In September 2022, investigators published findings on an understudied stress associated with advanced cancer care—unmet death preferences. Many adolescent or young adult patients with cancer express that they would prefer to die at home; however, when combined with caregiver capabilities and necessary symptom management, most of these patients ultimately die in the hospital setting, underscoring an unmet need for this patient population.

Other topics in supportive care include a brief snapshot of cannabinoid products in the context of cancer-related pain management. During the 2022 ONS Bridge, Karen Hande, PhD(c), DNP, ANP-BC, CNE, FAANP, ANEF, offered an overview of what cannabinoid products are and what it means for patients to be taking consumed cannabidiol (CBD) vs marijuana, to improve cannabis-related dialogue between nurses and patients.

Moreover, September saw some key clinical updates in the gynecologic and genitourinary oncology spaces. Read below to see how immunotherapy is eliciting responses in urothelial carcinoma and how real-world patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer are achieving promising response with pembrolizumab (Keytruda) plus bevacizumab (avastin).

Better End-of-Life Options Are Needed for AYA Patients With Advanced Cancer

Innovative strategies are needed to ensure that adolescents and young adults with cancer who prefer to die at home can make that choice. Most adolescent or young adults (AYA) with advanced cancer prefer to die at home, according to results of a qualitative interview study published in 

Unfortunately, the desire of many of AYA patients is not realized with up to two-thirds of AYAs passing away in the hospital setting, underscoring an unmet need regarding death preferences in this population.

Oncology Nurses: What Cannabinoid Is Your Patient Taking?

In a presentation during the 2022 ONS Bridge, Karen Hande, PhD(c), DNP, ANP-BC, CNE, FAANP, ANEF, provided an overview of what some of the popular cannabinoid products are that patients with cancer may be taking.

EphrinB2 Inhibition With PD-1/PD-L1 Immunotherapy Induces Promising Responses in Progressive Metastatic Urothelial Cancer

A combination of pembrolizumab and soluble EphB4-human serum albumin (sEphB4-HSA) may elicit superior overall survival and objective response rates in patients with platinum-refractory metastatic urothelial carcinoma than PD-1/PD-L1 therapy alone, according to findings from a phase 2 trial (NCT02717156) published in the 

Opinion: Understanding Spoon Theory Is Essential for Oncology Nurses

Thanks to advances in oncology, the number of long-term survivors is growing. However, this disease often saps patients and, by extension, nurses of their strength. The spoon theory has been widely used in chronic illnesses, but it can also be applied to cancer. In this opinion piece, Debi Fischer, MSW, BSN, BA, LCSW, RN unpacks spoon theories and explains its utility for patients with cancer.

Pembrolizumab Plus Bevacizumab and Cyclophosphamide Shows Promising Efficacy, Tolerability in Recurrent Ovarian Cancer

Real-world data presented during the 2022 ESMO congress showed that pembrolizumab combined with the anti-VEGF agent bevacizumab plus oral metronomic cyclophosphamide displayed minimal toxicity in a significant number of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Articles

Each month, we take a look back at the most popular Oncology Nursing News® stories. Here are the top 5 stories from September 2022.

Oncology Nursing News Top Stories: September 2022

Kristi Rosa joined MJH Life Sciences in 2016 and has since held several positions within the company. Prior to working at the company, she served as lead copywriter and marketing coordinator at The Strand Theater. Email: krosa@onclive.com

Sodium thiosulfate (Pedmark) has been approved to prevent hearing loss in pediatric patients who are 1 year or older and who require cisplatin-based regimen for localized, nonmetastatic solid tumors.

The efficacy of the product was examined in pediatric patients who were undergoing treatment with cisplatin-based chemotherapy for their cancer who were included in the following 2 multicenter, open-label, randomized controlled trials: SIOPEL 6 (NCT00652132) and COG ACCL0431 (NCT00716976).

The first new drug application (NDA) submission for the agent received a priority review designation from the FDA in August 2020.

 However, a few days later, the FDA issued a 

 (CRL) to Fennec Pharmaceuticals, the drug developer, after a pre-approval inspection of the manufacturing facility for sodium thiosulfate revealed deficiencies that resulted in a Form 483, which detailed conditions or practices that needed to be addressed before the agent could receive approval.

After receipt of the final minutes from a Type A meeting with the FDA, the NDA for Pedmark was resubmitted to the regulatory in June 2021.

 The application was accepted by the FDA later that month for filing.

 However, in November 2021, a second CRL was issued to the company after manufacturing deficiencies were still identified.

 In April 2022, the FDA accepted the NDA resubmission for filing, and the target action date was set for September 23, 2022.

The multicenter, randomized, controlled, open-label, phase 3 SIOPEL 6 trial enrolled 114 patients who were between the ages of 1 month and 18 years who were receiving 6 cycles of perioperative cisplatin-based chemotherapy for standard-risk hepatoblastoma.

Study participants were randomly assigned 1:1 to receive cisplatin-based chemotherapy with (n = 61) or without (n = 53) sodium thiosulfate, which was dosed based on body weight and administered intravenously over the course of 15 minutes beginning 6 hours after completion of each cisplatin infusion. For those weighing less than 5 kg, 5 kg to 10 kg, or more than 10 kg, sodium thiosulfate was administered at 10 g/m2, 15 g/m2, and 20 g/m2, respectively.

Stratification factors included country and age (older or younger than 15 months). The primary outcome of the trial was the percentage of patients with Brock grade 1 or higher hearing loss, which was evaluated using pure tone audiometry following study treatment or at an age of at least 3.5 years—whichever was later.

Among the patients who underwent randomization, the median age was 1.1 years (range, 1.2 months to 8.2 years), and 55% were male. Moreover, 60% of patients were White, 11% were Asian, and 1.8% were Black or African American.

Data showed that the incidence of hearing loss was lower in those who received sodium thiosulfate and cisplatin vs cisplatin alone, at 39% and 68%, respectively (unadjusted relative risk 0.58; 95% CI, 0.40-0.83).

The multicenter, randomized, controlled, open-label phase 3 COG ACCL0431 trial included 125 patients between the ages of 1 year and 18 years who were receiving a chemotherapy regimen that included a cumulative cisplatin dose of 200 mg/m2 or higher, with individual cisplatin doses to be infused over 6 hours or less.

Here, study participants were randomly assigned in a 1:1 fashion to receive cisplatin-based chemotherapy with (n = 61) or without (n = 64) sodium thiosulfate. Cisplatin was given in accordance with each trial site's disease-specific treatment protocols. Participants were given sodium thiosulfate starting 6 hours following each infusion of cisplatin was completed, at a dose that was bioequivalent to the recommended dose. The infusion with the product needed to be completed at least 10 hours following the next cisplatin infusion if the treatment protocol called for several daily doses of cisplatin.

Patients were stratified based on whether they received prior cranial radiation (yes vs no). In those without prior cranial radiation, randomization was further stratified by age (<5 years vs ≥5 years) and duration of cisplatin infusion (<2 hours vs ≥2 hours).

The primary outcome for the trial was hearing loss in accordance with American Speech-Language-Hearing Association criteria, which was evaluated at baseline and 4 weeks after the final course of cisplatin.

Efficacy was examined in a subset of 77 patients who had localized, nonmetastatic solid tumors, who comprised the intention-to-treat population. The median age in these patients was 8 years (range, 1-18) and 61% were male. Sixty-two percent of patients were White, 14% were Black or African American, and 2.6% were Asian. The median Karnofsky or Lansky performance status was 90 (range, 50-100).

Twenty-seven percent of patients had an underlying diagnosis of medulloblastoma, 26% had osteosarcoma, 23% had germ cell tumor, 10% had neuroblastoma, 8% had hepatoblastoma, 2.6% had atypical teratoid/rhabdoid tumor, 1.3% had choroid plexus carcinoma, and 1.3% had anaplastic astrocytoma. Seven percent of patients previously received radiation.

Findings indicated that the incidence of hearing loss was lower in the sodium thiosulfate/cisplatin arm vs the cisplatin-alone arm, at 44% and 58%, respectively (unadjusted relative risk, 0.75;95% CI, 0.48-1.18).

Regarding safety, the most common toxicities reported in the 2 trials included vomiting, nausea, decreased hemoglobin, hypernatremia, and hypokalemia.

FDA Approves sodium thiosulfate to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, nonmetastatic solid tumors. News release. FDA. September 20, 2022. Accessed September 20, 2022. https://bit.ly/3BXm47E

Fennec Pharmaceuticals announces FDA filing acceptance and priority review of new drug application for Pedmark. News release. Fennec Pharmaceuticals. April 13, 2020. Accessed September 20, 2022. 

Fennec Pharmaceuticals receives complete response letter from the FDA for its new drug application for Pedmark to prevent ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic, solid tumors. News release. Fennec Pharmaceuticals. August 11, 2020. Accessed September 20, 2022. 

Fennec Pharmaceuticals resubmits new drug application to US Food and Drug Administration for Pedmark. News release. Fennec Pharmaceuticals, Inc. May 28, 2021. Accessed September 20, 2022. 

Fennec Pharmaceuticals announces FDA acceptance of new drug application resubmission for Pedmark. News release. Fennec Pharmaceuticals, Inc. June 22, 2021. Accessed September 20, 2022. 

Fennec Pharmaceuticals receives complete response letter from the FDA for its new drug application for Pedmark to prevent ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic, solid tumors. News release. Fennec Pharmaceuticals. November 30, 2021. Accessed September 20, 2022. 

Fennec Pharmaceuticals announces FDA acceptance for filing of new drug application resubmission for Pedmark. News release. Fennec Pharmaceuticals. April 27, 2022. Accessed September 20, 2022. 

Pedmark. Prescribing information. Fennec Pharmaceuticals, Inc; 2022. Accessed September 20, 2022. https://bit.ly/3R1zd3Z

The FDA has approved sodium thiosulfate to protect the hearing of pediatric patients who are at least 1 year old and are receiving cisplatin-based treatments. 

Sodium Thiosulfate Gets Green Light for Chemotherapy-Induced Hearing Loss in Pediatric Patients

Videos

Shifting focus to the second patient profile of HER2+ gastric cancer, key opinion leaders highlight the risk and management of diarrhea in this setting.

Patient Profile 4: A Patient with HER2+ Gastric Cancer Treated With T-DXd Who Develops Diarrhea 

Panelists briefly review ongoing clinical trials with trastuzumab deruxtecan in the setting of HER2+ gastric cancers.

Ongoing Clinical Trials With T-DXd in HER2+ Gastric Cancer

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

The rise in popularity of oral anticancer therapy has introduced problems of access and insurance coverage that oncology nurses previously did not have to deal with, according to expert presenters at the 2022 Oncology Nurse Society Bridge. However, many resources are available to nurses, and a key first step is to ask patients how they are faring financially.

“Even though you might not have all the answers right then and there when you’re talking to the patient, don’t shy away from a discussion you can have [about] their finances,” said Mary Anderson, BSN, RN, OCN, an oral oncolytic nurse navigator at Norton Cancer Institute.

Anderson presented alongside Christina Bach, MBE, MSW, LCSW, OSW-C, FAOSW; and Nora Hansen, CPhT, in a presentation titled “Managing Oral Cancer Therapies: What Are Your Tools?” The team highlighted the scope of the problem of financial-related toxicities, best practices for financial toxicity assessment, and resources to help nurses connect their patients to the care they need. 

When assessing patients for the first time, oncology nurses are encouraged to ask the following questions:

Are you able to get to the pharmacy to pick up your medications?

Are you able to get medications delivered to your home?

Other key questions include asking the patient to describe their insurance coverage plan, to highlight any other expenses they are worried may arise during their cancer care (ie, transportation, parking, child care, loss of income), if they are concerned about job loss, if they have had difficulty getting a prescription in the past, if their out-of-pocket expenses are what they expected, and if they are worried about financial toxicity affecting their quality of life.

“I start with making sure that folks understand that I’m not trying to be intrusive or overstep my bounds in asking really personal and private questions that we just don’t [normally talk about],” Anderson said. “I always say; ‘I know this is personal. I know a lot of people don’t want to talk about it. But knowing this information, is going to help me help you. And this is all between the two of us.’”

“We are validating that this is uncomfortable,” she added. “We’re also validating that it’s hard to ask for help—and also giving them permission at any time to say, ‘You know what, I don't want to answer that question.’”

Unfortunately, medical debt represents the number 1 cause of personal bankruptcy in the United States.

 Since 2010, cancer care spending has increased by approximately $175 billion. It is expected to continue to grow and reach $246 billion by 2030.

 Moreover, the average out of pocket expenses per patient increased from $1800 to $2900 per month since 2010.

“We have a major crisis when it comes to medical debt in this country,” Bach, an oncology social worker with OncoLink added. “A lot of that has to do with the way cancer [treatment] has changed a great deal in terms of oral oncolytics.”

“What is available to patients and how they access them is quite different than it was when I started as an oncology social worker in 2000,” she added. “[In 2000,] almost [every patient] was admitted for all their treatment for multiple days, it was covered by their major medical [insurance], and there were very few oral medications available.”

Presenters noted that solutions to help patients are also unfortunately limited: assistance from co-pay foundations are limited to certain diseases, procedures, and availability. In private practice oncology settings, which are often the only geographical option available to patients, charity care is not usually offered.

In addition, the Unites States has historically not regulated drug prices or had a system for drug price negation and a diagnosis of cancer does not equate to automatic approval for disability. Paid family leave varies across states but is generally limited—meaning that job loss (and consequent health insurance loss) is a reality faced by many Americans with cancer.

“Our solutions are limited,” Bach said. “I often feel like my hands are tied. It is very frustrating and also very morally distressing.”

Because of these increasing costs, it is not uncommon for patients to delay or forego treatments because of their financial burden. However, it is documented in the literature that financial toxicity is often linked to poorer outcomes.

Financial hardships often also extend into survivorship; 54% of survivors are between the ages of 18 and 64 years, 42% of whom reported experiencing financial hardships following diagnosis. Debt is most prevalent in populations under the age of 64 years, as well as in Black communities.

Previously, the problem in the United States was that most patients were uninsured. However, in 2022, the problem has become that patients are underinsured.

The speakers noted that it can be difficult for patients and nurses alike to understand the difference between Medicare A, B, and D. They outlined the general difference between plans as part of their presentation:

Medicare Part A is hospital insurance and is often premium-free;

Medicare part B is outpatient medical, and patients must opt in and pay a monthly premium;

Medicare part D is voluntary prescription drug coverage, patient pays premium and co-insurance (deductible and up to 25%);

Medicare part C is known as the “advantage plan;” it is offered by private insurance plans that contract with Medicare, it covers the same services as Medicare A, B, and some drug coverages, and patients choose their provider and plan, such as HMO;

Patients may also have Medicare supplements, which is optional additional coverage for co-insurance and deductibles. 

Insured patients are responsible for paying a premium, a deductible, the copay, the co-insurance, but may be unaware of additional items that are not covered. These may include cancer related needs or services, such as wigs, supplements, lymphedema garments, some durable medical equipment, private duty assistance, and indirect costs, including transportation, parking, child/elder care, loss of income/wages, and caregiving. This represents a heavy financial burden for many, speakers agreed.

The recently approved Inflation Reduction Act is expected to help ease some of the financial toxicity that patients face by capping the amount that a patient is expected to pay per year and lowering premium prices.

 Moreover, the act introduced the concept of price drug negations the consequences of which could be monumental for patients, according to Bach. However, despite the act’s approval, many of the benefits are many years away.

In the meantime, nurses should know that although they play a crucial role in helping connect patients to the resources they need, they are part of a team of players who can help patients navigate the world of insurance. Other professionals who can be leveraged include private brokers, social workers, financial navigators/advocates, state health insurance assistance programs (SHIAPS) counselors, ACA navigation assistance, private brokers. Because there are so many people invested in helping connect patients to help, nurses should not feel alone or intimidated to bring up the conversation: they are not expected to solve the problem, but they can help improve the situation.

The experts also recommend that oncology nurses leverage online resources, such as, 

ONS Guidelines™ to Support Patient Adherence to Oral Anticancer Medications

Cancer Support Community Financial Navigation

Gordon D. 50% of Americans now carry medical debt; a new chronic condition for millions. Forbes. October 13, 2021. Accessed September 26, 2022. 

Abrams HR, Durbin S, Huang CX, et al. Financial toxicity in cancer care: origins, impact, and solutions. 

. 2021;11(11):2043-2054. doi:10.1093/tbm/ibab091

Yabroff KR, Han X, Song W, et al. Association of medical financial hardship and mortality among cancer survivors in the United States. 

. 2022;114(6):863-870. doi:10.1093/jnci/djac044

Fact sheet: the Inflation Reduction Act supports workers and families. News release. The White House. August 19, 2022. Accessed September 26, 2022. 

Mary Anderson, BSN, RN, OCN; and Christina Bach, MBE, MSW, LCSW, OSW-C, FAOSW, discuss approaches to help patients navigate financial toxicity and insurance coverage in the age of oral anticancer drugs. 

Rise of Oral Cancer Drugs Signal Deeper Financial Toxicity Issues for Patients 

Neoadjuvant cemiplimab elicited promising pathologic complete responses in patients with cutaneous squamous cell carcinoma. 

Promising Pathologic Complete Response Rate Observed With Neoadjuvant Cemiplimab in Cutaneous Squamous Cell Carcinoma

ASCO has released new guidelines concerning the optimal treatment of patients with metastatic clear cell renal cell carcinoma following a systematic literature review by an expert panel. 

ASCO Guidelines Aim to Outline Updated Recommendations for ccRCC Management 

Milagros Elia, MA, APRN, ANP-BC, discusses ways that nurses can advocate for their patients and help them manage health-related symptoms in the context of changing local environments. 

Climate Change and Evolving Threats to Public Health: The Oncology Nurse’s Role

On September 22 and 23, 2022, the FDA’s Oncologic Drugs Advisory Committee (ODAC) convened for a hearing to assess the risk-benefit ratio of 3 agents. 

ODAC Committee Votes Against Upholding 3 Indications in Lung and Hematologic Malignancies

Selpercatinib was approved by the FDA for RET fusion–positive non–small cell lung cancer and locally advanced or metastatic RET fusion–positive solid tumors. 

Selpercatinib Is Approved for 2 RET Fusion–Positive Solid Tumors, Non–Small Cell Lung Cancer

Intense-modulated therapy was associated with less patient-reported toxicities than conventional radiotherapy and demonstrated a comparable efficacy profile. 

Intense-Modulated Radiation Therapy Reduces Chronic Diarrhea and Urinary Toxicity in Women With Cervical or Endometrial Cancer

For patients receiving an aromatase inhibitor for hormone receptor–positive, HER2-negative breast cancer, the addition of abemaciclib doubled median progression-free survival vs placebo.

Addition of Abemaciclib to Aromatase Inhibitor Therapy Prolongs Survival in HR+/HER2- Breast Cancer

Sotorasib doubled the progression-free survival rate in patients with KRAS G12C–mutated non–small cell lung cancer. 

Phase 3 Findings Showcase PFS Benefit with Sotorasib for Patients With KRAS G12C+ NSCLC

Debi Fischer is a nurse at the University of Miami surgical oncology step down unit. Prior to that she worked in orthopedics and neurology for many years. In addition to her nursing experience, she has earned a master’s degree in social work. Becoming a Licensed Clinical Social Worker was a long-sought-after goal which she finally attained. She is a caregiver for her family and her dogs as well.

Debi Fischer, MSW, BSN, BA, LCSW, RN, discusses the launch of the Florida Cancer Connect program and what this initiative represents for patients across the United States. 

Opinion: New Cancer Treatment Options in Florida Represent Larger Shift Toward Centralized Care

Julie Malo, CCRP, a research nurse with the University of Montreal, discusses a nurse-directed initiative examining how the gut microbiome affects immune checkpoint blockade responses in patients with non–small cell lung cancer. 

Nurse-Led Research Links Saturate Fatty Acids to Improved Immunotherapy Responses in NSCLC

Patients with hepatocellular carcinoma achieved a median overall survival of 15.9 months with tislelizumab and 14.1 months with sorafenib.

Tislelizumab Rivals Sorafenib in Improving OS in Unresectable Hepatocellular Carcinoma

The FDA has approved eflapegrastim to treat febrile neutropenia. The agent should be administered 24 hours following cytotoxic chemotherapy. It comes with warnings for fatal splenic rupture, acute respiratory distress syndrome, sickle cell crisis, glomerulonephritis, leukocytosis, thrombocytopenia, and myelodysplastic syndrome. 

FDA Approves Eflapegrastim to Decrease Risk of Infection in Patients Receiving Cytotoxic Chemotherapy 

Focused discussion on the management of antibody drug conjugate–related adverse events in gastric cancer, with a focus on neutropenia. 

T-DXd in HER2+ Gastric Cancer: Managing Neutropenia and Other AEs 

A broad overview of the treatment armamentarium for patients receiving first- or second-line therapy for HER2+ gastric cancer.

First- and Second-Line Treatment Options for HER2+ Gastric Cancer

In a real-world analysis of patients with hepatocellular carcinoma, the median overall survival with lenvatinib was 9.7 months in the low-dose group and 7.6 months in the recommended-dose group.

Top Medical News

Oncology Nursing News Top Stories: September 2022

Sodium Thiosulfate Gets Green Light for Chemotherapy-Induced Hearing Loss in Pediatric Patients

Patient Profile 4: A Patient with HER2+ Gastric Cancer Treated With T-DXd Who Develops Diarrhea

Ongoing Clinical Trials With T-DXd in HER2+ Gastric Cancer

Rise of Oral Cancer Drugs Signal Deeper Financial Toxicity Issues for Patients

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