Abstract
11519 Background: The randomized phase II MEDISARC trial (NCT03317457) tested durvalumab (DUR) and tremelimumab (TRE) vs. doxorubicin (DOX) in soft tissue sarcoma (STS) patients in first-line therapy. The study showed no PFS benefit (HR 1.22; 95%CI 0,90-1.64; P = .4049), but a trend in prolonged OS (HR 0.73; 95%CI 0.54-0.99; P = .185) in favor of DUR-TRE (Grünwald et al. ESMO 2024: LBA90). The current analysis reports on patient reported outcomes (PROs) under treatment. Methods: We utilized EORTC QLQ-C30 printed questionnaires in randomized patients. PRO were assessed during screening and under treatment every 12 weeks until progression, and 4 weeks after last dose. Time to deterioration (TTD; decrease by 5 points) and mean change from baseline was measured for QLQ-C30 domains. Formal statistic testing was not performed. Results: The median follow-up for DUR-TREM vs. DOX were 34.0 mo. (25.6-42.2) and 37.9 mo. (31.5-37.9). The median duration of therapy was 2.8 (0-13) and 2.1 (0-4) mo., respectively. 86 of 92 (93.5%) patients had ≥1 PRO assessments and were included into the analyses. The completion rate at week 12 was 41.3%. Mean baseline global health status (GHS) was 54.1 (SD: 25.64) and 56.5 (SD: 28.47), respectively. GHS above the median was associated with improved OS and PFS in both arms, indicating a possible predictive biomarker. Under treatment, changes in PRO domains at 12 weeks were noted. TTD favored DUR-TRE in selected functional and symptom domains. Details will be shown at the meeting. Conclusions: MEDISARC is the first study to compare check-point inhibitor and doxorubicin treatment in sarcoma patients. PRO measures from baseline to week 12 favored DUR-TRE. Overall, results indicated better symptom and quality of life in patients treated with DUR-TRE. Clinical trial information: NCT03317457. [Table: see text]
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