Abstract: Background and purpose: Patient with metastatic soft tissue sarcoma has a poor prognosis with median survival time of less than 1 year. Doxorubicin combined with ifosfamide (IFO) (AI regimen) is frequently used in the first-line treatment for patients with metastatic soft tissue sarcoma. Pegylated liposomal doxorubicin (PLD) is the liposomal formulation of doxorubicin and has exhibited less toxicity. Therefore our study was aimed to evaluate the efficacy and safety of PLD combined with IFO as the first-line treatment for patients with advanced or metastatic soft tissue sarcoma (STS). Methods: A total of 25 chemotherapy-naive patients with advanced or metastatic STS were enrolled in this study between November 2013 and December 2015. All patients received treatment of PLD 30 mg/m², d1, plus IFO 1.8 g/m², d1-5, repeatedly every 21 days. Results: All patients received 1-8 cycles of treatment, at a median of 4 cycles. Among 25 patients, partial response was observed in 9 patients (36%), stable disease (SD) was observed in 12 patients (48%) and progressive disease (PD) in 4 patients (16%). The disease control rate (DCR, CR+PR+SD) was 84%. The median progression-free survival (PFS) was 7.3 months (95%CI, 4.6 to 10.0 months). The grade 3/4 toxicities included leukopenia (20%), neutropenia (28%), anemia (4%) and vomiting (4%). Conclusion: Combination therapy comprising PLD and IFO was effective and well tolerated as first-line treatment for patients with advanced or metastatic STS, which warrants further research.

Key words: Pegylated liposomal doxorubicin, Ifosfamide, Advanced, Metastatic, Soft tissue sarcoma