A phase II study of eribulin in recurrent or refractory osteosarcoma: A report from the Children's Oncology Group
Year: 2018
Type: article
Study design: Clinical Trial
Abstract: 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/m 2 /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.
Source: Pediatric Blood & Cancer
DOI: 10.1002/pbc.27524
Institutions: Connecticut Children's Medical Center, University of California, San Francisco, UCSF Benioff Children's Hospital, Children's Oncology Group, University of Southern California, Phoenix Children's Hospital, University of Mississippi Medical Center, Johns Hopkins University, Johns Hopkins Medicine, Johns Hopkins Hospital, Alfred I. duPont Hospital for Children, The University of Texas at San Antonio Health Science Center, Children's Hospital of Philadelphia, University of Pennsylvania, The University of Texas MD Anderson Cancer Center, Dana-Farber/Boston Children's Cancer and Blood Disorders Center
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W2899477358
