Guest guest Posted December 28, 2006 Report Share Posted December 28, 2006 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 Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 28, 2006 Report Share Posted December 28, 2006 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 > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 28, 2006 Report Share Posted December 28, 2006 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 > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 28, 2006 Report Share Posted December 28, 2006 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 Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 28, 2006 Report Share Posted December 28, 2006 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 > > > > > > Quote Link to comment Share on other sites More sharing options...
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