Early-stage estrogen receptor positive (ER+) breast cancer is a life-altering experience and a very personal journey for each individual fighting this disease. The overload of information about your disease, diagnosis, treatment and preventing recurrence can be overwhelming. At Biotheranostics, our goal is to be a valuable resource to ER+ breast cancer patients and your healthcare team.
To help you better understand what an ER+ diagnosis means for you, we’re introducing a bi-monthly blog series to help answer some of your ER+ breast cancer questions and provide you with conversation points to discuss with your family, friends and healthcare team. Our first topic is an important one, covering the latest breast cancer developments presented by clinicians and companies at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting.
ASCO is the largest (30,000+ oncology professionals) cancer meeting for sharing new scientific findings that may alter the way patients are diagnosed, treated and followed. This year’s ASCO, which focused on patient-centered care and research, featured many important developments in the field of ER+ breast cancer. We reviewed 150+ data presentations and have summarized some of the diagnostic, treatment and side effect management presentations to share with you.
If you are not familiar with Biotheranostics, we are a company that provides a test called Breast Cancer Index to help ER+, early-stage breast cancer patients with their physicians make personalized treatment decisions beyond year 5. Breast Cancer Index assesses your risk of the cancer returning after 5 years, as well as your likelihood of benefitting from continuing anti-estrogen therapy for an additional 5 years. For more information regarding Breast Cancer Index, please visit our Answers Beyond 5 website.
The following ASCO data recaps are intended to inform you and initiate conversations with your doctor about the latest information on ER+ breast cancer diagnosis and treatments presented at the 2016 ASCO Annual Meeting and do not constitute medical advice from Biotheranostics for the treatment of your disease or management of your treatment side effects. If you have further questions regarding any one of the topics below, please consult with your healthcare team.
2016 ASCO Annual Meeting ER+ Breast Cancer Updates
We presented results from a validation study expanding the utility of Breast Cancer Index to include testing of ER+, early-stage breast cancer patients with 1-3 positive lymph nodes (previously, the prognostic, or risk assessment, component of the test was only able to assess risk of late distant recurrence for lymph node negative patients).
Data Presentation: Validation of a prognostic model integrating Breast Cancer Index (BCI) with tumor size and grade for prediction of distant recurrence in hormone receptor-positive (HR+) breast cancer with 1-3 positive nodes.
What we found: We tested 402 hormone receptor (HR+) and lymph node positive (1-3 positive lymph nodes) patients to determine if Breast Cancer Index (BCI) can help evaluate the risk of the cancer returning (recurrence) in these patients. In the study, Breast Cancer Index identified >20% of these patients as having very low risk with a 15‑year risk of metastatic recurrence of <1.5%. Risk was determined by combining the proprietary Breast Cancer Index gene expression signature with tumor size and tumor grade to provide a patient’s individual percent risk of the cancer coming back.
What it means: The validation of the Breast Cancer Index (BCI) test for patients with 1-3 positive nodes means that Breast Cancer Index can now better assess the risk of recurrence for these patients, who were previously generally assumed to be at high risk for cancer recurrence. Knowing your personal risk of the cancer returning is an important piece of information to help you and your doctor make the right treatment decision for you.
Questions to consider: I was considered high risk because my cancer spread to the lymph nodes, but can the new BCI test for lymph node positive patients with 1-3 nodes help determine my individual risk? Can we use my original biopsy or surgical specimen to run the test? (Visit Answers Beyond 5 to help answer some of your questions and prepare for a conversation with your healthcare team.)
- National Cancer Institute – Cancer Diagnosis and Staging
- National Cancer Institute – Tumor Grade Fact Sheet
Additional ASCO Presentations
Data Presentation #2: A randomized trial (MA.17R) of extending adjuvant letrozole for 5 years after completing an initial 5 years of aromatase inhibitor therapy alone or preceded by tamoxifen in postmenopausal women with early-stage breast cancer.
What They Found: This 1,918 patient trial looked at extended (continued treatment for an additional 5 years) aromatase-inhibitor (AI) therapy with letrozole (Femara) versus no treatment (placebo) in postmenopausal women who had already completed 5 years of an AI therapy. Results from the trial included:
- Disease-free survival for 10 years of AI therapy was 95% vs. 91% with 5 years of AI (P=0.01*) Patients who received 10 years of AI experienced a higher percentage of bone fractures (14%) compared to those who did not receive extended AI therapy (9%; P=0.001)
- There was also a greater incidence of new-onset osteoporosis with AI therapy (11%) vs. placebo (6%; P<0.001)
- In a related presentation of patient-reported outcomes from this study, patients treated with extended AI also reported more vasomotor symptoms, such as hot flashes for one year up to three years of therapy
*A p-value helps you determine if the results of a study are statistically significant. A small p-value (typically < 0.05) indicates that a particular result is statistically significant, meaning that the result is unlikely to be caused by chance alone.
What It Means: An additional 5 years of AI therapy may help some women, however the percent that benefited was about 4%. Extended therapy was also associated with increased risk of additional adverse events such as osteoporosis and bone fractures. It is important to weigh the potential benefits versus possible risks of continuing AI therapy beyond 5 years. Talk to your doctor about tools to help with the decision. Professional reactions to how the study results should impact clinical care were mixed and this Medscape article “What Will You Tell Breast Cancer Patients About MA-17R?” sums up these reactions.
Questions to Consider: What does the potential 4% reduction of cancer recurrence mean to me? Am I willing to continue AI therapy for an additional 5 years for a 4% reduction in disease recurrence? What is my personal risk of recurrence? Are there ways to determine whether or not I am among the 4% likely to benefit from continuing treatment? What does my doctor think about these study results?
- National Cancer Institute – Hormone Therapy for Breast Cancer
Data Presentation #3: Predictors of recurrence during years 5-14 in 46,138 women with ER+ breast cancer allocated 5 years only of endocrine therapy (ET).
What they found: This research looked at the records of 46,138 patients with ER+ breast cancer for the potential of cancer recurrence after 5 years of hormonal therapy. The focus was to investigate whether traditional tumor-specific clinical factors could predict the likelihood of recurrence in years 5-14 post-diagnosis. Results concluded that the risk of recurrence continues in years 5-14 and that risk of recurrence after Year 5 increases with larger tumor size, higher tumor grade, and number of positive nodes. Even the group of patients with the best prognosis by traditional tools (small tumor, low grade, node-negative) still has a risk of recurrence after Year 5.
What is means: These results reiterate that for ER+ breast cancer, the risk of recurrence continues even after 5 years. However, results also demonstrate the difficulty in assessing individualized risk of recurrence based on traditional methods. Ask your doctor about genomic tests, such as Breast Cancer Index, to help assess your personal risk of the cancer returning after 5 years.
Questions to consider: Would I like to know my risk level of cancer returning after completing 5 years of therapy? What is “low risk” for me?
Data Presentation #4: BONADIUV trial: A single blind, randomized placebo controlled phase II study using oral ibandronate for osteopenic women receiving adjuvant aromatase inhibitors: Final safety analysis.
What they found: This study of 202 patients looked at the safety of adding ibandronate (Boniva) to help offset bone loss in osteopenic (where body is slow at replacing bone loss) patients on an aromatase inhibitor (AI) therapy. While four patients dropped out the ibandronate arm of the trial due to toxicity, the adverse event rates across all patients in the trial were basically the same.
What it means: Trial results demonstrated that adding Boniva while being treated with AI therapy is safe overall and did not lead to increase in treatment related adverse events. The strategy to proactively reduce a side effect risk of bone loss with AI therapy could help keep patients on their treatment for the full term.
Questions to consider: Does adding Boniva make sense for me? My bone mineral density results have remained steady, but should I still take Boniva or another bisphosphonate medicine? What does my doctor think about my risk of bone fractures?
Data Presentation #5: Exploring the role of physician communication about adjuvant endocrine therapy among breast cancer patients on active treatment: A qualitative analysis.
What they found: This 22 patient communication survey looked at the exchange between physicians and patients about their endocrine therapy to determine if the quality of the communication led to better treatment consistency. They found that mutual communication that lead to clear information exchange, decision-making, patient enabling, and emotional support helped patients understand the benefit/risk of endocrine therapy and continued use of therapy.
What it means: Women’s interactions and communication with their physician may be an important factor that contributes to the continued use of anti-estrogen therapy (AET) Physicians who communicate information about AET treatment benefits, purpose, and expectations in a way that patients understand may improve consistency with treatment recommendation.
Questions to consider: How is my communication with my doctor? Is my doctor communicating enough about treatment experiences with me? How can I improve my communications with my healthcare team?
Study Introduction: Tamoxifen versus aromatase inhibitors for the adjuvant treatment of breast cancer in older women: A feasibility study to examine differences in cognitive outcomes.
What are they looking for? This is a feasibility study that will be combined into a larger study to compare the cognitive effects of hormonal treatment (Tamoxifen vs Aromatase Inhibitors) on older women (60+) diagnosed and treated for the first time. For more information regarding this trial, please visit the clinical trial page.
What the trial potentially means: This could be valuable information to help determine effects of Tamoxifen and Aromatase Inhibitors on cognitive function in older women. Data could potentially lead to intervention methods to offset this side effect.
Questions to consider: Am I interested in participating in this type of trial?
We hope this ASCO data recap helped inform and empower you to be a part of the discussion in treatment decisions with your healthcare team.
Stay tuned for our next topic in the coming weeks: Beyond Diagnosis: What Are My Options with ER+ Breast Cancer?