Envirocancer.cornell.edu

The Ribbon
The National Cancer Institute’sStudy of Tamoxifen and Raloxifene (STAR) .1 A Newsletter of the Cornell University
Program on Breast Cancer and
Decision Analysis of Tamoxifen for thePrevention of Invasive Breast Cancer .6 Environmental Risk Factors
in New York State
Activist PerspectiveThe Dark Side of the STAR Trial .8 Volume 5, Number 4, Late Fall 2000
The National Cancer Institute’s
Study of Tamoxifen and Raloxifene (STAR)
An Interview with Dr. Worta McCaskill-Stevens, Program Director for STAR, Division of Cancer Prevention, National Cancer Institute What is your role at NCI (the National Cancer providing the women with many levels of information about breast cancer risk. There is a lot of education wecan do about breast cancer risk and prevention, and I am a medical oncologist by training. I came to that is not just for the lay public or the women, but also NCI having been Co-Director of the Breast Care and Research Center at Indiana University, so I came withbreast cancer treatment experience. Another project of When do you see us having a more complete mine was investigating clinical trial participation among understanding of the role of these types of drugs? African Americans. I am the Program Director for theSTAR trial. I do administrative work on the trial and I think it’s going to be a while because, as you provide clinical input into the National Surgical know, this is a family of drugs — selective estrogen Adjuvant Breast and Bowel Project (NSABP) and the receptor modulators. Tamoxifen is the one about which we know the most. There are other drugs that are beingdeveloped at the same time, which is very characteristic What are your hopes for the ultimate benefits to of science – it’s not a static environment. Obviously be gained by women as a result of this study, because tamoxifen has traversed from treatment and which of course, is a huge effort? moved into prevention, we do know a lot about it. We You are correct, it is a huge effort. We don’t have know more about this drug than we do for most of our operative biomarkers — although we are working on oncological treatment drugs. What’s new, and all the them — to make our clinical trials shorter. STAR is questions that we don’t have answered, are the long- only the second largest US breast cancer prevention term benefits of using a preventative agent. Ultimately trial. It’s an exciting area in that we are doing what the we would love to have the “wonder drug” that would NCI/NIH does best: providing leadership in combating reduce the risk of developing breast cancer, with less morbidity and mortality from disease through research, or no risks. We would also like to be able to provide all in this case, on breast cancer. Not only are we the answers to questions such as “how long do the investigating the objectives of the trial, but because we benefits last?” The only way that we are going to know are doing prevention and not treatment, we are also those answers is through the investigation.
Institute for Comparative and Environmental Toxicology Cornell Center for the Environment STAR Schema
primary care physicians about explainingrisks and benefits of chemo-prevention.
Oncologists have been doing this for quite some time. This has not been the case withprimary care physicians. There was a jointeffort by Zeneca, various oncologists, andNCI as well, called Discovery International, which went to various sites throughout the how to counsel about risks and benefits. The second step of the Discovery International gynecologists. This is an important pointbecause one of the issues that women oftenhave to deal with is the question of hormonereplacement therapy. These women seek the clearly in all participating sites in the STARtrial there are massive education and outreach efforts. Concomitant with those efforts are the In the first year, STAR enrolled 6,139 women, probably more frequent efforts made by the membership from the over 47,000 who went through the of the NSABP – there is mandatory attendance of all individualized, no-obligation risk assessment. Of principal investigators and coordinators at the STAR the over 47,000, over 29,000 of these women were sites to the large cooperative group meetings. This last eligible based on their risk. These eligible women need meeting in fact had workshops addressing many of these to then make their choice based on their own issues: the hormone replacement issue, minority understanding of their risk and an understanding of the recruitment issues, gynecological issues, etc.
two drugs’ known risks and benefits. Can you describethe guidance they receive in doing so? At what point does a woman considering the trialneed to come into contact with a professional? Each woman will receive an individualized riskassessment form which, in addition to providing a At some point, she has to sit down with a health predicted breast cancer risk, will compare that risk to a practitioner and go through everything, but she can woman who is of the same age and race, but without initially fill out the forms by herself. As for the final the increased risk factors of developing breast cancer.
decision-making process, this cannot be done without For each of the events (benefits or risks), women are consulting with a health practitioner.
provided an analysis, of the expected number of cases The lowest assessed risk which would make a if 10,000 women were not treated to the expected cases woman eligible for STAR is equivalent to that of that may be prevented or caused if all women were an average 60-year-old woman, or a 1.7% risk treated with tamoxifen. NSABP will make sure the of breast cancer in five years (17 in 1,000). Some women do not have any of the conditions which would would argue that this is not “high risk.” Do you feel render them ineligible from their medical history.
that eligible women in this range of risk are self- Women come with a varying amount of information.
Some, after receiving the information we make availableto them, go to their family members, or other women, In the first Breast Cancer Prevention Trial (BCPT), 60 to their primary care physicians – to discuss the idea of was the average age at which women developed breast their participation in the trial. In considering those roles, cancer. Age, as you know, is the primary risk factor for there are efforts from various angles to try to educate breast cancer. If you are 60 years old, you are approaching your peak. Even though it continues to and encouraging women to participate in better health increase, many of those women don’t live, and secondly, care – and breast health care. In fact, this is not a static they are often confronted with things that would prohibit situation because age is a strong risk factor: the same them from considering breast cancer prevention at that woman may become eligible in a year when she’s older.
point in time. So 60 is important, and it is high risk.
Her ultimate choice will be an informed choice.
Two things about the women who participated in BCPT: You have said that “the benefits and risks of 75% of them had a five-year predicted risk of greater tamoxifen are the same in African-American and than 2.0. In addition to that, the benefits of breast cancer white women. Women of all races can feel prevention in BCPT traversed all age groups and all comfortable about considering STAR if they are five-year risk groups as well. So as for the impact, even at increased risk of breast cancer.” Indeed African- for the 25% of women with risk between 1.7 and 2.0, American women, who have historically been there was still a benefit for them in terms of reducing underrepresented in cancer trials, are being actively their risk of developing breast cancer.
recruited for STAR. Can you comment on this? The eligibility criteria for the two trials is different. For Yes, our analysis showed that among 1200 women, BCPT you could be 60 and that would render you tamoxifen is as effective in African-American women eligible, but that is not the case for STAR. For STAR, as it is in white women in reducing the risk of age alone does not render you eligible, your assessed contralateral breast cancer. We also found out that the rates of the two main side effects, endometrial cancerand blood clots, were no greater in African-American As for the breakdown of the percent of women enrolled in STAR to date by five-year breast cancer risk, we havethat information (see chart).
In terms of recruitment, what we learned from BCPTwas that we need to go into the communities. Towardthe end of recruitment of that trial, funding was put Five-year
Percent of Women
forward to five sites that were areas with significant Breast Cancer Risk
in STAR to date
minority populations. We hired an outreach coordinatorto go in and provide information about the trial. This proved for that particular trial to be the most successfulroute. Of course, 3% (total minority participants in the trial) was not where we would want to be, so that approach has been massively expanded for the STARtrial. It’s a great learning process for any investigators who are out there. You must have people who are outthere in the community who understand the variouscultures and the various languages. We now have the In the African-American community, the incidence of trial components available in Spanish. There are now breast cancer is lower but the mortality is higher, and ten, and going to be 14 sites to be targeted for minority the population has not historically had access to the populations. There are other infrastructures in place at clinical trials. African American women come in to NCI, and we are learning how to do it better. We have STAR knowing that they are more likely to die of breast a minority-based community clinical oncology cancer, which is true, but risk assessment is based on program; eight are now funded to provide clinical trials incidence, so the eligibility threshold is higher. These to areas that have 40% minorities in their areas.
women have said they are ready to learn about theirbreast cancer risk and learn about clinical trials. They We are working with all minority groups. The get to a level of trust, and then often find out they are Philadelphia chapter of the National Medical not eligible. That’s of course good news, except that Association, which is the African-American equivalent for a community that has not been engaged in this to the American Medical Association, is now a STAR process historically, it can be disappointing for them site. I am also working among the Latino community, after they feel they had taken the steps to become for example in New Mexico and in Puerto Rico. I am proactive. This is an interesting challenge for us to work working among Native Americans to try to facilitate within. But we are providing women with information, tribal approval of the STAR trial in light of Native STAR Trial
Possible Benefits and Risks – Sample Case*
Potential Benefits: Treatment may reduce the risk of a certain type of wrist fracture called Colles’ fracture by about 39%, and also reduce the risk from fractures of the spine by about 26%.
Potential Risk: Treatment may increase the occurrence of cataracts by about 14%.
Americans having had their history of atrocities with of the BCPT trial was the 86% reduction in atypical unethical medical trials. These are issues we need to hyperplasia, which is a pre-malignant condition. But be very sensitive about; it’s all a learning process.
we don’t know all the answers about the physiologyand pathology from a healthy breast to a diseased one.
These are drugs that cannot be used on a long-term basis. Women with breast cancer who use Cancer takes a long time to develop. The Breast tamoxifen for more than five years have an Cancer Prevention Trial was stopped early increased likelihood of recurrence. How should because the researchers felt that tamoxifen we think of this in terms of preventative effects? should not be withheld from the placebo group. Perhaps when we are talking about a breast cancer Those placebo group members are being actively “prevented” by either drug we are more realistically recruited for STAR. STAR does not have a placebo group. How will we be able to do long-term follow-up,to determine how the incidence of breast cancer in We don’t know. When a woman has estrogen receptor- women who have taken tamoxifen or raloxifene positive breast cancer in one breast, it does not mean compares to women who have taken neither? that were she to develop a second primary tumor in theother breast, it would also be ER-positive. Our decision 1100 women from BCPT placebo group have gone on to intervene in the prevention arena for five years is to STAR and another 600 have gone on to take based on treatment data. We have clear-cut data that tamoxifen, but we are left still with several thousand there is not a treatment benefit beyond five years — women who can be followed from the placebo arm of however, it does appear that there is a prolonged benefit BCPT. As for the logic behind not having a placebo from taking tamoxifen for five years that extends out group in STAR, in my mind this is very clear. You to ten years. We don’t have confirmation of that yet for cannot have a placebo group when you have a drug women taking tamoxifen for prevention for five years.
which leads to a 49% reduction in breast cancer risk in There are studies that are continuing in the prevention a trial of 13,000 women. It’s not ethical.
arena, such as the European studies.
Can you comment further on the issue of side We don’t know all the molecular answers to those questions. One of the criticisms of BCPT was thatperhaps we were treating early breast cancer that Tamoxifen and raloxifene have side effects. It already existed. Clearly one of the compelling elements may help to put things into perspective to consider that we are now getting more and more data that show the the profile of these drugs was very poor. Women are hormone replacement drugs are not the wonder drugs becoming more savvy and coming to their decision- that everyone thought they were. Hormone replacement making with better information about their personal therapy has the same blood clotting risk, but health. We know that there are women whose health unfortunately women have not been informed. If you situation is not going to permit them to address their ask women what they were told about hormone high risk of breast cancer through the trial or tamoxifen.
replacement therapy, many of them would tell you that But there are women who are high risk and healthy for they were not told much. The informed consent about Commentary on STAR
Michael P. Osborne, MD, FRCS, FACS The “Study of Tamoxifen and Raloxifene (STAR) in raloxifene or no drug. The use of historical controls is Postmenopausal Women at Increased Risk for Invasive not appropriate as they may have different eligibility Breast Cancer” (P-2) is a clinical trial currently being parameters compared to the STAR trial making it conducted by the National Surgical Adjuvant Breast difficult to extrapolate data to patients on the STAR and Bowel Project (NSABP). This large, multi-center trial. Moreover, like most clinical trials, this data will trial is the first North American trial to compare two not be available for many years (Osborne, 1999).
different pharmaceuticals, tamoxifen and raloxifene,as preventive agents for breast cancer. Tamoxifen, in One of the criticisms of the tamoxifen prevention trial the NSABP’s Breast Cancer Prevention Trial (P-1), is whether patients are actually receiving treatment for demonstrated a decrease in the incidence of breast an early, undetected breast cancer. It is postulated that cancer by about 50% in patients at increased risk for some patients in the P-1 had early breast cancers that developing the disease (Fisher et al., 1998). An early were not detected on mammography or physical exam.
clinical trial of raloxifene to evaluate its efficacy in This means that some of the patients who developed preventing osteoporosis, the Multiple Outcomes of breast cancer may not represent those at increased risk Raloxifene Evaluation (MORE), suggested that and did not have the disease. For the patients on raloxifene may also decrease the incidence of breast tamoxifen, the drug would actually treat the cancer, cancer (Cummings et al., 1999). The STAR trial potentially delaying its manifestation. However, for compares the effectiveness of these two drugs at the patients on placebo, these cancers would continue decreasing the incidence of breast cancer as well as to grow until detectable. This may account for the compares their associated side effects.
increased incidence of breast cancer in the placebogroup as opposed to the tamoxifen group. The placebo As expected from the NSABP, the STAR trial is well data may have merely represented patients with early designed. It is a large, prospective, double-blinded, undetectable cancer that did not receive treatment. This randomized trial involving approximately 23,000 may also be true for the STAR trial; tamoxifen is an women that will provide important information agent that is proven to treat cancer, while raloxifene concerning raloxifene. Although the study design is has never been tested or proven as such. However, well planned, there are some areas of concern. The intuitively it would seem likely that raloxifene will be STAR trial will not provide data on breast cancer associated mortality of the patients in the study(Osborne, 1999). Initially, the P-1 trial had patients in Additionally, it has consistently been a challenge to a placebo control group; but these patients were incorporate minority populations into research trials allowed to cross to tamoxifen when the results were within the United States, as seen in the P-1 trial. The published (Fisher et al., 1998). Because of the cross efforts put forth to incorporate minorities into the over there will be no control group to compare breast NSABP treatment and prevention trials are to be cancer mortality data. It will be difficult to establish a applauded. The directors of the STAR trial have gone difference in mortality of patients taking tamoxifen, out into the community and attempted to bring the prevention trial to the minority populations. The developing it. The use of raloxifene to treat patients challenge is not only reaching the different populations, with breast cancer or a history of breast cancer is but also assisting them in understanding the benefit- unproven. The information gained from this trial should risk ratio in relation to them. In the past the comparable not be interpreted and used to treat patients with breast side effects of tamoxifen in other settings made it cancer. Furthermore, the use of raloxifene as a reasonable to apply the same criteria for tamoxifen use preventive agent for breast cancer is unproven. Patients in all ethnic groups. Whether or not this will hold true should not receive raloxifene as a preventive agent for with raloxifene is unknown. The experience with breast cancer unless they are on a clinical trial raloxifene is still rather limited in comparison References
Summary. The STAR trial will help to answer an
Fisher B., J.P. Constatino, D.L. Wickerham, et al.
important question related to breast cancer prevention.
“Tamoxifen for prevention of breast cancer: Report of the However, this trial is not without limitations. There is National Surgical Adjuvant Breast and Bowel Project P-1 little information related to breast cancer mortality in study.” J Nat Can Inst, 90 (18) (1998): 1371-1388.
this group of high-risk women. The use of a preventiveagent may decrease the amount of breast cancer, Cummings S.R., S. Eckert, K.A. Kruefer, et al: “The effect of raloxifene on risk of breast cancer in however the number of patients that die from breast postmenopausal women: Results from the MORE cancer may not be significantly different. Because the randomized trial. ” JAMA, (1999) 281: 2189-2197.
biology of breast cancer is still not completelyunderstood, it is unknown if this prevention trial is Osborne M.P. “Chemoprevention of breast cancer.” actually treating occult breast cancers not yet Surg Clin North Am, 79(5) (1999): 1207-1221.
detectable. Again, the hurdle with incorporating Osborne M.P. “Breast cancer prevention by minorities in prevention clinical trials remains.
antiestrogens.” Ann NY Acad Sci, (1999) 889: 146-51.
Minorities are consistently underrepresented in clinical Cheblowski R.T., D.E. Collyar, M.R. Somerfield, et al.
trials and incorporating them poses a challenge for the “American Society of Clinical Oncology technology directors of the STAR trial. In addition, this trial assessment on breast cancer risk reduction strategies: specifically targets postmenopausal women who do not Tamoxifen and raloxifene.” J Clin Oncol , 17(6) have breast cancer, but are at increased risk for Research Commentary
Decision Analysis of Tamoxifen for the Prevention of
Invasive Breast Cancer
Grann VR, Sundararajan V, Jacobson JS, Whang W, Heitjan DF, Antman KH, Neugut AI. (Herbert Irving ComprehensiveCancer Center, Department of Medicine, College of Physicians and Surgeons, Columbia University, New York) Cancer Journalof Scientific American 6(3):169-78, 2000. Seema A. Khan MD, Associate Professor of Surgery, Northwestern Memorial Hospital Women who are at increased risk for developing breast analysis model to aid physicians who are counseling cancer and have completed child bearing now have women at increased risk of breast cancer regarding the option of taking tamoxifen for five years in order to decrease their breast cancer risk. However, for manywomen this is a difficult decision to make, since The researchers have used a mathematical model to tamoxifen does have some adverse effects, and the risk/ predict overall benefit in terms of quality adjusted benefit analysis is not straightforward. In an attempt survival for three different age groups of women: 35- to clarify some of these issues, researchers from 49, 50-59, and over 60 years. They have made Columbia University have developed a decision allowances for the side effects of tamoxifen, and the cost of tamoxifen therapy, as well as the cost of cancer, stroke, and clots in the deep veins of the legs treatment of any complications. Quality of life estimates which can travel to the lungs) become more common for these calculations were derived from a recent study with age, older women who take tamoxifen have a where women were asked how much added life-time higher chance of suffering serious side effects from they were willing to trade for time spent in three states: tamoxifen, but have a smaller benefit as we have seen taking chemopreventive medication, diagnosis of and above. Thus when the higher risks of therapy are treatment for invasive breast cancer, and time living balanced against the smaller benefits in older women, the overall gain is small. For young women on the otherhand, the benefits are larger, the risks are smaller The model predicted that the greatest preventive benefit (women in the tamoxifen arm of the BCPT did not suffer of tamoxifen would be seen in women who start the adverse events associated with tamoxifen use at treatment early in life (the 35-49 year age group). The significantly higher frequency than women in the actual time gained in this age group was surprisingly placebo arm of the trial) and the overall balance is in small (69 days), but this number needs to be interpreted favor of using tamoxifen for breast cancer prevention.
with the understanding that in models such as these,the benefit of a particular treatment is actually being The authors then looked at the cost of using tamoxifen averaged across a large number of people who are being for breast cancer prevention, and the costs of treating subjected to the treatment. When we consider serious side effects, and estimated the cost per life year individuals, the benefit will be large for a small minority saved by tamoxifen use. Again, because the benefit is (those who would have developed breast cancer, but larger in younger women, and the likelihood of side did not because of preventive therapy), and zero for the effects is smaller, the cost per life year saved was smaller rest (women who would never have developed breast cancer, with or without tamoxifen, and those who The results of the model were varied using different develop breast cancer despite tamoxifen).
estimates of the duration of the beneficial effect of In fact, most women will not benefit from preventive tamoxifen in terms of breast cancer protection. The tamoxifen, because most women would not have available data from several different analyses suggest developed breast cancer in their lifetimes even without that this protective benefit outlasts the actual duration tamoxifen. For example, the threshold for of tamoxifen use by at least 5 to 10 years, and perhaps recommending preventive treatment with tamoxifen is longer. The authors redid the calculations assuming a a breast cancer risk of about 2% over five years. An 80- 5, 10, and 15 year duration of tamoxifen benefit after year-old woman belonging to this risk group, might have stopping therapy. They found, naturally, that increment a lifetime chance of developing breast cancer of about in longevity was greater, and the cost per year of life 5%, and 95 out of 100 women in this age group, with saved smaller, in all age groups as one assumes this risk level, will die of other causes. On the other increasing duration of benefit. Again, the actual numbers hand, a 40-year-old tamoxifen eligible woman with a they derived are used only for purposes of illustration five-year breast cancer risk of 2%, will have a lifetime and do not have any real meaning if they are applied to risk of 25%. It is easy to see from these figures that a individuals. Assuming a 15 year duration of benefit after woman who is at high enough risk to be eligible for stopping tamoxifen, the quality adjusted survival (i.e.
tamoxifen at a young age actually has a much higher accounting both for the increased lifespan of women lifetime risk for breast cancer than an older woman, benefiting from tamoxifen and the effect of adverse side even though their short term risk might be similar. In effects on this gain) is illustrated as follows: risk benefit calculations, the benefit of the treatment is Assuming a 15 year duration of benefit after usually found to be proportional to the risk of disease, stopping tamoxifen, the quality adjusted survival and the model used in this study again validates this (i.e. accounting both for the increased lifespan general principle, showing us that women at higher of women benefiting from tamoxifen and the effect lifetime risk derive greater benefit.
of adverse side effects on this gain) is 105 days The second part of the calculation of the risks and for a woman starting tamoxifen at age 35, 66 benefits of tamoxifen has to do with the adverse effects days if starting at age 50, and 45 days if starting that might be experienced by women taking tamoxifen.
at age 60. The mean cost per quality adjusted Since the serious side effects of tamoxifen (uterine life year saved is about $19,000, 41,000 and 67,000 respectively for each of these groups. is that women over the age of 60 or 65 have in general These costs are comparable to other life- a lower expectation of benefit, at higher cost, from the extending interventions, such as mammography, use of tamoxifen for the prevention of breast cancer. In but the cost benefit ratio is substantially less this age group it may still be advisable for women to take tamoxifen if they are at substantially increased riskof developing breast cancer, but the present threshold The advice that women who are considering tamoxifen of a five year risk of 2% may not be sufficient to warrant can take away from this cost benefit analysis — which the quality of life and financial cost of tamoxifen.
echoes the conclusions drawn from other analyses — Activist Perspective
The Dark Side of the STAR Trial
The promise is dazzling: not one but two pills to prevent Richard Klausner, Director of NCI, ended the trial and breast cancer. Which one does a better job? That’s the declared that answer “an unequivocal yes,” heralding spin from the National Cancer Institute (NCI) about results that showed there were “45% fewer cases of their multi-million dollar STAR trial (Study of invasive breast cancer in women who took tamoxifen Tamoxifen and Raloxifene) for breast cancer prevention. The goal: enroll 22,000 healthy “high risk” The tamoxifen trial was halted prematurely, 14 months women, half of whom will take tamoxifen for five years, before its scheduled conclusion, to allow women in the the other half will take raloxifene for the same time placebo group the option of taking tamoxifen. Because the BCPT failed to recruit enough women (the study During the first 18 months since the study was design called for 16,000, but only 13,388 were announced, only 6,139 women have signed up. So the recruited) and was stopped too soon, it did not show a NCI is revving up recruitment, particularly among difference in mortality, that is, whether taking tamoxifen African American women and other women of color, actually saved lives. Nor did the brief trial determine using scare tactics that distort the risk/benefit ratio of long-term risks versus benefits, or the optimal length taking either of these drugs. The reality is that every of time a “high risk” well woman should remain on woman in the trial is being exposed to drugs with potentially life-threatening side effects.
Scientists from Britain and Milan criticized the NCI Therein lies the dark side of the STAR trial, the failure findings and decision to halt the BCPT early, citing to ask the question: which drug does a better job than a their own large, longer-term studies that failed to show placebo (i.e. a dummy pill which is like taking no drug that tamoxifen prevented breast cancer in healthy at all)? The absence of a placebo group in the STAR women. The U.S. Food and Drug Administration also trial is not just a design flaw; it is a lapse in ethics and disagreed with NCI and refused to allow Zeneca (now a callous disregard for women’s health. It is also an AstraZeneca), the manufacturer of tamoxifen, to use unconscionable misuse of public funds.
the term prevention in advertising the drug.
Nevertheless, many media reports still refer to The Breast Cancer Fund has been concerned about STAR since its inception, just months after thepremature termination of the Breast Cancer Prevention The Breast Cancer Fund, The National Breast Cancer Trial (BCPT), also known as the tamoxifen trial.
Coalition and other leading breast cancer and women’s Women in the BCPT took either tamoxifen or a placebo health organizations are strongly opposed to the STAR to see if tamoxifen could prevent breast cancer in trial not only because of its lack of ethics in failing to healthy women at increased risk for the disease. Dr.
have a placebo arm, but also because its predecessor trial (BCPT) left too many unresolved issues. Most The most serious risks of tamoxifen, outlined above, importantly, during the BCPT approximately 96% of are most common in women over 50, the women at the women taking a placebo did not get breast cancer greatest risk for breast cancer and therefore most likely and 98% of the women taking tamoxifen did not get to take the drug as a preventive measure. Raloxifene, breast cancer. This means there was only a 2% absolute manufactured by Eli Lilly and marketed as Evista, is reduction in risk, which leads to the second major issue another story. Evista is a synthetic hormone with both with STAR: whether tamoxifen’s small reduction in estrogenic and anti-estrogenic effects, advertised as “a the absolute risk of breast cancer outweighs the risks it new way to prevent osteoporosis” (while admitting that poses to healthy women. The most serious of these “its effect on fractures is not yet known”) and reduce risks include uterine cancer, blood clots in the legs and the levels of LDL (the “bad” cholesterol).
The reported risks of Evista are similar to tamoxifen’s The third unresolved issue of STAR is the definition risk but, according to a professor of environmental of “high risk.” Women at greatest risk for breast cancer medicine at the University of Illinois School of Public are those believed to have inherited defects in either of Health, one unreported risk – ovarian cancer – could the two breast cancer susceptibility genes. However, prove even more deadly. Writing in the Chicago experts agree that less than 10% of all women Tribune (April 19, 1998), Dr. Samuel Epstein says: diagnosed with breast cancer carry these defects, and “Lilly’s pre-market clearance study clearly shows that very few women have ever been tested for these genes.
Evista induces ovarian cancer in both mice and rats.at The reality is that the vast majority of women with dosages well below the recommended therapeutic breast cancer have no family history of the disease.
level.” While effects in rodents are not proof of human Yet, NCI now offers a computer “risk disk” to women risk, there is strong scientific consensus that interested in taking tamoxifen even though there are carcinogenic effects in two rodent species constitutes fundamental questions about the criteria, including family history, used for determining an individual’s risk.
Eli Lilly also claims that Evista poses no risks of breast Using NCI’s criteria would classify 29 million and uterine cancers. However, the pre-market trials of American women at increased risk of getting breast Evista lasted less than four years, too short a time to cancer, creating a $6 billion market for AstraZeneca.
measure such risks. Epstein called Lilly’s suppression The fourth serious issue with STAR is its zealous of its own evidence about ovarian cancer risk “reckless recruitment of ethnic women despite the fact that only and threatening to women’s health and life.” He also 3% of the BCPT participants were African American.
termed the FDA’s marketing approval of the drug Again, undaunted by the inadequate information without the ovarian cancer warning “equally reckless.” provided by its first tamoxifen trial, the STAR trial is targeting African American, Native American and other The STAR trial could have been used to address many under-represented women, suggesting that it provides of the unanswered questions from the BCPT tamoxifen a long-awaited opportunity for women of color to take study. It could have tested each drug against a placebo part in clinical trials. Is this truly an effort about women to properly evaluate the risk/benefit ratio compared to and breast cancer prevention, or is it about amassing nothing or to a vegetarian diet or to a diet containing numbers to satisfy research statistics and to market soy products or to other factors. But instead of drugs? Once again, NCI is underestimating just how advancing research in the direction of breast cancer savvy many women have become about issues related prevention, STAR is exposing healthy women to toxic to their health, perhaps as evidenced by the slow accrual drugs in a way that will ultimately provide no new Despite these major unresolved issues about tamoxifen, This trial, which gives a whole new meaning to “star NCI has hitched their wagon to STAR, hyping it as quality,” reminds us of one breast cancer activist’s “the largest breast cancer prevention study in North summary of the tamoxifen trial: “Bad drug. Bad America.” It might also be called the largest wholesale exploitation of healthy women since DES and theDalkon Shield. Without a placebo group, STAR willexpose 22,000 women to one of two drugs withpotentially life-threatening side effects.
Ad Hoc Discussion Group
The BCERF Ad Hoc Discussion Group meeting on Breast Cancer Network, of which IBCA is an active September 28 was held in the Faculty Commons in participant. Andi remarked that this network is “going Martha Van Rennselaer Hall on the Cornell campus in to be a powerful voice in the coming years,” and Ithaca. The meeting drew over 30 people for updates outlined the major legislative issues that they are and discussion on breast cancer-related services and prioritizing. These issues include: good cancer activism in the Tompkins County area, and related mapping; improvements on the Pesticide Sales and Use research on the Cornell campus. It was the first Ad Hoc Registry; placing more survivors on the Health Science Discussion group meeting facilitated by BCERF’s new Research Board, and; developing a state funding stream for services. Bob Riter, new to his position at IBCAand formerly a faculty member at Ithaca College, Rod provided the group with the Director’s update on introduced himself, sharing his personal background BCERF activity. He highlighted the following activities of being a male breast cancer survivor. Welcome, Bob! Comparative Cancer Program at Cornell
• Three Critical Evaluations were available for public University
comment: Alachlor, Phosmet, and Mancozeb.
Dr. Rodney Page, Director of the Comparative Cancer • The five BCERF Education Tool Kit modules have Program at Cornell, described the mission and priorities entered the field testing phase; 28 sites around the of this new undertaking at Cornell. He described to the group how the “10,000 years of shared intimacy” • Shape magazine had an article highlighting BCERF’s between people and their companion animals need tobe drawn upon in answering cancer research questions.
‘4 E’s’ for breast cancer risk reduction concept(Eating, Exposure, Exercise, and Exams).
For example, many important known facts aboutenvironment and cancer in animals may enable the Rod told the group that he is active in spearheading a enhancement of cancer surveillance. The group was faculty appointment in environment and cancer: a high eager to discuss possibilities for improvement in both priority of his will be to have researchers “on the human and animal cancer surveillance, and the increase ground” to pursue timely research opportunities. He in knowledge about risk factors that may result. He also mentioned that he has submitted a request for pointed to the fact that breast cancer develops even supplemental funding, for BCERF to pursue focused more frequently in dogs than in women, and tends to projects in new areas of logical expansion: non- behave in a similar way. This paves the way for a wealth pesticide chemicals and breast cancer risk, and of transferable knowledge. Dr. Page included BCERF childhood cancers. Rod welcomes input into the five- as a major strength in its planned collaborative outreach year plan that is currently being prepared.
component. For more information see The Ribbon,Volume 5, Number 2, Spring 2000 or contact Dr. Page The Ithaca Breast Cancer Alliance
Andi Gladstone and Bob Riter, Director and Associate Phytochemicals
Director of the Ithaca Breast Cancer Alliance,overviewed the history and current direction of their Dr. Ruihai Liu, of the Department of Food Science, support, education and advocacy group. Andi gave an described his research analyzing the antioxidant eloquent “thank you” to BCERF for its role in activity of fruits and vegetables when looked at contributing to IBCA’s educational program. She synergistically, and when the whole fruit (with peel) is provided some historical information on the group, included, in his in vitro experiments. His hypothesis is including early efforts to move toward a statewide that the benefits of a diet rich in fruits and vegetables network of breast cancer organizations. This eventuallycame about through the Albany-based New York State FACT SHEETS
Single copies available at no cost. For multiple copies please contact BCERF General Information on Breast Cancer
Pesticides and Breast Cancer Risks
__FS # 3–-Understanding Breast Cancer Rates __FS # 5–-The Biology of Breast Cancer __FS # 9–-Estrogen - Relationship Diet and Lifestyle
Pesticide-Related Issues
__FS #1–-Phytoestrogens__FS # 8–-Childhood Life Events __FS # 4–-Reducing Pesticide Exposure: Resource Sheet __FS #7A–-Drinking Water--Part I: Contaminant Sources __FS #7B–-Drinking Water--Part II: Treatment Options __FS #21–-Avoiding Exposure: Protective Clothing __FS #25–-Pesticide Residue Monitoring and Food Safety __FS #30–-Health Effects of Pesticides; Response to __FS #39–-Meat, Poultry & Fish __FS #31–-IPM Around the Home and Garden__FS #35–-IPM: Talking to Your Customers CRITICAL EVALUATIONS OF PESTICIDES
AND BREAST CANCER
Critical Evaluations are available on the BCERF web pageas portable document files (pdf), and can be accessed onthe BCERF web site (see address below).
If you would like to order a hard copy please indicate below
and send your check payable to Cornell University for $3.00
each, to cover the cost of reproduction and mailing.
NAME________________________________________________ Address_______________________________________________ ______________________________________________________ Telephone _____________________________________________ Cornell University
Fax __________________________________________________ Program on Breast Cancer
and Environmental Risk Factors in New York State
Email ________________________________________________ 112Rice HallIthaca, NY 14853-5601Phone: (607) 254-2893; FAX: (607) 255-8207 are attributable to the complex mixtures of how does this influence susceptibility to exposures? phytochemicals in those foods. Dr. Liu emphasized that We thank Sandra for engaging the group with this his research results point to the importance of whole foods, and that pharmacological doses of vitamins maydo more harm than good in risk reduction. He notedthat, in his research, different fruits had differentinhibitory impacts on the proliferation of, for example, MARK YOUR CALENDARS!
colon cancer versus liver cancer cells. Dr. Liu said that these results also point to the need for a diet that includes Natural History of the Breast
Ad Hoc Discussion Group meetings are open to any Sandra Steingraber, Visiting Assistant Professor with and all stakeholders to come together to discuss issues BCERF, shared some of her explorative research on related to breast cancer and environmental risk factors. mammary gland biology, sharing much interestinginformation on “the natural history of the breast.” Herresearch contributes to her work-in-progress on theecology of pregnancy and childbirth. In this work,questions arise such as, if in the seventh week of The Ribbon is published by the Cornell Program on BreastCancer and Environmental Risk Factors in New York State.
pregnancy mammary gland development begins, then what is the potential impact of prenatal chemicalexposures on the developing breast? Her work stimulates other questions such as, if the breasts Carmi Orenstein, M.P.H., Assistant Director continue to develop, as “a house with additions worked Associate Editor and Designer
on one week per month” until approximately age 35, Carin Rundle, Administrative/Outreach Coordinator Cornell University
Program on Breast Cancer and Environmental
Risk Factors in New York State
112 Rice Hall, Cornell University
Ithaca, NY 14853-5601

Source: http://envirocancer.cornell.edu/newsletter/pdf/v5i4.pdf