Archive for December, 2011

Welcome to our Newsletter Archive!

To Our BCT Community:

We are very excited to bring you this first issue of talking About Trials, our new BCT newsletter. Brought to you every other month, “talking about trials” is precisely what we plan to do as we cover interesting topics that explore clinical research from many different perspectives. It seems only fitting that our inaugural issue would examine the events leading up to the first clinical trial that definitively changed breast cancer care, showing that simple mastectomy (and ultimately lumpectomy) was as effective as radical mastectomy. This blog will capture all of our newsletter articles in their entirety.

You will hear from many voices in talking About Trials. Each issue will highlight a personal reflection from a trial participant, researcher or healthcare provider. In this issue, Elly Cohen, Program Director of BCT, talks about her experience in a supportive care trial after completing chemotherapy. We would love to hear your personal story. Send it to us at help-desk@bctrials.org.

Lastly, you may be wondering why talking about Trials has such a different “look and feel” from our website. That’s because BreastCancerTrials.org is about to get a facelift with a new design and expanded educational information about clinical trials. Consider this a sneak preview!

Sincerely, The BCT Team

December 1, 2011 at 8:02 pm 4 comments

The Rise and Fall of the Radical Mastectomy

And the Clinical Trial that Led to Its Demise

For most newly diagnosed breast cancer patients, the option of breast conserving surgery (lumpectomy followed by radiation or simple mastectomy) is taken for granted. But that was not always the case. Forty years ago radical mastectomy was the standard of care. It took a controversial and landmark clinical trial to spare women from this unnecessary and disfiguring surgery.

William S. Halsted, an accomplished young surgeon at Johns Hopkins, first performed the “radical mastectomy,” also known as the Halsted procedure, in 1882. With surgery as a breast cancer patient’s only option, a woman treated by Halsted (and the many surgeons who followed his method) not only had her entire breast removed, but also the surrounding tissue, lymph nodes and the pectoral muscles. Halsted hypothesized that breast cancer grew in a slow, orderly way, spreading from the breast to the lymph nodes and finally to other parts of the body. Despite the resultant disfigurement, Halstead believed that the more extensive the surgery, the less likely the cancer would be to return.

Halsted’s procedure and his belief about the pathology of cancer persisted among physicians in the United States for a very long time. It was not until 1951 that another cancer surgeon seriously challenged Halsted’s underlying assumptions.  Ian MacDonald, a Canadian teaching in Los Angeles, argued that the relative aggressiveness of breast and other cancers was biologically determined and did not necessarily conform to Halsted’s “one size fits all” model of growth. That being the case, radical mastectomy might not be necessary for all women, especially those with slow-growing tumors.

Relatively few surgeons supported MacDonald’s theory. One of them was George “Barney” Crile, Jr., whose father, also a cancer surgeon, was renowned for describing in horrific detail the effects of radical mastectomies on his patients. In the early 1950s, Crile, Jr., became the first surgeon in the United States to offer women a choice – radical mastectomy or simple mastectomy. He performed his last radical mastectomy in 1954. Praised for his actions by a small but vocal group of patients, Crile’s less extensive simple mastectomy was vigorously attacked by his colleagues, some of whom considered it “equivalent to malpractice.”

By the 1960s, the lines were drawn: surgeons were either for or against radical mastectomy citing published case reports based on their own subjective clinical experience. At the same time, breast cancer patients increasingly began to question the efficacy of the Halsted procedure. Among the clamor, another group argued that the only way to objectively determine the effectiveness of radical mastectomy was through a randomized clinical trial, a relatively new concept at the time (Note: The first clinical trial was conducted in 1948 to evaluate the use of streptomycin for tuberculosis). But many physicians disagreed with the whole notion of gathering objective evidence: they didn’t support patients being randomly assigned to one surgical procedure or another nor would they trust the results, preferring to rely on their own experiences of working with patients and monitoring outcomes.

If ever there was a person to unite the contentious parties, it was Bernard Fisher, a prominent surgeon-scientist. Starting in 1958, Fisher pursued a life-long interest in breast cancer research straddling both the laboratory and clinic. From laboratory studies on tumor metastasis, he theorized that breast cancer was a systemic disease and that those women associated with poor survival outcomes were likely to have undetected tumor cells that had already spread to distant organs at the time of diagnosis. If this was true, then radical mastectomy was unlikely to improve outcomes over simple mastectomy.

Eager to apply scientific principles to his hypotheses, in 1967, Fisher became the first chair of National Adjuvant Breast and Bowel Project (NSAPB). Under his leadership NSABP launched NSABP-04 in 1971, the first randomized trial in America that compared radical mastectomy with simple mastectomy or simple mastectomy followed by radiation therapy. Published in 1974, its early results based on findings from 1,700 patients enrolled at 34 institutions, showed that the survival outcomes for patients were the same regardless of which type of treatment was performed.

Despite the mounting evidence to the contrary, many surgeons continued to advise their patients that the Halsted procedure was in their opinion the ‘safest’ treatment. But as later results from NSABP- O4 and other trials confirmed the efficacy of the simple mastectomy, the medical profession altered its standard treatment for breast cancer patients. In 1983, there were only 5,000 radical mastectomies performed in the country (down from 46,000 in 1974).

The controversy surrounding radical mastectomies has had far reaching consequences that continue to be felt. Not only did it pave the way for the acceptance of clinical trials as the standard by which all advances in breast cancer are evaluated (BreastCancerTrials.org currently lists over 500 U.S. breast cancer studies), but it also empowered women for the first time to talk openly about their experiences of breast cancer and to be actively involved in their care. With their “collective voice,” these women found a place at the table alongside health policy makers, funders, and research investigators. Breast cancer patient advocacy had been born.

Further Reading

The Breast Cancer Wars: Hope, Fear, and the Pursuit of a Cure in Twentieth-Century America Barron H. Lerner, Oxford University Press, 2001

Bernard Fisher Reflects on a Half-Century’s Worth of Breast Cancer Research Interview with Kate Travis, 2005

The Emperor of All Maladies: A Biography of Cancer, Siddhartha Mukherjee, Simon & Schuster, Inc., 2010  

December 1, 2011 at 8:01 pm Leave a comment

A Personal Story

 Elly Cohen is Program Director of BreastCancerTrials.org and a Senior Analyst with the Carol Franc Buck UCSF Breast Care Center. Elly was diagnosed with Stage 1 breast cancer in 1998 and after surgery received chemotherapy and hormone therapy. Below she talks about her experience in a clinical trial.

What trial did you participate in? 

I volunteered for a study that was comparing the effect of two types of support groups on participants’ emotional, mental and physical wellbeing. The control group took a more traditional group counseling approach while the experimental group added alternative activities such as yoga, art and dance therapy.  I was hoping to be part of the experimental group, but was randomized to the control.

Why did this trial attract you in particular?

I was not having much success with traditional cancer support groups, where the attendees varied from week-to-week. This trial appealed to me because all the women involved were recently diagnosed and more or less in the same situation as me – going through treatment or making decisions about treatment. Since it was limited to 3 months, I hoped that the participants would attend regularly (which they did) and I would get to know them on a deeper level.

How was your experience in the end? 

In some ways it hasn’t ended. There were five of us who met together for the entire 3-month period and despite my misgivings about being in the control group, it was a wonderful experience. We had a great facilitator and, although we didn’t know each other beforehand, we developed a close relationship over our shared breast cancer experience.  Over the 13 years since the trial ended, we have helped each other cope with recurrences and several of us still get together on a regular basis.

Did they ever tell you which group had the better results?

After 12 years, they still send us follow-up questionnaires. The investigators have told us that the results revealed that each group scored better, that is showed improvements, on subsequent analyses of wellbeing but in different ways.

Is that your only personal experience of clinical trials?

No, I almost participated in another trial studying whether women with early stage breast cancer would have a lowered risk recurrence if they took Femara® (an aromatase inhibitor) after 5 years of tamoxifen compared to tamoxifen alone. But as I was preparing to enroll in the trial, it was stopped because the first reported results convincingly showed that Femara® taken after tamxoxifen was superior to tamoxifen alone. In this trial, the control group received a placebo after tamoxifen, since receiving no therapy was the standard of care at the time. After they stopped the trial, my oncologist prescribed Femara®, which I continued to take for 5 years.

What would your advice be to women who are thinking about entering a clinical trial?

You should make sure you understand the purpose of the trial and what would be expected of you as a study participant.  If this is a treatment trial, ask the investigator to review the benefits and risks and how these compare to your other treatment options. Rules regarding insurance coverage for trial participants vary from state-to-state so it is important to confirm with your carrier that it will cover any medical cost not covered by the trial sponsor. Most importantly, make sure that you feel comfortable with the research team. Remember you are volunteering to be a study participant and that it is your right to withdraw from a trial at any time and for any reason.

Editor’s Note: BCT provides a list of questions to ask a research site when considering trial participation.

December 1, 2011 at 7:52 pm Leave a comment

Calendar/Events December 2011

2011 CTRC-AACR San Antonio Breast Cancer Symposium
Dec. 6-10, 2011
San Antonio, TX
The Latest From the San Antonio Breast Cancer Symposium
http://www.CancerCare.org
Free teleconference
Feb. 8, 2012, 1:30 PM EST
Metastatic Support Call
Young Survival Coalition
Free Support Group
Dec 13, 2011, 8:00 PM EST

December 1, 2011 at 7:43 pm Leave a comment



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