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Aromatase inhibitors: side effects reported by 622 women.

Salgado BA, Zivian MT.. Breast Cancer Action, San Francisco, CA

http://www.bcaction.org/PDF/AIReport.pdf for complete survey results

Background: Aromatase inhibitors (anastrozole, letrozole, and exemestane) are

quickly becoming one of the most commonly prescribed breast cancer treatments

for postmenopausal women with breast cancer. Because these drugs have only been

approved for use recently, and two of the three aromatase inhibitors moved

quickly into the treatment setting due to FDA Priority Review or Accelerated

Approval status, little is known about their short and long-term side effects.

Previous trials of aromatase inhibitors have reported some adverse effects. The

purpose of this survey is to collect information from patients on the side

effects of aromatase inhibitors.

Methods: An Aromatase Inhibitor Side Effects Survey (AI Survey) was posted to

the Breast Cancer Action web site in August 2005. Additionally, other breast

cancer and womens health organizations announced the AI survey through

newsletters, emails and web site links. Despite the limitations and biases that

self-reporting introduces, patient-derived data on treatment side effects are

clinically meaningful for both doctors and patients. The survey included

demographic questions, questions concerning the aromatase inhibitor prescribed,

and questions regarding medical condition. These were followed by a list of 38

side effects that respondents rated for severity. The surveys side effects list

was compiled from side effects listed on the FDA labels for aromatase

inhibitors. Respondents were also asked if they had experienced any unlisted

side effects. Over 600 completed surveys were received and included in the data

set. Data were analyzed using SPSS (Version 14.0 for Windows).

Results: The distribution of the survey respondents from the United States

reflects the expected distribution based on of the incidence of breast cancer

throughout the country (p < .01). Among the women who discontinued using an AI,

exemestane was taken for a significantly shorter period of time (8 months) than

either letrozole (15 months) or anastrazole (29 months) (p = .002). Over 60% of

the respondents reported experiencing stroke and cough. Over 50% reported

swelling of limbs, and flu-like symptoms. Women 30-39 years-old gave the highest

severity ratings to stroke; women 50-59 years-old women gave highest severity

ratings to cough (p < .000). In addition to reporting on the side effects listed

in the survey, respondents reported experiencing over 35 additional side

effects.

Discussion: Recent advances have led to the development of aromatase inhibitors

for adjuvant treatment of postmenopausal breast cancer patients. However, many

patients are experiencing adverse effects which can be disabling and may lead to

cessation of therapy. Patients and doctors should discuss possible side effects

before beginning treatment with aromatase inhibitors so that patients are able

to make fully informed decisions. The side effects information from this survey

will also assist doctors with patient management for those currently taking

aromatase inhibitors.

From BCAction

About Aromatase Inhibitors

Aromatase inhibitors are a type of hormone therapy for postmenopausal women with

breast cancer. AIs prevent the aromatase enzyme from converting the hormone

androgen into estrogen. Produced by the adrenal gland and found throughout the

body, androgen is the principal source of estrogen for postmenopausal women. AIs

have only been approved for use by postmenopausal women. They are ineffective in

premenopausal women whose ovaries are still producing estrogen (which is not

affected by the aromatase enzyme). None of these drugs has been approved by the

FDA for use by healthy women at high risk of developing breast cancer.

Three AIs are currently approved by the FDA for the treatment of breast cancer

in postmenopausal women: anastrozole (Arimidex), exemestane (Aromasin), and

letrozole (Femara). Anastrozole and letrozole are both nonsteroidal aromatase

inhibitors. Th ey are described as reversible because they bind reversibly to

the aromatase enzyme.

Exemestane is a steroidal inhibitor that forms an irreversible bond with the

aromatase enzyme, permanently stopping the activity of the enzyme.

Anastrozole (Arimidex)

Arimidex is indicated for adjuvant treatment of postmenopausal women with

hormone-receptor-positive early breast cancer.

Arimidex is indicated for the fi rst-line treatment of postmenopausal women with

hormone-receptor-positive or hormone-receptor-unknown locally advanced or

metastatic breast cancer.

Arimidex is indicated for the treatment of advanced breast cancer in

postmenopausal women with disease progression following tamoxifen therapy.

Exemestane (Aromasin)

Aromasin is indicated for adjuvant treatment of postmenopausal women with

estrogen-receptor-positive early breast cancer who have received two to three

years of tamoxifen and are switched to Aromasin for completion of a total of fi

ve consecutive years of adjuvant hormonal therapy.

Aromasin is indicated for the treatment of advanced breast cancer in

postmenopausal women whose disease has progressed following tamoxifen therapy.

Letrozole (Femara)

Femara is indicated for the adjuvant treatment of postmenopausal women with

hormone-receptor-positive early breast cancer.

Femara is indicated for the extended adjuvant treatment of early breast cancer

in postmenopausal women who have received fi ve years of adjuvant tamoxifen

therapy.

Femara is indicated for fi rst-line treatment of postmenopausal women with

hormone-receptor-positive or hormone-receptor-unknown locally advanced or

metastatic breast cancer.

Femara is also indicated for the treatment of advanced breast cancer in

postmenopausal women with disease progression following anti-estrogen therapy.

Summary of Findings

The first 612 completed surveys received were analyzed for this report. Major

findings include:

1. Most respondents (96%) reported one or more side effects.

2. The side effects reported by over 50% of respondents were: stroke (65%),

cough (64%), swelling of the arms and legs (59%), fl u-like symptoms (58%), and

anxiety (51%).

3. Many women reported side effects in addition to those on our list, including

joint-related side effects, vaginal atrophy and dryness, a rise in cholesterol

levels, and general pain.

4. Over 50% of respondents stated that their menopause was not naturally

occurring. For these women, menopause was either pharmaceutically or surgically

induced.

5. Ten women (1.6%) reported that they discontinued using an AI because of

subsequent menstruation or vaginal bleeding.

6. About 30% of the respondents discontinued the use of an AI­84% because of

side effects they were experiencing, and close to half of them (47%)

specifically because of joint-related side effects.

7. Over one-third (37%) of respondents reported receiving no information from

their doctors about short-term side effects; nearly two-thirds (63%) reported

receiving no information from their doctors about long-term side effects.

Recommendations

1. Conduct additional research on short-term and long-term side effects of AIs.

2. Provide the results of this research to doctors and patients.

3. Use caution when prescribing AIs to perimenopausal women, as well as to

premenopausal women who have been rendered menopausal by chemotherapy or ovarian

function suppression.

+++++++++++++++++++++++++++++++++++++++++++++++

BCO News is brought to you by BREAST CANCER OPTIONS, a grassroots organization

focusing on Health Advocacy, Support and Education. The information is intended

for educational purposes only, in order to help you make informed health choices

and may not have been touched upon by your doctors. We are not doctors and we do

not recommend any particular treatments. We are sending this information to

advise you of the complete scientific overview that is currently available,

although we may not necessarily endorse it. http://www.breastcanceroptions.org

Link to comment
Share on other sites

Thank you nne, this is most appreciated!

Ruth

>

> Aromatase inhibitors: side effects reported by 622 women.

> Salgado BA, Zivian MT.. Breast Cancer Action, San Francisco, CA

> http://www.bcaction.org/PDF/AIReport.pdf for complete survey results

>

> Background: Aromatase inhibitors (anastrozole, letrozole, and

exemestane) are quickly becoming one of the most commonly prescribed

breast cancer treatments for postmenopausal women with breast cancer.

Because these drugs have only been approved for use recently, and two

of the three aromatase inhibitors moved quickly into the treatment

setting due to FDA Priority Review or Accelerated Approval status,

little is known about their short and long-term side effects. Previous

trials of aromatase inhibitors have reported some adverse effects. The

purpose of this survey is to collect information from patients on the

side effects of aromatase inhibitors.

>

> Methods: An Aromatase Inhibitor Side Effects Survey (AI Survey) was

posted to the Breast Cancer Action web site in August 2005.

Additionally, other breast cancer and womens health organizations

announced the AI survey through newsletters, emails and web site

links. Despite the limitations and biases that self-reporting

introduces, patient-derived data on treatment side effects are

clinically meaningful for both doctors and patients. The survey

included demographic questions, questions concerning the aromatase

inhibitor prescribed, and questions regarding medical condition. These

were followed by a list of 38 side effects that respondents rated for

severity. The surveys side effects list was compiled from side effects

listed on the FDA labels for aromatase inhibitors. Respondents were

also asked if they had experienced any unlisted side effects. Over 600

completed surveys were received and included in the data set. Data

were analyzed using SPSS (Version 14.0 for Windows).

>

> Results: The distribution of the survey respondents from the United

States reflects the expected distribution based on of the incidence of

breast cancer throughout the country (p < .01). Among the women who

discontinued using an AI, exemestane was taken for a significantly

shorter period of time (8 months) than either letrozole (15 months) or

anastrazole (29 months) (p = .002). Over 60% of the respondents

reported experiencing stroke and cough. Over 50% reported swelling of

limbs, and flu-like symptoms. Women 30-39 years-old gave the highest

severity ratings to stroke; women 50-59 years-old women gave highest

severity ratings to cough (p < .000). In addition to reporting on the

side effects listed in the survey, respondents reported experiencing

over 35 additional side effects.

>

> Discussion: Recent advances have led to the development of aromatase

inhibitors for adjuvant treatment of postmenopausal breast cancer

patients. However, many patients are experiencing adverse effects

which can be disabling and may lead to cessation of therapy. Patients

and doctors should discuss possible side effects before beginning

treatment with aromatase inhibitors so that patients are able to make

fully informed decisions. The side effects information from this

survey will also assist doctors with patient management for those

currently taking aromatase inhibitors.

>

> From BCAction

> About Aromatase Inhibitors

> Aromatase inhibitors are a type of hormone therapy for

postmenopausal women with breast cancer. AIs prevent the aromatase

enzyme from converting the hormone androgen into estrogen. Produced by

the adrenal gland and found throughout the body, androgen is the

principal source of estrogen for postmenopausal women. AIs have only

been approved for use by postmenopausal women. They are ineffective in

premenopausal women whose ovaries are still producing estrogen (which

is not affected by the aromatase enzyme). None of these drugs has been

approved by the FDA for use by healthy women at high risk of

developing breast cancer.

> Three AIs are currently approved by the FDA for the treatment of

breast cancer in postmenopausal women: anastrozole (Arimidex),

exemestane (Aromasin), and letrozole (Femara). Anastrozole and

letrozole are both nonsteroidal aromatase inhibitors. Th ey are

described as reversible because they bind reversibly to the aromatase

enzyme.

> Exemestane is a steroidal inhibitor that forms an irreversible bond

with the aromatase enzyme, permanently stopping the activity of the

enzyme.

>

> Anastrozole (Arimidex)

> Arimidex is indicated for adjuvant treatment of postmenopausal women

with hormone-receptor-positive early breast cancer.

> Arimidex is indicated for the fi rst-line treatment of

postmenopausal women with hormone-receptor-positive or

hormone-receptor-unknown locally advanced or metastatic breast cancer.

> Arimidex is indicated for the treatment of advanced breast cancer in

postmenopausal women with disease progression following tamoxifen

therapy.

> Exemestane (Aromasin)

> Aromasin is indicated for adjuvant treatment of postmenopausal women

with estrogen-receptor-positive early breast cancer who have received

two to three years of tamoxifen and are switched to Aromasin for

completion of a total of fi ve consecutive years of adjuvant hormonal

therapy.

> Aromasin is indicated for the treatment of advanced breast cancer in

postmenopausal women whose disease has progressed following tamoxifen

therapy.

> Letrozole (Femara)

> Femara is indicated for the adjuvant treatment of postmenopausal

women with hormone-receptor-positive early breast cancer.

> Femara is indicated for the extended adjuvant treatment of early

breast cancer in postmenopausal women who have received fi ve years of

adjuvant tamoxifen therapy.

> Femara is indicated for fi rst-line treatment of postmenopausal

women with hormone-receptor-positive or hormone-receptor-unknown

locally advanced or metastatic breast cancer.

> Femara is also indicated for the treatment of advanced breast cancer

in postmenopausal women with disease progression following

anti-estrogen therapy.

> Summary of Findings

> The first 612 completed surveys received were analyzed for this

report. Major findings include:

> 1. Most respondents (96%) reported one or more side effects.

> 2. The side effects reported by over 50% of respondents were: stroke

(65%), cough (64%), swelling of the arms and legs (59%), fl u-like

symptoms (58%), and anxiety (51%).

> 3. Many women reported side effects in addition to those on our

list, including joint-related side effects, vaginal atrophy and

dryness, a rise in cholesterol levels, and general pain.

> 4. Over 50% of respondents stated that their menopause was not

naturally occurring. For these women, menopause was either

pharmaceutically or surgically induced.

> 5. Ten women (1.6%) reported that they discontinued using an AI

because of subsequent menstruation or vaginal bleeding.

> 6. About 30% of the respondents discontinued the use of an AI­84%

because of side effects they were experiencing, and close to half of

them (47%) specifically because of joint-related side effects.

> 7. Over one-third (37%) of respondents reported receiving no

information from their doctors about short-term side effects; nearly

two-thirds (63%) reported receiving no information from their doctors

about long-term side effects.

>

> Recommendations

> 1. Conduct additional research on short-term and long-term side

effects of AIs.

> 2. Provide the results of this research to doctors and patients.

> 3. Use caution when prescribing AIs to perimenopausal women, as well

as to premenopausal women who have been rendered menopausal by

chemotherapy or ovarian function suppression.

>

> +++++++++++++++++++++++++++++++++++++++++++++++

> BCO News is brought to you by BREAST CANCER OPTIONS, a grassroots

organization focusing on Health Advocacy, Support and Education. The

information is intended for educational purposes only, in order to

help you make informed health choices and may not have been touched

upon by your doctors. We are not doctors and we do not recommend any

particular treatments. We are sending this information to advise you

of the complete scientific overview that is currently available,

although we may not necessarily endorse it.

http://www.breastcanceroptions.org

>

>

>

>

>

>

Link to comment
Share on other sites

Thank you for sharing that nne! This just confirms

my " symptoms " on the A.I. and helps me justify my decision to switch

to the Tamoxifin.

Hugs!

Ellen

>

> Aromatase inhibitors: side effects reported by 622 women.

> Salgado BA, Zivian MT.. Breast Cancer Action, San Francisco, CA

> http://www.bcaction.org/PDF/AIReport.pdf for complete survey

results

>

> Background: Aromatase inhibitors (anastrozole, letrozole, and

exemestane) are quickly becoming one of the most commonly prescribed

breast cancer treatments for postmenopausal women with breast

cancer. Because these drugs have only been approved for use

recently, and two of the three aromatase inhibitors moved quickly

into the treatment setting due to FDA Priority Review or Accelerated

Approval status, little is known about their short and long-term

side effects. Previous trials of aromatase inhibitors have reported

some adverse effects. The purpose of this survey is to collect

information from patients on the side effects of aromatase

inhibitors.

>

> Methods: An Aromatase Inhibitor Side Effects Survey (AI Survey)

was posted to the Breast Cancer Action web site in August 2005.

Additionally, other breast cancer and womens health organizations

announced the AI survey through newsletters, emails and web site

links. Despite the limitations and biases that self-reporting

introduces, patient-derived data on treatment side effects are

clinically meaningful for both doctors and patients. The survey

included demographic questions, questions concerning the aromatase

inhibitor prescribed, and questions regarding medical condition.

These were followed by a list of 38 side effects that respondents

rated for severity. The surveys side effects list was compiled from

side effects listed on the FDA labels for aromatase inhibitors.

Respondents were also asked if they had experienced any unlisted

side effects. Over 600 completed surveys were received and included

in the data set. Data were analyzed using SPSS (Version 14.0 for

Windows).

>

> Results: The distribution of the survey respondents from the

United States reflects the expected distribution based on of the

incidence of breast cancer throughout the country (p < .01). Among

the women who discontinued using an AI, exemestane was taken for a

significantly shorter period of time (8 months) than either

letrozole (15 months) or anastrazole (29 months) (p = .002). Over

60% of the respondents reported experiencing stroke and cough. Over

50% reported swelling of limbs, and flu-like symptoms. Women 30-39

years-old gave the highest severity ratings to stroke; women 50-59

years-old women gave highest severity ratings to cough (p < .000).

In addition to reporting on the side effects listed in the survey,

respondents reported experiencing over 35 additional side effects.

>

> Discussion: Recent advances have led to the development of

aromatase inhibitors for adjuvant treatment of postmenopausal breast

cancer patients. However, many patients are experiencing adverse

effects which can be disabling and may lead to cessation of therapy.

Patients and doctors should discuss possible side effects before

beginning treatment with aromatase inhibitors so that patients are

able to make fully informed decisions. The side effects information

from this survey will also assist doctors with patient management

for those currently taking aromatase inhibitors.

>

> From BCAction

> About Aromatase Inhibitors

> Aromatase inhibitors are a type of hormone therapy for

postmenopausal women with breast cancer. AIs prevent the aromatase

enzyme from converting the hormone androgen into estrogen. Produced

by the adrenal gland and found throughout the body, androgen is the

principal source of estrogen for postmenopausal women. AIs have only

been approved for use by postmenopausal women. They are ineffective

in premenopausal women whose ovaries are still producing estrogen

(which is not affected by the aromatase enzyme). None of these drugs

has been approved by the FDA for use by healthy women at high risk

of developing breast cancer.

> Three AIs are currently approved by the FDA for the treatment of

breast cancer in postmenopausal women: anastrozole (Arimidex),

exemestane (Aromasin), and letrozole (Femara). Anastrozole and

letrozole are both nonsteroidal aromatase inhibitors. Th ey are

described as reversible because they bind reversibly to the

aromatase enzyme.

> Exemestane is a steroidal inhibitor that forms an irreversible

bond with the aromatase enzyme, permanently stopping the activity of

the enzyme.

>

> Anastrozole (Arimidex)

> Arimidex is indicated for adjuvant treatment of postmenopausal

women with hormone-receptor-positive early breast cancer.

> Arimidex is indicated for the fi rst-line treatment of

postmenopausal women with hormone-receptor-positive or hormone-

receptor-unknown locally advanced or metastatic breast cancer.

> Arimidex is indicated for the treatment of advanced breast cancer

in postmenopausal women with disease progression following tamoxifen

therapy.

> Exemestane (Aromasin)

> Aromasin is indicated for adjuvant treatment of postmenopausal

women with estrogen-receptor-positive early breast cancer who have

received two to three years of tamoxifen and are switched to

Aromasin for completion of a total of fi ve consecutive years of

adjuvant hormonal therapy.

> Aromasin is indicated for the treatment of advanced breast cancer

in postmenopausal women whose disease has progressed following

tamoxifen therapy.

> Letrozole (Femara)

> Femara is indicated for the adjuvant treatment of postmenopausal

women with hormone-receptor-positive early breast cancer.

> Femara is indicated for the extended adjuvant treatment of early

breast cancer in postmenopausal women who have received fi ve years

of adjuvant tamoxifen therapy.

> Femara is indicated for fi rst-line treatment of postmenopausal

women with hormone-receptor-positive or hormone-receptor-unknown

locally advanced or metastatic breast cancer.

> Femara is also indicated for the treatment of advanced breast

cancer in postmenopausal women with disease progression following

anti-estrogen therapy.

> Summary of Findings

> The first 612 completed surveys received were analyzed for this

report. Major findings include:

> 1. Most respondents (96%) reported one or more side effects.

> 2. The side effects reported by over 50% of respondents were:

stroke (65%), cough (64%), swelling of the arms and legs (59%), fl u-

like symptoms (58%), and anxiety (51%).

> 3. Many women reported side effects in addition to those on our

list, including joint-related side effects, vaginal atrophy and

dryness, a rise in cholesterol levels, and general pain.

> 4. Over 50% of respondents stated that their menopause was not

naturally occurring. For these women, menopause was either

pharmaceutically or surgically induced.

> 5. Ten women (1.6%) reported that they discontinued using an AI

because of subsequent menstruation or vaginal bleeding.

> 6. About 30% of the respondents discontinued the use of an AI­84%

because of side effects they were experiencing, and close to half of

them (47%) specifically because of joint-related side effects.

> 7. Over one-third (37%) of respondents reported receiving no

information from their doctors about short-term side effects; nearly

two-thirds (63%) reported receiving no information from their

doctors about long-term side effects.

>

> Recommendations

> 1. Conduct additional research on short-term and long-term side

effects of AIs.

> 2. Provide the results of this research to doctors and patients.

> 3. Use caution when prescribing AIs to perimenopausal women, as

well as to premenopausal women who have been rendered menopausal by

chemotherapy or ovarian function suppression.

>

> +++++++++++++++++++++++++++++++++++++++++++++++

> BCO News is brought to you by BREAST CANCER OPTIONS, a grassroots

organization focusing on Health Advocacy, Support and Education. The

information is intended for educational purposes only, in order to

help you make informed health choices and may not have been touched

upon by your doctors. We are not doctors and we do not recommend any

particular treatments. We are sending this information to advise you

of the complete scientific overview that is currently available,

although we may not necessarily endorse it.

http://www.breastcanceroptions.org

>

>

>

>

>

>

Link to comment
Share on other sites

Thank you nne....I'm going to make a copy of it next month when my Mom

and I are moved into our new house and my stuff is out of storage...then,

I'll send it to my FORMER ONCOLOGIST who tried to tell me that my side

effects were not due to the A.I.'s that he put me on!!! LOL!!!!! I'm now

happily on Tamoxifen. I do have hot flashes but that is SO MUCH BETTER than

the joint pain and lack of energy I had on the A.I.'s!!!

Hugs,

Aromatase Inhibitors Side Effects Reported.........

Aromatase inhibitors: side effects reported by 622 women.

Salgado BA, Zivian MT.. Breast Cancer Action, San Francisco, CA

http://www.bcaction.org/PDF/AIReport.pdf for complete survey results

Background: Aromatase inhibitors (anastrozole, letrozole, and exemestane)

are quickly becoming one of the most commonly prescribed breast cancer

treatments for postmenopausal women with breast cancer. Because these drugs

have only been approved for use recently, and two of the three aromatase

inhibitors moved quickly into the treatment setting due to FDA Priority

Review or Accelerated Approval status, little is known about their short and

long-term side effects. Previous trials of aromatase inhibitors have

reported some adverse effects. The purpose of this survey is to collect

information from patients on the side effects of aromatase inhibitors.

Methods: An Aromatase Inhibitor Side Effects Survey (AI Survey) was posted

to the Breast Cancer Action web site in August 2005. Additionally, other

breast cancer and womens health organizations announced the AI survey

through newsletters, emails and web site links. Despite the limitations and

biases that self-reporting introduces, patient-derived data on treatment

side effects are clinically meaningful for both doctors and patients. The

survey included demographic questions, questions concerning the aromatase

inhibitor prescribed, and questions regarding medical condition. These were

followed by a list of 38 side effects that respondents rated for severity.

The surveys side effects list was compiled from side effects listed on the

FDA labels for aromatase inhibitors. Respondents were also asked if they had

experienced any unlisted side effects. Over 600 completed surveys were

received and included in the data set. Data were analyzed using SPSS

(Version 14.0 for Windows).

Results: The distribution of the survey respondents from the United States

reflects the expected distribution based on of the incidence of breast

cancer throughout the country (p < .01). Among the women who discontinued

using an AI, exemestane was taken for a significantly shorter period of time

(8 months) than either letrozole (15 months) or anastrazole (29 months) (p =

..002). Over 60% of the respondents reported experiencing stroke and cough.

Over 50% reported swelling of limbs, and flu-like symptoms. Women 30-39

years-old gave the highest severity ratings to stroke; women 50-59 years-old

women gave highest severity ratings to cough (p < .000). In addition to

reporting on the side effects listed in the survey, respondents reported

experiencing over 35 additional side effects.

Discussion: Recent advances have led to the development of aromatase

inhibitors for adjuvant treatment of postmenopausal breast cancer patients.

However, many patients are experiencing adverse effects which can be

disabling and may lead to cessation of therapy. Patients and doctors should

discuss possible side effects before beginning treatment with aromatase

inhibitors so that patients are able to make fully informed decisions. The

side effects information from this survey will also assist doctors with

patient management for those currently taking aromatase inhibitors.

From BCAction

About Aromatase Inhibitors

Aromatase inhibitors are a type of hormone therapy for postmenopausal women

with breast cancer. AIs prevent the aromatase enzyme from converting the

hormone androgen into estrogen. Produced by the adrenal gland and found

throughout the body, androgen is the principal source of estrogen for

postmenopausal women. AIs have only been approved for use by postmenopausal

women. They are ineffective in premenopausal women whose ovaries are still

producing estrogen (which is not affected by the aromatase enzyme). None of

these drugs has been approved by the FDA for use by healthy women at high

risk of developing breast cancer.

Three AIs are currently approved by the FDA for the treatment of breast

cancer in postmenopausal women: anastrozole (Arimidex), exemestane

(Aromasin), and letrozole (Femara). Anastrozole and letrozole are both

nonsteroidal aromatase inhibitors. Th ey are described as reversible because

they bind reversibly to the aromatase enzyme.

Exemestane is a steroidal inhibitor that forms an irreversible bond with the

aromatase enzyme, permanently stopping the activity of the enzyme.

Anastrozole (Arimidex)

Arimidex is indicated for adjuvant treatment of postmenopausal women with

hormone-receptor-positive early breast cancer.

Arimidex is indicated for the fi rst-line treatment of postmenopausal women

with hormone-receptor-positive or hormone-receptor-unknown locally advanced

or metastatic breast cancer.

Arimidex is indicated for the treatment of advanced breast cancer in

postmenopausal women with disease progression following tamoxifen therapy.

Exemestane (Aromasin)

Aromasin is indicated for adjuvant treatment of postmenopausal women with

estrogen-receptor-positive early breast cancer who have received two to

three years of tamoxifen and are switched to Aromasin for completion of a

total of fi ve consecutive years of adjuvant hormonal therapy.

Aromasin is indicated for the treatment of advanced breast cancer in

postmenopausal women whose disease has progressed following tamoxifen

therapy.

Letrozole (Femara)

Femara is indicated for the adjuvant treatment of postmenopausal women with

hormone-receptor-positive early breast cancer.

Femara is indicated for the extended adjuvant treatment of early breast

cancer in postmenopausal women who have received fi ve years of adjuvant

tamoxifen therapy.

Femara is indicated for fi rst-line treatment of postmenopausal women with

hormone-receptor-positive or hormone-receptor-unknown locally advanced or

metastatic breast cancer.

Femara is also indicated for the treatment of advanced breast cancer in

postmenopausal women with disease progression following anti-estrogen

therapy.

Summary of Findings

The first 612 completed surveys received were analyzed for this report.

Major findings include:

1. Most respondents (96%) reported one or more side effects.

2. The side effects reported by over 50% of respondents were: stroke (65%),

cough (64%), swelling of the arms and legs (59%), fl u-like symptoms (58%),

and anxiety (51%).

3. Many women reported side effects in addition to those on our list,

including joint-related side effects, vaginal atrophy and dryness, a rise in

cholesterol levels, and general pain.

4. Over 50% of respondents stated that their menopause was not naturally

occurring. For these women, menopause was either pharmaceutically or

surgically induced.

5. Ten women (1.6%) reported that they discontinued using an AI because of

subsequent menstruation or vaginal bleeding.

6. About 30% of the respondents discontinued the use of an AI­84% because of

side effects they were experiencing, and close to half of them (47%)

specifically because of joint-related side effects.

7. Over one-third (37%) of respondents reported receiving no information

from their doctors about short-term side effects; nearly two-thirds (63%)

reported receiving no information from their doctors about long-term side

effects.

Recommendations

1. Conduct additional research on short-term and long-term side effects of

AIs.

2. Provide the results of this research to doctors and patients.

3. Use caution when prescribing AIs to perimenopausal women, as well as to

premenopausal women who have been rendered menopausal by chemotherapy or

ovarian function suppression.

+++++++++++++++++++++++++++++++++++++++++++++++

BCO News is brought to you by BREAST CANCER OPTIONS, a grassroots

organization focusing on Health Advocacy, Support and Education. The

information is intended for educational purposes only, in order to help you

make informed health choices and may not have been touched upon by your

doctors. We are not doctors and we do not recommend any particular

treatments. We are sending this information to advise you of the complete

scientific overview that is currently available, although we may not

necessarily endorse it. http://www.breastcanceroptions.org

Link to comment
Share on other sites

yes thanks marianne,

i hope to get my printer working so next time i see my onc i can show him

this, i tried tamo but not good on that either, hmm i guess we leave a lot up to

god and hope that things will be ok, sandy in oz

Ellen emc_mom4@...> wrote:

Thank you for sharing that nne! This just confirms

my " symptoms " on the A.I. and helps me justify my decision to switch

to the Tamoxifin.

Hugs!

Ellen

>

> Aromatase inhibitors: side effects reported by 622 women.

> Salgado BA, Zivian MT.. Breast Cancer Action, San Francisco, CA

> http://www.bcaction.org/PDF/AIReport.pdf for complete survey

results

>

> Background: Aromatase inhibitors (anastrozole, letrozole, and

exemestane) are quickly becoming one of the most commonly prescribed

breast cancer treatments for postmenopausal women with breast

cancer. Because these drugs have only been approved for use

recently, and two of the three aromatase inhibitors moved quickly

into the treatment setting due to FDA Priority Review or Accelerated

Approval status, little is known about their short and long-term

side effects. Previous trials of aromatase inhibitors have reported

some adverse effects. The purpose of this survey is to collect

information from patients on the side effects of aromatase

inhibitors.

>

> Methods: An Aromatase Inhibitor Side Effects Survey (AI Survey)

was posted to the Breast Cancer Action web site in August 2005.

Additionally, other breast cancer and womens health organizations

announced the AI survey through newsletters, emails and web site

links. Despite the limitations and biases that self-reporting

introduces, patient-derived data on treatment side effects are

clinically meaningful for both doctors and patients. The survey

included demographic questions, questions concerning the aromatase

inhibitor prescribed, and questions regarding medical condition.

These were followed by a list of 38 side effects that respondents

rated for severity. The surveys side effects list was compiled from

side effects listed on the FDA labels for aromatase inhibitors.

Respondents were also asked if they had experienced any unlisted

side effects. Over 600 completed surveys were received and included

in the data set. Data were analyzed using SPSS (Version 14.0 for

Windows).

>

> Results: The distribution of the survey respondents from the

United States reflects the expected distribution based on of the

incidence of breast cancer throughout the country (p < .01). Among

the women who discontinued using an AI, exemestane was taken for a

significantly shorter period of time (8 months) than either

letrozole (15 months) or anastrazole (29 months) (p = .002). Over

60% of the respondents reported experiencing stroke and cough. Over

50% reported swelling of limbs, and flu-like symptoms. Women 30-39

years-old gave the highest severity ratings to stroke; women 50-59

years-old women gave highest severity ratings to cough (p < .000).

In addition to reporting on the side effects listed in the survey,

respondents reported experiencing over 35 additional side effects.

>

> Discussion: Recent advances have led to the development of

aromatase inhibitors for adjuvant treatment of postmenopausal breast

cancer patients. However, many patients are experiencing adverse

effects which can be disabling and may lead to cessation of therapy.

Patients and doctors should discuss possible side effects before

beginning treatment with aromatase inhibitors so that patients are

able to make fully informed decisions. The side effects information

from this survey will also assist doctors with patient management

for those currently taking aromatase inhibitors.

>

> From BCAction

> About Aromatase Inhibitors

> Aromatase inhibitors are a type of hormone therapy for

postmenopausal women with breast cancer. AIs prevent the aromatase

enzyme from converting the hormone androgen into estrogen. Produced

by the adrenal gland and found throughout the body, androgen is the

principal source of estrogen for postmenopausal women. AIs have only

been approved for use by postmenopausal women. They are ineffective

in premenopausal women whose ovaries are still producing estrogen

(which is not affected by the aromatase enzyme). None of these drugs

has been approved by the FDA for use by healthy women at high risk

of developing breast cancer.

> Three AIs are currently approved by the FDA for the treatment of

breast cancer in postmenopausal women: anastrozole (Arimidex),

exemestane (Aromasin), and letrozole (Femara). Anastrozole and

letrozole are both nonsteroidal aromatase inhibitors. Th ey are

described as reversible because they bind reversibly to the

aromatase enzyme.

> Exemestane is a steroidal inhibitor that forms an irreversible

bond with the aromatase enzyme, permanently stopping the activity of

the enzyme.

>

> Anastrozole (Arimidex)

> Arimidex is indicated for adjuvant treatment of postmenopausal

women with hormone-receptor-positive early breast cancer.

> Arimidex is indicated for the fi rst-line treatment of

postmenopausal women with hormone-receptor-positive or hormone-

receptor-unknown locally advanced or metastatic breast cancer.

> Arimidex is indicated for the treatment of advanced breast cancer

in postmenopausal women with disease progression following tamoxifen

therapy.

> Exemestane (Aromasin)

> Aromasin is indicated for adjuvant treatment of postmenopausal

women with estrogen-receptor-positive early breast cancer who have

received two to three years of tamoxifen and are switched to

Aromasin for completion of a total of fi ve consecutive years of

adjuvant hormonal therapy.

> Aromasin is indicated for the treatment of advanced breast cancer

in postmenopausal women whose disease has progressed following

tamoxifen therapy.

> Letrozole (Femara)

> Femara is indicated for the adjuvant treatment of postmenopausal

women with hormone-receptor-positive early breast cancer.

> Femara is indicated for the extended adjuvant treatment of early

breast cancer in postmenopausal women who have received fi ve years

of adjuvant tamoxifen therapy.

> Femara is indicated for fi rst-line treatment of postmenopausal

women with hormone-receptor-positive or hormone-receptor-unknown

locally advanced or metastatic breast cancer.

> Femara is also indicated for the treatment of advanced breast

cancer in postmenopausal women with disease progression following

anti-estrogen therapy.

> Summary of Findings

> The first 612 completed surveys received were analyzed for this

report. Major findings include:

> 1. Most respondents (96%) reported one or more side effects.

> 2. The side effects reported by over 50% of respondents were:

stroke (65%), cough (64%), swelling of the arms and legs (59%), fl u-

like symptoms (58%), and anxiety (51%).

> 3. Many women reported side effects in addition to those on our

list, including joint-related side effects, vaginal atrophy and

dryness, a rise in cholesterol levels, and general pain.

> 4. Over 50% of respondents stated that their menopause was not

naturally occurring. For these women, menopause was either

pharmaceutically or surgically induced.

> 5. Ten women (1.6%) reported that they discontinued using an AI

because of subsequent menstruation or vaginal bleeding.

> 6. About 30% of the respondents discontinued the use of an AI­84%

because of side effects they were experiencing, and close to half of

them (47%) specifically because of joint-related side effects.

> 7. Over one-third (37%) of respondents reported receiving no

information from their doctors about short-term side effects; nearly

two-thirds (63%) reported receiving no information from their

doctors about long-term side effects.

>

> Recommendations

> 1. Conduct additional research on short-term and long-term side

effects of AIs.

> 2. Provide the results of this research to doctors and patients.

> 3. Use caution when prescribing AIs to perimenopausal women, as

well as to premenopausal women who have been rendered menopausal by

chemotherapy or ovarian function suppression.

>

> +++++++++++++++++++++++++++++++++++++++++++++++

> BCO News is brought to you by BREAST CANCER OPTIONS, a grassroots

organization focusing on Health Advocacy, Support and Education. The

information is intended for educational purposes only, in order to

help you make informed health choices and may not have been touched

upon by your doctors. We are not doctors and we do not recommend any

particular treatments. We are sending this information to advise you

of the complete scientific overview that is currently available,

although we may not necessarily endorse it.

http://www.breastcanceroptions.org

>

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