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Axel Stuart Merseburger, MD, PhD, explained that with TKIs like axitinib, it is necessary for oncology nurses to spend time with each patient to provide the best care.

Becoming Familiar With Patients’ AEs is Essential, Says Expert

Avelumab in combination with axitinib was found effective and safe as frontline treatment for advanced RCC in real-world findings.

Real-World Data Back First-Line Avelumab and Axitinib in Advanced RCC

Patient-reported outcomes were consistent between patients with RCC using tivozanib/nivolumab and tivozanib monotherapy according to study findings.

Person acute kidney injury Comprehensive image overview of kidneys showing sudden loss of function | Image Credit: © Premium Graphics - stock.adobe.com.

Tivozanib Combo Yields Similar PROs to Monotherapy in Advanced Clear Cell RCC

Katy Beckermann, MD, PhD, explained that oncology nurses and APPs should be ready to administer and explain dose modifications for patients with RCC.

Dose Reductions Possible for Tivozanib With and Without Nivolumab for RCC

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Real-world data show that older adults with lenalidomide-refractory MM have poor survival outcomes after 1 to 3 lines of therapy.

Older Patients with Lenalidomide-Refractory MM May Face Treatment Gaps

Clinical response rates were higher in patients with phlebotomy-dependent polycythemia vera who received rusfertide than in those who received placebo.

Rusfertide Plus SOC Reaches Response End Point in Phlebotomy-Dependent PV

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

The FDA has granted PYX-201 fast track designation for treatment of recurrent or metastatic HNSCC after progression post-chemoimmunotherapy.

PYX-201 Receives FDA Fast Track Designation for Recurrent/Metastatic HNSCC

Staying up to date with data from trials and information from organizations dedicated to cancer research is crucial for oncology nurses and APPs.

Keeping Up With Cancer Research to Provide Patients With Up-to-Date Care

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This past year, the role of ctDNA testing has expanded to guide treatment decisions for providers and patients with cancer.

Cancer Care Advancements in 2024 and Beyond

In the April 2024 issue of Oncology Nursing News, stories focus on bladder-preserving treatment options in bladder cancer, recent FDA approvals, conference news, and embracing vicarious resilience.

The Importance of Quality of Life in Bladder Cancer

No system can properly flourish without constant efforts to diversify, and the nursing field is no exception.

Questions of Accessibility and Inclusion Continue to Draw Attention in Oncology Nursing

The COVID-19 pandemic has lasted longer than most of us predicted, and extra demands and strain have been placed upon the shoulders of all those who work in health care—particularly nurses

A Call for Resilience and Rest for the Oncology Nurse

When compared to standard of care, ciltacabtagene autoleucel (cilta-cel; Carvykti) displayed improvements in patient-reported outcomes including greater health-related quality of life (HRQOL) and delayed worsening of symptoms in patients with relapsed, lenalidomide (Revlimid)-refractory multiple myeloma in findings from phase 3 trial CARTITUDE (NCT04181827) published in 

At a median follow-up of 15.9 months (IQR, 12.4-17.8), the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) compliance post-baseline score was 70% to 81% for patients who received cilta-cel and 79% to 89% for patients who received standard of care; the MySIm-Q median time to sustained worsening of symptoms was 23.7 months with cilta-cel and 18.9 months with standard of care (HR, 0.42; 95% CI, 0.26-0.68; 

European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core C30 (EORTC QLQ-C30) global health status (GHS) 12-month score mean changes were +10.1 points (95% CI, 7.0-13.1) for cilta-cel and −1.5 points (95% CI, −5.3 to 2.3) for standard of care; for EuroQol 5-Dimension 5-Level (EQ-5D-5L) visual analogue scale mean changes were +8.0 (95% CI, 5.2-10.7) and +1.4 (95% CI, −1.9 to 4.7), respectively.

“In CARTITUDE-4, cilta-cel provided greater improvements than standard of care in overall HRQOL, including multiple functional domains and patient-reported pain and fatigue, in patients with lenalidomide-refractory multiple myeloma after 1 to 3 previous lines of therapy,” Roberto Mina, MD, at the University of Turn, and author of the study, and fellow authors, stated. “Improvements were sustained until at least month 12 and encompassed overall health status, functioning, and multiple myeloma-specific symptoms including pain and fatigue.”

A total of 419 patients were randomly assigned, in a 1:1 ratio, to receive cilta-cel (n = 208) or standard of care (n = 211). Those in the cilta-cel arm underwent apheresis, 1 or more cycles of bridging therapy depending on clinical status and cilta-cel manufacturing time, and lymphodepletion consisting of 300 mg/m

 fludarabine daily for 3 days. Then, 5 to 7 days after lymphodepletion, patients were given a single cilta-cel infusion at a target dose of 0.75x10

 CAR-T cells/kg. Standard of care was either 1800 mg of subcutaneous daratumumab (Darzalex), 4 mg of oral pomalidomide (Pomalyst), and 40 mg of oral or intravenous dexamethasone in 28-day cycles (n = 182), or 4 mg of oral pomalidomide, 1.3 mg/m

 of subcutaneous bortezomib (Velcade), and 40 mg of oral dexamethasone in 21-day cycles (n = 26).

To be included in the study, patients needed to be lenalidomide-refractory or relapsed/refractory multiple myeloma who received 1 to 3 prior lines of therapy with a proteasome inhibitor and an immunomodulatory drug, as well as an ECOG performance status of 0 or 1. Those who received prior CAR T-cell or anti-BCMA therapies were not permitted enrollment.

Clinical efficacy was previously reported with progression-free survival (PFS) as the primary end point, however, time to sustained worsening of patient-reported symptoms, change from baseline in the MySIm-Q, the EORTC QLQ-C30, and the EQ-5D-5L, were key secondary end points.

The median time to improvement on the MySIm-Q total symptom scale was 2.8 months (IQR, 0.3-6.2) for cilta-cel and 1.7 months (IQR, 1.2-3.0) for standard of care; on the total impact scale, it was 2.8 months (IQR, 0.4-6.5) and 1.4 months (IQR, 1.1-3.0). At month 12, 35% of the cilta-cel group and 14% of the standard of care group achieved clinically meaningful improvements in total multiple myeloma score compared with 11% and 33%, respectively, who achieved worse scores.

EORTC QLQ-C30 physical functioning, role functioning, and social functioning were all improved in the cilta-cel group, though they were not improved in the standard of care group.

In the cilta-cel group, EQ-5D-5L visual analogue scale scores fell from baseline to month 3, then increased over time to a least-squares mean of +8.0 points (95% CI, 5.2-10.7) at month 12 compared with a +1.4-point increase in the standard of care group. Results were similar at 18 months.

At the median follow-up of 15.9 months (IQR, 12.4-17.8), the primary analysis from the CARTITUDE-4 trial showed that cilta-cel “significantly improved” PFS over standard of care (HR, 0.26; 95% CI, 0.18-0.38; 

<.001), increased the overall response rate (ORR; 85% vs 67%, respectively), depth of response (73% vs 22%), and rate of minimal residual disease negativity (61% vs 16%).

“With previously reported data showing that cilta-cel significantly improves PFS, ORR, and depth of response vs standard of care, the improvements in HRQOL that we observed support the use of cilta-cel in earlier lines of treatment for lenalidomide-refractory multiple myeloma,” the authors concluded.

Mina R, Mylin AK, Yokoyama H, et al. Patient-reported outcomes following ciltacabtagene autoleucel or standard of care in patients with lenalidomide-refractory multiple myeloma (CARTITUDE-4): results from a randomised, open-label, phase 3 trial. 

. 2025;12(1):e45-e56. doi:10.1016/S2352-3026(24)00320-X

Median time to sustained worsening of symptoms was 23.7 months with cilta-cel, compared with 18.9 months with SOC.

Cilta-Cel Associated With Higher HRQOL for Lenalidomide-Refractory MM

While high-risk multiple myeloma can be difficult to treat with aggressive therapies, treatment considerations with the help of diagnostic tools may prove helpful when determining when to de-escalate treatment for certain patients.

At a recent Community Case Forum hosted by Oncology Nursing News, Mark Davis, PA-C, a physician assistant from Texas Oncology, Southwest Forth Worth Cancer Center, and colleagues discussed disease burden and diagnostic tools, as well as risk stratification and treatment approaches in high-risk multiple myeloma.

“In terms of risk stratification, we use the International Staging System [ISS], which is more or less the old way of doing it…” Davis explained during the event, adding that providers use the revised ISS with lactate dehydrogenase (LDH) levels and high-risk cytogenetics of chromosomal abnormalities. “So somebody who has a double-hit myeloma, that means they have 2 chromosomal abnormalities, and that is going to put them at a higher risk classification.”

Factors associated with high-risk disease or the progressive relapse setting include those with newly diagnosed myeloma who have a revised ISS of III, extramedullary disease, circulating plasma cells, and cytogenic abnormalities. For patients with newly diagnosed multiple myeloma, cytogenic abnormalities associated with high risk for disease progression or relapse include Del(1p32), t(4;14), t(14;16), t(14;20), Del(17p) or monosomy 

 mutation, 1q21 gain or amplification, and MYC translocation.

“As an [advanced practice provider (APP)] we can really help clinicians not only identify high-risk patients based on cytogenetics but also those who have a short course of remission and identify them as high risk as well,” Davis said in an interview with Oncology Nursing News. “And so patients who have disease progression within 2 years of their induction therapy, [that] automatically puts them in a subgroup of high-risk disease. And we are trying to tailor therapies differently in those patient populations that have more aggressive disease.”

Factors that may impact treatment for patients include their personal preferences, physical activity, work productivity, comorbidities, quality of life, disease symptoms and control, treatment-related toxicities that could lead to discontinuation, treatment convenience (oral vs intravenous), and financial toxicity.

With high-risk myeloma, it is a disease that can be difficult to treat. To further complicate management, many patients are unable to receive intense treatment because of comorbidities.

At the Community Case Forum, Davis presented a case of a 76-year-old female with ISS stage II myeloma, who is not eligible for a transplant and also presents with early-stage Parkinson’s disease that is currently controlled with treatment. At diagnosis, she presented with severe lower back and neck pain, has experienced increasing fatigue and mobility challenges, and reported with an ECOG performance status of 1.

The case, Davis noted, highlights certain patients’ inability–for example, older, frail, or transplant-ineligible patients–to receive aggressive therapy, whether considered high risk or not, and, in turn, the need for treatment de-escalation.

The attendees were polled on what regimen should be prescribed for the frontline treatment of this patient, including:

bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone (VRd), which included CRd lite;

daratumumab (Darzalex) plus lenalidomide and dexamethasone (Dara-Rd);

ixazomib (Ninlaro) plus lenalidomide and dexamethasone (Ixa-Rd); or

a quadruplet regimen like Dara-VRd or Dara-VMP)

Results were evenly divided-50% of respondents said that they would consider VRd while the other half were in favor of Dara-Rd.

“Both of those responses are on par to 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 that include transplants.”

He added that these patients will also often be offered, in the community setting, a doublet that has inferior results due to concerns of toxicity. “More recent data from the MAIA study [NCT02252172]

 showed similar tolerance in older patients who were treated with Dara-RD vs Rd. Hopefully, this data will encourage clinicians to move further away from doublets even in our frail patients.”

Similarly, he added, often patients who are elderly or frail would not be offered a quadruplet regimen either. “You're often going to have to de-escalate [treatment] in some form or fashion.”

To aid in predicting long-term remission, the use of minimal residual disease (MRD) is growing in the multiple myeloma landscape.

“There's now studies ongoing about de-escalating therapy based on MRD, but also just even outside of that, from a prognostic value, it's more accurate than our M spikes,” Davis explained. “…MRD is most valuable when patients are wanting to de-escalate, and this could be a leverage point.”

In the case study, the patient was treated with frontline Dara-Rd. Following 9 months of treatment, she presented with an ECOG performance score of 2, a complete remission that was followed by a partial response at month 1 and very good partial response at month 8, with stable chemistry labs. In addition, the patient experienced grade 3 neutropenia that lasted for 1 cycle of treatment and appeared refractory to a single dose of granulocyte colony-stimulating factor. Her imaging revealed no new findings.

At 12 months, the patient’s ECOG performance score was 1 and she is stable in CR, chemisty and hematology labs, and continuance of no new findings on her imaging. Of note, her Parkinson’s disease remained in control with daily functioning that was consistent with baseline findings.

“MRD negativity at 12 months alone has also been associated with overall survival improvement. So again, it just highlights, for us, the relevance of deepening responses and maintaining somebody in a state of undetectable disease,” he said, highlighting that MRD negativity led to a median progression-free survival of 63 months, compared 27 months among patients with CR achievement, based on data from a pooled analysis of 3 Pethema/GemDavis clinical trials.

NCCN. Clinical Practice Guidelines in Oncology. Multiple myeloma, version 1.2025. Accessed December 12, 2024. 

https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf

Facon T, Kumar S, Plesner T, et al. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. 

. 2019;380:2104-2115. doi:10.1056/NEJMoa1817249.

Lahuerta JJ, Paiva B, Vidriales MB, et al. Depth of Response in Multiple Myeloma: A Pooled Analysis of Three PETHEMA/GEM Clinical Trials. 

. 2017;35(25):2900-2910. doi:10.1200/JCO.2016.69.2517.

“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

Navigating Immune-Related Adverse Events With Nivolumab in Upper GI Cancer

Video content above is prompted by the following:

•	What are the key irAEs to monitor in patients receiving nivolumab, and how do you differentiate these from disease-related symptoms ?

•	How do you approach the management of moderate to severe irAEs, and what factors determine whether immunotherapy should be paused or discontinued?


Experts discuss key immune-related adverse events (irAEs) to monitor in patients receiving nivolumab, how to differentiate these from disease-related symptoms, and how to manage moderate to severe irAEs, including factors that determine whether immunotherapy should be paused or discontinued.

The 1945 atomic bombings in Japan left instantaneous death and destruction, but it wasn’t until years later that the devastating lasting effects began to appear in the population. At first, leukemia from radiation exposure was diagnosed among bombing survivors. Then, cases of solid cancers, such as bladder, breast, colon, lung, and thyroid, emerged.

Although the scientists who created the atomic bomb understood the increased risk of cancer from radiation exposure, this wasn’t common knowledge to the average person. Still, today, with the known risks, radiation is routinely used to treat many types of cancer. Furthermore, chemotherapy, chimeric antigen receptor (CAR) T-cell therapy, and certain targeted therapies are also some of the best ways to eradicate cancer cells that are growing inside of a person’s body despite the possibility that these treatments may lead to the formation of secondary cancer.

The development of a new cancer following primary cancer treatment is called secondary malignancy, and these account for 19% of all cancer diagnoses in the United States.

In addition to the type of primary cancer treatment used, other risk factors for secondary cancers include environmental exposures, genetics, and lifestyle choices.

 For instance, sun exposure, smoking, and alcohol use may play a role in secondary malignancy development, says Megan Wanca, APRN, DNP, FNP-C.

However, one of the most significant risk factors is radiation therapy. The dosage and length of time and frequency it was given can affect a patient’s secondary malignancy risk.

 For example, sarcomas are more common in areas that received higher doses of radiation or areas that were near the treatment site.Carcinomas, leukemias, mesotheliomas, and myelodysplastic syndromes (MDS) are also associated with radiation therapy. Typically, leukemias appear within 10 years of initial treatment, but solid tumors may occur 10 years or later.

Certain organs, such as the breast and thyroid, have a higher risk for developing cancers after radiation exposure compared with other organs.

Moreover, a patient’s age at the time of radiation therapy may influence later cancers. If a patient receiving radiation treatment to the chest for Hodgkin lymphoma is closer to menarche, she may be at an increased risk of radiation therapy–induced breast cancer. However, if she is closer in age to menopause, that patient’s breast cancer risk may be decreased.

Secondary esophageal, lung, kidney, thyroid, contralateral breast, and uterine cancers, as well as lymphomas and leukemias, can be seen in patients with breast cancer who were treated with radiation therapy. Specifically, breast cancer survivors who smoke have a significant increase in the risk of ipsilateral second lung cancer.

A meta-analysis of 13 clinical trials that included more than 760,000 patients with breast cancer showed an association between breast cancer radiation therapy and an increased risk of a second nonbreast cancer more than 5 years after primary cancer treatment.

Men treated with external beam radiation therapy for prostate cancer also have a higher cumulative incidence of secondary cancer compared with those who were treated with radical prostatectomy, according to study findings published in 

. The researchers examined the risk in more than 7600 men and observed an increased risk of genitourinary and lung cancers in these men more than 5 to 15 years post-treatment.

“Just like with radiation, the risk of secondary malignancy increases with higher doses of chemotherapy, longer treatment time, or higher intensity of the dosing,” says Wanca, who is a hematology/oncology nurse practitioner at Vanderbilt University Medical Center in Nashville, Tennessee.

Chemotherapy-related secondary malignancies include leukemias, such as acute myeloid leukemia (AML) and acute lymphoblastic leukemia, and MDS. Certain chemotherapies such as alkylating agents, platinum-based drugs, and anthracycline topoisomerase II inhibitors put patients at greater risk.

The Childhood Cancer Survivor Study, which included more than 25,000 survivors, observed the risk of developing leukemia to be 6 times greater in survivors compared with the general population. The retrospective cohort study showed that 77 survivors developed subsequent leukemia—49 survivors received a diagnosis of late leukemia with a median time of 7.8 years after treatment, and 28 survivors received a diagnosis of very late leukemia with a median of 25.4 years later. AML, MDS, and chronic myeloid leukemia were the most common leukemia subtypes seen. Moreover, an epipodophyllotoxin dose greater than 4000 mg/m

 was associated with an increased risk for these leukemias.

New treatment options, such as targeted and CAR T-cell therapies, pose a small risk for secondary cancers. Vemurafenib (Zelboraf) and dabrafenib (Tafinlar), which target 

, are known to have a higher risk of squamous cell carcinomas.

In recent years, a clinical trial and a report investigated whether CAR T-cell therapy caused secondary T-cell lymphomas. The one investigation, published in 

, analyzed the case of a patient with multiple myeloma who had been treated with ciltacabtagene autoleucel (Carvykti). The investigators found evidence of a CAR gene in the T-cell lymphoma cells along with other genetic alterations and concluded that the CAR T-cell therapy likely contributed to the second cancer.

However, more long-term data is needed to get a clear understanding of the secondary malignancy risk that may stem from these treatments, explains Wanca.

Radiation, chemotherapy, targeted therapy, and CAR T-cell therapy have risks, but they are helping patients live longer every day. There are benefits and risks in every situation, but the crucial part is ensuring patients and caregivers are as informed as possible to weigh the pros and cons for themselves, says Johnny Rollins, MSN, APRN, ANP-C, who is associate director of Advance Practice Programs—Survivorship and a thyroid cancer survivorship provider at The University of Texas MD Anderson Cancer Center in Houston, Texas.

When creating a cancer treatment plan, oncology nurses and advanced practice providers (APPs) explain the drug that will be used and its adverse effects (AEs) to the patient. Treatment goals can be very individualized, explains Rollins.

“Some patients have upcoming plans that they want to be involved in, and it’s important for nurses to connect with their patients and understand what their goals are to help them achieve those goals,” says Rollins. “Oncology nurses hold a crucial role in helping patients navigate their cancer journey. Patients get that big ‘c’ word in front of them, and their eyes can just glaze over. It’s important for the nurses to take that time and let the patients and their caregivers ask questions.”

Education is one of the most powerful tools for a patient, and this can come directly from their nursing team. For instance, provide patients and their caregivers with an evidence-based information sheet that they can bring home. Oncology nurses and APPs can also encourage patients to sit with the information, ask questions, and take their time in treatment decision-making so they can understand all the risks and AEs.

“It may involve multiple visits and multiple messages but let them experience the emotions and we can talk them through [them],” says Wanca. “Every day I get to be with patients on some of their darkest days. I don’t think fear should outweigh the benefit of getting the primary treatment.”

Both Rollins and Wanca can’t stress enough the importance of making sure patients and survivors have a caregiver present. It can be a spouse, partner, family member, or friend. But really, it’s having another set of eyes and ears to absorb the information being provided. In some cases, a patient may want to keep their disease a secret or at other times a caregiver wants a different treatment plan to be considered, explains Rollins. “One of our most basic, essential roles is educating [them] and having the patient and caregiver on the same page,” he says.

To help mitigate secondary cancer risk and monitor survivors, nurses and APPs should help patients schedule surveillance follow-up appointments. At those appointments, providers can perform physical exams and conduct imaging and blood tests to investigate for any signs or symptoms of new cancer development.

It helps to have a good survivorship clinic, explains Rollins, who also manages the Thyroid Cancer Survivorship Clinic at MD Anderson. The oncology teams at this institution use a tool called the MD Anderson Symptom Inventory, which is a patient-reported outcome measure. Each clinic’s questionnaire has specific questions related to its type of cancer and help nurses and APPs identify the severity of symptoms experienced by patients and how they may be affecting their quality of life. From there, patients can be referred to the treating oncologist or to a new clinic depending on the type of symptoms they’re experiencing, says Rollins.

Patients who receive certain cancer treatments are at greater risk of secondary malignancies and must be educated accordingly.

Mike Hennessy Jr

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