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Old 12-10-2012, 07:58 AM   #1
Hopeful
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Surviving Breast Cancer Shouldn't Mean Relinquishing Intimacy

IMNG Medical Media. 2012 Dec 5, MG Sullivan

SAN ANTONIO (IMNG) - Women with breast cancer shouldn't have to relinquish the life-affirming power of sexual intimacy.

Breast cancer brings many challenges that can relegate sexual health to the bottom of the problem list, but helping women preserve or regain that facet of the lives is an important part of a holistic treatment plan, Dr. Michael L. Krychman said at the San Antonio Breast Cancer Symposium.

Unfortunately, most plans don't include any discussion of sexual intimacy and many women don't broach the subject alone, said Dr. Krychman, executive director of the Southern California Center for Sexual Health and Survivorship Medicine, Newport Beach, and a clinical professor at the University of California, Irvine.

"We now recognize that cancer can be a chronic disease that our patients can often live with for a very long time. Intimacy and relationships are very important for women, as they progress through their cancer care," he noted.

'Just Be Glad You're Alive'

Breast cancer patients don't always get the kind of team approach afforded to those with other illnesses, he said.

"When a patient has diabetes, the treatment team includes an endocrinologist, a dietitian. There are lifestyle changes, foot exams, eye exams. It's a team approach designed to target and improve every area the disorder affects. But when we talk about sexuality and breast cancer, the reaction often is, 'Just be glad you're alive.' Women can be told to just say goodbye to that part of their lives."

It doesn't have to be that way, said Dr. Krychman, who spoke at a session on breast cancer survivorship.

"We need to get past this problem with talking about women's sexuality. Women are embarrassed to bring it up, and when they do they're often subjected to a paternalistic reaction" that sends a very clear negative message about their feeling and desires, he said.

Addressing sexuality, however, isn't just about helping women feel good emotionally. It also can be about helping women stay compliant with the drugs that keep them physically healthy.

"One woman came to me after she stopped taking her maintenance therapy because of the effect it was having on her sex life," Dr. Krychman said. "She told me, 'I'd rather have 5 years of a life lived in color than 10 years of a life lived in shadow.' "

He was able to convince her that she could have both the years and the enjoyment of those years.

"I follow what I call a conservative-aggressive approach. We start with the conservative interventions, like addressing vaginal dryness and atrophy with moisturizers and lubricants, getting back on a healthy diet, and exercising. But we don't send a woman away with a bottle of lubricant and say, 'Come back in 6 months.' We like to see patients at least once a month to check on progress, and if things aren't going well we move on to something more," he explained.

Topical estrogens are the go-to treatment for sexual problems in women without cancer, but the jury is still out on whether they are good for women with breast cancer. "We now know that topical may not really be just topical. Hormones can be absorbed systemically even in the small doses seen in vaginal preparations."

Nonhormonal Drugs in the Pipeline

But two nonhormonal drugs in development - flibanserin and bremelanotide - could be promising treatments, Dr. Krychman said.

Flibanserin, a postsynaptic 5-HT(1A) agonist/5-HT(2A) antagonist, has been studied in more than 10,000 women and shown to increase libido and response in those with female sexual arousal disorder (FSAD) and hypoactive sexual desire disorder (HSDD).

In 2010, the Food and Drug Administration refused to approve it, saying that the side effects of dizziness, nausea, and vomiting seemed to outweigh its benefits.

Last year, however, Sprout Pharmaceuticals of Raleigh, N.C., purchased the drug and raised $20 million for its further development. The company is planning to resubmit data from the 14 existing trials, along with a new validation study, next year.

In October, a 12-month open-label extension study in 1,723 women reported some positive results. By 52 weeks, HSDD symptoms had fallen to remission levels in 90% of the group (J. Sex. Med. 2012 Oct 11. [doi:10.1111/j.1743-6109.2012.02942.x.]).

Bremelanotide is another promising drug, Dr. Krychman said. Like flibanserin, the melanocortin receptor 4 agonist got a new lease on life after the FDA nipped its development in 2007. At that point, the drug was being investigated for erectile dysfunction and female sexual dysfunction in both pre- and postmenopausal women. It was formulated as an intranasal powder but caused blood pressure spikes in some of the men who used it. FDA rejected the initial application as a libido-boosting drug but didn't rule out its development for other purposes.

Palatin Technologies, the New Jersey company developing the drug, reformulated it into a subcutaneous injection, which did not affect blood pressure in new safety studies. On that basis, Palatin went ahead with a phase IIB trial in 327 premenopausal women with FSAD, HSDD, or both. The company announced positive results last month.

According to a statement, "[the results] demonstrate that women taking bremelanotide showed clinically meaningful and statistically significant increases in the number of satisfying sexual events and also showed clinically meaningful and statistically significant improved measures of overall sexual functioning and distress related to sexual dysfunction, compared to placebo."
There were no blood pressure problems, although some women did quit the drug because of nausea and vomiting of mild to moderate intensity. Palatin intends to launch a phase III trial next year.

Dr. Krychman has disclosed that he is a consultant/advisor for Warner Chilcott, Pfizer, and Sprout.

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