Real-World Performance of a Comprehensive Genomic Profiling Test Optimized for Small Tumor Samples
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- Scott A. Tomlins
- Strata Oncology, Ann Arbor, MI
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- Daniel H. Hovelson
- Strata Oncology, Ann Arbor, MI
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- Jennifer M. Suga
- Kaiser Permanente, Dept of Medical Oncology, Vallejo, CA
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- Daniel M. Anderson
- Metro-Minnesota Community Oncology Research Consortium (MMCORC), St Louis Park, MN
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- Han A. Koh
- Kaiser Permanente, Bellflower, CA
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- Elizabeth C. Dees
- The University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC
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- Brendan McNulty
- UNC Rex Healthcare, Raleigh, NC
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- Mark E. Burkard
- University of Wisconsin Carbone Cancer Center, Madison, WI
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- Michael Guarino
- ChristianaCare's Helen F. Graham Cancer Center & Research Institute, Newark, DE
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- Jamil Khatri
- ChristianaCare's Helen F. Graham Cancer Center & Research Institute, Newark, DE
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- Malek M. Safa
- Kettering Cancer Center, Kettering, OH
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- Marc R. Matrana
- Ochsner Cancer Institute, New Orleans, LA
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- Eddy S. Yang
- University of Alabama at Birmingham, Birmingham, AL
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- Alex R. Menter
- Kaiser Permanente Medical Group, Denver, CO
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- Benjamin M. Parsons
- Gundersen Health System, La Crosse, WI
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- Jennifer N. Slim
- MultiCare, Auburn, WA
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- Michael A. Thompson
- Advocate Aurora Health Care, Milwaukee, WI
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- Leon Hwang
- Kaiser Permanente Mid Atlantic, Rockville, MD
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- William J. Edenfield
- Prisma Health Cancer Institute, Greenville, SC
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- Suresh Nair
- Lehigh Valley Health Network, Allentown, PA
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- Adedayo Onitilo
- Marshfield Clinic, Marshfield WI
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- Robert Siegel
- Bon Secours St Francis Cancer Center, Greenville, SC
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- Alan Miller
- SCL Health Colorado, Broomfield, CO
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- Timothy Wassenaar
- ProHealth Care, Waukesha, WI
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- William J. Irvin
- Bon Secours St Francis Medical Center Midlothian, Midlothian, VA
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- William Schulz
- Swedish American, Rockford, IL
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- Arvinda Padmanabhan
- Baptist Health, Lexington, KY
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- Vallathucherry Harish
- High Point Medical Center, High Point, NC
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- Anneliese Gonzalez
- UT Health-Memorial Hermann Cancer Institute, Houston, TX
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- Abdul Hai Mansoor
- Kaiser Permanente Northwest, Portland, OR
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- Andrew Kellum
- North Mississippi Medical Center, Tupelo, MS
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- Paul Harms
- University of Michigan Health Systems, Ann Arbor, MI
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- Stephanie Drewery
- Strata Oncology, Ann Arbor, MI
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- Jayson Falkner
- Strata Oncology, Ann Arbor, MI
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- Andrew Fischer
- Strata Oncology, Ann Arbor, MI
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- Jennifer Hipp
- Strata Oncology, Ann Arbor, MI
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- Kat Kwiatkowski
- Strata Oncology, Ann Arbor, MI
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- Lorena Lazo de la Vega
- Strata Oncology, Ann Arbor, MI
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- Khalis Mitchell
- Strata Oncology, Ann Arbor, MI
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- Travis Reeder
- Strata Oncology, Ann Arbor, MI
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- Javed Siddiqui
- Strata Oncology, Ann Arbor, MI
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- Hana Vakil
- Strata Oncology, Ann Arbor, MI
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- D. Bryan Johnson
- Strata Oncology, Ann Arbor, MI
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- Daniel R. Rhodes
- Strata Oncology, Ann Arbor, MI
抄録
<jats:sec><jats:title>PURPOSE</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>MATERIALS AND METHODS</jats:title><jats:p> 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 mm<jats:sup>2</jats:sup> tumor surface area [TSA], DNA or RNA yield < 1 ng/µL, 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. </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> Among 31,165 (97.2%) samples where PCR-CGP was attempted, 10.7% had < 20% TC and 59.2% were small (< 25 mm<jats:sup>2</jats:sup> 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. </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> 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. </jats:p></jats:sec>
収録刊行物
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- JCO Precision Oncology
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JCO Precision Oncology (5), 1312-1324, 2021-11
American Society of Clinical Oncology (ASCO)