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Combined pathologic-genomic algorithm for early-stage breast cancer improves cost-effective use of the 21-gene recurrence score assay.

ABSTRACT: Background:The 21-gene recurrence score (RS) (Oncotype DX®; Genomic Health, Redwood City, CA) partitions hormone receptor positive, node negative breast cancers into three risk groups for recurrence. The Anne Arundel Medical Center (AAMC) model has previously been shown to accurately predict RS risk categories using standard pathology data. A pathologic-genomic (P-G) algorithm then is presented using the AAMC model and reserving the RS assay only for AAMC intermediate-risk patients. Patients and methods:A survival analysis was done using a prospectively collected institutional database of newly diagnosed invasive breast cancers that underwent RS assay testing from February 2005 to May 2015. Patients were assigned to risk categories based on the AAMC model. Using Kaplan-Meier methods, 5-year distant recurrence rates (DRR) were evaluated within each risk group and compared between AAMC and RS-defined risk groups. Five-year DRR were calculated for the P-G algorithm and compared with DRR for RS risk groups and the AAMC model's risk groups. Results:A total of 1268 cases were included. Five-year DRR were similar between the AAMC low-risk group (2.7%, n?=?322) and the RS??30 high-risk group (23.0%, n?=?141). Using the P-G algorithm, more patients were categorized as either low or high risk and the distant metastasis rate was 3.3% for the low-risk group (n?=?739) and 24.2% for the high-risk group (n?=?272). Using the P-G algorithm, 44% (552/1268) of patients would have avoided RS testing. Conclusions:AAMC model is capable of predicting 5-year recurrences in high- and low-risk groups similar to RS. Further, using the P-G algorithm, reserving RS for AAMC intermediate cases, results in larger low- and high-risk groups with similar prognostic accuracy. Thus, the P-G algorithm reliably identifies a significant portion of patients unlikely to benefit from RS assay and with improved ability to categorize risk.

SUBMITTER: Gage MM

PROVIDER: S-EPMC5961181 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Combined pathologic-genomic algorithm for early-stage breast cancer improves cost-effective use of the 21-gene recurrence score assay.

Gage M M MM Mylander W C WC Rosman M M Fujii T T Le Du F F Raghavendra A A Sinha A K AK Espinosa Fernandez J R JR James A A Ueno N T NT Tafra L L Jackson R S RS

Annals of oncology : official journal of the European Society for Medical Oncology 20180501 5

<h4>Background</h4>The 21-gene recurrence score (RS) (Oncotype DX®; Genomic Health, Redwood City, CA) partitions hormone receptor positive, node negative breast cancers into three risk groups for recurrence. The Anne Arundel Medical Center (AAMC) model has previously been shown to accurately predict RS risk categories using standard pathology data. A pathologic-genomic (P-G) algorithm then is presented using the AAMC model and reserving the RS assay only for AAMC intermediate-risk patients.<h4>P ...[more]

PMID: 29788166

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Project description:ImportanceThe 21-gene assay recurrence score is increasingly used to personalize treatment recommendations for systemic therapy in postmenopausal women with estrogen receptor (ER)- or progesterone receptor (PR)-positive, node-positive breast cancer; however, the relevance of the 21-gene assay to radiotherapy decisions remains uncertain.ObjectiveTo examine the association between recurrence score and locoregional recurrence (LRR) in a postmenopausal patient population treated with adjuvant chemotherapy followed by tamoxifen or tamoxifen alone.Design, setting, and participantsThis cohort study was a retrospective analysis of the Southwest Oncology Group S8814, a phase 3 randomized clinical trial of postmenopausal women with ER/PR-positive, node-positive breast cancer treated with tamoxifen alone, chemotherapy followed by tamoxifen, or concurrent tamoxifen and chemotherapy. Patients at North American clinical centers were enrolled from June 1989 to July 1995. Medical records from patients with recurrence score information were reviewed for LRR and radiotherapy use. Primary analysis included 316 patients and excluded 37 who received both mastectomy and radiotherapy, 9 who received breast-conserving surgery without documented radiotherapy, and 5 with unknown surgical type. All analyses were performed from January 22, 2016, to August 9, 2019.Main outcomes and measuresThe LRR was defined as a recurrence in the breast; chest wall; or axillary, infraclavicular, supraclavicular, or internal mammary lymph nodes. Time to LRR was tested with log-rank tests and Cox proportional hazards regression for multivariate models.ResultsThe final cohort of this study comprised 316 women with a mean (range) age of 60.4 (44-81) years. Median (interquartile range) follow-up for those without LRR was 8.7 (7.0-10.2) years. Seven LRR events (5.8%) among 121 patients with low recurrence score and 27 LRR events (13.8%) among 195 patients with intermediate or high recurrence score occurred. The estimated 10-year cumulative incidence rates were 9.7% for those with a low recurrence score and 16.5% for the group with intermediate or high recurrence score (P = .02). Among patients who had a mastectomy without radiotherapy (n = 252), the differences in the 10-year actuarial LRR rates remained significant: 7.7 % for the low recurrence score group vs 16.8% for the intermediate or high recurrence score group (P = .03). A multivariable model controlling for randomized treatment, number of positive nodes, and surgical type showed that a higher recurrence score was prognostic for LRR (hazard ratio [HR], 2.36; 95% CI, 1.02-5.45; P = .04). In a subset analysis of patients with a mastectomy and 1 to 3 involved nodes who did not receive radiation therapy, the group with a low recurrence score had a 1.5% rate of LRR, whereas the group with an intermediate or high recurrence score had a 11.1% LRR (P = .051).Conclusions and relevanceThis study found that higher recurrence scores were associated with increased LRR after adjustment for treatment, type of surgical procedure, and number of positive nodes. This finding suggests that the recurrence score may be used, along with accepted clinical variables, to assess the risk of LRR during radiotherapy decision-making.

Project description:BackgroundDrivers behind the adoption of gene expression profiling in breast cancer oncology have been shown to include exposure to physician colleagues' use of a given genomic test. We examined adoption of the Oncotype DX 21-gene breast cancer recurrence score assay (ODX) in the United States after its incorporation into clinical guidelines. The influence of patient-sharing ties and co-location with prior adopters and the role of these potential exposures across medical specialties on peers' adoption of the test were examined.MethodsWe conducted a retrospective cohort study of women with incident breast cancer using a 100% sample of fee-for-service Medicare enrollee claims over 2008-2011. Peer networks connecting medical oncologists and surgeons treating these patients were constructed using patient-sharing and geographic co-location. The impact of peer connections on the adoption of ODX by physicians and testing of patients was modeled with multivariable hierarchical regression.ResultsAltogether, 156,229 women identified with incident breast cancer met criteria for cohort inclusion. A total of 7689 ODX prescribing physicians were identified. Co-location with medical oncologists who adopted the test in the early period (2008-2009) was associated with a 1.38-fold increase in the odds of a medical oncologist adopting ODX in 2010-2011 (95% CI = 1.04-1.83), as was co-location with early-adopting surgeons (odds ratio [OR] = 1.25, 95% CI = 1.00-1.58). Patients whose primary medical oncologist was linked to an early-adopting surgeon through co-location (OR = 1.17, 95% CI = 1.04-1.32) or both patient-sharing and co-location (OR = 1.17, 95% CI = 1.03-1.34) were more likely to receive ODX.ConclusionsExposure to surgeon early adopters through peer networks and co-location was predictive of ODX uptake by medical oncologists and testing of patients. Interventions focused on the role of surgeons in molecular testing may improve the implementation of best practices in breast cancer care.

Dataset Information

Combined pathologic-genomic algorithm for early-stage breast cancer improves cost-effective use of the 21-gene recurrence score assay.

Publications

Combined pathologic-genomic algorithm for early-stage breast cancer improves cost-effective use of the 21-gene recurrence score assay.

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