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
1960P - Clinical outcomes of the patients with alveolar soft part sarcoma developed brain metastasis
Presenter: Yu Toda
Session: Poster session 15
1961P - Prevalence of diagnostic discrepancies in soft tissue and bone tumors from initial diagnosis to referral center
Presenter: Khomsit Thongthammachat
Session: Poster session 15
1963P - Comprehensive profiling of chordoma reveals tumor microenvironment subtypes and unique molecular findings
Presenter: Marina Voropaeva
Session: Poster session 15
1964P - Biomimetics of three-dimensional (3D) osteosarcoma (OS) models: A scoping review
Presenter: Vinesh Sandhu
Session: Poster session 15
1965P - Transcriptional analysis of immune microenvironment of chordomas of the skull base and mobile spine
Presenter: Jason Roszik
Session: Poster session 15
1966P - Extending the interval of denosumab treatment for unresectable giant cell tumor of bone
Presenter: Toshiyuki Kunisada
Session: Poster session 15
1967P - A single-arm multicenter trial of the combination of anlotinib with chemotherapy in patients with stage IIb classic osteosarcoma of the extremity
Presenter: Fan Tang
Session: Poster session 15
1968P - Metastatic Ewing sarcoma, patterns of care and outcomes of patients in a real-life setting: The Metabone national observational study
Presenter: coline ducrot
Session: Poster session 15
1969P - Intratumoral immune infiltrates in chondrosarcoma (ChS)
Presenter: Piotr Rutkowski
Session: Poster session 15
1970P - Metastatic chondrosarcoma, patterns of care and outcomes of patients in a real-life setting: The Metabone national observational study
Presenter: coline ducrot
Session: Poster session 15