In this episode of The Vitals, Krista M. Rubin, RN, MS, FNP-BC, joins Oncology Nursing News® to discuss best nursing practices with tebentafusp-tebn (Kimmtrak) for patients with unresectable or metastatic uveal melanoma. Rubin is a nurse practitioner with the Center for Melanoma at Massachusetts General Hospital, with over 20 years of experience caring for patients with melanoma. She is also the chair of the Melanoma Nursing Initiative.

Tebentafusp was approved in January 2022 for the treatment of patients with unresectable or metastatic uveal melanoma in adult patients whose disease harbors HLA-A*02:01. Findings from the phase 3 IMCgp100-202 trial (NCT03070392) showed that patients who received this agent experienced superior overall survival than patients who received investigators choice of therapy (HR, 0.51; 95% CI, 0.37-0.71; P < .0001).

As Rubin highlights in the discussion, cytokine release syndrome and rash are some of the most common adverse events (AEs) observed with the bispecific antibody. A step-up dose is used to ease patients onto treatment. Patients are admitted to inpatient care for the first 3 infusions to observe their reactions; however, according to Rubin, after that third cycle, management of AEs becomes straightforward and if patients show positive responses, they can continue to receive a weekly dose indefinitely. 

Episode Notes:

Discussion Highlights:

The drug is it's intravenous; it is given in our outpatient clinic, however, patients are admitted to the hospital overnight. Time Stamp 6:37

If there was a serious case of CRS, then these patients would get medications, specifically tocilizumab, to minimize the effects. TS 7:38

With nurses that are able to proactively identify and know how to manage [AEs], patients can do extremely well. TS12:52

Online Articles

In this episode of The Vitals, Beth Faiman, PhD, CNP, weighs in on the current trajectory of research and clinical practice in multiple myeloma. 

Faiman is a nurse practitioner and researcher with the Cleveland Clinic, as well as a board member of the NP/PA Center of Excellence in Multiple Myeloma. According to her, one of the biggest changes of late was the publication of a study in Lancet Discovery, findings of which suggest that patients with biomarker-defined defined disease, as well as 60% or more bone marrow plasma cells (BMPCs), or a free light chain ratio (FLCratio) of at least 10, have a longer time to progression and a lower 2-year progression risk than was previously believed. Whereas the median time to progression was previously reported to be 9.2 months, the new study found the median time to be 30.1 months. Moreover the 2-year progression risk was 45.45%, rather than the previously reported 85.21%. 

As Faiman points out, in 2014, the International Myeloma Working Group had added patients with at least 60% BMPCs, FLCratio equal to or greater than 100, and greater than 1 MRI-defined focal lesion of at least 5 mm (SLiM CRAB multiple myeloma) to the diagnostic category of multiple myeloma. However, this newer review suggests that this classification may need to be revisited. 

Faiman also touches on shifts in approved BCMA-directed therapies for patients, namely, the accelerated approval of teclistamab-cqyv (Tecvayli) in October of 2022, and the removal of belantamab mafodotin-blmf (Blenrep) from the market in November 2022. She notes that there are ongoing efforts to reincorporate belantamab mafodotin into clinical practice and that she is optimistic about reintroducing this treatment back into her practice—as the dosing schedule and toxicity profile was favorable for patients. 

Episode Notes

“Supporting [a] patient while they are in their maintenance phase [of treatment]; checking the blood counts, keeping up [with] health maintenance, making sure their bones are strong and all those other supportive care things, are so important.”

“If you have a heavily pretreated patient on some of the new cellular therapies or bispecifics, that they have to be admitted to the hospital, we have to logistically manage who’s going to be admitted on what day and when.”

“The nice thing about belantamab was that it was an [intravenous] IV [therapy] every 3 weeks, it is directed against BCMA, and it was very well tolerated.”

The Vitals Podcast:
 

References

1.     Ludwig H, Kainz S, Schreder M, Zojer N, Hinke A. SLiM CRAB criteria revisited: temporal trends in prognosis of patients with smoldering multiple myeloma who meet the definition of ‘biomarker-defined early multiple myeloma’-a systematic review with meta-analysis. EClinicalMedicine. 2023;58:101910. doi:10.1016/j.eclinm.2023.101910 

2.     FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma. FDA. October 25, 2022. Accessed April 10, 2023. https://bit.ly/3f3HffB

3.     GSK provides an update on Blenrep (belantamab mafodotin-blmf) US marketing authorization. News release. GlaxoSmithKline. November 22, 2022. Accessed April 10, 2023. http://bit.ly/3gniPi1

In this episode of The Vitals, Lindsay Diamond, MSN, AGNP-C, AOCNP, spoke on updated data from the CheckMate 274 trial (NCT02632409), which were presented during the 2023 ASCO Genitourinary Cancers Symposium (ASCO GU), and commented on different trials paving the way in urothelial carcinoma. 

According to Diamond, who is a nurse practitioner and clinical program manager of the GU Oncology Clinical Trials Department at the Icahn School of Medicine at Mount Sinai, the disease-free survival (DFS) outcomes from Checkmate 274 were very promising, as they signify that adjuvant treatment with nivolumab (Opdivo) may be able to help patients reach certain milestones. This trial showed that at a median follow-up of 36.1 months, the median DFS with adjuvant nivolumab was 52.5 months vs 8.4 months with placebo in the PD-L1 population (1% or greater). Moreover, in the intention-to-treat population, the median DFS were 22.0 vs 10.9 months, respectively.

Adjuvant nivolumab was approved for patients with urothelial carcinoma who are at high risk of recurrence after radical resection based on earlier data from CheckMate 274.

Moving forward, she hopes to continue to see positive readouts from this trial, as well as more research in bladder-sparing treatment approaches and better tumor markers to help patients track their diseases responses to treatment. 

Interested in learning more from the meeting? Check out our coverage of 2023 ASCO GU here. 

We want to hear from you! Which ASCO GU data do you think will be practice-changing? 

Email [email protected] with your feedback.

Episode Notes:

"There is this mentality when patients have localized disease, of ‘well, it’s not metastatic and you had it removed so you’re fine,’ but those patients still live with cancer every day of their life after that surgery and it’s a waiting game." Time stamp (TS) 3:05

"We, as providers, know that 30% of patients or so could have a serious immune-related adverse effect from immunotherapy, but the majority of patients are going to do fine on it." TS 5:17

"Generally, clinical trials looking at bladder sparing approaches [are important], whether it’s our study HCRN GU16-257 [NCT03558087]—that looks at chemotherapy and immunotherapy—or other trials that look at just chemotherapy." TS 6:47


 Oncology Nursing News® Online Articles

·      CheckMate 274 Follow-Up Supports the Use of Adjuvant Immunotherapy in Bladder Cancer

·      Pembrolizumab Shows Antitumor Activity at 45-Month Follow-Up in BCG-Unresponsive Papillary NMIBC

·      Real-World Data Supports Front-Line Maintenance With Avelumab For Locally Advanced, Metastatic Urothelial Carcinoma

·      Neoadjuvant Split-Dose Chemotherapy Represents Potential New Standard of Care for High-Risk UTUC

·      Maximizing Potential of Immunotherapy Requires Appropriate irAE Management


Video Interviews

·      Laura Wood on the Integration of Avelumab, Erdafitinib, and Enfortumab Vedotin into Urothelial Cancer Care

·      Predicting Immunotherapy Response in Bladder Cancer
 
The Vitals Podcast

·      Chemo Cheat Sheets Help Nurses During Drug Delivery

·      A Look Back at 2022 FDA Approvals in Oncology


References

1.     Galsky M, Witjes JA, Gschwend J, et al. Extended follow-up results from the CheckMate 274 trial. J Clin Oncol. 2023;41(suppl 6):LBA443. doi:10.1200/JCO.2023.41.6_suppl.LBA443

2.     FDA approves nivolumab for adjuvant treatment of urothelial carcinoma. FDA. News release. August 19, 2021. Accessed April 3, 2023. https://bit.ly/3ztbkfm 

It takes a special skillset for nurses to care for patients whose disease continues to relapse after multiple lines of therapy, shares Stephanie Jackson, DNP, MSN, RN, AOCNS, BMTCN.

“I tell my younger staff who aren’t used to seeing patients this sick, ‘even if that patient doesn’t survive, what an honor for us to be a part of their journey,’” she tells Oncology Nursing News®.

For this episode of The Vitals, Jackson, an oncology and bone marrow transplant clinical nurse specialist and unit director at UCLA Medical Center, recalls the story of a patient with acute lymphoblastic leukemia (ALL) who relapsed following treatment with induction chemotherapy and whose disease did not respond to blinatumomab (Blincyto). The team chose to give this patient an off-the-shelf CD22-directed CAR T-cell therapy—which was successful, until the patient ultimately relapsed 6 weeks later. 

Jackson emphasizes how, in addition to his physical symptoms, this patient was burdened by worry for his family. As the primary breadwinner in a family with a 2-year-old daughter, he was stressed about how to continue caring for his family. Moreover, he grappled with a language barrier prevented the patient from understanding the complexity of the treatments that the team was prescribing for him. Therefore, Jacksons’ team had to find innovative ways to ensure that the patient, and his family, felt well supported throughout his treatment. 

“The biggest challenge we had was [ensuring] his understanding of how sick he really was, the complexity of the treatment, and that he wouldn’t be able to go back to work right away,” she says.

This was a 29 year old male that was diagnosed with Philadelphia chromosome–negative ALL. Time stamp TS 2:13

Given that it’s a clinical trial [product], we don’t always know [what to expect]. We know with the FDA approved products, the 2 biggest factors we need to monitor patients for is cytokine release syndrome and neurotoxicity. These were the things we were watching for. TS 5:38

We did a lot of work with our social worker, he was Mixteca Alto, an indigenous population within the Mexican community, and we wanted to make sure we had the appropriate interpreters. TS 8:09

Oncology Nursing News® Online Articles

Oncology Nursing News® Publication Features

Data presented during the 2023 Gastrointestinal Cancers Symposium have accentuated the amount of ongoing research across many of these hard-to-treat gastrointestinal malignancies, according to Terri Pollack, DNP, APRN, FNP-C, PMHNP-BC. Specifically, data surrounding the utility of circulating tumor DNA (ctDNA) should be exciting for RNs and nurse practitioners alike, as it allows providers and patients to visualize if a treatment is working long before a traditional test would show. 

Pollack is a nurse practitioner with the Gastrointestinal Cancer Site Disease Group in the Department of Medical Oncology at the University of Miami Sylvester Comprehensive Cancer Center. For this episode of The Vitals, she discusses key data presented during the GI Cancers Symposium. Besides promising data with ctDNA, she also discusses data from the phase 3 SUNLIGHT trial (NCT04737187), which showed that adding bevacizumab (Avastin) to trifluridine/tipiracil (Lonsurf) improved overall survival in patients with refractory metastatic colorectal cancer (mCRC) and the phase 3 BREAKWATER study (NCT04607421), which is assessing encorafenib (Braftovi) plus cetuximab (Erbitux) along with chemotherapy for patients with BRAF V600E–mutant mCRC.

“Great things are coming,” she told Oncology Nursing News®. 

Episode Notes: 

“For those individuals and their families that understand what we've explained about [ctDNA]; it's really exciting” Time stamp TS 5:50

“From a clinical perspective, we can utilize the data from the ctDNA results to sort of overshadow a scan that we might not see anything yet. It’s just this other tool in the toolbox. I feel like it's maybe going to be like a power drill instead of a little screwdriver.” TS 6:54

“Three point three months in median overall survival really can mean a lot to an individual challenged with this type of cancer and their family.” TS 10:51

The Vitals Podcast

In this episode of The Vitals, Nilesh Kalariya, PhD, AGPCNP-BC, AOCNP; and Laura J. Zitella, MS, RN, ACNP-BC, AOCN, discuss data from the 64th American Society of Hematology Annual Meeting and Exposition that have the greatest potential to change oncology nursing practice. 


Kalariya, a nurse practitioner with the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center, recently spoke with Oncology Nursing News® highlighted research from the University of Pennsylvania which showed clinical utility of a frailty phenotype tool and contextualized the role of CAR T-cell therapy for patients with multiple myeloma. He also discussed whether data from a subgroup analysis of patients with multiple myeloma who received the anti-BCMA CAR T-cell therapy in the KarMMa-2 trial (NCT03601078) supports moving it forward in the treatment lineup.


Zitella, a nurse practitioner in the Department of Hematology, Blood & Marrow Transplant, and Cellular Therapies Program at the UCSF Helen Diller Family Comprehensive Cancer Center and an associate clinical professor with the School of Nursing University of California, San Francisco, also spoke with Oncology Nursing News®, highlighting exciting advances with BTK inhibitors and how nurses can promote safe eating habits after data from ASH demonstrated that the neutropenic diet does not benefit patients. on which data from the 2022 ASH meeting might have the greatest impact on nurses working in hematologic oncology.


Interested in learning more from ASH? Check out our coverage of the 2022 ASH Meeting here.

The Vitals Podcast:


·      Stephanie Jackson Unpacks Recent Advances in Leukemia Treatments


·      Cardiac Complications in Blood Cancers

·      FDA Grants Pirtobrutinib Accelerated Approval for Relapsed/Refractory MCL

·      Noncovalent BTK Inhibitors May Fill Unmet Needs in CLL and Other Top ASH Takeaways


·      Optimizing Frailty Tools Are A Vital Component of Improving Care Across Hematologic Malignancies


·      Phase 3 Data Support Leaving the “Neutrodiet” Behind After Stem Cell Transplant


·      Induction and Maintenance With Ibrutinib Proves Effective for Mantle Cell Lymphoma


·      Zanubrutinib Outperforms Ibrutinib in Head-to-Head Trial for Relapsed/Refractory CLL/SLL

Aaron Gerds on JAK Inhibitor Therapy for Anemic Patients With Myelofibrosis

In this episode of The Vitals, we interview 2 nurse practitioners about their key takeaways from the 2022 San Antonio Breast Cancer Symposium (SABCS). 

“As time goes [on], we learn more,” says Loyda Braithwaite, MSN, RN, AGPCNP-BC, AOCN. Specifically, as more safety data with fam-trastuzumab deruxtecan-nxki (Enerhtu) comes to light, providers are getting a better idea of how to anticipate and handle potentially serious adverse events such as interstitial lung disease and left ventricular dysfunction. Braithwaite, who is an oncology nurse practitioner at the University of Wisconsin Carbone Cancer Center in Madison, highlights exciting developments in HER2-positive breast cancer and for patients with metastatic disease, as well as the potential benefit of oral selective estrogen receptors degraders, throughout the discussion.

Moreover, according to Jamie Carroll, APRN, CNP, MSN, a nurse practitioner at Mayo Clinic in Rochester, Minnesota, data presented at the meeting may change patient conversations in the adjuvant setting. Findings from the POSITIVE (NCT02308085) trial suggest that pausing adjuvant endocrine therapy may be safe for women with hormone receptor–positive breast cancer who wish to pursue pregnancy.

“It's a common discussion that we have and it’s helpful to know that the POSITIVE trial did not see that disrupting endocrine therapy impacted disease outcomes,” Carroll says. “That’s helpful for patients and providers to know that they’re not seeing an increase in recurrence when endocrine therapy is paused to achieve pregnancy.”

Interested in learning more from SABCS? Check out our coverage of the conference here.

·      Sarah Donahue Highlights Destiny-Breast04 Trial Takeaways for Patients With HR+, HER2-Low Metastatic Breast Cancer

·      Sri Kota Weighs in On the Evolving Breast Cancer Paradigm

·      Emerging Data Showcases Promising Advancements for Patients With HER2-Low Breast Cancer

·      POSITIVE Study Findings Shift Conversations on Pregnancy in ER+ Breast Cancer

·      CBD Oil Shows Modest Improvements in Tamoxifen-Related Adverse Effects

·      Antidiarrheal Prophylaxis Remains a Key Focus in TKI Treatment for Patients with HER2+ Breast Cancer

·      Real-World Data Show Neoadjuvant Pertuzumab/Trastuzumab Increases pCR Rates in HER2+ Breast Cancer

Grace Choong and Matthew Goetz On the Impact of Adjuvant Endocrine Therapy Omission in ER+ Positive Breast Cancer

·      Hurvitz SA, Hegg R, Chung WP, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: Updated survival results of the randomized, phase 3 study DESTINY-Breast03. Presented at: 2022 San Antonio Breast Cancer Symposium; December 6-10, 2022; San Antonio, TX.

·      Krop, Ian et al T-DXd yields superior outcomes over chemotherapy-based regimens in patients previously treated with T-DM1 participating in the phase III DESTINY-Breast02 trial. Presented at: 2022 San Antonio Breast Cancer Symposium; December 6-10, 2022; San Antonio, TX.

·      Rugo HS, Bardia A, Marmé F, et al. Sacituzumab govitecan vs treatment of physician’s choice: efficacy by Trop-2 expression in the TROPiCS-02 study of patients with HR+/HER2– metastatic breast cancer. Presented at: 2022 San Antonio Breast Cancer Symposium; December 6-10, 2022; San Antonio, TX. 

·      Hurvitz S, Wang LS, McAndrew NP, et al. TRIO-US B-12 TALENT: neoadjuvant trastuzumab deruxtecan (T-DXd) with or without anastrozole for HER2-low, HR+ early-stage breast cancer. Presented at: 2022 San Antonio Breast Cancer Symposium; December 6-10, 2022; San Antonio, TX.

·      Bardia A, Bidard FC, Neven P, et al. EMERALD phase 3 trial of elacestrant versus standard of care endocrine therapy in patients with ER+/HER2- metastatic breast cancer: updated results by duration of prior CDK4/6i in metastatic setting. Presented at: 2022 San Antonio Breast Cancer Symposium; December 6-10, 2022; San Antonio, TX.

·      Partridge A, Niman SM, Ruggeri M, et al. Pregnancy outcome and safety of interrupting therapy for women with endocrine responsIVE breast cancer: primary results from the POSITIVE trial (IBCSG 48-14 / BIG 8-13). Presented at: 2022 San Antonio Breast Cancer Symposium; December 6-10, 2022; San Antonio, TX.

In this special episode of “The Vitals,” we ring in the New Year by combing through 2022 FDA approvals. Listen as associate editor, Lindsay Fischer, recounts key approvals on a month-by-month basis, with input from some of the investigators from behind the research. To read the full information surrounding the approvals, be sure to check out our news coverage below. Other resources can also be found below. 
As always, thank you for listening to The Vitals, and for all the engagement in 2022. We look forward to bringing you more oncology news in 2023. 

The Vitals Podcast:

Listen: Sarah Donahue Highlights Destiny-Breast04 Trial Takeaways for Patients With HR+, HER2-Low Metastatic Breast Cancer 

Complementary therapies, such as acupuncture, can deliver significant benefits when used in combination with standard therapies, according to Heather Jackson, PhD, FNP-BC, NEA-BC, FAANP.

In this episode of The Vitals, Jackson, who is administrative director of advanced practice at Vanderbilt University Medical Center, Vanderbilt Ingram Cancer Center, discusses how complementary acupuncture helped one thyroid cancer survivor achieve his goal of stopping opioid use to manage his cancer-related pain. Throughout the discussion, she highlights common questions patients have about acupuncture, what different forms of treatment are available, and how providers can assess the efficacy of the integrative therapy. 

“My advice would be to always consider [acupuncture] as an adjunct [option],” Jackson says. “There is a lot of miscommunication sometimes with complementary therapies, [where] people will assume that’s the only option. That’s not what we’re saying. When we say complementary, we [mean] in addition to.”

Episode Notes:

“He was still having a lot of facial pain [in] his left cheek and neck and TMJ [temporomandibular joint dysfunction] pain. He had been taking oxycodone—15 mg 4 times a day but he came to me and said, ‘I’m a father, I’m a husband. And it’s really sedating for me. I can’t sit down at meals, I can’t enjoy social activities, anything I do is uncomfortable.’ ” Time stamp TS 02:19

“I looked at his medicine regimen and I said, ‘Well, it’s not the cure all. But I think it could be a piece of the pie.’ When we think about treating pain, if you’re going to treat the whole person, you have to think about all the different aspects of the person.” TS 03:09

“The acupuncture that we do in our clinic is a modified acupuncture technique. It’s not full body, it’s limited to the ear. They call it auricular acupuncture.” TS 05:19

“He’s actually not in my clinic anymore because we got him off of everything. I think he just needed help getting through that period of getting off the medicine.” TS 12:10

Jackson HJ, Peal K. Auricular acupuncture for the treatment of cancer-related pain. Oncology Issues. 2022;37(4):32-35. doi:10.1080/10463356.2022.2079353

Jackson HJ, Walters J, Raman R. Auricular acupuncture to facilitate outpatient opioid weaning: a randomized pilot study. Med Acupunct. 2021;33(2):153-158. doi:10.1089/acu.2020.1450

Jackson HJ, López C, Miller S, Englehardt B. Neonatal abstinence syndrome: an integrative review of neonatal acupuncture to inform a protocol for adjunctive treatment. Adv Neonatal Care. 2019;19(3):165-178. doi:10.1097/ANC.0000000000000630

Jackson HJ, Lopez C, Miller S, Engelhardt B. A acoping review of acupuncture as a potential intervention for neonatal abstinence syndrome. Med Acupunct. 2019;31(2):69-84. doi:10.1089/acu.2018.1323

Jackson HJ, Lopez C, Miller S, Englehardt B. Feasibility of auricular acupressure as an adjunct treatment for neonatal opioid withdrawal syndrome (NOWS). Subst Abus. 2021;42(3):348-357. doi:10.1080/08897077.2020.1784360

Jackson HJ, Reneau MG, Hande K. A scoping review of measures utilized to assess patient satisfaction with acupuncture treatments within randomized controlled trials. Med Acupunct. 2022;34(5):308-315. doi:10.1089/acu.2022.0015

For this episode of The Vitals, Oncology Nursing News® speaks with Aliènne Salleroli, MS, BSN, RN, OCN, an assistant patient services manager at Yale-New Haven Health Smilow Cancer Hospital, and cochair of the Yale New Haven Hospital Diversity, Equity, and Inclusion Nursing Task Force. Earlier this year, Salleroli presented research on how racial diversity within oncology nursing is not enough to create lasting change—there needs to also be racial diversity within oncology nursing leadership to inspire positive outcomes. However, when it comes to making change on an individual level, the best thing that an oncology nurse leader can do is help initiate dialogue. 
“We need to walk before we can run,” says Salleroli. “Before we start these enormous interventions, which are wonderful, we really need to lay down this foundation to put down some groundwork by making [equity, diversity, and inclusion] a part of everything that we do.”
 
 Episode Highlights

“The results were quite interesting because they were not what I expected them to be: diversity alone will not increase positive outcomes. There also needed to be strong leadership as well [and] there needs to be a unified vision within the organization that will help support these changes and support diversity as well.” Time stamp (TS) 02:02

“changing the paradigm of how we envision diversity was equally as important as how we implement the interventions themselves.” TS 02:24

“it's important for other nurses not only just to see that representation, but to have that representation, [this means] being able to create policies and interventions that are that directly impact nurses of color as well.” TS 04:40

“Diversity, equity inclusion should be thought of like quality and safety. It should stand alone on its own, but yet, every nurse should always have quality and safety on their mind with every single intervention that they do, they should always be thinking about quality and safety.” TS 10:53

“Systemic racism is a huge problem and a national health crisis. It is no different in oncology. We need to make sure that all of our bases are covered— that we view this with just as much importance as everything else that we do.” TS 13:51

Oncology Nursing News® Publication Features

Salleroli A. Racial Diversity Within Oncology Healthcare Leadership Increases Positive Outcomes. Presented at: 47th Annual Oncology Nursing Society Congress; April 27-May 1, 2022; Anaheim, CA. Abstract P161.
Dotson E, Nuru-Jeter A. Setting the stage for a business case for leadership diversity in healthcare: history, research, and leverage. J Healthc Manag. 2012;57(1):35-46; discussion 45-46.