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Life-Saving Breast Cancer Drugs Going Untaken in Appalachia

Nearly a third of breast cancer survivors in Appalachia are not taking critical, potentially life-saving follow-up treatment despite having insurance that would pay for it, a troubling new study has found.

Researchers cross-examined cancer registries with Medicare claims data and determined that of 428 women, approximately 30 percent failed to follow through with their prescribed adjuvant hormone therapy, a treatment to prevent the cancer's recurrence.

"Almost a third of the prescriptions for adjuvant hormone therapy were not filled, which is much, much higher compared to what we usually see in commercially insured populations," said Rajesh Balkrishnan, PhD, of the University of Virginia School of Medicine's Department of Public Health Sciences. "Usually it ranges from about 10 [percent] to 15 percent, so this is almost double that. A third of the women going without adjuvant hormone therapy – that is a scary prospect."

The findings, published in the journal Medicine, highlight a major problem in Appalachia, a region where cancer is a leading cause of death and access to healthcare can be a challenge. "This study was one of the first of its kind looking at this region, with not only severe socioeconomic deprivation but geographical barriers to care," Balkrishnan said. "Women often have to drive many miles to get to the nearest tertiary cancer center or the pharmacy."

Notably, the researchers found that women were more likely to stick with an older drug, tamoxifen, than with newer aromatase inhibitors. Balkrishnan said he suspects the findings speak to circumstances specific to the region. "One, the diffusion of newer technologies is much slower in Appalachia. Also, the other issue that comes to the forefront is that many of these medications have pretty severe side effects," he said. "I think what is also happening here is that there are high rates of discontinuance of the medication because a lot of patients are not counseled properly on how to manage the side effects of these medications and how to take medications in conjunction with other aspects of their lifestyles and daily living."

"Just having insurance doesn't seem to be enough," Balkrishnan said. "All the women we followed had Medicare Part D insurance [covering prescription medications]. But clearly in spite of insurance, the use and continuation of these medications, which is recommended at a level of 80 percent or higher, is not there in a third of the population."

The study is but the first step in a larger research project Balkrishnan plans to carry out. "Future studies need to tease out why these factors exist and maybe focus a little bit on intervention to improve access and use of essential, life-prolonging medication," he said.

He noted that the study used data collected before the implementation of the federal Affordable Care Act. "We need to see if policies which are being put in place to increase affordability and access to care are actually making a difference," he said.



Medicine, online edition, July 2015

University of Virginia Health System (http://www.healthsystemvirginia.edu)

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Estrogen-Suppressing Drugs Substantially Reduce Breast Cancer Deaths

A class of hormonal drugs called aromatase inhibitors substantially reduce the risk of death in postmenopausal women with the most common type of breast cancer, a major study of more than 30,000 women shows.

The research underlines the importance of aromatase inhibitors in the treatment of estrogen receptor (ER)-positive breast cancer – and shows they reduce risk of death by significantly more than the older hormonal treatment tamoxifen.

The study, published in the journal The Lancet, is relevant to postmenopausal women with ER-positive breast cancer, which accounts for over 80 percent of cases which occur after menopause. Each trial had used both aromatase inhibitors and tamoxifen at various times during the course of treatment.

In the study, researchers from the Aromatase Inhibitors Overview Group – chaired by Professor Mitch Dowsett at The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust – collaborated with colleagues at the Clinical Trials Service Unit at The University of Oxford, to combine the results from 31,920 women in nine clinical trials.

The study was funded by Cancer Research UK and the Medical Research Council and conducted under the umbrella of the Early Breast Cancer Trialists Collaborative Group.

Aromatase inhibitors suppress the synthesis of estrogens and are taken by postmenopausal women with hormone-sensitive (ER-positive) breast cancer. They have previously been reported to reduce the risk of recurrence more effectively than tamoxifen, but improvements in survival had not been demonstrated.

The current study showed that taking aromatase inhibitors for five years reduced the risk of postmenopausal women with ER positive breast cancer dying of their disease by 40 percent within 10 years of starting treatment, compared with no hormonal treatment. This compares with the 30 percent reduction achieved by taking tamoxifen for five years.

Current clinical guidelines reflect the uncertainty in when to use aromatase inhibitors or tamoxifen in the course of treatment but the new study could help clarify these recommendations.

Study lead author Professor Mitch Dowsett, Head of the Academic Department of Biochemistry and of the Centre for Molecular Pathology at The Royal Marsden and The Institute of Cancer Research, London, said: "Our global collaboration has revealed that the risk of postmenopausal women with the most common form of breast cancer dying of their disease is reduced by 40 percent by taking five years of an aromatase inhibitor – a significantly greater protection than that offered by tamoxifen.

"Aromatase inhibitors remove only the tiny amount of estrogen that remains in the circulation of women after the menopause – but that's enough to have a substantial impact on a wide range of ER-positive tumors, despite their extraordinary differences at the molecular level.

"But aromatase inhibitor treatment is not free of side-effects, and it's important to ensure that women with significant side-effects are supported to try to continue to take treatment and fully benefit from it."

Professor Paul Workman, Chief Executive of The Institute of Cancer Research, London, said: "The evidence on aromatase inhibitors has been accumulating for well over a decade, but it has taken this huge and complex study to make sense of all the data, and provide a firm basis for clinical guidelines.

"It tends to be the discovery of new treatments that grabs the headlines, but it is just as important to maximize the benefit patients get from existing treatments, through major, practice-changing studies like this."

The study was published in The Lancet alongside another major breast cancer study of a different drug type – called bisphosphonates – led by researchers at Oxford and the University of Sheffield and also funded by Cancer Research UK and the Medical Research Council.

Commenting on both studies, Nell Barrie, Cancer Research UK's senior science information manager, said: "These two studies give further evidence that aromatase inhibitors and bisphosphonates – both currently available treatments – help prevent breast cancer coming back in women who have been through the menopause. Both these studies, supported by Cancer Research UK, highlight how improvement in cancer treatment is made through painstaking hard work and the collection of many years of data, before clear trends start to emerge.

"Bisphosphonates help keep bones healthy, and these results show they reduce the chance of breast cancer returning in the bones in post-menopausal women. Aromatase inhibitors block the body's ability to make estrogen, which can fuel the growth of breast cancer, and these results confirm that they can help to stop the disease from returning after treatment."




The Lancet, July 24, 2015

Institute of Cancer Research (http://www.icr.ac.uk)

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