Surabhi Dangi-Garimella, PhD

Despite the fact that aging and aromatase inhibitor (AI) therapy can increase fracture risk, the older women get, the less likely they are to have baseline bone density testing before going on AI therapy after breast cancer treatment, according to a recent study.

NCCN Guidelines recommend that patients have bone mineral density testing before treatment with an AI begins, as well as antiresorptive therapy such as a bisphosphonate to slow down bone loss. These recommendations are not widely followed in practice, however, as researchers from the Medical College of Wisconsin discovered.

The retrospective study searched claims data for Medicare Parts A, B and D to identify women aged 67 years and older with incident breast cancer in 2006 and 2007 who started AI therapy. The claims data provided the researchers with information on patient demographics, bone density testing, as well as other treatments that they would have received through 2012. Additionally, information on treatment with bisphosphonates, as recommended by NCCN, was included in the evaluation.

Overall, they found that baseline bone density testing was noted in two-thirds of the women, but the rate of testing dwindled with age: 73 percent of women in the 67- to 70-year age bracket were tested for bone density, compared with only 51 percent who had crossed the 85-year mark. Treatment with a bisphosphonate to promote resorption also decreased with age, the authors reported.

“This study highlights suboptimal US compliance with guideline recommendations for baseline [bone mineral density] testing when starting AI therapy,” said lead study author John Alan Charlson, in a statement.

Charlson, an associate professor of medicine in the Division of Hematology and Oncology at the Medical College of Wisconsin, added that, “While a larger number of older patients did receive bisphosphonates, this does not explain the disparities in bone density findings, or even substantially change our finding that attending to [bone mineral density] was higher in lower risk, younger women.”

Steven J. Isakoff, a member of the NCCN Guidelines Panel for Breast Cancer, said the findings are especially important when seen in the context of other studies now suggesting that the risk of bone fracture is even higher in women using AIs than previously recognized:

“Many women may now be using aromatase inhibitors beyond five years, which may further increase the risk of fractures,” Isakoff said in a statement.

“This study highlights that, as a breast cancer community, we need to do a better job screening for bone health, because with proper screening and treatment, many of these fractures can be prevented, particularly in the older patients at highest risk for fractures but who have the lowest rates of bone health screening.”

Surabhi Dangi-Garimella, PhD, is a writer and editor for the American Journal of Managed Care, Evidence-Based Oncology. Read more at 

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AI therapy can put breast cancer survivors at risk for bone fractures, making bone density monitoring important. 

The Importance of Monitoring Bone Density in Survivors of Breast Cancer

A session at the 2016 National Comprehensive Cancer Network (NCCN) Annual Conference opened today with a spotlight on finding more effective ways to encourage and deliver palliative care services across a variety of settings in oncology, with an eye toward introducing these services earlier in the cancer care trajectory, facilitating better provider—patient communication, and improving overall patient and caregiver quality of life.

“Palliative care has a lot of different aspects,” acknowledged panel moderator Toby C. Campbell. He said the practitioner community needs to focus on cutting-edge palliative care, “as we build the infrastructure to meet palliative care needs of cancer patients … upstream from end-of-life care and hospice.”

Campbell, an associate professor of medicine at the University of Wisconsin School of Medicine and Public Health, is both an oncologist and an expert in palliative care. In the panel discussion, he delineated the many levels of palliative care: primary palliative care (such as what primary care doctors provide), secondary palliative care (what all oncologists provide), and tertiary palliative care (expert-level palliative care).

Patients with cancer who are hospitalized in an inpatient oncology unit typically have a relatively short life expectancy, noted Campbell, “but palliative care programs are now moving to ambulatory or outpatient divisions. While most models are referral-based, they are not successful due to high ‘no-show’ rates,” he continued. “Then there are the programs built into the patient’s treatment.”

Finally, “there is also home-based palliative care, which is where I think the future of palliative care is.”

Setting the stage for the morning’s discussion was panelist Shirin Malekpour, a math educator at the University of Wisconsin-Madison, who, along with her family, cared for her mother, a pediatric hematologist/oncologist based in Iran, after she was diagnosed with stage III ovarian cancer in January of 2012.

“Although my husband was aware of palliative care, being a hematologist himself, and my mom also a doctor, we were so physically and emotionally drained, that we did not know the right questions to ask,” Malekpour said. She added that the medical team at the hospital was underprepared for palliative care.

Malekpour described an incident that occurred during her mother’s treatment: “One night a fellow came late to the hospital when [my mother] was vulnerable and alone. He got a [do not resuscitate] signature from her. It made us really upset … not that we did not agree with her decision. It was just how it was handled.” She said that was the time when they obtained palliative care for her mother, but only because her husband was a part of the team.

Carri Siedlik a nurse practitioner in the Palliative Care Program at the University of Nebraska Fred & Pamela Buffett Cancer Center, noted that discussing palliative care requires a major time commitment, and oncologists often don’t have time to sit down to discuss issues beyond the actual treatment.

 “Just looking at what people talk about, the content analysis studies suggest there’s very little redundancy,” between what oncologists discuss and what palliative care specialists bring up with patients, Campbell concurred.

“Palliative care conversations are usually about psychological, emotional, and physical symptoms; goals of care, and coping strategies,” Campbell said. An oncologist’s conversations, on the other hand, would be much more clinical and related to such issues as trials, therapy options, as well as some symptom discussions.

Sophia Smith stressed the importance of teamwork. Smith, an associate professor in the School of Nursing at Duke University, said it is very difficult for oncologists to have all of these conversations with the patient in 15 minutes, a reality that underscores the multidisciplinary aspect of palliative care: “social workers, palliative care experts, oncologists, nurse practitioners … there’s an entire team involved.”

Do oncologists perceive these other practitioners as a threat to the patient—oncologist relationship?

It is about building a relation with the oncologist, replied Siedlik. “Some of them at our hospital do see us as a threat. I always make sure, though, that the oncologist is comfortable with my role … I have built that relationship with them.”

Maria Dans, who serves as Director of Palliative Care Services at the Siteman Cancer Center at Barnes-Jewish Hospital in St. Louis, agreed, explaining that she always consults with her patient’s physicians. “I definitely do not want to threaten that relationship. I also find it helpful to open the conversation with the patient or the family, as well, if I tell them I spoke to their primary doctor,” she continued.

Breaking Down Other Barriers to Palliative Care

“I always try to separate my oncology hat from my palliative care hat to ensure I don’t tread on the primary oncologist’s realm,” Campbell said. Rather, he asks the patients to share what their primary oncologist recommended in terms of their clinical care.

A poll of the audience taken during the session elicited another barrier to delivering palliative care: patients may want to give up their clinical treatment.

“We found that patients were more likely to participate in a clinical trial if they were seeing a palliative care specialist,” Campbell said in response to the poll results. “So, at the University of Wisconsin, we have found a flip side to what the audience identified as a barrier.”

Smith said that she has found that survivors often feel rejected by their oncologists. Survivorship care could be converted into a team effort, according to Smith, where the oncologist, the palliative care specialist, and the social worker continue to care for the survivor. “A lot of what we do in survivorship is palliative care, so a lot of parallels can be drawn.”

Finances can be another stressor in the patient care continuum and should be factored into other patient symptoms as part of palliative care discussions. Campbell noted that when financial toxicity is included along with other physical symptoms (for example as part of a distress thermometer, Smith added), it encourages patients to open up about their financial distress.

Duke has been partnering with Reimagine, a program which educates patients on four typical conversations on palliative care. It provides online content and group-facilitated meetings led by a social worker. Patients can conveniently get together with their peers, online. The end goal, Smith explained, is not only to improve the situation for patients and caregivers, but also to enhance their communication with providers.

Surabhi Dangi-Garimella, PhD, is a writer and editor for the 

A session at the 2016 National Comprehensive Cancer Network (NCCN) Annual Conference opened today with a spotlight on finding more effective ways to encourage and deliver palliative care services across a variety of settings in oncology.

Team-Based Approach Crucial in Addressing Palliative Care

of their disease and treatment symptoms can have a significant impact on outcomes, possibly due to adherence issues. Currently, adequately validated measures for patient-reported disease- and treatment-related symptom burden in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) are scarce. Identifying this gap, scientists at the MD Anderson Cancer Center developed a short, validated, reliable patient-reported outcome measure of symptoms and symptom burden experienced by AML and MDS patients. The results from this study were consolidated in a poster that was presented on the first day of the annual meeting and exposition of the American Society of Hematology, held December 5-8, 2015, in Orlando, Florida.

A total of 152 patients with AML and 97 patients with MDS who were recruited to this study rated the 13 core symptom items (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, trouble remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness and tingling), six proposed AML/MDS symptom items (muscle weakness, malaise, fever, headache, diarrhea, skin problems), and six interference items (general activities, mood, work, relations with others, walking and enjoyment of life) on a 0 to 10 scale (0 = not present or no interference; 10 = as bad as can be imagined or complete interference), twice, one to two days apart. Patient clinical and demographic information was collected from medical records and analyzed using descriptive statistics.

The study found that both groups of patients endorsed similar symptoms, and none of the means of the four final AML/MDS symptoms were significantly different between the groups.

This study led the authors to conclude that the lack of recognition of symptoms experienced by patients with AML and MDS can lead to inadequate management of symptoms, interfere with the ability of patients to function and enjoy life, and impact the tolerability of and adherence to treatment regimens. The authors believe that their questionnaire, a patient-reported outcomes measure (PROM), is sensitive because it could recognize significant differences in symptom severity between AML inpatients and MDS outpatients.

The study’s lead author, Loretta A. Williams, Ph.D., R.N., M.S.N., assistant professor in the Department of Symptom Research at MD Anderson Cancer Center, told 

, “We were not sure that a single instrument would be appropriate for both AML and MDS. We were glad that, while the instrument is sensitive to differences in severity of symptom burden between the two diseases, the same set of symptoms was appropriate for both.” 

Williams sees potential for this PROM to be used by pharmaceutical companies in clinical trials of leukemia therapy because it was developed using the FDA guidance for patient-reported outcomes for labeling indications.

Some of the treatments used in patients with AML and MDS — many of whom are in their 60s and 70s &mdash; are quite harsh, and choosing these treatments for these older patients can be a difficult decision, considering their potential impact on quality of life (QOL). In the absence of cure, improving a patient’s QOL is important in the last year or so of life. With this objective, researchers from the Moffitt Cancer Center compared QOL between groups receiving intensive therapy, non-intensive therapy and supportive care, the results of which were presented in the same poster session Dec. 5.

Eighty-five patients, 60 years of age and older and diagnosed with high-risk MDS and AML, were recruited from Moffitt Cancer Center between December 2013 and April 2015. Forty-six patients received intensive therapy, 34 received non-intensive therapy and five received supportive therapy. The Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) questionnaire was used as the measure for QOL, with the following goals:

Comparing the difference in QOL scores measured by the FACT-Leu versions for intensive chemotherapy, non-intensive therapy and supportive care within seven days of new treatment, or of a decision to pursue supportive care at one month or later.

To determine QOL predictors of AML and high-risk MDS from age, comorbidity, fatigue and diagnosis.

To test the moderating effect of treatment with age, comorbidity and fatigue on QoL.

The authors observed that the intensive treatment group had a significant improvement in their QOL scores at one month post-treatment. Considering the predictors of QOL, a significantly negative correlation was recorded between fatigue and QOL, indicating that, as fatigue increased, QOL decreased. However, the QOL scores for age, comorbidity and fatigue were not moderated by treatment.

The authors conclude that the most intensive treatment improved QOL scores at one month and that fatigue is a significant predictor of QOL in this patient population. They suggest further studies with a larger, more diverse sample to explore the relationship between treatment approaches and QOL, in addition to intervention studies in AML and high-risk MDS focused on fatigue management.

Lead study author Sara M. Tinsley, Ph.D., A.R.N.P., A.O.C.N., from the Moffitt Cancer Center, said in an email that, “In our practice at Moffitt, we discuss various treatment options and their most common side effects, with very limited quality-of-life data to guide our discussions. We discuss risk-to-benefit ratio, with the risk of death from treatment and the benefit of prolonged survival. From our preliminary findings, we can also inform patients that treatment with intensive treatment can improve their quality of life at one month post-treatment.” She hopes that these findings will inform decision making and lead to more longitudinal evaluation of QoL in patients with high-risk MDS and AML.

Two posters presented at the annual meeting of the American Society of Hematology discussed patient-reported outcome measures and quality-of-life indicators as supportive tools for treatment in individuals being treated for acute myeloid leukemia and myelodysplastic syndrome.

Patient-Reported Outcomes and Quality-of-Life Measures in Myeloid Disease Can Help Inform Treatment Decisions

Women who take birth control pills may be protecting themselves against endometrial cancer — and not just during the years that they use these medications, but in the long term, according to an international study published in 

The analysis revealed that every five years of oral contraceptive use reduced the risk of endometrial cancer by about a quarter, and the reduction of risk persisted for more than 30 years after the women had stopped using the contraceptive agent. In high-income countries, 10 years of oral contraceptive use reduces the risk of developing endometrial cancer before age 75 years from 2.3 to 1.3 cases per 100 users, the authors found. However, the risk reduction varied by tumor type — it was stronger for carcinomas than sarcomas.

The incidence of endometrial cancer is rare in women younger than 45 years of age, but the risk of disease increases in women 55 years and older. The American Cancer Society estimates that more than 10,000 women will die of uterine cancers in the United States in 2015.

According to the study’s authors, about 400,000 cases of endometrial cancer in women 75 years or younger may have been prevented in developed nations — as a result of oral contraception &mdash; during the period between 1965 and 2014, 50 percent of that in the last decade.

“The strong protective effect of oral contraceptives against endometrial cancer — which persists for decades after stopping the pill &mdash; means that women who use it when they are in their 20s or even younger continue to benefit into their 50s and older, when cancer becomes more common,” explained study author Valerie Beral, a professor at the University of Oxford, in a press release.

She added, “Previous research has shown that the pill also protects against ovarian cancer. People used to worry that the pill might cause cancer, but in the long term the pill reduces the risk of getting cancer.”

In conducting the study, the researchers combined data on 27,276 women with endometrial cancer from 36 epidemiological studies from North America, Europe, Asia, Australia and South Africa. The median age of the women was 63 years and the median year of diagnosis was 2001. While 35 percent of the 27,276 women reported using oral contraception for a median of three years, 39 percent of the more than 115,500 women in the control arm of the study had used oral contraceptives for a median duration of 4.4 years.

Despite the fact that estrogen levels in pills in the early decades were double those in contraceptive pills manufactured today, the reduction in risk was comparable, which suggests that the amount of hormones in the lower-dose pills is still sufficient to reduce the incidence of endometrial cancer, according to the authors.

The proportional risk reduction did not vary substantially by women’s reproductive history, adiposity (amount of body fat), alcohol use, tobacco use or ethnicity.

In an accompanying commentary in the journal, Nicolas Wentzensen and Amy Berrington de Gonzalez, of the Division of Cancer Epidemiology and Genetics at the National Institutes of Health, discussed other ongoing studies examining the use of oral contraceptives as chemoprevention, these in women carrying BRCA1 and BRCA2 mutations or mutations that can lead to the development of Lynch syndrome.

“Even if the biological mechanisms remain elusive and the existing evidence falls short of wider recommendations for chemoprevention, women need to be more aware of the unintended benefits and the risks of oral contraceptives, so that they can make informed decisions,” they wrote.

Women who take birth control pills may be protecting themselves against endometrial cancer -- and not just during the years that they use these medications, but in the long term.

Surabhi Dangi-Garimella, PhD

The Importance of Monitoring Bone Density in Survivors of Breast Cancer

Team-Based Approach Crucial in Addressing Palliative Care

Patient-Reported Outcomes and Quality-of-Life Measures in Myeloid Disease Can Help Inform Treatment Decisions

Birth Control Pills May Protect Against Endometrial Cancer

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