Understanding the supportive care needs of early-phase cancer clinical trial (CT) participants.

Abstract

26 Background: Early phase CTs investigate novel therapeutic approaches for patients with cancer, but little is known about the use of supportive care services among participants in early phase CTs. Methods: We conducted a retrospective chart review of consecutive patients enrolled in Phase 1 CTs from 2017-2019, capturing sociodemographics, clinical data, and use of supportive care services from the electronic health record. We calculated the Royal Marsden Hospital (RMH) prognostic score using data at the time of CT trial enrollment based on patients’ lactate dehydrogenase, albumin, and number of sites of metastasis. The RMH score ranges from 0-3, with scores of 2+ indicating a poor prognosis. We explored differences in patient characteristics, supportive care use, and clinical outcomes based on the RMH prognosis score. Results: Among 426 patients treated on Phase 1 CTs during the study period, the median age was 63.0 years (range 20.5-85.2 years), and most were female (56.1%), white race (85.1%), and had metastatic cancer (97.7%). The most common cancer types were gastrointestinal (22.1%), lung (20.0%), and breast (10.6%) cancer. Under half (31.6%) had an RMH score indicating a poor prognosis. Patients with a poor prognosis score had a worse performance status (ECOG ≥1: 80.2% v 58.3%, p < .001) and more prior treatment (3+ prior lines: 49.5% v 35.0%, p = .001) compared to those without a poor prognosis score. Those with a poor prognosis score were more likely to receive palliative care before or during CT participation (40.5% v 27.1%, p = .011). We observed no significant differences in the rates of nutrition (69.1% v 64.0%), social work (62.2% v 63.8%), or physical therapy (64.5% v 61.7%) consults between those with and without a poor prognosis score. We found that those with an RMH score indicating a poor prognosis had a shorter time on trial (median: 49 vs 87 days, p < .001) and worse survival (median: 139 v 379 days, p < .001). Conclusions: Early phase CT participants represent an advanced cancer population with unique supportive care needs, and we identified a group with a particularly poor prognosis for whom earlier intervention with supportive care services may be needed. Our findings highlight the need to prospectively examine these characteristics along with patient-reported outcomes to better understand the distinct supportive care needs of this population and guide the development of targeted interventions.