Apatinib for patients (pts) with advanced soft tissue sarcoma (STS) after chemotherapy: A prospective, open-label, single-arm, multicentered study.

Authors

null

Haiyan Hu

Affiliated Sixth People's Hospital, Shanghai Jiaotong University, Shanghai, China

Haiyan Hu , Yang Yao , Zhengfu Fan , Hongmei Zhang , Jing Chen , Xing Zhang , Yong Chen , Guofan Qu , Gang Huang , Yuhong Zhou , Wenxi Yu , Xiaowen Wang , Rongyuan Zhuang

Organizations

Affiliated Sixth People's Hospital, Shanghai Jiaotong University, Shanghai, China, Beijing Cancer Hospital, Beijing, China, Xijing Hospital, Xi'an, China, Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China, Sun Yat-Sen University Affiliated Oncology Hospital, Guangzhou, China, Fudan University Shanghai Cancer Center, Shanghai, China, Harbin Medical University Cancer Hospital, Harbin, China, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China, Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai, China, Department of Clinical Oncology, Xijing Hospital, the Fourth Military Medical University, Xi'an, Xi'an, China

Research Funding

Pharmaceutical/Biotech Company
Jiangsu Hengrui Pharmaceutical CO.,LTD

Background: The development of STS therapeutics has been challenging, especially patients who failed chemotherapy. Anti-angiogenesis inhibitors had shown activity in STS, Apatinib is a TKI targeting on VEGFR-2 which has shown activity in many solid tumors. Methods: A Phase II, open-label, Single-arm, multicentered study was conducted in previously treated pts with advanced STS in China. The patients received apatinib 500mg orally qd in a 28-day-cycle, until disease progression or unacceptable adverse events. Antitumor response assessment was performed every 8 weeks per RECIST V1.1. The primary endpoint was PFS rate in 6 months and secondary endpoint was ORR and OS. Results: As cut-off on Jan 20th 2019, a total of 53 patients were enrolled in 9 centers, 51 patients received at least 2 cycles of Apatinib, 1 patient is still in treatment. The main histological subtypes were alveolar soft part sarcoma(n = 11), synovial sarcoma(n = 6), leiomyosarcoma (n = 6), clear cell sarcoma(n = 6) and undifferentiated pleomorphic sarcoma(n = 5). Overall, 27 of 51 patients were progression free at six months and the 6-m PFS rate was 53.32% (95%CI 37.76%, 66.63%). Until final follow-up, the ORR was 18.75% (9/48) and DCR was 87.5% (42/48). Additionally, median PFS was 7.13 (95%CI 3.84, 9.23) months and median OS has reached up to 24.67 (9.30-NE) months. Adverse events (AEs) were detected among all pts, hypertension and proteinuria are the most common AEs, occurred in 84.91% and 73.57% pts respectively. Grade 3/4 related adverse events were detected in 86.79% of pts, Grade 3/4 hypertension was the most common grade3/4 AE (56.60%). Conclusions: Overall, the present study demonstrates that apatinib has a clinically meaningful anti-tumor activity in pretreated STS pts, showing durable responses and prolonged overall survival. Some of the pts had a long-time benefit from the treatment. Apatinib was safe and generally well tolerated. Further studies on specific STS subtypes would be meaningful. Clinical trial information: NCT03064243.

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Abstract Details

Meeting

2020 ASCO Virtual Scientific Program

Session Type

Poster Session

Session Title

Sarcoma

Track

Sarcoma

Sub Track

Soft Tissue Tumors

Clinical Trial Registration Number

NCT03064243

Citation

J Clin Oncol 38: 2020 (suppl; abstr 11553)

DOI

10.1200/JCO.2020.38.15_suppl.11553

Abstract #

11553

Poster Bd #

441

Abstract Disclosures