Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision Making for Early-Stage, Operable Breast Cancer: Update of the ASCO Endorsement of the Cancer Care Ontario Guideline

2019 ◽  
Vol 37 (22) ◽  
pp. 1965-1977 ◽  
Author(s):  
N. Lynn Henry ◽  
Mark R. Somerfield ◽  
Vandana G. Abramson ◽  
Nofisat Ismaila ◽  
Kimberly H. Allison ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Decision Making ◽  
Lymph Node ◽  
Systemic Therapy ◽  
Early Stage ◽  
Positive Lymph Node ◽  
Adjuvant Systemic Therapy ◽  
Node Negative ◽  
Therapy Decision ◽  
Chemoendocrine Therapy

PURPOSE To update the American Society of Clinical Oncology endorsement of the Cancer Care Ontario recommendations on the Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision Making for Early-Stage, Operable Breast Cancer. METHODS Two phase III trials—the Trial Assigning Individualized Options for Treatment (TAILORx) in women with hormone receptor–positive, node-negative tumors and the Microarray in Node-Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy (MINDACT) trial—provided the evidence for this update. UPDATED RECOMMENDATIONS Shared decision making between clinicians and patients is appropriate for adjuvant systemic therapy for breast cancer. For patients older than age 50 years and whose tumors have Onco type DX recurrence scores less than 26, and for patients age 50 years or younger whose tumors have Onco type DX recurrence scores less than 16, there is little to no benefit from chemotherapy. Clinicians may offer endocrine therapy alone for these patients. For patients age 50 years or younger with recurrence scores of 16 to 25, clinicians may offer chemoendocrine therapy. Patients with recurrence scores greater than 30 should be considered candidates for chemoendocrine therapy. Based on informal consensus, the Panel recommends that oncologists may offer chemoendocrine therapy to patients with Onco type DX scores of 26 to 30. The MammaPrint assay could be used to guide decisions on withholding adjuvant systemic chemotherapy in patients with hormone receptor–positive lymph node–negative breast cancer and in select patients with lymph node–positive cancers. In both patients with node-positive and node-negative disease, evidence of clinical utility of the MammaPrint assay was only apparent in those determined to be at high clinical risk; the Panel thus did not recommend use of MammaPrint assay in patients determined to be at low clinical risk. Remaining recommendations from the 2016 ASCO guideline endorsement are unchanged. Additional information is available at www.asco.org/breast-cancer-guidelines .

scholarly journals Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update

2017 ◽  
Vol 35 (24) ◽  
pp. 2838-2847 ◽  
Author(s):  
Ian Krop ◽  
Nofisat Ismaila ◽  
Fabrice Andre ◽  
Robert C. Bast ◽  
William Barlow ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Systemic Therapy ◽  
Hormone Receptor ◽  
Early Stage ◽  
Adjuvant Systemic Therapy ◽  
Node Negative ◽  
Clinical Risk ◽  
Hormone Receptor Positive ◽  
High Clinical Risk ◽  
Positive Breast Cancer

Purpose This focused update addresses the use of MammaPrint (Agendia, Irvine, CA) to guide decisions on the use of adjuvant systemic therapy. Methods ASCO uses a signals approach to facilitate guideline updates. For this focused update, the publication of the phase III randomized MINDACT (Microarray in Node-Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy) study to evaluate the MammaPrint assay in 6,693 women with early-stage breast cancer provided a signal. An expert panel reviewed the results of the MINDACT study along with other published literature on the MammaPrint assay to assess for evidence of clinical utility. Recommendations If a patient has hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative, node-negative breast cancer, the MammaPrint assay may be used in those with high clinical risk to inform decisions on withholding adjuvant systemic chemotherapy due to its ability to identify a good-prognosis population with potentially limited chemotherapy benefit. Women in the low clinical risk category did not benefit from chemotherapy regardless of genomic MammaPrint risk group. Therefore, the MammaPrint assay does not have clinical utility in such patients. If a patient has hormone receptor–positive, HER2-negative, node-positive breast cancer, the MammaPrint assay may be used in patients with one to three positive nodes and a high clinical risk to inform decisions on withholding adjuvant systemic chemotherapy. However, such patients should be informed that a benefit from chemotherapy cannot be excluded, particularly in patients with greater than one involved lymph node. The clinician should not use the MammaPrint assay to guide decisions on adjuvant systemic therapy in patients with hormone receptor–positive, HER2-negative, node-positive breast cancer at low clinical risk, nor any patient with HER2-positive or triple-negative breast cancer, because of the lack of definitive data in these populations. Additional information can be found at www.asco.org/breast-cancer-guidelines and www.asco.org/guidelineswiki .

Recurrence Score across the age spectrum: Is there an age discrimination?

2013 ◽  
Vol 31 (26_suppl) ◽  
pp. 27-27
Author(s):  
Franz Omar Smith ◽  
Marie Catherine Lee ◽  
Geza Acs ◽  
William J. Fulp ◽  
Ji-Hyun Lee ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Lymph Node ◽  
Treatment Planning ◽  
Tumor Size ◽  
Predictive Power ◽  
Early Stage ◽  
Recurrence Score ◽  
Positive Lymph Node ◽  
Node Negative

27 Background: Treatment planning for early-stage estrogen receptor (ER) positive, lymph node negative breast cancer was based on prognostic factors with limited predictive power such as age. The Recurrence Score (RS) from the Oncotype DX assay (ODX) provides predictive power transcending age but is rarely applied to the elderly or young patients (pts). We examined our experience with RS along the age continuum. Methods: Retrospective review was conducted of prospectively gathered breast cancer pts having a RS obtained as part of their cancer care. Eligibility for performance of the ODX was based on NCCN guidelines or physician discretion. Comparisons on RS were made by age groups (young: <45yrs; middle: >45yrs -<70yrs: elderly: >70yrs) using general linear regression model and the exact Wilcoxon Rank Sum Test. Results: 677pts had 681 tumors with RS available (89 young, 476 middle and 112 elderly pts). Median RS for the study pts was 17 (range 0-85) and 16, 17, and 15 for the young, middle, and elderly respectively. Median age was 58yrs (range: 27-95); young, middle, and elderly was 42, 58, and 74yrs respectively. Age as a continuous or categorical variable was not predictive of RS (p value = 0.38, 0.58 respectively). No significant differences were seen between age cohorts for histology, mitotic rate, lymphovascular invasion (LVI), grade, nodal status, stage, or strength of ER positivity. Mastectomy rates were higher in the young (57.5%), compared to the middle (42.5%) and elderly (39.6%) (p=0.02). Median invasive tumor size was 1.6, 1.5, and 1.5cm for young, middle, and elderly. Larger tumor size, as a continuous variable, equaled higher RS (p=0.046). Other significant factors predicting higher RS were increased mitosis (p<0.001), LVI (p=0.013), high grade (p<0.001), and weak (<10%) ER positivity (p<0.001). Nodal status, stage, and histology did not affect RS. Conclusions: Age has limited predictive power for treatment planning for breast cancer. Age alone should not preclude recommendations for performance of ODX in estrogen receptor positive lymph node negative early stage breast cancer as the RS distribution across the spectrum of age is well matched.

scholarly journals Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: ASCO Clinical Practice Guideline Update—Integration of Results From TAILORx

2019 ◽  
Vol 37 (22) ◽  
pp. 1956-1964 ◽  
Author(s):  
Fabrice Andre ◽  
Nofisat Ismaila ◽  
N. Lynn Henry ◽  
Mark R. Somerfield ◽  
Robert C. Bast ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Endocrine Therapy ◽  
Systemic Therapy ◽  
Early Stage ◽  
Disease Free Survival ◽  
Invasive Disease ◽  
Axillary Node ◽  
Adjuvant Systemic Therapy ◽  
Additional Information ◽  
Chemoendocrine Therapy

PURPOSE This focused update addresses the use of Onco type DX in guiding decisions on the use of adjuvant systemic therapy. METHODS ASCO uses a signals approach to facilitate guideline updating. For this focused update, the publication of the Trial Assigning Individualized Options for Treatment (TAILORx) evaluating noninferiority of endocrine therapy alone versus chemoendocrine therapy for invasive disease–free survival in women with Onco type DX scores provided a signal. An expert panel reviewed the results of TAILORx along with other published literature on the Onco type DX assay to assess for evidence of clinical utility. UPDATED RECOMMENDATIONS For patients with hormone receptor–positive, axillary node–negative breast cancer whose tumors have Onco type DX recurrence scores of less than 26, there is little to no benefit from chemotherapy, especially for patients older than age 50 years. Clinicians may recommend endocrine therapy alone for women older than age 50 years. For patients 50 years of age or younger with recurrence scores of 16 to 25, clinicians may offer chemoendocrine therapy. Patients with recurrence scores greater than 30 should be considered candidates for chemoendocrine therapy. Based on informal consensus, the panel recommends that oncologists may offer chemoendocrine therapy to these patients with recurrence scores of 26 to 30. Additional information can be found at www.asco.org/breast-cancer-guidelines .

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