Clinical Insights: May 2015

Friday, May 22, 2015

STATEMENT OF NEED

The overall goal is to update the healthcare professional’s knowledge of cancer detection and prevention and to understand current and new research regarding state-of-the-art care for those with or at risk for cancer.

TARGET AUDIENCE

Intended for advanced practice nurses, registered nurses, and other healthcare professionals who care for cancer patients.

OVERALL EDUCATIONAL OBJECTIVES

Upon completion, participants should be able to:

  • Describe new preventive options and treatments for cancer patients
  • Identify options for individualizing the treatment for cancer patients
  • Review new evidence to facilitate survivorship and supportive care for cancer patients

ACCREDITATION STATEMENT

Dannemiller is approved by the California Board of Registered Nursing, Provider Number 4229, for 1.0 contact hour. CBRN credit is not accepted by the Michigan and Utah State licensing boards.

DISCLOSURES

The planners and authors of this CE activity have disclosed no relevant financial relationships with any commercial companies pertaining to this activity.

METHOD OF PARTICIPATION

  1. Read the articles in this section in its entirety.
  2. Go to www.dannemiller.com/onn-May-2015
  3. Complete and submit the CE posttest and activity evaluation.
  4. Print your Certificate of Credit.

This activity is provided free of charge to participants.

Breast Cancer

Discussing Genetic Risk May Benefit All Patients With Breast Cancer

Christina Izzo

Many women who are diagnosed with breast cancer are concerned about the genetic risk of developing other cancers themselves or of a loved one developing cancer. A large amount of those concerns are not being addressed, however, according to a new study.
 
The study, published early online in the Journal of Clinical Oncology, found that 35% of breast cancerpatients expressed a strong desire for genetic testing, but 43% of those women did not have a relevant discussion with a healthcare provider.
 
“Our findings suggest a marked unmet need for discussion about genetic risk,” said study author Reshma Jagsi, MD, DPhil, associate professor of radiation oncology at the University of Michigan Medical School, in a statement.
 
Approximately 5% to 10% of patients with breast cancer have an inherited genetic mutation that drives their cancer. In addition, many women who reported interest in genetic testing were at low risk of having a mutation, and thus doctors would not have typically discussed genetic risk with them.

“With recent judicial opinions, direct-to-consumer marketing, and celebrity reports, the public has become much more aware that genetic testing is available,” Jagsi said. “But genetic risk is complex. Even patients unlikely to have elevated genetic risk may still benefit from a discussion.”

For the study, researchers surveyed 1536 women who had been treated for breast cancer identified through the SEER databases from Detroit and Los Angeles.
 
The results showed that 35% of these women expressed a strong desire for genetic testing, 28% reported discussing testing with a healthcare professional, and only 19% reported undergoing genetic testing.
 
Younger women, Spanish-speaking Latinas, and those with a family history of cancer expressed the strongest desire for genetic counseling.

Minority patients were also significantly more likely to have an “unmet need for discussion” concerning genetic counseling, with results showing Spanish-speaking Latinas being nearly five times more likely to experience this unmet need compared with white, non–Spanish-speaking patients.
 
The results also found that the patients who had a strong desire for testing reported being worried that other members of their family might get breast cancer in the future.
This worry was highest among Latinas who spoke only Spanish, with 83% reporting this concern.These women were also more likely to report
worry about their own risks when evaluated in long-term follow-up as survivors.
 
Nearly half of those who had an unmet need for discussion about genetic testing were worried about breast cancer, and only a quarter of those who did not have an unmet need reported this worry.
 
In an accompanying Journal of Clinical Oncology podcast, Jennifer E. Axilbund, MS, CGC, a genetic counselor at the Johns Hopkins Breast Center, pointed out that this study “highlights the discrepancy between perceived risk and actual risk.”
 
“As the participants were identified through SEER registries, one would assume that the majority of respondents were not appropriate for genetic testing,” Axilbund continued. “Yet, depending on race and ethnicity, up to 60% of respondents had a strong desire for genetic testing, whereas only around 10% would be expected to actually meet indications for testing.”
 
Axilbund mostly attributed this trend to the lack of understanding of breast cancer genetics and the fact that only a small percentage of breast cancers can be connected to known genetic mutations. The study authors also attributed the desire for genetic testing to ongoing media coverage of breast cancer genetic testing.
 
“Much of this coverage focuses on sensational issues, such as prophylactic mastectomy in young,healthy women, rather than the limited utility of current genetic testing to truly define risk,” Axilbund said.
 
Therefore, all patients may benefit from a discussion of genetic risk, even if the patient is perceived to be at low risk, as this may increase education on the subject and also reduce worry, the authors concluded.
 
“By addressing genetic risks with patients, we can better inform them of their true risk of cancer returning or of developing a new cancer,” Jagsi said. “This could potentially alleviate worry and reduce confusion about cancer risk.”

Reference
Jagsi R, Griffith KA, Kurian AW, et al. Concerns about cancer risk and experiences with genetic testing in a diverse population of patients with breast cancer [published online before print April 6, 2015]. J Clin Oncol

Prostate Cancer

ADT May Impact Physical Function, Highlighting Need for Exercise

Christina T. Logudice

Building on an earlier 12-month study,researchers from the University Health Network in Toronto, Canada, found that impact from androgen deprivation therapy (ADT) on physical function persisted over 36 months, indicating that ADT has lasting effects which need to be addressed.
 
“Most men [with prostate cancer] starting ADT remain on it for at least 2 to 3 years, so it is important to determine whether the observed 12-month declines in physical function with ADT persist, worsen, or resolve over time,” the researchers wrote.
 
The new study2 included 87 men with nonmetastatic prostate cancer who were starting continuous ADT, 86 men with prostate cancer who did not receive ADT, and 86 healthy men, with the latter two groups serving as controls.

All three groups were recruited from two tertiary-care academic cancer centers in Toronto, between May 2004 and September 2007 and were frequency-matched by age, education, and walking independence at baseline.
 
Throughout the study, participants’ physical function was assessed using the 6-minute walk test (6MWT), grip strength on a Jamar dynamometer, and the Timed Up and Go (TUG) test. Quality of life (QOL) was measured using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). All physical function and QOL measures were assessed at baseline and at 3, 6, 12, 18, 24, 30, and 36 months.
 
Using mixed effects regression models from baseline to 36 months, the researchers found statistically significant differences between the ADT group and controls for all three measures of physical function. ADT users performed more poorly than both control groups on the 6MWT, with controls showing initial improvements in this measure over the first 6 months of the study
followed by stabilization (P = .003; all reported comparisons are with healthy controls).
 
At 3 months, grip strength declined in ADT users and then stabilized over time, whereas both controls did not exhibit significant declines in grip strength over time (P = .004). Finally, ADT users demonstrated gradual worseningof their TUG scores, whereas these scores remained stable or improved slightly in both control groups (P <.001).

With regard to QOL, all three cohorts had similar baseline scores on the physical component summary of the SF-36, but they declined in ADT users and remained stable for both control groups (P <.001). Scores on the mental component summary of the SF-36 remained stable in all groups (P = .08) for ADT users vs controls). There was also no difference between groups in baseline scores in either the Barthel index or the Lawton-Brody index, and these scores remained stable over time in all three cohorts.
 
Study authors assessed whether or not age had an impact on the observed changes in physical function over time. They found that although baseline levels of physical performance were lower in older participants across all cohorts, the effects of ADT were not statistically different by age group for any of the objective physical performance measures or self-reported measures.
 
ADT use was associated with persistent, clinically relevant declines in physical function that is independent of age. Although most declines stabilized, they did not improve beyond the first 6 months of use, and lower extremity function continued to worsen over time, as shown by patients’ TUG scores.
 
“[Our] results will help clinicians and patients to better understand the risks of ADT. Moreover, they reinforce the need for greater adoption of exercise programs among ADT users, regardless
of whether they are new or established users, to reverse or prevent these declines,” the authors concluded. 

References
  1. Alibhai SMH, Breunis H, Timilshina N, et al. Impact of androgendeprivation therapy on physical function and quality of life in men with non-metastatic prostate cancer. J Clin Oncol. 2010;28:5038-5045.
  2. Alibhai SM, Breunis H, Timilshina N, et al. Long-term impact of androgen-deprivation therapy on physical function and quality of life [published online March 24, 2015]. Cancer.

Nurse Perspective

 
Frank delaRama Frank delaRama, RN, MSN, AOCNS
Clinical Nurse Specialist Oncology Genomics
Prostate Cancer Nurse Navigator
Palo Alto Medical Foundation
Palo Alto, CA
 
Men facing prostate cancer will often have the option of androgen deprivation therapy (ADT) as part of their treatment plan, ranging from neoadjuvant ADT given prior to radiation therapy, to palliative ADT for late-stage and metastatic prostate cancers.

Although ADT is well-proven to be effective in treating prostate cancer, the side effect profile can greatly impact quality of life for men, with decreasing libido, erectile dysfunction, hot flashes, and fatigue. We seem to have concrete advice and remedies for our patients dealing with the first few symptoms listed here, but dealing with fatigue is somewhat vague, both in assessment and intervention. This study’s findings contribute some important evidence connecting ADT directly to fatigue, independent of other variables.

Knowing that ADT will likely cause a clinically significant increase in fatigue, nurses can use this opportunity to teach patients, even prior to starting ADT, about strategies to minimize, or even prevent, fatigue.

Using evidence-based practice guidelines from the Oncology NursingSociety, exercise is the only intervention officially listed as “recommended for practice.”1 We advise patients about taking antiemetics prior to therapy that may cause nausea and vomiting, so perhaps we can also present an exercise regimen as an essential part of a care plan in anticipation of ADT.
 
Other interventions for fatigue are also gaining ground, and deemed “likely to be effective.” These include yoga, mindfulness-based stress reduction, and cognitive behavioral therapy.1 Based upon the evidence, including the study presented here, nurses can better illustrate the value of exercise as a preventive measure against what we could call “anticipatory fatigue” for men
starting ADT.
 
Not quite as easy as telling our patients to take a pill before treatment, convincing our patients to start an exercise regimen may be a much tougher task. Yet, given the evidence, the impact upon quality of life can be not only long lasting, but wide ranging, affecting overall health and wellness.
 

Reference
1. Mitchell SA, Hoffman AJ, Clark JC, et al. Putting evidence into practice: an update of evidence-based interventions for cancer-related fatigue during and following treatment. Clin J Oncol Nurs. 2014;18 (suppl):38-58. doi: 10.1188/14.CJON.S3.38-58. https://www.ons.org/practice-resources/pep/fatigue. Accessed May 1, 2015. 

Ovarian Cancer

Studies Illuminate Olaparib's Role in Ovarian Cancer

Darcy Lewis
 
Two studies are providing more insight into the efficacy and safety profile of the PARP inhibitor olaparib in ovarian cancer. A post hoc exploratory analysis of interim phase II trial results continued to find no significant difference in overall survival (OS) with the drug, while in a separate study involving a pooled analysis of six clinical trials, taking olaparib monotherapy at time of relapse showed median responses lasting nearly 8 months.

The data were presented March 28, 2015, at the 2015 Society of Gynecologic Oncology’s (SGO) Annual Meeting on Women’s Cancer.

Olaparib received an accelerated approval from the FDA December 19, 2014 for the treatment of women with BRCA-positive advanced ovarian cancer following three or more prior lines of chemotherapy. In the phase II trial leading up to the FDA approval, maintenance monotherapy with 400-mg, twice-daily olaparib led to a significant improvement in progression-free survival versus placebo, especially in patients with a BRCA mutation (BRCAm); however, no statistically significant increase in OS was seen in either the overall or the BRCAm populations.
 
Investigators hypothesized that with 12% of patients in the placebo arm receiving a PARP inhibitor after disease progression, this may have confounded the results. In the post hoc analysis involving 198 patients reported at SGO, all patients from trial sites where at least one patient received post-progression treatment with a PARP inhibitor were excluded.
 
This resulted in a change in the OS hazard ratio (HR) in BRCA-positive patients at a 95% confidence interval as follows: OS HR all sites = 0.73 (0.45-1.17); PARP inhibitor sites excluded = 0.52 (0.28-0.97). Due to small sample sizes and data immaturity (currently 58%), further analysis will follow when the data mature.
 
Lead author Ursula A. Matulonis, MD, said the findings from the post hoc analysis may support the initial hypothesis that the beneficial impact of olaparib on OS may have been confounded
by patients switching treatments due to disease progression.
 
“This analysis showed that placebo patients had longer treatment with a subsequent PARP inhibitor than with placebo,” she said at the conference. “Despite the later use of a PARP inhibitor in the course of their disease, patients still received benefit.” Matulonis is medical director of gynecologic oncology at Dana-Farber Cancer Institute.
 
In the pooled analysis of 300 women with relapsed ovarian, peritoneal, or fallopian tube cancer, all patients had received olaparib 400-mg capsules twice daily as monotherapy in one of six prospective clinical trials. The analysis used germline BRCAm status and patient outcomes data based on definitions from the original trials and assessed objective response rate (ORR) using RECIST criteria and duration of response (DoR) based on CT/MRI imaging at baseline.
 
Median DoR was 7.4 months in the overall study population and 7.8 months in patients who received ≥3 prior chemotherapy regimens; ORR was 36% and 31%, respectively.
 
Adverse events (AEs) were recorded throughout the six trials and graded by NCI CTCAE. AEs of any grade were seen in more than 25% of patients, ranging from 26% with abdominal pain (n = 79) to 65% with nausea (n = 196). Grade 3 or 4 AEs ranged from 1% with diarrhea (n = 4) to 14% with anemia (n = 43).
 
Serious AEs (SAEs) were reported in 30% of patients overall and 34% of those who had received three or more lines of chemotherapy. Causally related SAEs occurred in 10% of patients. Eight
patients had an AE that led to death, but none was considered causally related to olaparib. Olaparib’s overall tolerability profile was similar in patients with and without the germline BRCA 
mutation.
 
“It’s important to note that adverse events were generally low grade and manageable without olaparib discontinuation,” lead author Matulonis said. “And duration of response was not reduced in patients who had received three or more prior lines of chemotherapy. Further, olaparib treatment benefits were observed in all patient subgroups.”
 

References
1. Matulonis UA, Harter P, Gourley C et al. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer and a BRCA mutation: overall survival adjusted for post-progression PARP inhibitor therapy. Presented at: 2015 Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer; March 28-31, 2015; Chicago, IL. Abstract 13.
2. Matulonis UA, Penson RT, Domchek SM, et al. Olaparib monotherapy in patients with advanced relapsed ovarian cancer and a germline BRCA1/2 mutation: a multi-study sub-analysis. Presented at: 2015 Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer; March 28-31, 2015; Chicago, IL. Abstract 14.

Cervical Cancer

Telephone Counseling Provides Psychosocial Support to Cervical Cancer Survivors

Christina Izzo

A new study has found that a psychosocial telephone counseling intervention helps improve mood and quality of life in cervical cancer survivors.

The results, published in the Journal of Clinical Oncology, show that a psychosocial telephone counseling intervention benefits mood and quality of life, including cancer-specific and gynecologic
concerns, for this population of patients.
 
“What our work has determined over the yearspreceding this trial was that women with cervical cancer in particular are one of the most distressed group of cancer survivors, if not the most in the United States,” lead author Lari Wenzel, PhD, associate director for population science and cancer control at the University of California, Irvine Chao Family Comprehensive Cancer Center, said. “Also, this is a group who may not get the amount or type of supportive care services that could be beneficial.”

Cervical cancer patients are often young and underserved minorities, said Wenzel. Survivors  of the disease often face quality of life disruptions that can linger for long periods of time after treatment has ended, such as sexual and childbearing functioning concerns.
 
Wenzel said the idea of testing a telephone counseling intervention made sense in this situation because these patients are “a group that don’t avail themselves of typical services such as a support group at a hospital or elsewhere.”
 
For the study, 204 patients who were ≥9 months and <30 months from diagnosis were randomized to receive the telephone counseling service or usual care.

The psychological telephone counseling intervention included five weekly sessions and a 1-month booster. Patients reported outcomes at baseline and 4 and 9 months after enrollment.

The participants in the telephone counseling group received a 5-minute pre-call to schedule the first session, which took up to 60 minutes. The rest of the sessions ranged from 20 to 60
minutes and included topics on managing stress and emotions, health and wellness, managing relationships and sexuality concerns, and communicating with the healthcare team.
 
After each session, the counselor would prepare a summary letter of the session along with “homework” assignments to help the patient overcome stresses or concerns that they had talked with the counselor about.
 
Wenzel said one of the benefits of this strategy was that even though the counselors talked about general themes around areas that cancer survivors find important, the homework assignments
allowed the treatment to be tailored for each individual.

A Potential Biobehavioral Pathway
The study also looked to see if there was an association between quality of life and biomarkers.

Interestingly, the study found a correlation between the improvement in patient-reported outcomes and a decrease in both T-helper type 2 (TH-2) and counter-regulatory cytokines.
 
“We know that in individuals that experience chronic psychological stress, their immune system tends to shift a bit, its ‘immunological stance,’ to try to make more antibodies to keep the body from getting an infection rather than having an immune system that is ready and primed to fight the infection once it arrives. We call that a T-helper type 2 or TH-2, response,” study author Edward L. Nelson, MD, FACP, chief of the Hematology/Oncology Division and associate professor of Medicine, Molecular Biology & Biochemistry, at the University of California, Irvine, said in an interview.

“So under chronic psychological stress, the amount of TH-2 is much higher than it is when you don’t have that chronic psychological stress. TH-1 and TH-2 can be thought of as being on
opposite sides of a seesaw. TH-1 responses are thought to be best for fighting cancers and virus infections. If you have a whole bunch of TH-2, you have less TH-1.”
 
The study found that women who had improvement in the quality of life and a decrease in their stress level also saw a decrease in TH-2.
 
“This study reinforces a paradigm that connects the psychological state to downstream effects on the neuroendocrine and immune systems, the immune system in particular,” he said. “If you’re going to ask the immune system to behave in the way that you would like it to behave, to fight off cancer, especially with some of our other now novel immunotherapeutic strategies, you would like it to be tuned up in a way that makes it most likely that it is going to be effective.”
 
Although the study didn’t explore whether a decrease in TH-2 resulted in either longer control of a tumor or improved survival, stress raises TH-2, which is associated with decreased magnitude of TH-1.
 
“Under situations of chronic psychological stress, the immune system is…not tuned up for fighting off tumors,” Nelson continued. “And so, as we start to think about ways to tap into the immune system for fighting off cancer, we would do well to think about how we can address the psychological state to help our immune system be tuned up to do the best job that it can.”

The Benefits of Counseling
The study found that survivors receiving the psychosocial telephone counseling intervention had significantly improved depression and gynecologic and cancer-specific concerns at 4 months
compared with those who only received usual care (P <.05) and the significant differences in gynecologic and cancer-specific concerns were sustained at 9 months.

Based on these data, Wenzel said there’s plenty that oncology nurses can take away and even use in practice.
 
“I know that [oncology nurses] are already sensitive to the psychosocial issues of cancer patients,” she said. “But I think that they can look at this cancer population and if they start out by saying ‘Well, this is a population that is particularly in need of supportive care efforts,’ and it’s not one-size-fits-all, but [nurses] might be able to have a conversation to be able to understand the issues that these women are facing in such a way that this conversation and a follow-up care plan could be very helpful for the patient.”
 
“I think the other thing that oncology nurses can take away is the understanding that these women are going to have some rather profound stressors and disruption of their quality of life,” Nelson said. “So lots of times, having our patients know what’s coming and knowing that there are other resources that are available to help them is a way, in and of itself, to decrease the distress.”

Looking forward, Wenzel said she believes that these patients would benefit from booster or maintenance sessions, to help the patients continue their progress.
 
“This could be extremely cost-effective if we’re helping people long-term,” she said. “But this is something we need to test to see if we can help people long term.”
 
Some changes might need to be made to the counseling service, too, Wenzel said.
 
Data showed that those with higher depressionin the telephone intervention arm were significantly more likely to drop out of the study.In order to combat this in the future, Wenzel said she plans to make the first session more interactive.
 
“Some of the questions that we were asking were quite probing in terms of level of depression, sexual dysfunction, relationships, interactions with the healthcare team, and you can imagine if you’re already experiencing a level of depression that’s rather profound, sometimes actually people just want to turn inward and don’t want to talk about it,” she said. “So I think what I would do differently in our session 1 is to be sensitive to those presumed issues and allow the counselor and the patient to develop a relationship at a pace that the patient is optimally comfortable with.”
 
The intervention also has the potential to be brought into the clinic, Wenzel said. And implementing the intervention closer to the time of diagnosis may help improve stress and quality of life earlier, with potential long term benefits as well.
 
“Since this [study] has been published, we’ve heard from many physicians who have said they would appreciate help with this population,” she said.
 
The intervention also has the potential to be tested as a web-based intervention or more closely integrate technology, such as email or text messaging. This intervention can also be tested among other cancer survivors, Nelson said.
 
“There are other patient populations besides women with cervical cancer and cervical cancer survivors who also have fairly profound disruptions in their quality of life,” he said. “So we’d like to be able to know if this same strategy can be applied to those patient populations.”

Reference
Wenzel L, Osann K, Hsieh S, et al. Psychosocial telephone counseling for survivors of cervical cancer: results of a randomized behavioral trial. J Clin Oncol. 2015;33(10):1171-1179.

Nurse Perspective

 
Marieta Branis, DNP, ANP, NP-C Marieta Branis, DNP, ANP, NP-C
Women’s Oncology Division
John Theurer Cancer Center
Hackensack, NJ
 
Regardless of the cancer diagnosis, quality of life is a major aspect of survivorship. Studies have shown that cancer survivors have psychological, emotional, and cognitive issues that affect their well-being long after their cancer treatment has ended.
 
The National Cancer Institute defines a cancer survivor as any person diagnosed with cancer, from the time of the initial diagnosis through the rest of their life. Healthcare professionals need to be sensitive to the multitude of complex aspects affecting the long-term care of cancer survivors.
 
Comprehensive follow-up care, including assessment and appropriate referrals to psychosocial, nutrition, physical therapy, cardiology, neurology, and other specialized services, is necessary to ensure most appropriate management of the long-term side effects cancer survivors may experience.
 
Best evidence-based practice indicates that proper cancer survivorship care starts at the time of diagnosis. This is ideal, and the benefits of such an approach greatly improve the quality of life of the cancer survivor.
 
The study published by Wenzel et al in the Journal of Clinical Oncology highlights the great impact of psychosocial intervention in the quality of life of long-term survivors of cervical cancer. Cervical cancer is one of the most common cancers in women, and the severity of treatment-related side effects often linger after the therapy has been completed, causing a variety of disruptions in the day-to-day lives of these women.
 
The benefit of psychosocial counseling is reflected in the opportunity to open the communication between the patients and healthcare providers to have such issues as depression, anxiety, fear, fatigue, and sexual dysfunction addressed and possibly alleviated. Improved survivorship care starts with better education, assessment, and implementation of coping mechanisms,so cancer patients can overcome the difficulties associated with long-term survivorship challenges.

 

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