Related Experiment Videos
OLIE, ITCC-082: a Phase II trial of lenvatinib plus ifosfamide and etoposide in relapsed/refractory osteosarcoma
Nathalie Gaspar1, Quentin Campbell-Hewson2, Jie Huang3
1Department of Childhood & Adolescent Oncology, Gustave Roussy Cancer Campus, Villejuif, France.
Abstract:
While survival rates for patients with relapsed/refractory osteosarcoma are low, kinase inhibitors have shown efficacy in its treatment. The multikinase inhibitor lenvatinib, plus ifosfamide and etoposide, showed antitumor activity in a Phase II study in patients with relapsed/refractory osteosarcoma. This Phase II randomized controlled trial (OLIE) will assess whether the combination of lenvatinib + ifosfamide + etoposide is superior to ifosfamide + etoposide alone in children, adolescents and young adults with relapsed/refractory osteosarcoma. The primary end point is progression-free survival; secondary and exploratory end points include, but are not limited to, overall survival, objective response rate, safety and tolerability, pharmacokinetic characterization of lenvatinib in the combination treatment, quality of life and quantification of baseline unresectable lesions that are converted to resectable.
Insights
Lenvatinib plus chemotherapy shows promise for relapsed/refractory osteosarcoma. This trial compares lenvatinib combination therapy against standard chemotherapy in young patients to improve progression-free survival.
Area of Science:
- Pediatric Oncology
- Medical Oncology
- Pharmacology
Background:
- Osteosarcoma is a rare bone cancer with poor survival rates in relapsed/refractory cases.
- Kinase inhibitors represent a promising therapeutic avenue for treating this challenging condition.
- Previous studies indicated antitumor activity of lenvatinib in combination with chemotherapy for relapsed/refractory osteosarcoma.
Purpose of the Study:
- To evaluate the efficacy of lenvatinib in combination with ifosfamide and etoposide compared to ifosfamide and etoposide alone.
- To determine if this combination therapy improves progression-free survival in pediatric, adolescent, and young adult patients.
- To assess secondary endpoints including overall survival, response rates, safety, and quality of life.
Main Methods:
- A Phase II randomized controlled trial (OLIE) was conducted.
- Patients with relapsed/refractory osteosarcoma were randomized to receive either lenvatinib + ifosfamide + etoposide or ifosfamide + etoposide alone.
- Progression-free survival served as the primary endpoint.
Main Results:
- The abstract does not contain results, as this is a trial design description.
- Further details on efficacy and safety will be reported upon study completion.
Conclusions:
- The OLIE trial is investigating a novel combination therapy for relapsed/refractory osteosarcoma.
- Results are anticipated to guide future treatment strategies for this patient population.
- This study aims to establish a new standard of care for young patients with difficult-to-treat osteosarcoma.