Screen failures among patients who consented for early phase cancer clinical trials (EPCTs).

Abstract

e23013 Background: EPCTs represent an important treatment option for patients with cancer. However, trials often have strict eligibility criteria and screen failures (SFs) can limit enrollment. We sought to identify reasons for SFs among potential EPCT participants, evaluate associations between SFs and overall survival (OS), and describe use of supportive care services and subsequent therapies among patients with SFs. Methods: Using an institutional EPCT database, we identified adult patients who signed consent for an EPCT between 1/2021 – 10/2025 but did not receive treatment on the trial. We retrospectively reviewed the electronic health record to obtain patient demographics, clinical characteristics, reasons for SFs, receipt of palliative care (PC), advanced care planning (ACP), future therapies, and OS. Results: Table 1 provides the reasons for SFs. Among 273 identified patients (median age = 64.1 years [range 18.4 – 90.2], 52% female), most common reasons for SFs were clinical decline (CD; 28%) and lab abnormalities (19%); 6% with unknown reason were excluded from table. Patients with CD had increased risk of death (HR 2.3, p < 0.0001) compared to other reasons for SF, while those with SFs due to patient preference and lack of measurable disease had longer survival (HR 0.4, p = 0.001; HR 0.2, p < 0.0001); see Table 1 for OS results. Among all patients, median OS was 3.9 months (95% CI 3.3 – 5.1) and median follow up was 26.1 months (95% CI 22.9-29.8). Most patients (66%) were referred from within the hospital system and nearly half (48%) had received 3+ lines of therapy; 30% had participated in a prior EPCT. Among internal referrals, the majority did not have prior PC (70%), ACP documentation (70%), or advance directive (92%). Most patients (64%) received another line of therapy after SF, including 11% who enrolled on another EPCT. Of those with CD, 49% pursued hospice/supportive care, 36% received another line of therapy, and 11% died during screening. Conclusions: Reasons for SFs are varied, with CD as the most common. We found that most patients had no prior PC receipt or ACP documentation, despite having advanced disease and receiving multiple prior lines of therapy. Notably, most patients received further therapies and some experienced extended survival. Further work is needed to better understand and address reasons for SFs to improve care for this population. Reason for SF N (%) Median OS (months, 95% CI) OS HR (95% CI) P Clinical decline 76 (28) 1.6 (1.2 - 5.6) 2.3 (1.7 - 3.1) <.0001 Lab abnormality 52 (19) 3.9 (2.2-7.8) 1.1 (0.8-1.6) .450 Patient preference 28 (10) 20.2 (3.4 - NR) 0.4 (0.3 - 0.7) .001 Multiple reasons 23 (8) 2.7 (1.3 - 4.0) 1.4 (0.9 - 2.3) .148 New CNS disease 22 (8) 3.9 (2.5 - 6.3) 1.3 (0.8 - 2.1) .248 Comorbidity 19 (7) 6.3 (3.9 - NR) 0.7 (0.4 - 1.2) .221 Trial logistics 14 (5) 6.0 (2.6 - 11.7) 0.9 (0.5 - 1.5) .587 Medication interaction 12 (4) 11.2 (2.1 - NR) 0.6 (0.3 - 1.3) .179 No measurable disease 11 (4) NR (14.0 - NR) 0.2 (0.1 - 0.5) <.0001