Most patients travel to receive CAR T-cell therapy at a specialized center and clear communication with the primary care provider following treatment is key in ensuring appropriate follow-up care, says Sherry Adkins, MSN, ANP-C.

Adkins is a nurse practitioner in the Department of Myeloma and Lymphoma at University of Texas MD Anderson Cancer Center, who has been involved with several CAR T-cell therapy trials. She also serves as the supervisor for advanced practice providers administering CAR T-cell therapies at the institution.

®, Adkins discussed the significance of the 

recent FDA approval of lisocabtagene autoleucel

 (Breyanzi) in the second-line setting for patients with large B-cell lymphoma.

In the discussion, she highlights the value of communicating common effects to the primary care provider such as low blood counts following this therapy, and to give clear instructions on when the patient would require a transfusion for anemia or thrombocytopenia.

It is also important that the primary care provider be cognizant of the prophylactic antimicrobials that a patient should be taking following treatment, she added. At MD Anderson, Adkins notes that patients are treated with antiviral and anti-pneumocystis pneumonia prophylactically for 1 year to protect them against shingles, which was reported among patients who ended their prophylaxis early.

“It is important for the patient to know [this information as well],” Adkins adds, advising that patients keep a copy of their CAR T-cell therapy information on hand should a medical emergency arise. “If they ever need to go to the emergency department, they can present that to the emergency department to help [the care team] understand some things about [their] CAR T-cell therapy.”

Videos

Sherry Adkins, MSN, ANP-C, discusses some key considerations in ensuring quality patient care after they have completed CAR T-cell therapy at a specialized center.

Sherry Adkins Talks Primary Care Provider Communication Following CAR T-cell Therapy

Lindsay Fischer is the Associate Editor at ONN. She joined MJH life sciences in 2021 after graduating from Rutgers University with majors in both English and Spanish and a minor in creative writing. When she is not writing, or researching the latest oncology nursing news, Lindsay is an amateur backpacker and rollerblader. Email Lindsay at lfischer@mjhlifesciences.com

Fam-trastuzumab deruxtecan-nxki (Enhertu) has received accelerated approval from the FDA based on findings from DESTINY-Lung02 (NCT04644237). The antibody-drug conjugate has been approved for previously treated patients with 

-mutated unresectable or metastatic non–small cell lung cancer (NSCLC).

Phase 2 findings showed that the overall response rate among a pre-specified patient cohort (n = 52) was 57.7% (95% CI, 43.2%-71.3%), as confirmed by blinded independent central review. Complete responses were observed in 1.9% of patients and partial responses were observed in 55.8% of patients. The median duration of response was 8.7 months (95% CI 7.1-not estimable). Further analyses on DESTINY-Lung02 trial are anticipated at upcoming medical meetings.

“The approval of trastuzumab deruxtecan in NSCLC is an important milestone for patients and the oncology community,” Bob T. Li, MD, PhD, MPH, a medical oncologist and physician-scientist at Memorial Sloan Kettering Cancer Center, said in a news release. “After 2 decades of research into the role of targeting 

 in lung cancer, the approval of the first HER2-directed treatment option validates 

 as an actionable target in lung cancer and marks an important step forward for treating this patient population with unmet medical needs.”

The recommended dose of trastuzumab deruxtecan is 5.4 mg/kg administered as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. For patients who require dose reduction because of adverse events (AEs), the first recommended dose reduction for NSCLC is 4.4 mg/kg, followed by 3.2 mg/kg. If a patient is unable to tolerate 3.2 mg/kg, treatment should be discontinued.

Trastuzumab deruxtecan should not be re-escalated following a dose reduction. If a patient misses a dose or has it delayed, the dose should be administered as soon as possible. Providers should not wait until the next planned cycle, but rather adjust the schedule so to maintain a 3-week interval between doses.

According to the label, the targeted therapy is moderately emetogenic, and may induce delayed nausea and/or vomiting. Prophylactic antiemetic medications are recommended and should be administered in accordance with institutional guidelines.

Trastuzumab deruxtecan is associated with the following clinically significant AEs: interstitial lung disease (ILD)/pneumonitis, neutropenia and left ventricular dysfunction.

-mutant NSCLC who received this agent at 5.4 mg/kg. The median onset time was 2.8 months (range, 1.2-21 months). Approximately 1% of patients died because of ILD complications.

Patients should be taught to report any cough, dyspnea, fever, or any new or worsening respiratory symptoms. Patients suspected of having ILD should be assessed via radiographic imaging. Consulting a pulmonologist may be appropriate.

For asymptomatic ILD, corticosteroid treatment may be considered, with a treatment hold until recover. In the event of grade 2 or higher ILD, systematic corticosteroid treatment should be initiated promptly, and continued for at least 14 days with a gradual taper across a minimum of 4 weeks. Patients diagnosed with symptomatic ILD must permanently discontinue trastuzumab deruxtecan.

Decreased neutrophil counts occurred in 65% of patients with NSCLC who received trastuzumab deruxtecan, of whom 16% had grade 3 or 4 severity. The median onset time was 22 days (range, 2-664 days). Approximately 1.1% of patients developed febrile neutropenia. Complete blood counts should be assessed at baseline and monitored after each dose. Depending on neutropenia severity, dose interruptions or reductions may be necessary.

Left ventricular dysfunction occurred in 3.6% of patients, of which 0.4% were grade 3. Left ventricular ejection fraction (LVEF) decreased has been observed with anti-HER2 therapies, including trastuzumab deruxtecan. LVEF should be assessed at baseline and at regular intervals throughout treatment. If LVEF drops below 40% or an absolute decrease from baseline greater than 20% is detected, the targeted therapy should be permanently discontinued. If symptomatic congestive heart failure occurs, the therapy should be discontinued.

As of August 2022, the agent has not been studied in patients with a history of clinically significant heart disease of LVEF less than 50% before treatment initiation.

Patients should also be educated about the embryo-fetal toxicity associated with the drug. Common AEs included in the trial included nausea (61%), decreased white blood cell count (60%), decreased hemoglobin (58%), decreased neutrophil count (52%), decreased lymphocyte count (43%), decreased platelet count (40%), decreased albumin (39%), increased aspartate aminotransferase (35%), increased alanine aminotransferase (34%), fatigue (32%), constipation (31%), decreased appetite (30%), vomiting (26%), increased alkaline phosphatase (22%), and alopecia (21%).

If not immediately used, trastuzumab deruxtecan should be protected from light and stored in a refrigerator between 36 to 46 degrees Fahrenheit. It should not be frozen. If not used after 24 hours, it should be discarded.

The reconstituted agent should be dilated in an intravenous infusion bag containing 100 mL of 5% dextrose injection, USP. It should not be diluted with sodium chloride injection, USP.

It is compatible with infusion bags composed of polyvinylchloride or polyolefin, filters used during administrations should also be composed of polyvinylchloride or polyolefin. The first infusion should be given over a 90-minute span. If well tolerated, further infusions can be given over a 30-minute span.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for HER2-mutant non-small cell lung cancer. FDA. Updated August 11, 2022. Accessed August 12, 2022. https://bit.ly/3bVts9g

Enhertu. Prescribing information. Daiichi Sankyo Company, Ltd; 2022. Accessed August 12, 2022. 

Articles

The FDA has approved trastuzumab deruxtecan for patients with HER2-mutated non–small cell lung cancer after the DESTINY-Lung02 results demonstrated a 57% overall response rate with the agent. The drug comes with warning for interstitial lung disease, neutropenia, and left ventricular dysfunction. 

HER2-Directed Therapy, Trastuzumab Deruxtecan, Approved for Metastatic NSCLC

Following data from a 22-month extended follow-up, the FDA has granted capmatinib (Tabrecta) full approval for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors harbor a 

 exon 14 skipping, as detected by an FDA-approved test.

 on the same indication based on initial overall and duration of response (DOR) rates observed in the GEOMETRY mono-1 trial (NCT02414139), a multicenter, non-randomized, open-label, multi-cohort study. Patients with metastatic disease (n = 160) and a mutation leading to 

 exon skipping received 400 mg of oral capmatinib twice daily until disease progression or unacceptable toxicity.

Data supporting the 2020 accelerated approval included the overall response rate (ORR), which was 68% (95% CI, 55%-80%) among the treatment-naïve subgroup (n = 60) and 44% (95% CI, 34%-54%) in the pretreated group (n = 100). The DOR was 16.6 months (95% CI, 8.4-22.1) and 9.7 months (95% CI, 5.6-13), respectively.

The recommended dose for capmatinib is 400 mg orally twice daily with or without food. Patients should be instructed to swallow the tablets whole.

 They should not be broken, crushed, or chewed. If a patient misses or vomits a dose, they should not attempt to make up the dose, but instead wait and take the next dose at the scheduled time.

In the event of adverse reactions, providers should reduce the dose to 300 mg twice daily. At second adverse event (AE), the dose should be further reduced to 200 mg twice daily. Patients who are unable to tolerate 200 mg twice daily should permanently discontinue the drug.

The drug comes with warnings for interstitial lung disease (ILD) and pneumonitis, hepatotoxicity, and pancreatic toxicity. Patients should be educated for their increased risks of these events and taught to monitor and report the appropriate symptoms.

Approximately 4.8% of patients enrolled in GEOMETRY mon-1 experienced ILD or pneumonitis, and 1.9% of these cases were graded as grade 3. One patient died as a result of ILD/pneumonitis and 9 patients discontinued treatment because of ILD/pneumonitis complications.

Any signs of pulmonary symptoms, including dyspnea, cough, and fever should be monitored and reported immediately. The median time-to-onset time for grade 3 or worse events was 1.8 months (0.2 months – 1.7 years). Capmatinib should immediately be withheld if this AE is suspected and discontinued if it is positively identified.

An increased in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was observed in 15% of patients who received capmatinib, of which 7% became grade 3 or 4. Three patients discontinued treatment because of hepatotoxicity.

Liver function should be tested at baseline and monitor every 2 weeks throughout the first months of treatment. These tests should include ALT, AST, and total bilirubin. After 3 months, la should be collected once a month, or as clinically indicated, with more frequent routine assessment for those who develop increased transaminases or bilirubin. If severe AEs begin to develop, it may be appropriate to withhold, dose reduce, or permanently discontinue capmatinib.

Fourteen patients experienced elevations in amylase and lipase levels, 7% and 1.9% of whom experienced grade 3 and 4 severity, respectively. Three patients discontinued because of pancreatic toxicity. One patient permanently discontinued treatment because of grade 3 pancreatitis.

Amylase and lipase levels should be assessed at baseline and regularly monitored throughout treatment. If severe AEs begin to develop, it may be appropriate to withhold, dose reduce, or permanently discontinue the agent.

Overall, the most common serious AEs included dyspnea (7%), pneumonia (7%), pleural effusion (4.3%), musculoskeletal pain (3.8%), general physical health deterioration (2.9%), ILD/pneumonitis (2.7%), and vomiting (2.4%). Fatal AEs occurred in 0.5% of treated patients, with pneumonitis representing the leading specified cause (0.3%).

Seventeen patients needed to discontinue because of an AE. The AEs most commonly associated with discontinuation included ILD/pneumonitis (2.4%), edema (2.4%), fatigue (1.3%), and pneumonia (1.1%).

Dose interruptions occurred in approximately 57% of patients on the trial. The AEs most likely to require a dose interruption included edema, increased blood creatinine, nausea, increased lipase, vomiting, increased ALT, dyspnea, pneumonia, fatigue, increased amylase, increased AST, musculoskeletal pain, abdominal pain, and increased blood bilirubin. The AEs most likely to require a dose reduction were edema, increased ALT, and increased blood creatinine.

According to a news release, nearly 70% of patients with NSCLC have a genomic mutation, and 3% to 4% of patients with NSCLC have 

The approval of this agent represents another targeted therapy for those 4000 to 5000 patients with this oncogenic driver mutation.

FDA approves capmatinib for metastatic non-small cell lung cancer. FDA. August 10, 2022. Accessed August 11, 2022. 

Capmatinib. Prescribing information. Novartis Pharmaceuticals Corp; 2022. Accessed August 11, 2022. https://bit.ly/3JLN2kQ

Novartis announces FDA approval of MET inhibitor Tabrecta for metastatic non-small cell lung cancer with METex14. May 6, 2020. Accessed August 11, 2022. https://bit.ly/2SIEmTc

The FDA has granted capmatinib regular approval for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have a mutation leading to MET exon 14 skipping. The drug comes with warning for pneumonitis, hepatotoxicity, and pancreatic toxicity. 

Capmatinib Snags Full FDA Approval for MET Exon 14 Skipping NSCLC

The great resignation, spurred by the COVID-19 pandemic, has taken an enormous toll on the nursing field. 

In a poll conducted in September 2021, results showed that 20% of health care professionals had abandoned their position since February 2020.

Furthermore, a report examining labor trends in 2020 found that 24% of all hired nurses leave their position within 1 year of being hired.

 Coupled with increasing demand and a depletion of resources, many units are losing nurses  and other staff at an unsustainable rate.

From a financial perspective, the average cost of a single bedside registered nurse (RN) turnover is $40,038, and cost of turnover per health care system for every 1000 nurses hired is $9,609,120.

Although there is no single solution to address the staffing crisis, institutions can start with the onboarding process to better engage and retain employees. Solidified onboarding processes, structured mentorship programs, and clear pathways for career development are crucial factors in ensuring that new hires feel valued and supported.

“Once you invest in a person—through the process of hiring, interviewing, bringing them through a solid orientation—you show them that you want them to stay,” Nicola Stewart, MHL, RN-NC, BSN, OCN, a complex gastrointestinal cancer nurse navigator at Methodist Healthcare at Sarah Cannon Cancer Institute in San Antonio, Texas, explained in an interview with 

. “[It is important] to focus on that individual and to create a family atmosphere. It is how you inspire loyalty and how you create a support system at work.”

Stewart joined Lance Ortega, MBA, BSN, RN, OCN, director of nursing services at Texas Oncology in Dallas; and Lyndsey Conway, MN, RN, BMTC, of Seattle Cancer Care Alliance in Washington, in a presentation at the 2022 Oncology Nursing Society Congress.

Their presentation, “Mission Possible: Enhancing Oncology Nurse Recruitment and Retention,” highlighted the causes of RN turnover, including stress, burnout, inflexibility, lack of representation, too much overtime, and external competition. They also presented opportunities for institutions to address those root causes. One of those considerations is through enhanced onboarding strategies and ongoing developmental support.

“There is no 1 magical fix to correct these issues,” Ortega said in an interview with Oncology Nursing News®. “The series of events that led us here, as an industry and profession, [was] complex, longstanding, and sometimes subtle but profound. That means our solutions to these dilemmas will need to be creative, innovative, and more outside-the-box than ever before. The solutions will also not occur overnight or even on the first attempt, and our path forward will be long and very difficult at times. However, for the sake of our patients and the overall health care system, we need leaders and organizations [to be] committed to and engaged in changing the face of nursing for the future in such a way that we reinvigorate our staff to remember their reasons why they became, and continue to be, a nurse.

One critical aspect of a good onboarding program is mentorship, Stewart explained in the presentation.

 Everyone needs guidance, new nurses especially, and the key to ensuring this is through a well-defined mentorship program, she said. Preceptors from different units should be intentionally matched to preceptees and rotated among different preceptees during orientation to expose a new hire to multiple people because, as Stewart explained, 1 person never has all the answers.

Incentivizing mentors and preceptors with bonuses helps ensure that teachers are enthusiastic about educating the new nurses. “Identifying mentorship opportunities and having a good, quality preceptor [is critical],” Stewart said. In addition, training preceptors on how to mentor and instruct new staff by providing clear guidelines and expectations for the onboarding process should be a key pillar of the program. Regular check-ins to evaluate the progress of the trainee, as well as the enthusiasm and desire of the mentor to continue precepting, are also important. 

“Even the best preceptors need breaks from time to time,” Ortega said, adding that “new nurses need methodical and unrushed onboarding with a preceptor who is willing and wanting to onboard these nurses in an environment that is as conducive to learning as possible.”

A methodical and unrushed program, according to Ortega, comprises evidence-based materials and competency cutoffs that have been vetted by those currently performing the role. The program should have a timeline for milestones that is both realistic for the position and tailored to the new nurse’s learning style and experience level. Furthermore, Ortega said, environment should be a key consideration when thinking about onboarding. A busy or chaotic floor or unit may not be conducive to learning and development. Identifying floors or areas that are ideal for training and onboarding can contribute to an improved overall learning environment.

Stewart also recommended building the team through enthusiasm and positivity. She acknowledged that it is a difficult time to work in nursing, and that listening to colleagues and supporting them is important to show them that you are there for them.

“Once you create that family and that bond, relationships have been created. It’s difficult to [want] to walk away from that,” Stewart said. Finally, investing in an individual and their future with their company is a great way to establish a desire to continue with the company. “Appreciate the loyalty, offer longevity bonuses, and be there for one another,” Stewart said.

Anna Vioral Gavin PhD, MEd, RN, OCN, BMTCN

“When I moved to ambulatory oncology, there was [no] infrastructure built for onboarding oncology nurses,” Anna Vioral Gavin, PhD, MEd, RN, OCN, BMTCN, reflected in an interview with Oncology Nursing News®. “It’s taken us 3 years to get to where we are today—to build the infrastructure to properly onboard an oncology nurse—with 26 geographically dispersed locations.”

Vioral, who is director of oncology practice and professional development at the Allegheny Health Network Cancer Institute in Pittsburgh, Pennsylvania, helped to launch a successful oncology practice and professional development program at her institution with a focus on building resiliency in the ambulatory setting.

One challenge was how to centralize an innately decentralized onboarding experience. This led to the development of the Oncology Professional Proficiency Initiative, an individualized onboarding experience within the Allegheny Health Network.

“In-patient [nursing] has a lot in infrastructure for onboarding, but ambulatory settings tend to be all over the place,” Vioral said. 

Vioral’s professional development team meets with new oncology nurses during the week following their initial hire, along with the preceptor and the manager. The novice nurses are asked to complete a self-assessment of skills and past experience, which provides direction for what they should be focusing on in their biweekly meetings.

“If they’ve been starting [intravenous infusions] IVs for 20 years, we spend [approximately] 10 minutes with them teaching them our way,” Vioral explained. “Whereas, if they’ve not done certain types of infusions, then we spend that time working on those infusions.”

The biweekly meetings are scheduled over 90 days, and during that time the new hires are expected to meet the rudimentary goals of oncology nursing. Another unique piece of the proficiency initiative is that in the first 2 weeks of onboarding, the nurses’ main responsibility is to learn more about the roles in the institute and the locations.

“[New nurses] are assigned a role observation for their location. For example, if they were hired into medical oncology, they have a document that has them sit with each role in each department, including medical oncology, radiation oncology, support care services, hematology, and gynecologic oncology,(surgical oncology, is optional). They will sit with the front desk for anywhere from 30 minutes to 2 hours; they will go with the medical assistant; they will go with the clinical pharmacists and watch how [prescriptions] are prepared, verified, and mixed. They [will gain an understanding of] the timeframe of why things take solong back there with certain drugs. That helps them in the front end, when they’re administering [drugs, because] they understand the workflow process of the office. [Nurses will] follow a physician and an advanced practice nurse. They even spend a full day in radiation oncology observing the workflows there. And then we set up informal connections with all our supportive care services,” Vioral said.

Trainees receive a document that helps them identify who are the institute’s genetic counselors, who are members of nutritional services, etc. This becomes an additional resource for them, allowing them to know who plays what role in the institute. The team also hosts an “Oncology Interprofessional Onboarding Course,” which is held every month for all new hires across the cancer institute. The first 4 hours encompass soft skills; such as conflict resolution, de-escalation, and communication skills however, the afternoon features breakout discipline-based sessions. For nurses, there is a special emphasis on supportive care therapies and nononcology infusions, as well as oncologic emergencies and management of patients with cancer .

Notably, all new hires are all expected to test out of the chemotherapy program, even if they arrive with a chemotherapy card.

“This serves as a bridge into how we do things here,” Vioral explained. “Even if they’ve been an oncology nurse for 30 years, it gets them used to our organization and how we do things.”

The program has been fruitful. Many recently hired nurses shared in an anonymous survey that the program not only helped them feel supported and confident to independently care for their patients, but they also felt it built their resilience.

One nurse said that the Allegheny Health Network onboarding experience helped them “bounce back from difficult situations because the training taught how to step back and remain calm to handle patients professionally and efficiently.” Other new hires’ responses stated that the program was “incredibly helpful” in becoming familiar with “all the roles involved with the Allegheny Health Network team” and let them focus on the areas they individually neededassistance with.

One nurse shared that the program helped build resilience by assuring new hires that the role takes to time to adapt to; another shared that they really appreciated the fact that someone was consistently checking up with them to ensurethey understood their role.

“This onboarding program was the best I’ve ever had,” one respondent shared.

When it comes to training, faster isn’t always better, according to Vioral. Hasty training can lead to attrition if employees do not feel they have the resources to successfully do their job.

“I love patients, but staff is what makes the difference,” Vioral, who has worked in patient care for more than 33 years, said. “If an employee is not [properly] trained, [does] not like what they are doing, or we are not meeting their needs, they are going to leave—which [affects] the quality of care we give to our patients.”

When employees leave, Vioral’s team needs to bring more nurses in and train them, which can be costly. This can be another barrier to care. However, whenever the opportunity presents itself, Vioral will try to shift a nurse to a new area rather than see them leave. “So rather than lose them from the organization, I will do everything in my power to get them to stay,” Vioral said.

When first initiating this program, something that Vioral frequently was asked was, “Why are you stealing my nurse?”

“That was a huge barrier,” she said. “I would say, ‘I’m not stealing your nurse.

It’s an oncology nurse with a very sound understanding of oncology. They’re going to leave if they lose interest.’” Vioral noted, “We have medical oncology, surgery, chemo, nurse navigation….We have so many opportunities. Some nurses do not want to move up; they want to stay lateral and move into different roles and learn them. We’re professionally developing them into a new area of nursing.”

When you move nurses and do not have to retrain new nurses, you save yourself money and time and become more efficient, Vioral said. 

The decision to allocate sources to the outpatient setting can sometimes be a hurdle, she added. Inpatient services may feel as though the time and money spent on training is a loss to their department. However, according to Vioral, “The outpatient setting is where oncology is now. It is not all inpatient nursing anymore. If you have an oncology nurse who wants to do that, they are going to go to another organization or ambulatory to get what they need.” Ultimately, lateral moves are a way to retain nurses across the institution, she said.

Similarly, Stewart emphasized the need to look at an individual’s potential growth beyond their current position during the onboarding process. “A new patient care assistant on their first day could be the future chief nursing officer,” Stewart said. “You never know what [individuals] will want to do in the future and what capabilities they possess. You want to grow these [employees] and avoid turnover so you can build within for generations to come.”

“Investing in our nurses is key to future retention,” Ortega said. “If you survey most nurses, specifically surrounding their reasons for staying with their current company, the vast majority of them will say their coworkers and patients keep them there. Strategies for retaining nurses needs to focus on those areas as a foundation and expand from there. So I think about things [such as] increased educator positions and roles to engage and knowledge- share experiences with the staff and even patients. Survey the nurses to see what is most appealing to them. This could include things [such as] different scheduling options, retention bonuses, different salary models, new workflows and staffing patterns.”

Overall, experts agreed that engagement is at the heart of retention. Listening to new nurses and acting on their behalf goes far in making them feel heard and valued. By investing at the beginning, most organizations will see increased loyalty and, ultimately, boosted retention. 

1. Ortega L, Stewart N, Conway L. Mission possible: enhancing oncology nurse recruitment and retention. Presented at: 47th Annual Oncology Nursing Society Congress; April 27-May 1, 2022, Anaheim, CA.

2. Galvin G. Nearly 1 in 5 health care workers have quit their jobs during the pandemic. Morning Consult. October 4, 2021. Accessed July 14, 2022. https://morningconsult.com/2021/10/04/

health-care-workers-series-part-2-workforce/

3. NSI National Health Care Retention & RN Staffing Report. NSI Nursing Solutions, Inc. Accessed July 11, 2022. https://www.nsinursingsolutions.com/Documents/Library/NSI_ National_Health_Care_Retention_Report.pdf

In an unprecedented age of health care burnout, hospital administrators may
need to think outside of the box to find ways to engage and support employees.

Structured Onboarding Processes Boost Employee Retention 

The addition of novel targeted and immunotherapies, as well as antibody-drug conjugates, into the urothelial cancer (UC) treatment paradigm has accentuated the importance of the oncology nurse’s role in patient education and symptom management, according to Laura Wood, RN, MSN, OCN.

“I’d like nurses to know that we’ve made significant strides in improving treatment options for patients with urothelial carcinoma,” Wood said in an interview with 

 “Nurses play a critical role in providing education to patients and caregivers, ensuring that [adverse effects] AEs and [immune-related AEs] irAEs are identified early so appropriate interventions can be initiated, [all] while continuing to provide emotional support [to patients] as they navigate the cancer journey.”

Wood, a retired oncology nurse specialist with the Cleveland Clinic Taussig Cancer Institute, recently presented on treatment updates in the schema as part of the 

®, she highlighted avelumab (Bavenzio), erdafitinib (Balversa), and enfortumab vedotin-ejfv (Padcev) as 3 key drugs that nurses caring for patients with urothelial carcinoma should be aware of underscoring what makes them unique and what the best AE management looks like with them.

The current standard of care maintenance treatment for patients with locally advanced or metastatic urothelial cancer that has not progressed with frontline platinum-based chemotherapy is avelumab. This drug was approved for patients who have received prior treatment with at least 1 line of platinum-based chemotherapy following positive results from the JAVELIN Bladder 100 trial (NCT02603432),

 which compared the efficacy of avelumab plus best supportive care (BSC) against BSC alone.

An analysis of long-term outcomes found that the 30-month overall survival (OS) rate with avelumab (n = 350) was 43.7% compared with 33.5% with BSC (n = 350). In addition, the median progression-free survival (PFS) was 5.5 months vs 2.1 months (HR, 0.54; 

 < .001) in the experimental and control arms, respectively, and the 30-month PFS rate was 19.3% vs 6.3%, respectively.

“Nurses need to be aware that this treatment is available, [and] that it is an approved option for patients who are doing well and benefiting from first-line platinum-based chemotherapy,” Wood said. “They also need to know that it requires pre-medication for the first 4 infusions due to the potential for an infusion-related reaction. That is unique compared to the other checkpoint inhibitors we use in oncology.”

As of August 2022, National Comprehensive Cancer Network guidelines dictate that patients with locally advanced or metastatic disease who are cisplatin-eligible may receive cisplatin-based combination chemotherapy followed by avelumab maintenance therapy or dose-dense methotrexate, vinblastine, doxorubicin, cisplatin (DDMVAC) with growth-factor support for 3 to 6 cycles followed by avelumab maintenance therapy.

Patients who are cisplatin ineligible may receive gemcitabine plus carboplatin chemotherapy followed by avelumab maintenance therapy. They may also receive atezolizumab (Tecentriq) or pembrolizumab (Keytruda) if their tumors express PD-L1 and they are not eligible for any platinum-based chemotherapy regardless of PD-L1 expression. They may also receive gemcitabine with or without paclitaxel.

For second-line treatment, the preferred agent is pembrolizumab (category 1 post-platinum). Other favorable alternatives to pembrolizumab include the immune checkpoint inhibitors, nivolumab (Opdivo) and avelumab; and monotherapy with the agents erdafitinib, and enfortumab vedotin. Paclitaxel, docetaxel, and gemcitabine are also viable options included in the guideline.

In certain circumstances, depending on a patient’s prior treatment history, the following options may also be useful: ifosfamide, doxorubicin, and gemcitabine; gemcitabine plus paclitaxel; gemcitabine plus cisplatin; and DDMAC with growth-support factor.

Erdafitinib is approved for patients with locally advanced or metastatic UC that is susceptible to 

 genetic alterations and that has progressed during or following at least 1 line of platinum-based chemotherapy—including within 12 months of neoadjuvant or adjuvant therapy.

The companion tests to determine if a patient is eligible for erdafitinib are the Theraseen GRGR RGQ RT-PCR kit, and the formalin-fixed, paraffin embedded (FFPE) tissue sample.

“Tumor testing is required,” Wood stressed. “There’s biomarker testing involved, and [erdafitinib] is approved for patients who have progressed during or following frontline platinum-based chemotherapy. [It] remains a mainstay in our treatment plan within 12 months of neoadjuvant or adjuvant therapy.”

Notably, Wood highlighted, “The unique component to erdafitinib is that there is the potential for dose titration.”

The starting dose for erdafitinib is 8 mg once daily (two 4-mg tablets). After the patient has been taking erdafitinib for 14 to 21 days, the dose can be increased to 9 mg (three 3 mg tablets) so long as they are able to tolerate the drug and their serum phosphate labels are at appropriate levels.

Nurses should note that the treatment can increase a patient’s phosphorus levels, putting them at risk of hyperphosphatemia.

“Again, we’re looking at sequential therapy,” Wood said. “One of the unique [AEs] is the potential for an increased phosphorus level and that is something we do not normally include in our laboratory panels. But it is critical to monitor for that with [and to] educate patients about a low phosphorus diet as well.”

Patients should restrict phosphate intake to 600 mg to 800 mg daily. However, if serum phosphate exceeds 7.0 mg/dL, it may be appropriate to add an oral phosphate bunder until the levels return to less than 5.5 mg/dL.

Erdafitinib is also be associated with ocular toxicities. According to the package insert, 19% of patients experienced all-grade dry eye with the agent, 17% experience blurred vision, 6% cataracts, and 5% keratitis. The percentage of patients who experience grade 3 or greater ocular toxicities was much smaller at 1%, 0%, 2% and 3%, for dry eye, blurred vision, cataracts, and keratitis, respectively.

Moreover, 25% of patients experience serous retinopathy/retinal pigmen epithelial detachment (CSR/RPED). The median onset time to first occurrence was 50 days.

“Nurses need to be aware of the potential for increased phosphorus levels and the need to educate patients and caregivers about the drug dose and drug formulation change if dose escalation is appropriate,” Wood summarized.

The last drug that Woods covered in her presentation was enfortumab vedotin.

“Enfortumab vedotin is an antibody-drug conjugate Targets Nectin-4 protein on UC cells,” she said to 

 “The drug binds with the Nectin-4 protein, the linker dissolves, and the microtubular payload is released—leading to cell cycle arrest and apoptosis.”

The agent is indicated for adults with locally advanced or metastatic disease who have previous PD-1 or PD-L1 inhibition and platinum-based chemotherapy. Patients receiving this drug must be ineligible for cisplatin-containing chemotherapy and must have previously received at least 1 or more prior lines of therapy.

The recommended dose for enfortumab vedotin is 1.25 mg/kg. The maximum dose is 125 mg/kg. It is administered intravenously (IV) over 30 minutes on days 1, 8, and 15, as part of a 28-day cycle.

Nurses should be aware that this agent can cause severe and fatal cutaneous AEs, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). These reactions frequently occur throughout the first treatment cycle but may also occur later.

The drug also comes with warning for skin reactions, hyperglycemia and diabetic ketoacidosis, pneumonitis, peripheral neuropathy, ocular disorders, dry eye symptoms, blurred vision, increased lacrimation, conjunctivitis, and infusion site extravasation.

Patients should be educated on the risk of infusion site reactions, hyperglycemia, pneumonitis, and vision changes. They should also be advised to use artificial tear substitutes to both prevent or treat dry eyes. Moreover, baseline assessments and continued monitoring for peripheral neuropathy are advised.

According to Wood, there are numerous investigative therapies with promising efficacy and safety profiles. One of these agents is N-803, a mutant IL-15–based immunostimulatory fusion protein complex.

, findings from the ongoing phase 2/3 QUILT 3.032 trial (NCT03022825) showed that among 160 patients with carcinoma in situ, or papillary Bacillus Calmette-Guérin (BCG)–unresponsive non–muscle invasive bladder cancer, the complete response rate was 71% (95% CI, 60.1%-80.5%). The median duration of response was 26.6 months and at a 2-year data cut-off, the OS rate was 100%.

Based on findings from the QUILT 3.032 trial, a biologics license application has been filed with and 

. The decision date has been set for May 23, 2023, under the Prescription Drug User Fee Act.

Wood highlighted a biomarker gaining traction in UC—Trop-2. In May 2021, the 

FDA granted sacituzumab govitecan (Trodelvy) accelerated approval

 based on phase 2 findings from the TROPHY-U-01 trial (NCT03547973).

Data showed a viable response among patients with pretreated metastatic UC who received the Trop-2-directed antibody-drug conjugate. In a single cohort of 133 patients with a median range of 3 prior lines of therapy, the objective response rate was 27% and a measurable disease decrease was observed in 77% of patients. In addition, the median PFS was 5.4 months, and the median OS was 10.9 months.

Continued approval is contingent on findings from the confirmatory phase 3 TROPiCS-04 trial (NCT04527991).

Woods noted in her presentation that nurses should encourage and support participation in clinical trials and give continued attention to understanding the importance of pre-treatment and on-treatment biopsy requirements for biomarker testing, as well as leveraging multidisciplinary care including palliative care for disease-related symptom management.

Wood L. Novel approaches to Renal and Urothelial Cancers. Presented at: 

 School of Nursing Oncology™; July 29-30, 2022; San Diego, CA.

Powles T, Park SH, Voog E, et al. Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): long-term follow-up results from the JAVELIN Bladder 100 trial

. 2022;40(suppl 6):487. doi:10.1200/JCO.2022.40.6_suppl.487

NCCN. Clinical practice guidelines in oncology. Bladder cancer, version 2.2022. Accessed August 9, 2022. https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf

Balversa. Prescribing information. Janssen Products, LP; 2019. Accessed August 10, 2022. 

Padvec. Prescribing information. Astellas Pharma US, Inc; 2019. Accessed August 10, 2022. 

Chang SS, Chamie K, Gonzalgo ML, et al. Positive efficacy and safety phase 3 results in both CIS and papillary cohorts BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) after IL-15RαFc superagonist N-803 (Anktiva) and BCG infusion. 

. 2022;40(suppl 6):431. doi:10.1200/JCO.2022.40.6_suppl.431

ImmunityBio announces FDA acceptance of biologics license application for N-803 in BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ. News release. Immunity Bio. July 28, 2022. Accessed August 10, 2022. 

Tagawa ST, Balar AV, Petrylak DP, et al. TROPHY-U-01: a phase II open-label study of sacituzumab govitecan in patients with metastatic urothelial carcinoma progressing after platinum-based chemotherapy and checkpoint inhibitors. 

. 2021;39(22):2474-2485. doi:10.1200/JCO.20.03489

FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer. News release. FDA. April 13, 2021. Accessed August 10, 2022. https://bit.ly/3tgxmgy

Avelumab, erdafitinib, and enfortumab vedotin-ejfv are 3 critical drugs in the treatment of urothelial cancer with distinct safety profiles, according to a presentation at the 6th Annual School of Nursing Oncology™ Meeting. 

Approaches to Urothelial Care Call for Nuanced AE Management

A biologics license application for the IL-15 superagonist N-803 has been accepted and the agent will be reviewed for the treatment of patients with Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer carcinoma in situ.

N-803 BLA Undergoes Review For BCG-Unresponsive Non–Muscle Invasive Bladder Cancer in Situ

In a presentation at the 6th Annual School of Nursing Oncology™, Laura Wood, RN, MSN, OCN, highlights key nurse takeaways with VEGF TKI/immune checkpoint inhibitor therapy for patients with renal cell carcinoma. 

Evolution of Frontline VEGF TKI/Immunotherapy Treatments Propels Field of Renal Cell Carcinoma

At the 6th Annual SONO meeting, Kelley A. Rone, DNP, RN, AGNP-C, reviewed evidence supporting molecular testing in patients with colorectal cancer. 

Molecular Profiling Is a Necessity in Colorectal Cancer Treatment 

Patients with previously treated non–small cell lung cancer experienced a median overall survival of 16.9 months with second- or third-line tislelizumab vs 11.9 months with docetaxel. 

Tislelizumab Maintains Superior Overall Survival Benefit Vs Docetaxel in Pretreated NSCLC

Paula Anastasia, RN, MN, AOCN, highlights circumstances in which patients may not be eligible to receive benefit with a PARP inhibitor. 

Paula Anastasia on PARP Inhibitor Ineligibility Factors for Women With Ovarian Cancer

Treatments options for various histologies of leukemia are expanding with FDA approvals for drugs such as the combination of ivosidenib/azacitidine and the CAR T-cell therapy brexucabtagene autoleucel.

Nurses Adapt to New Hematology Advances and Approvals in Leukemia Treatment  

Patients with hormone-sensitive prostate cancer who received darolutamide in combination with docetaxel experienced superior overall survival and time-to-pain progression benefit. 

FDA Approves Darolutamide Tablets for Select Patients With Prostate Cancer

The biologics license application for omidubicel has been granted priority review and will be assessed as a potential treatment for patients with blood cancer who require allogeneic hematopoietic stem cell transplant.

FDA OKs Omidubicel Priority Review For Patients in Need of Allogeneic HSCT

The FDA has scheduled 3 sessions for the Oncologic Drugs Advisory Committee to review updates on the new drug application for poziotinib tablets and data for the continued approval of indications for melphalan flufenamide and duvelisib.

FDA Schedules ODAC Meetings to Review Pending Drug Applications

Beth Sandy, MSN, CRNP, discusses the application of 2 FDA approved drugs for patients with non–small cell lung cancer and an exon 20 insertion mutation.

Beth Sandy on Incorporating Amivantamab and Mobocertinib into Clinical Practice for Patients With EGFR Exon 20 Insertion NSCLC

The FDA has approved the first targeted therapy for patients with HER2-low metastatic breast cancer.

Trastuzumab Deruxtecan Is Approved for Patients With Metastatic HER2-Low Breast Cancer

Medical providers should strive to make all patients feel welcome and safe.

Addressing Disparities: Practicing Inclusion for LGBTQ+ Patients With Cancer

Sherry Adkins, MSN, ANP-C, discusses the significance of incorporating CAR T-cell therapy regimens, such as lisocabtagene autoleucel, into earlier lines of treatment for patients with relapsed/refractory large B-cell lymphoma.

Adkins Discusses Benefit of Second-line CAR T-Cell Therapy in Large B-Cell Lymphoma

At the 6th Annual SONO meeting, Beth Sandy, MSN, CRNP, reviewed available treatment options for patients with identified driver mutations in non–small cell lung cancer.

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