Defining best practices for tissue procurement in immuno-oncology clinical trials: consensus statement from the Society for Immunotherapy of Cancer Surgery Committee

Abstract

Immunotherapy is now a cornerstone for cancer treatment, and much attention has been placed on the identification of prognostic and predictive biomarkers. The success of biomarker development is dependent on accurate and timely collection of biospecimens and high-quality processing, storage and shipping. Tumors are also increasingly used as source material for the generation of therapeutic T cells. There have been few guidelines or consensus statements on how to optimally collect and manage biospecimens and source material being used for immunotherapy and related research. The Society for Immunotherapy of Cancer Surgery Committee has brought together surgical experts from multiple subspecialty disciplines to identify best practices and to provide consensus on how best to access and manage specific tissues for immuno-oncology treatments and clinical investigation. In addition, the committee recommends early integration of surgeons and other interventional physicians with expertise in biospecimen collection, especially in clinical trials, to optimize the quality of tissue and the validity of correlative clinical studies in cancer immunotherapy.

In vitro 3D liver tumor microenvironment models for immune cell therapy optimization

“…Current methods of biopsy extraction, preservation and patient-derived tissue or cell line maintenance are varied and often result in the loss of significant TME populations. 125 Efforts to culture patient biopsies containing tumor cells and the cells in the TME are very promising 125–129 and will likely pave the way for highly physiologically relevant patient-derived complex 3D models.…”

Development of preclinical and clinical models for immune-related adverse events following checkpoint immunotherapy: a perspective from SITC and AACR

“…Beyond local institutional multidisciplinary efforts, 97 large national biobanking and translational efforts are also essential, particularly for rare cancers and irAEs. Similar to the CDMs needed for effectively sharing, aligning and integrating clinical data across institutions, the development of standardized operating procedures for sample collection from each organ subtype is required, 108 and specific cryopreservation approaches are needed for a range of downstream measurements. These gold-standard procedures should be consensus driven and disseminated publicly so that consortia of universities, academic medical centers and community hospitals can bank biospecimens paired with key clinical data in a uniform way and pool resources to empower larger and more comprehensive translational research efforts, which are essential to study some of the rarest (eg, T1DM) and most fatal irAEs (eg, myocarditis with myasthenia).…”

The Promise of Patient-Derived Preclinical Models to Accelerate the Implementation of Personalised Medicine for Children with Neuroblastoma

“…The technical improvements in molecular tests (which require less and less tissue and can often be performed on fixed tissue) and the widespread use of genome-wide investigations (as opposed to single-gene testing) to determine eligibility to treatment with targeted agents will eventually facilitate this decision. Although some authors have attempted to formalize their tissue prioritization protocols [ 31 , 32 , 33 ], this is a dynamic balance, and we can anticipate that PDX will move up in the priorities list, as their role in treatment decision making becomes broader.…”