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Cilta-Cel Improves QOL, Extends Treatment Breaks vs SOC in R/R Myeloma

Acupuncture Use in BC Predicted by Social Determinants of Health

Gene expression in peripheral blood as well as patient-reported outcomes differed for those with acute myeloid leukemia undergoing induction chemotherapy.

Variability Found in PROs, Gene Expression During AML Induction Chemo

Using tools like the ICE Score could improve consistency in grading neurotoxicity tied to bispecific antibodies in hematologic cancers.

Blinatumomab-Linked ICANS Cases Higher Than Previously Reported

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Both those receiving either expected or less-than-expected starting dosages of ruxolitinib for myelofibrosis treatment reduced daily dosages over 12 months.

As-Expected Ruxolitinib Starting Dose Outperforms Lower Dosage in Myelofibrosis

Findings from the phase 1 BrainChild-03 trial support breakthrough designation for BCB-276 for pediatric diffuse intrinsic pontine glioma.

Breakthrough Designation Granted to BCB-276 for Pediatric DIPG

The FDA approved penpulimab-kcqx combination and monotherapy for non-keratinizing nasopharyngeal carcinoma.

FDA Approves 2 Indications for Penpulimab-kcqx in Non-Keratinizing NPC

From 2018 to 2022, cancer mortality dropped across race and ethnicity.

Cancer Mortality Decreased Over 20 Years Despite COVID-19 Pandemic

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Recent research highlighted the need for reliable information to address the educational and psychosocial needs of patients with newly diagnosed metastatic breast cancer.
 

Study Shows Need for Evidence-Based, Educational Material for Providers and Patients with Metastatic Breast Cancer

As oncology nurses, we are all too familiar with the financial burdens our patients face following a cancer diagnosis. Beyond the physical and emotional toll of a cancer diagnosis, many patients experience significant financial distress as they navigate the costs of care, including insurance co-pays, transportation, and lost wages. To mitigate these challenges, some patients turn to crowdfunding platforms, like GoFundMe, to support themselves and their families during treatment.

Crowdfunding for Gynecologic Oncology Care

O’Connor et al. examined the role of crowdfunding in helping patients with gynecologic cancer offset the financial strain caused by medical and non-medical costs of cancer care, often referred to as financial toxicity.

This cross-sectional study examined 600 GoFundMe crowdfunding campaigns, with 200 each for patients with cervical, uterine, and ovarian cancers. Campaigns were selected based on specific criteria, including a US residency and a single gynecologic cancer diagnosis.

The study analyzed campaign goals, total funds raised, unmet financial needs, and geographic distribution, noting whether campaigns originated from Medicaid expansion or non-expansion states. Financial needs were identified from campaign descriptions, with the authors noting whether crowdfunding was for medical or non-medical expenses or both.

The median campaign goal was $10,000, while the median amount raised was $2828—just 28% of the goal. Only 8.7% of campaigns reached their goal, after a median duration of 54 days online.

Ovarian cancer campaigns generally aimed higher and raised larger amounts of money from more donors compared to cervical cancer campaigns. The median donation of ovarian cancer campaigns was $10,500, compared to $10,000 in cervical cancer (

While ovarian cancer campaigns raised more money than cervical and uterine cancer campaigns, there was no significant difference in the percentage of the campaign goal achieved across cancer types.

Across the 3 cancer types, over 80% of campaigns sought funds for treatment-related costs, such as medical bills. Cervical cancer campaigns more frequently mentioned non-medical costs like lost wages and living expenses, highlighting a potentially broader range of unmet needs compared to uterine and ovarian cancer campaigns.

Many campaigns mentioned inadequate insurance coverage as a major driver of financial need. Around 13.5-20.5% of patients were underinsured.

Across gynecologic cancers, campaigns were fundraising for surgery (29-33.5%), chemotherapy (35-50%), and radiation (2-32%). Cervical cancer campaigns had the highest percentage of requests for radiation therapy (cervical, 32.0%; uterine, 15.5%; ovarian, 2.0%).

Campaigns from non-Medicaid expansion states were overrepresented, particularly for cervical and uterine cancer patients. Non-expansion states, which have more restrictive Medicaid eligibility, leaving many low-income individuals without access to coverage, accounted for 40% of cervical cancer campaigns, 44.5% of uterine cancer campaigns, and 30.5% of ovarian cancer campaigns.

These figures are largely higher than the expected 31.4% based on population distribution, suggesting that patients from non-expansion states may face greater financial burdens and are more likely to turn to crowdfunding to cover medical and non-medical expenses.

The study highlights that while crowdfunding has emerged as a resource to help patients offset costs, it often falls short of meeting their full financial needs, with most campaigns raising only a fraction of their goals.

Nurses can play a pivotal role in mitigating the financial toxicity of cancer care by educating patients about available financial assistance programs, including nonprofit organizations, hospital-based support, and local resources. Additionally, nurses can facilitate discussions around healthcare coverage and Medicaid eligibility—especially for patients in non-expansion states—and connect them with social workers or financial counselors for further assistance.

Emotional support is also vital, as nurses can help patients navigate the complex emotional toll of financial distress, recognizing the significant impact it can have on both mental and physical health.

While crowdfunding may offer some relief, it is not a sustainable solution for most patients. By guiding patients toward more reliable financial support systems, oncology nurses can help reduce financial toxicity and ultimately improve their overall well-being.

O'Connor RM, Huang DS, Rimel BJ, et al. Unmet financial needs among patients crowdfunding to support gynecologic cancer care. 

. 2024;186:199-203. doi:10.1016/j.ygyno.2024.05.017

Oncology nurses can support patients facing financial toxicity by offering guidance on available resources and providing emotional support.

Contributor

Opinion: Crowdfunding Falls Short in Gynecologic Cancer

The FDA approved neoadjuvant therapy with durvalumab (Imfinzi) for use with gemcitabine and cisplatin, followed by adjuvant durvalumab monotherapy after radical cystectomy in adults with muscle invasive bladder cancer (MIBC).

The combination’s efficacy was shown in the randomized, open-label, multicenter phase 3 trial NIAGARA (NCT03732677), in which 1,063 patients were randomized 1:1 to treatment with neoadjuvant durvalumab plus chemotherapy followed by adjuvant durvalumab after surgery or neoadjuvant chemotherapy followed by surgery.

Adverse effects (AEs) were consistent with previous experience with durvalumab plus platinum-based chemotherapy.

The combination has a recommended dose of 1,500 mg of durvalumab every 3 weeks with chemotherapy during neoadjuvant treatment and 1,500 mg of durvalumab monotherapy every 4 weeks in the adjuvant setting for patients with a body weight greater than or equal to 30 kg. Treatment is recommended until patients experience unacceptable toxicity, recurrence, or disease progression that prevents definitive surgery.

Event-free survival (EFS) and overall survival (OS), primary and secondary end points, respectively, of NIAGRA, were statistically significantly improved by the combination therapy.

Median EFS was not reached (NR) in the durvalumab plus chemotherapy arm (95% CI, NR-NR) vs 46.1 months (95% CI, 32.2-NR) in the chemotherapy arm (hazard ratio [HR], 0.68; 95% CI, 0.56-0.82; two-sided 

 < .0001). Median OS was NR in both arms (HR, 0.75; 95% CI, 0.59-0.93; two-sided 

 from a pre-planned interim analysis of NIAGARA that compared the above treatment with durvalumab and chemotherapy to placebo indicated that the combination indicated no new safety signals.

Most patients in both arms of the trial experienced AEs of any cause (99% in the durvalumab arm; 100% in the comparator arm), of which 69% and 68%, respectively, were grade 3 or 4. Serious AEs occurred in 62% and 55% of patients, respectively.

AEs that led to death (5%; 6%), discontinuation of study treatment (21%; 15%), discontinuation of neoadjuvant durvalumab (9%; not applicable [NA]), discontinuation of neoadjuvant chemotherapy (14%; 15%), not undergoing radical cystectomy (1%; 1%), delayed surgery (2%; 1%), and discontinuation of adjuvant durvalumab (8%; NA) occurred.

In both arms, 41% of patients had potentially treatment-related AEs (TRAEs). Of those, 0.6% resulted in death in both arms. Immune-mediated AEs of any grade were reported in 21% of patients taking durvalumab and 3% of patients in the chemotherapy arm. In the adjuvant phase, potential TRAEs were seen in 41% and 6% of patients in the durvalumab and placebo arms, respectively; 6% and 1% of these were grade 3/4. No potential adjuvant TRAEs led to death in either arm.

The most common any-grade AEs were nausea (durvalumab arm, 54%; placebo arm, 49%), anemia (39%; 41%), constipation (39%; 39%), fatigue (36%; 32%), urinary tract infection (30%; 29%), decreased appetite (27%; 25%), neutropenia (26%; 31%), pyrexia (21%; 17%), diarrhea (21%; 14%), vomiting (19%; 18%), blood creatinine increase (19%; 15%), asthenia (18%; 18%), neutrophil count decrease (15%; 14%), and pruritis (15%; 7%).

FDA approves durvalumab for muscle invasive bladder cancer. FDA. March 28, 2025. Accessed March 28, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer

Powles T, Van der Heijden MS, Galsky M, et al. A randomized phase III trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer (NIAGARA). Presented at: 2024 ESMO Congress; September 13-17, 2024; Barcelona, Spain. Abstract LBA5.

The FDA has approved neoadjuvant durvalumab plus chemotherapy followed by adjuvant durvalumab after radical cystectomy in MIBC.

FDA Approves Perioperative Durvalumab Plus Chemotherapy for MIBC

New data from a real-world, multicenter study published in the 

Journal of Occupational Environmental Hygiene

 show that the Splashblocker portable toilet  cover is effective in reducing the number of particles released in toilet plume aerosols (TPA) in hospitals.

Across 145 toilets in 15 hospitals, the median reduction in particle concentration after implementation of Splashblocker was approximately 100%, with a mean of 101±11% (

 = .0002). Of note, this was regardless of HEPA filter usage. Without a cover, mean particle concentration was 3951#/L±8606 #/L, and the median was 1916 #/L (range: 136-71,959).

As noted in the study, the release of toxins from patient urine has been identified as a significant risk for oncology nurses, and it is recommended by the Oncology Nursing Society that oncology nurses cover toilets with a plastic-backed pad when flushing waste from patients.

“We need to be thinking about all the different avenues of exposure. We’ve gotten pretty good—not perfect—on wearing PPE for administering chemo and disconnecting chemo… But this is an area that, really, we haven’t really done much about,” said Seth Eisenberg, RN, ON, BMTCN, in an interview with Oncology Nursing News. “People have to realize that you need to step up and do things for protection. So that's an obligation for the profession.”

Of note, 94 (85%) toilets demonstrated a particle count reduction of at least 90% when covered with Splashblocker, 107 (97%) showed reduction by at least 80%, and 3 (less than 3%) toilets had a reduction of less than 80%. Investigators found that these toilets had uneven surfaces that cause several gaps of 2-3 mm each between the porcelain and the cover.

“Given the observed variability in effectiveness, future studies might also consider a more nuanced examination of design and environmental factors to optimize particle reduction strategies in healthcare settings,” Eisenberg and Changjie Cai, PhD, noted in the publication of the results.

Floors with HEPA filters were associated with statistically lower ambient particle levels (376±857 #/L) vs floors without HEPA filters (7432±9207#/L). Mixed-effects modeling demonstrated that particle reduction with the Splashblocker in place was significant regardless of floor level (1 through 18), room type (inpatient vs outpatient), geographical state, or flush volume.

Particle counts were measured with a TSI 9306-04 v2 optical particle counter (OPC), which was programmed for a 15-second delay, allowing study personnel to exit the room to reduce further airflow disturbances. The 

 was placed at a distance of 66 cm above the floor to represent the breathing zone of a nurse leaning to flush a toilet.

Measurements were taken for 60 seconds per flush to simulate the greatest amount of time a healthcare worker would typically remain in the room after flushing a patient’s urine. Six bin sizes were studied: 0.3-0.5 µm, 0.5-0.7 µm, 0.7-1.0 µm, 1.0-2.0 µm, 2.0-5.0 µm, and 5.0-25 µm. Particles smaller than 300 nm were not measured.

In an interview with Oncology Nursing News, Eisenberg recounted some of the more remarkable observations he and study personnel found in the differences in rooms when measuring.

“One bathroom we measured…we measured it uncovered first, and then we go back in, usually about 15 minutes later, and measure the ambient [particles] to make sure it went back down to baseline,” said 

. “It never went down. And we actually opened up the door and propped it open with a trash can to try to get it to ventilate. And even after 45 minutes, that bathroom still had a high concentration of particles.”

Researchers examined rooms where patients were not present in order to reduce the effect of airflow disturbances and reduce interruptions to regular care.

Eisenberg S, Cai C. Reducing the particles generated by flushing institutional toilets. Part II: Assessing a portable and reusable toilet cover in U.S. hospitals. 

. 2024;21(12):847-856. doi:10.1080/15459624.2024.2398752

While ambient particle levels differed by HEPA filter status, Splashblocker significantly reduced particles emitted from toilet plume aerosols regardless. 

Splashblocker May Reduce Toilet Plume Aerosols in Oncology Setting 

Seth Eisenberg, ASN, RN, OCN, BMTCN, discusses real-world findings on a portable toilet seat cover for hospital toilets

Seth Eisenberg, ASN, RN, OCN, BMTCN, discusses real-world Splashblocker data

A real-world study across 15 hospitals demonstrated that the Splashblocker, a reusable toilet barrier, significantly reduced aerosolized particles from urine, minimizing potential exposure to harmful drugs for oncology nurses and advanced practice providers, among other healthcare professionals.

Journal of Occupational and Environmental Hygiene

, researchers took into account HEPA filtering, floor elevation, and building age among other factors when 

 of the Splashblocker toilet cover in the clinical setting, according to lead investigator Seth Eisenberg, ASN, RN, OCN, BMTCN.

Oncology Nursing News spoke with Eisenberg about the real-world study’s key considerations and results. The study examined toilets at 15 hospitals across the country and tested particle number concentrations before and after flushing, with and without the toilet cover.

Eisenberg noted that factors including the age of the building and HEPA filtering made a difference at baseline, but after using the Splashblocker, reductions in particle count was similar across bathrooms.

Well, there’s been an ongoing concern over, I’d say, the decades about potential exposure in oncology, particularly to drugs that are excreted in urine. And so an oncology nurse actually came up with the concept of designing a solid, removable and 

 that could actually prevent or minimize the amount of exposure of the aerosols that come out of a toilet.

. What happens in the laboratory is great, but we need to get this out and see what's happening clinically as well.

So we designed a large scale, multi-center study, and we ended up enrolling 15 different hospitals across the country, and there was no statistical difference in the elevation of the buildings.

What we did find, however, [was] that there was a definitely a difference in the design of the ventilation in the bathrooms. Older facilities tended to be less efficient at removing aerosols from bathrooms. We found several bathrooms that had ventilation was totally nonfunctioning.

[In] one bathroom, we measured it: it was an outpatient facility, a shared bathroom. We were there, we measured it uncovered first, and then we go back in, usually about 15 minutes later, and measure the ambient to make sure it went back down to baseline, because you need to know where you're starting from.

It didn't go down. It never went down. We actually opened up the door and propped it open; even after 45 minutes, that bathroom still had a high concentration of particles because the vent in the ceiling was not doing anything at all.

HEPA-filtered bathrooms tend to have fewer ambient particles. So it means, when you made a baseline, it was statistically significantly lower.

Once we put the cover on, all bets were off. With a Splashblocker in place, it was [a] 99% reduction, which is almost as if the toilet was never flushed at all. It's like it never happened.

This transcript has been edited for clarity and conciseness.

Eisenberg S, Cai C. Reducing the particles generated by flushing institutional toilets. Part II: Assessing a portable and reusable toilet cover in U.S. hospitals. 

Seth Eisenberg, ASN, RN, OCN, BMTCN, explained his research on a toilet cover for oncology nurses to potentially reduce exposure to infectious pathogens and hazardous drugs.

Toilet Cover May Significantly Reduce Aerosol Exposure in Hospital Bathrooms

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. 

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

Kevin Wright

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