The influence of 21-gene recurrence score assay on chemotherapy use in a population-based sample of breast cancer patients
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To quantify the influence of RS assay on changing chemotherapy plans in a general practice setting using causal inference methods.
We surveyed 3880 newly diagnosed breast cancer patients in Los Angeles and Georgia in 2013–14. We used inverse propensity weighting and multiple imputations to derive complete information for each patient about treatment status with and without testing.
A half of the 1545 women eligible for testing (ER+ or PR+, HER2−, and stage I–II) received RS. We estimate that 30% (95% confidence interval (CI) 10–49%) of patients would have changed their treatment selections after RS assay, with 10% (CI 0–20%) being encouraged to undergo chemotherapy and 20% (CI 10–30%) being discouraged from chemotherapy. The subgroups whose treatment selections would be changed the most by RS were patients with positive nodes (44%; CI 24–64%), larger tumor (43% for tumor size >2 cm; CI 23–62%), or younger age (41% for <50 years, CI 23–58%). The assay was associated with a net reduction in chemotherapy use by 10% (CI 4–16%). The reduction was much greater for women with positive nodes (31%; CI 21–41%), larger tumor (30% for tumor size >2 cm; CI 22–38%), or younger age (22% for <50 years; CI 9–35%).
RS substantially changed chemotherapy treatment selections with the largest influence among patients with less favorable pre-test prognosis. Whether this is optimal awaits the results of clinical trials addressing the utility of RS testing in selected subgroups.
KeywordsBreast cancer 21-gene recurrence score assay Chemotherapy Population studies
This work was supported by the National Cancer Institute (P01CA163233 to the University of Michigan). The collection of cancer incidence data used in this study was supported by the California Department of Public Health pursuant to California Health and Safety Code section 103885; Centers for Disease Control and Prevention’s (CDC) National Program of Cancer Registries, under cooperative agreement 5NU58DP003862-04/DP003862; the NCI’s Surveillance, Epidemiology and End Results Program under contract HHSN261201000140C awarded to the Cancer Prevention Institute of California, contract HHSN261201000035C awarded to the University of Southern California (USC), and contract HHSN261201000034C awarded to the Public Health Institute. The collection of cancer incidence data in Georgia was supported by contract HHSN261201300015I, Task Order HHSN26100006 from the NCI and cooperative agreement 5NU58DP003875-04-00 from the CDC. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript. The ideas and opinions expressed herein are those of the author(s) and endorsement by the State of California, Department of Public Health, the NCI, and the CDC or their Contractors and Subcontractors is not intended nor should be inferred. We thank Steve Shak MD and Genomic Health Inc. for collaboration on RS assay test linkage to the iCanCare data. We acknowledge the outstanding work of our project staff (Mackenzie Crawford, MPH and Kiyana Perrino, MPH from the Georgia Cancer Registry; Jennifer Zelaya, Pamela Lee, Maria Gaeta, Virginia Parker, BA, and Renee Bickerstaff-Magee from USC; Rebecca Morrison, MPH, Rachel Tocco, MA, Alexandra Jeanpierre, MPH, Stefanie Goodell, BS, and Rose Juhasz, PhD, from the University of Michigan). These people were compensated for their contributions to the work. We acknowledge with gratitude our survey respondents.
Compliance with ethical standards
Conflicts of interest
Allison Kurian has received research funding for work performed outside of the current study from Myriad Genetics, Invitae, Ambry Genetics, GenDx, and Genomic Health. The other authors have no conflicts of interest to disclose.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study. Consent was assumed when a completed survey was returned.
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