Real-world data from a retrospective study showed that pembrolizumab (Keytruda) combined with the anti-VEGF agent bevacizumab (Avastin) plus oral metronomic cyclophosphamide displayed minimal toxicity with long-term clinical responses in a significant number of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Data were presented in a poster at the ESMO Congress 2022.

Following the completion of a phase 2 clinical trial (NCT02853318) conducted at Roswell Park Comprehensive Cancer Center in Buffalo, New York, investigators used the regimen of pembrolizumab 200 mg intravenously (IV) plus bevacizumab 15 mg/kg IV every 3 weeks plus 50 mg daily cyclophosphamide on a 21-day cycle in clinical practice.

Heavily pretreated patients (n = 55) were enrolled in the retrospective, single-center study. These patients had a mean number of 3.4 prior lines of chemotherapy received (range 1-9).

The median overall survival (OS) was 14 months (95% CI, 11-not reached) with a 6-month OS rate of 93.7% and a 12-month rate of 65%. The objective response rate (ORR) was 42%, including 3 patients with a complete response (CR). Slightly less than half (49%) of patients achieved stable disease and the total clinical benefit rate was 91%. The median progression-free survival (PFS) was 7.8 months (95% CI, 4.5-10.3) and the 6-month and 12-month PFS rates of were 61.1% and 24.5%, respectively.

Stable disease at 24 weeks or more was reported in 26% of patients and was 74% at less than 24 weeks. Only 9% of the patients included in the retrospective study experienced disease progression.

Investigators reported that these data also demonstrated improved quality-of-life outcomes.

The mean age of patients in the retrospective study was 63.4 years. Nine patients (17%) were BRCA positive, 11 (20%) were PD-L1 positive, and 32 (58%) had a history of platinum chemotherapy resistance. Prior bevacizumab therapy was reported in 30 (55%) of those in the trial and 3 (6%) had previous cyclophosphamide treatment.

Single-agent immune checkpoint inhibitors are not largely effective in the treatment of recurrent ovarian cancer and because there is limited efficacy with traditional second-line chemotherapies in this patient population, investigators aimed to determine if the combination therapy would have a promising efficacy with ORR and PFS as measurements of the efficacy primary end point.

The combination therapy had a minimal toxicity in the retrospective study. The most common adverse events (AEs) of any grade included fatigue, nausea/vomiting, abdominal pain, and constipation. Fatigue has the highest incidence, reported among over 90% of patients.

Comparatively, in the phase 2 trial, patients in the safety population (n = 40) experienced AEs of any grade and grade 3 or 4 at a rate of 83.5% and 32.5%, respectively.

The median PFS was 10.0 months (90% CI, 6.5-17.4). The ORR was 47.5%, including a 7.5% CR rate. The clinical benefit rate was 95% with 47.5% of patients having stable disease. The durable response rate was 25%.

The combination of pembrolizumab, bevacizumab, and metronomic cyclophosphamide may be a future treatment for recurrent ovarian cancer, study authors wrote in conclusion.

Poblete S, Caulkins MA, Roche CL, et al. Pembrolizumab in combination with bevacizumab and oral metronomic cyclophosphamide for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer—real-life clinical experience. Poster presented at: 2022 European Society for Medical Oncology; September 9-13, 2022; Paris, France.

Zsiros E, Lynam S, Attwood KM, et al. Efficacy and safety of pembrolizumab in combination with bevacizumab and oral metronomic cyclophosphamide in the treatment of recurrent ovarian cancer: a phase 2 nonrandomized clinical trial. 

. 2021;7(1):78-85. doi:10.1001/jamaoncol.2020.5945

Articles

Real-world data from a retrospective study 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.

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

Cannabinoids are becoming more popular for patients with cancer as a pain management strategy. However, with inconsistent laws across states and federal bodies, it can be difficult for nurses and patients to comfortably discuss cannabinoids and cannabinoid use.

As the public perception and patient success stories with unconventional, alternative, and natural therapeutics shift consumer attitudes, it is important for nurses and their patients to understand the differences in the products and the adverse effects associated with each. According to a study by Butler et al in 2021, nearly half of individuals who participated in a survey who had consumed cannabidiol (CBD) did not disclose use to their health care provider.

“We see a lot of patients who have been trying to talk to us about CBD [cannabidiol], and cannabinoids and THC, [tetrahydrocannabinol]” Karen Hande, PhD(c), DNP, ANP-BC, CNE, FAANP, ANEF, a professor of nursing at Vanderbilt University School of Nursing, said in a presentation during the Oncology Nursing Society Bridge.

Although Hande stated in her presentation that she was no expert in cannabinoids or medical cannabis, her clinical research primarily focuses on helping patients effectively manage their cancer-related pain. Therefore, she has become very interested in cannabis and has dedicated a lot of time and research to best understand the evidence-based data that exists for these products. In her presentation, “Cannabinoids for Patients With Cancer,” Hande discussed the available evidence on CBD and the possible risks, particularly in vulnerable populations.

“I think it’s just important for under us to understand a kind of broad overview about cannabinoids and THC and CBD, because this gives us a better understanding of where the laws come into play,” Hande said. She added, “It took me quite some time to try to understand all the differences and trying to make sure I give the correct information to my patients.”

A key concept for oncology nurses to understand, according to Hande, is the variations of cannabinoids.

Cannabinoids are compounds found in the cannabis plant. These compounds interact with the human endocannabinoid system. The exact relationship still required further understanding.

“Cannabis has many names for [many] strains, and hemp and marijuana are under this big umbrella of cannabis plants; they are all considered to be 1 species: the cannabis sativa plant,” she said. “This is a genus of flowering plants. And these can contain about over 100 phytocannabinoids, [and] they have a wide range of effects on the body in the brain.”

The following products are derived from cannabis: marijuana, hemp, THC, and CBD. In addition, there are man-made synthetic cannabinoids (K2/Spice); however, these agents are designed to mimic the mind-altering effects of illicit drugs. For her talk, Hande chose to focus on the products derived from the plant itself, as oncology nurses are more likely to encounter patients using plant-derived products.

If a patient reports marijuana use, this means they are using the dried flowers, leaves, stems, and seeds of the cannabis plant. Marijuana is also known as cannabis, weed, pot, or dope. Specifically, it can be defined as a plant with at least 0.3% delta-9 THC by weight. It is consumed by smoking (joints, blunts, bongs), vaping (vaporizing electronics devices), or by mixing or infusing it into foods or drinks (edibles).

“This is an important differentiating factor that I’ll be highlighting regularly through this talk,” Hande said during her presentation. “Marijuana is more than 0.3% of THC by weight.”

Marijuana is the most used federally illegal drug in the United States, with approximately 18% of Americans reported using it at least once in 2019 (~48.2 million Americans).1

Because marijuana has THC, it is associated with the following health risks: alterations in memory, learning, attention, decision-making, coordination, emotion, and reaction times.2 In terms of long-term health, marijuana has been linked to an increased risk of psychosis and schizophrenia,3 and, like other drugs, it’s use during pregnancy may increase the risk of embryo-toxicities.4 Moreover, this drug, depending on where it is sourced, may be laced with other substances. Consumers may or may not be aware of other substances in their product.

Using marijuana in combination with other agents may also result in impairment and can increase the risk of overdose.

Federally, marijuana is illegal as a recreational drug. It is classified as a schedule 1 drug, per the Drug Enforcement Agency. Although it is legal in some states for medical for nonmedical adult use, this does not mean that is safe, Hande noted. Specifically, smoking marijuana can expose users to harmful chemicals, and insufficient evidence exists to document the safest method for consuming.

Legally, hemp must contain a THC concentration of less than 0.3% by dry wright. It is the same species of plant as the cannabis plant and, along with bamboo, it is one of the fastest growing plants on Earth. There are almost no restrictions on hundreds of compounds made by the plant. Industrial hemp is cannabis sativa plant grown specifically for industrial or medicinal use.

“Many states across the country have hemp cultivation,” Hande said. “This allows cultivation of hemp from commercial or research or pilot programs. There are only a few states that do not allow cultivation of hemp.”

In 2018, the farm bill legalized the production and sale of hemp and its extracts, removing the product from the controlled substance act. Of note, per federal law, hemp cannot contain greater than 0.3% THC. If the concentration of THC surpasses this measurement, it is classified as marijuana.

As of September 2022, 47 states have enacted legislation to establish hemp production programs or cultivation research.

THC is a compound of the cannabis plant. This psychoactive agent causes, what is known as a high. It is consumed via dabbing—a specific method for inhaling THC concentrates.

Unfortunately, the concentrated forms of THC mean that there is an increased risk of additives or contaminating substances existing in the product.

CBD is another active cannabinoid found in the cannabis plant. This agent is not psychoactive and consequently does not cause a high.

CBD can be derived either directly from the cannabis plant or from a hemp product. The key difference between cannabis- and hemp-derived CBD is the concentration of THC. Hemp-derived CBD must have a THC concentration less than 0.3% to be federally legal. CBD products containing greater concentrations are federally illegal but are legal under some states.

“The main difference between cannabis and hemp-derived CBD is the amount of THC that it can contain,” Hande stressed. “Hemp-derived CBD includes less than 0.3% of the THC. [Therefore,] it’s federally legal to use hemp-derived CBD, but CBD products that contain more than 0.3% of THC are federally illegal. This is where the conflict between the state and the federal laws [can arise].”

The extraction process for CBD and THC are similar; farmers harvest the hemp and it is sent to an extractor. If the extraction is not performed with pharmaceutical grade standards, the CBD may become contaminated with THC, chemical solvents, or even pesticides. This is compounded by the fact that the US does not hold CBD supplies to a standard, and federal enforcement is lacking.

CBD can be converted into delta-8-THC, delta-9 THC, and other THC isomers through a solvent, acid, and heat. These products end up with higher concentrations of delta-8 THC than those which occur naturally in the cannabis plant. Consequently, these products may create harmful by-products that presently are not well-characterized.

Delta-8 THC products are increasing in popularity, in both marijuana- and hemp-based markets. It is appearing in markets that are operating legally under state, territorial, or tribal laws.

As of 2022, most states and territories permit full and restricted marketplaces where consumers can purchase hemp and hemp-derived CBD products.

According to Hande, there are a wide variety of delta-8 THC-containing products in the market. For example, vapes, smokable hemp sprayed with delta-8 THC extract, distillates, tinctures, gummies, chocolates, and even infused beverages can fit into this category. Moreover, the testing method for these products are still under development. This means that Delta-8 THC products may not be systematically tested for contaminants such as heavy metals, solvents, or pesticides which can cause adverse health effects.

How to Talk to Your Patient About Cannabinoid Use

Nurses hold a key role in discussing not only the risks of cannabinoid use but providing educational information for the safe consumption. Should a patient be interested in trying CBD products, counsel on the lack of evidence, contaminants, misleading labels, and legal issues of surrounding use. One approach to counter the “buyer beware” notion is to provide evidence-based patient education and to screen for any drug/drug interactions that may occur should the patient consume CBD products.

Additionally, assessing the patient’s baseline knowledge base before use will be beneficial and open communication may help establish trust and increase reported use between the patient and the health care provider. Finally, addressing the topic early on in care may remove the barrier of the stigma surrounding cannabinoid use.

Hande concluded by adding that many trials are ongoing in the cannabinoid arena and that results are expected to be published over the next several years. She noted that the oncology nurses should be up-to-date on the latest findings to provide guidance.

Marijuana and public health data and statistics. Centers for Disease Control and Prevention. June 8, 2021. Accessed September 14, 2022. bit.ly/3ROqaoi

Testai FD, Gorelick PB, Aparicio HJ, et al. Use of marijuana: effect on brain health: a scientific statement from the American Heart Association. 

. 2022;53(4):e176-e187. doi:10.1161/STR.0000000000000396

Di Forti M, Quattrone D, Freeman TP, et al. The contribution of cannabis use to variation in the incidence of psychotic disorder across Europe (EU-GEI): a multicentre case-control study. 

. 2019;6(5):427-436. doi:10.1016/S2215-0366(19)30048-3

Health effects of marijuana and cannabis-derived products presented in new report. National Academies. January 12, 2017. Accessed September 14, 2022. 

Karen Hande, PhD(c), DNP, ANP-BC, CNE, FAANP, ANEF, explains the difference between some of the popular cannabinoid products that patients with cancer may be taking.

Oncology Nurses: What Cannabinoid Is Your Patient Taking?

® spoke with Christine Miaskowski, PhD, RN

professor in the Department of Physiological Nursing and Anesthesia at UCSF School of Nursing. Miaskowski discusses results from research which showcases an increased risk of hearing loss among patients who received platinum- or taxane-based cancer treatments. She also discusses the importance of including hearing assessments as a standard of care for survivors.

Top takeaways from the discussion include:

“When we did audio metrically confirmed hearing loss [assessments], we found that between 50% to 70% of survivors had confirmed hearing loss.” 

“It’s really, very surprising because it is a group of patients with very common cancers: breast, lung, gynecologic and GI [gastrointestinal] malignancies.” 

“The good news is that the type of hearing loss these patients experience is amenable to a hearing aid. So, if we can get people tested, and they demonstrate this kind of hearing loss, we can improve their quality of life.” 

“Nurses care about interactions with other people, people’s quality of life, [their] social function… if you've got hearing loss, and you're sitting at a table with people, and you can't hear them, you're not going to be likely to participate.” 

“We don’t even think about [some of] these consequences; in terms of occupation, social gatherings, safety for a child… We really, as nurses, need to be doing something about this.” 

Episode 33: Balancing the Benefit and Toxicity of Cisplatin in Young Children with Cancer

Episode 45: Key Advances in Cancer Survivorship Toxicity Management

Audiological Assessments May Be Vital Component of Cancer Survivorship Care Following Chemotherapy

Hearing Loss Found in Testicular Cancer Survivors After Cisplatin Therapy

Genetic Mutation Could Play Role in Cisplatin-Induced Hearing Loss

Oncology Nursing News® Publication Features

Survivors Need Research-Based Interventions and Stronger Coordination Across Care Continuum

What Are the Needs of Cancer Survivors 5 Years or More After Treatment?

Everyone's Business: Taking Survivorship Care to the Next Level

Heather E. Wheeler Discusses Cisplatin-Induced Hearing Loss

Cheung S, Henderson-Sabes J, Mastick J, et al. Cancer survivors and neurotoxic chemotherapy: hearing loss and tinnitus. 

. Published online July 27, 2022. doi:10.1136/spcare-2022-003684

Romano A, Capozza MA, Mastrangelo S, et al. Assessment and management of platinum-related ototoxicity in children treated for cancer. 

2020;12(5):1266. doi:10.3390/cancers12051266

Biro K, Noszek L, Prekopp P, et al. Characteristics and risk factors of cisplatin-induced ototoxicity in testicular cancer patients detected by distortion product otoacoustic emission. 

. 2006;70(3):177-184. doi:10.1159/000093776

Cheraghi S, Nikoofar P, Fadavi P, et al. Short-term cohort study on sensorineural hearing changes in head and neck radiotherapy

2015;32(7):200. doi:10.1007/s12032-015-0646-3

Langer T, am Zehnhoff-Dinnesen A, Radtke S, Meitert J, Zolk O. Understanding platinum-induced ototoxicity. 

. 2013;34(8):458-469. doi:10.1016/j.tips.2013.05.006

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In this episode of “The Vitals,” Christine Miaskowski, PhD, RN, discusses research showcasing that adult patients receiving either a platinum-based chemotherapy, taxane alone, or a combined regimen of platinum- and taxane-based treatment may be at risk of hearing loss. 

Are Hearing Tests Necessary For Adult Cancer Survivors?

Most adolescent or young adults 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.

“Our data suggest a preference for home death for most AYAs with advanced cancer,” wrote Oreofe O Odejide, MD, assistant professor of medicine and medical oncology at the Dana-Farber Cancer Institute, and co–investigators.

“Unfortunately, this preference is aspirational for many, as the majority die in hospital settings. To ensure that the EOL [end-of-life] experiences of AYAs align with their preferences, robust home-based services for symptom control and logistical/psychosocial support for family caregivers and siblings are imperative: we need innovative strategies that close the gap between preferred and actual location of death to achieve high-quality EOL care for AYAs with cancer.”

In the US, more than 9000 AYA patients die of cancer every year, and existing data suggests that EOL care for may be less than optimal in this population. High-intensity care, frequent hospitalizations, intensive care unit admission, and chemotherapy in the last month of life can all contribute to negative EOL experiences. These are more likely to occur for AYA patients than with older adults or young children. Moreover, most AYA patients die in the acute-care setting. Findings from a 2021 study published in 

 estimated that 69% of AYA patients pass away while admitted.

Investigators sought to better understand patient preferences—specifically, preferential EOL locations.1 Therefore, they conducted quantitative interview studies of AYA patients with advanced disease and compiled responses along with the responses of their family caregivers and clinicians. Interviews occurred between December 6, 2018, and January 5, 2021. Eligible participants were identified from clinical lists, administrative databases, and clinician referrals. The study included a total of 80 individuals: 23 patients, 28 family caregivers, and 29 clinicians.

The interviews revealed that multiple factors influence an AYAs choice of death location. The driving rationale comes from a want to be around family and friends but other reasons for include a desire for comfort, a sense of normalcy, and wanting to be protected from the isolation of being in the hospital.

One participant stated: “Rather than being in a situation where my last days are spent on a hospital bed and my parents and my loved ones have to come to the hospital, I would rather kind of share those experiences in the last days in a home – I would rather pass at home.”

External factors, however, may influence an AYA patient’s decision, and persuade them to elect an in-hospital death. One reason for this may be that there are more logistical considerations necessary for an at-home death. Caregivers were more likely to recognize these logistical considerations, which include need for pain and symptom management.

One caregiver described circumstances surrounding a patient that would influence admission to a hospital being preferential. “Had she experienced a tremendous amount of pain, we would have sought another way of you know either getting continuous IV [intravenous] morphine…or we would have brought her back to the hospital,” the caregiver responded. “And although she wouldn’t have wanted that decision, the pain decision would have superseded the decision to keep her home.”

A clinician backed that sentiment, noting, “Most [individuals] feel it would be nice to be at home, but then the question is: at what cost?… The symptom burden is high here—few [individuals] that I’ve met are willing to be at home at the cost of risk of symptom control.”

Moreover, there is the desire of the caregiver to preserve the home as a place “untouched” by death, particularly for the benefit of a sibling, which may persuade AYA patients to choose a hospital death. One caregiver acknowledged that her family did not want to “mar” their home space and did not want the patient’s younger sibling to witness her brother’s death.

Although most AYAs expressed that they would prefer to pass away at home, they also acknowledged a family member preference and, consequently, they expressed concern about imposing additional trauma on their family members if they choose to stay at home. The desire to experience EOL comfort for themselves, and the need to not to be a burden to their family, created a tension that was identified in the study. Results noted that many AYAs chose a hospital-death specifically to limit the potential burden on their family members.

Lastly, the need for hospice care is at odds with the desire to pass away at home. Although hospice care can be useful in facilitating an at-home death, there are limitations, and some families may opt to bring their loved one in for inpatient hospice care despite patient preferences. For example, a bereaved caregiver reported that their loved one died in a hospice house rather than at home because of inability to access the high level of care needed to facilitate a home death.

Another stated, “One thing I wish is that in-home hospice services would be able to do 24-hour care, not nursing care, but [provide an] aide to stay with the patient. Because I had to put him in a hospice house because he couldn’t die at home because I couldn’t care for him anymore. That was hard for me.”

Although at-home hospice services represent an interesting tactic to try and make at-home deaths feasible, gaps still remain in this type of care and will need to be expanded if families are truly able to take advantage of these services rather than inpatient hospice. Similarly, robust home-based services for symptom control and logistical/psychosocial support for family caregivers and siblings are imperative and warrant further investigation.

Given the stress that surrounds EOL experiences, seeking invocative solutions to improve the level of comfort for these patients is necessary, the authors concluded.

Odejide OO, Fisher L, Kushi LH, et al. Patient, family, and clinician perspectives on location of death for adolescents and young adults with cancer. 

Published online August 18, 2022. doi:10.1200/OP.22.00143

Coltin H, Rapoport A, Baxter NN, etc. Locus-of-care disparities in end-of-life care intensity among adolescents and young adults with cancer: a population-based study using the IMPACT cohort. 

 2022;128(2):326-334. doi:10.1002/cncr.33926.

Innovative strategies are needed to ensure that adolescents and young adults with cancer who prefer to die at home are able to make that choice.

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

Cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANs), and prolonged cytopenia are the key adverse events (AEs) of interest linked with treatment with ADP-A2M4CD8, a next-generational autologous T-cell receptor designed to target solid tumors, according to an updated analysis of the SURPASS trial (NCT04044859). However, most cases of these AEs resolved during the SURPASS trial, and the efficacy data associated with this novel agent warrant further clinical trial investigation in multiple tumor types.

“The efficacy of the ADP-A2M4CD8 as monotherapy in heavily pretreated patients with advanced metastatic disease across multiple major solid tumors are encouraging,” David S. Hong, MD, deputy chair of the Department of Investigational Cancer Therapeutics, in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, said in a presentation of the findings during the 

2022 European Society of Medical Oncology Congress

. “The safety profile remains acceptable, and the data to-date support advanced clinical trials and further investigation, including combination approaches.”

CRS emerged as an AE of special interest in the study. Ultimately, 32 patients (72.7%) experienced CRS. Among these, 6 patients (14%) developed grade 3 or worse CRS. The median time to onset was 3 days (range, 1-9) and the median time to resolution was 5 days (range, 1-15). In the case of 27 patients (61%), anti-IL6 therapy was effective in managing the AE. 

Cytopenia and ICANS also represented key AEs related to this treatment. A quarter of enrolled patients (n = 11; 25%) developed grade 3 or greater prolonged cytopenia during week 4 post-infusion. In addition, 3 patients (6.8%) in the study experienced an ICANS; of which 5% (n = 2) were grade 3 or greater.

For any-grade AEs, the most common were CRS (72.7%), neutropenia (29.5%), anemia or decreased red blood count (22.7%), pyrexia (22.7%), fatigue (20.5

, leukopenia (15.9%), rash (15.9%), and thrombocytopenia (15.9%).

Some patients also experienced dyspnea (13.6%), hypoxia (13.6%), ICANS (13.6%), pleural effusion (13.4%), febrile neutropenia (11.4%), hypotension (11.4%), and tachycardia (11.4%).

The percentage of patients who developed a SAE (grade 3 or higher) was 61.4%, among these serious cases included CRS (31.8%), hypoxia (6.8%), ICANs (6.8%), and pyrexia (6.8%).

Unfortunately, there were 2 cases of grade 5 (fatal) serious AEs (SAEs). The first was 60-year-old patients with ovarian cancer. This patient had a large tumor burden in her lungs and had received prior lung radiotherapy. The cause of her death was a combination pneumonia and CRS. The other patient was a 71-year-old man who had adenocarcinoma in his esophagus. This patient had a history of chronic anemia and had developed new lesions in his liver. The cause of his death was bone marrow failure.

SURPASS is a phase 1 trial designed to evaluate the safety and tolerability of ADP-A2M4CD8. Its secondary objective is to evaluate the antitumor activity of the investigational agent. Investigators are also using the findings to explore the persistence, phenotype, function of transduced and nontransduced T cells, and the tumor and serum factors that may influence response or resistance.

ADP-A2M4CD8 is a next-generation specific peptide enhance affinity receptor (SPEAR) T-cell therapy which is designed to increased potency by expressing a CD8α coreceptor, which are genetically engineered alongside the T-cell receptor with the intent of increasing CD4-positive T-cell potency. Investigators hypothesize that this will increase the T-cell receptor binding avidity and enhance the polyfunctional response of engineered CD4-positive T cells against MAGE-A4 tumors.

The overall confirmed response rate among patients receiving this treatment for solid tumors was 28% (n = 12); 5% of patients (n = 2) achieved unconfirmed responses and are awaiting confirmatory scans. The median duration of responses was 12 weeks (range; 7-65 weeks) and the disease control rate was 81%. Patients who achieved confirmed clinical responses had diagnoses of ovarian, esophagogastric junction, urothelial, head and neck, and synovial sarcoma cancers.

The screening phase of the SURPASS trial involved screening for human leukocyte antigen and MAGE-A4 immunohistochemistry testing. Patients who were eligible to enroll underwent baseline tumor measurements, followed by lymphodepletion (days –7 to –4) and subsequent ADP-A2M4CD8 infusion. Following the T-cell infusion, patients received nivolumab (Opdivo) every 4 weeks.

Monotherapy was administered to 60 patients. A cohort of 30 patients received combination therapy with an anti–PD1-inhibitor. Long-term follow-up for this study will range between 1 to 15 years.

Among 44 eligible participants, the median age was 59.0 years (range, 31-75). Twenty-three participants were male (52.3%), and the median H-score was 250.0 (range, 95-300). Thirteen patients had an ECOG performance status of 0 (29.5%) and 31 had a performance status of 1 (70.5%). Twenty-nine patients had a target tumor greater than 5 cm (65.9%).

The median number of transduced T cells × 109 was 4.64 (range, 0.95-9.95), and the median number of lines of prior therapies was 3 (range, 1-8).Twenty-three patients received systemic bridging therapy (52.3%).

Tumor types included were as follows: 31.8% of patients had ovarian cancer (n = 14), 29.5% had esophagogastric junction, esophageal, or gastric cancer (n = 13), and 15.9% had urothelial (n = 7), 9% had head and neck cancer (4%), 4.5% had non–small cell lung cancer, 4.5% had melanoma (n = 2), 2.3% had synovial sarcoma (n = 1), and 2.3% had myxoid round cell liposarcoma (n = 1).

“The efficacy and safety results with ADP-A2M4CD8 continues to show an acceptable benefit-to-risk profile in multiple MAGE-A4–positive unresectable or metastatic tumors,” Hong concluded. “The efficacy and safety results with monotherapy support expansion into combination therapy with an anti–PD-1 checkpoint inhibitor.”

Based on the positive findings presented during this update, an additional treatment cohort with nivolumab has been initiated in the SURPASS phase 1 trial. Further, phase 2 studies assessing the agent are planned including for patients with esophageal and esophageal gastric junction (SURPASS-2; NCT04752358), which is recruiting, and for patients with ovarian cancer (SURPASS-3).

Hong DS, Asch A, Calvo E, et al. Updated safety and efficacy from SURPASS, the phase I trial of ADP-A2M4CD8, a next-generation autologous T-cell receptor T-cell therapy in previously treated patients with unresectable or metastatic tumors. Presented at: European Society for Medical Oncology Congress 2022; September 9-11, 2022; Paris, France.

In the phase 1 SURPASS trial, 72% of patients with solid tumors developed any-grade cytokine release syndrome following an infusion of ADP-A2M4CD8. The median time to resolution was 5 days. 

Cytokine Release Syndrome and Neurotoxicity Emerge as Primary AEs of Interest With Solid Tumor T-Cell Receptor Therapy 

In August 2022, the relationship between nutrition and cancer was put to the test: myths surrounding sugar, soy, and vegan diets, and their ability to improve or injure patient outcomes were debunked. Similarly, the American Society of Clinical Oncology (ASCO) released updated guidelines with recommendations for diet and exercise for patients undergoing active treatment.

Oncology nurse research took center stage as new findings showed that taxane-based chemotherapy caused hearing loss in the majority of patients with breast, gastrointestinal, gynecological, or lung cancer. 

® discussed the findings and implications in clinical practice in an exclusive interview with principal investigator Christine Miaskowski, PhD, RN.

Finally, nurses play a powerful role in improving the quality of care for patients. Hear from experts how nurses can help ensure that patients with ovarian cancer receive optimized treatment plans, as well as help create an inclusive environment for all they attend to in their practice.

Dispelling Nutrition Myths for Patients With Cancer

Entering the words nutrition and cancer into Google returns as many as 718 million hits. With an overabundance of opinions, it can be challenging to separate fact from fiction. Therefore, in this feature, Nicole Franklin, MS, RDN, CSO, LDN, a registered dietician with the American Oncology Network, calls out 3 commonly held myths about nutrition and cancer and uncovers the bottom line.

New research efforts led Christine Miaskowski, PhD, RN, show that most adult cancer survivors who undergo treatment with either a platinum-based chemotherapy, taxane alone, or a combined regimen of platinum- and taxane-based treatment, experience some degree of hearing loss. In an interview with 

 Miaskowski, a professor in the Department of Physiological Nursing and Anesthesia at UCSF School of Nursing, highlights what these findings mean for clinical practice.

Nurses Play Key Role in Facilitating Maintenance Therapy With PARP Inhibitors in Ovarian Cancer

®, Paula Anastasia, RN, MN, AOCN, a gynecologic Oncology Clinical Nurse Specialist for UCLA Health, offers a recap of her presentation at 

. She discusses ways in which nurses can help facilitate maintenance therapy with PARP inhibitors such as olaparib (Lynparza), rucaparib (Rubraca), and niraparib (Zejula), and emphasizes the value of germline testing for this patient population.

ASCO Outlines Recommend Aerobic and Resistance Exercises for Patients Undergoing Active Cancer Treatment

ASCO recently convened a panel of experts to conduct a comprehensive literature review of existing data regarding the role of diet, weight, and exercise in defining patient outcomes. The updated guidelines formally recommend aerobic and resistance exercises for patient with cancer, although they note that this is an area of research that continues to be overlooked in clinical trial designs.

1. Addressing Disparities: Practicing Inclusion for LGBTQ+ Patients With Cancer

Identifying and acknowledging disparities helps providers work together to improve access to care and treatment and reduce the cancer risks. Among individuals in the LGBTQ+ community there is less access to care because of a lack of inclusive health care, underrepresentation and exclusions in clinical trials, and lack of coverage for appropriate screenings.

In this feature, our partners at Cancer Care outline key ways that nurses can improve their care delivery and create a practice that is inclusive for marginalized communities.

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

Oncology Nursing News Top Stories: August 2022

All women with ovarian cancer should receive genetic testing, according to Paula Anastasia, RN, MN, AOCN. However, certain actionable targets may be missed depending on the tests ordered in the clinic.

“When we talk about genetic testing, germline testing, now we want panel testing because in addition to the 

 pathogenic variants, there are other pathogenic variants in that family [such as] 

,” says Anastasia, who notes that for nurses working at institutions without genetic counselors onsite, there are valuable genetic counselor services online, which not only provide tests but help contextualize the results for providers and patients alike.

Anastasia recently gave a talk on PARP inhibitor optimization as part of the 

® to discuss what nurses need to know about this class of agents.

There are 2 approved PARP inhibitors for ovarian maintenance therapy, Anastasia says. However, it is important to determine if a patient has a homologous recombination deficiency (HRD) to see if they are eligible for a PARP inhibitor, she adds, noting that studies have shown that patients with a germline mutation or an HRD-positive tumor have a better clinical benefit with a PARP inhibitor.

Lastly, Anastasia underscores the importance of a patient’s prior adverse effect profile from chemotherapy.

“We want to know: how did patients do with their frontline therapy?” she explains. “Did they require growth factors? Was there dose reduction? Do patients have a history of hypertension, which may indicate whether or not they would tolerate something like niraparib?”

All of these are important considerations, she concludes.

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Paula Anastasia, RN, MN, AOCN, underscores the value of genetic testing in personalizing treatment decisions in ovarian maintenance therapy. 

Paula Anastasia Emphasizes Importance of Genetic Testing in Selecting Maintenance Therapy for Ovarian Cancer

Most adult cancer survivors who undergo treatment with either a platinum-based chemotherapy, taxane alone, or a combined regimen of platinum- and taxane-based treatment, experience some degree of hearing loss, according to results from a study published in 

Among 273 survivors of breast, gastrointestinal, gynecological, or lung cancer, the rate of audiogram-confirmed hearing loss ranged from 52.3% to 71.4%. The rate of tinnitus among survivors ranged from 37.1% to 40.0%. In terms of treatment, 12.8% received a platinum-containing regimen, 56.8% a taxane-containing regimen, and 30.4% a platinum-containing and taxane-containing regimen. No differences were observed across the 3 different groups of chemotherapy-treated patients.

“It’s really very surprising because it is a group of patients [with] very common cancers: breast lung, and gynecologic malignancies,” senior and corresponding author Christine Miaskowski, PhD, RN, professor for the Department of Physiological Nursing and Anesthesia at UCSF School of Nursing, said in an interview with 

Miaskowski served as investigator in a previous trial assessing the rates of chemotherapy-induced neuropathy in cancer survivors which also asked participants to self-report hearing loss occurrence. To the investigators’ surprise, 40% of these patients reported hearing loss and 25% reported tinnitus.

“When we found this high rate of hearing loss, I went to our clinician colleagues, I went to the nurses, I went to the physicians and said: Do you ask about this? Nobody asks. So, we wrote another grant,” Miaskowski said. “Lo and behold, we found that between 50% to 70% of survivors have audio-metrically confirmed hearing loss.”

pediatric patients receiving platinum-based regimens

 In adults, hearing loss assessments have generally been limited to patients receiving aggressive platinum compounds as part of active treatment for 

Known risk factors for cisplatin-induced ototoxicity include a higher cumulative dose, younger age at exposure, concomitant radiation, being male, and the coadministration of other potentially ototoxic compounds, such as antibiotics.

 Taxane, which may be administered as monotherapy or in combination with platinum compounds, has been found to induce neurotoxic effects in the peripheral nervous system; however, its relation to ototoxicity is not well understood.

“The majority of the literature about hearing loss is related to platinum compounds, which is commonly prescribed across these common cancers,” Miaskowski noted. “What was a new finding—in terms of the drug regimens—is that there is another class of neurotoxic drugs called taxanes. It has been known for a long time that [taxanes] produce peripheral neuropathy. [But] one of the new findings from this study was that these compounds are equally likely to produce hearing loss and or tinnitus.”

Breast, gastrointestinal, gynecological, and lung cancer represent the 4 most common cancer types in the US, and platinum- or taxane-based regimens are the most common treatments for these malignancies. Therefore, when the larger study indicated that the rates of ototoxicity might be high in these areas, the investigators began to home in on this finding.

This study conducted audiometric assessments that obtained pure tone air conduction thresholds bilaterally at frequencies of between 0.25 kHz to 16.0 kHz. Each survivor’s audiogram was evaluated in hearing using the National Health and Nutrition Examination Survey–modified Occupational Safety and Health Administration standards and adjusted for age-related and gender-related changes.

According to Miaskowski and her coinvestigators, survivors should be screened for hearing loss and tinnitus on a routine basis. Further, patients who demonstrate signs of hearing loss should be assessed via audiogram to see whether they require a hearing aid.

“The good news is that the type of hearing loss these patients experience is amenable to a hearing aid,” she said. “If we can get people tested, and they demonstrate this kind of hearing loss, we can improve their quality of life.”

Moreover, according to Miaskowski, this interventional strategy does not present with many challenges.

“I don’t think there are huge problems with testing,” she said. “A physician can prescribe [it and] you go to Costco and get a hearing test. The tests are readily available. [However,] we should be doing this because [individuals] really underestimate the amount of hearing loss they’re experiencing, and it’s treatable.”

If a survivor scored poorer than the 50th percentile for their age or gender, they were classified as having experienced hearing loss. If they reported that they were conscience of tinnitus for more than 10% of their waking time, they were classified as having tinnitus. Parametric and nonparametric tests were used to evaluate differences among the chemotherapy groups.

Since manageable interventions are available, Miaskowski said that nurses can help improve quality of life by ensuring the survivors are receiving audiological assessments throughout their longitudinal care.

“We often do not think about those consequences, in terms of occupation, social gathering, etc,” she said. “But I think, as nurses, we need to be [encouraging these] assessments.”

For example, Miaskowski noted that if a patient has hearing loss, they are less likely to participate in social functions or gatherings because they may not be able to hear others. “There are consequences in terms of mood, quality of life, [and] social interaction,” she said. “I’ve gotten emails from patients [including] one nurse who contacted me and said that her hearing loss is so significant that she’s having trouble hearing blood pressures. It has [effects] on employment and function, [as well].”

Cheung S, Henderson-Sabes J, Mastick J, et al. Cancer survivors and neurotoxic chemotherapy: hearing loss and tinnitus. 

Hearing loss for cancer survivors is largely underreported, but once identified, is easily treatable, according to Christine Miaskowski, PhD, RN.

Patients actively receiving cancer treatment are encouraged to engage in aerobic and resistance exercises to alleviate treatment-related toxicities and improve quality of life, according to a new guideline published by ASCO.

The updated guideline follows a literature analysis of 52 systematic reviews on the topics of exercise, died, and weight management, and results of 23 randomized clinical trials. Each of the selections underscored the value that exercise interventions may interpose on patients receiving either systemic therapy, radiation, or surgery.

Of note, this guideline represents the first of its kind to specifically focus on patients who are actively receiving treatment. It is intended for oncology professionals and designed to provide evidence-based recommendations for optimized treatment tolerance, quality of life, and cancer control outcomes.

Recommendation No. 1: Aerobic and Resistance Exercises

Oncology providers should encourage patients on active treatment to incorporate aerobic and resistance exercises to mitigate treatment-related adverse events (AEs).

Aerobic and resistance exercises have the potential to reduce fatigue, preserve cardiorespiratory fitness, physical functioning, and strength. In some populations, the benefits reach further; they may maintain or improve quality of life as well as help reduce anxiety and depression. Moreover, these interventions have a low risk of AEs.

It is important to note that although ASCO labeled this as a strong recommendation in the outline, the evidence quality is still moderate to low, and the benefits are not intended to extend to overall treatment outcomes or completion rates but instead are centered on improving life quality throughout treatment.

An ASCO expert panel conducted a comprehensive literature assessment to determine how diet, weight, and exercise play a role in defining patient outcomes.

Gynecologic Cancers