Patient & Survivor Care

SAN ANTONIO – Adjuvant aromatase inhibitor therapy in women with early-stage breast cancer was associated with worse oral health–related quality of life in a preliminary analysis from an ongoing prospective cohort study.

“Oral health is critical to overall health, and the findings of this study suggest the need to focus attention on dental health education for these patients related to improved home care regimens and optimizing intervals for dental evaluations,” Linda S. Taichman, Ph.D., said at the San Antonio Breast Cancer Symposium.

The study – the first ever to report on oral health issues in women with early breast cancer on aromatase inhibitors (AIs) – included 58 postmenopausal women. Half were on adjuvant AIs; the other half were recruited at the time of screening mammography, didn’t have breast cancer, and weren’t taking an AI. The two groups were similar in terms of demographics, frequency of daily brushing and flossing, and frequency of dental visits.

At entry into what is scheduled to be an 18-month study, participants completed the Oral Health Impact Profile–14 and the Michigan Oral Health–Related Quality of Life Scale, both of which measure self-reported dysfunction, discomfort, and disability on a self-rated 5-point scale.

The adjuvant AI users reported significantly lower oral health–related quality of life than controls in multiple domains: more pain and aching in the mouth; greater discomfort when eating; a need to limit the foods they eat; interruption of meals; a feeling of being self-conscious, tense, and embarrassed about problems in their mouth; and being irritable with others. The longer patients had been on an AI, the lower their oral health quality of life scores, Dr. Taichman of the University of Michigan School of Dentistry, Ann Arbor, reported.

Oral health quality of life was unrelated to whether a breast cancer patient had undergone chemotherapy.

Saliva flow rate as an indicator of oral health was measured at baseline. Women on AIs were less likely to be able to produce a 2-mL saliva sample.

The study sample size was insufficient to determine if there were differences between specific AIs in terms of patient oral health. Additional studies are ongoing, Dr. Taichman added.

She noted that both groups of women had room for improvement in terms of their oral care regimens. At baseline, only about 40% of subjects reported brushing every day, and less than half of the women flossed daily.

The study is funded by the Michigan Institute for Clinical Health Research. She reported having no relevant financial conflicts.

[email protected]

SAN ANTONIO – Adjuvant aromatase inhibitor therapy in women with early-stage breast cancer was associated with worse oral health–related quality of life in a preliminary analysis from an ongoing prospective cohort study.

“Oral health is critical to overall health, and the findings of this study suggest the need to focus attention on dental health education for these patients related to improved home care regimens and optimizing intervals for dental evaluations,” Linda S. Taichman, Ph.D., said at the San Antonio Breast Cancer Symposium.

The study – the first ever to report on oral health issues in women with early breast cancer on aromatase inhibitors (AIs) – included 58 postmenopausal women. Half were on adjuvant AIs; the other half were recruited at the time of screening mammography, didn’t have breast cancer, and weren’t taking an AI. The two groups were similar in terms of demographics, frequency of daily brushing and flossing, and frequency of dental visits.

At entry into what is scheduled to be an 18-month study, participants completed the Oral Health Impact Profile–14 and the Michigan Oral Health–Related Quality of Life Scale, both of which measure self-reported dysfunction, discomfort, and disability on a self-rated 5-point scale.

The adjuvant AI users reported significantly lower oral health–related quality of life than controls in multiple domains: more pain and aching in the mouth; greater discomfort when eating; a need to limit the foods they eat; interruption of meals; a feeling of being self-conscious, tense, and embarrassed about problems in their mouth; and being irritable with others. The longer patients had been on an AI, the lower their oral health quality of life scores, Dr. Taichman of the University of Michigan School of Dentistry, Ann Arbor, reported.

Oral health quality of life was unrelated to whether a breast cancer patient had undergone chemotherapy.

Saliva flow rate as an indicator of oral health was measured at baseline. Women on AIs were less likely to be able to produce a 2-mL saliva sample.

The study sample size was insufficient to determine if there were differences between specific AIs in terms of patient oral health. Additional studies are ongoing, Dr. Taichman added.

She noted that both groups of women had room for improvement in terms of their oral care regimens. At baseline, only about 40% of subjects reported brushing every day, and less than half of the women flossed daily.

The study is funded by the Michigan Institute for Clinical Health Research. She reported having no relevant financial conflicts.

[email protected]

SAN ANTONIO – Adjuvant aromatase inhibitor therapy in women with early-stage breast cancer was associated with worse oral health–related quality of life in a preliminary analysis from an ongoing prospective cohort study.

“Oral health is critical to overall health, and the findings of this study suggest the need to focus attention on dental health education for these patients related to improved home care regimens and optimizing intervals for dental evaluations,” Linda S. Taichman, Ph.D., said at the San Antonio Breast Cancer Symposium.

The study – the first ever to report on oral health issues in women with early breast cancer on aromatase inhibitors (AIs) – included 58 postmenopausal women. Half were on adjuvant AIs; the other half were recruited at the time of screening mammography, didn’t have breast cancer, and weren’t taking an AI. The two groups were similar in terms of demographics, frequency of daily brushing and flossing, and frequency of dental visits.

At entry into what is scheduled to be an 18-month study, participants completed the Oral Health Impact Profile–14 and the Michigan Oral Health–Related Quality of Life Scale, both of which measure self-reported dysfunction, discomfort, and disability on a self-rated 5-point scale.

The adjuvant AI users reported significantly lower oral health–related quality of life than controls in multiple domains: more pain and aching in the mouth; greater discomfort when eating; a need to limit the foods they eat; interruption of meals; a feeling of being self-conscious, tense, and embarrassed about problems in their mouth; and being irritable with others. The longer patients had been on an AI, the lower their oral health quality of life scores, Dr. Taichman of the University of Michigan School of Dentistry, Ann Arbor, reported.

Oral health quality of life was unrelated to whether a breast cancer patient had undergone chemotherapy.

Saliva flow rate as an indicator of oral health was measured at baseline. Women on AIs were less likely to be able to produce a 2-mL saliva sample.

The study sample size was insufficient to determine if there were differences between specific AIs in terms of patient oral health. Additional studies are ongoing, Dr. Taichman added.

She noted that both groups of women had room for improvement in terms of their oral care regimens. At baseline, only about 40% of subjects reported brushing every day, and less than half of the women flossed daily.

The study is funded by the Michigan Institute for Clinical Health Research. She reported having no relevant financial conflicts.

[email protected]

SAN ANTONIO – Annual health care costs and utilization jump several-fold in nonelderly breast cancer survivors with concomitant depression, according to an analysis from the U.S. military health system.

Analysis of the records of 2,851 breast cancer survivors whose care is provided by the Department of Defense military health system indicated that 15.9% were diagnosed with depression in the time interval within 1 year prior to and 2 years after their cancer diagnosis. These dual-diagnosis patients averaged $15,471 annually in health care costs covering inpatient and outpatient services and outpatient prescriptions in the first years after being diagnosed with breast cancer, compared with $8,297 per year in those without a diagnosis of depression, Diana D. Jeffery, Ph.D., reported at the San Antonio Breast Cancer Symposium.

The mean annual number of hospital admissions was tripled: 0.33 in breast cancer survivors with depression and 0.11 in survivors without depression. The dual-diagosis group averaged 1.94 hospital bed days annually, compared with 0.58 in breast cancer survivors without depression. Breast cancer survivors diagnosed with depression averaged 28 outpatient visits annually, while those without depression averaged 16.5, according to Dr. Jeffery, a senior researcher at the Defense Health Agency in Falls Church, Va.

Fifty percent of the breast cancer survivors were diagnosed with hypertension, making this the most common chronic comorbid condition. A diagnosis of depression, anxiety, adjustment, or stress disorder was present in 37.5% of the breast cancer survivors, making this group of psychiatric diagnoses the second most prevalent comorbidity. Twenty-three percent of the breast cancer survivors had received a diagnosis of heart disease, 20% had diabetes, 16% had asthma or chronic obstructive pulmonary disease, and 17% were obese. No demographic characteristics proved predictive of an increased likelihood of being diagnosed with depression, she said.

Of note, nearly one-half of the patients with depression had been diagnosed with the affective disorder during the year prior to receiving their breast cancer diagnosis.

Dr. Jeffery said that, while these data on health care costs and utilization in breast cancer survivors with concomitant depression are likely to be of particular interest to health plans, they also show what is likely to happen following adoption of the American Society of Clinical Oncology 2014 guidelines on screening and care of depression and anxiety in adults with cancer.

The guidelines recommend that all cancer patients and cancer survivors periodically be evaluated for symptoms of depression and anxiety using validated measures across the trajectory of care to “reduce the human cost of cancer” (J. Clin. Oncol. 2014;32:1605-19).

Adoption of the depression screening guidelines will likely increase the number of breast cancer survivors with a mental health diagnosis, which, as Dr. Jeffery’s study demonstrates, will boost health care costs and utilization. On the other hand, identifying and intervening effectively in patients with mild symptoms that haven’t yet risen to the level that meets diagnostic criteria for clinical depression should yield cost savings as well as quality-of-life benefits, she added.

The Department of Defense military health system, under a health plan known as Tricare, serves 9.5 million beneficiaries in 360 military treatment clinics worldwide. It’s a system with very few restrictions upon medical-ordered cancer follow-up care, according to Dr. Jeffery.

She reported having no financial conflicts regarding this study.

[email protected]

SAN ANTONIO – Annual health care costs and utilization jump several-fold in nonelderly breast cancer survivors with concomitant depression, according to an analysis from the U.S. military health system.

Analysis of the records of 2,851 breast cancer survivors whose care is provided by the Department of Defense military health system indicated that 15.9% were diagnosed with depression in the time interval within 1 year prior to and 2 years after their cancer diagnosis. These dual-diagnosis patients averaged $15,471 annually in health care costs covering inpatient and outpatient services and outpatient prescriptions in the first years after being diagnosed with breast cancer, compared with $8,297 per year in those without a diagnosis of depression, Diana D. Jeffery, Ph.D., reported at the San Antonio Breast Cancer Symposium.

The mean annual number of hospital admissions was tripled: 0.33 in breast cancer survivors with depression and 0.11 in survivors without depression. The dual-diagosis group averaged 1.94 hospital bed days annually, compared with 0.58 in breast cancer survivors without depression. Breast cancer survivors diagnosed with depression averaged 28 outpatient visits annually, while those without depression averaged 16.5, according to Dr. Jeffery, a senior researcher at the Defense Health Agency in Falls Church, Va.

Fifty percent of the breast cancer survivors were diagnosed with hypertension, making this the most common chronic comorbid condition. A diagnosis of depression, anxiety, adjustment, or stress disorder was present in 37.5% of the breast cancer survivors, making this group of psychiatric diagnoses the second most prevalent comorbidity. Twenty-three percent of the breast cancer survivors had received a diagnosis of heart disease, 20% had diabetes, 16% had asthma or chronic obstructive pulmonary disease, and 17% were obese. No demographic characteristics proved predictive of an increased likelihood of being diagnosed with depression, she said.

Of note, nearly one-half of the patients with depression had been diagnosed with the affective disorder during the year prior to receiving their breast cancer diagnosis.

Dr. Jeffery said that, while these data on health care costs and utilization in breast cancer survivors with concomitant depression are likely to be of particular interest to health plans, they also show what is likely to happen following adoption of the American Society of Clinical Oncology 2014 guidelines on screening and care of depression and anxiety in adults with cancer.

The guidelines recommend that all cancer patients and cancer survivors periodically be evaluated for symptoms of depression and anxiety using validated measures across the trajectory of care to “reduce the human cost of cancer” (J. Clin. Oncol. 2014;32:1605-19).

Adoption of the depression screening guidelines will likely increase the number of breast cancer survivors with a mental health diagnosis, which, as Dr. Jeffery’s study demonstrates, will boost health care costs and utilization. On the other hand, identifying and intervening effectively in patients with mild symptoms that haven’t yet risen to the level that meets diagnostic criteria for clinical depression should yield cost savings as well as quality-of-life benefits, she added.

The Department of Defense military health system, under a health plan known as Tricare, serves 9.5 million beneficiaries in 360 military treatment clinics worldwide. It’s a system with very few restrictions upon medical-ordered cancer follow-up care, according to Dr. Jeffery.

She reported having no financial conflicts regarding this study.

[email protected]

SAN ANTONIO – Annual health care costs and utilization jump several-fold in nonelderly breast cancer survivors with concomitant depression, according to an analysis from the U.S. military health system.

Analysis of the records of 2,851 breast cancer survivors whose care is provided by the Department of Defense military health system indicated that 15.9% were diagnosed with depression in the time interval within 1 year prior to and 2 years after their cancer diagnosis. These dual-diagnosis patients averaged $15,471 annually in health care costs covering inpatient and outpatient services and outpatient prescriptions in the first years after being diagnosed with breast cancer, compared with $8,297 per year in those without a diagnosis of depression, Diana D. Jeffery, Ph.D., reported at the San Antonio Breast Cancer Symposium.

The mean annual number of hospital admissions was tripled: 0.33 in breast cancer survivors with depression and 0.11 in survivors without depression. The dual-diagosis group averaged 1.94 hospital bed days annually, compared with 0.58 in breast cancer survivors without depression. Breast cancer survivors diagnosed with depression averaged 28 outpatient visits annually, while those without depression averaged 16.5, according to Dr. Jeffery, a senior researcher at the Defense Health Agency in Falls Church, Va.

Fifty percent of the breast cancer survivors were diagnosed with hypertension, making this the most common chronic comorbid condition. A diagnosis of depression, anxiety, adjustment, or stress disorder was present in 37.5% of the breast cancer survivors, making this group of psychiatric diagnoses the second most prevalent comorbidity. Twenty-three percent of the breast cancer survivors had received a diagnosis of heart disease, 20% had diabetes, 16% had asthma or chronic obstructive pulmonary disease, and 17% were obese. No demographic characteristics proved predictive of an increased likelihood of being diagnosed with depression, she said.

Of note, nearly one-half of the patients with depression had been diagnosed with the affective disorder during the year prior to receiving their breast cancer diagnosis.

Dr. Jeffery said that, while these data on health care costs and utilization in breast cancer survivors with concomitant depression are likely to be of particular interest to health plans, they also show what is likely to happen following adoption of the American Society of Clinical Oncology 2014 guidelines on screening and care of depression and anxiety in adults with cancer.

The guidelines recommend that all cancer patients and cancer survivors periodically be evaluated for symptoms of depression and anxiety using validated measures across the trajectory of care to “reduce the human cost of cancer” (J. Clin. Oncol. 2014;32:1605-19).

Adoption of the depression screening guidelines will likely increase the number of breast cancer survivors with a mental health diagnosis, which, as Dr. Jeffery’s study demonstrates, will boost health care costs and utilization. On the other hand, identifying and intervening effectively in patients with mild symptoms that haven’t yet risen to the level that meets diagnostic criteria for clinical depression should yield cost savings as well as quality-of-life benefits, she added.

The Department of Defense military health system, under a health plan known as Tricare, serves 9.5 million beneficiaries in 360 military treatment clinics worldwide. It’s a system with very few restrictions upon medical-ordered cancer follow-up care, according to Dr. Jeffery.

She reported having no financial conflicts regarding this study.

[email protected]

SAN ANTONIO – Losing weight and exercising may be an important key to good outcomes in some women with breast cancer – especially those with hormone receptor–negative tumors.

For women with tumors that are both estrogen and progesterone receptor negative, losing at least 5 pounds or 5% of total body weight decreased the 10-year risk of all-cause mortality by 64%, Dr. Rowan T. Chlebowski said at the San Antonio Breast Cancer Symposium.

Although it was a post hoc exploratory analysis, the subgroup findings suggest that a lifestyle intervention program could be an effective way to help increase a woman’s chances of surviving, said Dr. Chlebowski, chief of medical oncology at the UCLA Medical Center, Los Angeles.

“From a scientific standpoint, others will have to look at this post hoc analysis and decide whether the data warrant further investigation in a trial to confirm the findings,” he said. “But, on an operational basis, for a woman with breast cancer, there are so many other health benefits associated with this kind of weight loss. For example, this has been shown to significantly reduce the risk of progression from prediabetes to diabetes – and that is a very important health consideration for women with breast cancer.”

And obviously, he added, losing weight and getting active carry a myriad of other health benefits, all of which exert their own positive influences.

Dr. Chlebowski reported long-term follow-up data from the Women’s Intervention Nutrition Study (WINS). It enrolled 2,437 women from 1994 to 2001 who had been treated for early-stage breast cancer. The women, aged 48-79 years, were randomly assigned to a lower-fat dietary intervention group or to a control group that ate their regular diet. The intervention group met monthly with a registered dietitian and provided food journals. They were also encouraged to increase physical activity.

At the start of the study, both groups consumed similar amounts of calories from fat, about 57 g/day or 30% of daily caloric intake. At the end of the first year of observation, the women in the dietary intervention group had reduced their fat intake by an average of 24 g/day, compared with only a 5-gram/day drop in the control group. The difference between the two groups was maintained throughout the trial. By the fifth year of the trial, the women in the intervention group weighed an average of 6 pounds less than did the women in the control group.

But at the current follow-up (maximum of 20 years), there was no significant between-group difference in disease-free survival (17% deaths in the control groups vs. 13.6% in the intervention group), either in the entire group or in the subgroup of those with estrogen and progesterone receptor–positive tumors.

However, in the subanalysis of those who were hormone receptor negative, the difference was significant, with a 2-year survival advantage in the intervention group (14 vs. 12 years; hazard ratio, 0.64; P = .045).

The findings may be particularly important for women with triple-negative tumors, since, Dr. Chlebowski noted, data suggest that about 73% of women with ER/PR-negative cancers are anticipated to be triple negative.

He said the protective mechanism is not entirely clear, but may be due more to total calorie decrease than to decreasing fat alone – despite fat’s proclivity to increase total estrogen levels.

“Estrogen does not seem to be the driver here,” he said. Instead, the benefit may have more to do with controlling growth factors, inflammation, and glucose levels.

He did point out that the data are a bit old, and that only 6% of women in the study received tamoxifen. But he stressed that further investigation could refine the results and that, in any case, controlling weight confers a multitude of benefits.

Dr. Chlebowski had no disclosures. The WINS study was sponsored by the National Cancer Institute.

[email protected]

On Twitter @alz_gal

SAN ANTONIO – Losing weight and exercising may be an important key to good outcomes in some women with breast cancer – especially those with hormone receptor–negative tumors.

For women with tumors that are both estrogen and progesterone receptor negative, losing at least 5 pounds or 5% of total body weight decreased the 10-year risk of all-cause mortality by 64%, Dr. Rowan T. Chlebowski said at the San Antonio Breast Cancer Symposium.

Although it was a post hoc exploratory analysis, the subgroup findings suggest that a lifestyle intervention program could be an effective way to help increase a woman’s chances of surviving, said Dr. Chlebowski, chief of medical oncology at the UCLA Medical Center, Los Angeles.

“From a scientific standpoint, others will have to look at this post hoc analysis and decide whether the data warrant further investigation in a trial to confirm the findings,” he said. “But, on an operational basis, for a woman with breast cancer, there are so many other health benefits associated with this kind of weight loss. For example, this has been shown to significantly reduce the risk of progression from prediabetes to diabetes – and that is a very important health consideration for women with breast cancer.”

And obviously, he added, losing weight and getting active carry a myriad of other health benefits, all of which exert their own positive influences.

Dr. Chlebowski reported long-term follow-up data from the Women’s Intervention Nutrition Study (WINS). It enrolled 2,437 women from 1994 to 2001 who had been treated for early-stage breast cancer. The women, aged 48-79 years, were randomly assigned to a lower-fat dietary intervention group or to a control group that ate their regular diet. The intervention group met monthly with a registered dietitian and provided food journals. They were also encouraged to increase physical activity.

At the start of the study, both groups consumed similar amounts of calories from fat, about 57 g/day or 30% of daily caloric intake. At the end of the first year of observation, the women in the dietary intervention group had reduced their fat intake by an average of 24 g/day, compared with only a 5-gram/day drop in the control group. The difference between the two groups was maintained throughout the trial. By the fifth year of the trial, the women in the intervention group weighed an average of 6 pounds less than did the women in the control group.

But at the current follow-up (maximum of 20 years), there was no significant between-group difference in disease-free survival (17% deaths in the control groups vs. 13.6% in the intervention group), either in the entire group or in the subgroup of those with estrogen and progesterone receptor–positive tumors.

However, in the subanalysis of those who were hormone receptor negative, the difference was significant, with a 2-year survival advantage in the intervention group (14 vs. 12 years; hazard ratio, 0.64; P = .045).

The findings may be particularly important for women with triple-negative tumors, since, Dr. Chlebowski noted, data suggest that about 73% of women with ER/PR-negative cancers are anticipated to be triple negative.

He said the protective mechanism is not entirely clear, but may be due more to total calorie decrease than to decreasing fat alone – despite fat’s proclivity to increase total estrogen levels.

“Estrogen does not seem to be the driver here,” he said. Instead, the benefit may have more to do with controlling growth factors, inflammation, and glucose levels.

He did point out that the data are a bit old, and that only 6% of women in the study received tamoxifen. But he stressed that further investigation could refine the results and that, in any case, controlling weight confers a multitude of benefits.

Dr. Chlebowski had no disclosures. The WINS study was sponsored by the National Cancer Institute.

[email protected]

On Twitter @alz_gal

SAN ANTONIO – Losing weight and exercising may be an important key to good outcomes in some women with breast cancer – especially those with hormone receptor–negative tumors.

For women with tumors that are both estrogen and progesterone receptor negative, losing at least 5 pounds or 5% of total body weight decreased the 10-year risk of all-cause mortality by 64%, Dr. Rowan T. Chlebowski said at the San Antonio Breast Cancer Symposium.

Although it was a post hoc exploratory analysis, the subgroup findings suggest that a lifestyle intervention program could be an effective way to help increase a woman’s chances of surviving, said Dr. Chlebowski, chief of medical oncology at the UCLA Medical Center, Los Angeles.

“From a scientific standpoint, others will have to look at this post hoc analysis and decide whether the data warrant further investigation in a trial to confirm the findings,” he said. “But, on an operational basis, for a woman with breast cancer, there are so many other health benefits associated with this kind of weight loss. For example, this has been shown to significantly reduce the risk of progression from prediabetes to diabetes – and that is a very important health consideration for women with breast cancer.”

And obviously, he added, losing weight and getting active carry a myriad of other health benefits, all of which exert their own positive influences.

Dr. Chlebowski reported long-term follow-up data from the Women’s Intervention Nutrition Study (WINS). It enrolled 2,437 women from 1994 to 2001 who had been treated for early-stage breast cancer. The women, aged 48-79 years, were randomly assigned to a lower-fat dietary intervention group or to a control group that ate their regular diet. The intervention group met monthly with a registered dietitian and provided food journals. They were also encouraged to increase physical activity.

At the start of the study, both groups consumed similar amounts of calories from fat, about 57 g/day or 30% of daily caloric intake. At the end of the first year of observation, the women in the dietary intervention group had reduced their fat intake by an average of 24 g/day, compared with only a 5-gram/day drop in the control group. The difference between the two groups was maintained throughout the trial. By the fifth year of the trial, the women in the intervention group weighed an average of 6 pounds less than did the women in the control group.

But at the current follow-up (maximum of 20 years), there was no significant between-group difference in disease-free survival (17% deaths in the control groups vs. 13.6% in the intervention group), either in the entire group or in the subgroup of those with estrogen and progesterone receptor–positive tumors.

However, in the subanalysis of those who were hormone receptor negative, the difference was significant, with a 2-year survival advantage in the intervention group (14 vs. 12 years; hazard ratio, 0.64; P = .045).

The findings may be particularly important for women with triple-negative tumors, since, Dr. Chlebowski noted, data suggest that about 73% of women with ER/PR-negative cancers are anticipated to be triple negative.

He said the protective mechanism is not entirely clear, but may be due more to total calorie decrease than to decreasing fat alone – despite fat’s proclivity to increase total estrogen levels.

“Estrogen does not seem to be the driver here,” he said. Instead, the benefit may have more to do with controlling growth factors, inflammation, and glucose levels.

He did point out that the data are a bit old, and that only 6% of women in the study received tamoxifen. But he stressed that further investigation could refine the results and that, in any case, controlling weight confers a multitude of benefits.

Dr. Chlebowski had no disclosures. The WINS study was sponsored by the National Cancer Institute.

[email protected]

On Twitter @alz_gal

Objective To identify predictors of resolution of abnormal cancer screening tests in patients who received navigation.

Methods We examined data on patients with abnormal breast (n = 256) or cervical (n = 150) screening tests or symptoms who received navigation as part of the Ohio Patient Navigator Research Program during 2007-2010. We used multivariable Cox proportional hazards regression models to identify predictors of time to resolution (ie, when a patient’s clinical abnormality or abnormal screening test was determined to be a benign condition or a cancer diagnosis).

Results The median time to resolution was 183 days for navigated patients with breast abnormalities and 172 days for navigated patients with cervical abnormalities. In patients with breast abnormalities, those who reported at least 1 barrier to care during navigation (HR, 0.66; 95% CI, 0.51-0.86) or higher perceived stress (HR, 0.90; 95% CI, 0.82-0.98) had slower resolution. Among patients with cervical abnormalities, those who reported at least 1 barrier to care during navigation had slower resolution (HR, 0.62; 95% CI, 0.42-0.91). Patients with cervical abnormalities had faster resolution if they had private health insurance, but this effect was present only in younger women (interaction P = .003).

Limitations Unknown generalizability of results because patients were female and from clinics in central Ohio.

Conclusions Several variables predicted whether patient navigation led to faster resolution, and predictors differed somewhat by disease site. Results will be useful in improving current patient navigation programs and designing future programs.

Funding American Cancer Society and the National Institutes of Health 

Objective To identify predictors of resolution of abnormal cancer screening tests in patients who received navigation.

Methods We examined data on patients with abnormal breast (n = 256) or cervical (n = 150) screening tests or symptoms who received navigation as part of the Ohio Patient Navigator Research Program during 2007-2010. We used multivariable Cox proportional hazards regression models to identify predictors of time to resolution (ie, when a patient’s clinical abnormality or abnormal screening test was determined to be a benign condition or a cancer diagnosis).

Results The median time to resolution was 183 days for navigated patients with breast abnormalities and 172 days for navigated patients with cervical abnormalities. In patients with breast abnormalities, those who reported at least 1 barrier to care during navigation (HR, 0.66; 95% CI, 0.51-0.86) or higher perceived stress (HR, 0.90; 95% CI, 0.82-0.98) had slower resolution. Among patients with cervical abnormalities, those who reported at least 1 barrier to care during navigation had slower resolution (HR, 0.62; 95% CI, 0.42-0.91). Patients with cervical abnormalities had faster resolution if they had private health insurance, but this effect was present only in younger women (interaction P = .003).

Limitations Unknown generalizability of results because patients were female and from clinics in central Ohio.

Conclusions Several variables predicted whether patient navigation led to faster resolution, and predictors differed somewhat by disease site. Results will be useful in improving current patient navigation programs and designing future programs.

Funding American Cancer Society and the National Institutes of Health 

Objective To identify predictors of resolution of abnormal cancer screening tests in patients who received navigation.

Methods We examined data on patients with abnormal breast (n = 256) or cervical (n = 150) screening tests or symptoms who received navigation as part of the Ohio Patient Navigator Research Program during 2007-2010. We used multivariable Cox proportional hazards regression models to identify predictors of time to resolution (ie, when a patient’s clinical abnormality or abnormal screening test was determined to be a benign condition or a cancer diagnosis).

Results The median time to resolution was 183 days for navigated patients with breast abnormalities and 172 days for navigated patients with cervical abnormalities. In patients with breast abnormalities, those who reported at least 1 barrier to care during navigation (HR, 0.66; 95% CI, 0.51-0.86) or higher perceived stress (HR, 0.90; 95% CI, 0.82-0.98) had slower resolution. Among patients with cervical abnormalities, those who reported at least 1 barrier to care during navigation had slower resolution (HR, 0.62; 95% CI, 0.42-0.91). Patients with cervical abnormalities had faster resolution if they had private health insurance, but this effect was present only in younger women (interaction P = .003).

Limitations Unknown generalizability of results because patients were female and from clinics in central Ohio.

Conclusions Several variables predicted whether patient navigation led to faster resolution, and predictors differed somewhat by disease site. Results will be useful in improving current patient navigation programs and designing future programs.

Funding American Cancer Society and the National Institutes of Health 

What an exciting and challenging year 2014 has been! As it draws to a close, we also celebrate the first year of the merger between The Journal of Supportive Oncology and Community Oncology to form our current title, The Journal of Community and Supportive Oncology. We hope that by combining the clinical and supportive/palliative components of our specialty, we are able to serve as a vital forum and resource by providing you with a “one-stop shop” to support you in your practice of oncology.  

What an exciting and challenging year 2014 has been! As it draws to a close, we also celebrate the first year of the merger between The Journal of Supportive Oncology and Community Oncology to form our current title, The Journal of Community and Supportive Oncology. We hope that by combining the clinical and supportive/palliative components of our specialty, we are able to serve as a vital forum and resource by providing you with a “one-stop shop” to support you in your practice of oncology.  

What an exciting and challenging year 2014 has been! As it draws to a close, we also celebrate the first year of the merger between The Journal of Supportive Oncology and Community Oncology to form our current title, The Journal of Community and Supportive Oncology. We hope that by combining the clinical and supportive/palliative components of our specialty, we are able to serve as a vital forum and resource by providing you with a “one-stop shop” to support you in your practice of oncology.  

SAN ANTONIO – Electroacupuncture proved significantly more effective than gabapentin for treatment of hot flashes in breast cancer survivors in a randomized, placebo-controlled clinical trial.

Acupuncture was far better tolerated as well. The rate of treatment-related adverse events was higher in patients randomized to gabapentin than to women assigned to electroacupuncture, sham acupuncture, or placebo, Dr. Jun J. Mao reported at the San Antonio Breast Cancer Symposium.

The study included 120 women who had completed their primary treatment for breast cancer and were experiencing troublesome hot flashes at least twice daily. Participants were randomized to 8 weeks of treatment with electroacupuncture, sham acupuncture, gabapentin at 300 mg t.i.d., or placebo. The primary endpoint was change from baseline to week 8 in patients’ hot flash composite score as gleaned from their daily hot flash diary. The secondary endpoint was durability of response based upon the hot flash composite score at week 24, fully 4 months after patients went off treatment, explained Dr. Mao, a family physician and licensed acupuncturist at the University of Pennsylvania, Philadelphia.

From a baseline mean hot flash score of 14.3, scores dropped by a mean of 7.4 points by week 8 in the electroacupuncture recipients. This represented a significantly greater treatment effect, compared with the reductions of 5.9 points with sham acupuncture, 5.2 points with gabapentin, and 3.4 points with placebo.

Only acupuncture showed a durable treatment benefit at 24 weeks. Indeed, the magnitude of the reduction in hot flash scores 4 months after the final acupuncture session was, intriguingly, even greater than at 8 weeks, both for electroacupuncture and sham acupuncture. The mean reduction in hot flash score at 24 weeks was 8.5 points in the electroacupuncture group, as compared with 7.4 points at week 8. Sham acupuncture showed a mean 6.1-point decrease in the hot flash score at week 24, gabapentin a 4.6-point reduction, and placebo a 2.8-point drop.

No serious adverse events were noted during the study. However, 48% of gabapentin-treated patients reported treatment-related adverse events, compared with 29% on placebo, 19% who got electroacupuncture, and 3% with sham acupuncture, Dr. Mao continued.

The adherence rate to acupuncture was 90%, versus 75% with gabapentin.

Electroacupuncture entailed using a TENS unit to pass a 2-Hz current through acupuncture needles placed at traditional points. There were two sessions per week for the first 2 weeks, then once-weekly sessions for the remaining 6 weeks.

“The needle insertion is generally brief, 5-10 minutes. Then the patient rests for about 20 minutes,” according to the family physician.

Sham acupuncture utilized nonpenetrating Streitberger needles at nontraditional acupuncture points.

Discussant Dr. Michelle E. Melisko noted that this is one of the largest randomized trials of acupuncture for hot flashes ever done, and it included women of widely varied ages and a substantial African American population. It’s also the first study she’s aware of to compare acupuncture to a nonhormonal medication.

She observed that hot flashes tend to be particularly frequent, severe, and often more debilitating in breast cancer survivors than in the general population. Gabapentin (Neurontin) and venlafaxine (Effexor) are probably the two most widely prescribed centrally acting drugs for treatment of hot flashes in breast cancer survivors.

“Gabapentin is often an appealing choice. In my practice it’s a drug often used to kill two birds with one stone. It can make people sleepy, so if patients are having hot flashes and night sweats it’s nice to give them an agent they can take at bedtime that might have the dual effects of reducing hot flashes as well as improving their sleep,” said Dr. Melisko, an oncologist at the University of California, San Francisco.

She noted that a systematic review of gabapentin for hot flashes in 901 patients in seven clinical trials, including four studies in breast cancer survivors, concluded the drug resulted in 20%-30% reductions in hot flash frequency and severity, but with a dropout rate twice that for placebo (Clin. Therapeutics 2009;31:221-35).But lots of breast cancer survivors say they don’t want to take an additional side effect–laden medication to treat a different set of treatment-induced side effects, Dr. Melisko continued. They’re interested in trying complementary and alternative medicine. And while a Cochrane review has concluded that acupuncture resulted in a significant reduction in hot flash severity but not frequency (Cochrane Database Syst. Rev. 2013 July 30;7:CD007410), Dr. Melisko noted that many of the trials included in that analysis may have been too brief to give acupuncture a fair shake.

Dr. Mao agreed.

“By 4 weeks in our trial you see only about one-half of the eventual effect of electroacupuncture. So if you design a short trial you may not get to the full therapeutic dose,” he said. “With acupuncture, it’s a slow start but eventual substantial effect. I tell patients you need to give acupuncture a therapeutic trial of at least six treatments. If at that point you don’t have any benefit, it may not work for you, but if you don’t try that amount it’s suboptimal.”

In acupuncture trials across the board, whether in the setting of cancer, chronic pain, or various other conditions, roughly one-third of patients are nonresponders, according to Dr. Mao.

His study was funded by the NIH’s National Center for Complementary and Alternative Medicine. He reported having no financial conflicts.

[email protected]

SAN ANTONIO – Electroacupuncture proved significantly more effective than gabapentin for treatment of hot flashes in breast cancer survivors in a randomized, placebo-controlled clinical trial.

Acupuncture was far better tolerated as well. The rate of treatment-related adverse events was higher in patients randomized to gabapentin than to women assigned to electroacupuncture, sham acupuncture, or placebo, Dr. Jun J. Mao reported at the San Antonio Breast Cancer Symposium.

The study included 120 women who had completed their primary treatment for breast cancer and were experiencing troublesome hot flashes at least twice daily. Participants were randomized to 8 weeks of treatment with electroacupuncture, sham acupuncture, gabapentin at 300 mg t.i.d., or placebo. The primary endpoint was change from baseline to week 8 in patients’ hot flash composite score as gleaned from their daily hot flash diary. The secondary endpoint was durability of response based upon the hot flash composite score at week 24, fully 4 months after patients went off treatment, explained Dr. Mao, a family physician and licensed acupuncturist at the University of Pennsylvania, Philadelphia.

From a baseline mean hot flash score of 14.3, scores dropped by a mean of 7.4 points by week 8 in the electroacupuncture recipients. This represented a significantly greater treatment effect, compared with the reductions of 5.9 points with sham acupuncture, 5.2 points with gabapentin, and 3.4 points with placebo.

Only acupuncture showed a durable treatment benefit at 24 weeks. Indeed, the magnitude of the reduction in hot flash scores 4 months after the final acupuncture session was, intriguingly, even greater than at 8 weeks, both for electroacupuncture and sham acupuncture. The mean reduction in hot flash score at 24 weeks was 8.5 points in the electroacupuncture group, as compared with 7.4 points at week 8. Sham acupuncture showed a mean 6.1-point decrease in the hot flash score at week 24, gabapentin a 4.6-point reduction, and placebo a 2.8-point drop.

No serious adverse events were noted during the study. However, 48% of gabapentin-treated patients reported treatment-related adverse events, compared with 29% on placebo, 19% who got electroacupuncture, and 3% with sham acupuncture, Dr. Mao continued.

The adherence rate to acupuncture was 90%, versus 75% with gabapentin.

Electroacupuncture entailed using a TENS unit to pass a 2-Hz current through acupuncture needles placed at traditional points. There were two sessions per week for the first 2 weeks, then once-weekly sessions for the remaining 6 weeks.

“The needle insertion is generally brief, 5-10 minutes. Then the patient rests for about 20 minutes,” according to the family physician.

Sham acupuncture utilized nonpenetrating Streitberger needles at nontraditional acupuncture points.

Discussant Dr. Michelle E. Melisko noted that this is one of the largest randomized trials of acupuncture for hot flashes ever done, and it included women of widely varied ages and a substantial African American population. It’s also the first study she’s aware of to compare acupuncture to a nonhormonal medication.

She observed that hot flashes tend to be particularly frequent, severe, and often more debilitating in breast cancer survivors than in the general population. Gabapentin (Neurontin) and venlafaxine (Effexor) are probably the two most widely prescribed centrally acting drugs for treatment of hot flashes in breast cancer survivors.

“Gabapentin is often an appealing choice. In my practice it’s a drug often used to kill two birds with one stone. It can make people sleepy, so if patients are having hot flashes and night sweats it’s nice to give them an agent they can take at bedtime that might have the dual effects of reducing hot flashes as well as improving their sleep,” said Dr. Melisko, an oncologist at the University of California, San Francisco.

She noted that a systematic review of gabapentin for hot flashes in 901 patients in seven clinical trials, including four studies in breast cancer survivors, concluded the drug resulted in 20%-30% reductions in hot flash frequency and severity, but with a dropout rate twice that for placebo (Clin. Therapeutics 2009;31:221-35).But lots of breast cancer survivors say they don’t want to take an additional side effect–laden medication to treat a different set of treatment-induced side effects, Dr. Melisko continued. They’re interested in trying complementary and alternative medicine. And while a Cochrane review has concluded that acupuncture resulted in a significant reduction in hot flash severity but not frequency (Cochrane Database Syst. Rev. 2013 July 30;7:CD007410), Dr. Melisko noted that many of the trials included in that analysis may have been too brief to give acupuncture a fair shake.

Dr. Mao agreed.

“By 4 weeks in our trial you see only about one-half of the eventual effect of electroacupuncture. So if you design a short trial you may not get to the full therapeutic dose,” he said. “With acupuncture, it’s a slow start but eventual substantial effect. I tell patients you need to give acupuncture a therapeutic trial of at least six treatments. If at that point you don’t have any benefit, it may not work for you, but if you don’t try that amount it’s suboptimal.”

In acupuncture trials across the board, whether in the setting of cancer, chronic pain, or various other conditions, roughly one-third of patients are nonresponders, according to Dr. Mao.

His study was funded by the NIH’s National Center for Complementary and Alternative Medicine. He reported having no financial conflicts.

[email protected]

SAN ANTONIO – Electroacupuncture proved significantly more effective than gabapentin for treatment of hot flashes in breast cancer survivors in a randomized, placebo-controlled clinical trial.

Acupuncture was far better tolerated as well. The rate of treatment-related adverse events was higher in patients randomized to gabapentin than to women assigned to electroacupuncture, sham acupuncture, or placebo, Dr. Jun J. Mao reported at the San Antonio Breast Cancer Symposium.

The study included 120 women who had completed their primary treatment for breast cancer and were experiencing troublesome hot flashes at least twice daily. Participants were randomized to 8 weeks of treatment with electroacupuncture, sham acupuncture, gabapentin at 300 mg t.i.d., or placebo. The primary endpoint was change from baseline to week 8 in patients’ hot flash composite score as gleaned from their daily hot flash diary. The secondary endpoint was durability of response based upon the hot flash composite score at week 24, fully 4 months after patients went off treatment, explained Dr. Mao, a family physician and licensed acupuncturist at the University of Pennsylvania, Philadelphia.

From a baseline mean hot flash score of 14.3, scores dropped by a mean of 7.4 points by week 8 in the electroacupuncture recipients. This represented a significantly greater treatment effect, compared with the reductions of 5.9 points with sham acupuncture, 5.2 points with gabapentin, and 3.4 points with placebo.

Only acupuncture showed a durable treatment benefit at 24 weeks. Indeed, the magnitude of the reduction in hot flash scores 4 months after the final acupuncture session was, intriguingly, even greater than at 8 weeks, both for electroacupuncture and sham acupuncture. The mean reduction in hot flash score at 24 weeks was 8.5 points in the electroacupuncture group, as compared with 7.4 points at week 8. Sham acupuncture showed a mean 6.1-point decrease in the hot flash score at week 24, gabapentin a 4.6-point reduction, and placebo a 2.8-point drop.

No serious adverse events were noted during the study. However, 48% of gabapentin-treated patients reported treatment-related adverse events, compared with 29% on placebo, 19% who got electroacupuncture, and 3% with sham acupuncture, Dr. Mao continued.

The adherence rate to acupuncture was 90%, versus 75% with gabapentin.

Electroacupuncture entailed using a TENS unit to pass a 2-Hz current through acupuncture needles placed at traditional points. There were two sessions per week for the first 2 weeks, then once-weekly sessions for the remaining 6 weeks.

“The needle insertion is generally brief, 5-10 minutes. Then the patient rests for about 20 minutes,” according to the family physician.

Sham acupuncture utilized nonpenetrating Streitberger needles at nontraditional acupuncture points.

Discussant Dr. Michelle E. Melisko noted that this is one of the largest randomized trials of acupuncture for hot flashes ever done, and it included women of widely varied ages and a substantial African American population. It’s also the first study she’s aware of to compare acupuncture to a nonhormonal medication.

She observed that hot flashes tend to be particularly frequent, severe, and often more debilitating in breast cancer survivors than in the general population. Gabapentin (Neurontin) and venlafaxine (Effexor) are probably the two most widely prescribed centrally acting drugs for treatment of hot flashes in breast cancer survivors.

“Gabapentin is often an appealing choice. In my practice it’s a drug often used to kill two birds with one stone. It can make people sleepy, so if patients are having hot flashes and night sweats it’s nice to give them an agent they can take at bedtime that might have the dual effects of reducing hot flashes as well as improving their sleep,” said Dr. Melisko, an oncologist at the University of California, San Francisco.

She noted that a systematic review of gabapentin for hot flashes in 901 patients in seven clinical trials, including four studies in breast cancer survivors, concluded the drug resulted in 20%-30% reductions in hot flash frequency and severity, but with a dropout rate twice that for placebo (Clin. Therapeutics 2009;31:221-35).But lots of breast cancer survivors say they don’t want to take an additional side effect–laden medication to treat a different set of treatment-induced side effects, Dr. Melisko continued. They’re interested in trying complementary and alternative medicine. And while a Cochrane review has concluded that acupuncture resulted in a significant reduction in hot flash severity but not frequency (Cochrane Database Syst. Rev. 2013 July 30;7:CD007410), Dr. Melisko noted that many of the trials included in that analysis may have been too brief to give acupuncture a fair shake.

Dr. Mao agreed.

“By 4 weeks in our trial you see only about one-half of the eventual effect of electroacupuncture. So if you design a short trial you may not get to the full therapeutic dose,” he said. “With acupuncture, it’s a slow start but eventual substantial effect. I tell patients you need to give acupuncture a therapeutic trial of at least six treatments. If at that point you don’t have any benefit, it may not work for you, but if you don’t try that amount it’s suboptimal.”

In acupuncture trials across the board, whether in the setting of cancer, chronic pain, or various other conditions, roughly one-third of patients are nonresponders, according to Dr. Mao.

His study was funded by the NIH’s National Center for Complementary and Alternative Medicine. He reported having no financial conflicts.

[email protected]

Vasomotor and musculoskeletal symptoms associated with aromatase inhibitor adjuvant therapy do not signal a more intense treatment response and thus do not predict better survival in women with breast cancer, according to a report published online Dec. 15 in Journal of Clinical Oncology.

Even though several retrospective exploratory analyses have suggested that treatment-emergent symptoms may be associated with improved survival in this patient population, this secondary analysis of data in a large international prospective randomized clinical trial argues otherwise. “It is premature to counsel patients on whether to continue or change their adjuvant AI therapy based on symptoms,” said Dr. Vered Stearns of the Kimmel Cancer Center, Johns Hopkins University, Baltimore, and her associates.

To investigate whether adverse effects might be useful in informing treatment decisions, the investigators analyzed data from the NCIC Clinical Trials Group MA.27 trial – an open-label phase III study conducted in 2003-2008 and involving 7,567 postmenopausal women who had hormone receptor–positive breast cancer. After completing their initial treatment and a washout period to allow for any adverse effects related to it, these participants were randomly assigned to receive adjuvant therapy with either anastrozole (3,787 women) or exemestane (3,789 women) and followed for a median of 4 years. To collect treatment-related symptoms in a standardized manner, they completed Common Terminology Criteria for Adverse Events questionnaires at baseline and at regular intervals afterward.

A relatively high number of these participants (34%) reported already having such symptoms at baseline, which may reflect rebound symptoms from hormone therapy withdrawal during the washout period. For women who had no symptoms at baseline, 25% reported them at 6 months and 52% reported them by 12 months.

At 3-month follow-up, 96 of the 403 women with severe symptoms discontinued treatment; the rate of treatment discontinuation was 12% at 6 months and 10% at 12 months. The most common reason cited for discontinuation was joint pain.

The emergence of new or worsening vasomotor and musculoskeletal symptoms showed no association with recurrence-free survival. There was no correlation between recurrence-free survival and symptoms at baseline or symptoms induced by AI therapy at 3 months, 6 months, or 12 months in the overall study population or in any subgroup of patients, Dr. Stearns and her associates said (J. Clin. Oncol. 2014 Dec. 15 [doi:10.1200;JCO.2014.57.6926]).

These findings indicate that treatment-emergent symptoms should be managed as effectively as possible but not held up as evidence that adjuvant therapy is working. “Women should be supported through treatment and encouraged to remain on their AI regardless of their symptoms,” the investigators added.

Vasomotor and musculoskeletal symptoms associated with aromatase inhibitor adjuvant therapy do not signal a more intense treatment response and thus do not predict better survival in women with breast cancer, according to a report published online Dec. 15 in Journal of Clinical Oncology.

Even though several retrospective exploratory analyses have suggested that treatment-emergent symptoms may be associated with improved survival in this patient population, this secondary analysis of data in a large international prospective randomized clinical trial argues otherwise. “It is premature to counsel patients on whether to continue or change their adjuvant AI therapy based on symptoms,” said Dr. Vered Stearns of the Kimmel Cancer Center, Johns Hopkins University, Baltimore, and her associates.

To investigate whether adverse effects might be useful in informing treatment decisions, the investigators analyzed data from the NCIC Clinical Trials Group MA.27 trial – an open-label phase III study conducted in 2003-2008 and involving 7,567 postmenopausal women who had hormone receptor–positive breast cancer. After completing their initial treatment and a washout period to allow for any adverse effects related to it, these participants were randomly assigned to receive adjuvant therapy with either anastrozole (3,787 women) or exemestane (3,789 women) and followed for a median of 4 years. To collect treatment-related symptoms in a standardized manner, they completed Common Terminology Criteria for Adverse Events questionnaires at baseline and at regular intervals afterward.

A relatively high number of these participants (34%) reported already having such symptoms at baseline, which may reflect rebound symptoms from hormone therapy withdrawal during the washout period. For women who had no symptoms at baseline, 25% reported them at 6 months and 52% reported them by 12 months.

At 3-month follow-up, 96 of the 403 women with severe symptoms discontinued treatment; the rate of treatment discontinuation was 12% at 6 months and 10% at 12 months. The most common reason cited for discontinuation was joint pain.

The emergence of new or worsening vasomotor and musculoskeletal symptoms showed no association with recurrence-free survival. There was no correlation between recurrence-free survival and symptoms at baseline or symptoms induced by AI therapy at 3 months, 6 months, or 12 months in the overall study population or in any subgroup of patients, Dr. Stearns and her associates said (J. Clin. Oncol. 2014 Dec. 15 [doi:10.1200;JCO.2014.57.6926]).

These findings indicate that treatment-emergent symptoms should be managed as effectively as possible but not held up as evidence that adjuvant therapy is working. “Women should be supported through treatment and encouraged to remain on their AI regardless of their symptoms,” the investigators added.

Vasomotor and musculoskeletal symptoms associated with aromatase inhibitor adjuvant therapy do not signal a more intense treatment response and thus do not predict better survival in women with breast cancer, according to a report published online Dec. 15 in Journal of Clinical Oncology.

Even though several retrospective exploratory analyses have suggested that treatment-emergent symptoms may be associated with improved survival in this patient population, this secondary analysis of data in a large international prospective randomized clinical trial argues otherwise. “It is premature to counsel patients on whether to continue or change their adjuvant AI therapy based on symptoms,” said Dr. Vered Stearns of the Kimmel Cancer Center, Johns Hopkins University, Baltimore, and her associates.

To investigate whether adverse effects might be useful in informing treatment decisions, the investigators analyzed data from the NCIC Clinical Trials Group MA.27 trial – an open-label phase III study conducted in 2003-2008 and involving 7,567 postmenopausal women who had hormone receptor–positive breast cancer. After completing their initial treatment and a washout period to allow for any adverse effects related to it, these participants were randomly assigned to receive adjuvant therapy with either anastrozole (3,787 women) or exemestane (3,789 women) and followed for a median of 4 years. To collect treatment-related symptoms in a standardized manner, they completed Common Terminology Criteria for Adverse Events questionnaires at baseline and at regular intervals afterward.

A relatively high number of these participants (34%) reported already having such symptoms at baseline, which may reflect rebound symptoms from hormone therapy withdrawal during the washout period. For women who had no symptoms at baseline, 25% reported them at 6 months and 52% reported them by 12 months.

At 3-month follow-up, 96 of the 403 women with severe symptoms discontinued treatment; the rate of treatment discontinuation was 12% at 6 months and 10% at 12 months. The most common reason cited for discontinuation was joint pain.

The emergence of new or worsening vasomotor and musculoskeletal symptoms showed no association with recurrence-free survival. There was no correlation between recurrence-free survival and symptoms at baseline or symptoms induced by AI therapy at 3 months, 6 months, or 12 months in the overall study population or in any subgroup of patients, Dr. Stearns and her associates said (J. Clin. Oncol. 2014 Dec. 15 [doi:10.1200;JCO.2014.57.6926]).

These findings indicate that treatment-emergent symptoms should be managed as effectively as possible but not held up as evidence that adjuvant therapy is working. “Women should be supported through treatment and encouraged to remain on their AI regardless of their symptoms,” the investigators added.

SAN FRANCISCO – Unless there is a clear contraindication to anticoagulation therapy, cancer patients who have an incidental pulmonary embolism discovered during imaging studies should receive chronic anticoagulation, preferably with a low-molecular-weight heparin, based on study results presented at the annual meeting of the American Society of Hematology.

Without anticoagulation therapy, the risk for a recurent venous thromboembolic event was fourfold higher among 926 cancer patients who had a pulmonary embolism discovered during CT imaging for reasons other than suspicion of pulmonary embolism (PE), according to Dr. Tom van der Hulle of Leiden (the Netherlands) University Medical Center.

Among cancer patients who did receive an anticoagulant, low-molecular-weight heparin (LMWH) was significantly better than warfarin at preventing recurrent venous thromboembolism (VTE) or PE. Compared with warfarin, LMWH also was associated with a significantly lower risk for bleeding.

“Our study confirms the high risk of recurrent [VTE] in patients with cancer-associated incidental pulmonary embolism, but it also provides outcomes if patients are left untreated,” Dr. van der Hulle said at a briefing prior to his presentation of the data.

Risk for primary and recurrent VTE is particularly high for patients with pancreatic cancer, lung cancer, metastatic adenocarcinoma of gastroinestinal or gynecologic origin, and brain tumors, noted Dr. Agnes Lee of the University of British Columbia in Vancouver. Dr. Lee also presented data at the briefing but was not involved with the study.

“Once the patients are started on treatment for their clotting episode, for a DVT or PE, a minimum of 3-6 months of anticoagulation is recommended. After that, we look at patients to see whether they have ongoing reasons to develop recurrent thrombosis. So this would be patients who have active cancer – they’re still receiving chemotherapy, they have obvious evidence of cancer or metastatic disease, or they’re sick for other reasons. These are patients who would then continue on anticoagulant therapy,” she added.

Dr. van der Hulle and his colleagues conducted a pooled meta-analysis of 926 patients with cancer who had an incidental PE discovered during a CT scan. The researchers compared results for patients treated with LMWH (79%), a vitamin K antagonist (predominantly warfarin, 11%), and for those who did not receive prophylaxis with an anticoagualant because of contraindications.

They looked at recurrent VTE, major bleeding episodes, and death at 6 months and conducted subgroup analyses based on patient management and thrombus location.

Patients with metastatic disease comprised 74% of those treated with LMWH, 62% of those treated with a vitamin K antagonist, and 73% of untreated patients.

The overall pooled 6-month risk of symptomatic recurrent VTE was 5.8%. The risk of major bleeding was 4.7%, and the risk of death was 37%.

Risk of recurrent VTE was 6.2% for patients treated with LMWH and 6.4% for those treated with a vitamin K antagonist. Recurrent VTE risk was 12% for untreated patients.

Major bleeding was seen in 3.9% of LMWH-treated patients and in 13% of vitamin K antagonist–treated patients (hazard ratio 3.9; 95% confidence interval, 1.6-10).The 6-month mortality rates were 37% for patients treated with LMWH, 28% for those treated with warfarin or a related drug, and 47% for untreated patients.

When the authors looked at the location of the thrombus – isolated subsegmental incidental PE vs. central PE – they found that the risk of recurrent isolated embolism was 7.8% and for central embolism was 5.5%.

Dr. van der Hulle said that the findings of this observational study should preferably be confirmed in a randomized trial, but acknowledged that, given the risk of no treatment, a placebo-controlled trial might be considered unethical.

The study was internally supported. Dr. van der Hulle and Dr. Lee reported no relevant conflicts of interest.

SAN FRANCISCO – Unless there is a clear contraindication to anticoagulation therapy, cancer patients who have an incidental pulmonary embolism discovered during imaging studies should receive chronic anticoagulation, preferably with a low-molecular-weight heparin, based on study results presented at the annual meeting of the American Society of Hematology.

Without anticoagulation therapy, the risk for a recurent venous thromboembolic event was fourfold higher among 926 cancer patients who had a pulmonary embolism discovered during CT imaging for reasons other than suspicion of pulmonary embolism (PE), according to Dr. Tom van der Hulle of Leiden (the Netherlands) University Medical Center.

Among cancer patients who did receive an anticoagulant, low-molecular-weight heparin (LMWH) was significantly better than warfarin at preventing recurrent venous thromboembolism (VTE) or PE. Compared with warfarin, LMWH also was associated with a significantly lower risk for bleeding.

“Our study confirms the high risk of recurrent [VTE] in patients with cancer-associated incidental pulmonary embolism, but it also provides outcomes if patients are left untreated,” Dr. van der Hulle said at a briefing prior to his presentation of the data.

Risk for primary and recurrent VTE is particularly high for patients with pancreatic cancer, lung cancer, metastatic adenocarcinoma of gastroinestinal or gynecologic origin, and brain tumors, noted Dr. Agnes Lee of the University of British Columbia in Vancouver. Dr. Lee also presented data at the briefing but was not involved with the study.

“Once the patients are started on treatment for their clotting episode, for a DVT or PE, a minimum of 3-6 months of anticoagulation is recommended. After that, we look at patients to see whether they have ongoing reasons to develop recurrent thrombosis. So this would be patients who have active cancer – they’re still receiving chemotherapy, they have obvious evidence of cancer or metastatic disease, or they’re sick for other reasons. These are patients who would then continue on anticoagulant therapy,” she added.

Dr. van der Hulle and his colleagues conducted a pooled meta-analysis of 926 patients with cancer who had an incidental PE discovered during a CT scan. The researchers compared results for patients treated with LMWH (79%), a vitamin K antagonist (predominantly warfarin, 11%), and for those who did not receive prophylaxis with an anticoagualant because of contraindications.

They looked at recurrent VTE, major bleeding episodes, and death at 6 months and conducted subgroup analyses based on patient management and thrombus location.

Patients with metastatic disease comprised 74% of those treated with LMWH, 62% of those treated with a vitamin K antagonist, and 73% of untreated patients.

The overall pooled 6-month risk of symptomatic recurrent VTE was 5.8%. The risk of major bleeding was 4.7%, and the risk of death was 37%.

Risk of recurrent VTE was 6.2% for patients treated with LMWH and 6.4% for those treated with a vitamin K antagonist. Recurrent VTE risk was 12% for untreated patients.

Major bleeding was seen in 3.9% of LMWH-treated patients and in 13% of vitamin K antagonist–treated patients (hazard ratio 3.9; 95% confidence interval, 1.6-10).The 6-month mortality rates were 37% for patients treated with LMWH, 28% for those treated with warfarin or a related drug, and 47% for untreated patients.

When the authors looked at the location of the thrombus – isolated subsegmental incidental PE vs. central PE – they found that the risk of recurrent isolated embolism was 7.8% and for central embolism was 5.5%.

Dr. van der Hulle said that the findings of this observational study should preferably be confirmed in a randomized trial, but acknowledged that, given the risk of no treatment, a placebo-controlled trial might be considered unethical.

The study was internally supported. Dr. van der Hulle and Dr. Lee reported no relevant conflicts of interest.

SAN FRANCISCO – Unless there is a clear contraindication to anticoagulation therapy, cancer patients who have an incidental pulmonary embolism discovered during imaging studies should receive chronic anticoagulation, preferably with a low-molecular-weight heparin, based on study results presented at the annual meeting of the American Society of Hematology.

Without anticoagulation therapy, the risk for a recurent venous thromboembolic event was fourfold higher among 926 cancer patients who had a pulmonary embolism discovered during CT imaging for reasons other than suspicion of pulmonary embolism (PE), according to Dr. Tom van der Hulle of Leiden (the Netherlands) University Medical Center.

Among cancer patients who did receive an anticoagulant, low-molecular-weight heparin (LMWH) was significantly better than warfarin at preventing recurrent venous thromboembolism (VTE) or PE. Compared with warfarin, LMWH also was associated with a significantly lower risk for bleeding.

“Our study confirms the high risk of recurrent [VTE] in patients with cancer-associated incidental pulmonary embolism, but it also provides outcomes if patients are left untreated,” Dr. van der Hulle said at a briefing prior to his presentation of the data.

Risk for primary and recurrent VTE is particularly high for patients with pancreatic cancer, lung cancer, metastatic adenocarcinoma of gastroinestinal or gynecologic origin, and brain tumors, noted Dr. Agnes Lee of the University of British Columbia in Vancouver. Dr. Lee also presented data at the briefing but was not involved with the study.

“Once the patients are started on treatment for their clotting episode, for a DVT or PE, a minimum of 3-6 months of anticoagulation is recommended. After that, we look at patients to see whether they have ongoing reasons to develop recurrent thrombosis. So this would be patients who have active cancer – they’re still receiving chemotherapy, they have obvious evidence of cancer or metastatic disease, or they’re sick for other reasons. These are patients who would then continue on anticoagulant therapy,” she added.

Dr. van der Hulle and his colleagues conducted a pooled meta-analysis of 926 patients with cancer who had an incidental PE discovered during a CT scan. The researchers compared results for patients treated with LMWH (79%), a vitamin K antagonist (predominantly warfarin, 11%), and for those who did not receive prophylaxis with an anticoagualant because of contraindications.

They looked at recurrent VTE, major bleeding episodes, and death at 6 months and conducted subgroup analyses based on patient management and thrombus location.

Patients with metastatic disease comprised 74% of those treated with LMWH, 62% of those treated with a vitamin K antagonist, and 73% of untreated patients.

The overall pooled 6-month risk of symptomatic recurrent VTE was 5.8%. The risk of major bleeding was 4.7%, and the risk of death was 37%.

Risk of recurrent VTE was 6.2% for patients treated with LMWH and 6.4% for those treated with a vitamin K antagonist. Recurrent VTE risk was 12% for untreated patients.

Major bleeding was seen in 3.9% of LMWH-treated patients and in 13% of vitamin K antagonist–treated patients (hazard ratio 3.9; 95% confidence interval, 1.6-10).The 6-month mortality rates were 37% for patients treated with LMWH, 28% for those treated with warfarin or a related drug, and 47% for untreated patients.

When the authors looked at the location of the thrombus – isolated subsegmental incidental PE vs. central PE – they found that the risk of recurrent isolated embolism was 7.8% and for central embolism was 5.5%.

Dr. van der Hulle said that the findings of this observational study should preferably be confirmed in a randomized trial, but acknowledged that, given the risk of no treatment, a placebo-controlled trial might be considered unethical.

The study was internally supported. Dr. van der Hulle and Dr. Lee reported no relevant conflicts of interest.