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It is crucial for nurses to be aware of adverse events that can occur in patients who are receiving CAR T-cell therapy, explained one expert.

Adverse Events of CAR T-Cell Therapy

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

Overview of the Safety Profile of CAR-T Therapy

Video content above is prompted by the following:

Could you start by giving an overview of the safety profile of CAR-T therapies for multiple myeloma?

In your experience, what are the most common and impactful adverse events linked to ide-cel and cilta-cel?

How does this align with the safety data from the KarMMa and CARTITUDE studies?

How do the safety profiles of ide-cel and cilta-cel compare, and how do they stack up against other CAR-T therapies?

In what ways do these safety differences impact your choice of CAR-T product for different patient demographics?

Meet Rosie, 72-year-old Retired Graphic Designer With Multiple Myeloma Considering CAR-T Therapy With Ide-Cel

Rosie’s Journey with R/R MM

The combination of everolimus (Afinitor) and lanreotide (Somatuline), used as first-line treatment, significantly improved progression-free survival (PFS) and showed an acceptable safety profile compared to everolimus monotherapy in patients with unresectable or recurrent gastroenteropancreatic neuroendocrine tumors, recent trial findings demonstrated.

Results from the phase 3 STARTER-NET trial (jRCT1031200023) were presented at a press briefing prior to the 2025 Gastrointestinal Cancers Symposium.

At the interim analysis conducted in June 2024, the median PFS was 29.7 months (95% CI, 20.5-not evaluable [NE]) in the everolimus plus lanreotide group vs 11.5 months (95% CI, 9.0-19.8) in the everolimus monotherapy group. The stratified HR was 0.38 (99.91% CI, 0.15-0.96; one-sided 

The median overall survival (OS) analysis conducted in November 2024 was NE in both groups. The 1-year survival in the everolimus plus lanreotide group was 96.2% (range, 88.8%-98.8%) in the everolimus plus lanreotide group and 97.0% (range, 88.4%-99.2%) in the everolimus group. The HR for OS was 0.74 (95% CI, 0.25-2.24). A total of 13 events were observed; 11 were deaths from the primary disease, 1 was death from another disease, and 1 was unknown.

The objective response rate (ORR) was 23.0% (95% CI, 14.6%-33.3%) in the everolimus plus lanreotide group (n = 87) and 8.3% (95% CI, 3.4%-16.4%) in the everolimus group (

 = .011). Twenty-three percent and 8.3% of patients, respectively, experienced partial responses (PRs), 69.0% and 76.2% had stable disease (SD), 2.3% and 10.7% had progressive disease, and 5.7% and 4.8% were NE. 

The disease control rate (DCR) was 92.0% (95% CI, 84.1%-96.7%) and 84.5% (95% CI, 75.0%-91.5%), respectively (

“The combination of lanreotide and everolimus significantly prolonged PFS in poor prognostic population of [grade 1 or 2 gastroenteropancreatic neuroendocrine tumors], with a manageable toxicity,” Susumu Hijioka, MD, from the Department of Hepatobiliary and Pancreatic Oncology at the National Cancer Center, wrote in the presentation. “Everolimus plus lanreotide has the potential to become a new standard first-line treatment for patients with unresectable or recurrent [gastroenteropancreatic neuroendocrine tumors] of poor prognostic population.”

The primary trial end point was PFS. Secondary end points include OS, DCR, and safety.

A total of 250 patients were randomly assigned, in a 1:1 ratio, to either the everolimus at 10 mg/day plus lanreotide at 120 mg every 28 days or the everolimus monotherapy group was given everolimus at 10 mg/day.

Patients were required to be 20 years or older and have histologically proven grade 1 or 2 gastroenteropancreatic neuroendocrine tumors that are unresectable metastatic, or recurrent. Additional criteria include an ECOG performance status of 0 to 2, no prior history of treatment for metastatic or recurrent disease, and a Ki-67 index of 5% to 20% or a Ki-67 index of less than 5% with diffuse liver metastases.

Per a subgroup analysis for PFS, the first primary site of disease was the pancreas (n = 118) and the gastrointestinal tract (n = 50). The second primary site of disease was the pancreas (n = 118); the duodenum, jejunum, ileum, cecum, or appendix (n = 15); and the stomach, colon, or rectum (n = 35).

Regarding safety, adverse events (AEs) of grade 3 or higher occurred in 35.6% of patients in the everolimus and lanreotide group and 14.9% of patients in the everolimus group. The most common AEs of any grade were oral mucositis (62.1% and 67.8%, respectively), hyperglycemia (62.1% and 33.3%), and diarrhea (36.8% and 26.4%). The most common AEs of grade 3 or higher were hyperglycemia (9.1% and 1.1%), oral mucositis (8.0% and 4.6%), and fatigue (5.7% and 1.1%).

Hijioka noted that the trial was terminated early due to efficacy.

“While lanreotide and everolimus have each previously demonstrated the ability to extend PFS in patients with gastroenteropancreatic neuroendocrine tumors, combination treatment of lanreotide with everolimus was previously unstudied. Establishing this new treatment option benefits patients by expanding their therapeutic choices and potentially improving their prognosis and quality of life,” Laura Vater, MD, MPH, assistant professor of clinical medicine at Indiana University Simon Cancer Center, stated in a press release on the findings.

Susumu H, Honma Y, Machida N, et al. A phase III study of combination therapy with everolimus plus lanreotide versus everolimus monotherapy for unresectable or recurrent gastroenteropancreatic neuroendocrine tumor (JCOG1901, STARTER-NET). 

2025;43(suppl 4):652. doi:10.1200/JCO.2025.43.4_suppl.652

Combination of everolimus and lanreotide investigated in patients with gastroenteropancreatic neuroendocrine tumors. News release. ASCO. Accessed January 21, 2025. https://shorturl.at/RlfJR

Everolimus plus lanreotide resulted in a progression-free survival of 29.7 months in patients with gastroenteropancreatic neuroendocrine tumors, compared with 11.5 months with everolimus monotherapy.

Everolimus Plus Lanreotide Extends PFS in GEP-NETs

Aspirin reduced colorectal cancer recurrence by 50% in patients with 

 mutations after 3 years of use compared with placebo, as demonstrated in 3-year results from the ALASCCA trial (NCT02647099) presented at the 2025 ASCO Gastrointestinal Cancers Symposium.

“This is the first trial to show that mutations in this specific signal pathway, also beyond PIK3CA, predict aspirin response, expanding the target population to more than a third of the patients [with non-metastasized colorectal cancer],” Anna Martling, MD, PhD, FACS, FASCRS, Karolinska Institutet, Lund University, Akademiska University Hospital, said during a presentation of the results. “This is also an example of repurposing a safe, inexpensive, and globally available drug and it stresses the importance of genomic testing in colorectal cancer patients.”

The randomized placebo-controlled trial met its primary end point, reducing the risk for disease recurrence by 51% in patients with 

 exons 9/20 (Group A; HR, 0.49; 95% CI, 0.24-0.98; 

 alterations (Group B; HR, 0.42; 95% CI, 0.21-0.83; 

“This [hazard ratio in Group B] considerably expands the chargeable population to almost 40% of the patients,” Martling added.

In Group A, the 3-year recurrence rate was 7.7% (95% CI, 4.2%-12.5%) among those given aspirin, compared with 14.1% (95% CI, 9.2%-20.0%) in the placebo arm; the rates were 7.7% (95% CI, 4.2%-12.6%) vs 16.8% (95% CI, 11.4%-23.1%), respectively, in Group B.

As a secondary end point, there was no statistically significant difference in 3-year disease-free survival (DFS) rates among those who received aspirin vs placebo in Group A (88.5% [95% CI, 82.3%-92.6%] vs 81.4% [95% CI, 74.4%-86.7%], respectively; HR, 0.61; 95% CI, 0.34-1.08; 

 = .091). However, aspirin use significantly improved DFS rates in Group B (89.1% [95% CI, 83.1%-93.1%] vs 78.7% [95% CI, 71.4%-84.4%], respectively; HR, 0.51; 95% CI 0.29-0.88; 

In addition, Martling noted that, although the trial was not originally powered for subgroup analyses, the advantage of aspirin compared to placebo was observed in all subgroups of patients with colon cancer and rectal cancer; those who received or did not receive neoadjuvant and/or adjuvant treatment; across stage I, II, and III disease; and across females and males.

Severe adverse events occurred in 57 patients who received aspirin, compared with 38 in the placebo arm, with the most common being late post-operative complications (15 vs 8, respectively), deep vein thrombosis (9 vs 7), embolism (6 vs 4), infection (4 vs 4), heart disease (4 vs 3), inflammatory disorder (3 vs 4), and hemorrhage (4 vs 0).

“Aspirin is a well-established and a safe medical medication with well-known side effects,” Martling said. “The incidence of adverse events was as expected.”

She also highlighted the urgent need for improved therapeutic strategies and new biomarkers in colorectal cancer. “In more recent years, aspirin has been shown to reduce the number of colonic polyps in high-risk patients, as well as lower the incidence of colorectal cancer in individuals taking aspirin for cardiovascular reasons,” Martling explained, adding that previous research has also shown that post-diagnosis aspirin may eventually improve DFS. Further, evidence supported that 

 mutations may be a predictor of aspirin’s treatment effect.

Therefore, Martling et al aimed to examine the effect of aspirin on colorectal cancer recurrence by using alterations in the 

 pathway as a potential predictive genetic biomarker.

“Could a safe and inexpensive and widely available drug be repurposed to prevent recurrence in early-stage colorectal cancer next?” Martling hypothesized.

Across 33 hospitals in Sweden, Denmark, Finland, and Norway, 3,508 patients were screened for an alteration in the 

 pathway, of which 37% were identified (Group A, n = 515; Group B, n = 588). Of the 626 patients who continued to trial, 157 and 156 patients in Groups A and B, respectively, received 160 mg aspirin daily for 3 years, while 157 and 156 in each respective group received placebo.

Time to colorectal cancer recurrence (TTR) in Group A served as the primary outcome of the study, while secondary outcomes included DFS in Group A, TTR in Group B, DFS in Group B, and safety.

Median age was 66 years (range, 31-80). In total, 52% of patients were female, with 67% having been diagnosed with colon cancer (stage II, 53%), and 33% with rectal cancer (stage II, 40%). Fifty percent of patients with both rectal and colon cancer had received neoadjuvant therapy.

Martling A, Lindberg J, Myrberg IH, et al. Low-dose aspirin to reduce recurrence rate in colorectal cancer patients with PI3K pathway alterations: 3-year results from a randomized placebo-controlled trial. 

Liao X, Lochhead P, Nishihara R, et al. Aspirin use, tumor PIK3CA mutation, and colorectal-cancer survival. N Eng J Med. 2012;367(17):1596-606. doi:10.1056/NEJMoa1207756.

Aspirin reduced disease recurrence in patients with PI3K-mutated colorectal cancer, underscoring the value of early genomic testing.

Aspirin Linked to Lower CRC Recurrence in Patients With PI3K Mutations

Decoding Symptoms: When Fatigue Speaks Volumes

How do you help patients weigh the risks and benefits of different treatment options?

What tools or techniques do you use to ensure patients and caregivers fully understand their choices?

This program was made possible with support from Novartis Pharmaceuticals.

Panelists discuss how to help patients weigh the risks and benefits of different treatment options for paroxysmal nocturnal hemoglobinuria (PNH), outlining tools and techniques used to ensure that patients and caregivers fully understand their choices and make informed decisions.

Sattva S. Neelapu, MD

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