P. J., Simes, R. J., Stockler, M. R.
Format: Article
Language:English
Subjects:
Adult
Ambulatory Care - methods
cisplatin
Cisplatin - administration & dosage
Cross-Over Studies
Female
health services
Hospitalization
Humans
inpatient
Male
Middle Aged
Neoplasms - drug therapy
Neoplasms - epidemiology
outpatient
Patient Preference
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Summary:Background/Aims: 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). Conclusion: OP treatment was preferred by most patients, appeared safe and used less resources.
ISSN:1444-0903
1445-5994
DOI:10.1111/j.1445-5994.2010.02201.x