451P - The activity and safety of anlotinib combined with chemotherapy for patients with desmoid tumor: A retrospective study in a single institution

Background

Desmoid tumor (DT) is an aggressive fibroblastic neoplasm with a high propensity for local recurrence. Although multiple therapeutic modalities seem effective for DT, the standard systemic treatment for symptomatic and progressive DT remains controversial. As targeted therapy, tyrosine kinase inhibitors have been recently reported to contribute to the treatment of DT. Thus, the purpose of this study was to assess the efficacy and safety of chemotherapy anlotinib, a novel multi-kinase angiogenesis inhibitor, in patients with DT.

Methods

This retrospective, single-arm clinical trial recruited patients with desmoid tumor who received first-line therap. Patients received anlotinib and methotrexate plus vinorelbine until 12m or disease progression (PD). The primary endpoint was 6m PFS%. Secondary endpoints are PFS, OS, objective response (ORR), disease control rate (DCR) and safety. Tumor response was assessed by the Response Evaluation Criteria in Solid Tumors 1.1 criteria.

Results

Between April 2020 and June 2022, 13 patients were enrolled and 11 of them have received at least one tumor assessment. The median age was 34 (range: 10-67) years, 4 males (30.8%) and 9 females (69.2%). 1 (9.1%) patients achieved a complete response, 2 (18.2%) patients achieved a partial response and 8 patients (72.7%) achieved disease stability. The 6-month PFS rates were 100%. The disease control rate was 100% (11/11) and the objective response rate was 27.3% (3/11). The most common AEs were hypertension (18.2%), leukopenia (18.2%). No ≥grade 3 TRAE was recorded.

Conclusions

Anlotinib combine with chemotherapy was effective against DT with an acceptable safety profile, and significantly slowed the disease progression. Further, multicenter studies with a longer follow-up time are needed to characterize fully the clinical application of anlotinib combine with chemotherapy in DT.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.