Abstract
Background:International guidelines, including NICE, recommend using the 21-gene Recurrence Score assay for guiding adjuvant treatment decisions in ER+, HER2-negative early breast cancer (BC). We investigated the impact of adding this assay to standard pathological tests on clinicians'/patients' treatment decisions and on patients' decisional conflict in the United Kingdom.Methods:In this prospective multicentre study, eligibility criteria included: ER+ HER2-negative BC (N0/Nmic for patients ⩽50 years; ⩽3 positive lymph nodes for patients >50 years) and being fit for chemotherapy. Physicians'/patients' treatment choices and patients' decisional conflict were recorded pre- and post testing.Results:The analysis included 137 patients. Overall, adjuvant treatment recommendations changed in 40.7% of patients, with the direction of the change consistent with the Recurrence Score results (net decrease in chemotherapy recommendation rate in low Recurrence Score patients and net increase in high Recurrence Score patients). Patients' choices were generally consistent with physicians' recommendations. Post-testing, patients' decisional conflict decreased significantly (P<0.0001). In the 67 patients meeting the NICE criteria for testing, the recommendation change rate was 49.3%.Conclusions:Recurrence Score testing significantly influenced treatment recommendations overall and in the subgroup of patients meeting the NICE criteria, suggesting that this test could substantially alter treatment patterns in the United Kingdom.
Highlights
International guidelines, including National Institute for Health and Care Excellence (NICE), recommend using the 21-gene Recurrence Score assay for guiding adjuvant treatment decisions in ER þ, HER2-negative early breast cancer (BC)
Adjuvant treatment recommendations changed in 40.7% of patients, with the direction of the change consistent with the Recurrence Score results
The 21-gene Recurrence Score assay (Oncotype DX, Genomic Health, Inc., Redwood City, CA, USA) is a validated real-time reverse transcription PCR (RT–PCR) assay that provides prognostic (10-year risk of distant recurrence) and predictive information for patients with ER þ HER2 À early-stage invasive breast cancer treated with endocrine therapy (Paik et al, 2004; Habel et al, 2006; Paik et al, 2006; Goldstein et al, 2008; Albain et al, 2010; Dowsett et al, 2010; Toi et al, 2010; Mamounas et al, 2012; Sparano et al, 2015)
Summary
In this prospective multicentre study, eligibility criteria included: ER þ HER2-negative BC (N0/Nmic for patients p50 years; p3 positive lymph nodes for patients 450 years) and being fit for chemotherapy. All patients discussed at the post-surgical multidisciplinary team meeting at their respective institutions, who met the eligibility criteria and were suitable to receive chemotherapy as part of their adjuvant therapy were offered entry into the study. Once the Recurrence Score results became available, patients had a second consultation with the same oncologist to discuss the results and decide on adjuvant treatment. At both consultations, the patient and the oncologist independently completed a questionnaire (patients: decisional conflict scale (DCS) questionnaire; oncologists: confidence in treatment decisions) (O’Connor, 1993; Holt et al, 2013)
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