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The FDA granted namodenoson an orphan drug designation for patients who have pancreatic cancer. 

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Authors

Jessica Scruton, BSN, RN, CCM, is vice president of clinical transformation at Lightbeam Health Solutions.

Although technology alone can’t solve clinician burnout, it can provide the means for organizations to provide better care while increasing efficiency and alleviating stress.

Care Management Tools Can Mitigate Clinician Burnout

The advent of elacestrant (Orserdu) has drastically changed the second-line treatment landscape for patients with HR-positive, HER2-negative metastatic breast cancer who develop an 

Since elacestrant—like other frontline therapies in this patient population—is an oral regimen, it puts a key focus on patient-provider communication to monitor for adherence and adverse events.

At a recent community case forum, Michelle Taylor, ANP, and other nurses and advanced practice providers discussed the evolving landscape of second-line treatment of HR-positive, HER2-negative metastatic breast cancer.

“We know we've had some recent changes in this field over the last couple years, which are quite exciting for our patients,” Taylor, who is a nurse practitioner at Dignity Health Cancer Institute at St. Joseph’s in Phoenix, AZ, said.

Taylor mentioned that patients who have been on letrozole and an oral CDK4/6 inhibitor for years may not want to undergo chemotherapy or have to come into the infusion center to receive IV drugs.

“They've been able to treat this as like a chronic disease, and [sometimes] they don't really understand that this is a chronic disease, but it's an incurable chronic disease. So that means … eventually, in this setting, we will have to transition to an IV,” Taylor said.

The duration of prior therapies may also be considered when choosing a second-line therapy for this patient population. Of note, in a poll conducted at the forum, most attendees mentioned that patients at their practice are typically receiving a CDK4/6 inhibitor for approximately 1 year at their practice. Elacestrant tends to be more effective in patients who have been on an AI or fulvestrant plus CDK4/6 inhibitor for longer than 12 months, Taylor explained.

Elacestrant is an oral drug that is approved for ER-positive, HER2-negative 

-mutant advanced or metastatic breast cancer that has progressed after being treated with endocrine therapy. Considering the drug’s efficacy in this patient population—the phase 3 EMERALD trial (NCT03778931) demonstrated an improved progression-free survival (PFS) with elacestrant compared to standard of care—

testing is essential after a patient experiences progression.

“You have all those other older drugs you can reserve for later if you have something actionable now,” one attendee mentioned.

ESR1 Testing Is Crucial in Second-line HR+, HER2- Metastatic Breast Cancer

A Focus on Oral Adherence and Adverse Events

Similar to frontline CDK4/6 inhibitors, elacestrant is an oral drug, which puts a major focus on patient adherence. During the forum, Taylor asked attendees about the protocols they put in place to ensure that patients take their medications properly.

“Navigators and educators that go that have a chemo class for them … and then we go and reinforce,” one attendee said. “Every time we see them, we go over compliance, and then we have an oral compliance person that calls them as well.”

Providers should also discuss adverse events (AEs) with patients, as they can not only impact adherence but patient quality of life, too.

Since elacestrant can cause diarrhea, Taylor asked the panel of experts what they recommend for the AE. Answered included:

However, if patients are relying daily on those methods to treat diarrhea, it may indicate that they actually need a change in their elacestrant dosing.

“But if they’re using these every day, several times a day, then we need to do something with a dose adjustment,” Taylor said. “So I want to hear about those side effect reports and what they’re really dealing with.”

Others echoed Taylor’s sentiment that patient-provider communication is absolutely essential during the second-line treatment of HR-positive, HER2-negative metastatic breast cancer.

“With upfront management and frequent checks, patients tend to do just fine with those side effects,” an attendee said.

Oral drugs in the HR-positive, HER2-negative metastatic breast cancer space put a focus on clear patient-provider communication about adherence and adverse events. 

Oral Drugs Put a Focus on Adherence, Communication in Second-Line Breast Cancer

The second-line treatment of HR-positive, HER2-negative metastatic breast cancer has drastically evolved in recent years, putting a focus on 

 mutation monitoring at center stage, explained Dana J. Tolman, MSN, APRN, FNP-C.

“The very first medication that we started out with [for this patient population] was the SERM, tamoxifen. That was in the late 1970s and clearly, we have come a long way,” said Tolman, who is a nurse practitioner at Baptist Health Miami Cancer Institute.

 on the evolving treatment landscape in HR-positive, HER2-negative metastatic breast cancer.

A major concern in treating this patient population is the development of an 

 mutations are rare before patients undergo treatment for metastatic breast cancer, and typically emerge after a patient is exposed to endocrine therapy. Additionally, 

-mutant disease has fewer treatment options as it is usually resistant to treatment with an aromatase inhibitor, tamoxifen, and fulvestrant.

“[ESR1] has a decreased affinity for ligands, for example, the estrogens, the SERMs and the SERDs, and the ligand independent tumor growth, resulting in cancer proliferation, metastasis, and resistance,” Tolman explained.

Both the American Society for Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) recommend that patients are tested for 

 mutation via blood-based ctDNA tests, after each time they experience disease progression on endocrine therapy.

Once it is determined that the disease is 

, an oral drug that was approved in January 2023 for men and postmenopausal women with estrogen receptor (ER)–positive, HER2- negative 

-mutated advanced or metastatic breast cancer who experienced disease progression after endocrine therapy.

Elacestrant’s FDA approval was based on findings from the phase 3 EMERALD trial (NCT03778931), which showed that the drug improved progression-free survival (PFS) rates over standard of care (SOC). At 6 months, the PFS rates were 34.3% and 20.4% in the elacestrant and SOC groups, respectively. For patients specifically with an 

 mutation, 6-month PFS rates were 40.8% in the elacestrant group and 19.1% in the SOC group. Further, at 12 months, the PFS rates were 22.3% and 9.4%, respectively, in the entire study population and 26.8% vs 8.2% in the 

However, treatment decisions may become a bit more complicated if a patient’s disease has both an 

mutation as well as another targetable mutation, such as 

. Such was the case for one of the attendees at the case-based forum.

“I'm pretty sure she was on a PIK3 inhibitor. We were waiting [to switch her to elacestrant] because she was doing really well on a PIK3CA inhibitor,” the attendee said.

“You also have to think of what the patient would tolerate better,” another attendee responded. “So in our case, if a patient would tolerate any other medication better, typically we would gear toward that route.”

During a Community Case Forum series, breast cancer experts discussed the importance of testing for ESR1 mutations, in particular with the use of elacestrant, in HR-positive, HER2-negative metastatic breast cancer. 

Management of Skin and Nail AEs: Advice to Patients and Caregivers

Video content above is prompted by the following:

What advice do you provide to patients and/or caregivers to manage their oral and skin toxicities?

Experts provide advice to patients and caregivers on managing oral and skin toxicities.

Early Symptom Detection and the Impact on Patient Outcomes in GVHD

Now, let's focus on the crucial role that the care team plays in identifying and managing symptoms for cGVHD patients, particularly those with advanced disease.

What are the key symptoms you look for when assessing cGVHD patients? How do you approach symptom identification, especially for those with advanced disease?

Can you explain the importance of early symptom identification and management in cGVHD? How does this affect patient outcomes?

Panelists discuss how the care team identifies and manages symptoms in chronic graft-versus-host disease patients, particularly those with advanced disease, emphasizing key symptoms to monitor, approaches to symptom identification, and the critical importance of early detection and management for improving patient outcomes.

Managing Severe Symptoms and Disease Progression in the GVHD Journey

Can you describe the typical disease course for cGVHD patients, particularly those who progress to third-line treatment and beyond? What are some of the most severe symptoms they face?

How does the burden of cGVHD impact a patient's quality of life, and what are some of the long-term consequences if symptoms are not properly managed?

Panelists discuss how chronic graft-versus-host disease typically progresses in patients requiring third-line treatment and beyond, focusing on severe symptoms, the impact on quality of life, and potential long-term consequences of inadequately managed symptoms.

Comprehensive Patient Education and Symptom Awareness with GVHD

As an NP, how do you approach educating patients about cGVHD and its potential long-term effects? What resources or educational materials have you found most helpful in supporting patients and their caregivers? (brochures, apps, websites, videos?)

Panelists discuss how nurse practitioners educate patients about chronic graft-versus-host disease (cGVHD) and its long-term effects, exploring various educational resources and materials such as brochures, apps, websites, and videos that are most effective in supporting patients and their caregivers.

Jessica Scruton, BSN, RN, CCM

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