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Published on: March 18, 2014
A phase II study of eribulin in recurrent or refractory osteosarcoma: A report from the Children's Oncology Group
Michael S Isakoff1, Robert Goldsby2, Doojduen Villaluna3
1Center for Cancer and Blood Disorders, Connecticut Children's Medical Center, Hartford, Connecticut.
Background:
Patients with recurrent or refractory osteosarcoma have a poor prognosis with less than 30% surviving two years. Eribulin is a synthetic analog of halichondrin B, has a novel mechanism of action when compared with other microtubule inhibitors, and may have antitumor activity in osteosarcoma.
Methods:
A prospective study was designed to assess the disease control success at four months and objective response rates in patients with recurrent or refractory osteosarcoma treated with eribulin. Eligible patients were between 12 and 50 years of age, had measurable tumor, and met standard organ function requirements. Patients were given eribulin 1.4 mg/m2 /dose on days 1 and 8 of each 3-week cycle for up to 24 months if there was no progressive disease. Response to therapy was assessed using RECIST 1.1 criteria after cycles 2 and 5 and every fourth cycle thereafter.
Results:
Nineteen patients enrolled on the AOST1322 study. The median age of enrollment was 16 years (range, 12-25 years). Twelve patients were male and seven female. Eribulin was well tolerated, with neutropenia identified as the most common toxicity. The median progression-free survival was 38 days and no patients reached the four-month time point without progression. No objective responses were seen in any patient.
Conclusion:
This study rapidly assessed the clinical activity of a novel agent in this patient population. Eribulin was well tolerated, but there were no patients who demonstrated objective response, and all patients had progression prior to four months.
Insights
Eribulin, a novel agent, was evaluated in patients with recurrent or refractory osteosarcoma. The drug was well tolerated but did not demonstrate significant clinical activity, with no objective responses observed.
Area of Science:
- Oncology
- Pharmacology
Background:
- Recurrent or refractory osteosarcoma carries a poor prognosis, with survival rates below 30% at two years.
- Eribulin, a synthetic analog of halichondrin B, offers a novel mechanism of action distinct from other microtubule inhibitors.
- Potential antitumor activity of eribulin in osteosarcoma warrants investigation.
Purpose of the Study:
- To assess the disease control at four months and objective response rates in patients with recurrent or refractory osteosarcoma treated with eribulin.
- To evaluate the safety and tolerability of eribulin in this patient population.
Main Methods:
- A prospective study (AOST1322) enrolled 19 patients aged 12-50 years with measurable osteosarcoma.
- Eribulin was administered at 1.4 mg/m²/dose on days 1 and 8 of each 3-week cycle.
- Tumor response was assessed using RECIST 1.1 criteria at predefined intervals.
Main Results:
- The median age of the 19 enrolled patients was 16 years.
- Eribulin was generally well tolerated, with neutropenia being the most frequent toxicity.
- No objective responses were observed, and all patients experienced disease progression before the four-month mark, with a median progression-free survival of 38 days.
Conclusions:
- Eribulin demonstrated good tolerability in patients with recurrent or refractory osteosarcoma.
- The study concluded that eribulin did not show significant clinical activity in this patient group.
- All patients experienced disease progression prior to four months, indicating a lack of efficacy for eribulin in this setting.
