Abstract 54P
Background
ESMO recently published Next Generation Sequencing (NGS) testing recommendations for solid tumors, which includes cholangiocarcinoma (CCA), for use of small or large multigene target NGS panels to identify actionable variants. The European Medicines Agency has approved an FGFR2 inhibitor for advanced, metastatic CCA FGFR2 fusion positive patients. With more FGFR2 therapies anticipated, it will be important to identify all CCA patients with any FGFR2 fusion.
Methods
Using our Diagnostic Network for Precision Medicine (DXRX), 102 EU4 labs across France, Germany, Italy, and Spain were assessed for their capability to provide full coverage of FGFR2 fusions using NGS, in a clinical setting. Data was collected from between January-June 2020 and included NGS testing capabilities, sample type, FGFR2 fusion testing availability & turnaround time (TAT) to reporting results.
Results
Our analysis revealed Spain has the highest number of labs (86%) capable of detecting a full range of FGFR2 fusions. In contrast, fewer French NGS labs (36%) are prepared for routine clinical FGFR2 testing, however, they provide faster TAT (10 days versus median of 11.5 days and max of 14 days in Italy). 59% and 41% of German and Italian labs, respectively, provide full FGFR2 fusion detection. All labs test using solid tissue biopsies. Uptake of liquid biopsy use varies from 77% in France to 5% in Spain.
Conclusions
Gene fusion testing clinical utility is well established, and the breadth of possible actionable gene fusions (e.g., ALK, NTRK, FGFR2) in solid tumors continues to grow. NGS provides a means to identify any fusion present using a single test and is the recommended method of choice to provide simultaneous, full coverage of FGFR2 fusions where the paucity of tissue for tumors (e.g., CCA) limits PCR or FISH. Results reveal the proportion of labs ready to provide full FGFR2 fusion detection via NGS in CCA varies across the EU4. This may reflect a possible centralized approach to NGS testing in some countries. It may also highlight a need for more labs to prepare NGS use beyond common diseases (e.g., lung cancer) to rarer conditions like CCA.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
M. Sciortino; N. Atkey; B. Bisaro; G. Courtois; N. Holtkamp; J. Iparraguirre; B. Holt; P.V. Ricelli; S. Munksted; J. Clark: Financial Interests, Personal, Full or part-time Employment: Diaceutics.