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Abstract
Introduction:
The 12-gene colon cancer Recurrence Score assay is a clinically validated predictor of recurrence risk in stage II colon cancer patients. A survey was performed characterizing the assay’s impact on treatment recommendations for these patients.
Methods:
US medical oncologists (n = 346) who ordered the assay for ≥3 stage II colon cancer patients were asked to complete a web-based survey regarding their most recent such patient. Physicians surveyed represented users of the assay within the first 2 years of commercial availability which may include ‘early adopters’.
Results:
Most of 116 eligible physicians were in community practice (86%), with median 14.5 years’ experience (range = 2–40). Mean patient age was 61 years (range = 32–85); 81% had T3 disease, and 38% had comorbidities. Of 76 patients tested for mismatch-repair/microsatellite-instability (MMR/MSI), 13 (17%) were MMR-deficient/MSI-high; 46 (61%) MMR-proficient/MSI-low; and 17 (22%) unknown. Most patients (84%) had ≥12 nodes examined. Median Recurrence Score result was 20 (range = 1–77). Before assay, treatment recommendations were specified for 92 (79%) patients, with no recommendation for 24 (21%). Of the 92 with pre-assay recommendations, chemotherapy was planned for 52 (57%) and observation for 40 (43%); the assay changed recommendations for 27 (29%). Treatment intensity decreased for 18 (67%) and increased for nine (33%) patients; it was more likely to decrease for lower Recurrence Score values and increase for higher values (p < 0.001).
Conclusion:
For stage II colon cancer patients receiving Recurrence Score testing, 29% of treatment recommendations were changed. Use of the assay may lead to reductions in treatment intensity. Study limitations include retrospective design, data gathering during the first 2 years of assay availability only, and potential non-representativeness of respondents.
Transparency
Declaration of funding
The work described in this manuscript was funded by Genomic Health, Inc. The sponsor did not alter or influence the results of the study, which was conducted using clearly delineated analytic methods.
Declaration of financial/other relationships
MLee, ML, and CC are employees of Genomic Health, Inc. TC has no conflict of interest related to the conduct of the research described in this manuscript. TB, MB, and EC are employees of Partnership for Health Analytic Research, LLC, which was paid by Genomic Health, Inc. to conduct the research described in this manuscript. CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.
Acknowledgments
The authors thank Gordon H. Sun, MD, MS for critical review of the manuscript. This manuscript represents the original work of the authors, and all authors have contributed to the study and preparation of the manuscript. Parts of the results described in this manuscript were presented at the 2012 American Society of Clinical Oncology Annual Meeting (June 1–5, 2012; Chicago, IL; abstract published in J Clin Oncol 2012;30:[suppl; abstract 3626]) and at the 2012 Gastrointestinal Cancers Symposium (January 19–21, 2012; San Francisco, CA; abstract published in J Clin Oncol 2012;30:[suppl; abstract 398]).