TY - JOUR
T1 - Real-World Performance of a Comprehensive Genomic Profiling Test Optimized for Small Tumor Samples
AU - Tomlins, Scott A.
AU - Hovelson, Daniel H.
AU - Suga, Jennifer M.
AU - Anderson, Daniel M.
AU - Koh, Han A.
AU - Dees, Elizabeth C.
AU - McNulty, Brendan
AU - Burkard, Mark E.
AU - Guarino, Michael
AU - Khatri, Jamil
AU - Safa, Malek M.
AU - Matrana, Marc R.
AU - Yang, Eddy S.
AU - Menter, Alex R.
AU - Parsons, Benjamin M.
AU - Slim, Jennifer N.
AU - Thompson, Michael A.
AU - Hwang, Leon
AU - Edenfield, William J.
AU - Nair, Suresh
AU - Onitilo, Adedayo
AU - Siegel, Robert
AU - Miller, Alan
AU - Wassenaar, Timothy
AU - Irvin, William J.
AU - Schulz, William
AU - Padmanabhan, Arvinda
AU - Harish, Vallathucherry
AU - Gonzalez, Anneliese
AU - Mansoor, Abdul Hai
AU - Kellum, Andrew
AU - Harms, Paul
AU - Drewery, Stephanie
AU - Falkner, Jayson
AU - Fischer, Andrew
AU - Hipp, Jennifer
AU - Kwiatkowski, Kat
AU - Vega, Lorena Lazo de la
AU - Mitchell, Khalis
AU - Reeder, Travis
AU - Siddiqui, Javed
AU - Vakil, Hana
AU - Johnson, D. Bryan
AU - Rhodes, Daniel R.
N1 - Publisher Copyright:
Copyright © 2023 American Society of Clinical Oncology. All rights reserved.
PY - 2021
Y1 - 2021
N2 - PURPOSE Tissue-based comprehensive genomic profiling (CGP) is increasingly used for treatment selection in patients with advanced cancer; however, tissue availability may limit widespread implementation. Here, we established real-world CGP tissue availability and assessed CGP performance on consecutively received samples. MATERIALS AND METHODS We conducted a post hoc, nonprespecified analysis of 32,048 consecutive tumor tissue samples received for StrataNGS, a multiplex polymerase chain reaction (PCR)–based comprehensive genomic profiling (PCR-CGP) test, as part of an ongoing observational trial (NCT03061305). Sample characteristics and PCR-CGP performance were assessed across all tested samples, including exception samples not meeting minimum input quality control (QC) requirements (, 20% tumor content [TC],, 2 mm2 tumor surface area [TSA], DNA or RNA yield, 1 ng/mL, or specimen age . 5 years). Tests reporting ≥ 1 prioritized alteration or meeting TC and sequencing QC were considered successful. For prostate carcinoma and lung adenocarcinoma, tests reporting ≥ 1 actionable or informative alteration or meeting TC and sequencing QC were considered actionable. RESULTS Among 31,165 (97.2%) samples where PCR-CGP was attempted, 10.7% had, 20% TC and 59.2% were small (, 25 mm2 tumor surface area). Of 31,101 samples evaluable for input requirements, 8,089 (26.0%) were exceptions not meeting requirements. However, 94.2% of the 31,101 tested samples were successfully reported, including 80.5% of exception samples. Positive predictive value of PCR-CGP for ERBB2 amplification in exceptions and/or sequencing QC-failure breast cancer samples was 96.7%. Importantly, 84.0% of tested prostate carcinomas and 87.9% of lung adenocarcinomas yielded results informing treatment selection. CONCLUSION Most real-world 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 impact of biomarker-guided therapies.
AB - PURPOSE Tissue-based comprehensive genomic profiling (CGP) is increasingly used for treatment selection in patients with advanced cancer; however, tissue availability may limit widespread implementation. Here, we established real-world CGP tissue availability and assessed CGP performance on consecutively received samples. MATERIALS AND METHODS We conducted a post hoc, nonprespecified analysis of 32,048 consecutive tumor tissue samples received for StrataNGS, a multiplex polymerase chain reaction (PCR)–based comprehensive genomic profiling (PCR-CGP) test, as part of an ongoing observational trial (NCT03061305). Sample characteristics and PCR-CGP performance were assessed across all tested samples, including exception samples not meeting minimum input quality control (QC) requirements (, 20% tumor content [TC],, 2 mm2 tumor surface area [TSA], DNA or RNA yield, 1 ng/mL, or specimen age . 5 years). Tests reporting ≥ 1 prioritized alteration or meeting TC and sequencing QC were considered successful. For prostate carcinoma and lung adenocarcinoma, tests reporting ≥ 1 actionable or informative alteration or meeting TC and sequencing QC were considered actionable. RESULTS Among 31,165 (97.2%) samples where PCR-CGP was attempted, 10.7% had, 20% TC and 59.2% were small (, 25 mm2 tumor surface area). Of 31,101 samples evaluable for input requirements, 8,089 (26.0%) were exceptions not meeting requirements. However, 94.2% of the 31,101 tested samples were successfully reported, including 80.5% of exception samples. Positive predictive value of PCR-CGP for ERBB2 amplification in exceptions and/or sequencing QC-failure breast cancer samples was 96.7%. Importantly, 84.0% of tested prostate carcinomas and 87.9% of lung adenocarcinomas yielded results informing treatment selection. CONCLUSION Most real-world 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 impact of biomarker-guided therapies.
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U2 - 10.1200/PO.20.00472
DO - 10.1200/PO.20.00472
M3 - Article
C2 - 34476329
AN - SCOPUS:85115951489
VL - 5
SP - 1312
EP - 1324
JO - JCO Precision Oncology
JF - JCO Precision Oncology
ER -
