Abstract
PCR-based comprehensive genomic profiling (PCR-CGP): Feasibility from >20,000 tumor tissue specimens (TTS) and predicted impact on actionable biomarker identification versus hybrid capture (H)-CGP and plasma (P)-CGP
Journal of clinical oncology, Vol.38(15_suppl), pp.3574-3574
05/20/2020
DOI: 10.1200/JCO.2020.38.15_suppl.3574
Abstract
Abstract only
3574
Background: Tissue-based h-CGP is increasingly utilized for treatment selection in patients with advanced solid tumors but has high tumor surface area [TSA] requirements (≥25mm
2
for leading commercial tests). P-CGP is recommended when tissue is insufficient for H-CGP. Here we assessed the feasibility and clinical impact on actionable biomarker identification of PCR-CGP. Methods: We performed a post-hoc, non-prespecified analysis on 21,743 consecutive subjects with advanced solid tumors who sent TTS for PCR-CGP from 5/17-12/19 as part of an ongoing observational trial at > 20 U.S. health systems (NCT03061305). PCR-CGP was performed using StrataNGS, a single-site laboratory developed test assessing all CGP biomarker classes (including microsatellite instability (MSI) status and tumor mutation burden [TMB]). We predicted actionable biomarker identification rates for PCR-CGP, H-CGP and P-CGP if applied to all U.S. patients with advanced solid tumors through incorporating population incidence, biomarker frequencies, test TSA and tumor content requirements (or cfDNA detection rates), and performance characteristics. Actionable biomarkers were the 30 in 11 tumor types from the MolDX p-CGP local coverage determination (L38043), pan-tumor NTRK fusions and MSI, and TMB in lung cancer. Results: Among TTS from 21,734 patients with advanced cancer, 20,493 (94.3%) met TSA requirements for PCR-CGP (≥2mm
2
) vs. 9,281 (42.7%) for H-CGP. PCR-CGP reported results for 98.0% and 95.0% of patients with large (≥25mm
2
TSA) and small (2-24mm
2
) TS, respectively, in a median of 7 business days. Compared to 1,882 orthogonal actionable biomarker results, PCR-CGP accuracy was 96.6% and 96.5% in large and small TTS, respectively. Actionable biomarker frequency was highly correlated in PCR-CGP tested large vs. small TTS (r
2
= 0.99), as well as in this PCR-CGP cohort vs. a MSKCC institutional pan-cancer H-CGP cohort (r
2
= 0.92). If applied to all U.S. patients with advanced solid tumors, PCR-CGP has significantly greater predicted actionable biomarker identification rate (88.5%) compared to P-CGP (77.0%, N-1 chi-squared test, p < 0.0001) or H-CGP (54.3%, p < 0.0001). Conclusions: Half of TTS submitted for PCR-CGP did not meet H-CGP tissue requirements. PCR-CGP is feasible for the vast majority of patients and is predicted to expand the actionable biomarker evaluable proportion of patients with advanced solid tumors compared to H-CGP or P-CGP. Clinical trial information: NCT03061305 .
Details
- Title: Subtitle
- PCR-based comprehensive genomic profiling (PCR-CGP): Feasibility from >20,000 tumor tissue specimens (TTS) and predicted impact on actionable biomarker identification versus hybrid capture (H)-CGP and plasma (P)-CGP
- Creators
- Dan Rhodes - Strata Oncology, Ann Arbor, MIDaniel H Hovelson - Strata Oncology, Ann Arbor, MIJennifer Marie Suga - Kaiser Permanente Vallejo Medical CenterDaniel M. Anderson - Regions HospitalElizabeth Claire Dees - University of North Carolina at Chapel HillHan A. Koh - Kaiser PermanenteMark E. Burkard - University of Wisconsin Carbone Cancer CenterJamil Khatri - Christiana Care Health SystemMalek M. Safa - Kettering Medical CenterMarc Ryan Matrana - Ochsner Medical CenterEddy Shih-Hsin Yang - University of Alabama at BirminghamAlex R. Menter - Kaiser PermanenteBenjamin Marshall Parsons - Gundersen Health SystemJennifer Nadine Slim - MultiCare Auburn Medical CenterJayson Falkner - Strata Oncology, Ann Arbor, MITravis Reeder - Strata Oncology, Ann Arbor, MIHana Vakil - Strata Oncology, Ann Arbor, MIKat Kwiatkowski - Strata Oncology, Ann Arbor, MIBryan Johnson - Strata Oncology, Ann Arbor, MIScott A. Tomlins - Strata Oncology, Ann Arbor, MIStrata Network Investigators
- Resource Type
- Abstract
- Publication Details
- Journal of clinical oncology, Vol.38(15_suppl), pp.3574-3574
- DOI
- 10.1200/JCO.2020.38.15_suppl.3574
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Number of pages
- 1
- Language
- English
- Date published
- 05/20/2020
- Academic Unit
- Internal Medicine
- Record Identifier
- 9984701252602771
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