Participation in early phase clinical trials has become a prominent part of oncology patient management. Inevitably a proportion of patients require hospitalisation for management of disease or treatment related adverse events. We examined the incidence and pattern of hospitalisations in phase I clinical trial patients and correlated this with patient and trial related variables and clinical outcomes.
We conducted a retrospective review of the medical records of 193 patients with solid tumours treated on phase I clinical trials between July 2014 and October 2018 at a phase I trial unit. Unplanned hospitalisations occurring during trial participation were characterised and correlated with patient and trial related variables, best treatment response and duration on study.
Among the 193 patients, 104 hospitalisations were recorded involving 61 patients (32%). 19% of patients required hospitalisation for disease and 8% for treatment toxicity. Complete, partial response, stable and progressive disease were observed in 5%, 11%, 36% and 44% of patients respectively. Median duration on trial was 85 days (0 – 1412). 22 patients (11%) remained on trial for more than 12 months. Overall, hospitalisation did not correlate with treatment response or trial duration. However, disease-related hospitalisation was associated with lower therapeutic response (p<0.001) and early patient attrition (p<0.001). Hospitalisation resulting in treatment delay or dose reduction did not affect response or trial duration. Most hospitalisation events resolved (85%) and this correlated with response (p=0.002) and longer duration on trial (p<0.001). Treatment related mortality was 0.5% (n=1). No significant correlation between the rate of hospitalization and age, sex, tumour type or trial drug.
In our patient cohort, approximately a third of patients required hospitalisation and disease related hospitalisation correlated with worse clinical outcomes. Most hospitalisation events resolved and treatment related mortality was low. A proportion of patients derived significant and durable clinical responses.