Breast Cancer Guidelines Confirm Central Role Of 'Switch Strategy'

Guidelines from the 2007 St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer, published in the Annals of Oncology (annonc.oxfordjournals), confirm the value of switching from tamoxifen to an aromatase inhibitor (AI), such as exemestane, for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.[i]


Approximately 360,000 women in Europe are diagnosed with breast cancer each year. With up to two thirds of breast cancers requiring the hormone estrogen to grow, medicines such as exemestane are crucial for women affected by this disease, because they work by interfering with the supply of estrogen to the cancer and preventing it from growing. Switching from tamoxifen to exemestane has the potential to save lives among women diagnosed with hormone receptor positive early breast cancer.ii



The St Gallen guidelines are the consensus of breast cancer experts from around the world, who have assessed and recommended optimal treatment strategies for this disease, which affects the lives of thousands of women and their families.



"Guidelines are essential for physicians, as they ensure we are up to date with the latest recommendations for patient care," said Professor Charles Coombes, Head, Department of Oncology, Imperial College, London. "The St Gallen guidelines have confirmed the value of starting treatment with tamoxifen then switching to an aromatase inhibitor, enabling women to benefit from the advantages of both medicines. Exemestane, one of the aromatase inhibitors, has been proven to offer an overall survival benefit in the switch setting, and these latest guidelines confirm to physicians that we should continue to use it in this way to offer patients the very best care."



In hormone receptor positive breast cancer, the St Gallen panel expressed a clear preference for switching patients from tamoxifen to an AI, such as exemestane, which means more patients can benefit from exemestane's proven results in extending lives.



The guidelines follow publication of the Intergroup Exemestane Study (IES) in The Lancet earlier this year, which showed an overall survival benefit for women who switched from tamoxifen to exemestane, the only AI to have demonstrated overall survival in a single, double-blind trial.[ii] The IES, which randomized 4,724 patients across 37 countries, demonstrated that postmenopausal women[1] with early breast cancer, who switched to exemestane after 2-3 years of tamoxifen, experienced a 17% reduction in the risk of death compared to those who stayed on tamoxifen for the full 5 years of therapy.ii Exemestane was the first AI to receive approval in the switch setting.



Professor Coombes, who was lead investigator of the IES, continued, "The IES results, and now the St Gallen guidelines, confirm that switching to exemestane rather than staying on tamoxifen gives women an improved chance of survival. Furthermore, switching to exemestane has also been proven to have no significant adverse effect on quality of life compared to tamoxifen alone,[iii] making it a good all-round option for women."
















About exemestane[iv]


Exemestane is currently indicated for the adjuvant treatment of postmenopausal women with estrogen receptor positive invasive early breast cancer who have received 2-3 years of tamoxifen and are switched to exemestane for the completion of a total of 5 consecutive years of adjuvant hormonal therapy. Exemestane is also indicated for the treatment of advanced breast cancer in women with natural or induced postmenopausal states, whose disease has progressed following anti-estrogen therapy.



Exemestane should not be used in women who are premenopausal, are nursing or pregnant, have a known hypersensitivity to the drug, or are taking estrogen-containing agents. Exemestane should be used cautiously with drugs that are metabolised via CYP3A4 and have a narrow therapeutic window.


Exemestane was generally well tolerated across all clinical studies; undesirable effects were usually mild to moderate. The withdrawal rate due to adverse events in studies was 6.3% in patients with early breast cancer receiving adjuvant treatment with exemestane following initial adjuvant tamoxifen therapy and 2.8% in the overall patient population with advanced breast cancer receiving the standard dose of 25 mg. In patients with early breast cancer the most commonly reported adverse reactions were hot flushes (22%), arthralgia (17%) and fatigue (17%). In patients with advanced breast cancer the most commonly reported adverse reactions were hot flushes (14%) and nausea (12%). Most adverse reactions can be attributed to the normal pharmacological consequences of estrogen deprivation (e.g. hot flushes).


pfizeroncology


[i] Women with estrogen receptor positive or unknown status of disease.


[ii] Coombes RC et al. Survival and safety of exemestane versus tamoxifen after 2-3 years' tamoxifen treatment (Intergroup Exemestane Study): a randomised controlled trial. Lancet. 2007 Feb 17;369(9561):559-70


[iii] Fallowfield LJ et al. Quality of Life in the Intergroup Exemestane Study (IES) - a Randomized Trial of Exemestane versus Continued Tamoxifen after 2-3 years of Tamoxifen in Postmenopausal Women with Primary Breast Cancer. Journal of Clinical Oncology. Vol 24, No 6, Feb 20, 2006


[iv]Exemestane prescribing information (Summary of Product Characteristics dated 24 August 2005)

FDA To Conduct Surveys About STI, Pregnancy Prevention Language On Condom Packaging

FDA plans to survey 1,200 people in shopping malls nationwide on their understanding of a condom's efficacy in preventing sexually transmitted infections, including HIV, and unplanned pregnancies based on current labeling, the agency said on Thursday in a notice on its Web site, Bloomberg/Arizona Republic reports. According to the notice, survey responses will be "considered in FDA's condom labeling recommendations to provide important risk/benefit and use information associated with condoms in easily understood language."

Congress in 2000 directed FDA to "determine whether [condom] labels are medically accurate regarding the overall effectiveness or lack of effectiveness," Bloomberg/Republic reports. The agency in a 2005 review found that many people who use condoms are unsure how often the contraceptive fails to prevent pregnancy with typical use or that they provide less protection from certain STIs, such as genital herpes, Bloomberg/Republic reports. FDA in 2005 also proposed that labels on condom boxes and wrappers show data on unplanned pregnancies and varying levels of protection against STIs (Bloomberg/Arizona Republic, 6/14).

In addition, the agency in November 2005 published a draft guidance document for latex condom manufacturers. The document included a proposal that labels be required to state that condoms "greatly reduce but do not eliminate" the risk of pregnancy and HIV infection when used correctly during sexual intercourse but provide "less protection" from other STIs, including human papillomavirus and herpes, because those STIs can be spread through skin-to-skin contact. However, the guidance also says that "using latex condoms every time you have sex may still give you some benefits against these" STIs (Kaiser Daily HIV/AIDS Report, 6/22/06). FDA also recommended that condoms with spermicidal lubricant nonoxynol-9 include a warning that the lubricant can cause irritation that raises the risk of HIV transmission.

Any label changes would apply only to male condoms made with natural rubber latex, which account for almost 98% of sales in the U.S., FDA said. Guidelines for products made with lambskin or synthetic materials will be issued at a later date, the agency said (Bloomberg/Arizona Republic, 6/14).

"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

LA Times Examines Health Risks of, Alternatives to Hysterectomy

The LA Times on Monday examined the health risks of undergoing a hysterectomy and how many women's health experts increasingly are questioning the need for many of the 615,000 procedures that are performed annually in the U.S. The rate of hysterectomies performed in the U.S. decreased from 45.7 per 10,000 women in 2002 to 41.7 in 2003, according to the American College of Obstetricians and Gynecologists. More than 90% of hysterectomies performed in the U.S. are conducted because a woman has fibroids, endometriosis, abnormal bleeding, or a prolapsed or fallen uterus -- all conditions for which less-invasive surgery or nonsurgical treatments are available (Foreman, Los Angeles Times, 8/15). According to a study conducted by William Parker, a clinical professor at the University of California-Los Angeles David Geffen School of Medicine, and colleagues and published in the Aug. 1 issue of Obstetrics & Gynecology, more than half of the women who undergo hysterectomy each year in the U.S. also have their ovaries removed in order to eliminate their risk of developing ovarian cancer. However, the prophylactic removal of the ovaries -- which continue to produce small amounts of hormones even after a woman experiences menopause -- does not provide a health benefit, regardless of a woman's age at surgery, the study found. In addition, women who have their ovaries removed before age 65 might be at increased risk of heart disease because of a lack of estrogen in the body, Parker said. Overall, the younger a woman is when she has her ovaries removed, the more substantial the negative impact on her health and her chances of living to age 80 (Kaiser Daily Reproductive Health Report, 8/2). Some health advocates suggest that women seek alternative treatments to hysterectomy, such as myomectomy, the surgical removal of fibroids without removing the uterus; uterine artery embolization, which involves inserting small plastic pellets into blood vessels to cut off blood supply; or laparoscopic surgery, in which surgery to remove ovarian tumors is performed through a keyhole incision (Foreman, Los Angeles Times, 8/15).


Los Angeles Times


"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

More About Sex And Relationships Needed At Gynaecological Visits

Visits to a gynaecologist or midwife are generally associated with different tests and/or prescriptions for contraceptives, but could offer so much more. Women, doctors and midwives are agreed that gynaecological visits presents great opportunities for dialogue about sexual health, reveals a thesis from the Sahlgrenska Academy at the University of Gothenburg, Sweden.


Many young women see sex as a problem, the thesis shows. Almost 500 women aged 23-29 answered questions about their sex lives, their relationships and how they view gynaecological visits. One in five had a reduced sex drive and found it difficult to be satisfied together with their partner. Just as many said that they had been taken advantage of sexually or experienced other forms of sexual abuse.


"Many young women actually know little about their sexuality," says midwife Eva Wendt, who wrote the thesis. "If you feel confident about your body and understand how it works, sex is much easier and much more fun."


Nine out of ten young women think it natural to be asked questions about sexuality at a visit to a gynaecologist or midwife, the survey shows. Seven out of ten think it natural to be asked questions about sexual abuse.


"Women trust their doctor and their midwife - they are independent parties who have both expertise and a duty of confidentiality," says Wendt. "This paves the way for a dialogue when these professionals ask questions and can help women to reflect and see their own situation more clearly."


This view is shared by midwives, general practitioners and gynaecologists, but it is still relatively unusual for medical professionals to invite women to engage in in depth discussion of sexuality and relationships. Instead, visits are primarily medically oriented discussion of sexuality gets forgotten or time runs out.


"Both doctors and midwives describe opportunities to create respectful meetings and strengthen women by giving them information and encouraging them to have a positive view of sexuality," says Wendt. "Now that we know that women and medical professionals both want the same thing, perhaps sexuality and dialogue with the patient can be allotted more time at gynaecological visits."


Source: University of Gothenburg