Study: NSABP N9431 also known as BI65 was closed to accrual after 1119 women volunteered (opened in 1996/97 closed 12/31/01)
Clinical Trial to evaluate the effect of "Menstrual Cycle and Surgical Treatment of Breast Cancer".
This is a trial being conducted by the National Surgical Breast and Bowel Project. That means it is a large-scale trial involving many women. Hopefully it will yield some definitive information.
Women with breast cancer can sharply improve their chances of survival by timing surgery in the second half of their menstrual cycle. But
most British hospitals are ignoring the finding, which could save 400 lives a year, according to a leading cancer specialist.
New research shows women who have breast tumors removed during the first part of the cycle -- called the follicular phase from days three to 12-- have a survival rate after 10 years of 45 per cent. But thesurvival rate rises to 75 per cent for women who have the operation in the latter part of the month (the luteal phase).
The results, from a study of 112 women operated on at Guy's Hospital in London published Monday in the journal Cancer , confirms evidence that has been growing for a decade on the importance of timing in breast cancer
surgery. All breast cancer surgery is now performed in the luteal phase at Guy's but few other surgeons have followed suit.
Prof. Ian Fentiman, head of the Imperial Cancer Research Fund's Breast Unit at Guy's, who led the research, said: ``It has had no impact whatsoever. Surgeons are very happy to try out new technologies. But when it comes to
something as simple as the timing of an operation -- it just hasn't caught on.''
The findings of the Guy's study apply to pre-menopausal women but other research by the team suggests postmenopausal women could also be affected. In
the UK, where there are 13,000 deaths from breast cancer a year, it is estimated the change could save 300-400 lives. In the US, where there are
30,000 deaths it could save 2,000 lives.
The Guy's team has completed a second, prospective study of 200 women allocated for surgery in the luteal phase whom it has followed since 1991.
Those results are awaiting publication.
Fentiman said: ``I hope that will be the definitive study in terms of convincing the rest of the world.''
The importance of timing is linked with the effects of the hormonesn estrogen and progesterone on the cancer. The patients who do best have hormonally sensitive cancers.
Fentiman said: ``The simplest way to think of it is if you take out the tumor in the second half of the cycle it is like a hard boiled egg whereas if you take it out in the first half of the cycle it is like a raw egg and the chances of spilling the tumor cells are very much greater.''
Hormone levels may also be important in encouraging spilled tumor cells to get established in other parts of the body with their own blood supply and start to grow. Fentiman said: ``There are enormous variations in estrogen
levels between women. Progesterone levels are less variable -- they were only clear in the second half of the cycle. Women with higher levels of progesterone had significantly better survival.''
Estrogen levels in postmenopausal women were higher in heavier women and lower in lighter women and studies suggest the timing of cancer surgery
could be important for them, too.
Fentiman said: ``By changing the hormonal environment in
post-menopausal women we might have an effect on survival,'' he said.
Several major studies have suggested timing of surgery is important and Fentiman said he hoped to amass enough evidence to present to the National Institute for Clinical Excellence (NICE), the government body charged with
issuing guidelines on best practice to doctors. ``I hope I can present them with enough data to say there is something here,'' he said.
(Distributed by New York Times Special Features)
Ann's NOTE: The third paragraph states that this is another positive study in over a decade of such studies. How much evidence is NEEDED for this simple but seemingly important change to be implmented. A suggestion: We should all write or call our local cancer center or hospital and ask if the breast surgery department is aware of this and could implement it. TAKE ACTION TO HELP ALL WOMEN. Write a letter to your local paper explaining this situation. Ask your own surgeon.
My surgeon agreed with me almost 5 years ago that this was a good idea. I wonder if she offers the option of timed surgery to other patients. You can bet I will find out!
A strong advocate for Timing
explains in plain English
Bca Chemo & Biological Rhythms
Fertility Cycle Influence
Seasonal modulation of post-resection breast cancer metastasis
Timing of BCa recurrence After Surgical Removal Primary Tumor
Biomarkers & Prevention
Cancer Online, May 2001
Abstract: Prospective Study of Hormonal Milieu
Breast Cancer Research and Treatment, 6/01
Lunar Phases & Survival-Statistical Analysis
European J of Surg Onco,
Breast Cancer Res Treat, 9/02
Abstract # 780
Breast Ca Res & Treat, 8/04
Annals of Surg Onc, 9/04
Proceedings fo the Nat Academy of Sci, 2/05
Arch Intern Med. 11/06
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