Amanda Kahl, MPH Mary E. Charlton, PhD, Aaron D. Bossler, MD, PhD,

Completeness of molecular testing information among metastatic colorectal cancer patients – A comparison of data sources at an academic medical center Amanda Kahl, MPH Mary E. Charlton, PhD, Aaron D. Bossler, MD, PhD, Bradley D. McDowell, PhD, Elizabeth A. Chrischilles, PhD Oral Presentation, NAACCR/IACR June 13, 2019

Background • Targeted molecular cancer therapies are an important advancement in cancer treatment • Overarching research question: • How well have they been disseminated to eligible cancer patients?

Background – the Example of Metastatic Colorectal Cancer (CRC) • National Comprehensive Cancer Network (NCCN) 2019 guidelines state that any patient with metastatic CRC should be tested for • RAS (KRAS and NRAS) mutations • BRAF mutations • Microsatellite instability (MSI) • Determines if patients are eligible for certain targeted therapies and immunotherapies

Molecular tests to perform for each therapy

Major issues in addressing this research question:How well have they been disseminated to eligible cancer patients? • Cancer registries • Do not capture all of these tests • Do not capture all of the names of molecular therapies • These tests and therapies are not always performed or given during first course treatment • Hospital data sources (EMRs, pathology reports, etc) often only capture the care they had at that particular institution What is the best combination of data sources to answer this?

PCORnet CDM • PCORI (Patient-Centered Outcomes Research Institute) funded a number of institutions across the US to form the PCORnet CDM (Common Data Model) • CDM includes information on diagnosis, procedures, prescribing, dispensing, medication administration, and death data tables • Extracted from institutional billing and electronic health record data • Biomarker testing pulled via • CPT, HCPCS codes • Molecular-guided therapies pulled via • RxNorm Concept Unique Identifier (RXCUI), National Drug Code (NDC), CPT, HCPCS

Purpose • Discuss the completeness of molecular testing information across different data sources for metastatic CRC patients seen at the University of Iowa Hospitals and Clinics • Data Sources • Manual review of electronic medical records (EMR) • PCORnet CDM: CPT, HCPCS, prescribing, dispensing, etc. tables • Statewide Iowa Cancer Registry

Computational extraction Molecular therapy Molecular testing • Are patients receiving testing? • What testing are patients receiving? • Compare results across different sources • How well are therapies being disseminated? • Does treatment align with test results? • Compare results across sources • Can molecular pathology data be pulled electronically?

Patients diagnosed with stage IV CRC or stage I-III CRC and had metastatic ICD-9/10 code, 2013-2016 N=197 Methods: Study population Excluded: cancer of appendix N=15 Non-appendix cases N=182 Excluded: multiple tumors N=8 Did not have multiple tumors N=174 Excluded: stage I-III metastatic disease occurred after Dec. 31, 2017 N=2 Metastatic disease occurred before Dec. 31, 2017 N=172 Excluded: stage I-III no evidence of metastatic disease in medical record N=9 Had evidence of metastatic disease in medical record N=163 Excluded: did not meet with UIHC medical oncologist N=25 Met with UIHC Medical Oncologist N=138 Primary med onc at UIHC, N=105 Only received surgery + med onc consult, N=14 Only received med onc consult, N=19

Methods • Biomarkers collected • KRAS, HRAS, NRAS, BRAF, MSI • Molecular-guided therapies • Cetuximab, panitumumab, pembrolizumab, nivolumab, ipilimumab • Other targeted therapies • Bevacizumab, regorafenib, ramucirumab, ziv-aflibercept, vemurafenib

Results

Cohort • Majority male, White, married and had private insurance • Tumors were mostly • of the colon (75%) • adenocarcinoma histology (83%) • moderately differentiated (54%) • diagnosed at stage IV (66%)

Molecular testing received for metastatic CRC patients, all data sources

Molecular testing results for metastatic CRC patients, all data sources

Comparison of KRAS testing for metastatic CRC captured by EMR review vs Iowa Cancer Registry 65% 40%

Distribution of molecular testing months after diagnosis among metastatic CRC patients 41% 27% 38% 38%

Comparison of molecular testing for metastatic CRC captured by EMR manual review vs CDM/CPT Data

Metastatic CRC patients receiving molecular-guided vs targeted therapy at UIHC, 2013-2017

Molecular-guided therapies and testing for metastatic CRC patients

Comparison of molecular-guided therapies for metastatic CRC patients captured by EMR review vs CDM Data • 4 out of 22 patients who received molecular-guided therapy were not found in the CDM • Given outside of UIHC and/or the study window

Ability to identify computable pathology and genomic data • Extracted molecular testing data from EMR vs manual chart review Electronic extraction of EMR

Conclusions – Molecular testing • EMRs contained 98% of molecular testing and therapy information • Between EMR and ICR all molecular testing was found EMR vs Registry Data EMR vs CDM Data • Proportion of KRAS and BRAF testing found in CDM was similar to manual review • MMR testing was not found in the CDM because there is no specific CPT for the immunohistochemistry test • Cases the Registry missed • >60% of missed KRAS tests were performed >6 months after diagnosis • 2% of cases were missed via manual review

Conclusions • Targeted therapies: • Only 16% of patients received a molecular-guided therapy • CDM data missed 4 cases vs EMR review • Computational extraction • Able to pull if a test was done, but results are more difficult • Able to pull if test done in >98% of patients • Could only extract results for ~2/3 of patients

Questions? Thank you amanda-kahl@uiowa.edu

Distribution of molecular testing months after diagnosis among metastatic CRC patients by stage 41% 27% 38% 38%

Amanda Kahl, MPH Mary E. Charlton, PhD, Aaron D. Bossler, MD, PhD,