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Published on: July 25, 2020
Genomic profiling and expanded use of targeted anticancer drugs in solid cancers with exhausted evidence-based
Karin Holmskov Hansen1, Maria Bibi Lyng2, Annette Raskov Kodahl3,4
1Department of Oncology, Odense University Hospital, Odense, Denmark. holmskov-hansen@hotmail.com.
Background:
Genomic profiling of advanced solid cancer in patients with no further evidence based standard treatment options is a novel approach to identify potential experimental treatment options based on specific genomic alterations. Due to the expected short survival of these patients timely assessment of potential druggable targets is critical to minimize the risk of deterioration during the analysis. The primary objective of this prospective study is to evaluate the turnaround time for genomic profiling and the clinical investigational procedures. The secondary objectives are to investigate how often genomic alterations in tumor tissue gives rise to a matched treatment offer and evaluate the clinical outcome.
Methods:
The PRECODE study is a prospective, non-randomized, single-center cohort study conducted at Departments of Oncology and Pathology, Odense University Hospital, Denmark. Enrollment between March 1, 2019 and December 31, 2024. Eligibility criteria are age ≥ 18 years, written informed consent, advanced solid tumors, exhausted treatment options, ECOG performance status 0-2, adequate organ function and life expectancy ≥ 3 months. A core needle biopsy is analyzed by next generation sequencing using a pan-cancer comprehensive panel. Results are discussed weekly at institutional/local and national multidisciplinary tumor boards.
Discussion:
Strategies and methods for genomic profiling of advanced solid cancers differ. Rapid analysis and interpretation of sequencing data are key to avoiding delays in initiation potential experimental treatments, as these late-stage patients may quickly deteriorate. Although a highly optimized setup with fast-track clinical evaluation and genomic profiling has been established a subset will not be offered a targeted treatment due to deterioration. Local and national multidisciplinary teams have been established to optimize individualized treatment decisions. After genomic profiling a subset of patients will take part in clinical trials, which will constrain the reporting of overall survival or progression free survival.
Trial Registration:
Danish Ethics Committee, Projekt-ID: S-2018014, date of approval: 27- FEB- 2019) Danish Data Protection Agency (Journal no: 18/58329, date of approval: 23-NOV-2018).
Clinicaltrials:
gov Identifier: NCT05385081 (retrospectively registered).
Insights
Genomic profiling identifies targeted treatments for advanced cancers. Rapid analysis is crucial for timely experimental therapy in patients with limited options, though some may still deteriorate before treatment.
Area of Science:
- Oncology
- Genomics
- Precision Medicine
Background:
- Genomic profiling of advanced solid tumors offers a novel approach to identify experimental treatment options based on specific genomic alterations.
- Timely assessment of druggable targets is critical for patients with short survival to minimize deterioration during analysis.
Purpose of the Study:
- To evaluate the turnaround time for genomic profiling and associated clinical investigational procedures in advanced cancer patients.
- To determine the frequency of genomic alterations leading to matched treatment offers.
- To assess the clinical outcome of patients undergoing genomic profiling.
Main Methods:
- Prospective, non-randomized, single-center cohort study (PRECODE) at Odense University Hospital, Denmark.
- Enrollment of patients aged ≥18 years with advanced solid tumors and exhausted standard treatment options.
- Next-generation sequencing (NGS) using a pan-cancer comprehensive panel on core needle biopsies, with results discussed in multidisciplinary tumor boards.
Main Results:
- The study is ongoing with enrollment from March 1, 2019, to December 31, 2024.
- ClinicalTrials.gov Identifier: NCT05385081 (retrospectively registered).
- Ethical approvals obtained from the Danish Ethics Committee and Danish Data Protection Agency.
Conclusions:
- Rapid genomic profiling and data interpretation are essential to expedite potential experimental treatments for late-stage cancer patients.
- Despite optimized processes, some patients may deteriorate before a targeted treatment can be initiated.
- Multidisciplinary teams are crucial for optimizing individualized treatment decisions, with some patients participating in clinical trials.
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