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Anthracyclines May Not Be for Everyone: Report From the 29th Annual San

Breast Cancer Symposium

SAN ANTONIO, Dec. 18 /PRNewswire/ --

The anthracycline drugs used as a standard component of chemotherapy for

breast cancer patients (doxorubicin

and epirubicin) may cause serious side effects, including heart damage.

Women sometimes discontinue therapy, or avoid it altogether, because of

anxiety about the effects of these drugs. Unfortunately, some patients

will not respond to the drug, and will experience the often-devastating

side effects in vain. Now a report from the 29th Annual San

Breast Cancer Symposium suggests that there may be a straightforward way

to predict who will respond to anthracycline drugs, based on a commonly

measured tumor marker.

Multiple clinical trials have demonstrated reduced rates of cancer

recurrence and increased overall survival in patients receiving

anthracycline- containing regimens compared with those receiving

cyclophosphamide, methotrexate, and 5-fluorouracil (CMF), another

commonly used combination drug regimen.

At the Sunday morning General Session of the Symposium, Alessandra

Gennari, MD, from the National Cancer Research Institute in Genoa,

Italy, presented her research on the interaction between HER2 status and

response to chemotherapy containing anthracycline drugs. HER2 is a

protein that is

found on the surface of cells, and in some patients is related to the

uncontrolled growth of tumors. HER2 is the target of trastuzumab, a

targeted therapy that has been used in some breast cancer patients.

An interaction between HER2 status and response to doxorubicin has

been reported in some studies, but not in others. There have been

differences in

patient populations, differences in how HER2 is measured, and other

differences that make these studies difficult to compare. A major

problem has been that many of these studies enrolled too few patients,

making it difficult to determine if small or moderate variances are

important, or if they are just due to chance. Larger studies can be

conducted, but they are extremely expensive, and frequently take many

years to accrue enough patients.

Dr. Gennari and colleagues approached this problem by using a meta-

analytic approach to combine the results of published studies.

Meta-analysis is a powerful statistical technique that takes data from

multiple studies and combines them in one large " virtual " clinical trial.

Since first introduced by Sir Peto in the 1970s, meta-analysis

has become a widely used tool to enable researchers to use data that are

already available to answer clinically important questions.

Dr. Gennari identified several published studies that used

anthracycline- containing chemotherapeutic regimens and recorded

patients' HER2 status. Considered individually, these studies reported

contradictory results. For disease-free survival, a measure of how soon

cancer recurs, two of these studies showed that HER2 status had a

significant impact on response to anthracyclines, one showed a

borderline interaction, three showed no interaction, and one did not

measure disease-free survival. A similar picture was seen for overall

survival.

When the studies were combined in the meta-analysis, however,

anthracycline treatment was associated with a 29% decrease in risk of

relapse and a 27% decrease in risk of death in HER2-positive patients,

but had no effect on outcomes in HER2-negative patients.

Because HER2 status is now commonly measured in most women with

breast cancer, this breakthrough finding, if substantiated, will provide

a powerful new tool to help the patient and her physician make the best

possible choice of treatment.

SOURCE San Breast Cancer Symposium

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Hi Anne,

Are those percentages, 27 and 29, relative or absolute. Thanks for

any insight you can give.

Ruth

>

> Anthracyclines May Not Be for Everyone: Report From the 29th

Annual San

> Breast Cancer Symposium

>

> SAN ANTONIO, Dec. 18 /PRNewswire/ --

>

> The anthracycline drugs used as a standard component of

chemotherapy for

> breast cancer patients (doxorubicin

> and epirubicin) may cause serious side effects, including heart

damage.

> Women sometimes discontinue therapy, or avoid it altogether,

because of

> anxiety about the effects of these drugs. Unfortunately, some

patients

> will not respond to the drug, and will experience the often-

devastating

> side effects in vain. Now a report from the 29th Annual San

> Breast Cancer Symposium suggests that there may be a

straightforward way

> to predict who will respond to anthracycline drugs, based on a

commonly

> measured tumor marker.

>

> Multiple clinical trials have demonstrated reduced rates of

cancer

> recurrence and increased overall survival in patients receiving

> anthracycline- containing regimens compared with those receiving

> cyclophosphamide, methotrexate, and 5-fluorouracil (CMF), another

> commonly used combination drug regimen.

>

> At the Sunday morning General Session of the Symposium,

Alessandra

> Gennari, MD, from the National Cancer Research Institute in Genoa,

> Italy, presented her research on the interaction between HER2

status and

> response to chemotherapy containing anthracycline drugs. HER2 is a

> protein that is

> found on the surface of cells, and in some patients is related to

the

> uncontrolled growth of tumors. HER2 is the target of trastuzumab, a

> targeted therapy that has been used in some breast cancer patients.

>

> An interaction between HER2 status and response to

doxorubicin has

> been reported in some studies, but not in others. There have been

> differences in

> patient populations, differences in how HER2 is measured, and other

> differences that make these studies difficult to compare. A major

> problem has been that many of these studies enrolled too few

patients,

> making it difficult to determine if small or moderate variances

are

> important, or if they are just due to chance. Larger studies can

be

> conducted, but they are extremely expensive, and frequently take

many

> years to accrue enough patients.

>

> Dr. Gennari and colleagues approached this problem by using a

meta-

> analytic approach to combine the results of published studies.

> Meta-analysis is a powerful statistical technique that takes data

from

> multiple studies and combines them in one large " virtual " clinical

trial.

>

> Since first introduced by Sir Peto in the 1970s, meta-

analysis

> has become a widely used tool to enable researchers to use data

that are

> already available to answer clinically important questions.

>

> Dr. Gennari identified several published studies that used

> anthracycline- containing chemotherapeutic regimens and recorded

> patients' HER2 status. Considered individually, these studies

reported

> contradictory results. For disease-free survival, a measure of how

soon

> cancer recurs, two of these studies showed that HER2 status had a

> significant impact on response to anthracyclines, one showed a

> borderline interaction, three showed no interaction, and one did

not

> measure disease-free survival. A similar picture was seen for

overall

> survival.

>

> When the studies were combined in the meta-analysis, however,

> anthracycline treatment was associated with a 29% decrease in risk

of

> relapse and a 27% decrease in risk of death in HER2-positive

patients,

> but had no effect on outcomes in HER2-negative patients.

>

> Because HER2 status is now commonly measured in most women

with

> breast cancer, this breakthrough finding, if substantiated, will

provide

> a powerful new tool to help the patient and her physician make the

best

> possible choice of treatment.

>

> SOURCE San Breast Cancer Symposium

>

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Share on other sites

Hi Ruth,

This is (not Anne the doctor).

I don't know if these percentages are relative or absolute, but I saw

this other article on the Her2 board. This article includes relative

numbers, but is also stating adriamycin may not be worth the risk.

-

------------------

SAN ANTONIO, Dec. 15 -- Breast cancer patients may get similar benefit

with less cardiotoxicity if the anthracycline Adriamycin (doxorubicin)

is dropped from the adjuvant chemotherapy regimen containing Taxotere

(docetaxel) and Herceptin (trastuzumab).

So found the second interim analysis of the Breast Cancer International

Research Group study (BCIRG 006), reported Dennis Slamon, M.D., Ph.D.,

of the University of California in Los Angeles, at the San

Breast Cancer Symposium. Action Points

Explain to interested patients that the study suggests that Adriamycin

may not be necessary in chemotherapy regimens containing Taxotere and

Herceptin, but further study is needed.

This study was published as an abstract and presented orally at a

conference. These data and conclusions should be considered to be

preliminary as they have not yet been reviewed and published in a

peer-reviewed publication.

The second interim analysis included 3,222 patients with early stage

HER2-positive breast cancer followed for a mean of three years. The

patients were randomized to receive adjuvant therapy consisting of

Herceptin-Paraplatin-Taxotere or Adriamycin-Cytoxan-Taxotere-Herceptin

or the control regimen Adriamycin-Cytoxan-Taxotere.

Disease-free survival advantage at three years was similar between the

Herceptin-containing arms with and without Adriamycin (6% and 5%,

respectively), he said.

There was a reduction in relative mortality for the Herceptin- and

Adriamycin-containing arm (41%, P<0.0041 versus the regimen without

Herceptin, designated as control) compared with the non-Adriamycin arm

(34%, P<0.017 versus control).

However, the advantage was overshadowed by an increase in cardiac and

leukemia toxicity in the Adriamycin- and Herceptin-containing arms

compared with the arm without Adriamycin, Dr. Slamon said. There was

five times the risk of significant cardiotoxicity in the Adriamycin- and

Herceptin-containing arm compared with the non-Adriamycin arm.

Although Adriamycin has been a mainstay of breast cancer therapy, Dr.

Slamon said, " If we are causing more problems than we are solving, I

think we need to do something different. " Some cardiologists have

complained that with the use of anthracyclines, oncologists are merely

exchanging death by breast cancer with death by congestive heart failure.

At baseline, patient characteristics were similar between arms with a

mean age 49 and 54% hormone receptor positive and 29% axillary lymph

node negative in each. By three years, there were 462 disease-free

survival events including 185 deaths.

Compared to the control arm at the three year follow up, the researchers

reported:

The relative reduction in the risk of relapse was 39% (P<0.001) for the

Adriamycin- and Herceptin-containing arm and 33% (P=0.0003) for the

Herceptin arm without Adriamycin,

The hazard ratios for disease free survival were 0.61 (95% confidence

interval 0.48 to 0.76, P<0.0001) and 0.67 (95% CI 0.54 to 0.83,

P=0.0003), respectively,

Overall survival was 92% for the Adriamycin- and Herceptin-containing

arm and 91% for the non-Adriamycin Herceptin arm compared to 86% in the

control arm, and

The hazard ratios for disease free survival were 0.59 (95% CI 0.42 to

0.85, P=0.004) and 0.66 (95% CI 0.47 to 0.93, P=0.017), respectively.

Regarding toxicity for the Adriamycin- and Herceptin-containing arm

compared to the Herceptin arm without Adriamycin, the researchers reported:

Fewer cases of congestive heart failure (four versus 20, P=0.0015),

Fewer asymptomatic left ventricular ejection fraction declines (8.6

versus 18, P<0.0001),

Fewer cases of leukemia (four in Adriamycin-containing arms versus none

in the non-Adriamycin arm),

More grade 3 and 4 thrombocytopenia (5.4% versus 1.2%), and

More grade 3 and 4 anemia (5.8% versus 3.1%).

" The 006 update for HER2 positive malignancies shows the difference in

the number of disease free survival events and breast cancer deaths in

favor of [Adriamycin-Cyclophosphamide-Taxotere-Herceptin], neither of

which are statistically significant, is now exceeded by the number of

critical adverse events, " Dr. Slamon said.

He said this should raise the question as to what the role of

anthracyclines are in the adjuvant treatment of breast cancer.

However, it may be premature to call for eliminating anthracyclines from

the HER2 positive breast cancer armamentarium, said Shail Verma, M.D.,

of the Ottawa Cancer Center in Ottawa, who was uninvolved in the study.

" They are well on their way out, " he said. " The last thing you want to

see is a woman die in the adjuvant setting. "

The study was sponsored by Sanofi-Aventis and Genentech. Dr. Verma had

no relevant financial disclosures.

Primary source: San Breast Cancer Symposium

Source reference:

Slamon D, et al " BCIRG 006: 2nd interim analysis phase III randomized

trial comparing doxorubicin and cyclophosphamide followed by docetaxel

(AC→T) with doxorubicin and cyclophosphamide followed by docetaxel and

trastuzumab (AC→TH) with docetaxel, carboplatin and trastuzumab (TCH) in

Her2neu positive early breast cancer patients " SABCS 2006; General

Session 2: Abstract 52.

ruthiema36 wrote on 12/18/2006, 3:59 PM:

> Hi Anne,

> Are those percentages, 27 and 29, relative or absolute. Thanks for

> any insight you can give.

> Ruth

>

>

> >

> > Anthracyclines May Not Be for Everyone: Report From the 29th

> Annual San

> > Breast Cancer Symposium

> >

> > SAN ANTONIO, Dec. 18 /PRNewswire/ --

> >

> > The anthracycline drugs used as a standard component of

> chemotherapy for

> > breast cancer patients (doxorubicin

> > and epirubicin) may cause serious side effects, including heart

> damage.

> > Women sometimes discontinue therapy, or avoid it altogether,

> because of

> > anxiety about the effects of these drugs. Unfortunately, some

> patients

> > will not respond to the drug, and will experience the often-

> devastating

> > side effects in vain. Now a report from the 29th Annual San

>

> > Breast Cancer Symposium suggests that there may be a

> straightforward way

> > to predict who will respond to anthracycline drugs, based on a

> commonly

> > measured tumor marker.

> >

> > Multiple clinical trials have demonstrated reduced rates of

> cancer

> > recurrence and increased overall survival in patients receiving

> > anthracycline- containing regimens compared with those receiving

> > cyclophosphamide, methotrexate, and 5-fluorouracil (CMF), another

> > commonly used combination drug regimen.

> >

> > At the Sunday morning General Session of the Symposium,

> Alessandra

> > Gennari, MD, from the National Cancer Research Institute in Genoa,

> > Italy, presented her research on the interaction between HER2

> status and

> > response to chemotherapy containing anthracycline drugs. HER2 is a

> > protein that is

> > found on the surface of cells, and in some patients is related to

> the

> > uncontrolled growth of tumors. HER2 is the target of trastuzumab, a

> > targeted therapy that has been used in some breast cancer patients.

> >

> > An interaction between HER2 status and response to

> doxorubicin has

> > been reported in some studies, but not in others. There have been

> > differences in

> > patient populations, differences in how HER2 is measured, and other

> > differences that make these studies difficult to compare. A major

> > problem has been that many of these studies enrolled too few

> patients,

> > making it difficult to determine if small or moderate variances

> are

> > important, or if they are just due to chance. Larger studies can

> be

> > conducted, but they are extremely expensive, and frequently take

> many

> > years to accrue enough patients.

> >

> > Dr. Gennari and colleagues approached this problem by using a

> meta-

> > analytic approach to combine the results of published studies.

> > Meta-analysis is a powerful statistical technique that takes data

> from

> > multiple studies and combines them in one large " virtual " clinical

> trial.

> >

> > Since first introduced by Sir Peto in the 1970s, meta-

> analysis

> > has become a widely used tool to enable researchers to use data

> that are

> > already available to answer clinically important questions.

> >

> > Dr. Gennari identified several published studies that used

> > anthracycline- containing chemotherapeutic regimens and recorded

> > patients' HER2 status. Considered individually, these studies

> reported

> > contradictory results. For disease-free survival, a measure of how

> soon

> > cancer recurs, two of these studies showed that HER2 status had a

> > significant impact on response to anthracyclines, one showed a

> > borderline interaction, three showed no interaction, and one did

> not

> > measure disease-free survival. A similar picture was seen for

> overall

> > survival.

> >

> > When the studies were combined in the meta-analysis, however,

> > anthracycline treatment was associated with a 29% decrease in risk

> of

> > relapse and a 27% decrease in risk of death in HER2-positive

> patients,

> > but had no effect on outcomes in HER2-negative patients.

> >

> > Because HER2 status is now commonly measured in most women

> with

> > breast cancer, this breakthrough finding, if substantiated, will

> provide

> > a powerful new tool to help the patient and her physician make the

> best

> > possible choice of treatment.

> >

> > SOURCE San Breast Cancer Symposium

> >

>

>

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Share on other sites

Oops! Sorry and thanks for sending the following along. I have

decided against adriamycin and herceptin because of the

cardiotoxcity. I didn't know about the Leukemia aspect! Woah this

whole breast cancer thing is a crap shoot!!! Damned if you do and

damned if you don't.

Ruth

> > >

> > > Anthracyclines May Not Be for Everyone: Report From the 29th

> > Annual San

> > > Breast Cancer Symposium

> > >

> > > SAN ANTONIO, Dec. 18 /PRNewswire/ --

> > >

> > > The anthracycline drugs used as a standard component of

> > chemotherapy for

> > > breast cancer patients (doxorubicin

> > > and epirubicin) may cause serious side effects, including

heart

> > damage.

> > > Women sometimes discontinue therapy, or avoid it altogether,

> > because of

> > > anxiety about the effects of these drugs. Unfortunately, some

> > patients

> > > will not respond to the drug, and will experience the often-

> > devastating

> > > side effects in vain. Now a report from the 29th Annual San

> >

> > > Breast Cancer Symposium suggests that there may be a

> > straightforward way

> > > to predict who will respond to anthracycline drugs, based on a

> > commonly

> > > measured tumor marker.

> > >

> > > Multiple clinical trials have demonstrated reduced rates

of

> > cancer

> > > recurrence and increased overall survival in patients

receiving

> > > anthracycline- containing regimens compared with those

receiving

> > > cyclophosphamide, methotrexate, and 5-fluorouracil (CMF),

another

> > > commonly used combination drug regimen.

> > >

> > > At the Sunday morning General Session of the Symposium,

> > Alessandra

> > > Gennari, MD, from the National Cancer Research Institute in

Genoa,

> > > Italy, presented her research on the interaction between HER2

> > status and

> > > response to chemotherapy containing anthracycline drugs. HER2

is a

> > > protein that is

> > > found on the surface of cells, and in some patients is

related to

> > the

> > > uncontrolled growth of tumors. HER2 is the target of

trastuzumab, a

> > > targeted therapy that has been used in some breast cancer

patients.

> > >

> > > An interaction between HER2 status and response to

> > doxorubicin has

> > > been reported in some studies, but not in others. There have

been

> > > differences in

> > > patient populations, differences in how HER2 is measured, and

other

> > > differences that make these studies difficult to compare. A

major

> > > problem has been that many of these studies enrolled too few

> > patients,

> > > making it difficult to determine if small or moderate

variances

> > are

> > > important, or if they are just due to chance. Larger studies

can

> > be

> > > conducted, but they are extremely expensive, and frequently

take

> > many

> > > years to accrue enough patients.

> > >

> > > Dr. Gennari and colleagues approached this problem by

using a

> > meta-

> > > analytic approach to combine the results of published studies.

> > > Meta-analysis is a powerful statistical technique that takes

data

> > from

> > > multiple studies and combines them in one large " virtual "

clinical

> > trial.

> > >

> > > Since first introduced by Sir Peto in the 1970s, meta-

> > analysis

> > > has become a widely used tool to enable researchers to use

data

> > that are

> > > already available to answer clinically important questions.

> > >

> > > Dr. Gennari identified several published studies that

used

> > > anthracycline- containing chemotherapeutic regimens and

recorded

> > > patients' HER2 status. Considered individually, these studies

> > reported

> > > contradictory results. For disease-free survival, a measure

of how

> > soon

> > > cancer recurs, two of these studies showed that HER2 status

had a

> > > significant impact on response to anthracyclines, one showed a

> > > borderline interaction, three showed no interaction, and one

did

> > not

> > > measure disease-free survival. A similar picture was seen for

> > overall

> > > survival.

> > >

> > > When the studies were combined in the meta-analysis,

however,

> > > anthracycline treatment was associated with a 29% decrease in

risk

> > of

> > > relapse and a 27% decrease in risk of death in HER2-positive

> > patients,

> > > but had no effect on outcomes in HER2-negative patients.

> > >

> > > Because HER2 status is now commonly measured in most

women

> > with

> > > breast cancer, this breakthrough finding, if substantiated,

will

> > provide

> > > a powerful new tool to help the patient and her physician

make the

> > best

> > > possible choice of treatment.

> > >

> > > SOURCE San Breast Cancer Symposium

> > >

> >

> >

>

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When I went to the onc and was told I would go on Cytoxan, 5fu and Methotrexate,

he told me that somewhere down the line when I got older I could get leukemia as

a side effect of the Cytoxan. So far its been 16 1/2 yrs and I am doing ok. I

opted to take the Cytoxan figuring it was better to chance it than take a chance

of not being here had I opted not to take the chemo.

Hugs

nne

Breast Cancer Patients Soul Mates for Life

http://www.geocities.com/chucky5741/breastcancerpatients.html

BreastCancerStories.com

http://www.breastcancerstories.com/content/view/433/161/

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www.angelfeatherloomer.blogspot.com

Check out my other ornaments at

www.geocities.com/chucky5741/bcornament.html

Lots of info and gifts at:

www.cancerclub.com

Re: Anthracyclines May Not Be for Everyone: Report

From the 29th Annual San Breast Cancer Symposium

Oops! Sorry and thanks for sending the following along. I have

decided against adriamycin and herceptin because of the

cardiotoxcity. I didn't know about the Leukemia aspect! Woah this

whole breast cancer thing is a crap shoot!!! Damned if you do and

damned if you don't.

Ruth

> > >

> > > Anthracyclines May Not Be for Everyone: Report From the 29th

> > Annual San

> > > Breast Cancer Symposium

> > >

> > > SAN ANTONIO, Dec. 18 /PRNewswire/ --

> > >

> > > The anthracycline drugs used as a standard component of

> > chemotherapy for

> > > breast cancer patients (doxorubicin

> > > and epirubicin) may cause serious side effects, including

heart

> > damage.

> > > Women sometimes discontinue therapy, or avoid it altogether,

> > because of

> > > anxiety about the effects of these drugs. Unfortunately, some

> > patients

> > > will not respond to the drug, and will experience the often-

> > devastating

> > > side effects in vain. Now a report from the 29th Annual San

> >

> > > Breast Cancer Symposium suggests that there may be a

> > straightforward way

> > > to predict who will respond to anthracycline drugs, based on a

> > commonly

> > > measured tumor marker.

> > >

> > > Multiple clinical trials have demonstrated reduced rates

of

> > cancer

> > > recurrence and increased overall survival in patients

receiving

> > > anthracycline- containing regimens compared with those

receiving

> > > cyclophosphamide, methotrexate, and 5-fluorouracil (CMF),

another

> > > commonly used combination drug regimen.

> > >

> > > At the Sunday morning General Session of the Symposium,

> > Alessandra

> > > Gennari, MD, from the National Cancer Research Institute in

Genoa,

> > > Italy, presented her research on the interaction between HER2

> > status and

> > > response to chemotherapy containing anthracycline drugs. HER2

is a

> > > protein that is

> > > found on the surface of cells, and in some patients is

related to

> > the

> > > uncontrolled growth of tumors. HER2 is the target of

trastuzumab, a

> > > targeted therapy that has been used in some breast cancer

patients.

> > >

> > > An interaction between HER2 status and response to

> > doxorubicin has

> > > been reported in some studies, but not in others. There have

been

> > > differences in

> > > patient populations, differences in how HER2 is measured, and

other

> > > differences that make these studies difficult to compare. A

major

> > > problem has been that many of these studies enrolled too few

> > patients,

> > > making it difficult to determine if small or moderate

variances

> > are

> > > important, or if they are just due to chance. Larger studies

can

> > be

> > > conducted, but they are extremely expensive, and frequently

take

> > many

> > > years to accrue enough patients.

> > >

> > > Dr. Gennari and colleagues approached this problem by

using a

> > meta-

> > > analytic approach to combine the results of published studies.

> > > Meta-analysis is a powerful statistical technique that takes

data

> > from

> > > multiple studies and combines them in one large " virtual "

clinical

> > trial.

> > >

> > > Since first introduced by Sir Peto in the 1970s, meta-

> > analysis

> > > has become a widely used tool to enable researchers to use

data

> > that are

> > > already available to answer clinically important questions.

> > >

> > > Dr. Gennari identified several published studies that

used

> > > anthracycline- containing chemotherapeutic regimens and

recorded

> > > patients' HER2 status. Considered individually, these studies

> > reported

> > > contradictory results. For disease-free survival, a measure

of how

> > soon

> > > cancer recurs, two of these studies showed that HER2 status

had a

> > > significant impact on response to anthracyclines, one showed a

> > > borderline interaction, three showed no interaction, and one

did

> > not

> > > measure disease-free survival. A similar picture was seen for

> > overall

> > > survival.

> > >

> > > When the studies were combined in the meta-analysis,

however,

> > > anthracycline treatment was associated with a 29% decrease in

risk

> > of

> > > relapse and a 27% decrease in risk of death in HER2-positive

> > patients,

> > > but had no effect on outcomes in HER2-negative patients.

> > >

> > > Because HER2 status is now commonly measured in most

women

> > with

> > > breast cancer, this breakthrough finding, if substantiated,

will

> > provide

> > > a powerful new tool to help the patient and her physician

make the

> > best

> > > possible choice of treatment.

> > >

> > > SOURCE San Breast Cancer Symposium

> > >

> >

> >

>

------------------------------------------------------------------------------

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wowee ,

good to be informed i hope that i never need to have the chemo, but yeah catch

22 again, i must say i feel so much better off the arimidex due to my heart

problems and other side effects, makes you really think some days what to do for

the best, hugs to all sandy in oz

ruthiema36 ruthiema36@...> wrote:

Oops! Sorry and thanks for sending the following along. I have

decided against adriamycin and herceptin because of the

cardiotoxcity. I didn't know about the Leukemia aspect! Woah this

whole breast cancer thing is a crap shoot!!! Damned if you do and

damned if you don't.

Ruth

> > >

> > > Anthracyclines May Not Be for Everyone: Report From the 29th

> > Annual San

> > > Breast Cancer Symposium

> > >

> > > SAN ANTONIO, Dec. 18 /PRNewswire/ --

> > >

> > > The anthracycline drugs used as a standard component of

> > chemotherapy for

> > > breast cancer patients (doxorubicin

> > > and epirubicin) may cause serious side effects, including

heart

> > damage.

> > > Women sometimes discontinue therapy, or avoid it altogether,

> > because of

> > > anxiety about the effects of these drugs. Unfortunately, some

> > patients

> > > will not respond to the drug, and will experience the often-

> > devastating

> > > side effects in vain. Now a report from the 29th Annual San

> >

> > > Breast Cancer Symposium suggests that there may be a

> > straightforward way

> > > to predict who will respond to anthracycline drugs, based on a

> > commonly

> > > measured tumor marker.

> > >

> > > Multiple clinical trials have demonstrated reduced rates

of

> > cancer

> > > recurrence and increased overall survival in patients

receiving

> > > anthracycline- containing regimens compared with those

receiving

> > > cyclophosphamide, methotrexate, and 5-fluorouracil (CMF),

another

> > > commonly used combination drug regimen.

> > >

> > > At the Sunday morning General Session of the Symposium,

> > Alessandra

> > > Gennari, MD, from the National Cancer Research Institute in

Genoa,

> > > Italy, presented her research on the interaction between HER2

> > status and

> > > response to chemotherapy containing anthracycline drugs. HER2

is a

> > > protein that is

> > > found on the surface of cells, and in some patients is

related to

> > the

> > > uncontrolled growth of tumors. HER2 is the target of

trastuzumab, a

> > > targeted therapy that has been used in some breast cancer

patients.

> > >

> > > An interaction between HER2 status and response to

> > doxorubicin has

> > > been reported in some studies, but not in others. There have

been

> > > differences in

> > > patient populations, differences in how HER2 is measured, and

other

> > > differences that make these studies difficult to compare. A

major

> > > problem has been that many of these studies enrolled too few

> > patients,

> > > making it difficult to determine if small or moderate

variances

> > are

> > > important, or if they are just due to chance. Larger studies

can

> > be

> > > conducted, but they are extremely expensive, and frequently

take

> > many

> > > years to accrue enough patients.

> > >

> > > Dr. Gennari and colleagues approached this problem by

using a

> > meta-

> > > analytic approach to combine the results of published studies.

> > > Meta-analysis is a powerful statistical technique that takes

data

> > from

> > > multiple studies and combines them in one large " virtual "

clinical

> > trial.

> > >

> > > Since first introduced by Sir Peto in the 1970s, meta-

> > analysis

> > > has become a widely used tool to enable researchers to use

data

> > that are

> > > already available to answer clinically important questions.

> > >

> > > Dr. Gennari identified several published studies that

used

> > > anthracycline- containing chemotherapeutic regimens and

recorded

> > > patients' HER2 status. Considered individually, these studies

> > reported

> > > contradictory results. For disease-free survival, a measure

of how

> > soon

> > > cancer recurs, two of these studies showed that HER2 status

had a

> > > significant impact on response to anthracyclines, one showed a

> > > borderline interaction, three showed no interaction, and one

did

> > not

> > > measure disease-free survival. A similar picture was seen for

> > overall

> > > survival.

> > >

> > > When the studies were combined in the meta-analysis,

however,

> > > anthracycline treatment was associated with a 29% decrease in

risk

> > of

> > > relapse and a 27% decrease in risk of death in HER2-positive

> > patients,

> > > but had no effect on outcomes in HER2-negative patients.

> > >

> > > Because HER2 status is now commonly measured in most

women

> > with

> > > breast cancer, this breakthrough finding, if substantiated,

will

> > provide

> > > a powerful new tool to help the patient and her physician

make the

> > best

> > > possible choice of treatment.

> > >

> > > SOURCE San Breast Cancer Symposium

> > >

> >

> >

>

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  • 3 weeks later...

where is the Her2 board?

e

Re: Re: Anthracyclines May Not Be for Everyone:

Report From the 29th Annual San Breast Cancer Symposium

Hi Ruth,

This is (not Anne the doctor).

I don't know if these percentages are relative or absolute, but I saw

this other article on the Her2 board. This article includes relative

numbers, but is also stating adriamycin may not be worth the risk.

-

------------------

SAN ANTONIO, Dec. 15 -- Breast cancer patients may get similar benefit

with less cardiotoxicity if the anthracycline Adriamycin (doxorubicin)

is dropped from the adjuvant chemotherapy regimen containing Taxotere

(docetaxel) and Herceptin (trastuzumab).

So found the second interim analysis of the Breast Cancer International

Research Group study (BCIRG 006), reported Dennis Slamon, M.D., Ph.D.,

of the University of California in Los Angeles, at the San

Breast Cancer Symposium. Action Points

Explain to interested patients that the study suggests that Adriamycin

may not be necessary in chemotherapy regimens containing Taxotere and

Herceptin, but further study is needed.

This study was published as an abstract and presented orally at a

conference. These data and conclusions should be considered to be

preliminary as they have not yet been reviewed and published in a

peer-reviewed publication.

The second interim analysis included 3,222 patients with early stage

HER2-positive breast cancer followed for a mean of three years. The

patients were randomized to receive adjuvant therapy consisting of

Herceptin-Paraplatin-Taxotere or Adriamycin-Cytoxan-Taxotere-Herceptin

or the control regimen Adriamycin-Cytoxan-Taxotere.

Disease-free survival advantage at three years was similar between the

Herceptin-containing arms with and without Adriamycin (6% and 5%,

respectively), he said.

There was a reduction in relative mortality for the Herceptin- and

Adriamycin-containing arm (41%, P<0.0041 versus the regimen without

Herceptin, designated as control) compared with the non-Adriamycin arm

(34%, P<0.017 versus control).

However, the advantage was overshadowed by an increase in cardiac and

leukemia toxicity in the Adriamycin- and Herceptin-containing arms

compared with the arm without Adriamycin, Dr. Slamon said. There was

five times the risk of significant cardiotoxicity in the Adriamycin- and

Herceptin-containing arm compared with the non-Adriamycin arm.

Although Adriamycin has been a mainstay of breast cancer therapy, Dr.

Slamon said, " If we are causing more problems than we are solving, I

think we need to do something different. " Some cardiologists have

complained that with the use of anthracyclines, oncologists are merely

exchanging death by breast cancer with death by congestive heart failure.

At baseline, patient characteristics were similar between arms with a

mean age 49 and 54% hormone receptor positive and 29% axillary lymph

node negative in each. By three years, there were 462 disease-free

survival events including 185 deaths.

Compared to the control arm at the three year follow up, the researchers

reported:

The relative reduction in the risk of relapse was 39% (P<0.001) for the

Adriamycin- and Herceptin-containing arm and 33% (P=0.0003) for the

Herceptin arm without Adriamycin,

The hazard ratios for disease free survival were 0.61 (95% confidence

interval 0.48 to 0.76, P<0.0001) and 0.67 (95% CI 0.54 to 0.83,

P=0.0003), respectively,

Overall survival was 92% for the Adriamycin- and Herceptin-containing

arm and 91% for the non-Adriamycin Herceptin arm compared to 86% in the

control arm, and

The hazard ratios for disease free survival were 0.59 (95% CI 0.42 to

0.85, P=0.004) and 0.66 (95% CI 0.47 to 0.93, P=0.017), respectively.

Regarding toxicity for the Adriamycin- and Herceptin-containing arm

compared to the Herceptin arm without Adriamycin, the researchers reported:

Fewer cases of congestive heart failure (four versus 20, P=0.0015),

Fewer asymptomatic left ventricular ejection fraction declines (8.6

versus 18, P<0.0001),

Fewer cases of leukemia (four in Adriamycin-containing arms versus none

in the non-Adriamycin arm),

More grade 3 and 4 thrombocytopenia (5.4% versus 1.2%), and

More grade 3 and 4 anemia (5.8% versus 3.1%).

" The 006 update for HER2 positive malignancies shows the difference in

the number of disease free survival events and breast cancer deaths in

favor of [Adriamycin-Cyclophosphamide-Taxotere-Herceptin], neither of

which are statistically significant, is now exceeded by the number of

critical adverse events, " Dr. Slamon said.

He said this should raise the question as to what the role of

anthracyclines are in the adjuvant treatment of breast cancer.

However, it may be premature to call for eliminating anthracyclines from

the HER2 positive breast cancer armamentarium, said Shail Verma, M.D.,

of the Ottawa Cancer Center in Ottawa, who was uninvolved in the study.

" They are well on their way out, " he said. " The last thing you want to

see is a woman die in the adjuvant setting. "

The study was sponsored by Sanofi-Aventis and Genentech. Dr. Verma had

no relevant financial disclosures.

Primary source: San Breast Cancer Symposium

Source reference:

Slamon D, et al " BCIRG 006: 2nd interim analysis phase III randomized

trial comparing doxorubicin and cyclophosphamide followed by docetaxel

(AC→T) with doxorubicin and cyclophosphamide followed by docetaxel and

trastuzumab (AC→TH) with docetaxel, carboplatin and trastuzumab (TCH) in

Her2neu positive early breast cancer patients " SABCS 2006; General

Session 2: Abstract 52.

ruthiema36 wrote on 12/18/2006, 3:59 PM:

> Hi Anne,

> Are those percentages, 27 and 29, relative or absolute. Thanks for

> any insight you can give.

> Ruth

>

>

> >

> > Anthracyclines May Not Be for Everyone: Report From the 29th

> Annual San

> > Breast Cancer Symposium

> >

> > SAN ANTONIO, Dec. 18 /PRNewswire/ --

> >

> > The anthracycline drugs used as a standard component of

> chemotherapy for

> > breast cancer patients (doxorubicin

> > and epirubicin) may cause serious side effects, including heart

> damage.

> > Women sometimes discontinue therapy, or avoid it altogether,

> because of

> > anxiety about the effects of these drugs. Unfortunately, some

> patients

> > will not respond to the drug, and will experience the often-

> devastating

> > side effects in vain. Now a report from the 29th Annual San

>

> > Breast Cancer Symposium suggests that there may be a

> straightforward way

> > to predict who will respond to anthracycline drugs, based on a

> commonly

> > measured tumor marker.

> >

> > Multiple clinical trials have demonstrated reduced rates of

> cancer

> > recurrence and increased overall survival in patients receiving

> > anthracycline- containing regimens compared with those receiving

> > cyclophosphamide, methotrexate, and 5-fluorouracil (CMF), another

> > commonly used combination drug regimen.

> >

> > At the Sunday morning General Session of the Symposium,

> Alessandra

> > Gennari, MD, from the National Cancer Research Institute in Genoa,

> > Italy, presented her research on the interaction between HER2

> status and

> > response to chemotherapy containing anthracycline drugs. HER2 is a

> > protein that is

> > found on the surface of cells, and in some patients is related to

> the

> > uncontrolled growth of tumors. HER2 is the target of trastuzumab, a

> > targeted therapy that has been used in some breast cancer patients.

> >

> > An interaction between HER2 status and response to

> doxorubicin has

> > been reported in some studies, but not in others. There have been

> > differences in

> > patient populations, differences in how HER2 is measured, and other

> > differences that make these studies difficult to compare. A major

> > problem has been that many of these studies enrolled too few

> patients,

> > making it difficult to determine if small or moderate variances

> are

> > important, or if they are just due to chance. Larger studies can

> be

> > conducted, but they are extremely expensive, and frequently take

> many

> > years to accrue enough patients.

> >

> > Dr. Gennari and colleagues approached this problem by using a

> meta-

> > analytic approach to combine the results of published studies.

> > Meta-analysis is a powerful statistical technique that takes data

> from

> > multiple studies and combines them in one large " virtual " clinical

> trial.

> >

> > Since first introduced by Sir Peto in the 1970s, meta-

> analysis

> > has become a widely used tool to enable researchers to use data

> that are

> > already available to answer clinically important questions.

> >

> > Dr. Gennari identified several published studies that used

> > anthracycline- containing chemotherapeutic regimens and recorded

> > patients' HER2 status. Considered individually, these studies

> reported

> > contradictory results. For disease-free survival, a measure of how

> soon

> > cancer recurs, two of these studies showed that HER2 status had a

> > significant impact on response to anthracyclines, one showed a

> > borderline interaction, three showed no interaction, and one did

> not

> > measure disease-free survival. A similar picture was seen for

> overall

> > survival.

> >

> > When the studies were combined in the meta-analysis, however,

> > anthracycline treatment was associated with a 29% decrease in risk

> of

> > relapse and a 27% decrease in risk of death in HER2-positive

> patients,

> > but had no effect on outcomes in HER2-negative patients.

> >

> > Because HER2 status is now commonly measured in most women

> with

> > breast cancer, this breakthrough finding, if substantiated, will

> provide

> > a powerful new tool to help the patient and her physician make the

> best

> > possible choice of treatment.

> >

> > SOURCE San Breast Cancer Symposium

> >

>

>

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Hi e,

It's her2support.org

It has alot of useful info & good support from women who are Her2neu

positive.

Soft-answer wrote on 1/6/2007, 1:21 AM:

> where is the Her2 board?

>

> e

>

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