Research Related Tumour Biopsies in Early-Phase Trials with Simultaneous Molecular Characterisation - a Single Unit Experience.
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Authors
Biondo, A
Pal, A
Riisnaes, R
Shinde, R
Tiu, C
Lockie, F
Baker, C
Bertan, C
Crespo, M
Ferreira, A
Pereira, R
Figueiredo, I
Miranda, S
Gurel, B
Carreira, S
Banerji, U
de Bono, J
Lopez, J
Tunariu, N
Minchom, A
Pal, A
Riisnaes, R
Shinde, R
Tiu, C
Lockie, F
Baker, C
Bertan, C
Crespo, M
Ferreira, A
Pereira, R
Figueiredo, I
Miranda, S
Gurel, B
Carreira, S
Banerji, U
de Bono, J
Lopez, J
Tunariu, N
Minchom, A
Document Type
Journal Article
Date
2021-01-11
Date Accepted
2021-01-08
Abstract
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.
Citation
Cancer treatment and research communications, 2021, 27 pp. 100309 - ?
Source Title
Publisher
Elsevier BV
ISSN
2468-2942
eISSN
2468-2942
Collections
Research Team
Clinical Pharmacology – Adaptive Therapy
Clinical Pharmacology – Adaptive Therapy
Clinical Pharmacology – Adaptive Therapy