Abstract 1950P
Background
Neoadjuvant therapy might improve excision and limb salvage rates in locally advanced soft tissue sarcomas (STS). This phase II trial aimed to investigate the safety and activity of neoadjuvant pegylated liposomal doxorubicin (PLD) plus anlotinib in local advanced STS.
Methods
In this prospective, single-center, single-arm phase II study, major eligible criteria were locally advanced, non-metastasis, treatment-naive STS, age at 14-75 years old, pathological stage IIb/III, ECOG PS 0-2. Patients received PLD (50mg/m2, IV, D1, Q3W) and anlotinib (12mg/d, PO, D8-21, Q3W) for 2∼4 cycles. The primary endpoint was objective response rate (ORR). Secondary endpoints included overall survival (OS), progression-free survival (PFS), pathological complete response (ypT0/is ypN0, pCR) and safety.
Results
From November 2020 to November 2022, 45 patients were recruited. The median age was 47 years (range, 15-75) and 19 were female. The predominant histologies included Spindle cell sarcoma 7 (15.56%), Myxofibrosarcoma 5 (11.11%), Myxoid liposarcoma 5 (11.11%), Malignant peripheral nerve sheath tumor 4 (8.89%), Synovial sarcoma 4 (8.89%), Leiomyosarcoma 3 (6.67%). Median treatment cycles of neoadjuvant therapy were 2 (range, 1-4). The ORR and DCR of 29 patients with at least one assessment as Choi criteria was 62.1% and 100%, respectively. Of 39 (86.67%) patients underwent radical resection, 33 (84.62%) patients had an R0 resection. With a median follow-up time of 11.47 months, the median OS were not reached. Median PFS was 14.19 months, and the 1-year OS rate was 84.23%. The limb salvage rates was observed in 39 (100%) patients. The most common adverse events (AEs) of all grade were mucositis oral 19 (42.22%), proteinuria 13 (28.89%), neutropenia 12 (26.67%), and leucopenia 11 (24.44%). Grade 3/4 AEs were 13 (28.89%). PLD plus Anlotinib was well tolerated without significant unexpected toxic effects.
Conclusions
PLD combined with Anlotinib showed a promising efficacy and acceptable toxicity for patients with locally advanced soft tissue sarcomas, suggesting a potential therapeutic option for this population.
Clinical trial identification
NCT04765228.
Editorial acknowledgement
Legal entity responsible for the study
Y. Chen and W. Sun.
Funding
CSPC Ouyi Pharmaceutical Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
1971P - Metastatic osteosarcoma, patterns of care and outcomes of patients in a real-life setting: The Metabone national observational study
Presenter: Mathilde Reich
Session: Poster session 15
1972P - Molecular mechanism study of recurrence/metastasis for Enneking IIb osteosarcoma
Presenter: Junqiang Yin
Session: Poster session 15
1975P - Systemic therapy for KIT/PDGFRA wild-type GIST
Presenter: Mehdi Brahmi
Session: Poster session 15
1976P - Financial difficulties experienced by gastrointestinal stromal tumor (GIST) patients in the Netherlands: Data from a cross-sectional multicenter study
Presenter: Deborah van de Wal
Session: Poster session 15
1977P - A registry-based analysis of the projected genomic landscape among unclassified KIT/PDGFRA wildtype mutations in patients with gastrointestinal stromal tumors
Presenter: Jerry Call
Session: Poster session 15
1978P - Identification of SDH-deficient GIST increases after the implementation of diagnostic algorithm in Life Raft Group (LRG) patient registry data
Presenter: Denisse Evans
Session: Poster session 15
1979P - phase I trial of pembrolizumab in HIV-associated Kaposi sarcoma (KS)
Presenter: Kathryn Lurain
Session: Poster session 15
1980P - Artificial intelligence analysis shows enhanced CCNG1 expression in sarcoma tumors, a novel biomarker for DeltaRex-G tumor targeted retrovector encoding a CCNG1 inhibitor gene
Presenter: Sant Chawla
Session: Poster session 15
1981P - Histopathological diagnostic discrepancies in bone and soft tissue tumors referred to a specialist sarcoma center and its clinical impact
Presenter: Akira Kawai
Session: Poster session 15