1. Comprehensive genomic profiling of 30,000 consecutive solid tumors
- Author
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Gonzalez A, Elizabeth Claire Dees, Rhodes Dr, Kellum A, Kwiatkowski K, Hovelson Dh, Drewery S, Guarino M, Edenfield Wj, Leon Christopher Hwang, de la Vega Ll, Siegel R, Scott A. Tomlins, Mitchell K, Johnson Db, Suresh G. Nair Md, Adedayo A. Onitilo, Reeder T, Malek M. Safa, Falkner J, Wassenaar T, Javed Siddiqui, Miller A, Vakil H, Harish, Eddy S. Yang, Han A. Koh, Michael A. Thompson, McNulty B, Benjamin M. Parsons, Mark E. Burkard, Hipp J, Jennifer Marie Suga, Slim Jn, Irvin Wj, Anderson Dm, W. Schulz, Fischer A, Alex R. Menter, Arvinda Padmanabhan, Jamil Khatri, Mansoor Ah, Matrana Mr, and Paul W. Harms
- Subjects
Oncology ,medicine.medical_specialty ,Genomic profiling ,Observational Trial ,business.industry ,Prostate carcinoma ,medicine.disease ,Advanced cancer ,Text mining ,Internal medicine ,Multiplex polymerase chain reaction ,medicine ,Adenocarcinoma ,Solid tumor ,business - Abstract
PurposeTissue-based comprehensive genomic profiling (CGP) is increasingly utilized for treatment selection in patients with advanced solid tumors, however real-world tissue availability may limit widespread implementation. Here we established real-world CGP tissue availability and assessed CGP performance on consecutively received samples.Patients and MethodPost-hoc, non-prespecified analysis of 32,048 consecutive tumor tissue samples received for StrataNGS, a multiplex PCR based-CGP (PCR-CGP) test, as part of an ongoing observational trial (NCT03061305). Tumor tissue sample characteristics and PCR-CGP performance were assessed across all tested tumor samples, including exception samples not meeting minimum input requirements (2 tumor surface area [TSA], DNA or RNA yield 5yrs). Tests reporting at least one prioritized alteration or meeting all sequencing QC metrics (and ≥20% TC) were considered successful. For prostate carcinoma and lung adenocarcinoma, tests reporting at least one actionable/informative alteration or those meeting all sequencing QC metrics (and ≥20% TC) were considered actionable.ResultsPCR-CGP was attempted in 31,165 of 32,048 (97.2%) consecutively received solid tumor tissue samples. Among the 31,165 tested samples, 10.7% had low (2 TSA), highlighting the challenging nature of samples received for CGP. Of the 31,101 samples evaluable for input requirements, 8,079 (26.0%) were exceptions not meeting requirements. However, 94.2% of the 31,101 tested samples were successfully reported, including 80.6% of exception samples. Importantly, 80.6% of 1,344 tested prostate carcinomas and 87.8% of 1,144 tested lung adenocarcinomas yielded results informing treatment selection.ConclusionMost real-world tumor tissue samples from patients with advanced cancer desiring CGP are limited, requiring optimized CGP approaches to produce meaningful results. An optimized PCR-CGP test, coupled with an inclusive exception testing policy, delivered reportable results for >94% of samples, potentially expanding the proportion of CGP-testable patients, and thus the impact of biomarker-guided targeted and immunotherapies.
- Published
- 2020