This note marks the one year anniversary since Ann received her breast cancer diagnosis and we’d like to take this opportunity to share two favorable bits of news with you.

First, the chemotherapy Ann chose is the most effective available at this time for early-stage breast cancer like her’s. The second interim results from a phase III clinical trial conducted by the Breast Cancer International Research Group (BCIRG) were announced on Friday, December 5, at the San Antonio Breast Cancer Symposium (SABCS). The trial compares the efficacy of 5-FU versus Taxotere when administered along with Adriamycin and Cytoxan; these regimes go by the abbreviations FAC and TAC, respectively. (An article from the Wall Street Journal announcing the results appears below along with links to additional information that about the results available online.) We are very pleased to see that TAC, the regime that Ann chose, was the clear winner in both recurrence as well as overall survival for participants of the study with a 55 months median followup.

Last year when we had to decide on chemotherapy, TAC looked promising but with only 33 months median followup there was still some risk that the benefit would not be sustained—and could even reverse—in the long run. The only certainty about TAC was that it would have the toughest side-effects of all the alternatives her doctors offered. Now with this additional followup data Ann feels that the extra suffering she endured as a result of taking Taxotere may have some benefit. (She still has problems walking because of the nerve damage in her toes, a side-effect of Taxotere from which she is expected to recover fully.) We are very pleased and relieved to find that TAC’s benefits appear to be sustained over the long term.

Our second bit of good news is that Ann’s breast cancer did not result from genetic mutations that she inherited. Mutations in either of two genes known as BRCA1 and BRCA2 are responsible inherited breast cancer. The vast majority of breast cancer cases are not the result of BRCA1 or BRCA2 mutations. Nevertheless, Dr. Wendy Rubinstein, Director of the Center for Medical Genetics at Evanston Northwestern Healthcare, recommended reviewing Ann’s family tree for others with cancer because Ann was so young when diagnosed. It would be important to know if Ann had BRCA1 or BRCA2 mutations because it would impact her breast cancer treatment as well as expose her to a high risk of ovarian, pancreatic, and possibly other cancers. (Links to online information about BRCA1 and BRCA2 are below.) Several weeks (and many phone calls to aunts and cousins) later Dr. Rubinstein received Ann’s detailed pedigree. Based on this chart, Dr. Rubinstein concluded that there was less than a 1% chance that Ann had inherited mutations in BRCA1 or BRCA2. We are very pleased to confirm that neither Ann nor her siblings, nieces, and nephews have to worry about these mutations and their cause for breast and other cancers.

As I said at the beginning of this update, it’s been a year since Ann’s diagnosis. We are getting on with our lives and putting cancer in its place. The fog of chemotherapy side-effects continues to lift and we enjoy the clearer days. Unfortunately, there is no going back to “normal” and forgetting that this ever happened; Ann’s omnipresent lymphedema is a daily reminder and it places real limits on our lives. But, these are limits that we are gradually coming to understand, accept, and work within.

Right now, we are busy getting ready for TWO Christmases, one this weekend with Ann’s family and the other with Nello’s on the traditional date.

We’ve said it many times but we want you to know that you all have been wonderful support for both of us this past year. Thank you very much for your help and understanding.

We hope that your holiday plans are merry and bright.

Love,

Ann and Nello

HEALTH

Aventis Drug Aids Survival Rate In Early Stage of Breast Cancer

By RON WINSLOW and JULIA FLYNN Staff Reporters of THE WALL STREET JOURNAL

A chemotherapy cocktail including Aventis SA’s Taxotere significantly improved survival for women with early stage breast cancer and decreased the likelihood their cancer would recur when compared with standard treatment, researchers reported.

In a study involving 1,491 women, 87% of those randomly assigned to a regimen involving Taxotere were still alive 55 months later, compared with 81% of those taking the commonly used treatment including a drug called 5-fluorouracil, or 5-FU. The study also found that 75% of women remained free of disease compared with 68% on the standard treatment. The results translated into a 30% reduction in risk of death and a 28% reduction in chances of a relapse of the cancer, researchers said.

"This is one of the largest effects we’ve ever seen in a breast-cancer chemotherapy trial,’’ said John Mackey, a leader of the study and head of the Northern Alberta Breast Cancer Program at Cross Cancer Institute, Edmonton, Alberta. He presented the findings Friday night at the San Antonio Breast Cancer Symposium in Texas.

What impressed other cancer doctors is that the study-essentially a five-year follow-up-builds on the three-year results presented about two years ago. The “gold standard” in breast cancer is to see how well patients do five years after diagnosis, said Peter Ravdin, medical oncologist at University of Texas Health Science Center, San Antonio, who wasn’t involved in the study. Often, early positive results don’t hold up over a longer period.

"These results more than held up, they strengthened,’’ Dr. Ravdin said. A nearly one-third reduction in risk of dying within five years “is quite a big step forward’’ for breast cancer patients, he added.

About 60,000 American women and a total of 300,000 women world-wide are diagnosed each year with early stage breast cancer — when tumors are confined to the breast and lymph nodes in the armpit. They typically have the tumors removed surgically and may undergo radiation treatment as well as chemotherapy over several months following surgery.

Dr. Mackey said the results suggest that if all newly diagnosed patients got the new regimen, it would mean 18,000 additional women would be alive five years after their diagnosis.

The current standard chemotherapy cocktail, FAC, includes 5-FU and two other drugs, Adriamycin and Cytoxan. In the study, patients got either the 5-FU or Taxotere, but the companion medicines remained the same. Dr. Mackey said the results were essentially the same for all women in the study — whether they were pre- or postmenopausal and whether their tumors were considered sensitive to estrogen or not.

Taxotere is already approved for women with advanced, or metastatic, breast cancer, among other indications. Aventis, which supported the study, said it plans to use the results to file in the U.S., Europe and Japan in the first quarter of next year for approval to use the drug in early stage breast cancer.

The presentation of the findings at the meeting came on the heels of another report that was a boost for a new class of drugs called aromotase inhibitors in long-term treatment for some breast-cancer patients. Currently, women with what is characterized as estrogen-positive breast cancer take tamoxifen for as long as five years to help keep the tumors from coming back. The study, involving 448 post-menopausal women, found that switching from tamoxifen to AstraZeneca PLC’s drug Arimidex significantly reduced chances of the cancer’s recurrence.

A larger study, published recently in the New England Journal of Medicine, found that Femara, an aromatase inhibitor marketed by Novartis AG, sharply reduced risk of cancer recurrence among women starting the drug after completing five years on tamoxifen.

Separately, biotech company American Pharmaceutical Partners Inc. released the clinical data behind a previously reported study showing that its altered form of the breast cancer drug Taxol worked better at higher doses than the original drug, with a lesser incidence of most side effects. The company’s formulation encapsulates the active ingredient of Bristol-Myers Squibb Co.’s Taxol, paclitaxel, in a protein called albumin.

In September, American Pharmaceutical said its drug, Abraxane, had outperformed Taxol in the late-stage study involving 454 patients with cancer that had spread to other parts of the body. It released the data Friday at the San Antonio cancer symposium. Because the altered drug is designed to lead to a safer treatment regimen, higher doses can be used. In the Phase III trial, American Pharmaceutical used 50% more paclitaxel than standard Taxol.

The company said 33% of patients receiving Abraxane for three weeks saw shrinkages in their tumors compared with 19% of those taking Taxol over the same period, a difference that was highly statistically significant, according to Reuters news service. Moreover, the average patient taking Abraxane did not experience a worsening of symptoms for 21.9 weeks, compared with 16.1 weeks for those on Taxol, also a statistically significant advantage.

Write to Ron Winslow at ron.winslow@wsj.com and Julia Flynn at julia.flynn@wsj.com

Updated December 8, 2003 1:06 a.m.

TAC Links

Description of the Breast Cancer International Research Group (BCIRG) study and their protocol:

• http://www.bcirg.org/Internet/Studies/BCIRG+001.htm

Abstract and slides from SABCS presentation:

• http://www.abstracts2view.com/bcs03/view.php?nu=BCS3L_775
• http://www.aventis.com/main/attachments/98944820031208104011.pdf

On-demand audio re-broadcast of a 8-Dec-2003 conference call (by Aventis, the manufacturer of Taxotere) includes the SABCS presenter walking though his slides:

• http://aventis.nc3.de/webcast_2003_sabcs/popup.htm

Additional information about the study (mostly press releases) is available on the web:

• http://www.medicine-news.com/articles/texte/2003/December/text1.html
• http://www.aventis.com/main/page.asp?pageid=61596220031205002009&lang=en
• http://www.eurekalert.org/pub_releases/2003-12/cw-mai120503.php

BRCA1 and BRCA2 Links

Understanding the relation between genetics and breast cancer

• http://www.curetoday.com/backissues/v2n3/departments/earlydetection/index.html

Prevalence of BRCA1 and BRCA2 mutations

• http://www.myriadtests.com/provider/mutprev.htm

Benefits of testing for BRCA1 BRCA2

• http://www.myriadtests.com/provider/benefits_brac.htm

How to gather family history information in preparation for genetic counseling

• https://cancerhistory.myriadtests.com/myriadmain.php

Posted by Nello at December 17, 2003 5:01 PM

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