{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Xie L"],"funding":["Natural Science Foundation of Beijing Municipality (Beijing Natural Science Foundation)"],"pagination":["10473"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12647724"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["16(1)"],"pubmed_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."],"journal":["Nature communications"],"pubmed_title":["Apatinib plus ifosfamide and etoposide versus ifosfamide and etoposide in patients with advanced osteosarcomas (OAIE/PKUPH-sarcoma 11): a randomized phase II study."],"pmcid":["PMC12647724"],"funding_grant_id":["L234041"],"pubmed_authors":["Hua Y","Liu K","Wang D","Guo W","Xie L","Liu R","Pang Z","Sun X","Xu J","Ji T","Li Y","Yang Y","Wei R","Chen Z","Hu H","Wu S","Zhou G","Sun K","Shao S","Tang X"],"additional_accession":[]},"is_claimable":false,"name":"Apatinib plus ifosfamide and etoposide versus ifosfamide and etoposide in patients with advanced osteosarcomas (OAIE/PKUPH-sarcoma 11): a randomized phase II study.","description":"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.","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Nov","modification":"2026-06-05T16:48:56.841Z","creation":"2026-05-18T03:13:33.353Z"},"accession":"S-EPMC12647724","cross_references":{"pubmed":["41290609"],"doi":["10.1038/s41467-025-65467-8"]}}