Apatinib plus ifosfamide and etoposide versus ifosfamide and etoposide in patients with advanced osteosarcomas (OAIE/PKUPH-sarcoma 11): a randomized phase II study

Lu Xie, Jie Xu, Xin Sun, Kuisheng Liu, Kunkun Sun, Yuan Li, Rong Liu, Du Wang, Shurong Shao, Zhongjiang Chen, Zheng Pang, Guangxin Zhou, Sujia Wu, Yingqi Hua, Haiyan Hu, Ran Wei, Yi Yang, Tao Ji, Wei Guo () and Xiaodong Tang ()
Additional contact information
Lu Xie: Peking University People’s Hospital, Musculoskeletal Tumor Center
Jie Xu: Peking University People’s Hospital, Musculoskeletal Tumor Center
Xin Sun: Peking University People’s Hospital, Musculoskeletal Tumor Center
Kuisheng Liu: Peking University People’s Hospital, Musculoskeletal Tumor Center
Kunkun Sun: Peking University People’s Hospital, Department of Pathology
Yuan Li: Peking University People’s Hospital, Department of Radiology & Nuclear Medicine
Rong Liu: Peking University People’s Hospital, Department of Radiology & Nuclear Medicine
Du Wang: Jiangsu Hengrui Pharmaceuticals Co. Ltd., Department of Medical Affairs
Shurong Shao: Jiangsu Hengrui Pharmaceuticals Co. Ltd., Department of Medical Affairs
Zhongjiang Chen: Jiangsu Hengrui Pharmaceuticals Co. Ltd., Department of Medical Affairs
Zheng Pang: Jiangsu Hengrui Pharmaceuticals Co. Ltd., Department of Medical Affairs
Guangxin Zhou: Nanjing University, Department of Orthopedics, Jinling Hospital, Medical School
Sujia Wu: Nanjing University, Department of Orthopedics, Jinling Hospital, Medical School
Yingqi Hua: Shanghai Jiao Tong University School of Medicine, Department of Orthopaedics, Shanghai General Hospital
Haiyan Hu: Shanghai Jiao Tong University Affiliated Sixth People’s Hospital, Clinical Trial Center
Ran Wei: Peking University People’s Hospital, Musculoskeletal Tumor Center
Yi Yang: Peking University People’s Hospital, Musculoskeletal Tumor Center
Tao Ji: Peking University People’s Hospital, Musculoskeletal Tumor Center
Wei Guo: Peking University People’s Hospital, Musculoskeletal Tumor Center
Xiaodong Tang: Peking University People’s Hospital, Musculoskeletal Tumor Center

Nature Communications, 2025, vol. 16, issue 1, 1-9

Abstract: Abstract Relapsed or refractory osteosarcoma carries a poor prognosis after standard chemotherapy. We conducted a multicenter, randomized, phase II trial (NCT05277480) to compare apatinib plus ifosfamide/etoposide (IE) with IE alone in patients who had progressed following at least one prior line of chemotherapy. Patients were randomized 2:1 to receive apatinib (500 mg orally once daily) plus IE (ifosfamide 1.8 g/m²/day and etoposide 100 mg/m²/day, days 1–3 every 3 weeks) or IE alone (same doses, days 1–5 every 3 weeks). The primary endpoint was progression-free survival (PFS). Between April 14, 2022, and August 22, 2023, 81 patients were enrolled (53 in apatinib plus IE group and 28 in IE group). After a median follow-up of 19.9 months, the median PFS was 5.5 months (95% confidence interval [CI]: 3.9, 6.4) with apatinib plus IE compared with 3.4 months (95% CI: 1.4, 4.6) with IE (hazard ratio, 0.60; 95% CI: 0.37, 0.98; P = 0.0402). The trial met its pre-specified primary endpoint. These results suggest that apatinib plus IE may improve PFS in relapsed or refractory osteosarcoma, but as a randomized phase II study, the findings are exploratory and require confirmation in phase III trials.

Date: 2025
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DOI: 10.1038/s41467-025-65467-8

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