A cancer diagnosis and subsequent treatment can impact many areas of life—physically, emotionally, psychologically, and cognitively.

But one of the most commonly-affected areas of life impacted by disease and treatment—sexual health and intimacy&mdash;is often underestimated, according to world-renowned sexual medicine gynecologist and survivorship medicine expert Michael Krychman, MD.

To garner further insight on sexual intimacy in cancer survivorship, Oncology Nursing News spoke with Krychman, executive director, The Southern California Center for Sexual Health and Survivorship about the impact of cancer on sexual health, discussing the issues during clinical visits, and simple solutions for optimal quality of life.

: Should issues with sexual health and intimacy be anticipated with a cancer diagnosis?

: The vast majority of people diagnosed with cancer have issues with sexual intimacy at some point. The extent to which they’re impacted really depends on a lot of variables—type of cancer, the patient’s age, the grade, the treatment.

Clearly, if someone has early-stage cancer and is able to be treated in a less aggressive way, it may still have an impact on a variety of things, but not to the extent as it would for someone who is aggressively treated with chemotherapy, radiation, or surgery.

Cancer does change how you think about yourself, look about yourself, and feel about yourself as a sexual person.

What sexual health effects can be associated with cancer diagnosis and treatment?

There are certainly a lot of things that's are quite similar between both men and women, and I would say that they’re broken down into different classes. There are direct and indirect effects.

Direct effects from chemotherapy, radiation, or surgery can include pain, fatigue, and issues with desire, arousal, and achieving orgasms. Women can experience vaginal dryness and loss of sensation, which can easily lead to feeling a loss of femininity. Procedures resulting in scarring can also alter the patient’s view of themselves as a sexual person.

Indirect effects are results of treatment that negatively impact sexual health, including stress, financial concerns, difficulty finding comfort, and losing strength.

If you have radiation and can’t even put your arm around your partner, it may become a big issue. It affects a variety of different things, and it impacts the whole relationship.

For patients, is the psychological or physical aspect more impactful on their sexual health?

I think that it’s a dual issue. It’s a dual process, and it really depends on the person—every person is different.

In terms of perception, the disease changes the way that people view themselves as sexual beings, in particular, and causes sexual self-esteem issues.

It’s estimated that for breast cancer, anywhere between 50% and 100% of people have issues and that’s really related to the fact that people can be diagnosed at a variety of different stages and grades.

For clinicians, it’s a balance. You can’t treat a problem if you don't know that one exists, and I think that it’s important that you talk about the issue. Clinicians need to create a comfortable environment. They don’t need to be experts, but they need to make themselves available for partial assessments and be able to refer patients to specialized clinics.

Are patients typically apprehensive to speak with their providers about sexual health and intimacy?

I think that patients want to talk about it, but they don't know how and they have their own hang-ups. Why do they have their own hangs-ups? I think it’s because they feel like they have a laundry list of things to discuss and there’s only a certain amount of time to talk to their doctor. They also don't want to embarrass their clinician.

Then there is this “conspiracy of silence.” Patients feel that if sexual health were important, their healthcare provider would raise the topic during the visit. At the same time, the healthcare provider feels that if it were important to the patient, the patient would bring it up. So, either side is waiting for the other to talk about it first and ultimately, nobody brings it up.

Patients often think that they’re being selfish and should just be thankful they are alive, but it's not about being selfish—it’s about quality of life.

Are there gender discrepancies in discussing sexual health in cancer survivorship?

Both men and women are very uncomfortable talking about this issue. And believe it or not, men speak up more often because it’s much more acceptable for men to be sexualized in our society.

Every day on television, we see ads for Viagra, Cialis, and Levitra, presidential candidates talking about erections, famous athletes talking about testosterone—for men, it is very common to have that discussion. Women, however, are not allowed to be sexual in our society, so this is an issue.

How can nurses and healthcare providers help ease patients into conversations about sexual health issues?

I think that breaking the silence is the most important thing. Nurses do 90% of the care and get 10% of the credit. Doctors do 10% of the care and get 90% of the credit. I certainly think that nurses have a vital role in initiating these conversations.

Again, you can’t treat a problem if you don't know that one exists. Talking with patients about sexual health and intimacy in survivorship decreases isolation, normalizes the problem, and lets them know that they’re not crazy.

Sometimes, it's a challenge for providers. Clinicians can feel inadequate about their knowledge of treatment, but it’s important to know that there are a lot of simple solutions. There are hormone therapies, non-hormonal moisturizers and lubricants, herbal supplements, and vaginal dilators.

It’s also important for providers to be aware of the many facilities and experts that focus on sexual health and reclaiming sexual intimacy in order to refer patients in need.

What is your overarching message to survivors who feel that they may never regain a normal sex life?

My message is one of hope. There are simple solutions, and the best predictor of how you will do after is how you did before. Not everyone is going to be forthcoming and able to help you, but it’s important to recognize that there are solutions, sexual health is important for survivorship, and you have to advocate for your own health.

My philosophy is that sexual health is general health. There is emerging data showing that regular sex, ejaculations, and orgasms, may lead to lower grades of chronic disease and decrease chronic illness.

It’s also known that sex can decrease the risk of cardiovascular disease and increase immunity, and other studies have linked regular sex to lower rates of prostate and breast cancer.

I think that the power of sexual intimacy—the ability to change your hormones, improve emotional closeness, boost your immunity&mdash;is existential. We need to make sure that we don’t underestimate what we’re doing in terms of sexual health in cancer survivorship.

Articles

One of the most commonly-affected areas of life impacted by disease and treatment

Sexual Health in Survivorship: Simple Solutions Can Follow Speaking Up

A mandate enacted after the 2010 Patient Protection and Affordable Care Act (ACA) was supposed to improve health coverage for patients enrolled in clinical trials. However, nearly 63% of cancer centers and organizations that responded to a recent survey reported insurance denials of routine care costs associated with patient involvement in clinical trials during 2014.

In order to analyze disparities in coverage for clinical trials and their impact on trial participation, PhD student Christine Mackay, RN, MSA, CCRP, site development director of the Clinical Trials Office at the University of Kansas Cancer Center, joined fellow researchers in conducting the survey of members of cancer centers and organizations throughout the country.

The five-question study garnered 252 analyzable responses from individuals associated with organizations doing clinical trials. It was performed in collaboration with the Association of American Cancer Institutes (AACI), the Oncology Nursing Society, and the Midwest Cancer Alliance.

Among their findings is that policyholders are likely to be turned down for clinical trial coverage by insurance plans that were in existence prior to the signing of the ACA in March 2010 and are thus exempt from the clinical trial coverage requirements. Mackay explained that in many cases, patients may not be aware that they are insured by one of these plans, which account for about 40% of current plans in the United States, until they are denied coverage.

“This is a problem for us because we don’t ask insurance companies if patients are covered until after patients have reviewed and gone through the informed-consent process, which means that they’ve already agreed to participate in the trial,” Mackay said. “That’s the process that we follow. It’s similar, but not exactly the same at all institutions.”

The study also found that where prior insurance approval of a procedure, test, or medication is required, patients were three times more likely to experience denials than at sites without precertification requirements.

Of note, sites in those states with existing laws or agreements for coverage had similar rates of insurance denial post ACA as states without prior regulation, indicating the previous laws did not serve their intended purpose. Mackay added that many patients in line for a clinical trial choose a different treatment path because the 10-to-30-day waiting period associated with the precertification process is unacceptable to them.

Sometimes coverage is denied without justification, Mackay added. “Once you push the insurance companies a little bit and ask them how they’re exempt from the federal mandate, we found that some of the initial denials were wrong denials,” she said. “The patients are truly covered, but then it’s really a timing issue. The patient may not want or have that much time to wait to initiate treatment.”

In some cases, the time-consuming hurdle of unjustified denials could be attributable to third-party administrators. With a history of inconsistent state legislation and varying coverage by state, the administrators may be unaware of the federal mandate and are quick to deny clinical trial coverage, Mackay explained.

Mackay attributes the differences in coverage partly to a lack of clarity and enforcement of the mandate, explaining that it’s up to the insurance companies to follow the rules.

“Despite the fact that the advocacy groups requested and even suggested specific guidelines on how to follow this piece of the mandate, those guidelines were not issued,” she said. “I don’t know that insurance companies have taken the time to really understand the pieces of the mandate.”

Since her initial study, Mackay has administered a subsequent, detailed survey to shed light on the extent of coverage denials, as well as highlight the reasons behind unjustified denials. She also aims to identify whether fear of insurance denials affects clinical trial patient enrollment.

Mackay hopes to have results of this study soon. In the meantime, she said, providers need to educate their patients on the importance of participating in trials and encourage them to find out how much their insurance covers.

“Without clinical trials, we’re not able to move the field forward. It’s through the clinical trial process that new treatments become available to the widespread market,” she said. “Lack of adequate enrollment to trials and delays in enrollment limit the generalizability of the results and cause trials to fail to gather enough data. Removing the insurance barrier should help.”

Mackay C, Antonelli K, Bruinooge S, et al. Cancer center and community research program experience with insurance denials for clinical trial participation after ACA mandate. Presented at: 2015 AACI/CRI Meeting; October 25-27, 2015; Washington, DC.

A mandate enacted after the 2010 Patient Protection and Affordable Care Act (ACA) was supposed to improve health coverage for patients enrolled in clinical trials. 

Payers Still Denying Coverage Despite Clinical Trial Mandate

Individuals with detectable human papillomavirus (HPV)-16 in their mouthwash samples were 22 times more likely to develop oropharyngeal cancer (OPC) than those without the type of virus, according to findings of a new study.

Researchers from Albert Einstein College of Medicine also reported that the presence of other HPVs, usually on the skin, is linked to an increased risk of developing head and neck squamous cell carcinoma (HNSCC).

 and led by Led by Ilir Agalliu, MD, ScD, is based on a nested case-control study with 96,650 participants who did not have cancer at baseline. The patients participated in the American Cancer Society Cancer Prevention Study II Nutrition Cohort and the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial and were monitored for nearly 4 years.

A total of 132 participants—103 men and 29 women&mdash;developed HNSCC during the follow-up period, and detection of oral HPV-16 resulted in a positive association for oropharyngeal squamous cell carcinoma.

HPV-16 is a well-known cause of head and neck cancers, and in a companion editorial to the study, authors Dana L. Rollison, PhD, Moffitt Cancer Center, and Maura E. Gillison, MD, PhD, Ohio State University, noted that this study is the first to demonstrate conclusively that the presence of oral HPV-16 precedes the development of oropharyngeal cancers.

“These data are remarkably consistent with risk estimates from numerous case-controls studies. However, the study by Agalliu et al contributes to the existing body of evidence by supporting a temporal association between HPV exposure and HNSCC,” the authors explained. “By linking oral HPV detection directly to HNSCC risk, the Agalliu data have important implications for the use of oral HPV detection for OPC screening,”

The study also found that oral beta- and gamma-HPVs—usually detected in the skin&mdash;were associated with the development of head and neck cancers.

Detection of β1-HPV-5 type was associated with OPC, oral cavity, and laryngeal squamous cell carcinomas. The γ11- and γ12-HPV species were associated with both oral cavity and laryngeal squamous cell carcinomas.

The study authors noted that these added associations indicate a broader role for strains of HPV in causing head and neck cancers.

Rollison and Gillison also pointed out in their editorial that previous studies have shown types of β-HPV infection to be a risk factor for cutaneous squamous cell carcinoma (cSCC).

Although the epidemiological data are limited, the findings suggest an interaction between β-HPV infection and UV exposure that may modify the risk of developing cSCC. Furthermore, they noted that other factors such as tobacco smoking and genetics may increase incidence of HNSCC among people with oral HPV types.

The study was limited by the small size, which the authors said reflects the rarity of HNSCC, but further research may help determine if simple oral tests can indicate risk of potentially developing head and neck cancers:

“The use of easily collected oral mouthwash samples can provide a prospective marker for risk of HNSCC and oropharyngeal SCC.”

Agalliu I, Gapstur S, Chen Z, et al. Associations of oral α-, β-, and γ-human papillomavirus types with risk of incident head and neck cancer [published online before print January 21, 2016].

Rollison DE, Gillison ML. The alpha, beta, gammas of orabl human papillomavirus infection and head and neck cancer risk [published online January 21, 2016]. 

Oral HPV Test Shows Potential for Predicting Oropharyngeal Cancer Risk

Mounting research continues to show increased risk of cancer recurrence and death in obese individuals, but findings of a new study highlight the benefits of weight-loss interventions for overweight and obese cancer survivors.

Overweight and obese survivors who participated in a 15-week weight-loss program lost 5.3% of their baseline weight and had significant improvements in physical fitness and functioning, according to a randomized trial presented by Rachel L. Yung, MD, at the 2016 Cancer Survivorship Symposium in San Francisco.

“There have been few weight-loss interventions tested in cancer patients, especially in malignancies other than breast,” said Yung, a physician at the Dana-Farber Cancer Institute and an instructor of medicine at Harvard Medical School.

“There’s also a lack of financial support for these interventions.”

For the study, 30 patients were enrolled and randomized to immediately participate in a 15-week healthy living program implemented through an oncology clinic. Another 30 patients underwent a 15-week control period with delayed participation in the program.

Nearly all of the participants in both groups were women (97%) with a median age of 52. The average body mass index (BMI) was about 32 kg/m2, and 80% of the patients had breast cancer.

Led by health coaches and exercise physiologists, the healthy living program focused on reducing calories by between 500 and 1000 calories per day and engaging in 150 minutes of moderate to intense exercise per week. Patients made individualized weekly diet and exercise goals for themselves.

The primary objective was to examine weight loss, but the researchers also looked at the program’s effect on physical fitness, activity, and functioning, along with body composition and patient-reported outcomes, including fatigue, sleep patterns, and body image.

After 15 weeks, survivors in the intervention group had a 5.3% weight loss of 4.6 kg, compared with a weight gain of 0.2 kg in the control group (

 < .001). The majority of the weight lost was fat mass.

Participants who completed the weight-loss program also had an increase of 74 feet that they were able to walk in the 6-minute walk test to determine baseline physical fitness. In addition, patients in the intervention group were about to maintain their high baseline scores for physical functioning, but those in the control group had a reduction in their scores over the 15-week period.

Although not statistically significant, there was also improvement in patient-reported fatigue and sleep patterns. Yung noted that previous studies have shown that weight loss of at least 4 kg has been shown to have clinically meaningful implications in terms of general health benefits.

Since at least 2003, she said, “the research has increased showing a dramatic relationship between obesity and cancer—both developing cancer and cancer morbidity.”

She added that particular barriers can make lifestyle changes difficult for cancer survivors to accomplish.

Both providers and survivors are sometimes unaware of the link between cancer and obesity, Yung said. However, even if there is awareness of the correlation, survivors may experience residual adverse effects from their cancer therapy that prevent them from physical activity.

In addition, there is also a lack of financial support and access to effective intervention programs, Yung said.

The authors concluded that more research is needed to examine the feasibility and sustainability of such weight-loss programs, but said that these findings can serve as preliminary information for similar interventions in oncology practices.

Yung RL, Giobbie-Hurder A, Shockro L, et al. A randomized trial of a clinic-based weight loss intervention in cancer survivors. Presented at: Cancer Survivorship Symposium; January 15-16, 2016; San Francisco, CA. Abstract 167.

Mounting research continues to show increased risk of cancer recurrence and death in obese individuals, but findings of a new study highlight the benefits of weight-loss interventions for overweight and obese cancer survivors.


Weight-Loss Intervention Improves Fitness in Cancer Survivors

New research shows that survivors of testicular cancer may have an increased burden of morbidity after being treated with cisplatin-based chemotherapy, with obesity, neuropathies, and tinnitus and hearing loss among the most prevalent late effects.

Burden of morbidity also increased with age and had a negative impact on self-perception of health, according to a study presented by Sarah L. Kerns, PhD, MPH, at the 2016 Cancer Survivorship Symposium in San Francisco.

Most men with testicular cancer are diagnosed at a young age, and while the disease is highly curable with a 10-year survival rate of more than 95%, this population is vulnerable to future health conditions.

“Despite this excellent long-term survival profile, testicular cancer survivors are at risk for late adverse effects from treatment for many decades—most of their adult life,” said Kerns, a research assistant professor in the Department of Radiation Oncology at University of Rochester Medical Center.

“This really represents an important population in which to study late effects of cancer, in particular, cisplatin-based chemotherapy effects on health outcomes.”

The study evaluated 751 participants under age 50 at the time of their diagnosis who underwent cisplatin-based chemotherapy.

The survivors answered questionnaires about health outcomes and prescription drug use. Outcomes were mapped and graded for severity using the the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Grade 0 was categorized as no adverse effects, and grade 4 was the most severe.

Obesity was the most commonly reported health outcome (74%), followed by peripheral sensory neuropathy (63%), peripheral motor neuropathy (45%), tinnitus (45%), hearing loss (44%), and erectile dysfunction (29%).

“Obesity was by far the most frequent, and this likely reflects national trends in obesity rates in the United States as well as the effects of cisplatin, which is known to affect symptoms of metabolic syndrome,” Kerns said.

Considering the frequency and severity of each outcome, a cumulative burden of morbidity (CBM) was then derived.

Nearly 70% of testicular cancer survivors had a CBM score of medium, which was defined as at least one grade 2 health outcome or one grade 3 outcome. Twenty percent of survivors had a high CBM, defined by multiple grade 3 outcomes.

Only 2.5% reported having no adverse health outcomes, 8.3% had at least one grade 1 outcome, and 0.5% had a severe CBM score.

The findings showed that an increase in number and severity of health outcomes contributed to an increased CBM score. In addition, older age was associated with increased odds of having a worse CBM score, and an increasing CBM score showed a negative impact on self-perceived health (OR = 2.56, 95% CI 2.03-3.2; 

The authors noted that this finding shows that survivors perceive health conditions following chemotherapy as negatively impacting their health in survivorship.

Of the participants, 62.5% received bleomycin, etoposide, and cisplatin (BEP), and about one-third received etoposide and cisplatin (EP).

Each 100 mg/m2 increase in cisplatin was associated with worse CBM score when restricted to outcomes related to cisplatin exposure, including peripheral sensory neuropathy, hearing loss, tinnitus, vertigo, vestibular disorder, and chronic kidney disease (

The average time since chemotherapy at the point of evaluation was about 5 years, and only about 20% of participants had more than 10 years elapse since their last chemotherapy.

Kerns added that her study may underestimate morbidity since most of the participants may not have been at risk long enough to develop some late health outcomes.

Additionally, the cross-sectional design of the study does not allow for an establishment of a causal relationship between CBM score and cisplatin-based chemotherapy exposure.

The researchers concluded that future research should focus on defining validated measures to evaluate long-term CBM among survivors of testicular cancer and eventually develop risk-adapted survivorship care plans.

Kerns SL, Fung C, Williams A, et al. Cumulative burden of morbidity (CBM) among testicular cancer survivors (TCS) in the Platinum study. Presented at: Cancer Survivorship Symposium; January 15-16, 2016; San Francisco, CA. Abstract 106.

Addressing Cisplatin's Late Effects in Testicular Cancer Survivors

Breast reconstruction surgery has become an increasingly popular option among women following mastectomy, but a recent study has found that most women who opt for the procedure are ill-informed of the potential risks.

“The decision about breast reconstruction is a type of medical decision that we call ‘preference sensitive,’ in that the best or right choice depends mostly on patient preference,” lead author Clara Lee, MD, MPP, member, UNC Lineberger, associate professor, UNC School of Medicine Division of Plastic and Reconstructive Surgery, said in a statement.

“For these types of decisions, whether or not it was a good decision is whether or not the decision was informed, and whether or not the treatment matches what the patient prefers.”

In a prospective, cross-sectional study, investigators surveyed 126 patients who were planning to undergo a mastectomy and evaluated them over 20 months to assess their knowledge about breast reconstruction and their involvement in the decision-making process. They were asked general knowledge questions about the surgery as well as questions about complication risks.

, found patient knowledge about the risk of complications associated with breast reconstruction was especially low, with only 14.3% of patients answering questions about major complications correctly. A majority of the patients (70%) knew at least half of the important facts about breast reconstruction, but the average knowledge score among participants was 58.5%, which researchers classified as moderate knowledge.

“By that metric, patients did OK,” Lee said. “But I do think that’s a pretty low bar for surgery that’s purely optional.” The rates of women electing to undergo breast reconstruction after mastectomy have risen more than 24 percentage points to 36.4% in 2011 in patients with early-stage breast cancer.

Complications from breast reconstruction surgery—some of which can delay cancer treatment&mdash;can include difficulty healing, infection, swelling, fluid under the wound, and flap or implant complications.

The participants in the study were highly involved with their physicians in the decision-making process, but deficits in knowledge persisted.

Of the 126 women, 92% reported discussing the procedure with their providers, and 90.4% were asked their preference.

However, the findings suggest that providers emphasize advantages over disadvantages in their discussions as nearly 60% of patients reported hearing about the pros while only about 28% discussed the cons of breast reconstruction.

“Our general conclusion after this study is not that breast reconstruction is good or bad, but that patients don’t fully understand it, and we need ways to improve that,” Lee said.

The authors concluded that interventions are needed to help women navigate through the decision-making process. “I really care about making the lives of cancer patients better,” Lee said.

“I think a critical part of that is helping them to make good choices. And the other motivation for me is that I have a very strong passion for fairness in surgery and in medicine. People who value treatment should get it, and people who don’t actually want it, or really are worried about complications for elective procedures, shouldn’t have it.”

Lee CN, Ubel PA, Deal, AM, et al. How informed is the decision about breast reconstruction after mastectomy?: A prospective, cross-sectional study [published ahead of print December 31, 2015]. 

Breast reconstruction surgery has become an increasingly popular option among women following mastectomy, but a recent study has found that most women who opt for the procedure are ill-informed of the potential risks.


Patients Lack Knowledge of Breast Reconstruction Before Surgery

Despite national evidence- and consensus-based guidelines on posttreatment care, less than half of adolescents and young adults (AYAs) with Hodgkin lymphoma receive all of the recommended services within the first year after treatment, according to results of a pilot study being presented at the 2016 Cancer Survivorship Symposium.

In addition, only 30% of survivors at high risk for cardiac damage adhered to long-term recommendations including an echocardiogram, electrocardiogram, or multigated acquisition (MUGA) scan.

“When we examine adherence to guidelines like these, it’s actually an important part of high-quality care to see if we can identify gaps and hopefully close them,” lead author, Erin E. Hahn, PhD, MPH, research scientist, Kaiser Permanente Southern California, Department of Research and Evaluation, said during a presscast held in advance of the symposium.

Hodgkin lymphoma accounts for 12% of all new cancer diagnoses among AYAs, and while overall survival rate is very high, this population remains at high risk for short- and long-term effects related to their treatment throughout survivorship. The study evaluated electronic medical records of 354 AYA patients aged 15 to 39 who were diagnosed with Hodgkin lymphoma between 2000 and 2010. The patients were diagnosed, treated, and followed for at least 2 years at the Kaiser Permanente Southern California integrated healthcare system.

Using the National Comprehensive Cancer Network (NCCN) guidelines, the investigators measured adherence to short-term recommendations, including oncology visits, labs, imaging, and the flu vaccine, which was categorized as preventive care. Nearly all of the patients had an annual visit with their oncologist within the first 5 years of treatment (96%), and 70% received the recommended labs. Two-thirds received a recommended CT scan within the first year.

However, only 20% of patients received the recommended flu vaccine, bringing overall adherence to 48% within the first 12 months.

“I was happy to see that most patients were seeing their oncologists and having some appropriate testing in the first 5 years after treatment,” said Hahn. “I think there is work to be done to increase awareness of other guideline recommendations, and potentially access to services.”

The study also examined a subgroup of patients who were at least 10 years out of treatment and had received high-dose anthracycline-based chemotherapy plus radiation. NCCN guidelines recommend that this population of high-risk patients receive cardiac screening.

A majority of AYA patients received annual blood pressure testing, but less than half received one of the other recommended modalities—an echocardiogram, electrocardiogram, or MUGA scan.

Researchers noted that AYA patients who were diagnosed with Hodgkin lymphoma between 2006 and 2010 were more likely to adhere to posttreatment recommendations than those diagnosed between 2000 and 2005.

“One of our hypotheses was that as these guidelines became more familiar to clinicians and hopefully also to our patients, it might actually change the patterns of care that we see,” Hahn said, “and that did turn out to be true.”

The study authors plan to expand their research to include a larger cohort of patients and investigate long-term recommended services. Hahn noted that next steps involve designing and implementing systematic programs to address gaps in recommended care for the AYA patient population.

Presscast moderator and ASCO expert Merry-Jennifer Markham, MD, added that Hahn’s study highlights a need for further interventions.

“The survivorship care is really crucial in the adolescent and young adult population of Hodgkin lymphoma survivors because many of them—most of them, in fact&mdash;have long lives ahead of them,” she said.

“Clearly, we have some opportunities ahead of us to improve adherence to post-treatment guidelines and hopefully, as a result, survivorship outcomes for all.”

Hahn EE, Wu Y, Delgadillo JG, et al. Use of recommended post-treatment services for adolescent and young adult Hodgkin lymphoma survivors. Presented at: 2016 Cancer Survivorship Symposium; January 15-16, 2016; San Francisco, CA. Abstract 107.

Despite national evidence- and consensus-based guidelines on posttreatment care, less than half of adolescents and young adults (AYAs) with Hodgkin lymphoma receive all of the recommended services within the first year after treatment, according to results of a pilot study being presented at the 2016 Cancer Survivorship Symposium. 


Complete Guideline Adherence Low Among Young Hodgkin Lymphoma Survivors

A topical paste may prevent scarring and fibrosis caused by radiation in cancer therapy, according to a recent study led by researchers at NYU Langone’s Laura and Isaac Perlmutter Cancer Center.

In order to mimic the development of radiation dermatitis—an adverse event experienced by as many as 95% of patients&mdash;the researchers exposed the skin of mice to a single dose of radiation similar to what patients with cancer would receive over 5 weeks. Some of the mice were normal, and the others were genetically engineered to lack the adenosine A2A protein receptor.

Their skin was then treated daily with either an adenosine A2A receptor—blocking paste or a placebo. Previous studies have shown that the A2A receptor stimulates collagen production and thus, scarring. Radiation to the skin causes skin thickening and the buildup of fibrotic tissue, which in some cases can be severe enough for patients to stop treatment.

One month after exposure, the genetically-engineered mice developed no skin reaction. Mice treated with the A2A receptor—blocking paste accumulated 10% more skin-thickening collagen, whereas mice that received the placebo doubled their amount of collagen, skin-thickening, and fibrosis.

“Our latest study is the first to demonstrate that blocking or deleting the A2A receptor can be useful in reducing radiation-induced scarring in skin,” study author and rheumatologist, Bruce Cronstein, MD, director, NYU Langone’s Clinical and Translational Science Institute, said in a statement.

The research team developed the A2A receptor-blocking paste using 2.5 mg of active ingredient per milliliter of 3% carboxymethyl cellulose, a gum “binder” used to make drugs.

If successful, further testing could potentially lead to this anti-scarring paste becoming a viable treatment to prevent fibrosis in patients with early-stage cancer.

“The study also suggests that adenosine A2A receptor—antagonists may have broad application as drug therapies for preventing fibrosis and scarring, not just in the liver but also in the skin,” Cronstein said.

He added that the new paste could be especially useful for patients in preventing or improving radiation-induced skin changes because there are very few effective drugs on the market to treat fibrosis. Additionally, the paste used in the study can be applied directly to the skin and was not associated with adverse events.

The findings also indicate that A2A antagonist drugs may be effective in treating other diseases involving the skin and connective tissues, such as scleroderma and interstitial pulmonary fibrosis.

The research team plans to study the A2A receptor further to determine the mechanism underlying its role in scarring and fibrosis.

Perez-Aso M, Mediero A, Low YC, et al. Adenosine A2A receptor plays an important role in radiation-induced dermal injury. 

A topical paste may prevent scarring and fibrosis caused by radiation in cancer therapy, according to a recent study led by researchers at NYU Langone

Topical Paste Prevents Dermal Injury From Radiation Therapy

Studies show that cost is a factor in patient adherence to their oral anticancer medications, but the financial burden of oral chemotherapy drugs is projected to still be too high for millions of patients even when the Medicare Part D coverage gap, or “doughnut hole,” is fully closed.

Researchers analyzed 3334 Medicare formularies to identify insurance companies’ drug costs and cost-sharing designs of oral chemotherapy medications, as well as out-of-pocket costs for beneficiaries who do not receive low-income subsidies.

, found that in 2010, oral chemotherapy drugs cost the average patient $8100 per year. After the Affordable Care Act (ACA) closes the doughnut hole fully in 2020, researchers predict that beneficiaries will still spend an average of $5600 per year in out-of-pocket costs for these medications.

“While closing the doughnut hole will benefit many Part D enrollees, individuals using expensive drugs will continue to face very high out-of-pocket spending,” lead author Stacie Dusetzina, PhD, assistant professor at the University of North Carolina Eshelman School of Pharmacy and Gillings School of Global Public Health and member of Lineberger Comprehensive Cancer Center, said in a statement.

“These high drug costs may result in people not taking their medications as they should. That makes therapies less effective, which wastes time and money and has health and financial consequences for the patient.”

Medicare Part D has been offered through private health insurance since 2006 and is a key payer for oral chemotherapy medications. Part D’s doughnut hole is a gap in coverage that occurs once the beneficiary exceeds the drug coverage limit of $2960. Once the limit is breached, a cost sharing of 100% in out-of-pocket drug costs goes into effect until the catastrophic level of $4700 is reached.

The ACA’s provision to close the doughnut hole is intended to reduce cost sharing in yearly increments from 100% to 25% by 2020.

However, with an average price of more than $10,000 per month for oral anticancer therapies covered by Medicare in 2014, out-of-pocket costs after closing the gap will still exceed what the average beneficiary’s household spends on food each year.

Investigators used the Medicare July 2014 Prescription Drug Plan Formulary, Pharmacy Network, and Pricing Information Files from the Centers for Medicare & Medicaid Services (CMS) to identify 1114 stand-alone and 2230 Medicare Advantage prescription drug formularies.

Analyzing specifically dabrafenib (Tafinlar) and sunitinib (Sutent), the researchers found that annual out-of-pocket costs ranged from $6456 for dabrafenib to $12,160 for sunitinib. Assuming that the drug prices remain stable, the authors estimate an average of $5663 in out-of-pocket-costs across products, saving beneficiaries only about $2550 per year.

The authors note that drug adherence to oral therapies decreases as patients move into the doughnut hole, and findings of minimal variation in costs across formularies suggest that patients have few options in reducing financial burden by selecting a different coverage plan.

“With consideration of the rising prices for specialty drugs over the past decade, any projected cost savings from closing the doughnut hole likely would be lost for these drugs,” the authors conclude.

“Efforts should be made to improve affordability of specialty drugs for Medicare beneficiaries given that medication nonadherence and a forgoing of basic needs are associated with high out-of-pocket medication costs.”

 Dusetzina SB, Keating NL. Mind the gap: Why closing the doughnut hole is insufficient for increasing Medicare beneficiary access to oral chemotherapy [published online ahead of print December 7, 2015]. 

Studies show that cost is a factor in patient adherence to their oral anticancer medications, but the financial burden of oral chemotherapy drugs is projected to still be too high for millions of patients even when the Medicare Part D coverage gap, or â€œdoughnut hole,â€ is fully closed. 


After Doughnut Hole Closure, Oral Anticancer Drug Costs Still Too High for Many

The incidence of Hodgkin lymphoma (HL) in women typically precedes and covers prime childbearing years, but a new study has found that pregnancy does not increase the risk of relapse among women in remission.

Researchers reviewed healthcare registries and medical records from Swedish Cancer Register to evaluate 449 women diagnosed with HL between 1992 and 2009. The women were between ages 18 and 40 at diagnosis.

Follow-up began 6 months after diagnosis, when the disease was assumed to be in remission.

Of the 449 women, 144 (32%) became pregnant during the follow-up period, but only one experienced a pregnancy-associated relapse, which researchers defined as a relapse during pregnancy or within 5 years after delivery.

Among the women who did not become pregnant during the follow-up period, 46 had a relapse.

“Based on these findings, we see no evidence that Hodgkin lymphoma survivors who become pregnant are at higher risk for relapse,” lead author Caroline Weibull, MSc, a biostatistician and doctoral student, Department of Medical Epidemiology and Biostatistics, Karolinska Institutet in Stockholm, Sweden, said in a statement.

The population-based study, published in the 

, is the first large study to specifically examine whether pregnancy is a potential trigger for relapse of HL, according to the authors. The findings are consistent with previous, smaller studies.

The study also found that most of the relapses occurred shortly after diagnosis, while most pregnancies occurred later.

One possible theory to explain the lack of relapses in pregnant women in remission is the “healthy-mother effect,” meaning that women with less severe disease are more likely to become pregnant after diagnosis because they are at lower risk of relapse.

However, the authors noted that they found no evidence of the “healthy-mother effect” in their study.

“After accounting for difference in age and disease severity, we found that the probability of becoming pregnant did not differ markedly between patients with advance and early-stage disease or between patients who had different types of chemotherapy,” Weibull said.

Studies have shown that cancer survivors fear that pregnancy could promote a relapse, and because HL is the most common cancer in adolescents and young adults, many female survivors are of childbearing age.

“We conducted this study because Hodgkin lymphoma survivors, as well as clinicians, have expressed worries that pregnancy may increase the risk of relapse, despite a lack of empirical evidence to support such concerns,” co-author Ingrid Glimelius, MD, PhD, oncologist, Akademiska Hospital in Uppsala, Sweden and researcher affiliated with Uppsala University’s Department of Immunology, said in a statement.

“This rigorous study should help put those fears to rest.”

The authors conclude, however, that risk of relapse is highest in the first 2 to 3 years after diagnosis and, if possible, women should wait 2 years after finishing treatment before becoming pregnant.

Weibull CE, Eloranta S, Smedby KE, et al. Pregnancy and the risk of relapse in patients diagnosed with Hodgkin lymphoma [published online ahead of print December 14, 2015]. 