(P 428) MAINTENANCE PEGYLATED LIPOSOMAL DOXORUBICIN VERSUS ACTIVE SURVEILLANCE FOR ADVANCED SOFT TISSUE SARCOMA PATIENTS WHO HAD CONTROLLED DISEASE AFTER STANDARD ANTHRACYCLINE-BASED TREATMENT (MELODY)

Objective: The progression-free survival (PFS) associated with first-line chemotherapy for advanced soft tissue sarcoma (STS) remains suboptimal. Maintenance therapy with an active agent may delay disease progression beyond initial treatment, however cumulative cardiotoxicity limits prolonged use of conventional anthracyclines. Pegylated liposomal doxorubicin (PLD) with a more favorable cardiac safety profile presents a viable option for extended treatment.
MELODY is a multinational, randomized phase II trial designed to evaluate the clinical benefit of maintenance PLD versus active surveillance in pts with advanced STS who have achieved disease control following first-line anthracycline-based therapy. The trial incorporates patient-reported outcomes (PROs) to assess the impact of ongoing therapy on quality of life and translational endpoint to explore predictive biomarkers and support personalized treatment strategies.

Methods: Eligible criteria include advanced STS pts aged ≥ 18 years who had either CR, PR, or SD after first-line anthracycline-based therapy (at least five cycles).
Pts will be randomized 2:1 to receive PLD (40 mg/m² every 28 days, up to 12 cycles) or active surveillance. Crossover is not permitted.
The primary endpoint is progression-free survival (PFS) post randomization.
Secondary endpoints include QoL by EORTC C30 questionnaire, OS, 12-month PFS rate, ORR by RECIST 1.1, and time to next treatment. Left ventricular ejection fraction (LVEF) change will be an interest of safety.
Exploratory objectives include efficacy endpoints (PFS, OS, 12-month PFS rate) based on circulating tumor DNA (mandatory) and FDG PET/CT SUVmax (Optional).
Based on our systematic review (currently under submission), the mPFS for the control arm is estimated to be 4 months. A clinically meaningful improvement is anticipated in the experimental arm, with a mPFS of 8 months. Assuming 80% power and an alpha level of 0.1, a total of 63 evaluable subjects are required. Accounting for an anticipated 20% drop-out rate, MELODY plans to enroll a total of 81 subjects.

Results: N/A

Conclusion: N/A