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
1840P - RNASEH2B loss and PARP inhibition (parpi) in metastatic castration resistant prostate cancer (mCRPC)
Presenter: Juliet Carmichael
Session: Poster session 15
1841TiP - Darolutamide plus androgen-deprivation therapy (ADT) in patients with high-risk biochemical recurrence (BCR) of prostate cancer: A phase III, randomized, double-blind, placebo-controlled study (ARASTEP)
Presenter: Alicia Morgans
Session: Poster session 15
1842TiP - Phase II randomized trial of two dose levels of vobramitamab duocarmazine in participants with metastatic castration resistant prostate cancer (mCRPC; TAMARACK)
Presenter: Johann de Bono
Session: Poster session 15
1922P - Immunosarc II master trial: phase II of sunitinib and nivolumab in vascular sarcomas cohort - A GEIS, ISG and UCL study
Presenter: Nadia Hindi Muñiz
Session: Poster session 15
1923P - Combined analysis of phase III ANNOUNCE study and phase II study exploring olaratumab in advanced soft tissue sarcoma
Presenter: Yoichi Naito
Session: Poster session 15
1924P - Targeting microenvironment and cellular immunity in sarcomas with trabectedin combined with metronomic cyclophosphamide: The TARMIC study
Presenter: Cheng-Ming Sun
Session: Poster session 15
1925P - Results of SOC-2082 phase II study using metronomic gemcitabine, doxorubicin, and docetaxel plus nivolumab as second/third-line therapy for advanced leiomyosarcoma
Presenter: Neal Chawla
Session: Poster session 15
1926P - Trabectedin plus radiotherapy on symptomatic advanced sarcoma patients: Results from the SYNERGIAS study - A Spanish group for research in sarcoma (GEIS) phase II study
Presenter: Javier Martin-Broto
Session: Poster session 15
1927P - Epithelioid hemangio-endothelioma (EHE) in NETSARC: The nationwide series of 267 patients over 12 years
Presenter: Axel Le Cesne
Session: Poster session 15
1928P - Differential presentation and outcome of sclerosing epithelioid fibrosarcoma (SEF) vs low grade fibromyxoid sarcoma (LGFMS): The nationwide series of 330 patients in NETSARC since 2010
Presenter: Jean-Yves Blay
Session: Poster session 15