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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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A nurse practitioner discusses how breast cancer treatment can impact sexual health, and how nurses and APPs can guide patients through these effects. 

Sexual Health During Breast Cancer: ‘Just Being Heard Is Important’

The pharmaceutical company behind mesylate submitted a new drug application for a ready-to-use 3-month formulation of the drug. 

NDA Submitted for 3-Month Formulation of Mesylate for Advanced Prostate Cancer

Here’s a roundup of FDA approvals in the oncology space from October 2024. 

October 2024 FDA Approvals for Oncology

The FDA expanded the approval of methotrexate to include patients with pediatric acute lymphoblastic leukemia and polyarticular juvenile idiopathic arthritis. 

Methotrexate’s Approval Expanded to Include Pediatric ALL

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The ongoing dialogue regarding healthcare payment reform that attempts to incentivize high-value care by linking reimbursement to quality rather than quantity has largely ignored the ultimate consumer/buyer&mdash;the patient.

Value-Based Oncology Care Delivery Falls Short of Addressing Patients' Psychosocial Needs

After a patient with estrogen receptor (ER)-positive, HER2-negative metastatic breast cancer experiences disease progression on frontline therapy, it is essential that they be tested for an 

 mutation. ctDNA testing is the best way to do that, according to a physician assistant from Maimonides Cancer Center.

About ESR1 Mutations in Metastatic Breast Cancer

mutations are rare in untreated patients, they occur in approximately 40% of patients after they received endocrine therapy. These mutations occur in the ligand binding disease and make the disease resistant to aromatase inhibitors.

“It changes the shape so that the ligand cannot bind to the receptor, and it cannot do what it is supposed to do. The cancer starts to corroborate, and it causes progression of the disease,” Yan Pronin, PA-C, a physician assistant at Maimonides Cancer Center explained.

At a recent Community Case Forum, Pronin and colleagues discussed second-line treatment for ER-positive, HER2-negative metastatic breast cancer.

More specifically, ESR1 mutations alter the shape of the estrogen receptor, resulting in the receptor having a decreased affinity for ligands such as estrogen, selective estrogen receptor modulators, and selective estrogen receptor degraders (SERDs).

Elacestrant (Orserdu) was FDA-approved to treat patients with 

-mutant metastatic breast cancer in the second line, highlighting the importance of testing patients whose disease recurs or progresses on frontline endocrine therapy to see if they have the mutation. If they do, hormone therapies likely will not be effective.

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

Pronin polled attendees about what type of samples are sent for testing when patients in their practice with ER-positive, HER2-negative metastatic breast cancer experience recurrence on first-line therapy with a CDK4/6 inhibitor and aromatase inhibitor. Answers were:

Tumor tissue (archival tumor tissue): 12.5%

Blood (for liquid biopsy/ctDNA testing): 62.5%

Prior studies have used ctDNA to prove that hormone therapies lose their efficacy in treating metastatic breast cancer once it develops an 

 mutation. Data from the SoFEA trial (NCT00253422) and the EFFECT trial (NCT03778931) both showed that patients with ESR1-mutant disease, as detected via ctDNA, tended to show a trend toward inferior progression-free survival (PFS) and overall survival (OS) with exemestane or fulvestrant.

“Tissue biopsy is old school. It’s low sensitivity, it’s a very invasive procedure… it’s very high cost and requires more material, and its storage is also more complicated than liquid biopsy, which is just a blood test. It’s very easy and high sensitivity with ESR1 mutations. It’s minimally invasive, low cost and requires less tumor and has very simple preservation,” Pronin said. “That’s why we recommend ctDNA.”

1. Brett JO, Spring LM, Bardia A, Wander SA. ESR1 mutation as an emerging clinical biomarker in metastatic hormone receptor-positive breast cancer. 

 2021 Aug 15;23(1):85. doi: 10.1186/s13058-021-01462-3

2. Turner NC, Swift C, Kilburn L, et al. 

 Mutations and Overall Survival on Fulvestrant versus Exemestane in Advanced Hormone Receptor-Positive Breast Cancer: A Combined Analysis of the Phase III SoFEA and EFFECT Trials. 

. Oct 1;26(19):5172-5177. doi: 10.1158/1078-0432.CCR-20-0224.

Testing for ESR1 mutations is essential after ER-positive HER2-negative breast cancer progressed. 

ctDNA Has High Sensitivity ESR1 Mutations in Metastatic Breast Cancer

Following progression or relapse, it is key for providers to test for 

, as well as potential co-mutations, to guide second-line treatment decisions for patients with estrogen receptor (ER)-positive, HER2-negative advanced or metastatic breast cancer.

In particular, elacestrant (Orserdu) has proven effective in this patient population who previously received at least 1 line of endocrine therapy.

“Findings suggest that observed benefit with elacestrant versus standard of care [endocrine therapy] was not impacted by the presence of the common co-existing mutations or molecular expressions,” Erica Doubleday, MS, FNP-C, BSN, RN, said.

In a recent Community Case Forum event, , Doubleday of Oschner MD Anderson Cancer Center, led a discussion about the evolving landscape of second-line treatment for HR-positive, HER2-negative metastatic breast cancer.

Elacestrant in Co-Mutated, Metastatic Breast Cancer

 may be the best option for patients whose disease is positive for more than 1 mutation; however, it is essential to consider other patient characteristics when determining a treatment plan, Doubleday said.

She discussed a patient case, in which the individual expressed co-mutations of 

. The patient is 90 years old, so, at the time, she is only being treated with fulvestrant.

“However, when she does progress—and she will progress on it—we will most likely go with elacestrant … just for ease of use and less side effects,” Doubleday said. “We have to make it easy for her because she’s 90. … I think it’s important to look at the patient, look at their background, their age, performance status and really make the [treatment] decision off of that.”

 co-mutations is supported by findings from the EMRALD trial (NCT03778931). Data showed that among a subgroup of patients with the co-mutations who were previously treated with a CDK4/6 inhibitor, the median progression-free survival (PFS) was 5.45 months (95% CI, 2.14-10.84) with elacestrant, compared with 1.94 months (95% CI, 1.84-3.94) with standard endocrine monotherapy

To determine the best treatment available, biomarker testing is needed to identify 

 following each progression of the disease. Advanced practice providers (APPs) who attended the session mentioned that they sometimes face difficulty getting coverage for the testing.

“We had a very [heavily populated] Medicaid population and—as we know—Medicaid is strategic in what they will and will not cover. So a lot of things we want to do, we cannot because we do not have payment for it,” one attendee said.

Doubleday mentioned that APPs may be able to encourage patients to apply for patient assistance programs that will help lower the cost of the procedure.

“Depending on what company is used, they may have patient assistance [programs],” she said.

Bardia A, O'Shaughnessy J, Bidard F-C, et al. Elacestrant vs standard-of-care in ER+/HER2- advanced or metastatic breast cancer (mBC) with ESR1 mutation: key biomarkers and clinical subgroup analyses from the phase 3 EMERALD trial. Presented at the 2023 San Antonio Breast Cancer Symposium; December 5-9, 2023; San Antonio, TX. Abstract PS17-02.

Advanced practice providers discuss the second-line use of elacestrant in patients with co-mutated, ER+, HER2—advanced or metastatic breast cancer

Elacestrant Proves Effective in Advanced, Co-Mutated Breast Cancer

Nurse-Led Discussion on Diet During Radiation May Boost Quality of Life

Time-restricted eating—commonly known as “intermittent fasting”—may be a feasible way to improve quality of life in patients with cancer who are undergoing abdominal-pelvic radiotherapy, according to an ongoing phase II trial presented at the 2024 Society for Integrative Oncology 2024 Conference.

“There's a lot of clinical and pre clinical studies that have shown the intermittent fasting, like time-restricted eating diets can help reduce the ROS, which is reactive oxygen species, and also reduce the DNA damage,” study author Ziyi (Zoey) Huang, MD, research fellow at City of Hope said in an interview with 

. “So that overlaps with the R radiation mechanism of radiation cause cell death.”

The trial includes 48 patients with high-risk/node positive or locoregionally recurrent prostate cancer, locally advanced rectal or cervical cancer who were randomized to receive either nutritional counseling alone (control group) or nutritional counseling with time-restricted eating.

The time-restricted eating group is asked to fast for 12-14 hours on days when they receive radiation: 6-8 hours before and then 4-6 hours after. They are provided with “rescue foods” that have fewer than 50 calories and no added sugar, when needed.

, another study author, Yun Rose Li, MD, PhD, Assistant Clinical Professor, Department of Radiation Oncology, discussed how oncology nurses can play a critical role in educating patients about intermittent fasting—and general dietary practices—when undergoing radiation therapy.

Patients really value the opportunity to have these conversations and have the opportunity to be engaged in these conversations, because they often want to know, ,”What can I do to help improve my outcomes?” And often we just say, “Just show up for your treatments.” And that's not very satisfying. 

I think part of that is, is that patients really seek that out. And I think it's important that the whole care team is on board and counseling patients. And a lot of the questions that patients has it can totally be answered and supported by our nurses and our dietitians. … A lot of times in radiation oncology, we completely change the diet of the patient during the course of, say, pelvic radiation or head neck radiation, because [patients] can't tolerate the kind of foods they typically eat. Or it's just that the kind of food that they eat needs to be adjusted over the course of treatment, maybe softer foods, or foods that are more easily digestible or less like less rich in fiber, and so forth.

So the nurses actually do almost all of that education in the radiation oncology department, I sort of fill in the blanks. Or when patients have additional issues like come up, but the baseline education is actually done often by our nursing staff.

The way we structured our study was an added dietitian intervention as a part of that education process. But actually our nurses to the majority of that so I think in going forward, you know as a study, you know when we try to expand the study into the phase III setting, it would be actually a great opportunity to engage our nurses as part of the study, because I do think that they can provide the bulk of that education, because a lot of that is what we do as standard of care. We just tend to try to do it. We try to do it profile prophylactically. And when we talk about fasting, we also try to preempt that patient so they're aware and they're prepared. And I think that staff the battle is that they walk in the door prepared for what's to come, and that really lessens their anxiety and stress.

Huang Z, Feng Q, Abuali T, et. al. Early Feasibility Results from the TIDIER Trial: a Randomized, Phase II Clinical Trial of TIme-Restricted Eating Versus Dietary Counseling to Improve the Effect of Radiotherapy. Presented at: 2024 Society for Integrative Oncology Conference. October 25-27, 2024.

Research is analyzing the effect of imtermittent fasting on quality of life outcomes in patients undergoing radiation therapy. 

Onc Nurse TV

Patients with high-risk multiple myeloma need tailored treatments that take risk factors and lifestyle goals into account, explained Mark Davis, PA-C, a physician assistant from Texas Oncology, Southwest Forth Worth Cancer Center.

At a recent Community Case Forum hosted by Oncology Nursing News, Davis and colleagues discussed contemporary approaches for newly diagnosed multiple myeloma treatment.

“This is something I think that a lot of us, particularly in the [advanced practice provider (APP)] world can really help clinicians, because we’re so focused on chromosomal abnormalities but we often don’t take into account the time of progression,” Davis said.

He noted that a 1q amplification or gain (a genetic mutation observed in patients with myeloma) is only a high-risk feature if it is in combination with another chromosomal abnormality. Additionally, patients whose disease progresses within 2 years of transplant or maintenance therapy should also be classified as having high-risk disease.

High-Risk Myeloma Therapy Should Be Personalized

Davis said that treatment regimens for patients with myeloma should be created on a patient-by-patient basis.

“Treatment effectiveness can have different meanings to patients,” he said. For some patients, it’s the ability to continue activities of daily living. For others, it’s maintaining a good physical and mental well-being. And others recognize that being inactive can lead to impairment, which is associated with worse outcomes. So for every patient we encounter, they’re going to have different goals.”

APPs are essential in guiding conversations with patients to help determine what their goals are, and then which regimens may best fit them based on their goals, lifestyle, other comorbidities, and cost of treatment.

“All these drug therapies have roles,” Davis said. “For example, anytime you see cyclophosphamide as part of a regimen … that’s because patients might have renal impairment. It allows you to treat them more aggressively without compromising their kidney function.”

Another attendee also mentioned the need for patients with diabetes to avoid certain drugs that can exacerbate neuropathy.

“If they have diabetes and they already have neuropathy, bortezomib and Revlimid are going to increase [the adverse effect],” the attendee said.

Davis presented a case of a 76-year-old female with early-stage Parkinson’s disease that is currently controlled with treatment. She has ISS stage II myeloma and is not eligible for a transplant The patient presents with severe lower back and neck pain, has an ECOG status of 1, and has a goal of living longer, improving energy and mobility, and spending quality time with her grandchildren. She said she enjoys spending time outside but doing so is becoming limited due to increasing fatigue and mobility challenges.

The attendees were polled on what regimen should be prescribed for the frontline treatment of this patient. Results were evenly divided—50% of respondents said that they would consider bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone (a regimen known as VRd), including VRd lite. Meanwhile, the other 50% of patients voted for daratumumab (Darzalex) with lenalidomide, and dexamethasone (Dara-Rd).

“Both of those responses are what we would expect,” Davis said. “Frail and elderly patients are technically considered high-risk patients because historically, they’re unable to go with more aggressive therapies such as transplants.

Adverse Events May Lead to Treatment Alterations

Once patients have their therapy determined, the treatment can also change due to adverse events. 

Regardless of the therapy patients are on, newer treatment combinations help provide a positive outlook for those with myeloma.

“The outcomes are so much better with the treatments that we have, and patients can live longer,” Davis said.

“Treatment effectiveness can have different meanings to patients,” a physician assistant said when discussing therapy for high-risk myeloma. 

High-Risk Myeloma Treatment Is Not One-Size-Fits-All

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 

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. 

Ellen Miller-Sonet, Chief Strategy

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