21-Gene recurrence score and locoregional recurrence in lymph node-negative, estrogen receptor-positive breast cancer

1525 Background: The objective of this study was to incorporate evidence from two recently-published studies to reevaluate the cost-effectiveness of the 21-gene Recurrence Score (RS) assay (Oncotype DX) in the context of multifactorial decision making to guide the use of chemotherapy for node-negative, estrogen receptor–positive breast cancer in the United States from the societal and healthcare system perspectives. Methods: We developed a decision-analytic model to first cross-classify hypothetical patients by clinicopathologic characteristics according to the Adjuvant! using risk groups and RS risk groups. We generated estimates of long-term costs, survival, and quality-adjusted survival for the RS-guided and non–RS-guided strategies using a probabilistic state transition model. In addition to costs for the 21-gene assay, we assigned attributable costs for chemotherapy, hormonal therapy, monitoring for disease recurrence, and distant recurrence. For the societal perspective, we also considered incremental patient time costs. Costs and survival were discounted at 3% annually. Results: With the RS-guided strategy, 40.4% of patients were expected to receive chemotherapy relative to 47.3% in the non–RS-guided strategy. Targeted use of chemotherapy in the RS-guided strategy was expected to increase survival by 0.19 years (95% CI, 0.09 to 0.32) and 0.16 QALYs (95% CI, 0.08 to 0.28). Lifetime direct medical costs were expected to be $2692 (95% CI, 1546 to 3821) higher with the RS-guided strategy. The incremental cost-effectiveness ratios (ICERs) were $14,059 per life-year saved (95% CI, $6840-$28,912) and $16,677 per QALY (95% CI, $7613-$37,219). When incorporating lower indirect costs of $950 per patient, the ICERs were $9095 per life-year saved (95% CI, dominant-$23,397) and $10,788 per QALY (95% CI, $6840-$30,265). In probabilistic sensitivity analysis, more than 99% of the ICERs were less than $50,000 per life-year saved and per QALY. Conclusions: Our updated cost-effectiveness estimates are supportive of the economic value of the 21-gene RS assay in the setting of node-negative, estrogen receptor–positive breast cancer.

Download Full-text

Can Features Evaluated in the Routine Pathologic Assessment of Lymph Node–Negative Estrogen Receptor–Positive Stage I or II Invasive Breast Cancer Be Used to Predict the Oncotype DX Recurrence Score?

Archives of Pathology & Laboratory Medicine ◽

10.5858/2009-0439-oar.1 ◽

2010 ◽

Vol 134 (11) ◽

pp. 1697-1701

Author(s):

Jena Auerbach ◽

Mimi Kim ◽

Susan Fineberg

Keyword(s):

Breast Cancer ◽

Estrogen Receptor ◽

Lymph Node ◽

Invasive Breast Cancer ◽

Recurrence Score ◽

Mitotic Count ◽

Oncotype Dx ◽

Node Negative ◽

Estrogen Receptor Positive ◽

Pathologic Assessment

Abstract Context.—Oncotype DX is a multigene reverse transcription–polymerase chain reaction assay used to quantify recurrence risk in patients with stage I or II estrogen receptor–positive, lymph node–negative invasive breast cancer. The results are reported as a Recurrence Score (RS). The 16 cancer genes evaluated include a proliferation set, hormone receptor set, and HER2 set. The activity of these genes is addressed by pathologic assessment of breast cancers. Objective.—To determine if factors evaluated in pathologic evaluation of breast cancer could be used to predict Oncotype DX results. Design.—We studied 138 cases of invasive breast cancer for which Oncotype DX results and pathology data were available. Grading was performed by using Nottingham grading system. For hormone receptor immunostaining, 10% nuclear staining was considered a positive result. Results.—Oncotype DX RS was low in 81 cases, intermediate in 44 cases, and high in 13 cases. All 6 cases with both a negative progesterone receptor (PR) and a mitotic count score of 3 had a high RS. All 12 cases with both a negative PR and a mitotic count score greater than 1 had either an intermediate or high RS. Although Nottingham grade, PR status, mitotic count score, tumor size, and nuclear grade were each significantly associated with RS, in bivariate analyses the only variables that remained independently predictive of an intermediate or high RS score in a multivariate logistic regression model were negative PR and mitotic count score greater than 1. Conclusions.—Our study suggests that a mitotic count score greater than 1 combined with a negative PR result, as determined by pathologic assessment, could serve as a marker for an intermediate or high Oncotype DX RS.

Download Full-text

Association Between the 21-Gene Recurrence Score Assay and Risk of Locoregional Recurrence in Node-Negative, Estrogen Receptor–Positive Breast Cancer: Results From NSABP B-14 and NSABP B-20

Journal of Clinical Oncology ◽

10.1200/jco.2009.23.7610 ◽

2010 ◽

Vol 28 (10) ◽

pp. 1677-1683 ◽

Cited By ~ 383

Author(s):

Eleftherios P. Mamounas ◽

Gong Tang ◽

Bernard Fisher ◽

Soonmyung Paik ◽

Steven Shak ◽

...

Keyword(s):

Breast Cancer ◽

Estrogen Receptor ◽

Locoregional Recurrence ◽

Recurrence Score ◽

Distant Recurrence ◽

Locoregional Therapy ◽

Second Primary ◽

Node Negative ◽

Er Positive ◽

Positive Breast Cancer

Purpose The 21-gene OncotypeDX recurrence score (RS) assay quantifies the risk of distant recurrence in tamoxifen-treated patients with node-negative, estrogen receptor (ER)–positive breast cancer. We investigated the association between RS and risk for locoregional recurrence (LRR) in patients with node-negative, ER-positive breast cancer from two National Surgical Adjuvant Breast and Bowel Project (NSABP) trials (NSABP B-14 and B-20). Patients and Methods RS was available for 895 tamoxifen-treated patients (from both trials), 355 placebo-treated patients (from B-14), and 424 chemotherapy plus tamoxifen-treated patients (from B-20). The primary end point was time to first LRR. Distant metastases, second primary cancers, and deaths before LRR were censored. Results In tamoxifen-treated patients, LRR was significantly associated with RS risk groups (P < .001). The 10-year Kaplan-Meier estimate of LRR was 4.% (95% CI, 2.3% to 6.3%) for patients with a low RS (< 18), 7.2% (95% CI, 3.4% to 11.0%) for those with intermediate RS (18-30), and 15.8% (95% CI, 10.4% to 21.2%) for those with a high RS (> 30). There were also significant associations between RS and LRR in placebo-treated patients from B-14 (P = .022) and in chemotherapy plus tamoxifen–treated patients from B-20 (P = .028). In multivariate analysis, RS was an independent significant predictor of LRR along with age and type of initial treatment. Conclusion Similar to the association between RS and risk for distant recurrence, a significant association exists between RS and risk for LRR. This information has biologic consequences and potential clinical implications relative to locoregional therapy decisions for patients with node-negative and ER-positive breast cancer.

Download Full-text

Re: Tamoxifen and Chemotherapy for Lymph Node-Negative, Estrogen Receptor-Positive Breast Cancer

JNCI Journal of the National Cancer Institute ◽

10.1093/jnci/90.6.468 ◽

1998 ◽

Vol 90 (6) ◽

pp. 468-468

Author(s):

Carl D. Atkins

Keyword(s):

Breast Cancer ◽

Estrogen Receptor ◽

Lymph Node ◽

Node Negative ◽

Estrogen Receptor Positive ◽

Positive Breast Cancer

Download Full-text

The financial burden of using Oncotype Dx for patients with lymph node-negative and estrogen receptor-positive breast cancer in Australia

Asia-Pacific Journal of Clinical Oncology ◽

10.1111/ajco.12077 ◽

2013 ◽

Vol 10 (1) ◽

pp. 94-95 ◽

Cited By ~ 3

Author(s):

Shinichiro Sakata ◽

Michelle Cronk

Keyword(s):

Breast Cancer ◽

Estrogen Receptor ◽

Lymph Node ◽

Financial Burden ◽

Oncotype Dx ◽

Node Negative ◽

Estrogen Receptor Positive ◽

Positive Breast Cancer

Download Full-text

Cost-benefit of recurrence score–guided treatment using an Oncotype DX 21-gene assay: A single institution analysis.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.26_suppl.29 ◽

2013 ◽

Vol 31 (26_suppl) ◽

pp. 29-29

Author(s):

Kamal Kant Singh Abbi ◽

Nauman Shahid ◽

Muhammad Khurram Hameed ◽

Brian Fink ◽

Colette Gaba ◽

...

Keyword(s):

Breast Cancer ◽

Estrogen Receptor ◽

Lymph Node ◽

Early Stage ◽

Recurrence Score ◽

Cost Benefit ◽

Node Negative ◽

Gene Assay ◽

Estrogen Receptor Positive ◽

The Cost

29 Background: In 2010 the National Comprehensive Cancer Network recommended a 21-gene assay recurrence score (RS) to aid in the adjuvant treatment decision among patients with estrogen receptor positive, lymph node negative early stage breast cancer. Early-decision impact studies show that the RS can reduce overall chemotherapy use by 27%. This study was performed to assess the cost-benefit of the test for the patients diagnosed and treated an academic institute before 2010. Methods: Data from early breast cancer estrogen-receptor–positive and lymph-node–negative patients (n = 87), who were diagnosed and treated at our center from 2004-2010 were analyzed. All patients had the 21-gene recurrence test done to guide in their management. Cost of chemotherapy, adverse effects, and supportive care costs were calculated from previously published articles. Results: 66 patients with stage I breast cancer and 21 patients with stage II were analyzed. All but one patient had a tumor size more than 5mm. In total, 27 patients received chemotherapy. Characteristics of patients receiving chemotherapy are shown in the table. Cost of 21 gene recurrence score assay was $4,000. Savings for each patient who did not receive chemotherapy was $21,715 after accounting for cost of the test. The total savings for 60 patients who did not receive chemotherapy was $1,302,900. Conclusions: Use of the 21-gene assay in patients with early stage lymph node negative breast cancer improves health outcomes by avoiding chemotherapy-related adverse events. It also appears to add no incremental costs. This study emphasizes the cost-saving potential of the Oncotype Dx 21 gene assay. [Table: see text]

Download Full-text