Randomized Study of Apatinib plus Ifosfamide and Etoposide versus Ifosfamide and Etoposide in Patients With Advanced Osteosarcomas (OAIE/PKUPH-sarcoma 11)

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Abstract

Background: Retrospective analysis have indicated potential benefits of combining apatinib, a multi-targeted tyrosine kinase inhibitor, with ifosfamide and etoposide (IE) for advanced osteosarcoma. This study aims to compare the efficacy of apatinib plus IE versus IE alone in patients with relapsed or refractory osteosarcoma. Methods: This multicenter, randomized controlled trial (NCT05277480) involved patients with relapsed or refractory osteosarcoma, who had progressed on first-line chemotherapy, typically comprising high-dose methotrexate, doxorubicin, cisplatin with or without ifosfamide (MAP/I). Participants were randomized in a 2:1 ratio to receive either apatinib plus IE or IE alone. The apatinib plus IE group received 500 mg of oral apatinib daily, along with ifosfamide (1.8 g/m²/day) and etoposide (100 mg/m²/day) d 1-3 q3w. The IE group received the same daily regimen d 1-5 q3w. The primary endpoint was median progression-free survival (mPFS). Results: From April 2022 to August 2023, 81 patients were enrolled, with 53 receiving apatinib plus IE and 28 receiving IE alone. With median follow-up of 19.9 months, the mPFS was 5.5 months (95% confidence interval [CI], 3.9 to 6.4) for the apatinib+IE, compared to 3.4 months (95% CI, 1.4 to 4.6) for single IE (hazard ratio, 0.60; 95% CI, 0.37 to 0.98; P=0.0402). The median OS was 18.2 months (95% confidence interval [CI], 13.7 to 25.2) for apatinib+IE, compared to 22.9 months (95% CI, 19.3 to NE) for single IE (hazard ratio, 1.48; 95% CI, 0.76 to 2.89; P=0.2493). The incidence of neutropenia and thrombocytopenia was similar between two groups. Quality of life assessments revealed significant improvements in global health status in apatinib+IE. Conclusion: Combining apatinib with IE significantly enhances PFS in patients with relapsed or refractory osteosarcoma post MAP/I chemotherapy, maintaining an acceptable safety profile.

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