FDA Approves Abemaciclib With Endocrine Therapy for Early Breast Cancer
On October 12, 2021, the U.S. Food and Drug Administration (FDA) approved abemaciclib (Verzenio®) with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk for recurrence and a Ki-67 score ≥ 20%, as determined by an FDA-approved test. This is the first CDK4/6 inhibitor approved for adjuvant treatment of breast cancer.
Oncology Drug Reference Sheet: Sacituzumab Govitecan-Hziy
Initially marketed in April 2020 for treatment of adults with metastatic triple negative breast cancer, sacituzumab govitecan-hziy (Trodelvy®) received an additional approval in 2021 for the treatment of patients with locally advanced or metastatic urothelial cancer with prior treatments.
The Case of the Triple-Negative Breast Cancer Targeted Treatment
Ophelia is a 42-year-old patient who has been diagnosed with triple-negative breast cancer (TNBC). She completed neoadjuvant chemotherapy with dose-dense doxorubicin and cyclophosphamide, followed by paclitaxel and carboplatin. Her postsurgical pathology shows residual disease in the tumor (3.5 cm down from 4 cm) and 12 out of 18 lymph nodes that are positive for cancer. Ophelia tells you that she is very discouraged and expected a better treatment outcome.
U.S. Senators Introduce Metastatic Breast Cancer Access to Care Act
In April 2021, U.S. Senators Chris Murphy (D-CT) and Joni Ernst (R-IA) introduced the Metastatic Breast Cancer Access to Care Act, legislation that would waive the five-month waiting period for social security disability insurance (SSDI) and the 24-month waiting period for eligible Medicare benefits.
FDA Approves Pembrolizumab for High-Risk, Early-Stage, Triple-Negative Breast Cancer
On July 26, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) for high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and continued as a single agent as adjuvant treatment after surgery.
Imaging Test Identifies Treatment Choices for ER-Positive Breast Cancer
Using positron-emission tomography with a radioactive tracer identifies levels of progesterone receptor in patients with estrogen receptor-positive breast cancer, researchers reported in Nature Communications. The diagnostic tool would help clinicians determine which patients are most likely to respond to hormone therapies for breast cancer.
HER2 Status Has Implications for Breast Cancer Treatment and Nursing Care
Breast cancer is classified by several factors, including the presence of human epidermal growth factor receptor 2 (HER2), a type of growth-promoting protein found on the surface of cells. All breast cells have HER2 receptors, but some breast cancers have more HER2 receptors than normal, which may promote tumor growth. About 60% of breast cancers have some level of HER2 expression, and approximately one in five patients has high levels of the HER2 protein, which is considered HER2-positive.
FDA Approves Sacituzumab Govitecan for Triple-Negative Breast Cancer
On April 7, 2021, the U.S. Food and Drug Administration (FDA) granted regular approval to sacituzumab govitecan (Trodelvy®) for patients with unresectable locally advanced or metastatic triple-negative breast cancer who received two or more prior systemic therapies, at least one of which for metastatic disease.
FDA Issues Safety Communication for ADM Products Used in Implant-Based Breast Reconstruction
On March 31, 2021, the U.S. Food and Drug Administration (FDA) issued a safety communication informing patients, caregivers, and healthcare providers that certain acellular dermal matrix (ADM) products used in implant-based breast reconstruction may have a higher chance for complications or problems.
Manage Adverse Events From PI3K Inhibitors for Breast Cancer
In 2019, PI3K inhibitors became a new treatment option for postmenopausal women and men with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer with the U.S. Food and Drug Administration’s approval of alpelisib in combination with fulvestrant. Although alpelisib remains the only PI3K inhibitor approved today, others are in clinical trials, and the new class of agents has a unique safety profile.
Nursing Considerations for Breast Cancer Survivorship Care
More than 3.5 million people in the United States are living with a breast cancer diagnosis. Despite their large number, patients often report they do not receive appropriate follow-up care after completing treatment—and the situation is worsening, with pandemic-related delays in care affecting approximately half of breast cancer survivors.
FDA Approves Margetuximab-cmkb for Metastatic HER2-Positive Breast Cancer
On December 16, 2020, the U.S. Food and Drug Administration (FDA) approved margetuximab-cmkb (Margenza™) in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who previously received two or more anti-HER2 regimens, at least one of which was for metastatic disease.
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 .