Clinical Insights: March 2015

Friday, March 27, 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-Mar-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

Many Women Lack Knowledge of Their Own Breast Cancer

Patient understanding of their cancer diagnosis is thought to be important for informed treatment decision making, but new research has found that many breast cancer patients, and especially minority women, are unaware of the basic characteristics of their disease, including its stage, the grade of the tumor, and hormone receptor status.

All of these factors are taken into account when treatments are recommended for women. Importantly, the researchers suggested, patients who fully understand their cancer may be more likely to adhere to their treatment regimens.

For the study, telephone interviews were carried out with 500 women in the California Cancer Registry who had undergone surgery for breast cancer. They were surveyed on four characteristics of the tumor with which they had been diagnosed: ER status, HER2 status, stage, and grade.

Fifty-five percent of women said they knew their ER status; 33% reported knowing their disease stage; 32% said they knew the grade of their tumor; 13% said they knew all four characteristics; and 14% reported knowing none of them. In reality, the researchers determined, 56% of women were correct on their ER status; 58% reported the correct HER2 status; 57% were correct about the cancer’s stage; and 20% reported the correct grade. Only 8% were correct on all four questions. Women who self-identified as Hispanic or black had less knowledge about their tumors. Less knowledge was also associated with having less formal education and lower “health literacy.”

“Of all of these factors, a tumor’s grade is likely the least important element for patients to know, although physicians use grade to make decisions about treatments, including chemotherapy,” said study author Rachel Freedman, MD, MPH, in a statement. Freedman is a medical oncologist in the Susan F. Smith Center for Women’s Cancers at the Dana-Farber Cancer Institute.

Knowing the stage is more important, she said, because it is a measure of the patient’s risk, and knowing the cancer’s HER2 status could help patients with HER2-positive tumors understand why they need to take trastuzumab for 1 year. Patients with ER-positive breast cancers often take tamoxifen or aromatase inhibitors for many years, so that knowledge might motivate such women to stick to the regimen, she added.


Freeman RA, Kouri EM, West DW, Keating NL. Racial/ethnic disparities in knowledge about one’s breast cancer characteristics [published online January 26, 2015]. Cancer.

 

Nurse Perspective

 
Janice Famorca Tran, RN,MS, AOCNP, CBCN, ANP-C Janice Famorca Tran, RN,MS, AOCNP, CBCN, ANP-C
Texas Oncology Houston, TX
 

This study revealed interesting findings regarding the knowledge lacked by women in regard to their breast cancer. The lack of knowledge was seen more so in women who self-identified themselves as Hispanic or black, those with less educational attainment, and those with a lower level of health literacy.

As practitioners, it is critical to assess the patient’s emotional state, educational level, current stressors, and cultural barriers, as these factors can greatly influence how individuals comprehend the details of their breast cancer. Practitioners should be sensitive to these factors, and different strategies can be implemented based on the individual’s unique needs or circumstances at that time. These include having the patient take notes, make an audio recording, detailing pertinent information on their smartphone, providing educational pamphlets or videos, and the use of a translator can make a significant difference in patients’ comprehension of their condition.

I have also found that the simple use of analogies and associations when explaining medical terms and definitions promotes better patient comprehension. Patients should also be encouraged to organize their medical records (ie, pathology reports, imaging studies, history and physicals) into a folder so that they can readily access them. Additionally, practitioners should advise patients to access their patient portals regularly as these often store pertinent details of their medical condition.

 
 

Ovarian Cancer

Hormone Replacement Therapy Associated With Increased Ovarian Cancer Risk

A new analysis has shown that taking hormone replacement therapy to alleviate symptoms associated with menopause significantly increases the risk of developing the two most common types of ovarian cancer, even if the therapy is only taken for a few years.

A meta-analysis of epidemiological studies involving 21,488 postmenopausal women with ovarian cancer published online in The Lancet, found that women who used hormone replacement therapy (HRT) for at least 5 years are about 40% more likely to develop ovarian cancer than women who have never taken hormone therapy.

“For women who take HRT for 5 years from around age 50, there will be about one extra ovarian cancer for every 1000 users and one extra ovarian cancer death for every 1700 users,” study coauthor Professor Sir Richard Peto from the University of Oxford said.

The study was conducted under the auspices of the international Collaborative Group on Epidemiological Studies of Ovarian Cancer, organized by the University of Oxford and involving more than 100 researchers worldwide. The data analysis reported here is based on individual participant data from 52 prospective and retrospective studies, almost all from North America, Europe, and Australia.

More than half of the ovarian cancer cases analyzed were drawn from 17 prospective studies (n = 12,110), of whom 55% (n = 6601) had used HRT.

Researchers found that there was a significantly increased risk of developing ovarian cancer in current or recent HRT users (ie, women who had used HRT within the past 5 years) versus never-users (Relative risk [RR] = 1.37; 95% CI, 1.29-1.46; P = .0001).

Although the risk of ovarian cancer fell over time after stopping treatment, women who had used HRT for at least 5 years still had a somewhat increased risk of ovarian cancer 10 years later (RR = 1.25; 95% CI, 1.07-1.46; P = .005).

The increased risk was seen only for the two most common types of ovarian cancer (serous and endometrioid ovarian cancers) and not for the two less common types (mucinous and clear cell ovarian cancers).

HRT’s effect on the risk of developing ovarian cancer was the same for the two main types of hormone replacement therapy (preparations containing estrogen only, or estrogen together with a progestagen), according to the analysis, which also found that the proportional increase in risk was not materially affected by the age at which the therapy began, body size, past use of oral contraceptives, hysterectomy, alcohol use, tobacco use, or family history of breast or ovarian cancer.

Even though the use of hormone replacement therapy fell rapidly about a decade ago and has leveled off, there are about 6 million women in the United Kingdom and the United States who are still taking the therapy.

While the current World Health Organization, US, and European HRT guidelines do not mention ovarian cancer, the UK guidelines, which are currently being revised, state that the rate of ovarian cancer might increase only with longterm use.

According to study coauthor Professor Dame Valerie Beral, also from the University of Oxford, “The definite risk of ovarian cancer even with less than 5 years of HRT is directly relevant to today’s patterns of use—with most women now taking HRT for only a few years—and has implications for current efforts to revise UK and worldwide guidelines.”


Collaborative Group on Epidemiological Studies of Ovarian Cancer. Menopausal hormone use and ovarian cancer risk: individual participant meta-analysis of 52 epidemiological studies [published online February 13, 2015]. Lancet.

Nurse Perspective

 
Marieta Branis, DNP, ANP, NP-C Marieta Branis, DNP, ANP, NP-C
Women’s Oncology Division
John Theurer Cancer Center
Hackensack, NJ
 

Menopausal symptoms such as hot flushes, vaginal dryness, night sweats, depression, fatigue, weight gain, and decreased sexual function, can alter the quality of life for many women. To alleviate these symptoms hormone replacement therapy (HRT) can be used successfully

In the early 1990s, the use of HRT became increasingly popular, with the promise to women undergoing menopause to provide protection against osteoporosis and help decrease the severity of menopausal symptoms. The controversy and concerns related to HRT’s use occurred when data presented by studies such as the Women’s Health Initiative Study, the Million Women Study, and the HABITS Trial, suggested an increased risk of breast cancer, heart attack, blood clot, and stroke for women using HRT.

This study showed that women taking HRT to relieve symptoms associated with menopause are also at a significant increased risk for ovarian cancer. This adds to more debate and controversy regarding the safe use of hormone replacement therapy.

For current practice, healthcare providers are faced with a tough decision when it comes to recommending HRT for treatment of menopausal symptoms. This study does specify that women who used HRT for at least 5 years had an increased risk of ovarian cancer as high as 40%. The statistical significance of this report brings concern for practitioners, who will usually avoid prescribing HRT. Lifestyle changes, use of antidepressants, and certain over-the-counter medications are among the alternatives to HRT.

 

Prostate Cancer

Role of Active Surveillance in Patients With Intermediate-Risk Prostate Cancer

The risk of dying from prostate cancer increased fourfold when active surveillance was used to monitor men with intermediate-risk disease compared with low-risk prostate cancer patients, according to results of a new study presented at the 2015 Genitourinary Cancers Symposium. These findings suggest that while overtreatment of low-risk prostate cancer remains a concern, when it comes to intermediate-risk patients, more information is needed to determine who can safely be managed with active surveillance. (Abstract 163)

Active surveillance is recognized globally as standard care for low-risk and some intermediate- risk patients with prostate cancer. Patients on active surveillance undergo physical and digital rectal examinations, PSA measurements, and repeat tumor biopsies.

To glean a better understanding of the impact of this approach among intermediate-risk patients, researchers prospectively analyzed overall (OS) and cause-specific (CSS) survival data from 945 patients receiving active surveillance for their prostate cancer between 1995 and 2013. Of the total, 732 had low-risk disease, and 213 had intermediate-risk disease, defined as either Gleason score ≥7, PSA >10 ng/mL, or clinical stage T2b/2c. Patients in the two cohorts were followed for a median of 6.4 and 6.9 years, respectively, and 61.5% of men in the intermediate- risk group were aged >70 years.

“When we looked at the low- and intermediate- risk groups, we did see a difference in overall survival, represented by a hazard ratio of 2.1—meaning an approximately twofold higher risk of dying from any cause for patients in the intermediate-risk group,” noted study coauthor Andrew Loblaw, MD, a radiation oncologist at Sunnybrook Health Sciences Centre in Canada where the patient data were collected. At 10 years, OS for patients with low-risk disease was 84.2% versus 67.3% in the intermediate-risk group. OS at 15 years was 66.7% and 50.8%, respectively.

“What surprised us,” Loblaw continued, “was that there actually seemed to be a greater risk of dying from prostate cancer for patients with intermediate-risk disease. The hazard ratio [for CSS] was 3.7, so almost a fourfold increase, and that was statistically significant.” At 15 years, 96.7% of men were free of prostate cancer death in the low-risk group versus 88.5% in the intermediate- risk group.

Loblaw said these data confirm that for patients with low-risk prostate cancer, active surveillance remains “a very safe, reasonable, and appropriate approach that aligns with guideline recommendations.”

He cautioned, however, that “despite the selection factors that we used in our clinic for intermediate-risk patients, we’re still seeing, at least in this analysis, a greater risk of dying from prostate cancer, and we believe that more research is needed to better identify the group of intermediate-risk patients who may be watched conservatively.”

“We think there is a group out there, but we want to be able to reproducibly identify these individuals so that we can do so safely.”

Charles J. Ryan, MD, of the UCSF Helen Diller Family Comprehensive Cancer Center, concurred with this assessment. He noted the need to identify further markers of risk, including genomic and other biomarkers that are being studied and integrated into patient care.

 
 

Analysis Shows Increase in Higher-Risk Prostate Cancers

The proportion of men diagnosed with intermediate- or high-risk cancer based on PSA level increased by nearly 6% from 2011 to 2013, according to an analysis of men treated for the disease since 2005 presented at the 2015 Genitourinary Cancers Symposium. (Abstract 143)

The United States Preventive Services Task Force (USPSTF) issued a draft recommendation in 2011 that PSA not be used for prostate cancer screening regardless of age. This study measured the potential consequences of that decision and found a notable increase in higher- risk cases of the disease between 2011 and 2013—a trend that could produce an estimated additional 1400 prostate cancer deaths annually. The USPSTF had also drafted a similar recommendation in 2009, recommending that PSA not be used for prostate cancer screening in patients over the age of 74 years.

Data were analyzed on 87,562 patients diagnosed with prostate cancer between January 2005 and June 2013. A blood PSA level >10 signified intermediate- or high-risk prostate cancer, irrespective of tumor stage and grade.

The proportion of patients with prostate cancer and PSA >10 decreased gradually from 2005 to 2011. However, the proportion of patients diagnosed with intermediate- or high-risk prostate cancer, based on blood PSA level, increased by 3% each year between 2011 and 2013. The fraction of men older than 75 years with a PSA >10 increased by nearly double the rate of men in all age groups from 2011 to 2013. Rates of intermediate- or higher-risk prostate cancer were stable at 70% to 73% prior to 2011; however, that rate rose by 2.9% annually after 2011 without evidence of a plateau.

Study authors estimated that with 233,000 new prostate cancer cases predicted in the United States in 2014, there will be 14,000 additional higher-risk prostate cancer diagnoses nationwide in 2014 compared with 2011.

“Whether this effect can be attributed to the 2009 or 2011 recommendation by USPSTF is speculative,” said lead study author Timothy E. Schultheiss, PhD, professor and director of radiation physics at City of Hope in Duarte, California. “However, the USPSTF did acknowledge the existence of this effect but regarded it as insignificant. We believe that our data indicate that the USPSTF might reconsider their recommendation.”

Currently, the 10-year prostate cancer survival rates are approximately 95% for low-risk, 75% to 90% for intermediate risk, and 60% to 80% percent for high-risk disease. Researchers plan to update the analysis as new registry data become available.

 

Prostate Cancer

Men With Testicular Cancer More Likely to Develop Prostate Cancer

Men with a history of testicular cancer have a higher incidence of developing prostate cancer, including intermediate or high-risk prostate cancer, compared with those without a history of testicular cancer, according to the results of a study presented at the 2015 Genitourinary Cancer Symposium. (Abstract 177)

While previous studies have also shown an increased rate of prostate cancer in men with a history of testicular cancer, this is the first study that looked at the likelihood of developing intermediate- to high-risk prostate cancer in these patients.

“It is too soon to make any practice recommendations based on this single study, but the findings provide groundwork for further research into the biologic link between the two diseases,” explained senior study author Mohummad Minhaj Siddiqui, MD. He is an assistant professor of surgery at the University of Maryland School of Medicine and director of urologic robotic surgery at the University of Maryland Marlene and Stewart Greenebaum Cancer Center.

For the study, researchers analyzed SEER data from 32,435 men over the age of 40 years with a history of testicular cancer and compared that with a control group of 147,044 men over the age of 40 years who had a history of melanoma, since there is no known association between melanoma and prostate cancer.

Intermediate to high-risk prostate cancer was defined by a Gleason score of 7, or ≥8, respectively, Siddiqui said. Of nearly 180,000 men in this study, 3205 were diagnosed with prostate cancer. The analysis showed that the overall incidence of prostate cancer by the age of 80 years was 12.6% in the men with a history of testicular cancer compared with 2.8% of men who didn’t have a history of testicular cancer (P < .0001).

A sub-analysis of men with intermediate- to high-grade prostate cancer showed that the incidence of intermediate- to high-grade prostate cancer by age 80 years was 5.8% in the testicular cancer cohort compared with 1.1% in the control group (P <.0001).

Siddiqui suggested that given the study findings, men with a history of testicular cancer should discuss the risk and benefits of prostate cancer screening with their doctors. However, before changing any guidelines or recommendations, further validation studies are needed to confirm the study’s results and to determine if men with a history of testicular cancer should be screened more closely for prostate cancer.

 

Psychosocial Oncology

Patient Preferences Vary When Involving Family Members in Treatment Decisions

It is known that family members provide support during a cancer patient’s treatment, but a new study sheds some light on which cancer patients actually involve their family members in treatment decisions and may help physicians and nurses understand patients’ preferences when it comes to their care.

As cancer therapies continue to improve, they are also becoming complex, which makes it harder for patients and providers to determine the best course of treatment. Knowing how patients make decisions and understanding the role that families play in these decisions is crucial for optimizing patient participation in treatment decisions.

“Understanding how patients vary in their inclusion of family members in decisions—by ethnicity, language spoken, marital status, sex, age, insurance status, and veteran status—may help physicians to better assess their patients’ preferences for engaging family members in decisions,” Gabriella Hobbs, MD, from the Harvard Medical School and lead author of the study, said in a statement. “As we move to more patient-centered models of care, such assessments may help doctors personalize the care they offer their patients.”

The study surveyed 5284 patients with newly diagnosed lung or colon cancer and asked them how they involved their families in decisions about their care. The survey showed that only 1.5% of patients reported familycontrolled decisions while 49.4 % reported sharing decisions equally with their families. Additionally, 22.1% of patients reported some family input, and 28.5% reported they had little or no input from their families.

Non-English speaking Asian patients and Spanish-speaking Hispanic patients were the most likely to report equally shared decisions with their families, as were patients who were married, female, older, or insured. The study showed that patients who were veterans were the least likely to include their families in treatment decisions.

“Our study suggests that not all patients wish to include family in the same way,” Hobbs said. “By raising awareness of these preferences, we hope that physicians will be aware of these variations and elicit their patient’s preference on how they wish to include, or not to include, families in decision making.”


Hobbs GS, Landrum MB, Arora NK, et al. The role of families in decisions about cancer treatments [published online Februrary 23, 2015]. Cancer.
 

Palliative Care

Study Finds Differences in Toxicity Reporting

A study involving more than 1000 patients enrolled in randomized clinical trials has found that patient and physician assessment of treatment toxicities can vary and are frequently under-reported by physicians.

Compared with the patients’ reports, physicians’ under-reporting of all-grade toxicities ranged from 41% of the time for nausea to 74% of the time for anorexia. Rates of under-reporting by clinicians were lower for patients who reported the most severe symptoms, ranging from 13% for vomiting to 50% for anorexia. Research also looked at four other toxicities associated with anticancer treatment and found that agreement between patients and physicians was low for all of them (Table).

Table. Physician and Patient Toxicity Reporting1

Toxicitya (any grade) Reported by Neither Patient Nor Physician Reported by Physician but Not Patient Reported by Patient but Not Physician Reported by Both Patient And Physician
Anorexia 383 28 505 174
Nausea 335 100 266 388
Vomiting 700 107 134 149
Constipation 501 32 384 170
Diarrhea 643 57 197 191
Hair Loss 519 15 360 192

aRange of evaluable patients for each toxicity (n = 1086-1090).

The study is based on an analysis of patients enrolled in three trials conducted at 78 institutions in Italy and Canada. One trial included patients aged 65 to 79 years with early-stage breast cancer receiving adjuvant therapy with either a cyclophosphamide/methotrexate/fluorouracil regimen or docetaxel; the other two trials involved patients receiving first-line treatments for advanced non–small cell lung cancer, and the agents studied were gemcitabine/cisplatin regimens, rofecoxib, and erlotinib.

Three treatment cycles were used for the analysis, yielding 2482 evaluable cycles. The researchers coded toxicities according to National Cancer Institute criteria, and after each treatment cycle, patients completed a quality-of-life questionnaire that included toxicity-related symptom questions allowing for responses on a continuum from “not at all” to “very much.” “This study adds to a body of literature comparing toxicity reporting between patients and clinicians,” noted Claire Snyder, MHS, PhD, in a podcast accompanying publication of the study results in the Journal of Clinical Oncology.1

“The importance of this study’s finding of differences in patient and clinician reporting of toxicities is not that one perspective is more accurate or in some way better than the other, but that the two perspectives provide complementary information.” Snyder, an associate professor of medicine, oncology, and health policy and management at the Johns Hopkins Schools of Medicine and Public Health, said that these findings underscore the importance of capturing patient-reported outcomes (PROs) as part of toxicity reporting for clinical trials, but also the need to deploy systematic tools to obtain this information in routine practice where toxicity reporting faces similar obstacles.

Among these barriers, she and the study authors noted, is that physicians have a higher threshold for reporting toxicities and may attribute them to the disease rather than treatment. A number of tools have been developed to aid in the collection of information on toxicity and other PROs, said Snyder, including the NCI’s patient- reported outcomes version of the Common Terminology of Adverse Events (PRO-CTCAE), and she encouraged their greater utilization to integrate the patient voice both in research and practice.


1.Di Maio M, Gallo C, Leighl N, et al. Symptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials [published online January 26, 2015]. J Clin Oncol.

Nurse Perspective

 
David Leos, RN, MBA, OCN David Leos, RN, MBA, OCN
Clinical Research Nurse Supervisor
Department of Radiation Oncology
UT MD Anderson Cancer Center
Houston, TX
 

The reporting of toxicities associated with cancer treatment is always vital. This is especially true in the context of treatment under a clinical trial where the benefit to risk assessment relies so heavily on determining the true severity of events experienced and their attribution. Rather than there being a straightforward and long track record in accounting for the patient’s true experience, the prevailing trend of evidence and clinical experience shows us otherwise.

The literature continues to provide examples such as this article to illustrate the chasm that exists, in this case, between what providers and patients report. It is helpful to be reminded of the challenges inherent in patient–provider communications which may contribute to under-reporting toxicities.

This study underscores the importance of clinicians educating their patients on the value of non–self-censuring, which may be a characteristic of the age group and of the healthcare delivery systems involved. In doing so, perhaps related to stoicism or to avoid treatment holds, patients may not realize the equal importance of reporting the toxicity price that comes with the treatment benefit.

However, the issue of providing education to better estimate occurrence of toxicities is twofold. This study’s identification of the physician’s higher threshold for reporting such events as a barrier comes as no real surprise and should be a reminder not to second-guess the cause and severity of the toxicity event. Herein, the physician can be educated as well. It is not uncommon to hear toxicity profiles for newly introduced agents summed up by clinicians as being “well tolerated.”

Toleration of toxicities, like beauty, seems to be in the eyes of the beholder. Fortunately, there are initiatives such as the PRO-CTCAE coming forth that hopefully can provide some parity in the outcomes reported by patients and by their treating physician.

 


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