FDA Grants Accelerated Approval to Pembrolizumab for Locally Recurrent Unresectable or Metastatic TNBC
On November 13, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple negative breast cancer (TNBC) whose tumors express PD-L1 (combined positive score [CPS] ≥ 10) as determined by an FDA-approved test. FDA also approved the PD-L1 IHC 22C3 pharmDx as a companion diagnostic for selecting patients with TNBC for pembrolizumab.
Breast Cancer Prevention, Screening, Diagnosis, Treatment, Side Effect, and Survivorship Considerations
In the United States, breast cancer is the most commonly diagnosed cancer in women. One in eight women will develop invasive disease in their lifetime with approximately 270,00 new cases diagnosed in the United States in 2019. Caucasian women have the highest incidence rate, whereas African American women are most likely to die from the disease. The five-year survival rate is 91%, with an estimated 3.8 million breast cancer survivors living in the United States.
FDA Rejects Atezolizumab in Combination With Paclitaxel as Treatment for Breast Cancer
On September 8, 2020, the U.S. Food and Drug Administration (FDA) announced it did not approve atezolizumab (Tecentriq®) in combination with paclitaxel for treatment of breast cancer after a clinical trial studying the use of atezolizumab and paclitaxel in patients with previously untreated inoperable locally advanced or metastatic triple negative breast cancer (mTNBC) showed the drug combination did not work to treat the disease.
ACA Led to Higher Rates of Early Breast Cancer Diagnoses
Thanks to expanded Medicaid coverage from the Affordable Care Act (ACA), women diagnosed with breast cancer—and in particular, African American women who are more likely to experience breast cancer disparities—are getting their cancers found at earlier stages, according to researchers. The study findings were reported in JAMA Surgery.
Insulin Resistance May Explain Racial Disparity in Breast Cancer
Black women with breast cancer typically have a worse prognosis than white women, and the results of a new study suggest that insulin resistance may be a factor in the disparity. Findings from the study were reported in Breast Cancer Research.
Dietary Supplements May Affect Breast Cancer Chemo Outcomes
Antioxidant supplements are associated with increased disease recurrence and statistically nonsignificant increased risk of mortality in patients with breast cancer who were receiving cyclophosphamide, doxorubicin, and paclitaxel, according to findings from a study reported in the Journal of Clinical Oncology.
FDA Approves First New Drug Under International Collaboration, a Treatment Option for Patients With HER2-Positive Metastatic Breast Cancer
On April 17, 2020, as part of Project Orbis, the U.S. Food and Drug Administration (FDA) approved tucatinib (Tukysa™) in combination with chemotherapy (trastuzumab and capecitabine) for the treatment of adult patients with advanced forms of HER2-positive breast cancer that can’t be removed with surgery or have spread to other parts of the body, including the brain, and who have received one or more prior treatments.
New Treatments Show Promise for Metastatic HER2-Positive Breast Cancer
Two new drugs in clinical trials are extending survival for women with metastatic HER2-positive breast cancer that had progressed with previous treatment. One of the drugs was effective for brain metastasis, which is particularly difficult to treat. Results from both studies were reported in the New England Journal of Medicine.
Genomic Classifier Predicts Breast Cancer Radiation Benefit, Recurrence Risk
The Adjuvant Radiotherapy Intensification Classifier (ARTIC) predicts which women with early-stage breast cancer will benefit the most from radiotherapy, as well as their risk for locoregional recurrence after radiation, researchers reported in study findings published in the Journal of Clinical Oncology.
Latinas’ Breast Cancer Genetic Disparities Require More Focused Counseling and Testing
Breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death in Latina women. Compared to all patients with breast cancer, Latinas are the second most common ethnic group to carry BRCA1 deleterious mutations, after Ashkenazi Jewish women. However, Latinas are less likely to receive genetic counseling education, referrals, and testing services and have the least awareness of genetic testing compared to non-Hispanic whites and other minority populations. Research indicates that despite their low awareness, Latinas have high interest in participating in genetic counseling and testing.
FDA Approves Neratinib for Metastatic HER2-Positive Breast Cancer
On February 25, 2020, the U.S. Food and Drug Administration (FDA) approved neratinib (Nerlyn®) in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.
Breast Cancer Is More Fatal in Men Than Women
Men have higher death rates than women across all stages of breast cancer, study findings reported in JAMA Oncology show. In the study, five-year overall survival after a breast cancer diagnosis was 77.6% for men and 86.4% for women.
Multigene Testing Is Cost Effective for All Women With Breast Cancer
According to findings from a new analysis published in JAMA Oncology, multigene testing should be expanded to all women with breast cancer and not just those with certain family histories or clinical factors.
Research Guides the Transition of PEP Resources to ONS Guidelines
Lymphedema is one of the most common treatment side effects in patients with breast cancer. Estimates suggest that approximately 40% of all breast cancer survivors are at risk to develop lymphedema at some point in their lives. But as far back as 1998 and even before, some healthcare experts were predicting that lymphedema would be eliminated as a side effect from breast cancer treatment. Twenty-one years later, it’s still prevalent among breast cancer survivors, requiring careful management recommendations from oncology nurses to help patients live with this chronic issue.
CDK4/6 Plus AI Is Effective for Older Women With Breast Cancer
Combination treatment with a CDK4/6 inhibitor and aromatase inhibitor (AI) results in similar progression-free survival (PFS) rates in women with hormone receptor-positive, HER2-negative metastatic breast cancer who are aged 70 or older compared to younger women, according to study findings published in the Journal of Clinical Oncology.
USPSTF Updates Recommendations on Breast Cancer Prevention
Certain groups of women who are at increased risk for carrying BRCA1 or BRCA2 genes should be assessed for the need for genetic testing, and women at increased risk for breast cancer and low risk of adverse events should be offered risk-reducing medications, the U.S. Preventive Services Task Force (USPSTF) recommended.
Getting the Right Treatment at the Right Time Reduces Inequities in Breast Cancer Survival
Although death rates from breast cancer have been falling, the trend has not been equal among all women. Looking at breast cancer survival on a population level can tell us how effective our public health and healthcare systems are at early diagnosis, delivery of evidence-based treatment, and management of follow-up care.
Pediatric Cancer Survivors Have Higher Mortality After Adult Breast Cancer Diagnosis
Women who survived pediatric cancer but developed breast cancer as an adult are more than twice as likely to die prematurely, mostly from comorbid conditions, according to results of a study published in the Journal of Clinical Oncology.
Wasserman Schultz, Brooks Introduce EARLY Act for Breast Cancer Awareness
Health care is the top domestic policy issue for Americans, but with so many different ideas to make the healthcare system more accessible and affordable, the issue is becoming increasingly complex. Because of its far-reaching impact, health care is often a politically charged topic and little change has yet been seen on a legislative level.
Oncology Drug Reference Sheet: Atezolizumab’s Indications for Breast and Lung Cancer
The U.S. Food and Drug Administration (FDA) first approved atezolizumab (Tecentriq®) in 2016, but it received additional approvals when used in combination treatments for locally advanced or metastatic triple negative breast cancer (TNBC) and small cell lung cancer (SCLC) in March 2019.
Test Predicts Which Women Will Benefit From Chemo for Breast Cancer
A prediction test accurately identifies which women with estrogen receptor (ER)-positive, HER2-negative breast cancer will benefit from adjuvant chemotherapy, according to the results of a study published in Breast Cancer Research and Treatment.
FDA Links Breast Implants to Increased ALCL Risk
People with breast implants have a risk of developing breast implant-associated anaplastic large cell lymphoma (ALCL), the U.S. Food and Drug Administration (FDA) announced in April 2019. Typically the cancer is limited to the scar tissue and fluid near an implant, but some patients experience spread throughout the body. The risk increases with textured implants in particular.
FDA Approves Alpelisib for Metastatic Breast Cancer
On May 24, 2019, the U.S. Food and Drug Administration (FDA) approved alpelisib (Piqray®) in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
CDC’s Triple-Negative Breast Cancer Virtual Program Helps Patients Understand the Disease
Unlike other types of breast cancer, a triple-negative diagnosis doesn’t have any of the common receptors found in other breast cancers, presenting potential treatment challenges to patients and providers. To assist patients with triple-negative breast cancer, the Centers for Disease Control and Prevention (CDC) created a new virtual program, allowing patients to consult and ask questions to a virtual coach in the comfort of their own homes.
The Case of the Terrible Toxicities
After completing neoadjuvant chemotherapy for triple-negative invasive breast cancer, Madeline, age 32, had a bilateral mastectomy with reconstructive surgery. Final pathology showed residual disease in the breast and one lymph node, and her oncologist recommended adjuvant therapy with capecitabine (1,500 mg twice a day for 14 days, off for 7 days). Five weeks postoperatively, she started cycle 1. Eight days later, her husband called the cancer clinic reporting that over the past two days, his wife developed profound weakness, unremitting diarrhea despite using diphenoxylate and atropine as directed, and painful, red, swollen hands and feet. Her symptoms represented a drastic change from her usual routine and energy level.
FDA Approves Ado-Trastuzumab Emtansine for Early Breast Cancer
On May 3, 2019, the U.S. Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kakcyla®) for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.
FDA Approves Atezolizumab for PD-L1 Positive Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer
On March 8, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab in combination with paclitaxel protein-bound for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumor area), as determined by an FDA-approved test.
FDA Approves Trastuzumab and Hyaluronidase-oysk Injection for Subcutaneous Use
On February 28, 2019, the U.S. Food and Drug Administration (FDA) approved a trastuzumab and hyaluronidase-oysk injection, for subcutaneous use (Herceptin Hylecta). The drug is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase, for the treatment of HER2‑overexpressing breast cancer.
BRCA Is Not the Only Common Mutation for Breast and Ovarian Cancer
Multigene testing for hereditary breast and ovarian cancer has increased the detection predisposition genes beyond BRCA1 and BRCA2, according to study findings presented at the San Antonio Breast Cancer Symposium on December 7, 2018.
Comorbidities Negatively Impact Breast Cancer Survival
Missouri has a high breast cancer mortality rate, as well as high rates of type 2 diabetes, cardiovascular disease (CVD), and hypertension, which present more often in individuals who are poor, those living in rural areas, African Americans, and older adults. Women with comorbidities at the time of breast cancer diagnosis may have a worse prognosis, so researchers assessed survival disparities among these patient populations. According to the findings presented at the , comorbidities can negatively impact overall breast cancer survival.
Glutathione Plays a Role in Treatment-Related CINV
Chemotherapy-induced nausea and vomiting (CINV) can negatively affect nutritional intake, ability to work, and treatment adherence. Research suggests that younger age and female gender are the strongest predictors of CINV, but those may not be the only factors, particularly for delayed nausea, according to research findings presented at the San Antonio Breast Cancer Symposium on December 5, 2018.
Circulating Tumor Cells Predict Survival
Circulating tumor cells (CTCs) are identified in 20%–25% of patients with nonmetastatic breast cancer, and recent research suggests that detection of CTCs at five-year follow-up may predict late recurrence for nonmetastatic, estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–) breast cancer. In a study presented at the , researchers from the University of Texas MD Anderson Cancer Center found that the presence of CTCs in patients with nonmetastatic breast cancer was associated with shortened relapse-free survival (RFS), regardless of the subtype.
Educational Workshop Improves Patient-Perceived Knowledge About Their Disease
Patient education can improve interactions with their healthcare team and provide coping mechanisms for the psychosocial effects of metastatic breast cancer, according to study findings presented at the .
Tailored Education Improves Patient Satisfaction and Comprehension
Throughout the course of treatment, patients with breast cancer receive a significant amounts of information from their healthcare team. Researchers at the University of Colorado School of Medicine assessed and revamped the educational materials from the facility’s Memorial Radiation Oncology Department to achieve a patient comprehension of key treatment-related concepts of 75%. They found that although some educational concepts remained unmemorable or improperly emphasized, overall trends in comprehension indicated that a patient-tailored approach led to better satisfaction and outcomes, according to the findings presented at the .
Trastuzumab Remains Standard HER2+ Breast Cancer Therapy Despite Cardiac Risks
Trastuzumab can improve disease-free survival (DFS) and overall survival (OS) in patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer. Although some studies suggest that short-term treatment (less than one year) may reduce cardiac toxicity and cost without compromising outcomes, the results of a new study presented at the disagree.
Study Identifies Novel Triplet Therapy for HR+/HER2+ Breast Cancer
Researchers from the University of Colorado Denver Young Women Breast Cancer Translational Program in Aurora identified a potential triplet combination for the treatment of hormone receptor-positive (HR+) human epidermal growth factor receptor 2-positive (HER2+) breast cancer: HER2-targeted small molecule inhibitor tucatinib, CDK4/6 inhibitor palbociclib, and selective estrogen receptor blocker fulvestrant. They presented the findings at the .
Highly Emetogenic Chemotherapy Still Contributes to Potentially Avoidable Adverse Events
The Centers for Medicare and Medicaid Services (CMS) implemented an oncology outcome measure to assess the quality of care and determine outpatient hospital payment (OP-35: Admissions and Emergency Department Visits for Patients Receiving Outpatient Chemotherapy). The measure assesses 30-day postchemotherapy rates of inpatient or emergency department (ED) events deemed “potentially avoidable” because of an association with any of the 10 CMS-defined toxicities: anemia, dehydration, diarrhea, fever, nausea, emesis, neutropenia, pain, pneumonia, or sepsis. Researchers sought to assess those events when linked to highly emetogenic chemotherapy (HEC) in patients treated with anthracycline plus cyclophosphamide (AC), carboplatin, or cisplatin. They presented the findings at the .
Social Support May Play a Role in Treatment Adherence
Many women discontinue adjuvant endocrine therapy (AET) because of adverse events (AEs), and only half remain adherent at five years. Researchers from the University of Southern California, Los Angeles, found that continued social support for those women may improve AET adherence. They presented the findings at the .
Socioeconomic Factors Predict Survival in Nonmetastatic Breast Cancer
Racial and regional disparities impact the incidence of, mortality from, and survival from breast cancer, but the role of other socioeconomic factors is unclear. Researchers from Fudan University in Shanghai, China, conducted a large study and found that marital status, insurance status, median household income, and residence also contribute to survival from nonmetastatic breast cancer. They presented the findings at the .
Breast MRI Protocol Improves Patient Care
Magnetic resonance imaging (MRI) can help diagnose breast cancer, but it is costly. Leadership at the University of Washington in Bellingham developed a protocol to improve the timeliness of care, moving the time of MRI prior to surgeon evaluation, and found that it led to enhanced patient care, eliminated delays in treatment, avoided unnecessary tests, shifted appropriate care to primary-care providers, and provided all necessary data prior to initial surgical consultation. They presented the findings at the .
Patients Rank the Importance of PRO Measures Differently
Patient-reported outcomes (PROs) can improve patient satisfaction and potentially impact survival. However, PRO data are not well-collected outside of the research setting. Researchers at the Yale School of Medicine in New Haven, CT, conducting qualitative study assessed the most personally relevant PROs in women with metastatic breast cancer and observed substantial variation in patient preferences. They presented the findings at the .
Time to Treatment Discontinuation Shorter in Patients Who Receive First-Line Palbociclib
Current treatment guidelines recommend sequential hormone therapy for patients with hormone receptor-positive (HR+) metastatic breast cancer who are not in visceral crisis and whose disease is not refractory to endocrine treatment. Second-line fulvestrant monotherapy is a treatment option for patients in whom disease progresses after first-line palbociclib. Researchers used real-world data to evaluate the time to treatment discontinuation (TTD) of second-line fulvestrant in patients with HR+ human epidermal growth factor receptor 2-negative (HER2–) metastatic breast cancer who did (n = 88) and did not (n = 100) receive first-line palbociclib and found it was shorter in patients who received palbociclib. They presented the findings at the .
Overall Survival From Breast Cancer Differs Based on Tumor Type and Location
Triple-negative breast cancer tumors are thought to be more immunogenic than other breast cancer subtypes, such as luminal A/B or human epidermal growth factor receptor 2-positive (HER2+) tumors. Among all breast cancers, tumors appear more commonly in the upper outer quadrant. However, it is not clear whether expression of immune response genes vary with tumor location among the different subtypes. Researchers assessed gene expression associated with immune response pathways to identify potential treatment targets and presented the findings at the .
Tumor Heterogeneity May Affect Outcomes in Patients With DCIS
Intratumor heterogeneity can lead to cancer progression, and tumors with the highest levels of heterogeneity may be more likely to progress. Researchers compared mutational loads from separate areas of pure ductal carcinoma in situ (DCIS) to genetic heterogeneity in DCIS lesions that coexist with invasive cancer and presented the findings at the .
On-Treatment Genetic Testing Improves Accuracy of Tumor Response Prediction
Genetic testing during treatment can improve accuracy of response and outcome prediction compared to other prognostic tests, according to results from a study assessing on-treatment changes in gene expression in patients receiving chemotherapy. Researchers from Oikonomidou O Institute of Genetics and Molecular Medicine in Edinburgh, United Kingdom, presented the findings at the .
Study Identifies Factors Associated With Long-Term Survival in Metastatic Breast Cancer
Few women with metastatic breast cancer live five years or longer, and predictors of long-term survival are not well understood. Researchers from the University of Pittsburgh Medical Center (UPMC) in Pennsylvania identified demographic- and disease-specific factors related to survival and presented their findings at the .
Asymptomatic Screening Can Improve Survival Rates in Patients With Recurrent Breast Cancer
Current guidelines recommend asymptomatic surveillance of breast cancer only for the detection of locoregional recurrences. Researchers from the Asan Medical Center in Seoul, Republic of Korea, conducted a retrospective 10-year survival analysis of a large cohort of patients with recurrent breast cancer to identify the impact of early detection on survival outcomes and presented the findings at the .
Screening Intervention Improves Access to Mammograms
Access to quality breast cancer screening and treatment may contribute to racial disparities outcomes. In 2016, researchers at the urban safety net Cook County Health and Hospitals System in Chicago, IL, implemented changes in mammography practices, which included installing digital machines at one of four sites, centralizing reading of images at a single site with radiologists specialized in mammography, and increasing care coordination such as enhanced patient outreach efforts. The efforts improved screening volume and cancer detection, according to the results presented at the .