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Poster session 10

908P - Evaluation of anxiety, distress and satisfaction with a multi-cancer early detection test

Date

10 Sep 2022

Session

Poster session 10

Topics

Translational Research;  Basic Science

Tumour Site

Presenters

Deborah Schrag

Citation

Annals of Oncology (2022) 33 (suppl_7): S417-S426. 10.1016/annonc/annonc1061

Authors

D. Schrag1, T.M. Beer2, C.H. McDonnell III3, L. Nadauld4, C.A. Dilaveri5, E.A. Klein6, R. Reid7, C.R. Marinac8, K.C. Chung9, M. Lopatin10, E.T. Fung11, D.L. Patrick12

Author affiliations

  • 1 Medical Oncology/population Sciences, MSKCC - Memorial Sloan Kettering Cancer Center, 10065 - New York/US
  • 2 Hematology / Medical Oncology Department, OHSU - Center for Health & Healing Building 2, 97239 - Portland/US
  • 3 Radiology, Sutter Institute for Medical Research, 95816-5156 - Sacramento/US
  • 4 Medical Oncology/hematology, Intermountain Healthcare - Intermountain Cancer Center of St George, 84790 - St. George/US
  • 5 General Internal Medicine, Mayo Clinic, 55905 - Rochester/US
  • 6 Urology, Stanford Comprehensive Cancer Institute, 94305-545 - Stanford/US
  • 7 Medical Oncology/hematology, US Oncology, Inc., 80260-6805 - Thornton/US
  • 8 Research, Dana Farber Cancer Institute, 02215 - Boston/US
  • 9 Health Economics Outcomes, GRAIL, Inc., 94025 - Menlo Park/US
  • 10 Biostatistics, GRAIL, Inc., 94025 - Menlo Park/US
  • 11 Clinical Development, GRAIL, Inc., 94025 - Menlo Park/US
  • 12 Health Sciences, University of Washington, WA 98109 - Seattle/US

Resources

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Abstract 908P

Background

A multi-cancer early detection (MCED) test using methylation patterns in plasma cell-free DNA to detect a cancer signal and predict site of origin was evaluated in the prospective PATHFINDER study. Because MCED testing has the potential to cause anxiety and distress, participant-reported outcomes were assessed.

Methods

Adults ≥50 y with or without additional cancer risk factors (a cancer diagnosis >3 years prior, smoking history, genetic predisposition) underwent the MCED blood test to screen for cancer. When a cancer signal was detected, the diagnostic workup was directed by the physician. Participants completed the Patient Reported Outcomes Measurement Information System (PROMIS) anxiety short form (higher scores = increased anxiety) pre-MCED test, post return of MCED test results (RoR), diagnostic resolution, and at end of study (EOS; 12 months). An adapted Multidimensional Impact of Cancer Risk Assessment (MICRA, higher scores = worsening) was completed post RoR. A three-item satisfaction questionnaire was completed post RoR for those with a signal not detected or at diagnostic resolution for signal detected.

Results

Participants with a cancer signal detected had increased anxiety following RoR which decreased by EOS (Table). MICRA scores were low, though participants with cancer signal detected had greater distress and uncertainty and worse experience vs those with no signal detected (Table). Of the 89.4% of participants who completed the satisfaction questionnaire, most were satisfied with the test (n=5749/5920; 48.5% extremely satisfied, 33.3% very satisfied, 15.3% satisfied) regardless of the MCED test result or cancer status upon diagnostic resolution. Table: 908P

Scale (score range) completion rate n/N, % Signal detected mean (SD) No signal detected mean (SD)
PROMIS anxiety (0-100), Pre test 6434/6621, 97.2% n=88 47.0 (7.1) n=6346 47.6 (7.5)
Δ Post test at RoR 5789/6621, 87.4% 3.6 (7.2) 0.7 (6.4)
Δ Diagnostic resolution 58/91, 63.7% 2.5 (6.3)
True Positive 4.7 (6.1)
False Positive 0.8 (6.1)
Δ End of study 5310/6621, 80.2% 0.6 (7.2) 0.7 (7.1)
True positive 1.2 (6.4)
False positive 0.1 (7.8)
MICRA, Total score (0-95) 5914/6621, 89.3% n=50 28.4 (14.9) n=5864 8.8 (7.2)
Distress (0-30) 7.6 (6.9) 0.6 (1.8)
Uncertainty (0-45) 11.3 (7.4) 3.2 (4.2)
Positive experience (0-20, higher score = worse experience) 9.6 (4.6) 5.0 (5.5)

Conclusions

While anxiety was elevated following a positive MCED test result, it was more pronounced for participants diagnosed with cancer, and did approach baseline by EOS for both true and false positive participants. High rates of satisfaction were reported with MCED testing irrespective of test result.

Clinical trial identification

NCT04241796.

Editorial acknowledgement

We acknowledge Jennifer Hepker, PhD and Merrilee Johnstone, PhD (Prescott Medical Communications Group, Chicago, IL), and Neva West, PhD (NeuroWest Solutions, Seattle, WA) for medical writing, editorial, and administrative support that was funded by GRAIL LLC a subsidiary of Illumina Inc. currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated 29 October 2021.

Legal entity responsible for the study

GRAIL LLC a subsidiary of Illumina Inc. currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated 29 October 2021.

Funding

GRAIL LLC a subsidiary of Illumina Inc. currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated 29 October 2021.

Disclosure

D. Schrag: Non-Financial Interests, Personal, Other, Research Agreements: Dana-Farber Cancer Institute; Non-Financial Interests, Personal, Licensing Fees: Dana-Farber Cancer Institute; Financial Interests, Personal, Other, Sponsored Travel: Dana-Farber Cancer Institute; Financial Interests, Personal, Other, Consulting: JAMA; Financial Interests, Personal, Advisory Role: University of North Carolina; Non-Financial Interests, Personal, Advisory Role: GRAIL LLC a subsidiary of Illumina Inc. currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated 29 October 2021. T.M. Beer: Non-Financial Interests, Institutional, Advisory Role: GRAIL LLC a subsidiary of Illumina Inc. currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated 29 October 2021, Arvinas; Financial Interests, Institutional, Advisory Role: AbbVie, Amgen, Astellas Pharma, AstraZeneca, Bayer, Constellation, Janssen, Myovant Sciences, Pfizer, Sanofi, Sapience Therapeutics, Bristol Myers Squibb, Clovis, Dantari Pharmaceuticals, GlaxoSmithKline, Novartis, Tolero; Financial Interests, Personal and Institutional, Stocks/Shares: Arnivas; Financial Interests, Personal, Stocks/Shares: Salarius Pharmaceuticals; Other, Institutional, Research Grant, Grant paid to institution: AllianceFoundation, Astellas Pharma, Bayer, Boehringer Ingelheim, Corcept Therapeutics, Endocyte Inc., Exact Sciences Corp, Freenome, GRAIL LLC a subsidiary of Illumina Inc. currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated 29 October 2021, Harpoon Therapeutics, Janssen Research and Development, Medivation, Merck, Sotio, Theraclone Sciences/On, Zenith Epigenetics. C.H. McDonnell III: Financial Interests, Personal and Institutional, Stocks/Shares: Sutter Medical Group. L. Nadauld: Financial Interests, Personal, Stocks/Shares: Citizen Corporation, Clarifi, Guidance Genomics. E.A. Klein: Non-Financial Interests, Institutional, Advisory Role: GRAIL LLC a subsidiary of Illumina Inc. currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated 29 October 2021, Genome Health, GenomeDx Biosciences; Financial Interests, Institutional, Research Grant: GenomeDX Biosciences. K.C. Chung: Financial Interests, Institutional, Full or part-time Employment: GRAIL LLC a subsidiary of Illumina Inc. currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated 29 October 2021. M. Lopatin: Financial Interests, Institutional, Full or part-time Employment: GRAIL LLC a subsidiary of Illumina Inc. currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated 29 October 2021. E.T. Fung: Financial Interests, Institutional, Full or part-time Employment: GRAIL LLC a subsidiary of Illumina Inc. currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated 29 October 2021. D.L. Patrick: Financial Interests, Institutional, Advisory Role: GRAIL LLC a subsidiary of Illumina Inc. currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated 29 October 2021. All other authors have declared no conflicts of interest.

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