| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 2125090 | European Journal of Cancer | 2010 | 7 Pages |
BackgroundUnplanned hospital admissions (UHAs) in the context of oncology Phase I trials are important, yet rarely reported.MethodsAll patients admitted to the Royal Marsden Hospital Phase I clinical trials unit during February and March of 2005–2007 were included. The patient-, admission- and trial-related variables were collected. Correlations were sought between the occurrence of UHAs and the baseline patient/trial-related characteristics.ResultsOf the 308 admissions involving 177 patients, UHAs constituted 21% of all the admissions and 38% of the total bed occupancy. The majority of UHAs were cancer related (78%) and their occurrence was associated with a significant early patient attrition. Using multivariate analysis, the factors significantly associated with UHAs included age >60 years (RR 2.32, confidence interval (CI)-95% 1.12–4.81), ⩾3 metastatic sites (RR 3.26, CI-95% 1.54–6.90) and LDH > ULN (RR 2.18, CI-95% 1.06–4.46), with albumin <35 g/dL trending to significance (p = 0.052). The trials that contained cytotoxic chemotherapy incurred disproportionately higher rates of admissions (69.5%) than the trials that did not.ConclusionsUHAs constitute a substantial workload and impact on the speed and cost of, as well as resource allocation in Phase I oncology trials. The majority of UHAs are cancer rather than treatment related. The risk stratification to guide patient selection may help reduce the incidence of UHAs.
