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Bone Sarcomas

(P 51) OAIE TRIAL IN PROGRESS: A RANDOMIZED PHASE II TRIAL ASSESSING APATINIB IN COMBINATION WITH IFOSFAMIDE AND ETOPOSIDE(IE) VERSUS SINGLE IE CHEMOTHERAPY FOR RELAPSED OR REFRACTORY OSTEOSARCOMA

Location: The Liffey, Level 1

    Author(s)

  • Lu Xie, MD (she/her/hers)

    consultant and vice director of Musculoskeletal Tumor Center
    Peking University People's Hospital
    Beijing, Beijing, China (People's Republic)

    • Co-Author(s)

  • Jie Xu, MD

    Consultant
    Peking University People's Hospital
    Beijing, Beijing, China (People's Republic)

  • Xiaodong Tang, M.D.

    Chief
    Peking University People's Hospital
    Beijing, Beijing, China (People's Republic)

  • WG

    Wei Guo, N/A, M.D.

    Peking University People's Hospital
    Beijing, Beijing, China (People's Republic)

Objective: This phase II randomized controlled trial (OAIE) will assess whether the combination of Apa+IE is superior to IE alone in children, adolescents and young adults with relapsed/refractory osteosarcoma.

Methods: OAIE Trial is a national multiple-center, randomized phase II trial in patients with Relapsed or Refractory Osteosarcoma Progressed Upon First-line Chemotherapy [high-dose methotrexate (12 g/m2), doxorubicin (75 mg/m2), cisplatin (100-120 mg/m2) with or without ifosfamide (12 g/m2)]. Treatment arms consist of Apa 500 mg once daily (QD) orally plus Ifosfamide 1.8 g/m2/d d1-3 and etoposide 100 mg/m2/d d1-3 once every 3 weeks (Q3w) versus Ifosfamide 1.8 g/m2/d d1-5 and etoposide 100 mg/m2/d d1-5 once every 3 weeks (Q3w) for at least 10 cycles. The primary objective: to compare median Progression Free Survival (mPFS) between arms (RECIST 1.1, investigator assessed). Secondary endpoints include Objective Response Rate (ORR); Overall Survival(OS); safety; quality of life. Statistical

Design: Randomization 2:1; balanced for stratification factors: None. Assuming a mPFS month for patients on the control arm and estimated 6m improvement in mPFS (5m to 11m (HR 0.4545)) with 80% power using a 2-sided 5% level test requires a sample size of 78 including 10% drop out rate. The DSMC reviewed and recommended trial continuation in December 2022. Clinical trial information: NCT05277480.

Results: N/A if you are submitting under Trials in Progress.

Conclusion: N/A if you are submitting under Trials in Progress.