Identifying early-phase clinical trial (EP-CT) participants at risk for poor outcomes
Abstract
301 Background: EP-CTs investigate novel treatment options, with recent advances in personalized therapy leading to increased response rates, decreased toxicity, and improved survival. Identifying EP-CT participants at risk for poor outcomes could help identify those who may benefit most from targeted supportive care efforts. Methods: We retrospectively reviewed the electronic health records of consecutive patients enrolled in EP-CTs from 2017-2019 to obtain baseline characteristics (demographics and clinical factors), clinical outcomes (survival, time on trial, completion of dose-limiting toxicity [DLT] period, emergency room [ER] visits, hospitalizations, and hospice use), and receipt of supportive care services before/during trial (palliative care, social work, physical therapy [PT], and nutrition). We calculated the validated Royal Marsden Hospital (RMH) prognosis score using data at the time of EP-CT enrollment based on patients’ lactate dehydrogenase, serum albumin, and number of sites of metastasis. RMH scores range from 0-3, with scores of 2+ indicating a poor prognosis. We examined differences in patient characteristics, clinical outcomes, and receipt of supportive care services based on the RMH prognosis score. Results: Among 350 patients (median age = 63.2 years [range 23.0-84.3]; 57.1% female, 98.0% metastatic cancer), the most common cancer types were lung (23.4%), gastrointestinal (20.3%), and breast (12.0%). Nearly one-third (31.7%) had an RMH score indicating…
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