1651P Pegylated liposomal doxorubicin as first line treatment in patients with advanced soft tissue sarcoma: A single-center retrospective study

Abstract

Pegylated liposomal doxorubicin (PLD) is associated with equivalent efficacy, less cardiotoxicity and better toxicity profile than free doxorubicin; however, we have limited knowledge and experience in patients (Pts) with soft tissue sarcoma (STS). We retrospectively collected data (approved by ethics committee) on STS Pts treated with PLD (50 mg/m2 d1, q4w) from 2012 to 2018 at our institution. Inclusion criteria: Non-resectable or metastatic disease, first line treatment, non-rhabdomyosarcoma, complete medical record, ECOG 0-3. 34 pts were included. Female 62%, median age 52.5 (24-80), ECOG 0-1: 67%, ECOG 2-3: 33%. Leiomyosarcoma 35%, liposarcoma 17%, fibrosarcoma 9%, Undifferentiated pleomorphic sarcoma 9%, synovial 9%, other 21%. Primary site: Pelvic/abdominal 47%, extremities 41%, H&N 6%. Metastases: lung 56%, liver 35%, non-resectable retroperitoneal tumor 47%. Median number of cycles 3 (1-8). Progression Free Survival (PFS): 3 months, PFS 6 months: 32%. Overall Survival (OS) 10 months, OS 1 year: 38%. Pts ECOG ≤1: PFS 3.6 months, OS 13 months. Pts ECOG ≥2: PFS 1.4 months, OS 2.1 months. CR 6.9%, PR 13.8%, SD 34.4%, PG 44.9%, ORR 20.7%, CBR 55%. Subgroup analysis OS: ECOG HR 4.1 (CI 1.62-10.41; P=0.003), retroperitoneal disease HR 6.95 (CI 1.44-33.52; P=0.016). Toxicity: G1/4 asthenia 66.9%, mucositis 44%, anaemia 38.3%, Neutropenia 29.4%, palmar-plantar erythrodysesthesia 20.6%, Infusion related reactions 2.9%, reduction LVEF >10% 2.9%, treatment death associated 0%. Toxicity G3/4: Neutropenia 14.7%, asthenia 8.8%, mucositis 2.9%, anaemia 2.9%. ECOG 0-1 Toxicity G3/4: 8.3%. ECOG 2-3 Toxicity G3-4: 45.5%. PLD is an active drug in Pts with advanced STS and good performance status (PS). The results of the study indicate no benefit in PFS or OS and high toxicity in Pts with ECOG 2-3. Clinical trial or best supportive care remains the preferred treatment for pts with impaired PS.