Drug Development Unit, Royal Marsden Hospital/The Institute of Cancer Research, Downs Road, Sutton, SM2 5PT.
Drug Development Unit, Royal Marsden Hospital/The Institute of Cancer Research, Downs Road, Sutton, SM2 5PT.
Cancer Treat Res Commun. 2021;27:100309. doi: 10.1016/j.ctarc.2021.100309. Epub 2021 Jan 11.
Early-phase cancer clinical trials are becoming increasingly accessible for patients with advanced cancer who have exhausted standard treatment options and later phase trial options. Many of these trials mandate research tissue biopsies. Research biopsies have been perceived as ethically fraught due to the perception of potential coercion of vulnerable human subjects. We performed an audit of two years of practice to assess the safety of ultrasound (US)-guided research biopsies, and to look at the yield of a simultaneous tumour next-generation sequencing (NGS) and immunohistochemistry (IHC) molecular characterisation programme. We show that in our institution, US-guided research biopsies were safe, produced adequate tumour content and in a selected subset who underwent in-house NGS sequencing, showed a high rate of actionable mutations with 30% having a Tier 1 variant. Nevertheless, these research biopsies may only provide direct benefit for a minority of patients and we conclude with a reflection on the importance of obtaining truly informed consent.
早期癌症临床试验对于已经用尽标准治疗方案和晚期试验选择的晚期癌症患者来说越来越容易获得。许多此类试验都需要进行研究性组织活检。由于认为可能对弱势人类受试者施加了潜在的胁迫，因此研究性活检在伦理上一直存在争议。我们对两年的实践进行了审核，以评估超声 (US) 引导的研究性活检的安全性，并研究同时进行肿瘤下一代测序 (NGS) 和免疫组织化学 (IHC) 分子特征分析计划的效果。我们发现，在我们的机构中，US 引导的研究性活检是安全的，能够获得足够的肿瘤组织，并且在接受内部 NGS 测序的选定亚组中，有很高的比例显示出可采取行动的突变，其中 30% 存在一级变体。然而，这些研究性活检可能仅为少数患者提供直接的受益，因此我们得出结论，必须真正获得知情同意。
