Blay Jean-Yves
Department of Medical Oncology, Centre Léon Bérard, 28 Rue Laennec, 69008 Lyon, France.
Future Oncol. 2014 Jun;10(8 Suppl):s13-7. doi: 10.2217/fon.14.115.
The approval of trabectedin in Europe in 2007 for the treatment of advanced soft tissue sarcoma (STS) was based on four Phase II trials. The extensive clinical trials program currently underway with trabectedin indicates clearly the extent to which this novel agent remains a topic of scientific and clinical interest in the treatment of advanced STS. Results of several retrospective studies examining outcomes of patients treated beyond clinical trials and under everyday practice conditions, including compassionate use programs, were disclosed in 2013. These analyses complement the knowledge about trabectedin gained from previous and ongoing clinical studies. Collectively, the results confirm the activity of trabectedin in inoperable/metastatic STS and extend current knowledge about several aspects of its profile, highlighting in particular improved outcomes when trabectedin is used in earlier lines of therapy and when treatment is maintained in the absence of disease progression. Evidence that the safety profile of trabectedin does not differ materially between elderly (≥65 years) and younger patients suggests no need to discriminate on the basis of age; elderly patients who are sufficiently fit to receive chemotherapy and considered by their physicians as unsuited to receive doxorubicin/ifosfamide can be treated with trabectedin in the same manner as younger patients.
曲贝替定于2007年在欧洲获批用于治疗晚期软组织肉瘤(STS),其依据的是四项II期试验。目前正在进行的关于曲贝替定的广泛临床试验项目清楚地表明了这种新型药物在晚期STS治疗中仍是科学和临床关注话题的程度。2013年公布了几项回顾性研究的结果,这些研究考察了在临床试验之外以及日常实践条件下(包括同情用药项目)接受治疗的患者的预后情况。这些分析补充了从之前及正在进行的临床研究中获得的关于曲贝替定的知识。总体而言,结果证实了曲贝替定在不可切除/转移性STS中的活性,并扩展了目前关于其特征几个方面的认识,尤其突出了在早期治疗线中使用曲贝替定以及在无疾病进展时维持治疗时预后得到改善。曲贝替定在老年(≥65岁)和年轻患者中的安全性特征没有实质性差异的证据表明无需基于年龄进行区分;身体状况足以接受化疗且被医生认为不适合接受多柔比星/异环磷酰胺治疗的老年患者可以与年轻患者一样接受曲贝替定治疗。