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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

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