Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial

Albain, Kathy S.; Barlow, William E.; Shak, Steven; Hortobágyi, Gabriel N.; Livingston, Robert B.; Yeh, I‐Tien; Ravdin, Peter M.; Bugarini, Roberto; Baehner, Frederick L.; Davidson, Nancy E.; Sledge, George W.; Winer, Eric P.; Hudis, Clifford A.; Ingle, James N.; Perez, Edith A.; Pritchard, Kathleen I.; Shepherd, Lois E.; Gralow, Julie R.; Yoshizawa, Carl N.; Allred, D. Craig; Osborne, C. Kent; Hayes, Daniel F.

doi:10.1016/s1470-2045(09)70314-6

Cited by 1,261 publications

(1,062 citation statements)

References 29 publications

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“…Furthermore, the potential economic impact of the 21-gene expression assay in axillary-node-positive, estrogen-receptor-positive breast cancer continues to be a subject for future studies, based on the correlation between benefits of chemotherapy and results of the 21-gene expression assay in this clinical scenario. 35 In conclusion, requesting the 21-gene expression assay for Brazilian patients with axillary-node-negative, estrogenreceptor-positive breast cancer could reduce costs for third-party payers, conceivably optimizing use of resources for society and minimizing treatment toxicity for patients. This would especially be the case of patients with tumors size >2 cm, where cost savings are expected to be greater.…”

Section: Discussionmentioning

confidence: 99%

Potential economic impact of the 21-gene expression assay on the treatment of breast cancer in brazil

Bacchi¹,

Prisco²,

Carvalho³

et al. 2010

Rev. Assoc. Med. Bras.

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SummaryObjective. The 21-gene expression assay may support the decision regarding use of chemotherapy in early breast cancer. We sought to investigate the potential impact of incorporating the 21-gene expression assay into private practice in Brazil, from the perspective of third party payers. MethOds. We conducted a web-based survey with 30 (of a total of approximately 700) Brazilian medical oncologists, who were stratified by State according to the proportion of patients with breast cancer and private health insurance. We evaluated the possible treatment of first choice for patients with lymph-node-negative, estrogen-receptor-positive breast cancer, regardless of menopausal status. Interviewees were not aware of the objective of the study. Responses permitted a quantitative assessment of the care patterns regarding use of different chemotherapy regimens, type of premedication, use of growth factors, and use of intravenous antibiotics for febrile neutropenia. We calculated medication costs using the manufacturer's recommended prices. Other direct medical expenses, indirect medical costs, and non-medical costs were not included. Results. Considering a hypothetical cohort of 100 patients without access to the 21-gene expression assay, the survey showed that 84 patients would receive chemotherapy. Reclassifying patient eligibility for chemotherapy according to the 21-gene expression assay would lower this number to 49. For a hypothetical cohort of 100 patients with access to the test, US$ 79,361.43 would be saved in main direct medical costs. Such results, however, would greatly vary according to tumor size: the 21-gene expression assay could increase direct medical costs in T1 tumors, and decrease costs in cases with T >2 cm. cOnclusiOn. Considering the current price for the 21-gene expression assay in Brazil, our economic analysis suggests that such testing is an overall cost-saving, from the perspective of third party payers. Further, optimal use of resources would entail targeted use of the 21-gene expression assay.

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Section: Discussionmentioning

confidence: 99%

Potential economic impact of the 21-gene expression assay on the treatment of breast cancer in brazil

Bacchi¹,

Prisco²,

Carvalho³

et al. 2010

Rev. Assoc. Med. Bras.

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“…24,25 Furthermore, this 21 multigene assay is predictive of treatment response to endocrine therapy when the recurrence score is low and to chemotherapy when the recurrence score is high. 26,27 Proliferation-related genes receive the highest weighting in the algorithm and consequently make the greatest contribution to the determination of the recurrence score. Therefore, the test essentially differentiates good prognosis luminal A cases from poorer prognosis luminal B cases.…”

Section: Lp Feeley Et Almentioning

confidence: 99%

Distinguishing luminal breast cancer subtypes by Ki67, progesterone receptor or TP53 status provides prognostic information

et al. 2014

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The objectives of this study were to determine the prognostic significance of subgrouping estrogen receptor (ER)-positive breast tumors into low-and high-risk luminal categories using Ki67 index, TP53, or progesterone receptor (PR) status. The study group comprised 540 patients with lymph node negative, invasive breast carcinoma. Luminal A subtype was defined as being ER positive, HER2 negative, and Ki67 low (o14% cells positive) and luminal B subtype as being ER positive, HER2 negative, and Ki67 high (Z14% cells positive). Luminal tumors were also subgrouped into risk categories based on the PR and TP53 status. Survival analysis was performed. Patients with luminal B tumors (n ¼ 173) had significantly worse disease-free survival compared to those with luminal A tumors (n ¼ 186) (log rank P-value ¼ 0.0164; univariate Cox regression relative risk 2.00; 95% CI, 1.12-3.58; P ¼ 0.0187). Luminal subtype remained an independent prognostic indicator on multivariate analysis including traditional prognostic factors (relative risk 2.12; 95% CI, 1.16-3.88; P ¼ 0.0151). Using TP53 status or PR negativity rather than Ki67 to classify ER-positive luminal tumors gave similar outcome results to those obtained using the proliferation index. However, it was a combination of the three markers, which proved the most powerful prognostically. Ki67 index, TP53 status, or PR negativity can be used to segregate ERpositive, HER2-negative tumors into prognostically meaningful subgroups with significantly different clinical outcomes. These biomarkers particularly in combination may potentially be used clinically to guide patient management.

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“…It will also be helpful in future studies to compare PET parameters with other factors, such as gene expression signatures (Oncotype DX; Genomic Health Inc., Redwood City, Calif). 36 In conclusion, our current results indicate that PET parameters may help in predicting chemosensitivity of ERþ/HER2À breast cancer early during treatment. When they respond to neoadjuvant treatment, most of these tumors exhibit partial tumor shrinkage, and parameters like TLG provide higher predictive accuracy than SUV max measurements.…”

Section: Discussionmentioning

confidence: 54%

Estrogen receptor‐positive/human epidermal growth factor receptor 2‐negative breast tumors

Groheux

Hatt

Hindié

et al. 2013

Cancer

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BACKGROUND:The objective of this prospective study was to evaluate the ability of 18 F-fluorodeoxyglucose ( 18 F-FDG) positron emission tomography/computed tomography (PET/CT) to predict chemosensitivity in patients with estrogen receptor (ER)-positive/ human epidermal growth factor receptor 2 (HER2)-negative breast cancer. METHODS: Sixty-four consecutive patients underwent 18 F-FDG PET/CT scanning at baseline and after the second course of neoadjuvant chemotherapy (NAC). The evolution (D) between the 2 scans of image parameters (maximum standardized uptake value [SUV max ], SUV mean , metabolic tumor volume, and total lesion glycolysis [TLG]) was measured. Correlations between early changes in PET-derived parameters and pathologic response observed in surgical specimens after the completion of 8 courses of NAC were estimated with Mann-Whitney U tests. Response prediction on the basis of clinical data, histologic type, or molecular markers also was assessed (Fisher exact test). Receiver operating characteristic (ROC) analysis was used to compare the area under the curve (AUC) of each parameter. RESULTS: The best prediction of chemosensitivity was obtained with DTLG (À49% AE 31% in nonresponders vs À73% AE 25% in responders; P <.0001). Among the biologic parameters, only negative progesterone receptor status (57% responders vs 31% nonresponders; P ¼.04) and luminal B subtype (63% responders vs 22% nonresponders; P ¼.02) were predictive of a pathologic response. ROC analysis resulted in an AUC of 0.81, 0.73, 0.71, and 0.63 for DTLG, DSUV max , luminal subtype, and progesterone receptor status, respectively. CONCLUSIONS: When patients responded to NAC, the majority of ER-positive/HER2 negative tumors exhibited partial tumor shrinkage; and the PET parameters that combined volume and activity measurements, such as TLG, offered better accuracy for early prediction than the SUV max . Negative progesterone receptor status and luminal B subtype had weaker predictive power than PET-derived parameters. Cancer KEYWORDS: 18 F-fluorodeoxyglucose, positron emission tomography/computed tomography, maximum standardized uptake value, total lesion glycolysis, estrogen receptor-positive/human epidermal growth factor receptor 2 negative breast cancer, luminal tumor, neoadjuvant chemotherapy, metabolic response, pathologic response, chemosensitivity. INTRODUCTIONNeoadjuvant chemotherapy (NAC) is commonly offered to patients with locally advanced breast cancer and to women with primary operable but large breast cancer. This strategy allows more patients to undergo breast-conserving surgery and provides information on the efficacy of chemotherapy. Breast carcinoma is a heterogeneous class of tumors, and gene-expression profiling has led to the identification of 5 different subtypes with clinical implications (ie, luminal A, luminal B, basal-like, human epidermal growth factor receptor 2 [HER2]-like, and normal-like subtypes). 1 To some degree, these molecular subtypes can be distinguished using immunohistochemistry. 2 Estrogen receptor...

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Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial

Cited by 1,261 publications

References 29 publications

Potential economic impact of the 21-gene expression assay on the treatment of breast cancer in brazil

Potential economic impact of the 21-gene expression assay on the treatment of breast cancer in brazil

Distinguishing luminal breast cancer subtypes by Ki67, progesterone receptor or TP53 status provides prognostic information

Estrogen receptor‐positive/human epidermal growth factor receptor 2‐negative breast tumors

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