Posted on 02/14/2009 12:58:53 AM PST by neverdem
SAN ANTONIO — Two new statistical analyses of Women's Health Initiative data persuasively indicate that the recent abrupt decline in breast cancer incidence in the United States is attributable to a dramatic drop in the use of estrogen-plus-progestin menopausal hormone therapy, and not—as skeptics have argued—to less utilization of mammography.
Academic fencing over causality aside, the practical take-home message from the latest Women's Health Initiative (WHI) data analyses is that the breast cancer risk imparted by hormone therapy rises sooner and more steeply than previously recognized, and it swiftly declines after HT is discontinued, Dr. Rowan T. Chlebowski said at the San Antonio Breast Cancer Symposium.
“I think the good news for women here is that the risk rapidly dissipated in just a year or year and a half,” said Dr. Chlebowski, a medical oncologist at the Los Angeles Biomedical Research Institute in Torrance, Calif.
The WHI was an extremely large National Institutes of Health-sponsored study on the prevention of cardiovascular disease and other chronic diseases. The HT clinical trial portion was halted prematurely in July 2002 upon detection of an increased breast cancer rate in its treatment arm.
In response to this announcement, the annual number of prescriptions for menopausal HT in the United States plunged from 60 million in 2001 to 25 million in 2003.
This development was temporally related to a sudden 8.6% decrease in the national annual age-adjusted incidence of breast cancer (20,000 fewer cases per year) beginning in 2003.
The reduction has mostly affected the 50- to 69- year-old age group, and mostly has involved fewer estrogen receptor-positive tumors (N. Engl. J. Med. 2007;356:1670–4).
Critics argued that this breast cancer decline might be an artifact resulting from less use of mammography once women stopped taking HT. But in San Antonio, Dr. Chlebowski presented two new analyses—involving a total of nearly 57,000 WHI participants—that ruled out a change in mammography utilization as a significant causal factor.
One analysis involved 15,387 participants in the WHI randomized clinical trial who were assigned to 0.625 mg/day of conjugated equine estrogens plus 2.5 mg/day of medroxyprogesterone acetate, or to placebo. The breast cancer risk was 26% greater in the HT group, compared with placebo, during the 5.6-year intervention period, then declined by 27% post intervention.
During the final year before the intervention was halted, the annualized incidence of breast cancer was 0.61% in the HT arm and 0.41% with placebo. In the first year post intervention, the rates were 0.44% in the HT group and 0.36% in the control group.
Tellingly, there was virtually no difference in the proportion of patients in the two study arms who had a mammogram in the year before the study was halted, nor in the period beginning 2 years before, within 1 year after, or 2 years after, Dr. Chlebowski noted.
The second analysis involved 25,328 women who were not using menopausal HT at entry into the nonrandomized WHI observational study and 16,121 others who were taking estrogen plus progestin at entry.
During 2001, the HT users had a highly significant 79% increased risk of being diagnosed with breast cancer, compared with HT nonusers, after adjustment for age, body mass index, ethnicity, education, physical activity, Gail risk score, alcohol use, smoking status, family history of breast cancer, and other potential confounders. During 2002, the HT users had a 65% increased risk.
However, during 2003—after all WHI participants had been instructed to stop taking HT—women who were HT users at entry into the observational study had only a nonsignificant 18% increased breast cancer risk compared with HT nonusers at entry. In 2004, the women who had been on HT at entry had a 20% increased incidence of breast cancer, again statistically nonsignificant. (See box.)
In each arm of the observational study, the percentage of patients who had a mammogram remained unchanged every year during 2001–2004.
Among nearly 2,000 WHI observational study participants who were diagnosed with invasive breast cancer, the 5-year mortality was roughly 4% regardless of whether they had been taking estrogen plus progestin or were HT nonusers, according to Dr. Chlebowski. This finding stands in marked contrast to a report from the California Teachers Study (also presented during the San Antonio conference), which concluded that breast cancer patients who had been on HT had a significantly better prognosis than did HT never-users.
Session cochair Dr. Peter M. Ravdin of the University of Texas M.D. Anderson Cancer Center, Houston, noted that the initial WHI report of an increased breast cancer risk in HT users prompted a change in guidelines for prescribing menopausal HT, with only short-duration therapy being recommended as safe. Will the new WHI findings lead to further change in the guidelines? he asked.
“I think these results will tend to focus attention on what ‘short duration’ means,” Dr. Chlebowski replied. “One part of the story is that the risk is greater than we thought with longer-duration therapy. We can see the incidence curve going up starting in year 2 of the observational study. … So there's now a strong incentive for women to take HT for shorter intervals. I think the threshold for starting HT should be higher; there should be more attention to the duration, and I think interventions other than HT for climacteric symptoms should be a research priority.”
Dr. Chlebowski disclosed that he is on the speakers bureaus for AstraZeneca Pharmaceuticals LP, Abraxix BioScience Inc., and Novartis, and serves as a consultant to AstraZeneca, Novartis, Genentech Inc., and Eli Lilly & Co.
So the more hormones used in HT, the more cancer created?
Ping.
presumably then the breast cancer incidence among uninsured women was lower than for insured women?
A few months ago I weaned myself off instead of doing it cold turkey. I've been hormone therapy free for three months and I feel fine. I might wake up once a night with a night sweat but it's not that severe.
In the last year and a half, my sister, my sister-in-law, and two friends were diagnosed with breast cancer. They had surgery. Some had radiation or chemo, and some had both. They are presently doing well. Not one of them ever took HRT.
I have a friend who was diagnosed with ovarian cancer over 5 years ago, had surgery, chemo, and she’s presently not doing well. She had taken HRT for years, but evidently there is supposed to be no link between HRT and ovarian cancer.
I can’t take HT because I’m Factor V Leiden Positive (I clot too easily). I’ve just started perimenopause and the worst effect so far has been the “creepy crawlies.” I’ve had one hot flash but the fromication is making me nuts. It’s like someone’s poking you with a live wire! Like the night sweats, sleeping with that is impossible.
A very small amount of Estrace 3 times a week treats it just fine along with Clobetasol. Estrace is much more natural than the horse stuff.
Wyeth makes Prempro and tried to have the government block Estrace compounding. (For this condition we don't take orally and in Canada they can only get it by compunding the pill.)
For people with my rare condition it's scary. Now, Pfizer bought Wyeth and I hope they don't pursue this anti-compounding FDA arm twisting.
I will never have a male doctor for gynecological issues again, ever.
How discriminating of you...lol. Seriously just kidding.
My current doctor and nurse practitioner are wonderful. I can tell them anything without being ridiculed. They actually seem to care rather than trying to see how many women they can get in and out the door in a day. Enough time is always scheduled for questions and consultations.
The creepy crawlies were bad for me in the daytime and the night sweats were bad at night. I wasn’t sure I would survive it. Hubby wasn’t sure he would survive it either. I haven’t had many of the conventional hot flashes during the day. All of it is better now but it took three years.
Can you explain what you mean by creepy crawlies?
Cause and effect can't be stated that authoritatively, but correlations have been made, especially for longer term use of hormone replacement therapy. HRT is more commonly used as the abbreviation for hormone replacement therapy.
Epidemiologists are wont to use the term risk factor. Here's an example:
Herbal medicines for menopausal symptoms.
Many women are now using herbal medicines to try to relieve menopausal symptoms such as hot flushes and night sweats, in light of recent evidence suggesting that hormone replacement therapy (HRT) may increase the likelihood of breast cancer, ovarian cancer, venous thromboembolism, heart attacks and stroke. or example, one survey has suggested that around 40% of women in the UK have used complementary and alternative treatments for their menopausal symptoms.7 Here we review the efficacy and safety of herbal medicines for the relief of such symptoms.
IMHO, you can use likelihood, risk and probability interchangeably in these kinds of statements. HRT may not be the causative agent for initiating a particular cancer, but it could promote its growth or metastasis.
See comment# 12. Hormone replacement therapy is just one of the risk factors for breast or ovarian cancer.
It’s a sensation like something crawling under your skin, something like hot electric worms. It’s a hot stinging that moves and makes your skin feel like it’s separating from the muscle under it. I’ve even looked to see if my skin was moving but it wasn’t. That’s how it felt to me anyway.
That's even more unpleasant than I had expected! I feel as though I'm having increased problems with restless leg-type symptoms. I've wondered if it were hormone related.
I'm glad you're doing better, and if I get worse, I may head myself to TN. I actually had a female gynecologist tell me she could prescribe "PMS medicine" for me. Really? PMS medicine? "Oh yes!" she said. It was called serafem.
Too bad for her, I knew it was prozac and never went back. If that was all she could do for me, fine. Just admit that. But don't lie to me.
I started HRT in 1982 when I was 51. Soon went down to .325 dosage
I stopped taking it about 2 years ago, only becase I was just tired of taking it. I never let the safe/unsafe/safe reports bother me. I am 75 and have had a mammagram every year since since I was eligible. Up until this very moment I have been blessed with very good health but that could change tomorrow.
My doctor doesn’t use the HT that is made from horse urine as mentioned in the article but she does do the HRT cocktail. They use something different that she said was more natural. I took Estradiol and the other one was Prometrium. I took one estrogen pill and one Prometrium a day at the lowest dose possible. They fixed me right up but she let me know first thing that it was a temporary fix. Normally your body will adjust itself in time where menopause is concerned but the first few years are awful for some women. I think that by weaning myself off by gradually decreasing how often I took them helped me a lot.
She also checked my vitamin D level because without enough D you don’t make the best of calcium and they have also found that vitamin D fights breast cancer. I take one prescription strength vitamin D capsule a month. None of my male doctors checked me for vitamin D deficiency.
Good going GoldwaterChick! I hope I’m in as good shape as you are in my 70’s. I’m very small boned and bone loss is my main fear.
I turn 40 in June. Dr’s have ignored me for years. Too young for perimenopause, ya know. I’m ok right now, but I’d like to have my ducks in a row if things begin to get worse. Thanks for the info.
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I went through full menopause rather early. I had always had irregular menses so even missing a period for 6 months wasn’t unusual.
I went into see my Primary Care Doctor and he said since it had been 6 months since the last period, he wanted to do a blood test just to make sure. Sure enough I was fully menopausal at 44. He put me on Premarin .625 which helped my sleeping. I really didn’t have any other symptoms so I thought it was going to be a piece of cake. Most of the time I’d forget to take the premarin and wouldn’t have any hot flashes, night sweats and any of the other goodies associated with menopause.
Fast forward 1 1/2 years later and I hadn’t been taking the premarin for about 6 months. My then husband had active Chronic Lymphocitic Leukemia and there was plenty of stress to go around. I was irritable (which I attributed to his leukemia and my being the main support for our family). I started having a few hot flashes, not many, but a few. My doctor wanted me to take the premarin to see if it might help with the way I was coping with all of the stress. I agreed and it did help with the stress and irritability. I also quit having any hot flashes whatsoever.
I weaned myself off about 6 years ago and had no problems with the hot flashes, irritability, night sweats, etc.
In the meantime in Sept. 04 I had a perforated duodenal ulcer which required emergency surgery. In June of ‘06 I had to have another stomach surgery to correct scarring and problems associated with the first surgery.
Because of the type of ‘corrective’ surgery which basically was the bariatric surgery used for obese people. I became extremely malnourished, underweight and had all sorts of gastro-intestinal problems. Prior to the rouen(sp?) Y surgery I was height-weight proportionate. I was 5’0” and weighed 106 lbs going into surgery.
Since the last surgery I’ve had problems with being malnourished, severely underweight, constant nausea, other gastro issues and problems with ataxia (being off balance the majority of the time). At one time there was talk that home health care was going to have to file a report which probably would have resulted in my becoming a ward of the state of Oklahoma because I weighed 78 lbs even though I was eating more than I ever had prior to the second surgery.
I went into detail because not only was I dealing with all of the above, for the first time in my life I started having hot flashes and severe night sweats. The night sweats were so bad 4-5 times a night I’d wake up with not a dry stitch of clothing on me.
I knew the risks of taking premarin as did my new PCP but we both felt it might help with some of the weight loss and malnourishment. I’ve been on them now for about 9 months and have managed to get up to 98.8 pounds as of this last Monday.
For the longest time after starting the premarin I couldn’t get above 90 lbs and usually bounced in between 82 lbs to 87 lbs. It was a red letter day when my check-up last month showed I weighed 91.3 lbs. It was cause for celebration when I hit 98.8. I even optimistically have bought some new clothes as well as finding and beginning to wear some of my old size 4 petite jeans (even though the 4’s are baggy but the 2’s are a little too snug around my waist).
I still need to gain another 8 or 9 pounds as well as hold on to the weight I’ve managed to gain. When you’re one of those short people every pound matters.
My hope is once I’ve got a track record of staying above 95 lbs and positive blood tests, I can once more quit taking the premarin.
This last Monday was the first time in 2 1/2 years I’ve had a blood test showing I wasn’t out of whack or malnourished. I attribute that to the premarin.
Sorry about the novel, I just wanted to point out that sometimes you have to weigh the risks and make a difficult decision.
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