Clinical Insights: June 2018

Friday, June 22, 2018

Release Date: June 22, 2018
Expiration Date: June 22, 2019


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/ONN18June
  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®.

Patient Populations

Young Adults With Cancer Need Early Physical Activity Interventions

Kristie L. Kahl

Physical activity interventions should be individualized for adolescents and young adults (AYAs) with cancer, according to study findings presented at the Oncology Nursing Society 43rd Annual Congress.

These interventions are especially needed during and after treatment to relieve symptoms and improve function, said Jeanne Erickson, PhD, RN, of the University of Wisconsin–Milwaukee College of Nursing; however, few studies have explored symptoms and physical activity in AYAs during cancer treatment.

Despite the fact that cancer is the leading disease-related cause of death in AYAs, these patients tend to be an understudied population, and they also are generally less active during and after chemotherapy. Staying physically active offers important short- and long-term benefits for adult patients with cancer, including reduced symptom severity, improved physical function, and better tolerance to treatment.

Erickson and colleagues are conducting the randomized PROMIS-29 trial which is designed to examine the effects of physical activity interventions for AYAs to help them self-manage fatigue. In her presentation, she described the symptoms and physical activity of young adults during the early months of chemotherapy to provide baseline data for the larger study. Patients aged 18 to 39 years being treated at Milwaukee’s Froedtert Hospital/Medical College of Wisconsin Cancer Center and Children’s Hospital of Wisconsin and starting a chemotherapy regimen for any cancer diagnosis are eligible for the study.

To document baseline physical activity, participants wore an accelerometer for 7 days during chemotherapy administration to determine daily steps and amount of time spent in light, moderate, and/or vigorous physical activity. In addition, symptom severity was surveyed on day 1 of a patient’s chemotherapy cycle.

The 21 AYAs had an average age of 33 years, and most were female, white, married, and parents. Diagnoses included breast cancer (32%), lymphoma (31%), acute lymphocytic leukemia (25%), myeloma (6%), and melanoma (6%).

At baseline, the group averaged a daily 4638 steps (range, 1318-11,572), with 233.35 minutes of light physical activity weekly (range, 119-330), 16.08 minutes of moderate activity (range, 0.02-92), and no vigorous physical activity.

“These young adults were inactive during the early months of chemotherapy. We can measure that and compare that [with] an age-matched, national, healthy cohort. In that cohort, by average, young adults—males and females—had about 20 to 30 minutes of moderate physical activity a day, and this sample [just] had about 15,” Erickson said. “But there were various levels of physical activity in this sample, and their symptom scores were about average at the beginning of their chemotherapy regimen.”

For the PROMIS-29 profiling, a T score of 50 is considered average for the general US population. The mean standardized PROMIS-29 profile scores varied for physical function (49.48; range, 33.3-56.9), anxiety (56.33; range, 40.3-67.3), depression (52.27; range, 41-79.4), fatigue (55.86; range, 33.7-69.0), sleep disturbance (53.07; range, 37.5-66.0), ability to participate (49.56; range, 34.0- 64.2), and pain interference (50.33; range, 37.3-64.2).

“It is interesting [that] their symptoms were about average,” Erickson said. “There is some evidence that, in particular, AYAs have higher symptom severity scores than other ages, but that didn’t look to be true in this beginning sample that I have. So, I will be interested to see how their related symptoms change over the months of treatment and how that affects their physical activity.”

Another issue that interests Erickson: how AYA patients affected by chemotherapy spend the remaining hours of their day and how investigators can combat inactivity. She hopes that intervention will break that cycle of fatigue so that patients remain or become active over the months of chemotherapy.

REFERENCE
Erickson J, Swartz A, Tokarek N. Physical activity and symptoms in young adults with cancer in early months of chemotherapy. Abstract presented at: ONS 43rd Annual Congress; May 17-20, 2018; Washington, DC. ons.confex.com/ons/2018/meetingapp.cgi/Paper/3716.
 
Leukemia

Managing Patients Treated With Venetoclax Plus Rituximab for Relapsed/Refractory CLL

Mindy Waizer

A multidisciplinary team approach may help lead to optimal patient outcomes following the use of a powerful drug combination for patients with relapsed/refractory chronic lymphocytic leukemia (CLL), according to a presentation at the Oncology Nursing Society 43rd Annual Congress.

In April 2016, the FDA approved venetoclax (Venclexta), an oral inhibitor of the antiapoptotic protein B-cell lymphoma-2 (BCL-2), as a monotherapy for relapsed/refractory CLL.1 The agent demonstrated complete response (CR) rates of 16% to 20%, including patients with high-risk chromosome 17p deletion. In addition, 24-month progression-free survival (PFS) was 49%.2 In a phase Ib open-label, dose-escalation trial with 49 enrolled patients, venetoclax combined with intravenous rituximab (Rituxin), a CD20 antibody, resulted in significant improvements compared with venetoclax alone.2

Patients treated with the combination achieved a 51% CR rate, a 24-month PFS rate of 82%, and an ongoing response rate of 89%. The investigators noted finding indications that venetoclax can be discontinued once deep remission, defined as CR and/or minimal residual disease (MRD) negativity, has been achieved.3

Patients were enrolled between August 6, 2012, and May 28, 2014. The median time on study was 44 months (range, 1 day-62 months); 26 patients remain active on the study. As of July 2016, 18 patients with relapsed CLL who achieved a deep remission discontinued venetoclax and remained on study; as of January 26, 2018, 16 of the patients still had MRD-negativity. Prior to discontinuing therapy, the median time on venetoclax was 16 months (range, 4.6-39.8 months).

In her presentation at the congress, Peggy Alton, RN, RN, BSN, OCN, CCRP, of Duke University Medical Center in Durham, North Carolina, aimed to educate nurses about the management and care of patients during and following treatment with the venetoclax/ rituximab combination. Among her key points:
  • Responses can be maintained after discontinuing therapy when patients have achieved a deep response.
  • Patients should be monitored for progression with a physical examination and absolute lymphocyte count.
  • Nurses should discuss with patients the symptoms associated with progression—fever, fatigue, bruising, bleeding, night sweats, and weight loss.
  • Evaluation for disease progression is merited in the presence of the above symptoms, as well as palpation of an enlarged lymph node, rising absolute lymphocyte count, or a decrease in hemoglobin or platelets.

Alton also focused on managing the patient, during both treatment and the process of discontinuing the drugs. “One of the best things we can do is to educate the patients and the caregivers about the things they need to be watching for—the neutropenia, the thrombocytopenia, the signs of possible tumor lysis, which is often harder for them to tell clinically, because that’s more about what’s happening with their labs,” she said. “But certainly, [we must make] them aware to make sure they’re reporting everything to us.”

The study participants responded quickly to treatment, according to Alton. “In terms of tumor lysis and in the reduction of lymph nodes…patients could see a change within a week—if they were lymph nodes that they could see or feel in their neck,” she said. “It was a pretty rapid response.”

All patients experienced a treatment-emergent adverse effect in this study. The most common types of any grade among patients who discontinued venetoclax and remained on study included upper respiratory tract infection (67%), neutropenia (61%), and diarrhea (44%).

“When we started taking patients off venetoclax, we had to help patients understand that it was OK to stop treatments,” Alton said, “and that we were going to monitor them very closely to make sure that if there [was] evidence of disease progression, then obviously we would re-evaluate and determine what needs to be done or at what time point the treatment needs to be given.” 

REFERENCES
  1. FDA approves new drug for chronic lymphocytic leukemia in patients with a specific chromosomal abnormality [press release]. Silver Spring, MD: FDA; April 11, 2106. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm495253.htm. Accessed May 16, 2018.
  2. Seymour JF, Kippes TJ, Eichhorst B, et al. Venetoclax–rituximab in relapsed or refractory chronic lymphocytic leukemia [published online March 22, 2018]. N Engl J Med. 2018; 378:1107-1120. doi: 10.1056/NEJMoa1713976.
  3. Alton P, Brander D, Nandam R, Rodriguez K, Alter D. Management and care following treatment with venetoclax and rituximab for patients with relapsed chronic lymphocytic leukemia. Poster presented at: Oncology Nursing Society 43rd Annual Congress; May 17-20, 2018; Washington, DC. Poster-IS1. ons.confex.com/ons/2018/meetingapp.cgi/Paper/2792.

Nurse Perspective

  Phyllis McKiernan, MSN, APN, OCNPhyllis McKiernan, MSN, APN, OCN
Blood & Marrow Transplant Program
John Theurer Cancer Center, Hackensack, NJ


As oncology nurses, we are very accustomed to patients receiving “lifelong” therapy, especially patients who are being treated for relapsed or refractory disease. Patients typically continue therapy until they can no longer tolerate adverse effects or until disease progression. They often wonder what the duration of therapy will be, asking “How long is the treatment?” The study presented by Alton and colleagues offers evidence of a finite therapy for patients with relapsed chronic lymphocytic leukemia (CLL) treated with venetoclax in combination with rituximab.

Venetoclax as a monotherapy has been shown to produce durable responses in patients with relapsed CLL. In this study, when venetoclax was combined with rituximab, complete response (CR) rate was increased to 51%, and 59% achieved minimal residual disease (MRD)–negativity in the bone marrow.

Using MRD–negativity in addition to CR provides evidence of a deeper response and allows for a potential endpoint of therapy. When educating patients about discontinuing therapy, it is important to provide them with a plan for possible disease progression. As shown in this study, restarting the same regimen can result in regaining and maintaining CR.

For patients with high-risk, relapsed disease such as CLL, not having an end in sight for salvage therapy can be frustrating and disheartening. At the same time, patients want a therapy they can tolerate and that has the potential for durable responses. This study offers hope to patients who achieve an MRD–negative CR with venetoclax and rituximab—they may be able to stop therapy and enjoy continued durability of response, with the safety net of retreatment as a strategy for disease progression.

 
Ovarian Cancer

Expanding Olaparib Indications Demonstrate Need for Best Practices for Nurses

Jessica Skarzynski

As the FDA continues to approve indications for olaparib (Lynparza), healthcare providers and caregivers should be aware of the treatment’s potential adverse effects (AEs). To update oncology nurses on the PARP inhibitor’s new indications and formulations, as well as best practices for dosing and AE management, a team of authors presented guidelines at the Oncology Nursing Society 43rd Annual Congress.

Olaparib is currently approved for the following indications:
  • Maintenance therapy for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in adult patients with complete or partial response to platinum- based chemotherapy regardless of BRCA status
  • Adult patients with deleterious or suspected deleterious germline BRCA–positive, advanced ovarian cancer who received ≥3 prior lines of chemotherapy 
  • Patients with deleterious or suspected deleterious germline BRCA–positive, HER2–negative metastatic breast cancer who received prior chemotherapy in the neoadjuvant, adjuvant, or metastatic setting
  • Patients with hormone receptor–positive breast cancer treated with a prior endocrine therapy or considered inappropriate for endocrine therapy
Because of the changing treatment landscape, it is key that nurses understand the indication, formulation, and dosing of olaparib. The agent demonstrates significant progression- free survival in women and has a manageable toxicity profile. Additionally, olaparib has no significant detrimental effect on the patient’s quality of life, lead author Patricia McLaughlin, MSN, BSN, RN, ARNP-C, senior medical science liaison at AstraZeneca Pharmaceuticals, said in an interview with Oncology Nursing News®.

Nurses should be aware of olaparib’s 2 formulations: 100-mg and 150-mg tablets and 50-mg capsules. Because they are not bioequivalent, McLaughlin said, the 2 formulations cannot be substituted for each other on a milligram-to-milligram basis. The current recommended dose is 300 mg in tablet form (two 150-mg tablets), with a maximum permissible dose per day of 600 mg. Patients are not to exceed 4 tablets a day, and 100 mg tablets are to be used for dose reductions only.

Capsules are indicated just for patients with ovarian cancer who have received 3 or more prior lines of therapy; for them, the maximum dose per day is 800 mg. However, given the higher pill burden, the capsule formulation will eventually be phased out of US markets. “There is ongoing communication to healthcare practitioners to all prescribers regarding the phasing out of the capsule formulation,” McLaughlin said.

Dose interruptions are permitted for up to 4 weeks following an AE, noted the authors. Olaparib should be discontinued for 3 or more days before planned surgery or radiation therapy and can be reinstated after surgery and within 4 weeks of radiation therapy, once bone marrow function has fully recovered.

In the event of toxicity, dose reduction can be considered. For an initial treatment of 2 doses of two 150-mg tablets per day (for a total daily dose of 600 mg), the recommendation advises an initial reduction to one 150-mg and one 100-mg tablet per dose (for a total daily intake of 500 mg) and a final reduction to two 100-mg tablets per dose (for a total daily intake of 400 mg).

Knowing how to manage patients’ symptoms also is integral to maintaining the treatment’s effectiveness, McLaughlin said, so best practices suggest ways nurses can help patients deal with the most common AEs without dose interruptions or reductions.

The authors suggested managing nausea and vomiting, the most common AE, with antiemetics. The next most common AE, fatigue, is generally mild to moderate and appears within the first 3 months of treatment. Dose interruptions or reductions are permitted if required, but the authors suggest focusing on energy conservation, exercise, sleep, and nutritional counseling, as well as advising patients to be cautious if driving or using machinery.

Mild to moderate anemia, the third most common AE related to olaparib, is usually treated with iron, folic acid, and vitamin B12 supplements. Supportive treatments such as transfusions can also be used, along with a maximum dose interruption of 4 weeks, as well as dose reduction upon recovery.

Olaparib should be discontinued in patients who develop myelodysplastic syndrome/acute myeloid leukemia, pneumonitis, and embryo-fetal toxicity, the authors said. For women of childbearing potential, contraception is recommended during treatment for up to 6 months after the last dose, and lactating women should avoid breastfeeding during treatment and for a full month after their final dose.

Patients with mild to moderate liver impairment or mild kidney impairment do not need dose adjustments, but reductions are recommended for those with moderate kidney impairment.

REFERENCE
McLaughlin P, Vanderploeg H, Munley J, Briceno J. Patients first: nursing best practices for the new formulation, dosing, and indication of olaparib. Poster presented at: Oncology Nursing Society 43rd Annual Congress; May 17-20, 2018; Washington, DC. Poster-IS-19. epo.epostersonline. net/ons2018/node/2470?view=true.

 
LGBT Sensitivity

Nurses Seek More Education About LGBT Patients With Cancer

Kristie Kahl

nurses reported a desire to learn more about patients who identify as lesbian, gay, bisexual, and transgender (LGBT), but a lack of such training exists, according to survey results presented at the Oncology Nursing Society’s 43rd Annual Congress. In scientific and health literature, sexual minorities include individuals who identify as lesbian, gay, bisexual, pansexual, asexual, or queer; gender minorities include those who identify as transgender, transman, transwoman, nonbinary, gender-fluid, or queer.

“These terms allow us to encompass sexual orientations [in research] without limiting it at any point,” said Chasity Burrows Walters, PhD, RN, director of patient and caregiver engagement at Memorial Sloan Kettering Cancer Center (MSK) in New York, New York. “Sex is not gender. They are very different. This matters a lot to us in healthcare because when we think about biology, we need to think about anatomy—and in oncology care, this matters for screening purposes.”

Population surveys have suggested between 5.2 million and 9.5 million US adults identify as LGBT, but multifactorial barriers to equitable health care, including negative experiences, exist.

Although research demonstrates increasing efforts to educate nursing students in this area, other studies have shown that barriers persist. For example, sexual and gender minorities face discrimination, insurance, and insensitivity from providers and healthcare systems, and gender minorities also experience distress from discordance between gender and genitalia, lack of evidence for clinical decision making, and limited exposure, Walters said.

In addition, the LGBT population lacks data in the cancer space, despite overlapping risk factors that can lead to anal, breast, cervical, colorectal, endometrial, lung, and prostate cancers in this group. “We don’t have anything to go to [where we can] learn about the disparities and risks associated with these populations,” she added.

To establish warranted training needs, Walters and colleagues aimed to understand oncology nurses’ knowledge, beliefs, and skills regarding LGBT patients. They issued an online survey to 1253 healthcare professionals at MSK, including 941 nurses, to evaluate LGBT healthcare knowledge, beliefs, and communication behaviors, as well as willingness to treat LGBT patients, behaviors encouraging LGBT disclosure, and perceived importance of LGBT sensitivity training.

The investigators included 7 items on knowledge, adapted from published items; 12 items on beliefs, adapted from the Sexual Orientation Beliefs and Attitudes Toward Transgendered Individuals scales, as well as published items; and 18 items on skills adapted from the Gay Affirmative Practice Scale, as well as quantitative and qualitative items added by the study team.

Of note, 81 survey participants identified as LGBT, and 810 (86.1%) said they had a friend or family member in the LGBT community. In total, 86% of nurses surveyed had experience caring for individuals who identified as lesbian, gay, or bisexual, and 31% had experience with those who identified as transgender. However, just 4.7% of nurses answered all knowledge items correctly, and about half answered 3 of the 7 items correctly.

Higher knowledge scores appeared to be associated with favorable beliefs about sexual orientation and gender identity, favorable beliefs about LGBT healthcare, more open communication behaviors, greater encouragement regarding LGBT status disclosure, and greater perceived importance of LGBT sensitivity training. The investigators noted that these results are serving as the foundation for developing a communication skills training for nurses, and in the near future the findings will contribute to a mixed methods study comparing healthcare providers and LGBT patient preferences and perceptions regarding LGBT patient care.

“Across the board, we heard loud and clear from our nursing staff that they want more training in this area,” Walters said.

REFERENCE
Walters C, Banerjee S, Staley J, Haviland K. Nurses’ knowledge, beliefs, and skills toward LGBT patients. Abstract presented at: Oncology Nursing Society 43rd Annual Congress; May 17-20, 2018; Washington DC. ons.confex.com/ons/2018/meetingapp.cgi/Paper/3718

Nurse Perspective

 David Rice, PhD, RN, NP, NEA-BCDavid Rice, PhD, RN, NP, NEA-BC
Director, Education, Evidence Based Practice and Research
City of Hope, Duarte, CA


Gwendolyn Quinn, PhD, and colleagues wrote in CA: A Cancer Journal for Clinicians that what members of the lesbian, gay, bisexual, and transgender (LGBT) community share is the stigmatization of being a sexual or gender minority for whom little health-related—particularly, cancer-related— research has been conducted.

Given the lack of specific content in nursing and medical training curricula regarding the competent care of LGBT patients, it is not surprising that most healthcare providers have been taught how to deliver care within a heteronormative frame. They simply have not had sufficient training and practice to adequately care for LGBT patients. As a result, many LGBT persons report negative healthcare experiences and encounters.

In the study presented at the Oncology Nursing Society 43rd Annual Congress, Chasity Burrows Walters, PhD, RN, and her colleagues note that although there is a paucity of literature on healthcare provider perceptions of care regarding the LGBT population, the evidence does suggest negative attitudes toward and conflict in providing care to this population. In this study, Walters underscores the need for ongoing education of healthcare providers in the culturally competent care of LGBT patients and families. The survey results indicate that, in spite of a substantial proportion of the nurses and advanced practice providers having taken care of LGBT patients, knowledge scores overall are low. However, the results do point to the nurses’ willingness to receive training in LGBT patient care.

With these compelling data, we have an opportunity in all our practice settings to train our clinicians to continually strive to improve the care quality we provide to all patients and families. Given this, I ask that we continually remind ourselves of and reinforce provision 1 of the American Nurses Association Code of Ethics for Nurses with Interpretive Statements (2015): “The nurse practices with compassion and respect for the inherent dignity, worth, and unique attributes of every person.”

 

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