Impact of a Commercial Reference Laboratory Test Recurrence Score on Decision Making in Early-Stage Breast Cancer

Abstract

Purpose: To investigate whether recurrence score (RS) as determined using a commercial reference laboratory test influences clinicians' treatment recommendations and eventual treatment in patients with early-stage breast cancer. Methods:A retrospective analysis was performed on 74 patients from a community-based oncology practice with estrogen receptor (ER) -positive, lymph node (LN) -negative stage I or II breast cancer for which RS was obtained. Demographic and pathology information was extracted from medical records. Tenyear relapse-free survival was calculated using Adjuvant! Online. Treatment recommendations before the RS knowledge were compared with treatment recommendations after RS knowledge and to the treatment eventually administered. Results and Conclusion:A weak correlation was found between RS and both patient age and tumor size, modest correlation between RS and tumor grade, and modest correlation between RS and 10-year recurrence as determined by Adjuvant! Online. For 21% and 25% of patients, knowledge of the RS changed the clinicians' treatment recommendations and eventual treatment, respectively. The decision to change from hormone therapy to chemotherapy (with or without hormone therapy) was generally associated with high RS (high distant recurrence risk as determined by the commercial reference laboratory test), whereas the decision to change from chemotherapy to hormone therapy was generally associated with low RS (low distant recurrence risk as determined by the commercial reference laboratory test). Knowledge of the RS changed treatment recommendations and eventual treatment in patients with ER-positive/LN-negative early-stage breast cancer. Use of genomic-based prognosis may result in more accurate estimates of true recurrence risk than currently possible with commonly used prognostic factors (such as patient age, tumor size, and tumor grade) alone and thus lead to an increase in appropriate adjuvant therapy decision making.

The Effect of Oncotype DX Recurrence Score on Treatment Recommendations for Patients with Estrogen Receptor–Positive Early Stage Breast Cancer and Correlation with Estimation of Recurrence Risk by Breast Cancer Specialists

“…Several other studies have similarly determined RS changes adjuvant treatment recommendations by 18%-44% [25][26][27][28][29]. Moreover, the most common change in recommendations was from chemotherapy plus hormonal therapy to hormonal therapy alone.…”

A study of the impact of the 21‐gene breast cancer assay on the use of adjuvant chemotherapy in women with breast cancer in a Mexican public hospital

“…In this cohort 46 (48%) results were categorized as Low risk (<18), 30 (31%) were Intermediate risk (18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30), and 20 (21%) had High risk (!31) results (Table II). A sizable proportion of both N0 and Nþ patients were classified as Low risk.…”

“…Multiple studies have shown that use of the Oncotype DX Breast Cancer Assay affects treatment recommendations [14][15][16][17][18][19][20][21][22][23][24][25][26]. These studies demonstrated that analysis of treatment decisions before and after receipt of Recurrence Score information showed approximately a 30% decrease in chemotherapy recommendations [27].…”

Testing personalized medicine: patient and physician expectations of next-generation genomic sequencing in late-stage cancer care

“…In the context of personalized cancer care, much of the extant literature explores gene-expression profiling in the adjuvant and neo-adjuvant breast cancer setting (eg, Oncotype DX, Mammaprint). [17][18][19][20] Findings from this literature point to broad enthusiasm about the potential to 'personalize' care 17,21,22 and reduce uncertainty. 20,23 There is also, however, some evidence of patient confusion regarding the meaning of test results (eg, whether germline or somatic variants are identified).…”