To update recommendations on appropriate use of breast cancer biomarker assay results to guide adjuvant endocrine and chemotherapy decisions in early-stage breast cancer.
An updated literature search ...identified randomized clinical trials and prospective-retrospective studies published from January 2016 to October 2021. Outcomes of interest included overall survival and disease-free or recurrence-free survival. Expert Panel members used informal consensus to develop evidence-based recommendations.
The search identified 24 studies informing the evidence base.
Clinicians may use Onco
DX, MammaPrint, Breast Cancer Index (BCI), and EndoPredict to guide adjuvant endocrine and chemotherapy in patients who are postmenopausal or age > 50 years with early-stage estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative (ER+ and HER2-) breast cancer that is node-negative or with 1-3 positive nodes. Prosigna and BCI may be used in postmenopausal patients with node-negative ER+ and HER2- breast cancer. In premenopausal patients, clinicians may use Onco
in patients with node-negative ER+ and HER2- breast cancer. Current data suggest that premenopausal patients with 1-3 positive nodes benefit from chemotherapy regardless of genomic assay result. There are no data on use of genomic tests to guide adjuvant chemotherapy in patients with ≥ 4 positive nodes. Ki67 combined with other parameters or immunohistochemistry 4 score may be used in postmenopausal patients without access to genomic tests to guide adjuvant therapy decisions. BCI may be offered to patients with 0-3 positive nodes who received 5 years of endocrine therapy without evidence of recurrence to guide decisions about extended endocrine therapy. None of the assays are recommended for treatment guidance in individuals with HER2-positive or triple-negative breast cancer. Treatment decisions should also consider disease stage, comorbidities, and patient preferences.Additional information is available at www.asco.org/breast-cancer-guidelines.
This focused update addresses the use of Onco
DX in guiding decisions on the use of adjuvant systemic therapy.
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
DX scores provided a signal. An expert panel reviewed the results of TAILORx along with other published literature on the Onco
DX assay to assess for evidence of clinical utility.
For patients with hormone receptor-positive, axillary node-negative breast cancer whose tumors have Onco
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.
To provide recommendations on appropriate use of breast tumor biomarker assay results to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer.
A literature ...search and prospectively defined study selection sought systematic reviews, meta-analyses, randomized controlled trials, prospective-retrospective studies, and prospective comparative observational studies published from 2006 through 2014. Outcomes of interest included overall survival and disease-free or recurrence-free survival. Expert panel members used informal consensus to develop evidence-based guideline recommendations.
The literature search identified 50 relevant studies. One randomized clinical trial and 18 prospective-retrospective studies were found to have evaluated the clinical utility, as defined by the guideline, of specific biomarkers for guiding decisions on the need for adjuvant systemic therapy. No studies that met guideline criteria for clinical utility were found to guide choice of specific treatments or regimens.
In addition to estrogen and progesterone receptors and human epidermal growth factor receptor 2, the panel found sufficient evidence of clinical utility for the biomarker assays Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, and urokinase plasminogen activator and plasminogen activator inhibitor type 1 in specific subgroups of breast cancer. No biomarker except for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 was found to guide choices of specific treatment regimens. Treatment decisions should also consider disease stage, comorbidities, and patient preferences.
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 .
Background
Of the nearly 50,000 women in the United States who undergo treatment for ductal carcinoma in situ (DCIS) annually, many may not benefit from treatment. To better understand the impact of ...a DCIS diagnosis, patients self‐identified as having had DCIS were engaged regarding their experience.
Methods
In July 2014, a web‐based survey was administered through the Susan Love Army of Women breast cancer listserv. The survey included open‐ended questions designed to assess patients' perspectives about DCIS diagnosis and treatment. Deductive and inductive codes were applied to the responses; common themes were summarized.
Results
Among the 1832 women included in the analytic sample, the median age at diagnosis was 60 years. Four primary themes were identified: 1) uncertainty surrounding a DCIS diagnosis, 2) uncertainty about DCIS treatment, 3) concern about treatment side effects, and 4) concern about recurrence and/or developing invasive breast cancer. When diagnosed, participants were often uncertain about whether they had cancer or not and whether they should be considered a “survivor.” Uncertainty about treatment manifested as questioning the appropriateness of the amount of treatment received. Participants expressed concern about the “cancer spreading” or becoming invasive and that they were not necessarily “doing enough” to prevent recurrence.
Conclusions
In a large, national sample, participants with a history of DCIS reported confusion and concern about the diagnosis and treatment, which caused worry and significant uncertainty. Developing strategies to improve patient and provider communications regarding the nature of DCIS and acknowledging gaps in the current knowledge of management options should be a priority.
Ductal carcinoma in situ (DCIS) survivors often report feelings of uncertainty and concern about their diagnosis and treatment. Developing strategies to improve communication regarding the nature of DCIS as well as the potential benefits and harms of different DCIS management options should be a priority.
Abstract
Modern medical costs fall beyond most peoples' ability to pay and cause severe adverse effects that impact patients and families. It is time to team up with all stakeholders to provide ...solutions to systemic issues that thwart oncology's true goal to help patients survive their care and their cancer. Patients need realistic approaches that include (1) access to affordable treatments, (2) accountability and oversight toward patient costs and results in research, and (3) cost-effective drug supply once commercialized. Physicians play a critical role helping patients develop a plan that fits each person's medical, financial, and life situation.
Background
Audio recordings of oncology clinic discussions can help patients retain and understand information about their disease and treatment decisions. Access to this tool relies on acceptance of ...recordings by oncologists. This is the first study to evaluate experience and attitudes of oncologists toward patients recording clinic visits.
Methods
Medical, radiation, and surgical oncologists from 5 US cancer centers and community affiliates were surveyed to evaluate clinicians' experience, beliefs, and practices regarding patient‐initiated recordings.
Results
Among 360 oncologists (69% response rate), virtually all (93%) have experienced patients seeking to record visits. Although 75% are comfortable with recording, 25% are uncomfortable and 56% report concerns ranging from less thorough discussions to legal liability. Most (85%) always agree when patients ask to record, but 15% never or selectively allow recording. Although 51% believe recording is positive for the patient‐physician relationship, a sizable minority report that it can lead to less detailed conversations (28%) or avoidance of difficult topics, including prognosis (33%). Views did not vary based on subspecialty, practice setting, or geographic region, but older age and years in practice were associated with more positive views of recording. The majority of clinicians (72%) desire institutional policies to govern guidelines about recordings.
Conclusions
Most oncologists are comfortable with patient requests to record visits, but a sizable minority remain uncomfortable, and access to recording varies solely on physician preference. This difference in care delivery may benefit from institutional policies that promote access while addressing legitimate physician concerns over privacy and appropriate use of recordings.
Most oncologists are comfortable with patients recording consultations; however, 25% are uncomfortable, and more than half (56%) express concerns related to legal liability and limiting transparent discussions with patients. Institutional policies are needed to address the concerns of oncologists and enhance equitable care for patients.
We used results generated from the first study of the National Institutes of Health Sentinel Network to understand health concerns and perceptions of research among underrepresented groups such as ...women, the elderly, racial/ethnic groups, and rural populations.
Investigators at 5 Sentinel Network sites and 2 community-focused national organizations developed a common assessment tool used by community health workers to assess research perceptions, health concerns, and conditions.
Among 5979 individuals assessed, the top 5 health concerns were hypertension, diabetes, cancer, weight, and heart problems; hypertension was the most common self-reported condition. Levels of interest in research participation ranged from 70.1% among those in the "other" racial/ethnic category to 91.0% among African Americans. Overall, African Americans were more likely than members of other racial/ethnic groups to be interested in studies requiring blood samples (82.6%), genetic samples (76.9%), or medical records (77.2%); staying overnight in a hospital (70.5%); and use of medical equipment (75.4%).
Top health concerns were consistent across geographic areas. African Americans reported more willingness to participate in research even if it required blood samples or genetic testing.
To update an evidence-based technology assessment of chemoprevention strategies for breast cancer risk reduction. POTENTIAL INTERVENTIONS: Tamoxifen, raloxifene, aromatase inhibition, and ...fenretinide.
Outcomes of interest include breast cancer incidence, breast cancer-specific survival, overall survival, and net health benefit.
A comprehensive, formal literature review was conducted for relevant topics. Testimony was collected from invited experts and interested parties. The American Society of Clinical Oncology (ASCO) prescribed technology assessment procedure was followed.
More weight was given to published randomized trials. BENEFITS/HARMS: A woman's decision regarding breast cancer risk reduction strategies is complex and will depend on the importance and weight attributed to information regarding both cancer- and noncancer-related risks and benefits.
For women with a defined 5-year projected breast cancer risk of > or= 1.66%, tamoxifen (at 20 mg/d for 5 years) may be offered to reduce their risk. Risk/benefit models suggest that greatest clinical benefit with least side effects is derived from use of tamoxifen in younger (premenopausal) women (who are less likely to have thromboembolic sequelae and uterine cancer), women without a uterus, and women at higher breast cancer risk. Data do not as yet suggest that tamoxifen provides an overall health benefit or increases survival. In all circumstances, tamoxifen use should be discussed as part of an informed decision-making process with careful consideration of individually calculated risks and benefits. Use of tamoxifen combined with hormone replacement therapy or use of raloxifene, any aromatase inhibitor or inactivator, or fenretinide to lower the risk of developing breast cancer is not recommended outside of a clinical trial setting. This technology assessment represents an ongoing process and recommendations will be updated in a timely matter.
The conclusions were endorsed by the ASCO Health Services Research Committee and the ASCO Board of Directors.
PDF
