Clinical Insights: May 2019

Thursday, May 23, 2019

Release Date: May 22, 2019
Expiration Date: May 22, 2020


This activity is provided free of charge.

STATEMENT OF NEED

This CE article is designed to serve as an update on cancer detection and prevention and to facilitate clinical awareness of current and new research regarding state-of-the-art care for those with or at risk for cancer.

TARGET AUDIENCE

Advanced practice nurses, registered nurses, and other healthcare professionals who care for cancer patients may participate in this CE activity.
 
EDUCATIONAL OBJECTIVES

Upon completion, participants should be able to:
  • Describe new preventive options and treatments for patients with cancer
  • Identify options for individualizing the treatment for patients with cancer
  • Assess new evidence to facilitate survivorship and supportive care for patients with cancer
ACCREDITATION/CREDIT DESIGNATION STATEMENT

Physicians’ Education Resource®, LLC is approved by the California Board of Registered Nursing, Provider #16669 for 1 Contact Hour.
 
DISCLOSURES/RESOLUTION OF COI

It is the policy of Physicians’ Education Resource®, LLC (PER®) to ensure the fair balance, independence, objectivity, and scientific objectivity in all of our CE activities. Everyone who is in a position to control the content of an educational activity is required to disclose all relevant financial relationships with any commercial interest as part of the activity planning process. PER® has implemented mechanisms to identify and resolve all conflicts of interest prior to release of this activity.The planners and authors of this CE activity have disclosed no relevant financial relationships with any commercial interests pertaining to this activity.

METHOD OF PARTICIPATION
  1. Read the articles in this section in its entirety.
  2. Go to  www.gotoper.com/go/ONN19May
  3. Complete and submit the CE posttest and activity evaluation.
  4. Print your CE Certificate.
OFF-LABEL DISCLOSURE/DISCLAIMER

This CE activity may or may not discuss investigational, unapproved, or off-label use of drugs. Participants are advised to consult prescribing information for any products discussed. The information provided in this CE activity is for continuing medical nursing purposes only and is not meant to substitute for the independent medical judgment of a nurse or other healthcare provider relative to diagnostic, treatment, or management options for a specific patient’s medical condition. The opinions expressed in the content are solely those of the individual authors and do not reflect those of PER®.

Nutrition & Exercise

Targeted Dietary Interventions Are Necessary to Promote Healthy Lifestyle


An exercise intervention was no more effective than a more passive health promotion program in affecting nutrient intake in female cancer survivors, according to study results presented at the Oncology Nursing Society (ONS) 44th Annual Congress in Anaheim, California.1

The findings highlight the need for nurses to repetitively assess and monitor diet and exercise among cancer survivors to promote a healthy lifestyle, one of the study’s authors said.

“Healthy eating and regular physical activity are critical behaviors to minimize health risks in cancer survivors,” said So-Hyun Park, PhD, ANP-BC, RN, assistant professor at Hunter Bellevue School of Nursing at the City University of New York, during her presentation. “It is important to understand cancer survivors’ current diet and whether physical activity levels may affect their dietary behavior.”

In the randomized, controlled Yale Fitness Intervention trial, the researchers evaluated whether participation in an exercise intervention compared with more passive health promotion would affect nutrient intake over a 12-month period among 154 perimenopausal or early postmenopausal female cancer survivors. Women were assigned to either an aerobic resistance exercise intervention arm or a health promotion arm that involved home-based physical activity.

Both groups received written information on dietary guidelines, calcium and vitamin D supplementation, and national recommendations for physical activity.

Four-day dietary records were collected monthly at baseline and 6 and 12 months, and International Physical Activity Questionnaire (IPAQ) results were collected via telephone for 12 months.

The mean age was 51.9 years. The majority of women were white (88.3%), married (70%), employed (82%) and had children (78.6%) and a high level of education (57% college or graduate school). The study included survivors of breast cancer (83.1%), gynecologic cancers (11.7%), and lymphoma or colorectal cancer (5.2%).

At baseline, the energy and mean daily intake of 4 major nutrients were as follows:

Energy: 1535.0±406.1 kcal; energy per unit of weight: 21.2±8.0 kcal/kg
Protein: 70.4±18.4 g; protein per unit of weight: 1.0±0.3 g/kg
Total fat: 55.5±21.3 g
Carbohydrates: 183.8±57.9 g
Fiber: 17.0±8.0 g

Of note, protein intake was significantly higher in the control arm than in the intervention arm at baseline (1.0±0.4 g/kg vs 0.9±0.3 g/kg; P = .03). The researchers found no other significant differences between the groups at baseline.

Over the 12-month period, women in both groups demonstrated a reduced intake of energy, protein, total fat, and carbohydrates. However, fiber intake at 6 months increased slightly in both arms. The researchers observed no significant differences in changes between the 2 study arms at 6 and 12 months.

Next steps, Park said, should involve testing both exercise and nutrition interventions to assess whether multitargeted interventions improve healthy lifestyle behaviors. In addition, she recommended that qualitative studies be conducted to examine the factors that influence the physical activity and diet of this population.

REFERENCE
Park SH, Knobf T, Kerstetter J, Jeon S. Effect of an exercise intervention on nutrient intake in cancer survivors. Presented at: ONS 44th Annual Congress; April 11-14, 2019; Anaheim, CA. Abstract 4570.  
Blood Cancer

CAR-T Cell Therapy Continues to Change the Cancer Treatment Landscape

Brielle Benyon

Since the first FDA approval of tisagenlecleucel (Kymriah) in August 2017 to treat children and young adults with B-cell acute lymphoblastic leukemia (ALL),1 chimeric antigen receptor (CAR)-T cell therapy has continued to expand in use and improve outcomes for patients with various types of hematologic malignancies.

Months after the approval of tisagenlecleucel, axicabtagene ciloleucel (Yescarta) was approved to treat adults with relapsed or refractory diffuse large B-cell non-Hodgkin lymphoma (DLBCL).2 In May 2018, tisagenlecleucel earned FDA approval for use in this patient population as well.3 According to experts, more trials and approvals may be coming.

“This is a promising new therapy. Many trials are in progress, and I think lots of new [CAR-T] products and trials are coming, too,” said Misty Lamprecht, MS, APRN-CNS, AOCN, BMTCN, a clinical nurse specialist at The Ohio State University James Cancer Hospital.

Lamprecht joined JC Villasboas Bisneto, MD, a fellow in hematology/oncology at the Mayo Clinic, at the Oncology Nursing Society (ONS) 44th Annual Congress4 in Anaheim, California to discuss the promise—and potential adverse events (AEs)—of CAR-T cell therapy.

“We’ve seen responses out of proportion compared to what we’ve had before, and we see that these responses are lasting,” Bisneto said, noting that in the phase II ZUMA-1 trial that led to the initial approval of axicabtagene ciloleucel, there was an overall response rate (ORR) of 82% and a complete response (CR) rate of 54%.5 In the JULIET trial, which analyzed tisagenlecleucel in relapsed or refractory DLBCL, there was an ORR of 52% and a CR of 40%.6 This is a clear improvement over the results of SCHOLAR-1, which tested standard chemotherapy in this patient population and showed an ORR of 26% and a CR of 8%.7

Although CAR-T cell therapy is yielding exciting results for patients with blood cancer, this class of agents can also produce significant toxicities.

Cytokine release syndrome is one of the major AEs that oncology nurses should be vigilant for, explained Lamprecht. The syndrome, which is associated with T-cell expansion, usually happens between 1 and 14 days after cell infusion and can present with the following symptoms: fever, nausea/vomiting/diarrhea, hypotension/tachycardia, hypoxia/tachypnea, and rash. Cytokine release syndrome can range in severity from grade 1 to 4, with grade 4 typically treated with steroids (dexamethasone or methylprednisolone).3 One-third to one-half of patients (38% to 55%) receiving CAR-T cell therapies experience infections, of which 16% to 33% are grade 3 or higher.4 Therefore, nurses and other healthcare practitioners should evaluate and treat their patients for sepsis in addition to cytokine release syndrome if applicable. “Don’t be blinded by the fact that the patient has gotten CAR-T cell therapy,” Lamprecht said. “They are very immunocompromised, so don’t forget the risk of sepsis. It’s very real.”

Another common AE experienced by patients on CAR-T cell therapy is neurotoxicity, which can happen in 2 phases: from days 0 through 5 and after day 5. Patients should receive a full neurologic examination to rule out other causes of their symptoms. Then, practitioners should use the Immune Effector Cell-associated Encephalopathy (ICE) assessment to grade the patient’s neurotoxicity. The assessment includes orientation questions, sentence writing, following commands, object naming, and counting/spelling backwards.4

Lamprecht noted that patients with grade 1 neurotoxicity may become concerned when they experience word-finding difficulty. Patients with grade 2 or higher neurotoxicity may exhibit an altered mental state, which can become frightening for the patient’s caregivers.

“It can be really scary if you’re not prepared for it,” she said. “That family support piece is really necessary.”

Research is currently being conducted not only to create better CAR-T cell therapies—perhaps with fewer AEs—but also to expand the treatment to different types of cancer. “I believe the holy grail for CAR-Ts in the next year is bringing CAR-T cell therapy to solid tumors,” Bisneto said. “We’re just seeing a new way of treating diseases at large.”

REFERENCES

1. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm574058.htm. Published: August 30, 2017. Accessed: April 16, 2019.
2. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm581216.htm.Published: October 18, 2017. Accessed: April 16, 2019.
3. https://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm606540.htm. Published May 3, 2019. Accessed: April 19, 2019.
4. Lamprecht M, Villasboas JC. CAR-T: Where we are and where we are going. Presented at: ONS 44th Annual Congress in Anaheim, CA. April 11-14, 2019. https://ons.confex.com/ons/2019/meetingapp.cgi/Session/2115
5. Locke FL, Neelapu SS, Bartlett NL, et al. Primary results from ZUMA-1: a pivotal trial of axicabtagene ciloleucel (axicel; KTE-C19) in patients with refractory aggressive non-Hodgkin lymphoma (NHL). Presented at: 2017 AACR Annual Meeting; April 1-5, 2017; Washington, DC. Abstract CT019.
6. Schuster SJ, Bishop MR, Constantine S, et al. Chimeric antigen receptor T cells in refractory B-cell lymphomas. New England Journal of Medicine. 2019. 380:45-56. doi: 10.1056/NEJMoa1804980
7. Crump M, Neelapu SS, Farooq U, Van Den Neste E, et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. Nurse Perspective

Colette Chaney, RN Colette Chaney, RN
Clinical Research Operations Manager
Fred Hutchinson Cancer Research Center
Seattle, WA


PROBABLY THE MOST IMPORTANT issue for an oncology nurse to understand is how chimeric antigen receptor (CAR)-T cell therapy differs from traditional chemotherapeutic approaches. These are manufactured cells that are made directly from a patient’s lymphocytes; that manufacturing process takes time, and the patient needs to be managed during that timeline. There is a time element to actually being able to treat patients.

Oncology nurses and their patients also should understand the unique adverse event (AE) profile associated with these therapies, which includes cytokine release syndrome, neurotoxicities, and some on-target, off-tumor effects. Nurses can educate patients and their caregivers about these symptoms, as well as recognize when the patient may be experiencing some of them. Understanding how to assess patients for these symptoms and recognizing some of the hallmark features of these AEs is key.

It is also important for the oncology nurse to realize that because these patients have received a living drug, they will need to be followed for the rest of their lives to determine the long-term implications of these novel therapies.
 
Ovarian Cancer

Women with Ovarian Cancer Are Less Likely to Alert Doctors as Symptoms Worsen

Beth Fand Incollingo

The more severe their symptoms, the less likely women with ovarian cancer are to report the discomforts to their oncologists, a study has found.

Women with high symptom severity scores at the start of the study were 37% less likely to appropriately communicate those issues than women with low symptom severity scores, investigators found. A member of the research team from the University of Pittsburgh shared the findings at the Oncology Nursing Society (ONS) 44th Annual Congress in Anaheim, California.

Women with ovarian cancer tend to have multiple concurrent symptoms that negatively affect their quality of life, functionality, and treatment adherence, making the need for communication very important, said lead author Teresa Thomas, PhD, BA, RN, an assistant professor in the university’s School of Nursing. Symptoms often include abdominal pain, bloating, cramping, fear of recurrence or disease progression, indigestion, sexual dysfunction, vomiting, weight gain, weight loss, and neurological problems, she said, adding that underreported symptoms may be the ones that are most difficult for patients to talk about or for practitioners to manage.

The study hinged on previous evidence that women with ovarian cancer often struggle to communicate their cancer- and treatment-related symptoms to their healthcare providers. Research shows that just 61% of these patients have discussed their most-noticed symptom with a provider in any given month, and among those who have, 50% have not received a management recommendation, Thomas said. She added that 53% of the symptoms considered by patients to be top priorities have not been documented by providers.

The study sought to create a predictive model of inappropriate communication styles by determining the patient characteristics associated with varying levels of appropriate symptom communication at baseline. The study also sought to reveal the relationship between symptom communication and severity over time.

The investigators recruited women with recurrent ovarian cancer from 68 sites of a randomized clinical trial called the Written Representational Intervention to Ease Symptoms (WRITE Symptoms), sponsored by the Gynecologic Oncology Group. They selected 497 participants with ovarian cancer and at least 3 symptoms. The patients in the WRITE Symptoms study were randomized into 3 groups, with 1 receiving usual care, another using a website for guidance in dealing with symptoms on their own, and a third interacting with nurses one-on-one to have their symptoms documented.

Every 4 weeks, the 2 groups with symptom documentation completed the Symptom Representation Questionnaire, which rates the severity of 28 symptoms on an 11-point scale. These patients prioritized 3 symptoms over which they wanted to gain better control. A 4-item questionnaire assessed their communication of these top 3 symptoms with providers. Based on patients’ assessments of symptom severity, their communication was ranked as “appropriate” (severity of 0-10 and any level of communication) or “inappropriate” (severity of 5-10 and no or limited communication).

At the outset of the study, the investigators generated a mathematical model to predict the factors associated with inappropriate symptom communication styles, controlling for age, education, optimism, anxiety, depression, and social support. In addition, they analyzed changes in symptoms and communication over time by calculating score differences and correlations between symptom severity and communication appropriateness at each time point (baseline and 4, 8, and 12 weeks).

The team found that appropriate communication occurred for 42% to 94% of women’s top symptoms. Symptom severity was the strongest predictor of appropriate communication at baseline, with women who had high symptom severity scores 37% less likely to appropriately communicate than women who had low symptom severity scores. From baseline to 12 weeks, symptom severity decreased overall and appropriateness of communication increased overall. However, symptom severity remained negatively associated with appropriate communication during that time period.

“These results demonstrate that symptom severity was inversely related to appropriate communication,” the study authors wrote in an abstract. “Women experiencing severe symptom severity were less likely to report having appropriate communication about that symptom with their healthcare provider. This study underscores the need for healthcare providers to break the cycle of inappropriate symptom communication to ensure patients’ symptoms are adequately discussed and managed throughout women’s cancer experience.”

REFERENCES

Tomas T, Schenker Y, Cohen S, et al. Symptom severity is negatively associated with symptom communication over time among ovarian cancer survivors: establishing the need for appropriate symptom communication. Presented at: Oncology Nursing Society 44th Annual Congress; Anaheim, California; April 11-14, 2019. Abstract No. 4486.

Nurse Perspective

Paula Anastasia RN, MN, AOCN Paula Anastasia RN, MN, AOCN
UCLA Department of OB/GYN

THE MAJORITY OF WOMEN WITH ovarian cancer are diagnosed at an advanced stage and will have multiple recurrences resulting in numerous regimens of chemotherapy. Oncology nurses and practitioners are the experts in patient education and chemotherapy symptom management. Determining patient response to treatment may also include patients’ perception of their own quality of life and the degree of side effects. In an abstract authored by Teresa Thomas, PhD, RN and colleagues from the University of Pittsburgh School of Nursing, results are presented from a study of 497 women with ovarian cancer who identified and self-reported their three most severe symptoms at baseline and 4, 8, and 12 weeks. Symptom severity was inversely related to appropriate communication, as women were less likely to report having appropriate communication with their clinicians when their symptoms were more severe. This highlights the need for better education for women receiving treatment for recurrent ovarian cancer. Patients should be provided education and reassessment before, during, and after their therapy. This study demonstrates that improvement is needed in providing patients information and instruction on whom to contact when they are not feeling well, whether emotionally or physically, and that ongoing communication with the healthcare provider can lead to reduced symptom severity.
Bladder Cancer

Assessing PTSD Symptoms in Non–Muscle-Invasive Bladder Cancer Is Key


Kristie L. Kahl

Non–muscle-invasive bladder cancer (NMIBC) survivors may experience higher rates of post-traumatic stress disorder (PTSD) compared with the general population—highlighting the need for nurses to assess and manage these symptoms, according to study results presented at the Oncology Nursing Society (ONS) 44th Annual Congress in Anaheim, California.1

Because the recurrence rate for NMIBC is 50%, patients must undergo surveillance cystoscopies. The disease is typically treated with regular surveillance cystoscopies every 3 months for 2 years, followed by every 6 months for the next 3 years, and then once per year after that, explained Ahrang Jung, PhD, RN, postdoctoral research associate at the UNC Lineberger Comprehensive Cancer Center in Chapel Hill, North Carolina.

“That means over 5 years, non–muscle-invasive bladder cancer survivors need up to 14 cystoscopies. That is a lot,” she said during her presentation. “Being diagnosed with a life-threatening illness is capable of causing PTSD. And a substantial amount of research has been conducted regarding PTSD in cancer populations.”

Jung noted that recent evidence has suggested that cancer might be experienced as a traumatic event by some patients. The occurrence of PTSD among patients with other types of cancer, such as breast cancer, can range from 7% to 14%—a rate that is higher than that of the general adult population (4% to 7%). “Having a non-muscle-invasive bladder cancer diagnosis, high recurrence rates, and frequent surveillance cystoscopies followed by repeated treatment can be a risk factor for PTSD symptoms. And these symptoms might affect survivors’ quality of life,” Jung said.

Therefore, in a cross-sectional, descriptive, population-based survey, Jung and her fellow investigators aimed to examine the prevalence of PTSD and to identify predictive factors associated with it among NMIBC survivors identified through the North Carolina Central Cancer Registry. The survey collected patient demographics and clinical characteristics, PTSD Checklist for DSM-5 (PCL-5) scores, and Patient-Reported Outcomes Measurement Information System (PROMIS) Applied Cognition–General Concerns and Applied Cognition – Abilities scores. 

Of 2000 randomly selected patients, 1684 were deemed eligible for study participation, and 398 of them returned their surveys (response rate, 23.6%), of which 22 were incomplete and excluded from analysis. br>
Among the remaining 376 responders available for evaluation, the majority were male (72.3%), white (94.4%), and a median of 72 years old (range, 39-94). In addition, patients were a median 3.4 (range 1-6) years out from their original diagnosis when they responded to the survey.

The average score for PCL-5 was 7.1 (SD = 10.9) and ranged from 0 to 66 (the possible range is 0-80, with higher scores indicating more PTSD symptoms). Moreover, 5.3% of participants exhibited all four of the DSM-5 PTSD symptom clusters—intrusion, avoidance, negative alterations in cognitions and mood, and alterations in arousal and reactivity—consistent with a provisional PTSD diagnosis. In total, 28.7% of responders met the criteria for at least 1 PTSD symptom cluster.

PTSD symptoms had significant associations with age at study enrollment, current disease status, number of comorbidities, social support, and cognition score. Specifically, after controlling for confounding variables, the investigators found significantly higher PTSD symptoms among participants who were younger (P <.01), were not cured or did not know whether they were cured (P <.001), had more comorbidities (P <.001), had lower social support (P <.05), and had a higher PROMIS Applied Cognition – General Concerns score (P <.001). Jung noted that PTSD did not significantly vary by sex, race/ethnicity, receipt of transurethral resection of bladder tumor, or PROMIS Applied Cognition – Abilities score.

“Although NMIBC survivors are considered as early stage, 28.7% of them may be experiencing PTSD symptoms. This is more than expected from the general population and other cancers,” Jung said. “Therefore, healthcare providers should be mindful of this possibility when planning and delivering care. Specifically, assessment and management of PTSD symptoms are needed for NMIBC survivors in the survivorship phase of care. Those experiencing PTSD symptoms should be referred for counseling. Also, in future research, approaches to prevent the PTSD symptoms need to be developed.” .

REFERENCE

Jung A, Crandell J, Nielsen M, Mayer D. Post-Traumatic Stress Disorder in Non-Muscle-Invasive Bladder Cancer Survivors. Presented at: ONS 44th Annual Congress; April 11-14, 2019; Anaheim, CA. Abstract 5224.

External Resources

MJH Associates
American Journal of Managed Care
Cure
MD Magazine
Pharmacy Times
Physicians' Education Resource
Specialty Pharmacy Times
TargetedOnc
OncNurse Resources

Newsroom
Continuing Education
Discussions
Web Exclusives


About Us
Advertise
Advisory Board
Careers
Contact Us
Privacy Policy
Terms & Conditions
Intellisphere, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747

Copyright OncNursing 2006-2019
Intellisphere, LLC. All Rights Reserved.