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Studies Question a Breast Cancer Chemo Mainstay

Common Breast Cancer Chemo Drug Questioned; New Option May Offer More

Benefits

http://abcnews.go.com/Health/OnCallPlusBreastCancerNews/Story?id=4001402 &

page=1

By AUDREY GRAYSON

ABC News Medical Unit

Dec. 14, 2007

Support for a traditional mainstay of breast cancer chemotherapy treatment

may erode after two new studies find that the drug may only benefit a subset of

women with the disease.

Anthracyclines -- a commonly used class of chemotherapy drugs that also have

antibiotic properties -- can cause unpleasant side effects such as nausea,

vomiting and, in some cases, serious heart problems.

Being able to reliably tell which breast cancer patients would not likely

benefit from the drugs would help doctors spare many women these toxic side

effects.

Results from two studies presented Thursday at the 30th annual San

Breast Cancer Symposium now reveal that only women with HER2 positive breast

cancer -- a subset which accounts for only about 8 percent of women with breast

cancer worldwide -- will benefit significantly from standard

anthracycline-based chemotherapy.

Moreover, the research suggests that a different, investigative approach to

chemo, which combines Taxotere (doxetaxel)-based therapy with cyclophosphamide,

may offer better chances of survival -- along with less severe side effects.

Anthracycline-based therapies spurred controversy within the medical

community when they were first introduced nearly 30 years ago. But the

contention over

the benefit-to-risk ratio of anthracyclines was put to rest when the Oxford

Review published evidence supporting this treatment in 1993, citing that use of

the anthracycline treatment regimen improved chances of overall survival by 4

to 5 percent.

But Dr. Dennis Slamon, lead investigator of the study presented at SABCS

Thursday and chief of the division of hematology/oncology at UCLA's Jonsson

Comprehensive Cancer Center, said that his study found that there was actually

no

benefit whatsoever from the anthracycline treatment in breast cancer patients

who did not have HER2 positive breast cancer.

" It's a subgroup of a subgroup [of breast cancer patients] who have this

[HER2 positive] alteration that gives us huge benefit of anthracycline, giving

us

the illusion that in all of breast cancer there's this 4 to 5 percent

benefit, " he said. " In fact, there's a 30 percent [improvement in overall

survival] in

this small subgroup that was dragging the whole group up. ? And that was

dictating treatment decisions for the last almost three decades. "

A New Chemo Option?In the second study, researchers looked at more than 1,000

breast cancer patients who either took a combination of an anthracycline and

cyclophosphamide (AC) or the investigational Taxotere and cyclophosphamide

(TC) treatment.

What they found was that women treated with TC had a 31 percent reduction in

death risk. Moreover, women treated with TC were 26 percent less likely to

have their breast cancer return.

" The take-home message is that we have developed a chemotherapy regimen that

really is really practice-changing, " said Dr. , lead investigator

of the study and medical director and co-chairman of the Breast Cancer

Research Committee of U.S. Oncology Research Inc.

" This treatment with Taxotere-cyclophosphamide is more effective than one of

the standard regimens that has been standard for more than 30 years, and has

less potentially serious long-term side effects as well as immediate side

effects. "

Until now, a more effective treatment than standard anthracycline-based chemo

has never been available.

, himself a pioneer in the development of anthracycline-based

chemotherapy treatment nearly 30 years ago, said the benefit from the TC

combination was

observed across all patient groups, regardless of their age or even the type

of breast cancer they had.

" What we saw was benefit across all subgroups, " he said. " We did an analysis

of HER2 patients ? and saw that they benefited better [from TC] than with

standard treatment. We looked at HER2 negative patients, HER2 receptor positive

and node negative patients -- really in every subgroup we looked at TC was a

better treatment. "

Dr. Stefan Gluck, professor of medicine in the division of

hematology/oncology at the University of Miami, said that the new drug may be

the key to

offering effective treatment without the heart dangers posed by anthracyclines.

" Consequently, I have been using these regimens for the last two years or

so, " he said.

More Research NeededWhile many doctors believe these two studies have the

power to change the standard of care of breast cancer patients, some say that

further research into Taxotere is required before it will replace anthracyclines

as the standard of treatment.

" The only trouble with the studies was the fact that current treatment is not

AC [alone] but AC followed by Taxotere, " said Dr. Love, president and

medical director of the Dr. Love Breast Cancer Research Foundation.

" Since none of the studies addressed whether both was better than either alone,

it

is hard to say whether it will be practice-changing. "

Despite the continued doubt regarding the removal of anthracycline-based

regimens from breast cancer treatment, Slamon believes his and ' studies

reveal a crucial message about the current standard of breast cancer treatment.

" When you put [my study] in the context of what Dr. presented before

me, you can begin to see that understanding the molecular characterization of

the tumor allows us to throw away this one-size-fits-all approach [to breast

cancer treatment] where everyone receives an anthracycline, and use specific

therapies just for the right subclass of breast cancer [patients], " Slamon said.

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