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NT-17, a long-acting IL-7 agent, enhances CAR T-cell factors associated with efficacy in patients with relapsed/refractory DLBCL when administered 21 days post-CAR T infusion.

NT-I7 Enhances CAR T-Cell Efficacy in DLBCL

Oncology nurses should inform patients about adverse events and the signs of interstitial lung disease before treating their breast cancer with T-DXd. 

Nurses, Talk AEs, Interstitial Lung Disease, Before Treating With T-DXd

Distant relapse-free survival was maintained with non-operative management of pMMR locally advanced rectal cancer. 

Non-Operative Management of Rectal Cancer Does Not Worsen Distant RFS

Belrestotug plus dostarlimab-gxly improved ORR in patients with previously untreated, unresectable, locally advanced or metastatic, PD-L1–high NSCLC. 

Belrestotug/Dostarlimab Improves Responses in PD-L1–High Lung Cancer

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Megan is an assistant editor at MJH. She joined the company in 2022 after graduating from UMass Amherst with majors in communication and english. When not at work, Megan enjoys fishing, spending time with her twin sister, and listening to Taylor Swift on repeat. Email Megan at mhollasch@onclive.com

The PDUFA dates have been pushed for sotorasib and obeticholic acid for metastatic colorectal cancer and primary biliary cholangitis, respectively.

FDA Delays Decision Dates for Sotorasib and Obeticholic Acid

Amanda Brink is a nurse practitioner at the University of Texas MD Anderson Cancer Center. When she is not tending to patients in the hospital or clinic, she finds great satisfaction in crafting content to enlighten the public and her fellow nurses about a range of health topics.

Pharmacologic strategies may be able to prevent abnormal uterine bleeding in patients undergoing stem cell transplant.

Leuprolide, OCPs Manage Abnormal Uterine Bleeding in Stem Cell Transplant

Gina Mauro currently serves as Vice President of Content at MJH Life Sciences, overseeing 

®. Gina joined the company in 2015 and has held various positions on 

Prior to joining MJH Life Sciences, she worked at Gannett as a full-time reporter with the Asbury Park Press. Email: gmauro@onclive.com

Nivolumab plus AVD outperformed brentuximab vedotin plus AVD in patients with advanced-stage classical Hodgkin lymphoma. 

Nivolumab Regimen Boosts Outcomes in Advanced Hodgkin Lymphoma

Caroline Seymour joined MJH Life Sciences in 2018 and has expertise in video production and print/digital publication. Email: cseymour@onclive.com​

The FDA accepted a resubmission of a new drug application for frontline rivoceranib plus camrelizumab to treat unresectable, metastatic HCC. 

FDA OKs NDA Resubmission of Rivoceranib Plus Camrelizumab for HCC

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A form of T-cell (non-Hodgkin) lymphoma known as breast implant associated anaplastic large-cell lymphoma (BIA-ALCL) has been noted as a rare association with the implant-based approach of reconstructive surgery post mastectomy. 

Understanding Breast Implant-Associated Anaplastic Large Cell Lymphoma

David Leos, RN, MBA, OCN, Clinical Research Nurse Supervisor, Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, discusses clinical trial nurse competencies developed by ONS.

David Leos, RN, MBA, OCN, on Clinical Trial Nurse Competencies

Trastuzumab deruxtecan (T-DXd; Enhertu) is an antibody-drug conjugate used as standard therapy for HER2-positive and HER2-low unresectable or metastatic breast cancer.

 It is classified by the National Comprehensive Cancer Network (NCCN) as having high emetogenic risk.

Managing nausea in these patients can be challenging for oncology nurses due to the wide variety of available antiemetics, potential drug-drug interactions, and a patient’s prior success or failure with certain antiemetics, among other factors. Establishing protocols for managing side effects in specific treatment regimens is essential for streamlining care, improving patient tolerance, and reducing treatment interruptions or discontinuations.

Olanzapine has shown effectiveness in relieving chemotherapy-induced nausea and vomiting, particularly when combined with 5-HT3 receptor antagonists (5-HT3RAs), such as ondansetron or palonosetron, which block serotonin receptors to reduce nausea, and dexamethasone. A recent study by Sakai et al. aimed to assess the superiority of olanzapine over placebo for managing delayed and persistent nausea in patients receiving T-DXd.

The ERICA study: Evaluating Nausea Management with Olanzapine

The ERICA study was a placebo-controlled, double-blind, randomized phase II trial conducted in 43 hospitals in Japan between November 2021 and September 2023. Eligible patients were adults with HER2-positive or HER2-low metastatic breast cancer who were receiving their first cycle of T-DXd. Key exclusion criteria included patients requiring antiemetic treatment for nausea and vomiting at the time of enrollment.

Participants were randomized in a 1:1 ratio to receive either olanzapine (5 mg daily) or placebo from days 1 to 6, along with a 5-HT3RA (such as palonosetron) and dexamethasone on day 1. The primary endpoint was the complete response (CR) rate during the period of 1-5 days post-T-DXd, known as the delayed phase, defined as no emetic episodes and no use of rescue medication. Secondary endpoints included complete response (CR) rates during the acute phase (the first 24 hours following treatment), the persistent phase (days 2 to 6 after treatment), and the overall phase (encompassing both acute and persistent phases), as well as nausea severity and other symptoms, which were recorded daily in an electronic symptom diary.

Between November 2021 and September 2023, 168 patients were enrolled and randomly assigned to receive olanzapine (n = 85) or placebo (n = 83). After accounting for withdrawals and exclusions, the full analysis set included 165 patients (olanzapine, n = 82; placebo, n = 83).

Complete response (CR) rates during the delayed phase, was significantly higher in the olanzapine group (70.0%) compared to the placebo group (56.1%), with a difference of 13.9% (one-sided P = 0.047). In the persistent phase, CR rates were again higher in the olanzapine group (63.9%) compared to the placebo group (44.4%). However, CR rates in the acute phase were similar between the two groups (92.5% vs. 92.7%). The no nausea rate was also higher in the olanzapine group in both the delayed and persistent phases. Continuous greater efficacy of olanzapine over placebo was observed throughout the 21-day observation period.

Somnolence occurred in 25.0% of patients in the olanzapine group compared to 10.8% in the placebo group, with no severe cases. Hyperglycemia was noted in 7.5% of the olanzapine group.

Overall, olanzapine demonstrated improved efficacy in reducing CR rates and nausea compared to placebo, with a favorable safety profile and positive patient-reported outcomes.

Nursing Considerations for Olanzapine Use

Oncology nurses play a crucial role in monitoring the severity and frequency of treatment-related symptoms, particularly nausea. Patients may sometimes be reluctant to take olanzapine due to its other indications, such as schizophrenia. Therefore, oncology nurses can provide essential education about the role of olanzapine, especially when combined with 5-HT3 receptor antagonists and dexamethasone, in effectively managing nausea. Additionally, it is important for nurses to monitor patients closely for potential side effects, such as somnolence.

In conclusion, effective management of nausea in patients receiving T-DXd is essential for improving treatment adherence and overall quality of life. The ERICA study highlights the efficacy of olanzapine in reducing delayed and persistent nausea when used in conjunction with standard antiemetic therapy, providing a valuable option for oncology nurses in their practice. By establishing clear protocols and offering thorough patient education, oncology nurses can enhance symptom management, mitigate treatment interruptions, and ensure a supportive environment for patients navigating breast cancer.

1. Sakai H, Tsurutani J, Ozaki Y, et al. A randomized, double-blind, placebo-controlled phase II study of olanzapine-based prophylactic antiemetic therapy for delayed and persistent nausea and vomiting in patients with HER2-positive or HER2-low breast cancer treated with trastuzumab deruxtecan: ERICA study (WJOG14320B). 

. Published online September 14, 2024. doi:10.1016/j.annonc.2024.09.001

2. Notini G, Naldini MM, Sica L, et al. Management of Trastuzumab Deruxtecan-related nausea and vomiting in real-world practice. 

. 2024;14:1374547. Published 2024 Mar 11. doi:10.3389/fonc.2024.1374547

Oncology nurses play a crucial role in monitoring the severity and frequency of treatment-related symptoms, particularly nausea. 

Contributor

Opinion: Addition of Olanzapine Effectively Manages Nausea During T-DXd Treatment

The FDA approved zolbetuximab-clzb (Vyloy) plus fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive and have not previously been treated.

The approval is based off findings from the randomized phase 3 SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) trials, which showed that the zolbetuximab regimen led to statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared with standard of care.

Per the SPOTLIGHT trial, median PFS was 10.61 months (95% CI, 8.9-12.5) with the zolbetuximab regimen, compared with 8.67 months (95% CI, 8.2-10.3) in those who received placebo plus mFOLFOX (HR, 0.751; 95% CI, 0.598-0.942; 1-sided 

-value = .0066). Median OS was 18.23 months (95% CI, 16.4-22.9) and 15.54 months (95% CI, 13.5-16.5), respectively (HR, 0.750; 95% CI, 0.601-0.936; 1-sided 

Similarly, data from the GLOW trial showed that the median PFS was 8.21 months (95% CI, 7.5-8.8) in the zolbetuximab group, compared with 6.8 months (95% CI, 6.1-8.1) in a group of patients who received CAPOX (HR, 0.687; [95% CI, 0.544-0.866]; 1-sided 

-value = .0007). Median OS was 14.39 months (95% CI, 12.3-16.5) vs 12.16 months (95% CI, 10.3-13.7), respectively (HR 0.771; 95% CI, 0.615-0.965; 1-sided 

In both trials, treatment-related adverse events (TRAEs) were similar between the 2 treatment groups. The most common all-grade TRAEs in the SPOTLIGHT trial were vomiting, nausea, neutropenia, febrile neutropenia, diarrhea, intestinal obstruction, pyrexia, pneumonia, respiratory failure, pulmonary embolism, decreased appetite, and sepsis. For the GLOW trial, common TRAEs were vomiting, nausea, decreased appetite, decreased platelet count, upper gastrointestinal hemorrhage, diarrhea, pneumonia, pulmonary embolism, and pyrexia.

1. FDA approves zolbetuximab-clzb with chemotherapy for gastric or gastroesophageal junction adenocarcinoma. FDA. Oct. 18, 2024. Accessed Oct. 18, 2024. 

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zolbetuximab-clzb-chemotherapy-gastric-or-gastroesophageal-junction-adenocarcinoma?utm_medium=email&utm_source=govdelivery

2. Shitara K, et al. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. 

3. Shah MA, et al. Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. 

The FDA approved zolbetuximab-clzb plus fluoropyrimidine- and platinum-containing chemotherapy for patients with CLDN18.2-positive locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. 

FDA Approves Zolbetuximab Regimen for Locally Advanced, Unresectable Gastric/GEJ Adenocarcinoma

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.

David Leos, RN, MBA, OCN

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