A phase II study of eribulin in recurrent or refractory osteosarcoma: A report from the Children's Oncology Group
A phase II study of eribulin in recurrent or refractory osteosarcoma: A report from the Children's Oncology Group
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DOI：
10.1002/pbc.27524
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发表时间：
2019-02-01
影响因子：
3.2
通讯作者：
Janeway, Katherine A.
中科院分区：
文献类型：
--
作者：
Isakoff, Michael S.;Goldsby, Robert;Janeway, Katherine A.
背景复发性或难治性骨肉瘤患者预后差，2年生存率低于30%。艾日布林是软海绵素B的合成类似物，与其他微管抑制剂相比具有新的作用机制，可能对骨肉瘤具有抗肿瘤活性。方法采用前瞻性研究方法，观察艾日布林治疗复发性或难治性骨肉瘤患者4个月的疾病控制成功率和客观缓解率。符合条件的患者年龄在12至50岁之间，具有可测量的肿瘤，并符合标准器官功能要求。如果没有疾病进展，患者在每个3周周期的第1天和第8天给予艾日布林1.4 mg/m2/剂，持续24个月。在第2周期和第5周期以及此后每4个周期后，使用RECIST 1.1标准评估治疗应答。结果19例患者入组AOST 1322研究。入组的中位年龄为16岁（范围：12-25岁）。12例患者为男性，7例为女性。艾日布林耐受性良好，中性粒细胞减少症被确定为最常见的毒性。中位无进展生存期为38天，没有患者达到4个月的时间点而没有进展。在任何患者中均未观察到客观缓解。结论本研究快速评估了一种新型药物在该患者人群中的临床活性。艾日布林耐受性良好，但没有患者表现出客观反应，所有患者在4个月前都有进展。
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.