Anlotinib as a maintenance treatment for advanced soft tissue sarcoma after first-line chemotherapy (ALTER-S006): a multicentre, open-label, single-arm, phase 2 trial

Bushu Xu; Qiuzhong Pan; Hua Pan; Haomiao Li; Xianan Li; Jing Chen; Danmei Pang; Baoqing Zhang; Desheng Weng; Ruiqing Peng; Meiyu Fang; Xing Zhang

doi:10.1016/j.eclinm.2023.102240

Anlotinib as a maintenance treatment for advanced soft tissue sarcoma after first-line chemotherapy (ALTER-S006): a multicentre, open-label, single-arm, phase 2 trial

EClinicalMedicine. 2023 Sep 21:64:102240. doi: 10.1016/j.eclinm.2023.102240. eCollection 2023 Oct.

Authors

Bushu Xu¹, Qiuzhong Pan¹, Hua Pan¹, Haomiao Li², Xianan Li³, Jing Chen⁴, Danmei Pang⁵, Baoqing Zhang⁶, Desheng Weng¹, Ruiqing Peng¹, Meiyu Fang⁷, Xing Zhang¹

Affiliations

¹ Melanoma and Sarcoma Medical Oncology Unit, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.
² Department of Bone Oncology, The Third Affiliated Hospital of Southern Medical University, Guangzhou, China.
³ Department of Orthopedics, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.
⁴ Department of Medical Oncology, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
⁵ Department of Medical Oncology, The First People's Hospital of Foshan, Foshan, China.
⁶ Department of Orthopedics, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China.
⁷ Department of Rare and Head and Neck Oncology, Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.

Abstract

Background: No standard maintenance treatment has been obtained to prolong the response duration of soft tissue sarcoma (STS) after first-line chemotherapy. In this study, we aimed to evaluate the efficacy and safety of anlotinib as a maintenance treatment after chemotherapy in STS.

Methods: In this multicentre, open-label, single-arm phase 2 trial, patients with advanced STS who achieved partial response or stable disease after first-line anthracycline-based chemotherapy were enrolled between April 2019 and January 2022. All patients received anlotinib as a maintenance treatment. The primary endpoint was progression-free survival (PFS) of anlotinib maintenance treatment. Other endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR) and safety. This study is registered with ClinicalTrials.gov, NCT03890068.

Findings: At the data cut-off date (August 8, 2022), 49 patients were enrolled, including 17 with liposarcoma (35%) and 15 with leiomyosarcoma (31%). After a median follow-up of 17.1 months (IQR 9.0-27.2), the median PFS from the beginning of maintenance treatment was 9.1 months (95% CI 5.7-12.5), and the median OS was not reached, and the 1-year OS rate for anlotinib maintenance treatment was 98.0%. The best ORR and DCR were 16% (8/49, 95% CI 7-30) and 94% (46/49, 95% CI 83-99), respectively. Most of the treatment-related adverse events were grade 1-2. Of the grade 3-4 adverse events, the most common were hypertension (10%) and hand-foot syndrome reaction (6%).

Interpretation: Postchemotherapy maintenance treatment with anlotinib exhibits promising efficacy and tolerable toxicity in patients with advanced STS.

Funding: Chia Tai Tianqing Pharmaceutical Group Co., Ltd., the National Key Research and Development Program of China, and the National Natural Science Foundation of China.

Keywords: Anlotinib; First-line chemotherapy; Maintenance treatment; Soft tissue sarcoma.

Associated data

ClinicalTrials.gov/NCT03890068