Phase 2 study integrating early palliative care in advanced sarcoma patients for enhanced quality of life (SARQUALITY Trial: NCT06805669): An interim analysis.

Abstract

11552 Background: Patients (pts) with advanced cancer may experience substantial symptom burden that adversely affects quality of life (QoL). Although early palliative care (EPC) integrated with standard oncologic care (SOC) has demonstrated clinical benefit, patients with sarcoma have been underrepresented in prior studies. This phase II trial evaluates whether EPC combined with SOC improves outcomes in pts with advanced sarcoma compared with SOC alone. Results from the first interim analysis are presented. Methods: Adult pts with advanced sarcoma who are systemic treatment naïve were randomized (1:1) to either SOC alone or with EPC. EPC intervention included palliative care (PC) review within 4 weeks of randomization, routine PC contact and access to 24-hour support. Pts receiving SOC alone are referred to PC at time of clinical need. Pts complete Edmonton Symptom Assessment System (ESAS) and EORTC QLQ-C30 questionnaires at baseline, weeks 6, 12 and 24. The primary endpoint is the change in ESAS score at week 12 compared to baseline. Secondary endpoints include EORTC QLQ-C30 score change, emergency department (ED) attendance and overall survival (OS). The aim is to accrue 136 pts, providing 80% power at one-sided 5% level of significance to detect standardised difference of 0.45 between-group in ESAS score from baseline to 12 weeks. Results: Enrollment commenced in July 2024. At data lock (November 2025), 44 pts were enrolled (SOC, n=21; EPC, n=23). The cohort was predominantly female (n=29, 66%), with a median age of 60 years (range 29–85). Soft tissue sarcoma accounted for 43 cases (one had osteosarcoma); 39 (89%) pts had metastatic disease and 5 (11%) had locally advanced disease. Age, gender, race, histologic subtype, and number and sites of metastases were balanced between arms. ESAS and EORTC scores for pts in EPC arm (Table 1) but ED attendances were similar (EPC-24, SOC-23). In SOC arm, symptom management interventions (radiation, surgery) occurred more frequently than the EPC arm (12 vs. 2 pts). Seven pts were referred to PC from the SOC arm (median of 3.2 months from randomization). OS data is immature. Conclusions: The interim results of SARQUALITY trial demonstrate EPC has an impact on ESAS and EORTC scores, however, further data required to demonstrate if there is a benefit on QoL. There was a reduction in number of symptom management interventions in EPC arm, suggesting EPC may reduce need for additional interventions. Trial accrual is ongoing. Clinical trial information: NCT06805669 . Mean score change at 6, 12 and 24 weeks compared with baseline. Week 6 12 24 Arm EPC N=20 SOC N=20 p-value EPC N=18 SOC N=18 p-value EPC N=14 SOC N=15 p-value ESAS (95% CI) -1.8 (-9.0 – 5.5 3.8 (-0.2 – 7.7) 0.172 -3.4 (-13.9 – 7.1) 3.2 (-2.8 – 9.1) 0.261 -1.8 (-11.4 – 7.9) 4.5 (0.0 – 8.9) 0.220 EORTC QLQ (95% CI) -0.6 (-6.7 – 5.6) 4.5 (1.2 – 7.7) 0.143 0.2 (-5.6 – 6.0) 3.8 -2.5 – 10.1) 0.379 0.0 (-6.4 – 6.4) 4.4 (-1.2 – 10.0) 0.274