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<strong>BREAST</strong><br />
<strong>CANCER</strong><br />
<strong>ACTION</strong><br />
Newsletter #80<br />
February/March 2004<br />
®<br />
www.bcaction.org<br />
I N S I D E<br />
Executive Direc<strong>to</strong>r’s Column:<br />
Of Endpoints and Women’s Lives 2<br />
FDA Rejects Bid <strong>to</strong> Market<br />
Silicone Gel <strong>Breast</strong> Implants 2<br />
In Memory:<br />
Faith Fancher and Karen Holly 7<br />
Impressions From the 26th San An<strong>to</strong>nio<br />
<strong>Breast</strong> <strong>Cancer</strong> Symposium<br />
By Musa Mayer<br />
If you asked the advocates who were there<br />
what they thought of the 26th San An<strong>to</strong>nio<br />
<strong>Breast</strong> <strong>Cancer</strong> Symposium, you’d have<br />
gotten a decidedly mixed response. Some felt<br />
excited by and hopeful about what they were<br />
hearing, while for others there was little of<br />
genuine interest, and a growing disappointment<br />
that the promises of genomic research<br />
have produced so little that is useful so far.<br />
For some, the pace of emerging research was<br />
breathtaking; for others, it was vanishingly<br />
incremental and increasingly dis<strong>to</strong>rted by<br />
industry influences.<br />
Yet we all watched the same 44 featured<br />
presentations on nine huge screens arrayed<br />
throughout the cavernous ballroom of the<br />
Gonzalez Convention Center. Over the four<br />
days of the conference, 120 of us advocates<br />
maneuvered among 6,000 researchers,<br />
scientists, clinicians and industry people from<br />
80 countries. We all balanced plates of food<br />
as we peered at the poster displays detailing<br />
over 500 studies that had not been selected<br />
for feature presentation. While we tried <strong>to</strong><br />
make sense of it all, the sheer size and<br />
diversity of research presented guaranteed<br />
that the sense we made would reflect our own<br />
expectations and interests as much as it did<br />
the research itself.<br />
Extended coverage<br />
on our website!<br />
Visit www.bcaction.org <strong>to</strong> read Musa Mayer’s<br />
additional coverage of the San An<strong>to</strong>nio conference.<br />
(Or send BCA a self-addressed stamped envelope<br />
and we’ll mail you prin<strong>to</strong>uts of her two articles.)<br />
Pho<strong>to</strong>: Our booth at the San An<strong>to</strong>nio <strong>Breast</strong> <strong>Cancer</strong> Symposium.<br />
In the following report on the meeting,<br />
the names and numbers in brackets refer <strong>to</strong><br />
abstracts available at www.sabcs.org (click on<br />
“Abstracts Online 2003,” log in as a guest,<br />
and search by author).<br />
Let’s get real: Genomic models for<br />
prognosis, prediction, and treatment<br />
Since the sequencing of the human genome,<br />
great excitement—and even greater hype—<br />
have accompanied the genomic revolution in<br />
cancer diagnosis and treatment. What became<br />
clear <strong>to</strong> me in San An<strong>to</strong>nio this year was just<br />
how premature any results and conclusions<br />
are, at this point in time.<br />
After the successful development and<br />
approval of Herceptin® over five years ago,<br />
it seemed as if we had entered a brave new<br />
world of precisely targeted, less <strong>to</strong>xic, more<br />
effective combined therapies. However,<br />
developing a cocktail of targeted new drugs <strong>to</strong><br />
switch off the offending proteins that are<br />
involved in cancer has so far proven an overly<br />
simplistic model. A major stumbling block is<br />
that while we know that different tumors<br />
have different genetic signatures, we don’t yet<br />
know how <strong>to</strong> identify these tumors in any<br />
individual woman, or <strong>to</strong> determine what a<br />
particular profile may mean in terms of<br />
prognosis or treatment. With the exception of<br />
HER2 and ER/PgR testing, scientists haven’t<br />
managed <strong>to</strong> identify which cancers are most<br />
likely <strong>to</strong> respond <strong>to</strong> targeted therapies. Giving<br />
so-called targeted therapies <strong>to</strong> all patients in<br />
hopes of benefiting a small fraction raises<br />
serious questions about <strong>to</strong>xicity, resources,<br />
research priorities, and ethics.<br />
Faced with initial failures of their new,<br />
targeted therapies, some companies are now<br />
struggling <strong>to</strong> identify subgroups of patients<br />
for which their drugs may prove effective.<br />
One example is Biomira, manufacturer of the<br />
vaccine Thera<strong>to</strong>pe ® , which announced the<br />
continued on page 10<br />
CALENDAR<br />
BCA Event<br />
Saturday, April 24, noon–5 p.m.:<br />
“Taking Care in a Toxic Time.”<br />
Anne Lamott will emcee our seventh<br />
annual Town Meeting for Activists at<br />
the Oakland Asian Cultural Center,<br />
388 Ninth Street, Suite 290. Keynote<br />
speaker Sandra Hernandez, M.D.,<br />
will discuss how we can protect our<br />
health by implementing the precautionary<br />
principle. There will be workshops<br />
on mammography, breast<br />
cancer politics, the Rachel Carson<br />
<strong>Cancer</strong> Research Project, and BCA's<br />
Think Before You Pink campaign.<br />
For more information, visit www<br />
.bcaction.org.<br />
Other Events<br />
March 24–28 in Washing<strong>to</strong>n, D.C.:<br />
“From Awareness <strong>to</strong> Action: The<br />
Unequal Burden of <strong>Cancer</strong>.” The<br />
ninth biennial Symposium on Minorities,<br />
the Medically Underserved, and<br />
<strong>Cancer</strong> is presented by the Intercultural<br />
<strong>Cancer</strong> Council and Baylor<br />
College of Medicine. $150–$450.<br />
Read the program and register at<br />
http://iccnetwork.org/symposium.<br />
April 2–4, 2004, at the University<br />
of California, Berkeley: “Unite for<br />
Change: New Approaches <strong>to</strong><br />
Pesticides and Environmental<br />
Health.” This 22nd National Pesticide<br />
Forum is sponsored by Beyond<br />
Pesticides, Californians for Pesticide<br />
Reform, and Pesticide Action<br />
Network North America. Visit www<br />
.beyondpesticides.org for more information,<br />
including registration fees.
2<br />
February/March 2004<br />
<strong>Breast</strong> <strong>Cancer</strong> Action<br />
From the Executive Direc<strong>to</strong>r<br />
Of Endpoints and Women’s Lives:<br />
Reflections on San An<strong>to</strong>nio and Beyond<br />
By Barbara A. Brenner<br />
When I attend cancer meetings like<br />
the December 2003 San An<strong>to</strong>nio<br />
<strong>Breast</strong> <strong>Cancer</strong> Symposium<br />
(SABCS), I try <strong>to</strong> watch the news coverage <strong>to</strong><br />
see how the information is being presented <strong>to</strong><br />
the public. Often, when I compare the press<br />
coverage <strong>to</strong> my own perceptions of the<br />
meetings, I find myself wondering if I’m at the<br />
same conference that is being reported. This<br />
time, my wondering turned in<strong>to</strong> incredulity<br />
because, more than I remember from previous<br />
SABCS gatherings, the 2003 oral presentations<br />
conveyed very early data, and rarely<br />
focused on the impact of the treatments or<br />
prognostic <strong>to</strong>ols on women’s lives. Yet the<br />
press reports of those very same presentations<br />
suggested that lifesaving breakthroughs would<br />
be in clinics the next day.<br />
There are a number of consequences of<br />
presenting early data—and <strong>to</strong>uting it <strong>to</strong> the<br />
press. One is that, way <strong>to</strong>o often, the early<br />
indications don’t pan<br />
out, either because the<br />
drug under study is not<br />
as effective as it looks<br />
early on in small, tightly<br />
controlled studies, or<br />
because the other effects<br />
(usually called “side effects”) of the drug<br />
overwhelm the benefits. If clinical practice<br />
changes because of early indications, lots of<br />
people can get hurt if those indications turn<br />
out <strong>to</strong> be wrong. When the early data are<br />
presented orally, it’s not even possible <strong>to</strong> take<br />
a close look at the information being presented.<br />
The oral presentations often don’t<br />
show up in peer-reviewed journals until<br />
months later, if at all. And, of course, as the<br />
press reports the “breakthroughs,” patients<br />
start asking their doc<strong>to</strong>rs and favorite breast<br />
cancer organizations about them, even though<br />
they’re probably not ready for prime time.<br />
A typical scene<br />
at BCA’s booth<br />
at the San<br />
An<strong>to</strong>nio<br />
conference.<br />
Staff and<br />
volunteers<br />
stayed busy<br />
handing out<br />
materials and<br />
answering<br />
questions.<br />
As the push for faster progress—driven<br />
in part by patient needs and in another part<br />
(at least as great) by the potential for private<br />
profit—starts <strong>to</strong> reach a fever pitch, researchers<br />
have begun <strong>to</strong> use “surrogate<br />
endpoints” <strong>to</strong> evaluate the effectiveness of the<br />
treatments they are testing. The thinking<br />
behind using surrogate endpoints is very<br />
logical. When you’re trying <strong>to</strong> see if a drug<br />
delays recurrence or reduces the risk of death,<br />
you generally need <strong>to</strong> study a lot of patients<br />
over a long period of time <strong>to</strong> find out of if the<br />
drug really does what you hope it does. If you<br />
continued on page 11<br />
FDA Denies Application <strong>to</strong> Market Silicone Implants<br />
Our Newest<br />
<strong>Breast</strong><br />
Friend:<br />
Thomas V.<br />
Whalen, M.D.<br />
Tom Whalen<br />
chaired the<br />
Oc<strong>to</strong>ber 14–15<br />
FDA panel hearings<br />
that culminated in a 9-6 vote <strong>to</strong><br />
recommend reintroduction of silicone<br />
breast implants in<strong>to</strong> the general medical<br />
marketplace. On Oc<strong>to</strong>ber 31, Whalen<br />
sent a letter <strong>to</strong> FDA Commissioner Mark<br />
McClellan, decrying the vote and suggesting<br />
it was misguided.<br />
We’ll never know what happened<br />
behind the scenes, but the important thing<br />
is that on January 8, the FDA announced<br />
its rejection of the advisory committee’s<br />
recommendation.<br />
We at BCA commend Thomas V.<br />
Whalen for his vision and courage. He is<br />
a role model <strong>to</strong> other physicians and<br />
policymakers who are in a position <strong>to</strong><br />
speak up for women’s health. ◆<br />
Surprise: Good News From Washing<strong>to</strong>n!<br />
In a surprising but exciting step, the Food and Drug Administration (FDA) announced on<br />
January 8 that it had denied an application from Inamed, a Santa Barbara medical device<br />
manufacturer, <strong>to</strong> market silicone gel–filled breast implants. It is very unusual for the FDA <strong>to</strong><br />
move against the advice of its expert panels. The General and Plastic Surgical Devices<br />
Advisory Panel had voted 9-6 <strong>to</strong> recommend approval of Inamed’s application in Oc<strong>to</strong>ber.<br />
BCA’s position has been that there is not adequate evidence of long-term safety of the<br />
devices <strong>to</strong> warrant women’s elective use of the implants outside clinical trials. The FDA<br />
agreed. Inamed’s own research found that about 46 percent of the women who received<br />
the implants for reconstruction after mastec<strong>to</strong>my required re-surgeries within the two <strong>to</strong><br />
three years in which they were followed.<br />
The FDA released a 46-page draft guidance document clarifying the conditions by<br />
which breast implant manufacturers must find and present data supporting the safety of<br />
their products. BCA will submit comments on behalf of women with breast cancer during<br />
the 90-day comment period that will lead <strong>to</strong> issuance of final guidance by the FDA.<br />
BCA was part of a coalition of women’s health organizations that gave testimony urging<br />
caution about the devices at the Oc<strong>to</strong>ber 2003 hearings <strong>to</strong> consider the Inamed application.<br />
We are very pleased that the FDA has placed safety concerns and scientific evidence<br />
ahead of the commercial interests that lobbied so intensely in favor of the implants. ◆<br />
As we go <strong>to</strong> press, the FDA’s draft guidance document regarding implants is available on<br />
its website at www.fda.gov/cdrh/ode/guidance/1239.html.<br />
V<br />
isit www.bcaction.org for additional coverage, including our own<br />
Jane Sprague Zones’ firsthand report from the hearings, and Thomas V.<br />
Whalen’s letter <strong>to</strong> the FDA (see left). If you send a self-addressed stamped envelope,<br />
we’ll mail you prin<strong>to</strong>uts of the web material.
<strong>Breast</strong> <strong>Cancer</strong> Action February/March 2004 3<br />
<strong>Breast</strong> <strong>Cancer</strong> Action<br />
Mission Statement<br />
<strong>Breast</strong> <strong>Cancer</strong> Action carries the voices of<br />
people affected by breast cancer <strong>to</strong> inspire<br />
and compel the changes necessary <strong>to</strong> end<br />
the breast cancer epidemic.<br />
Core Principles and Values<br />
1. We are a membership-based organization<br />
that values the involvement of grassroots<br />
activists throughout the country and<br />
around the world <strong>to</strong> further our mission.<br />
2. We honor each person’s commitment<br />
and energy <strong>to</strong> our mission.<br />
3. We are not afraid <strong>to</strong> examine all sides of<br />
all issues.<br />
4. We cannot be bought.<br />
5. We tell the truth about what we discover.<br />
6. We serve individuals while reaching the<br />
broader population.<br />
7. We address the significance of environmental<br />
links <strong>to</strong> human health.<br />
8. We encourage people <strong>to</strong> participate fully<br />
in decisions relating <strong>to</strong> breast cancer.<br />
9. We believe access <strong>to</strong> information is vital.<br />
10. We work for structural changes <strong>to</strong>ward<br />
social justice <strong>to</strong> accomplish our mission.<br />
<strong>Breast</strong> <strong>Cancer</strong> Action<br />
55 New Montgomery Street, #323<br />
San Francisco, CA 94105<br />
Phone: 415/243-9301<br />
Toll free: 877/2-STOP-BC [877/278-6722]<br />
Fax: 415/243-3996<br />
E-mail: info@bcaction.org<br />
Web site: www.bcaction.org<br />
Board Members<br />
Jo Ann Madigan, President<br />
Renetia Martin, Vice President<br />
Denise Wells, Treasurer<br />
Ellen Lew, Secretary<br />
Dorothy Geoghegan, Mickey Hall, Jennifer<br />
Haroon (fellow), Gail Kaufman, Natalie<br />
Compagni Portis, Belle Shayer (emeritus)<br />
Staff<br />
Barbara A. Brenner, Executive Direc<strong>to</strong>r<br />
Celeste Janssen,<br />
Volunteer and Events Coordina<strong>to</strong>r<br />
Kendra Klein, Community Organizer<br />
Shelley Merid, Office Coordina<strong>to</strong>r<br />
Alex Momtchiloff, Development Direc<strong>to</strong>r<br />
Lisa Wanzor, Associate Direc<strong>to</strong>r<br />
BCA Newsletter<br />
© BCA 2004, ISSN #1088-386X, published<br />
bimonthly by BCA. Articles on detection and<br />
treatment do not constitute endorsements<br />
but are intended solely <strong>to</strong> inform. Call for<br />
permission before reprinting. To subscribe,<br />
send name and address <strong>to</strong> BCA. Requested<br />
annual donation is $50, but no one is<br />
refused for lack of funds.<br />
Edi<strong>to</strong>r and Layout: Jessica Manly Bucciarelli,<br />
Bucciarelli Communications<br />
Edi<strong>to</strong>rial Board: Barbara Brenner, Elaine<br />
Elinson, Lauren John, Jane Sprague Zones<br />
“<strong>Breast</strong> <strong>Cancer</strong> Action” and the BCA logo<br />
are the registered trademarks of <strong>Breast</strong><br />
<strong>Cancer</strong> Action. All rights reserved. Not <strong>to</strong> be<br />
used without express written permission.<br />
1<br />
What You See and What You Get:<br />
Media Coverage of the San An<strong>to</strong>nio Symposium<br />
By Barbara A. Brenner<br />
The media coverage of news from the December 2003 San An<strong>to</strong>nio <strong>Breast</strong> <strong>Cancer</strong><br />
Symposium was often in striking contrast <strong>to</strong> the studies reported on at the meeting. Three<br />
examples highlight the difference between what the press reported and what the<br />
researchers found. The names and numbers in brackets in this article refer <strong>to</strong> abstracts available<br />
at the conference website: www.sabcs.org.<br />
Gene profiles and targeted treatment<br />
A study of a multigene assay for predicting<br />
recurrence in node-negative, ER-positive<br />
patients treated with tamoxifen was reported<br />
by the New York Times in a s<strong>to</strong>ry headlined<br />
“Test May Aid Chemotherapy Decisions” and<br />
a lead sentence that read: “A new genetic test<br />
can help predict whether breast cancer will<br />
recur, providing a way <strong>to</strong> help women decide<br />
whether they need chemotherapy.”<br />
Using an array involving 21 breast cancer<br />
prognostic genes, Dr. Soonmyung Paik,<br />
direc<strong>to</strong>r of pathology at the National Surgical<br />
Adjuvant <strong>Breast</strong> and Bowel Project (NSABP),<br />
and his colleagues at Genomic Health (a private<br />
for-profit company) developed a recurrence<br />
score that they say they validated<br />
prospectively (even though all of the patients<br />
had long since been treated). Dr. Paik showed<br />
that the recurrence score provided an accurate<br />
and precise continuous curve for predicting<br />
the likelihood of a distant (nonlocal)<br />
recurrence in node-negative, ER+ patients<br />
treated with tamoxifen [Paik 16]. (See page<br />
10 for Musa Mayer’s discussion of this study.)<br />
This public/private partnership has not<br />
applied the scoring system <strong>to</strong> the placebo<br />
group in the NSABP B-20 trial, so it is not possible<br />
<strong>to</strong> tell the real effect of the tamoxifen in<br />
the trial. And, as a questioner noted, for the<br />
group that the recurrence score from the gene<br />
assay indicates <strong>to</strong> be at low risk, the score misclassifies<br />
10 percent of patients, meaning that<br />
the score is not perfect and it doesn’t tell which<br />
patients will experience a recurrence. In<br />
answer <strong>to</strong> that comment, Dr. Paik acknowledged<br />
that we may never be able <strong>to</strong> tell an<br />
individual patient whether her cancer will<br />
recur. The promise of gene profiling as a key <strong>to</strong><br />
individualized treatment is further away than<br />
the New York Times would have us believe.<br />
And the New York Times made only passing<br />
reference <strong>to</strong> the next study that was<br />
presented, which tried unsuccessfully <strong>to</strong><br />
validate the recurrence score system looking<br />
at untreated patients. In the M.D. Anderson<br />
study [Esteva 17], there was no statistically<br />
significant correlation between distant recurrence-free<br />
survival and the recurrence scores.<br />
2<br />
Predicting the risk of recurrence may be<br />
possible, but we’re not there yet, the New York<br />
Times s<strong>to</strong>ry notwithstanding.<br />
Aromatase inhibi<strong>to</strong>rs for ER-positive,<br />
postmenopausal patients<br />
One study looked at giving anastrozole <strong>to</strong><br />
patients already on tamoxifen, and whether<br />
that was better than continuing on tamoxifen<br />
[Boccardo 3]. The New York Times reported<br />
this study in a s<strong>to</strong>ry that began: “In a study<br />
comparing two drugs designed <strong>to</strong> prevent a<br />
recurrence of breast cancer, women who<br />
switched from the standard drug tamoxifen <strong>to</strong><br />
a newer type of treatment fared better than<br />
those who continued <strong>to</strong> take tamoxifen.”<br />
You would have heard something different<br />
had you been in the presentation hall,<br />
though it was clear something provocative<br />
was about <strong>to</strong> be presented when the study<br />
was introduced as likely <strong>to</strong> stimulate a lot of<br />
calls <strong>to</strong> oncologists’ offices. The study looked<br />
at giving anastrozole <strong>to</strong> patients already on<br />
tamoxifen, and whether that was better than<br />
continuing on tamoxifen. Though the<br />
researcher, Dr. Francesco Boccardo of the<br />
National <strong>Cancer</strong> Research Institute in Italy,<br />
pointed out that the results were very preliminary<br />
(426 patients—approximately half in<br />
each arm of the trial—and median follow-up<br />
of only two years), the trends show longer<br />
progression-free survival on the anastrozole<br />
arm of the trial. Overall survival was also better<br />
so far on anastrozole, but not statistically<br />
significantly so. There were more gastrointestinal<br />
complaints on anastrozole, and<br />
higher cholesterol levels; and more gynecological<br />
changes on tamoxifen.<br />
Despite the lack of statistically significant<br />
findings, the researcher concluded that, while<br />
it’s very early and we need <strong>to</strong> be extremely<br />
cautious, it appears <strong>to</strong> be better <strong>to</strong> switch<br />
early breast cancer patients <strong>to</strong> anastrozole<br />
after two <strong>to</strong> three years on tamoxifen. He then<br />
said that only a much larger trial would<br />
enable us <strong>to</strong> make definitive conclusions<br />
about the premise of this study.<br />
The New York Times did point out the<br />
inability of doc<strong>to</strong>rs <strong>to</strong> give their patients<br />
continued on page 4
4<br />
February/March 2004<br />
<strong>Breast</strong> <strong>Cancer</strong> Action<br />
3<br />
Media Coverage of San An<strong>to</strong>nio<br />
continued from page 3<br />
sound advice based on a study this small and<br />
this young, but you would have <strong>to</strong> read the<br />
whole s<strong>to</strong>ry <strong>to</strong> get that point.<br />
Abraxane: Better taxane delivery?<br />
Abraxane is a new way of delivering a breast<br />
cancer standard—paclitaxel (Taxol ® )<br />
[O’Shaughnessy 44]. The New York Times<br />
business section accurately reported this<br />
study with a s<strong>to</strong>ry headlined “New Drug Said<br />
<strong>to</strong> Improve Delivery of <strong>Cancer</strong> Medication.”<br />
Getting the word out: BCA’s booth at the San An<strong>to</strong>nio<br />
<strong>Breast</strong> <strong>Cancer</strong> Symposium<br />
Abraxane consists of microscopic<br />
particles of paclitaxel bound <strong>to</strong> albumin, a<br />
blood protein. The albumin appears <strong>to</strong> help<br />
the drug reach the tumors. The use of<br />
albumin means that Abraxane does not<br />
require Cremophor ® , a <strong>to</strong>xic solvent now<br />
used <strong>to</strong> deliver paclitaxel. Cremophor causes<br />
some of the side effects associated with<br />
paclitaxel, such as severe allergic reactions.<br />
To avoid those reactions, doc<strong>to</strong>rs give<br />
patients steroids before giving them<br />
paclitaxel, but steroids can also have side<br />
effects. Cremophor also requires special<br />
intravenous tubes for delivery because it can<br />
leach the plastic from normal tubes. Patients<br />
receiving Abraxane in the trial received<br />
higher dosages of paclitaxel and in a considerably<br />
shorter time span.<br />
At this early phase of this Phase III clinical<br />
trial, involving 460 women with metastasized<br />
breast cancer, tumors shrank in 33<br />
percent of those who received Abraxane,<br />
compared with 19 percent of those who received<br />
paclitaxel. It is <strong>to</strong>o early <strong>to</strong> tell whether<br />
the drug will prolong women’s lives. In<br />
addition, Abraxane caused more neuropathy<br />
than paclitaxel did, though reducing the<br />
Abraxane dosages might reduce this impact.<br />
The drug has not yet been approved by<br />
the FDA, though the s<strong>to</strong>ck of American<br />
Pharmaceutical Partners, the manufacturer of<br />
Abraxane, has been on the rise on the<br />
strength of the trial news. The company<br />
expects FDA approval in 2004. ◆<br />
Find Your Own Way of Giving<br />
We depend on you <strong>to</strong> be able <strong>to</strong> do what we do. Almost 60 percent of BCA’s income<br />
comes from individuals. Your gifts help keep our programs free of the restrictions that<br />
come with corporate and government funding. Unlike most other national breast cancer<br />
organizations, BCA is free <strong>to</strong> ask questions that corporations would rather we didn’t ask.<br />
Here are some ways you can help BCA:<br />
◆ Make your annual gift in monthly or quarterly installments and become a member of the<br />
Susan S<strong>to</strong>ne Circle, named in memory of an activist BCA Board member who believed<br />
strongly in this form of giving. A regular payment of $25, $50, or $100 gives us<br />
wonderful and predictable support with minimal shock <strong>to</strong> your budget. Contact Celeste<br />
Janssen at 415/243-9301, ext. 17, or via email at cjanssen@bcaction.org, <strong>to</strong> set up a<br />
monthly or quarterly payment schedule by check or credit card.<br />
◆ If you sell items on eBay, you can designate BCA as the beneficiary of all or part of the<br />
proceeds from your sales, through eBay’s Giving Works program. For more information<br />
go <strong>to</strong> www.ebay.com/givingworks, or call Alex Momtchiloff at 415/243-9301, ext. 15.<br />
◆ If you live in the Bay Area, donate used goods <strong>to</strong> San Francisco’s Community Thrift<br />
s<strong>to</strong>re and name BCA (account #236) as the beneficiary. Call the s<strong>to</strong>re at 415/861-4910<br />
for more information.<br />
◆ Designate BCA through your workplace giving program, including the Combined<br />
Federal Campaign (agency #0207). Many companies will match or even doublematch<br />
your donation. Check with your employer about their matching-gift program.<br />
◆ Designate BCA when United Way comes calling. Simply fill in BCA’s name and<br />
address on your workplace campaign form: <strong>Breast</strong> <strong>Cancer</strong> Action, 55 New<br />
Montgomery St., Ste. 323, San Francisco, CA 94105.<br />
Consumers Urged <strong>to</strong> “Think Before You Pink”<br />
By Carrie Spec<strong>to</strong>r<br />
Last Oc<strong>to</strong>ber, as corporations around the world cashed in on<br />
<strong>Breast</strong> <strong>Cancer</strong> Awareness Month with "philanthropic" pinkribbon<br />
product lines, <strong>Breast</strong> <strong>Cancer</strong> Action rolled out the second<br />
phase of Think Before You Pink, our campaign urging the public<br />
<strong>to</strong> think critically about marketing promotions like these.<br />
BCA’s campaign focuses this year on the cosmetics<br />
industry, which sponsors several high-profile cause-related<br />
marketing campaigns around breast cancer—yet whose<br />
products contain chemicals that may actually be associated<br />
with the development of the disease.<br />
With a revamped website and an ad on the op-ed page of the national edition of the<br />
New York Times (pictured), we drew attention <strong>to</strong> the troubling trend of corporate<br />
"pinkwashing" and encouraged consumers <strong>to</strong> pressure cosmetics companies <strong>to</strong> clean up<br />
their products. We provided contact information for companies that manufacture<br />
cosmetics with parabens and phthalates, two families of chemicals that are of particular<br />
concern when it comes <strong>to</strong> breast cancer—and we provided consumers with information on<br />
numerous lines of cosmetics that are free of these chemicals.<br />
Ultimately, the campaign urges the public <strong>to</strong> think about how funds raised for the “fight<br />
against breast cancer” are spent. As long as we believe we’re doing something meaningful<br />
about breast cancer by buying in<strong>to</strong> these corporate marketing schemes, the real work<br />
that needs <strong>to</strong> be done around treatment, access <strong>to</strong> care, and true prevention will continue<br />
<strong>to</strong> be underfunded and ignored. ◆<br />
After four years as BCA’s communications coordina<strong>to</strong>r, Carrie Spec<strong>to</strong>r has moved in<strong>to</strong> a position with<br />
a public health organization in Berkeley. BCA thanks Carrie for her stellar work. We look forward <strong>to</strong><br />
introducing you <strong>to</strong> our new communications officer in a future issue of this newsletter.<br />
Visit www.thinkbeforeyoupink.org <strong>to</strong> confront the pinkwashing companies.
<strong>Breast</strong> <strong>Cancer</strong> Action February/March 2004 5<br />
Clippings<br />
Pharma-funded Study Says<br />
Too Many Women Not Getting<br />
Enough Chemo<br />
In a study published in the December<br />
Journal of Clinical Oncology, a group<br />
called the Awareness of Neutropenia in<br />
Chemotherapy (ANC) Study Group reports<br />
on a retrospective study of 20,000 women<br />
with early-stage breast cancer that found<br />
that more than half did not receive the recommended<br />
schedule of chemotherapy.<br />
The study was reported as alarming on<br />
the assumption that women who didn’t get<br />
the full recommended dose or whose treatment<br />
was delayed for <strong>to</strong>o long may have<br />
been put at risk for recurrences that could<br />
have been avoided. However, the study did<br />
not look at whether the women who<br />
received less than the recommended treatment<br />
actually did worse than women who<br />
got the recommended dose over the recommended<br />
period of time. So, it is not clear<br />
whether these women were in fact put<br />
at risk.<br />
In addition, the only “side effect” of<br />
chemotherapy that the study examined as<br />
explaining the delays or reductions in treatment<br />
was neutropenia (chemotherapyinduced<br />
decline in certain white blood cells,<br />
which increases the risk of infection). There<br />
are many other things that might cause a<br />
woman’s treatment <strong>to</strong> be deferred or discontinued,<br />
including nausea, fatigue, mouth<br />
sores, and neuropathy.<br />
The drug most commonly used <strong>to</strong><br />
correct neutropenia is a colony-stimulating<br />
fac<strong>to</strong>r called Neupogen ® , which can add<br />
$20,000 <strong>to</strong> the cost of a chemotherapy<br />
regimen. Amgen, the funder of the study,<br />
produces Neupogen. An Amgen representative<br />
declined <strong>to</strong> state how much Amgen<br />
paid for the study.<br />
Lyman, G. et al., “Incidence and Predic<strong>to</strong>rs of<br />
Low Dose-Intensity in Adjuvant <strong>Breast</strong> <strong>Cancer</strong><br />
Chemotherapy: A Nationwide Study of<br />
Community Practices,” Journal of Clinical<br />
Oncology, December 15, 2003.<br />
Update: Genetics and Risk for<br />
Ashkenazi Jewish Women<br />
Mary-Claire King, continuing her work<br />
on the genetic underpinnings of<br />
breast cancer risk, has coauthored an<br />
important article with the New York <strong>Breast</strong><br />
<strong>Cancer</strong> Study Group on BRCA-related risk<br />
for Ashkenazi Jewish women (published in<br />
Science, Oc<strong>to</strong>ber 24, 2003).<br />
In order <strong>to</strong> accurately calculate risk, the<br />
research group determined the BRCA1<br />
and BRCA2 genotypes of more than 2,000<br />
relatives of women with breast cancer.<br />
They report an 82 percent lifetime risk of<br />
developing breast cancer in women with<br />
the genetic mutations associated with<br />
Ashkenazi ancestry. Half the women in the<br />
study who carried BRCA mutations and<br />
developed cancer did not have a family<br />
his<strong>to</strong>ry of breast cancer; in these cases,<br />
they were most likely <strong>to</strong> have inherited the<br />
genetic mutations from their father. Women<br />
who were born before 1940, those who<br />
exercised as young women, and those who<br />
had normal weight during adolescence<br />
developed breast cancer at a later age<br />
than those born after 1940.<br />
Research on Ashkenazi Jewish<br />
women’s genetic risks for breast cancer has<br />
shown inconsistent results. We are working<br />
on an article that summarizes the research<br />
for our next issue. Dr. King is a member of<br />
BCA’s Scientific Advisory Board.<br />
King, M.-C. et al., “<strong>Breast</strong> and Ovarian <strong>Cancer</strong><br />
Risks Due <strong>to</strong> Inherited Mutations in BRCA1 and<br />
BRCA2,” Science, Oc<strong>to</strong>ber 24, 2003.<br />
Adjuvant Letrozole Study<br />
Discontinued; Long-term Effects<br />
Still Unknown<br />
Astudy designed <strong>to</strong> test five years of<br />
letrozole (Femara ® ) treatment after<br />
tamoxifen therapy was discontinued in<br />
Oc<strong>to</strong>ber 2003, after a median follow-up of<br />
only 2.4 years.<br />
Letrozole has previously been found <strong>to</strong><br />
work better than tamoxifen for patients with<br />
metastatic disease who have HER2-<br />
positive tumors. This study was discontinued<br />
because the researchers observed<br />
fewer recurrences in the letrozole group<br />
compared with the placebo group. There<br />
were 5,187 women in the study. Local or<br />
metastatic recurrences of breast cancer or<br />
new cancers in the contralateral breast<br />
were noted in 75 women in the letrozole<br />
group, compared with 132 in the placebo<br />
group. The difference was statistically significant,<br />
meaning that it was 95 percent<br />
likely <strong>to</strong> be the result of a difference related<br />
<strong>to</strong> the drug, rather than chance.<br />
The discontinuation of the study leaves<br />
some important questions unanswered. We<br />
have no idea what the long-term effects of<br />
the drug might be, given that the median<br />
follow-up was only 2.4 years. In addition,<br />
the risk of osteoporosis in those in the trial<br />
was considerably higher for women on<br />
letrozole than for the placebo group. And<br />
even the study’s authors stated in the<br />
report that their results “leave the optimal<br />
duration of treatment undefined and the<br />
question of long-term <strong>to</strong>xicity unanswered.”<br />
The research community's tendency <strong>to</strong><br />
shoot first and ask questions later when it<br />
comes <strong>to</strong> drug pro<strong>to</strong>cols is fraught with peril,<br />
as we recently learned with the controversy<br />
over the benefits of hormone replacement<br />
therapy. The long-term effects of cancer<br />
“prevention” drugs—whether intended <strong>to</strong><br />
“prevent” recurrence or primary disease—<br />
can and do take decades <strong>to</strong> uncover.<br />
Goss, P. et al., "A Randomized Trial of Letrozole<br />
in Postmenopausal Women After Five Years of<br />
Tamoxifen Therapy for Early-Stage <strong>Breast</strong><br />
<strong>Cancer</strong>,” New England Journal of Medicine,<br />
November 6, 2003.
6<br />
Long-time AIDS Activist Discovers BCA<br />
By April Dembosky<br />
February/March 2004<br />
<strong>Breast</strong> <strong>Cancer</strong> Action<br />
Since her childhood<br />
days of watching<br />
the lawyer Perry<br />
Mason on television,<br />
Kathy Fisher has<br />
always believed in the<br />
power of the law <strong>to</strong><br />
achieve justice for all. Now a partner at<br />
Morrison & Foerster in San Francisco, with<br />
28 years of legal practice under her belt,<br />
Kathy dedicates much of her time and skill <strong>to</strong><br />
the service of social causes.<br />
To honor the many dear friends she has<br />
lost <strong>to</strong> AIDS and who are currently living with<br />
the disease, Kathy serves as general counsel<br />
for Pangaea, the SF AIDS Foundation’s<br />
international affiliate, and tries cases on behalf<br />
of AIDS organizations. She also makes regular<br />
donations in support of AIDS advocacy<br />
efforts. Recently, in the course of her pro<br />
bono work, Kathy added breast cancer <strong>to</strong> the<br />
<strong>to</strong>p of her list of activist concerns.<br />
With an extensive family his<strong>to</strong>ry of<br />
breast cancer, and a number of friends and<br />
colleagues affected by the disease, it seems<br />
logical that Kathy’s activist activities would<br />
extend <strong>to</strong> breast cancer. But for many years,<br />
the thought of working on breast cancer<br />
issues was <strong>to</strong>o close for comfort. “I didn’t<br />
want breast cancer in my life any more than it<br />
already was,” Kathy says, “I felt for a long<br />
time that breast cancer was just an inevitable,<br />
genetic destiny for me, my daughter, and<br />
other women I care about.”<br />
Kathy Fisher and her husband recently joined BCA’s Elenore Pred Circle, whose<br />
members have included BCA in their estate planning. For more information about<br />
planned giving and BCA, please contact Alex Momtchiloff, development direc<strong>to</strong>r, at<br />
(415) 243-9301, ext. 15, or via e-mail at amomtchiloff@bcaction.org.<br />
There’s<br />
nothing<br />
like it!<br />
Get inspired<br />
and get<br />
involved at<br />
BCA’s<br />
seventh<br />
annual Town<br />
Meeting.<br />
JOIN US:<br />
Saturday,<br />
April 24,<br />
Oakland<br />
Asian Cultural<br />
Center.<br />
When her mother became ill with breast<br />
cancer, and later her younger sister did as<br />
well, both women chose <strong>to</strong> keep the illness<br />
very private. Her mother was diagnosed in the<br />
late 1970s, a time when the stigma around<br />
the disease was so great that her illness<br />
became the great family secret. Fifteen years<br />
later, Kathy’s younger sister faced a different<br />
kind of silence in her battle with breast<br />
cancer—the uneasy quiet of the traditional<br />
support groups that seemed <strong>to</strong> support, above<br />
all, the cultural notion of female passivity<br />
around the disease.<br />
“My sister was not a shrinking violet,”<br />
Kathy says, recalling her distaste for the<br />
message that women ought <strong>to</strong> succumb <strong>to</strong> the<br />
disease without question or protest.<br />
When Kathy’s sister died in 1995, Ruth<br />
Borenstein, one of her colleagues at Morrison<br />
& Foerster, gave a donation <strong>to</strong> <strong>Breast</strong> <strong>Cancer</strong><br />
Action in her sister’s memory, introducing<br />
Kathy <strong>to</strong> an approach <strong>to</strong> the epidemic with<br />
which she could identify. Kathy was impressed<br />
with BCA’s straightforward and<br />
outspoken “<strong>Cancer</strong> Sucks” attitude <strong>to</strong>ward<br />
breast cancer. “I admire how BCA is honest<br />
about the science and single-minded about<br />
ending the breast cancer epidemic. And<br />
frankly,” Kathy notes, “I love their irreverence<br />
and sense of humor.”<br />
Kathy credits BCA’s realism, compassion<br />
and activist strategies for allowing her <strong>to</strong><br />
confront her fatalistic perspective on the<br />
disease and realize that there was a way <strong>to</strong> do<br />
something about it. She began giving yearend<br />
donations <strong>to</strong> BCA.<br />
Reviving an issue that she had long<br />
relegated <strong>to</strong> a small corner of her life, Kathy<br />
wanted <strong>to</strong> solidify her commitment <strong>to</strong> ending<br />
the disease that had affected her and her<br />
family so directly. She and her husband<br />
decided <strong>to</strong> include a bequest <strong>to</strong> BCA in their<br />
mutual wills. “We wanted <strong>to</strong> make sure that<br />
our lives and deaths were about giving <strong>to</strong><br />
causes that really affected us personally,”<br />
Kathy explains, “I signed up for life <strong>to</strong> give <strong>to</strong><br />
BCA because in addition <strong>to</strong> what BCA does<br />
and the materials they produce, they use<br />
money so well. BCA has immense integrity<br />
about that.”<br />
While a lot of organizations claim they<br />
are working <strong>to</strong> put themselves out of business,<br />
BCA member Kathy Fisher feels that<br />
BCA is one agency that really means it.<br />
“Unfortunately,” she says, “I’m confident they<br />
will be around long enough <strong>to</strong> make use of<br />
my bequest.” ◆
February/March 2004<br />
7<br />
Pho<strong>to</strong>: Gwen Rodgers<br />
In Memory of Two Good Friends<br />
Faith Fancher and Karen Holly, dear friends both <strong>to</strong> each<br />
other and <strong>to</strong> BCA, died within 10 days of each other last<br />
Oc<strong>to</strong>ber. These remarkable women are sharply missed by<br />
their families and friends, as well as by thousands of women<br />
and men whom they never met, but whose lives they <strong>to</strong>uched.<br />
Faith Fancher, 1950–2003<br />
We are deeply saddened by the loss of Faith Fancher, an<br />
Emmy-winning television news reporter and outspoken<br />
breast cancer activist who helped raise hundreds of<br />
thousands of dollars for local community breast cancer<br />
organizations serving low-income women and women of color.<br />
She died of metastatic disease at age 53.<br />
When Faith was first diagnosed with breast cancer in 1997,<br />
she made the courageous decision <strong>to</strong> share her journey through<br />
treatment in an award-winning series called “Faith’s S<strong>to</strong>ry,” which<br />
aired on KTVU, the San Francisco Bay Area’s Fox TV affiliate where<br />
Faith had worked since 1983. She later channeled her phenomenal<br />
energies in<strong>to</strong> “Friends of Faith,” an organization founded in her name<br />
by her friends and colleagues <strong>to</strong> provide grants <strong>to</strong> community<br />
organizations helping underserved women with breast cancer.<br />
Faith was a keynote speaker at BCA’s 2003 Town Meeting last<br />
April, where she talked about the power of community. In a nod <strong>to</strong> a<br />
tradition from her church in Tennessee where she was raised, Faith passed<br />
a box of tissues around the lecture hall before her speech, asking members<br />
of the audience <strong>to</strong> take one and wave it in the air—in lieu of applause—<br />
whenever they felt her words resonate.<br />
Here at BCA, we hold dear our memory of Faith on stage at that<br />
event, her spirit full and strong—her bald head from chemotherapy the only sign of her illness—<br />
with white tissues waving from all corners of the room, carrying affirmation from the crowd. ◆<br />
— Carrie Spec<strong>to</strong>r<br />
Karen Holly, 1954–2003<br />
A life is not measured by its length but by its depth.<br />
Karen Teresa Holly died of breast cancer on Oc<strong>to</strong>ber 29,<br />
2003. She was 49. First diagnosed with breast cancer in<br />
1989, Karen was a vibrant and luminous spirit who celebrated<br />
life in spite of four recurrences of the disease.<br />
Karen was well known as a poetic and impassioned public<br />
speaker who rallied providers, legisla<strong>to</strong>rs, scientists and fellow<br />
activists <strong>to</strong> call for increased research, treatment, and outreach.<br />
She was a vital member of many organizations, including <strong>Breast</strong><br />
<strong>Cancer</strong> Action.<br />
Karen continued, until her death, <strong>to</strong> promote the early<br />
detection and treatment of breast cancer for all women, particularly<br />
African Americans. A year before her death, Karen spoke <strong>to</strong><br />
California legisla<strong>to</strong>rs at the Joint Informational Hearing on <strong>Breast</strong><br />
<strong>Cancer</strong> and the Environment. She was the cover model for the 2004 edition of the Celebrate!<br />
calendar produced by the Contra Costa County African American Task Group.<br />
Karen once wrote: “When you paint a picture of me, don’t paint me as a saint. I’ve done<br />
some good, I’ve done some wrong, so use all your paint. Not the bright and light <strong>to</strong>nes, use some<br />
grey and dark. In fact, don’t put me on canvas, paint me in your hearts.” ◆<br />
— Kim Cox<br />
Kim Cox, MPH, works for Contra Costa Health Services and was the coordina<strong>to</strong>r of the former Contra<br />
Costa County <strong>Breast</strong> <strong>Cancer</strong> Partnership. Kim is an ovarian cancer survivor; she and Karen Holly met<br />
as patients at the Alta Bates Comprehensive <strong>Cancer</strong> Center. Contact <strong>Breast</strong> <strong>Cancer</strong> Action for a copy of<br />
Karen’s moving testimony at the 2002 legislative hearing.<br />
Are You Moving?<br />
Don’t leave the BCA newsletter<br />
behind! Please let us know your<br />
new address so that we can continue<br />
<strong>to</strong> send you breast cancer news and<br />
analysis that you won’t get anywhere<br />
else. Contact Celeste Janssen at:<br />
cjanssen@bcaction.org or (415)<br />
243-9301 or (877) 278-6722<br />
¿Habla usted español?<br />
Saber Es<br />
Poder<br />
(Knowledge<br />
Is Power) is<br />
the Spanishlanguage<br />
newsletter of<br />
<strong>Breast</strong> <strong>Cancer</strong><br />
Action. It is published three times a<br />
year. Past issues are archived at<br />
www.bcaction.org (click on “Get<br />
Informed”).<br />
Saber Es Poder covers a wide<br />
range of breast cancer <strong>to</strong>pics, including<br />
treatments, clinical trials, environmental<br />
links, and much more. To suggest<br />
<strong>to</strong>pics for future issues, contact Carmen<br />
Ortiz, project direc<strong>to</strong>r, at 415/243-9301,<br />
ext. 19, or coboricua@aol.com.<br />
BCA mails single and multiple<br />
copies of Saber Es Poder <strong>to</strong> individuals<br />
and institutions around the world. If you<br />
would like <strong>to</strong> add yourself or an<br />
organization or clinic <strong>to</strong> our mailing list,<br />
please contact Shelley Merid, smerid@<br />
bcaction.org, 415/243-9301, ext. 10, or<br />
(<strong>to</strong>ll-free) 877/278-6722.<br />
Alerts by E-mail<br />
Want up-<strong>to</strong>-the-minute news,<br />
notices, and action alerts on<br />
breast cancer—but hate <strong>to</strong> see your<br />
e-mailbox cluttered with unwanted<br />
messages?<br />
Sign up for BCA’s monthly listserv!<br />
The newsletter goes out on the first<br />
Wednesday of the month, with an<br />
occasional midmonth update for special<br />
events and alerts on short notice. Call<br />
415/243-9301 or e-mail cjanssen@<br />
bcaction.org or visit www.bcaction.org.
8<br />
February/March 2004<br />
<strong>Breast</strong> <strong>Cancer</strong> Action<br />
Donations in Memory<br />
BCA gratefully acknowledges donations made in memory of the following individuals between September 19 and December 16, 2003.<br />
Bella Abzug<br />
from Shane Snowdon<br />
Mrs. Wm. C. Atwater Jr.<br />
from Anonymous<br />
Lori Beckerman<br />
from Amy Markowitz<br />
and Bob Wachter<br />
Ruth Boldt<br />
from Jill Gallagher<br />
and Alicia Hasper<br />
Joan Silverman Bratman<br />
from Amy Logun<br />
and Steve Bratman<br />
Carol Cabell<br />
from Noemi Levine<br />
Kristina Calegari<br />
from Judith Gruber<br />
and Joseph Houska, Jr.<br />
Karen Camilleri<br />
from Marilee Ford<br />
Susan Campbell<br />
from Linda H. Johnson<br />
“<strong>Cancer</strong> victims sacrificed <strong>to</strong><br />
cancer-business”<br />
from Jean Clelland-Morin<br />
Lucia Centrone<br />
from Dora Weaver<br />
Susan Claymon<br />
from Betty and Martin Slavney<br />
from Allan W. Claymon<br />
Laura Cole<br />
from Miriam S<strong>to</strong>mbler<br />
and Kevin Kelem<br />
Carolyn Costello<br />
from Elaine S. Costello<br />
Their daughter-in-law<br />
from Barbara and Howard<br />
Rood<br />
E. Claire Dawson<br />
from Patricia Dawson<br />
Maryalice Derderian<br />
from Robert Blumengarten<br />
from Alexis Derderian<br />
Joanne Dumas<br />
from Joyce McKinney<br />
Juanita Englander<br />
from Joanna McKee Beam<br />
Carol Cameron Escobar<br />
from Alise and Willis<br />
Longyear<br />
Noel Evans<br />
from Joan Ferraris<br />
and Jon Norenburg<br />
David Faison<br />
from Barbara Wunsch<br />
and the Faison kids<br />
Faith Fancher<br />
from Michele R. Coleman<br />
from Margaret and F.G.<br />
Elizares<br />
Barbara Fetterolf<br />
from Equipment Brokers Co.<br />
from Jeanette Griffith<br />
from William Griffith<br />
from Ingrid Riegler<br />
Doris Fisher<br />
from Sue and Gary Thompson<br />
Helen Furness<br />
from Linda Paroubeck Patch<br />
Allen Hagan<br />
from Dee Dee Bloom<br />
Karen Jean Hall<br />
from Arlene De La Mora<br />
Karla Hansen<br />
from Geneva Jones<br />
and Vernon Jones<br />
Sandra Harris<br />
from Ben Harris<br />
Laura Ha<strong>to</strong>unian<br />
from Lorraine Kupferschmidt<br />
Laurel Hedley<br />
from Mary Hedley<br />
and Stephen P. Morrell<br />
Lorraine Hirsch<br />
from Elizabeth Crabtree<br />
and William Hirsch<br />
John Hoey<br />
from Anonymous<br />
Karen Holly<br />
from Kimberlee Sue Cox<br />
Helen and Charles Jenkins<br />
from Kathryn and Jeffrey Hall<br />
Tamar Kaufman<br />
from Anonymous<br />
Jane Gibbons Knopf<br />
from Anonymous<br />
Gayla Lacatena<br />
from Anonymous<br />
from Anonymous<br />
Betty Lamb<br />
from Linda and Curtis Boles<br />
Lauren Langford<br />
from Linda H. Johnson<br />
Rebecca Lepere<br />
from Suzanne Gooding<br />
Bess Krepistman Levine<br />
from Susan Laskin<br />
Elisa Lopez<br />
from Elsa Raitt<br />
Ellen Lowery<br />
from Margaret Walsh<br />
Alicia Madocks<br />
from Jill Gallagher<br />
and Alicia Hasper<br />
Elaine Masser<br />
from Vicki Schnitzer<br />
Jennelle Ashley Morris<br />
from Joyce Malmborg<br />
from Wayne Williams<br />
Josepha Moseley<br />
from Nancy Levin<br />
Rebecca Nataloni<br />
from Frances and John<br />
Nataloni<br />
Lorraine V. Painer<br />
from Merrill Clarke Hunn<br />
and Robert W. Hunn<br />
Roz Perry<br />
from Donna Brogan<br />
Anne Pietrafesa<br />
from Nancy Pietrafesa<br />
Joan Crowley Pires<br />
from Ellen Crowley<br />
Lula Mae Rohrer,<br />
from Anonymous<br />
Dixie Rose<br />
from Elizabeth and Ralph<br />
Long<br />
Elaine Rosenberg<br />
from Robin Spence<br />
Helen Savitz<br />
from Dee Dee Bloom<br />
Consuelo Segal<br />
from Robert Segal<br />
and Ju Zhen Segal<br />
Miriam Shapiro<br />
from Nelson and Dianne<br />
Shapiro<br />
Ronni Shapiro<br />
from Shirley Lidowsky<br />
Suzanne Snow<br />
from Mary Lou Creek<br />
Virginia Soffa<br />
from Annis Karpenko<br />
Barbara Somerville<br />
from Robin Somerville<br />
and Ann Hudson<br />
Doris (Maya) Sprangler<br />
from Robin Germain<br />
Susan S<strong>to</strong>ne<br />
from Diana EtsHokin<br />
from Margaret Norris<br />
and Nadine Navarro<br />
from Nancy Russell<br />
and Sharon Dinkin<br />
Susan S<strong>to</strong>ne’s birthday<br />
from Ellen Schwerin<br />
Anselm Strauss<br />
from Frances C. Strauss<br />
Margi Stuart<br />
from Anonymous<br />
Louise Taub<br />
from Barbara Rhine<br />
Auntie Helen Tonega<strong>to</strong><br />
from Barbara Attard<br />
Margo Trombetta<br />
from Deena Glass<br />
Jane Wilson<br />
from Anne Gurvin<br />
Jackie Winnow<br />
from Del Martin<br />
and Phyllis Lyon<br />
Carla Wofsy<br />
from Nancy Shemick<br />
Donations in Honor<br />
BCA gratefully acknowledges donations made in honor of the following individuals between September 19, 2003 and December 16, 2003.<br />
Kathy Addleson<br />
from April Dembosky<br />
All <strong>Cancer</strong> Patients<br />
from JoAnn and Terry O’Brien<br />
All women, especially<br />
survivors<br />
from Mary Lou Krenz<br />
Dipti Anderson<br />
from Leslie and Steve Rein<br />
Auntie Babs Attard<br />
from Barbara Attard<br />
BCA Board of Direc<strong>to</strong>rs<br />
from Kyra Subbotin<br />
and Henry Siegel<br />
BCA Newsletter<br />
from Eva and Daniel Lang<strong>to</strong>n<br />
BCA Staff and Volunteers<br />
from Susan and Robert<br />
Vanneman<br />
The BCA staff!<br />
from Kyra Subbotin<br />
and Henry Siegel<br />
Martha Bennett<br />
from Jennifer R. Macleod<br />
and Roderick K. Macleod<br />
Maggie Bernard<br />
from Cae Turner Bernard<br />
Patricia Bezalel<br />
from Shira Bezalel<br />
Marcia Billings<br />
from Margot Smith Chmel<br />
Linda Blackman<br />
from Hillery Jaffe-Urell<br />
Michelle Bourgault<br />
from Hedda Orkin<br />
Barbara Brenner<br />
from Mary Gregory<br />
from Carl Grunfeld<br />
from Connie Herrick<br />
from Chris Kitchel<br />
and James Hirabayashi<br />
from Laura Nathan<br />
from Tanya Neiman<br />
from Stuart and Ruth<br />
Newman<br />
from Jeanne Maddox<br />
Toungara<br />
from Lisa Westerback<br />
Barbara Brenner’s birthday<br />
from Joan MacQuarrie<br />
and Ellen Slack<br />
from Hedda Orkin, M.D.<br />
Barbara Brenner<br />
and Susie Lampert<br />
from Beverly Burns<br />
and Lynn Fountain<br />
from Gerald Epstein<br />
and Fran Deutsch<br />
from Sara Markel<br />
and Lloyd Altman<br />
Karen Brodi<br />
from Merle Woo<br />
Marilyn Brown<br />
from Joy Simha and Vasu,<br />
Anand and Maya Sudarsana<br />
Beverly Burns<br />
from Tanya Neiman<br />
Marilyn Cantlay<br />
from Marilyn Wallace<br />
Elizabeth Cheek<br />
from Cathy Kral<br />
Christian, Jennifer, Harriet<br />
from Anonymous<br />
Audrey Clark<br />
from Laura Guido-Clark<br />
Catherine Classen<br />
from Jennifer R. Macleod<br />
and Roderick K. Macleod<br />
Lanie Cohen<br />
from Deborah Cohen<br />
Jeannine Collins<br />
from Barbara Thomason<br />
and Anna Crawford<br />
Natalie Compagni Portis<br />
from Lifetime Enterprises Inc.<br />
from Deborah and Michael<br />
Sosebee<br />
Patty Crown<br />
from Meg Conkey<br />
Ms. Susan Diamond<br />
from Jennifer R. Macleod<br />
and Roderick K. Macleod<br />
Pat Dinges<br />
from Janet Burati<br />
from Adeline and Dennis<br />
Anderson<br />
from Helen Fisher<br />
from Paula and Kenneth<br />
Boshart<br />
from Janine Sloth<br />
from Deb Merritt<br />
from Linda Kimmel<br />
from Jane Petrone<br />
from Dorothy Camenga<br />
from Marjorie Variano<br />
Carol Doyle<br />
from Muffy Kibbey<br />
Shelley Eisner<br />
from Julie Gordon<br />
and Richard Eisner<br />
Family, friends, and<br />
professionals who helped her<br />
survive<br />
from Sally Saunders<br />
Helen Feihey<br />
from Denise and Mark<br />
Erickson<br />
50th Birthdays of: Kathy,<br />
Natalie, Vicki, Kristen and<br />
Herself<br />
from Janet Calmels<br />
Mary “Nana” Flyntz<br />
from Suzanne L. Dibble<br />
and Jeanne F. DeJoseph<br />
Marcy Fraser<br />
and Lana Sandahl<br />
from Gary Johnson<br />
Elizabeth Frey<br />
from Mary Margretta Love<br />
Margot Friedman<br />
and Nancy Delahoyd<br />
from Bruce Majors<br />
Jennifer Craig Gaines<br />
from Jennifer R. Macleod<br />
and Roderick K. Macleod<br />
Nanci Grail’s birthday<br />
from Nickie (Alice) Hilbert<br />
Boukitza Grinberg<br />
from Jennifer R. Macleod<br />
and Roderick K. Macleod<br />
Deanne Hanes<br />
from Jennifer R. Macleod<br />
and Roderick K. Macleod<br />
Linda Healy<br />
from Gloria Brickman<br />
Herself<br />
from Melinda Cogen<br />
Herself<br />
from Holly Kurzman<br />
Lisa Hoffman’s birthday<br />
from Alex Momtchiloff
<strong>Breast</strong> <strong>Cancer</strong> Action February/March 2004 9<br />
Donations in Honor continued<br />
Camille Howard<br />
from Catharine E. Kibira<br />
Julia Hunkins<br />
from Barbara Aamodt<br />
from Anna Laura Archer<br />
from Mary Ann Gerber<br />
from Eleanor Murphy<br />
from Sally and Donald Romig<br />
Charlotte Sue Imboden<br />
from Angela Johnson Meszaros<br />
Mr. and Mrs. Robert Kanner’s<br />
50th wedding anniversary<br />
from Beverly Robbins<br />
Linda Kanter<br />
from Patsy Policar<br />
Meredith McGovney Kaplan<br />
from Sarah Kaplan<br />
Anne Kasper’s support for<br />
Lila’s cousin<br />
from Lila Suna<br />
Judee King<br />
from Kathleen and Ralph<br />
Harms<br />
Chris Kitchel<br />
from Jill Gallagher<br />
and Alicia Hasper<br />
Kendra Klein<br />
from Joan Swirsky<br />
Nancy Klein<br />
from Carol and Jerry Schmidt<br />
Lisa Marks Kujawsky<br />
from Linda Marks<br />
and Rafael Lopez<br />
Esther Lande<br />
from Chiqui Somers<br />
Robbie Lipsman<br />
from Lisa Westerback<br />
Sharon Lund<br />
from Anonymous<br />
Adrienne Misson<br />
from Lisa Westerback<br />
Mothers Living S<strong>to</strong>ries Project<br />
from Hillery Jaffe-Urell<br />
Renetia Martin<br />
from Jeffrey Benevedes<br />
from Joseph Massey<br />
Katherine McKenney and her<br />
daughter<br />
from Pam Hewitt<br />
Liz Miles<br />
from Margot Smith Chmel<br />
Gerri and Larry Miller<br />
from Sara Gordon<br />
and Jane Balin<br />
Maria Minuzzo<br />
from Michael Minuzzo<br />
Rachel Morello-Frosch<br />
from Anonymous<br />
Adelita Moore<br />
from Karen Stevenson<br />
and Bill McClave<br />
Glendon Morreale<br />
from Sharon Izen<br />
Sara O’Donnell<br />
from Deborah Forter<br />
and Benjamin Hansbury<br />
The birth of Daisy Tomoko<br />
Orenstein<br />
from Barbara Brenner<br />
and Suzanne Lampert<br />
Anita Pagan<br />
from Robin Germain<br />
The successful treatment<br />
of Eileen Raihill<br />
from Arlis Grossman<br />
Dorothy Reed-Sleeper<br />
from Ruth Sleeper<br />
Daniel and Florence Rivel<br />
from H. Iris Schorr<br />
Ralph Roan<br />
from Sadja Greenwood<br />
Simone Rosen<br />
from Phyllis and Howard<br />
Cordover<br />
Louise Rothman Riemer<br />
from David Irons<br />
Nancy Russell<br />
from Nancy Trever<strong>to</strong>n<br />
Nancy Russell’s birthday<br />
from Sam Morrow<br />
Carole Scholler<br />
from Kathleen and Ralph<br />
Harms<br />
Evelyn Shaw<br />
from Jennifer R. Macleod<br />
and Roderick K. Macleod<br />
Joy Simha, Vasu, Anand,<br />
and Maya<br />
from Bella D. August<br />
Joy Smith<br />
from Jennifer R. Macleod<br />
and Roderick K. Macleod<br />
The 1973 Smithies<br />
from Roberta Lipsman<br />
and Eric Wright<br />
Sharon Solkowitz<br />
from Carolyn Stroebe<br />
Carrie Spec<strong>to</strong>r<br />
from Barbara Anger<br />
David Spiegel<br />
from Jennifer R. Macleod<br />
and Roderick K. Macleod<br />
Peg S<strong>to</strong>ne<br />
from Nancy S<strong>to</strong>ne<br />
and Charles Miller<br />
Leslie S<strong>to</strong>ne’s birthday<br />
from Arlene Shmaeff<br />
Roxy, Alana, and Jeanell<br />
Sudkamp<br />
from Jennifer Marschand<br />
Anne Swallow-Gillis<br />
from Jennifer R. Macleod<br />
and Roderick K. Macleod<br />
To celebrate 10 years of life<br />
after breast cancer<br />
from Jane Tolar<br />
Barbara Terrinoni<br />
from Jennifer R. Macleod<br />
and Roderick K. Macleod<br />
Adrienne Torf<br />
from Michael Dunn<br />
from Hilda Karp<br />
Shawn Murphy Verbrick<br />
from Nancy McKimens<br />
and Bob Murphy<br />
Marilyn Wallace<br />
from Marilyn Cantlay<br />
Lisa Wanzor<br />
from Laura Burrus<br />
Andrea Werlin<br />
from Leslie Rundell<br />
Mrs. Barbara Williams<br />
from Inez Sasse<br />
and Richard Sasse<br />
Connie Wofsy<br />
from Jennifer R. Macleod<br />
and Roderick K. Macleod<br />
Micky Wolfe<br />
from Virginia Wolfe<br />
The good health of Rochelle<br />
Wunsch<br />
from Barbara Wunsch<br />
and the Faison kids<br />
Henryka Yakushev<br />
from Jennifer R. Macleod<br />
and Roderick K. Macleod<br />
Abby Zimburg<br />
from Cae Turner Bernard<br />
Jane Zones<br />
from Sheryl Ruzek<br />
from Susan Schacher<br />
An Expression of Our Gratitude<br />
Special thanks <strong>to</strong>:<br />
◆<br />
◆<br />
◆<br />
◆<br />
Our generous volunteers and interns: Barbara Anger,<br />
Wendy Botwin, Beverly Canin, Barbara Carberry, Mary<br />
Jo Cargill, Marie Carmel, Jean Clelland, Anne Cohen,<br />
Sara O’Donnell, the Employment Plus volunteers, Carol<br />
Fong, Deb Forter, Cornelia Gates, Jami Gazzaniga,<br />
Alyssa Haeusslein, Tiffani Jessup, Ari Krakowski, Jody<br />
Kyle, Emily Lash, Nancy Oster, Kim Stiner-Zercoe, Stephen<br />
Wechsler, and Maria Wetzel. And the many individuals who<br />
take action in response <strong>to</strong> our e-alerts.<br />
All who helped with our fall major donor drive: Ruth<br />
Borenstein, Charlotte Burchard, Claudia Cappio,<br />
Natalie Compagni Portis, Laurie Earp, Martin<br />
Elsbach, Barbara Ehrenreich, Jessea Greenman,<br />
Mickey Hall, Mandy Hawes, Genevieve Howe, Gail<br />
Kaufman, Suzanne Lampert, Ellen Lew, Jo Ann Loulan,<br />
Jo Ann Madigan, Renetia Martin, Rachel Morello-Frosch,<br />
Raven~Light, Diane Sabin, David Salk, Diane Simpson,<br />
Sylvia Sokol, Ingrid Tischer, Angela Wall, Denise Wells,<br />
and Jane Zones.<br />
Stefanie Atkinson, Angela Padilla, Ruth Borenstein, Deborah<br />
Mosley, and the Morrison and Foerster Foundation for the<br />
“Angela’s Journey” pho<strong>to</strong>graphic exhibition benefiting BCA on<br />
November 14.<br />
David Salk and Focal Point Opticians, and Tulip Graphics for<br />
their generous assistance in promoting BCA’s Totally Chocolate<br />
benefit.<br />
◆ Matt Howe and Rebecca Booth for<br />
hosting a benefit for BCA at their home.<br />
◆ Chris<strong>to</strong>pher Esposi<strong>to</strong> and his colleagues in the<br />
Corporate Services division of Charles Schwab & Co.<br />
for contributing <strong>to</strong> BCA through a silent auction held on<br />
November 6.<br />
Our Super Fans Challenge Fund was a great success!<br />
The fund was used <strong>to</strong> match $20,000 of new and<br />
increased gifts by major donors ($250 and above) in our fall<br />
fundraising campaigns. We are deeply grateful <strong>to</strong> the BCA<br />
Super Fans: Ruth Borenstein, Claudia Cappio, Rachel<br />
Morello-Frosch, Suzanne Lampert, Sylvia Sokol,<br />
Peg S<strong>to</strong>ne, Karen Strauss, Kyra Subbotin, and<br />
Jane Sprague Zones; as well as the following<br />
individuals who contributed <strong>to</strong> the Super Fans<br />
Challenge Fund: Lawrence Brenner, Christine<br />
Grumm, James C. Hormel, Gail and Barry<br />
Kaufman, Melina Linder, Jo Ann Madigan,<br />
Marjorie Randolph, Denise Wells, and Eileen Hansen.<br />
To volunteer or <strong>to</strong> intern with BCA, please contact our Volunteer<br />
Coordina<strong>to</strong>r, Celeste Janssen, at cjanssen@bcaction.org. For<br />
information on holding a benefit for BCA, contact our development<br />
direc<strong>to</strong>r, Alex Momtchiloff, at amomtchiloff@bcaction.org.<br />
Both Alex and Celeste can be reached at 415/243-9301 or<br />
877/ 2STOPBC (877/278-6722).
10<br />
February/March 2004<br />
<strong>Breast</strong> <strong>Cancer</strong> Action<br />
Impressions From San An<strong>to</strong>nio<br />
continued from page 1<br />
disappointing results of its Phase III trials in<br />
metastatic breast cancer patients last summer.<br />
In San An<strong>to</strong>nio, the company presented a<br />
subset analysis that, while not conclusive in<br />
itself, offers a possible direction for new trials.<br />
Patients with ER+ tumors receiving hormonal<br />
treatments while undergoing Thera<strong>to</strong>pe<br />
showed a trend (not a statistically significant<br />
difference) <strong>to</strong>ward better time <strong>to</strong> disease<br />
progression and overall survival [Miles 36].<br />
Determining which patients are most<br />
likely <strong>to</strong> respond can transform a drug failure<br />
in<strong>to</strong> a success. The monoclonal antibody<br />
Herceptin would never have shown a benefit<br />
in breast cancer, Genentech researchers say,<br />
had they not been able <strong>to</strong> develop a test that<br />
predicted Herceptin response.<br />
To date, however, Genentech<br />
has been unable <strong>to</strong> devise such a<br />
test for its new drug Avastin ® ,<br />
which targets VEGF, a gene<br />
responsible for angiogenesis (the<br />
growth of blood vessels that feed<br />
tumors).<br />
Straightforward tests for<br />
gene expression are not always<br />
useful, it seems. Many if not most of the new<br />
agents don’t show enough activity by<br />
themselves, at least not in a general patient<br />
population. So, for rational combinations <strong>to</strong><br />
be designed, much more must be learned<br />
about the complex signaling pathways within<br />
cancer cells, crosstalk between genes, and<br />
messages from outside the cancer cell that<br />
govern cell proliferation and cell death<br />
(apop<strong>to</strong>sis).<br />
Although it is now “hot,” the genomic research<br />
paradigm is not the only avenue worthy<br />
of exploration. Which cancer cells researchers<br />
target may be important, as Max Wicha, of the<br />
University of Michigan, suggested in a plenary<br />
talk in San An<strong>to</strong>nio [Wicha P1]. His research<br />
elegantly demonstrates that tumor stem cells,<br />
the original cells from which all other cancer<br />
cells differentiate, may turn out <strong>to</strong> be of crucial<br />
importance in explaining drug resistance and<br />
the incurability of many cancers. Pointing <strong>to</strong><br />
the notable success in curing metastatic testicular<br />
cancer, Wicha suggested that therapies<br />
designed <strong>to</strong> target only stem cells may be<br />
much more effective.<br />
Mining the Past <strong>to</strong> Predict the Future:<br />
Is It Possible?<br />
With the introduction of microarray and<br />
related technologies a few years ago, where<br />
the entire genetic fingerprint of a cancer (or<br />
the most relevant genes) could be analyzed on<br />
a single chip, the door seemed <strong>to</strong> swing wide<br />
<strong>to</strong> precise individualization of treatment.<br />
A single test would have the power <strong>to</strong> predict<br />
the risk of recurrence, and then <strong>to</strong> tell a<br />
woman with breast cancer exactly which<br />
treatments she needed—or whether she<br />
needed no further treatment after surgery, an<br />
even more powerful revelation for the<br />
majority of newly diagnosed women whose<br />
breast cancers are actually cured by surgery<br />
alone. The concept was mind-boggling.<br />
Imagine no more overtreatment or<br />
undertreatment. No more one-size-fits-all.<br />
And for many if not most of us, there would<br />
be the certainty of knowing we were cured.<br />
Such were the hopes. So far, the possibilities<br />
have proven <strong>to</strong> be just that—possibilities.<br />
Determining which patients are<br />
most likely <strong>to</strong> respond can transform<br />
a drug failure in<strong>to</strong> a success.<br />
The study poised <strong>to</strong> be this year’s<br />
breakthrough news involved the use of the<br />
multi-gene RT-PCR test <strong>to</strong> predict recurrence,<br />
a new 21-gene microarray developed by<br />
Genomic Health. This test is derived from a<br />
combination of genes known <strong>to</strong> govern primarily<br />
cell proliferation and hormonal<br />
regulation in tumor cells. The revolutionary<br />
premise here is that this test is done on<br />
standard diagnostic pathology specimens,<br />
namely, archived, paraffin-embedded tumor<br />
tissue. If this is proven useful, researchers will<br />
be able for the first time <strong>to</strong> correlate archived<br />
tumor tissue with known patient outcomes<br />
from studies initiated and completed years<br />
ago, avoiding lengthy and costly “prospective”<br />
clinical trials.<br />
The validation study for RT-PCR was<br />
done through the National Surgical Adjuvant<br />
<strong>Breast</strong> and Bowel Project, one of the cancer<br />
cooperative groups responsible for many<br />
important clinical trials. Researchers hoped <strong>to</strong><br />
predict who was most and least likely <strong>to</strong> have<br />
a recurrence, based on tumor tissue alone.<br />
Using samples of the tissue of 668 nodenegative<br />
breast cancer patients with ER+<br />
tumors who were treated with tamoxifen<br />
during the 1980s, the study authors said that<br />
they were able <strong>to</strong> predict outcome better than<br />
any single prognostic fac<strong>to</strong>r, apart from tumor<br />
grade. The “low risk” group they identified<br />
had a risk of recurrence of 6.8 percent at 10<br />
years, while the “high risk” group had a<br />
recurrence rate of 30.5 percent [Paik 16].<br />
Genomic Health, who will be marketing<br />
this test as Oncotype DX early in 2004 for a<br />
minimum of $3,000, claims that it will help<br />
women with node-negative ER+ tumors<br />
taking tamoxifen (as most such patients do)<br />
select treatment more wisely. But even if the<br />
test is confirmed in other studies, how much<br />
will it really help the individual woman? How<br />
will the results be confounded if Arimidex ® is<br />
widely accepted as standard of care, rather<br />
than tamoxifen? Is a 6.8 percent risk of<br />
recurrence low enough for a woman <strong>to</strong> feel<br />
comfortable refusing tamoxifen? Wouldn’t a<br />
woman in the highest risk group be<br />
considering chemotherapy anyway? Today,<br />
oncologists combine fac<strong>to</strong>rs<br />
when considering prognosis,<br />
including tumor size, involved<br />
lymph nodes, tumor grade, etc.<br />
Several complex algorithms that<br />
feed recent data from clinical<br />
trials in<strong>to</strong> a computer program<br />
are freely available <strong>to</strong> assist in<br />
this task, such as Adjuvant at<br />
www. adjuvan<strong>to</strong>nline.com. So,<br />
it’s unclear what this test will add <strong>to</strong> the<br />
picture, even if its results are widely<br />
confirmed.<br />
And speaking of confirmation, another<br />
study presented at the conference, using the<br />
same test in a similar population, some of<br />
whom who did not receive tamoxifen, was<br />
conducted at M.D. Anderson <strong>Cancer</strong> Center.<br />
This study failed <strong>to</strong> show any predictive value<br />
for recurrence [Esteva 17]. So, much more<br />
work is clearly needed. A fundamental<br />
question <strong>to</strong> be asked here, according <strong>to</strong><br />
statistician Donald Berry of the M.D.<br />
Anderson <strong>Cancer</strong> Center, is whether these<br />
incredibly complex analyses of genetic<br />
expression are likely <strong>to</strong> ever provide reliable,<br />
reproducible results, given the multiplicity of<br />
potential data points, the difficulties with<br />
uniform data collection and pathology, and a<br />
variety of other statistical and methodological<br />
issues that make interpretation of tests like<br />
this fraught with problems. ◆<br />
Musa Mayer is a 14-year survivor and the author<br />
of four books including, most recently, After<br />
<strong>Breast</strong> <strong>Cancer</strong>: Answers <strong>to</strong> the Questions<br />
You’re Afraid <strong>to</strong> Ask (O’Reilly, 2003). She<br />
provides information and support for women with<br />
metastatic breast cancer daily at www.bclist.org<br />
and www.bcmets.org.<br />
THE NEXT SAN ANTONIO <strong>BREAST</strong> <strong>CANCER</strong> SYMPOSIUM WILL BE DECEMBER 8–11, 2004…
<strong>Breast</strong> <strong>Cancer</strong> Action February/March 2004 11<br />
From the Executive Direc<strong>to</strong>r<br />
continued from page 2<br />
can establish that some early change during<br />
the treatment process (the “surrogate<br />
endpoint”) indicates that a woman will have<br />
longer disease-free survival (DFS), more time<br />
<strong>to</strong> progression (TTP), or better chances of<br />
overall survival (OS), then you can move<br />
more quickly with smaller trials <strong>to</strong> complete<br />
evaluation of the treatment without waiting<br />
the many years it takes <strong>to</strong> establish DFS or OS<br />
themselves.<br />
But this logic only works if, in fact, the<br />
interim change correlates <strong>to</strong> the ultimate goals<br />
that you’re trying <strong>to</strong> achieve. What those goals<br />
are, of course, will be different depending on<br />
the stage of disease being treated. Overall<br />
survival is important <strong>to</strong> everyone who’s ever<br />
had a diagnosis, while TTP will be of greater<br />
concern <strong>to</strong> women living with metastatic<br />
breast cancer. But, whatever the goal of the<br />
therapy, the “surrogate” has <strong>to</strong> work as a<br />
stand-in. And there’s the rub. 1<br />
Several of the early (and theoretically<br />
“hot”) presentations at this meeting used the<br />
surrogate endpoint of Ki67 expression as<br />
evidence for DFS and, ultimately, OS. Ki67 is<br />
one of a number of genes that control cell<br />
proliferation. If a tumor expresses a lot of<br />
Ki67, the theory is that this will lead <strong>to</strong> more<br />
cell proliferation, and ultimately new or<br />
growing tumors. Basing their work on this<br />
theory, researchers are using Ki67 reduction<br />
as a surrogate endpoint in drug analysis. But<br />
after the presentation of two different studies<br />
that relied upon this surrogate endpoint, a<br />
member of the audience asked whether Ki67<br />
had been validated as a marker for clinical<br />
outcome. And, lo and behold, it turns out<br />
that, in the words of the researcher who was<br />
asked, the evidence that Ki67 is a good predic<strong>to</strong>r<br />
of recurrence is “very sketchy.” For that<br />
matter, there is no standard for measuring<br />
Ki67, and therefore no way <strong>to</strong> consistently<br />
evaluate its increase or decrease. And no<br />
studies were cited showing that changes in<br />
Ki67, in fact, correlate <strong>to</strong> an improved (or <strong>to</strong><br />
a worse) outcome in patients.<br />
Yet, despite this lack of a validated surrogate<br />
endpoint, researchers pointed <strong>to</strong><br />
suppression of Ki67 as evidence that anastrozole<br />
(Arimidex ® ) alone may be more effective<br />
than tamoxifen (Nolvadex ® ) alone or tamoxifen<br />
and anastrozole combined in the neoadjuvant<br />
setting for postmenopausal ER+<br />
women [Dowsett, 2]. This conclusion was<br />
reached even though the trial showed no<br />
statistical difference between anastrozole and<br />
tamoxifen in terms of clinical response in this<br />
very short (two-week) study involving 330<br />
patients.<br />
The same nonvalidated endpoint was<br />
used <strong>to</strong> evaluate the short-term effects of<br />
gefitinib (Iressa®) on ductal carcinoma in situ<br />
(Abstract 14). I was surprised—in fact,<br />
appalled—that anyone would test a drug as<br />
unproven as Iressa in a group of patients with<br />
non-life-threatening disease. 2 The trial showed<br />
a trend—but not statistically significant<br />
results—of Ki67 reduction from Iressa. Based<br />
on trend data of a nonvalidated endpoint, the<br />
researcher concluded that EGFR inhibi<strong>to</strong>rs<br />
such as Iressa should be studied in ERnegative<br />
DCIS. He also noted that, while drugs<br />
like Iressa may not work alone, they may work<br />
in combination with other compounds.<br />
How many drugs are healthy people<br />
going <strong>to</strong> have <strong>to</strong> take in the brave new world<br />
of cancer chemoprevention? And what will<br />
the long-term effects be? These questions<br />
weren’t answered at San An<strong>to</strong>nio. They<br />
weren’t even asked.<br />
In fact, the great thing missing in most of<br />
the presentations I heard at San An<strong>to</strong>nio was<br />
information about what the drugs under<br />
study meant for women’s lives. Given how<br />
little we know about surrogate endpoints and<br />
their relationship <strong>to</strong> patient outcomes, will<br />
patients really do better on the new drugs<br />
than on the old ones, taking in<strong>to</strong> account not<br />
only the breast cancer outcome but also the<br />
other effects of the drug?<br />
Many of the studies presented at San<br />
An<strong>to</strong>nio either did not consider the clinical<br />
impacts of the treatments, or minimized them.<br />
In a presentation I missed, researchers<br />
showed that docetaxel (Taxotere ® ) gave<br />
women with metastatic disease almost three<br />
more months of life than paclitaxel (Taxol ® ). I<br />
was entering the lecture hall as the talk was<br />
ending, but a breast surgeon from San<br />
Francisco who was on her way out whispered<br />
in my ear that these patients were trading<br />
three additional months of life against<br />
extraordinary bone pain. Apparently, this<br />
trade-off wasn’t discussed in the presentation<br />
or the questions afterwards.<br />
Someone—everyone—needs <strong>to</strong> remind<br />
the presenters at this meeting that what<br />
matters <strong>to</strong> patients is what these drugs do for<br />
them and <strong>to</strong> them, in both the short and the<br />
long run. Yet the breast cancer advocates at<br />
this meeting—120 registered out of the more<br />
than 6,000 people in attendance—were<br />
remarkably silent during the question-andanswer<br />
portions of the presentations I heard. I<br />
think we need <strong>to</strong> have more activists at the<br />
Community Organizer Kendra Klein shares BCA’s<br />
perspective with a visi<strong>to</strong>r <strong>to</strong> our booth at the San<br />
An<strong>to</strong>nio conference.<br />
San An<strong>to</strong>nio meeting <strong>to</strong> make sure that the<br />
concerns of women living with and at risk for<br />
breast cancer don’t get drowned out by the<br />
marketing hype that drives so many of the<br />
presentations. ◆<br />
If you’re interested in joining BCA at the 2004<br />
San An<strong>to</strong>nio <strong>Breast</strong> <strong>Cancer</strong> Symposium, contact<br />
Kendra Klein at 415/243-9301 or kklein@<br />
bcaction.org.<br />
1.The medical journals are filled with s<strong>to</strong>ries of<br />
surrogate endpoints that didn’t work out. Best<br />
known in breast cancer is probably the use of<br />
“tumor response rates” in evaluating high-dose<br />
chemotherapy/au<strong>to</strong>logous bone marrow<br />
transplant treatment. The tumor response rates<br />
did not, as it turned out, predict accurately for<br />
either overall survival or time <strong>to</strong> progression of<br />
disease. But we didn’t learn this before many,<br />
many women had had this often devastating<br />
treatment. See “Preliminary Results for NCI Show<br />
HDC Offers Little Benefit,” BCA Newsletter<br />
#54 (June/July 1999), viewable online at<br />
http://www.bcaction.org/<strong>Page</strong>s/Searchable<strong>Page</strong>s/<br />
1999Newsletters/Newsletter054A.html.<br />
2.I was as<strong>to</strong>nished <strong>to</strong> see this study because I<br />
recalled the presentation at San An<strong>to</strong>nio in 2002<br />
about Iressa in the metastatic setting (which was<br />
a failure—see “Changing Goals for Iressa,” BCA<br />
Newsletter #76, viewable online at http://<br />
www.bcaction.org/<strong>Page</strong>s/Searchable<strong>Page</strong>s/2003N<br />
ewsletters/Newsletter076I.html). I also know the<br />
controversy that arose over the FDA’s approval of<br />
Iressa for lung cancer despite lack of evidence of<br />
efficacy. At the 2003 conference, the presenter of<br />
the Iressa studies acknowledged that the latest<br />
studies are geared <strong>to</strong>ward “chemoprevention,”<br />
not treatment.<br />
…HOW MANY ACTIVISTS WILL BE THERE?
<strong>BREAST</strong><br />
<strong>CANCER</strong><br />
<strong>ACTION</strong><br />
55 New Montgomery<br />
Suite 323<br />
San Francisco<br />
California 94105<br />
Non-Profit Org.<br />
U.S. Postage<br />
PAID<br />
San Francisco, CA<br />
Permit No. 2500<br />
<strong>Return</strong> Service Requested<br />
Save the Date!<br />
BCA’s Seventh Annual Town<br />
Meeting: April 24, 2004.<br />
“Taking Care<br />
in a Toxic Time”<br />
Resources<br />
National Organizations:<br />
<strong>Breast</strong> <strong>Cancer</strong> Action<br />
415/243-9301<br />
877/2-STOP-BC (<strong>to</strong>ll-free)<br />
www.bcaction.org<br />
Mautner Project for Lesbians with <strong>Cancer</strong><br />
202/332-5536<br />
www.mautnerproject.org<br />
National Latina Health Organization<br />
510/534-1362<br />
www.latinahealth.org<br />
National Lymphedema Network<br />
800/541-3259<br />
www.lymphnet.org<br />
National Women’s Health Network<br />
202/347-1140<br />
www.womenshealthnetwork.org<br />
National Y-ME<br />
(referrals <strong>to</strong> local support groups)<br />
800/221-2141<br />
www.y-me.org<br />
Patient Advocate Foundation<br />
(insurance issues)<br />
800/532-5274<br />
www.patientadvocate.org<br />
Richard & Annette Bloch <strong>Cancer</strong> Foundation<br />
(free second opinion and peer referral)<br />
800/433-0464<br />
www.blochcancer.org<br />
U.S. Government:<br />
National <strong>Breast</strong> and Cervical <strong>Cancer</strong><br />
Early Detection Program<br />
(free or low-cost mammograms)<br />
888/842-6355<br />
www.cdc.gov/cancer/nbccedp<br />
Information on breast cancer/clinical trials<br />
sponsored by the National <strong>Cancer</strong> Institute<br />
800/4 <strong>CANCER</strong> (800/422-6237)<br />
www.cancer.gov/cancerinformation<br />
Information on adverse reactions<br />
<strong>to</strong> drug therapy<br />
800/FDA-1088 (800/332-1088)<br />
www.fda.gov/cder<br />
Tell Washing<strong>to</strong>n<br />
White House Hotline<br />
202/456-1111<br />
House & Senate Main Switchboard<br />
202/224-3121<br />
State of California:<br />
California Women’s Law Center<br />
888/774-5200<br />
www.cwlc.org<br />
California Department of Corporations<br />
(HMO complaints)<br />
800/400-0815<br />
www.dmhc.ca.gov<br />
San Francisco Bay Area:<br />
Charlotte Maxwell Complementary Clinic<br />
(for low-income women with cancer)<br />
510/601-7660<br />
www.charlottemaxwell.org<br />
Community <strong>Breast</strong> Health Project, Palo Al<strong>to</strong><br />
650/326-6686<br />
www.cbhp.org<br />
Project Open Hand (meals)<br />
415/447-2300 or 510/596-8200<br />
www.openhand.org<br />
The Wellness Community, Walnut Creek<br />
925/933-0107<br />
www.twc-bayarea.org<br />
Women’s <strong>Cancer</strong> Resource Center, Oakland<br />
510/420-7900<br />
www.wcrc.org<br />
Additional Resources:<br />
Medical Complaints<br />
Medical Boards (selected states)<br />
www.aimmembers.org/boarddirec<strong>to</strong>ry<br />
For Help on the Final Journey<br />
Hospice Education<br />
800/331-1620<br />
www.hospiceworld.org<br />
For more resources, visit www.bcaction.org