In Study, Sorafenib Plus Everolimus for Osteosarcoma Fails to Reach Primary Endpoint

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According to a new study published in the journal The Lancet Oncology, the combination of sorafenib and everolimus failed to meet the prespecified 6 month progression-free survival target for the treatment of patients with relapsed or unresectable osteosarcoma.

For this non-randomized phase 2 study, researchers enrolled 38 adults between 2011 and 2013 with relapsed or unresectable osteosarcoma who progressed after standard chemotherapy. Standard chemotherapy include cisplatin, doxorubicin, methotrexate, with or without ifosfamide. Patients received sorafenib 800mg/day orally and everolimus 5mg orally once daily until disease progression or unacceptable toxicity.

Results showed that a 6 months, 45% of those enrolled (95% CI: 28 - 61) were progression-free. In regard to safety, 66% of patients experienced adverse event-related dose reductions, short therapy interruptions, or both, and 5% of patients discontinued treatment.

The most frequent grade 3 or 4 adverse events were anemia, diarrhea, fatigue, hand and foot syndrome, hypophosphatemia, lymphopenia, oral mucositis, and thrombocytopenia. One patient experienced a grade pneumothorax and again when that patient's disease progressed.

Despite the combination's demonstrated efficacy, the study did not reach its primary endpoint of 6 month progression-free survival of 50% or higher. 

In Study, Sorafenib Plus Everolimus for Osteosarcoma Fails to Reach Primary Endpoint
Sorafenib and everolimus failed to meet the prespecified 6 month progression-free survival target
The authors aimed to investigate the activity of sorafenib in combination with everolimus in patients with inoperable high-grade osteosarcoma progressing after standard treatment.
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