Breast Cancer

Community Oncology Founding Editor Dr. Lee Schwartzberg, spoke with Dr. Joyce O'Shaughnessy at the Oncology Practice Summit in Las Vegas about emerging molecular biomarkers in breast cancer and shares some case-based treatment options to illustrate how these new predictive tools can be used. 

The Oncology Practice Summit was the 8th annual meeting of Community Oncology, the journal of clinical issues in community practice.  Dr. Schwartzberg was chair of the Summit, which was hosted this year by Community Oncology as well as The Journal of Supportive Oncology and The Oncology Report.

Community Oncology Founding Editor Dr. Lee Schwartzberg, spoke with Dr. Joyce O'Shaughnessy at the Oncology Practice Summit in Las Vegas about emerging molecular biomarkers in breast cancer and shares some case-based treatment options to illustrate how these new predictive tools can be used. 

The Oncology Practice Summit was the 8th annual meeting of Community Oncology, the journal of clinical issues in community practice.  Dr. Schwartzberg was chair of the Summit, which was hosted this year by Community Oncology as well as The Journal of Supportive Oncology and The Oncology Report.

Community Oncology Founding Editor Dr. Lee Schwartzberg, spoke with Dr. Joyce O'Shaughnessy at the Oncology Practice Summit in Las Vegas about emerging molecular biomarkers in breast cancer and shares some case-based treatment options to illustrate how these new predictive tools can be used. 

The Oncology Practice Summit was the 8th annual meeting of Community Oncology, the journal of clinical issues in community practice.  Dr. Schwartzberg was chair of the Summit, which was hosted this year by Community Oncology as well as The Journal of Supportive Oncology and The Oncology Report.

Community Oncology Editor Dr. Linda Bosserman spoke with Dr. Rowan Chlebowski at the Oncology Practice Summit in Las Vegas about the effect of diet and exercise on breast cancer patients.

The Oncology Practice Summit was the 8th annual meeting of Community Oncology, the journal of clinical issues in community practice.  Dr. Bosserman was a co-chair of the Summit, which was hosted this year by Community Oncology as well as The Journal of Supportive Oncology and The Oncology Report.

Community Oncology Editor Dr. Linda Bosserman spoke with Dr. Rowan Chlebowski at the Oncology Practice Summit in Las Vegas about the effect of diet and exercise on breast cancer patients.

The Oncology Practice Summit was the 8th annual meeting of Community Oncology, the journal of clinical issues in community practice.  Dr. Bosserman was a co-chair of the Summit, which was hosted this year by Community Oncology as well as The Journal of Supportive Oncology and The Oncology Report.

Community Oncology Editor Dr. Linda Bosserman spoke with Dr. Rowan Chlebowski at the Oncology Practice Summit in Las Vegas about the effect of diet and exercise on breast cancer patients.

The Oncology Practice Summit was the 8th annual meeting of Community Oncology, the journal of clinical issues in community practice.  Dr. Bosserman was a co-chair of the Summit, which was hosted this year by Community Oncology as well as The Journal of Supportive Oncology and The Oncology Report.

Draft recommendations being considered by the U.S. Preventive Services Task Force encourage clinicians to offer tamoxifen or raloxifene to women who have an increased risk of developing a first breast cancer and a low risk of side effects.

The document reaffirms 2002 recommendations from the Task Force with updated evidence on the risks and benefits of this prophylactic strategy and somewhat stronger wording, saying clinicians should "offer to prescribe" the drugs to appropriate candidates rather than simply "discuss" this option and "inform" patients of the risks and benefits.

The Task Force is accepting online comments about its draft until May 13 before finalizing its recommendations.

The draft document was informed by a systematic review of the literature that suggests tamoxifen or raloxifene can reduce the incidence of invasive breast cancer in higher-risk women by 7-9 cases per 100,000 women over 5 years, compared with placebo. The review by Dr. Heidi D. Nelson and her associates was published online in advance of print by the Task Force and by the Annals of Internal Medicine (Ann. Intern. Med. 2013;158:604-14). The incidence of breast cancer was lower with tamoxifen in a head-to-head trial, the Study of Tamoxifen and Raloxifene (STAR), with 5 fewer cases per 1,000 women on tamoxifen compared with raloxifene.

The drugs also reduce the incidence of fracture, with 7 fewer vertebral fractures per 1,000 women on raloxifene or 3 fewer nonvertebral fractures per 1,000 women on tamoxifen, the literature suggests.

Neither drug reduced deaths from breast cancer or deaths from any cause in the published studies, reported Dr. Nelson, a research professor in the departments of medical informatics and clinical epidemiology and medicine at Oregon Health and Sciences University, Portland. Data were lacking on use of these drugs by nonwhite, premenopausal, or elderly women who have comorbid conditions or are taking other medications

Because both of these selective estrogen receptor modulator drugs have potentially serious side effects, the Task Force recommended in both its 2002 guidelines and the 2013 draft that they not be used by women who are not at increased risk for breast cancer. In higher-risk women, both drugs increase the risk of thromboembolic events. Studies have associated tamoxifen with 4 extra thromboembolic events per 1,000 women and raloxifene with 7 excess events per 1,000 women. Tamoxifen use was associated with 4 extra endometrial cancers compared with placebo and increased the risk for ischemic stroke and cataracts. Both drugs can cause less serious side effects, most commonly vasomotor symptoms (hot flashes).

Few U.S. women use tamoxifen or raloxifene to prevent primary breast cancer, in part because it is not clear how to indentify candidates for this therapy, according to Dr. Nelson’s report. Models estimate that women with at least a 3% risk of developing breast cancer in the next 5 years are more likely to benefit than be harmed from tamoxifen or raloxifene, the Task Force draft states. The recommendations would apply to asymptomatic women aged 40-70 years with no history of breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or thromboembolic events.

An online risk assessment tool from the National Cancer Institute that is based on the Gail model of risk assessment can help estimate a person’s 5-year risk of invasive breast cancer, one of 13 risk-stratification models examined in the medical literature. Most models performed only slightly better than use of age alone to predict risk, Dr. Nelson reported. The Food and Drug Administration approved use of tamoxifen or raloxifene to prevent breast cancer if the 5-year risk is at least 1.67% under the Gail model, but women aged 60 years or older who had no other risk factors would meet this threshold using age alone, her review found.

Data are lacking on the optimal doses, and the duration and timing of therapy. The typical doses used to reduce invasive breast cancer risk in several randomized trials are 20 mg/day of tamoxifen or 60 mg/day of raloxifene for 5 years.

The Task Force draft deals only with tamoxifen and raloxifene because these are the only two drugs approved by the FDA to reduce the risk of hormone receptor–positive breast cancer. The draft recommendations note, however, that more data should be coming from trials of possible drug candidates such as aromatase inhibitors. Dr. Nelson’s review notes that tibolone, lasofoxifene, and exemestane reduced breast cancer risk in some trials and "may expand clinical options."

The American Cancer Society in 2013 urged women who are considering chemoprevention for breast cancer to discuss the risks and benefits with their physicians. A 2009 clinical practice guideline update by the American Society of Clinical Oncology said tamoxifen may be offered to women at increased risk of breast cancer and raloxifene may be offered to postmenopausal women at increased risk (J. Clin. Oncol. 2009;27:3235-58).

The American College of Obstetricians and Gynecologists’ 2002 Practice Bulletin #39 on selective estrogen receptor modulators said tamoxifen may be offered to women at high risk of breast cancer (Obstet. Gynecol. 2002;100:839-44). Joint guidelines from the Canadian Task Force on Preventive Health Care and the Canadian Breast Cancer Initiative’ Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer suggested in 2001 that women whose 5-year risk for breast cancer under the Gail model exceeds 5% may be candidates for tamoxifen preventive therapy (CMAJ 2001;164:1681-90).

The National Cancer Institute estimates that 232,340 breast cancers will be diagnosed in 2013 and 39,620 women will die from the disease.

Dr. Nelson and her associates reported having no financial disclosures other than receiving grants from the Agency for Healthcare Research and Quality, which funded the study.

sboschert@frontlinemedcom.com

Twitter: @sherryboschert

Draft recommendations being considered by the U.S. Preventive Services Task Force encourage clinicians to offer tamoxifen or raloxifene to women who have an increased risk of developing a first breast cancer and a low risk of side effects.

The document reaffirms 2002 recommendations from the Task Force with updated evidence on the risks and benefits of this prophylactic strategy and somewhat stronger wording, saying clinicians should "offer to prescribe" the drugs to appropriate candidates rather than simply "discuss" this option and "inform" patients of the risks and benefits.

The Task Force is accepting online comments about its draft until May 13 before finalizing its recommendations.

The draft document was informed by a systematic review of the literature that suggests tamoxifen or raloxifene can reduce the incidence of invasive breast cancer in higher-risk women by 7-9 cases per 100,000 women over 5 years, compared with placebo. The review by Dr. Heidi D. Nelson and her associates was published online in advance of print by the Task Force and by the Annals of Internal Medicine (Ann. Intern. Med. 2013;158:604-14). The incidence of breast cancer was lower with tamoxifen in a head-to-head trial, the Study of Tamoxifen and Raloxifene (STAR), with 5 fewer cases per 1,000 women on tamoxifen compared with raloxifene.

The drugs also reduce the incidence of fracture, with 7 fewer vertebral fractures per 1,000 women on raloxifene or 3 fewer nonvertebral fractures per 1,000 women on tamoxifen, the literature suggests.

Neither drug reduced deaths from breast cancer or deaths from any cause in the published studies, reported Dr. Nelson, a research professor in the departments of medical informatics and clinical epidemiology and medicine at Oregon Health and Sciences University, Portland. Data were lacking on use of these drugs by nonwhite, premenopausal, or elderly women who have comorbid conditions or are taking other medications

Because both of these selective estrogen receptor modulator drugs have potentially serious side effects, the Task Force recommended in both its 2002 guidelines and the 2013 draft that they not be used by women who are not at increased risk for breast cancer. In higher-risk women, both drugs increase the risk of thromboembolic events. Studies have associated tamoxifen with 4 extra thromboembolic events per 1,000 women and raloxifene with 7 excess events per 1,000 women. Tamoxifen use was associated with 4 extra endometrial cancers compared with placebo and increased the risk for ischemic stroke and cataracts. Both drugs can cause less serious side effects, most commonly vasomotor symptoms (hot flashes).

Few U.S. women use tamoxifen or raloxifene to prevent primary breast cancer, in part because it is not clear how to indentify candidates for this therapy, according to Dr. Nelson’s report. Models estimate that women with at least a 3% risk of developing breast cancer in the next 5 years are more likely to benefit than be harmed from tamoxifen or raloxifene, the Task Force draft states. The recommendations would apply to asymptomatic women aged 40-70 years with no history of breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or thromboembolic events.

An online risk assessment tool from the National Cancer Institute that is based on the Gail model of risk assessment can help estimate a person’s 5-year risk of invasive breast cancer, one of 13 risk-stratification models examined in the medical literature. Most models performed only slightly better than use of age alone to predict risk, Dr. Nelson reported. The Food and Drug Administration approved use of tamoxifen or raloxifene to prevent breast cancer if the 5-year risk is at least 1.67% under the Gail model, but women aged 60 years or older who had no other risk factors would meet this threshold using age alone, her review found.

Data are lacking on the optimal doses, and the duration and timing of therapy. The typical doses used to reduce invasive breast cancer risk in several randomized trials are 20 mg/day of tamoxifen or 60 mg/day of raloxifene for 5 years.

The Task Force draft deals only with tamoxifen and raloxifene because these are the only two drugs approved by the FDA to reduce the risk of hormone receptor–positive breast cancer. The draft recommendations note, however, that more data should be coming from trials of possible drug candidates such as aromatase inhibitors. Dr. Nelson’s review notes that tibolone, lasofoxifene, and exemestane reduced breast cancer risk in some trials and "may expand clinical options."

The American Cancer Society in 2013 urged women who are considering chemoprevention for breast cancer to discuss the risks and benefits with their physicians. A 2009 clinical practice guideline update by the American Society of Clinical Oncology said tamoxifen may be offered to women at increased risk of breast cancer and raloxifene may be offered to postmenopausal women at increased risk (J. Clin. Oncol. 2009;27:3235-58).

The American College of Obstetricians and Gynecologists’ 2002 Practice Bulletin #39 on selective estrogen receptor modulators said tamoxifen may be offered to women at high risk of breast cancer (Obstet. Gynecol. 2002;100:839-44). Joint guidelines from the Canadian Task Force on Preventive Health Care and the Canadian Breast Cancer Initiative’ Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer suggested in 2001 that women whose 5-year risk for breast cancer under the Gail model exceeds 5% may be candidates for tamoxifen preventive therapy (CMAJ 2001;164:1681-90).

The National Cancer Institute estimates that 232,340 breast cancers will be diagnosed in 2013 and 39,620 women will die from the disease.

Dr. Nelson and her associates reported having no financial disclosures other than receiving grants from the Agency for Healthcare Research and Quality, which funded the study.

sboschert@frontlinemedcom.com

Twitter: @sherryboschert

Draft recommendations being considered by the U.S. Preventive Services Task Force encourage clinicians to offer tamoxifen or raloxifene to women who have an increased risk of developing a first breast cancer and a low risk of side effects.

The document reaffirms 2002 recommendations from the Task Force with updated evidence on the risks and benefits of this prophylactic strategy and somewhat stronger wording, saying clinicians should "offer to prescribe" the drugs to appropriate candidates rather than simply "discuss" this option and "inform" patients of the risks and benefits.

The Task Force is accepting online comments about its draft until May 13 before finalizing its recommendations.

The draft document was informed by a systematic review of the literature that suggests tamoxifen or raloxifene can reduce the incidence of invasive breast cancer in higher-risk women by 7-9 cases per 100,000 women over 5 years, compared with placebo. The review by Dr. Heidi D. Nelson and her associates was published online in advance of print by the Task Force and by the Annals of Internal Medicine (Ann. Intern. Med. 2013;158:604-14). The incidence of breast cancer was lower with tamoxifen in a head-to-head trial, the Study of Tamoxifen and Raloxifene (STAR), with 5 fewer cases per 1,000 women on tamoxifen compared with raloxifene.

The drugs also reduce the incidence of fracture, with 7 fewer vertebral fractures per 1,000 women on raloxifene or 3 fewer nonvertebral fractures per 1,000 women on tamoxifen, the literature suggests.

Neither drug reduced deaths from breast cancer or deaths from any cause in the published studies, reported Dr. Nelson, a research professor in the departments of medical informatics and clinical epidemiology and medicine at Oregon Health and Sciences University, Portland. Data were lacking on use of these drugs by nonwhite, premenopausal, or elderly women who have comorbid conditions or are taking other medications

Because both of these selective estrogen receptor modulator drugs have potentially serious side effects, the Task Force recommended in both its 2002 guidelines and the 2013 draft that they not be used by women who are not at increased risk for breast cancer. In higher-risk women, both drugs increase the risk of thromboembolic events. Studies have associated tamoxifen with 4 extra thromboembolic events per 1,000 women and raloxifene with 7 excess events per 1,000 women. Tamoxifen use was associated with 4 extra endometrial cancers compared with placebo and increased the risk for ischemic stroke and cataracts. Both drugs can cause less serious side effects, most commonly vasomotor symptoms (hot flashes).

Few U.S. women use tamoxifen or raloxifene to prevent primary breast cancer, in part because it is not clear how to indentify candidates for this therapy, according to Dr. Nelson’s report. Models estimate that women with at least a 3% risk of developing breast cancer in the next 5 years are more likely to benefit than be harmed from tamoxifen or raloxifene, the Task Force draft states. The recommendations would apply to asymptomatic women aged 40-70 years with no history of breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or thromboembolic events.

An online risk assessment tool from the National Cancer Institute that is based on the Gail model of risk assessment can help estimate a person’s 5-year risk of invasive breast cancer, one of 13 risk-stratification models examined in the medical literature. Most models performed only slightly better than use of age alone to predict risk, Dr. Nelson reported. The Food and Drug Administration approved use of tamoxifen or raloxifene to prevent breast cancer if the 5-year risk is at least 1.67% under the Gail model, but women aged 60 years or older who had no other risk factors would meet this threshold using age alone, her review found.

Data are lacking on the optimal doses, and the duration and timing of therapy. The typical doses used to reduce invasive breast cancer risk in several randomized trials are 20 mg/day of tamoxifen or 60 mg/day of raloxifene for 5 years.

The Task Force draft deals only with tamoxifen and raloxifene because these are the only two drugs approved by the FDA to reduce the risk of hormone receptor–positive breast cancer. The draft recommendations note, however, that more data should be coming from trials of possible drug candidates such as aromatase inhibitors. Dr. Nelson’s review notes that tibolone, lasofoxifene, and exemestane reduced breast cancer risk in some trials and "may expand clinical options."

The American Cancer Society in 2013 urged women who are considering chemoprevention for breast cancer to discuss the risks and benefits with their physicians. A 2009 clinical practice guideline update by the American Society of Clinical Oncology said tamoxifen may be offered to women at increased risk of breast cancer and raloxifene may be offered to postmenopausal women at increased risk (J. Clin. Oncol. 2009;27:3235-58).

The American College of Obstetricians and Gynecologists’ 2002 Practice Bulletin #39 on selective estrogen receptor modulators said tamoxifen may be offered to women at high risk of breast cancer (Obstet. Gynecol. 2002;100:839-44). Joint guidelines from the Canadian Task Force on Preventive Health Care and the Canadian Breast Cancer Initiative’ Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer suggested in 2001 that women whose 5-year risk for breast cancer under the Gail model exceeds 5% may be candidates for tamoxifen preventive therapy (CMAJ 2001;164:1681-90).

The National Cancer Institute estimates that 232,340 breast cancers will be diagnosed in 2013 and 39,620 women will die from the disease.

Dr. Nelson and her associates reported having no financial disclosures other than receiving grants from the Agency for Healthcare Research and Quality, which funded the study.

sboschert@frontlinemedcom.com

Twitter: @sherryboschert

NEW ORLEANS – Dexamethasone was more effective than was placebo in relieving cancer-related fatigue in a double-blind randomized trial of patients with advanced cancer.

After 14 days of treatment, scores on the Functional Assessment of Chronic Illness Therapy (FACIT) fatigue subscale improved by nearly 6 points in the dexamethasone group (9.0 vs. 3.1; P = .008).

Patrice Wendling/IMNG Medical Media

"[Treatment] duration is very important in our patient population because when they are referred to us, it’s very late. They typically have a survival of just 28 to 7 days," Dr. Sriram Yennu said at the annual meeting of the American Academy of Hospice and Palliative Medicine.

Although 20%-50% of palliative care patients receive some form of corticosteroid, no steroid study to date has used cancer-related fatigue (CRF) as a primary outcome or assessed CRF with a validated outcome measure, he said. Fatigue is ubiquitous, however, contributing up to one-third of symptom distress in patients with advanced cancer.

The study enrolled 132 outpatients with a life expectancy of at least 4 weeks with three or more cancer-related symptoms (fatigue, pain, nausea, loss of appetite, depression, anxiety, or sleep disturbance), and randomly assigned them to oral dexamethasone 4 mg twice daily or placebo for 14 days.

The most common diagnosis was head and neck/lung cancer in 45 patients, followed by gastrointestinal cancer in 39, breast cancer in 13, and genitourinary in 10. Median patient age was 60; 81 patients were white, and the average FACIT fatigue score was 19.6, where 52 denotes no fatigue and 0 is severe fatigue.

Among 84 evaluable patients, total scores on FACIT favored the dexamethasone group (18.16 vs. 7.87; P = .03), as did scores on its physical subscale (5.25 vs. 1.32; P = .002), said Dr. Yennu of the department of palliative care and rehabilitation medicine, University of Texas MD Anderson Cancer Center, Houston.

Scores on the physical domain of the Edmonton Symptom Assessment Scale (ESAS) were better in the dexamethasone group than in the placebo group (–10.15 vs. –5.39; P = .04), according to the study, which earned Dr. Yennu a young investigator award.

Notably, scores were similar between the dexamethasone and placebo groups on the emotional subscale of FACIT (1.85 vs. 1.18; P = .49) and the ESAS psychological subscale (–1.48 vs. –2.08; P = .76). The emotional domain of the FACIT-F is measured by six items using a 0-4 scale where 0 is "not at all" and 4 includes statements like "I am losing hope in the fight against my illness." The finding suggests that the improvement in fatigue was likely not just a euphoric effect, as observed before in other steroid trials, Dr. Yennu said.

He expressed concern that corticosteroid use would increase toxicity, particularly insomnia, but no significant differences were observed between the dexamethasone and placebo groups regarding insomnia (3 vs. 4), overall adverse events (41 vs. 44) or serious adverse events (17 vs. 11).

Larger, long-term safety and efficacy studies are needed to address steroid dose and duration, and whether dexamethasone should be coupled with interventions targeting the psychological domain, he said. A 3-point difference in the FACIT is considered clinically important, but research in press in the Journal of Clinical Oncology, by Dr. Yennu and his colleagues, suggests a 10-point difference is more meaningful.

The American Cancer Society supported the study. Dr. Yennu reported having no financial disclosures.

pwendling@frontlinemedcom.com

NEW ORLEANS – Dexamethasone was more effective than was placebo in relieving cancer-related fatigue in a double-blind randomized trial of patients with advanced cancer.

After 14 days of treatment, scores on the Functional Assessment of Chronic Illness Therapy (FACIT) fatigue subscale improved by nearly 6 points in the dexamethasone group (9.0 vs. 3.1; P = .008).

Patrice Wendling/IMNG Medical Media

"[Treatment] duration is very important in our patient population because when they are referred to us, it’s very late. They typically have a survival of just 28 to 7 days," Dr. Sriram Yennu said at the annual meeting of the American Academy of Hospice and Palliative Medicine.

Although 20%-50% of palliative care patients receive some form of corticosteroid, no steroid study to date has used cancer-related fatigue (CRF) as a primary outcome or assessed CRF with a validated outcome measure, he said. Fatigue is ubiquitous, however, contributing up to one-third of symptom distress in patients with advanced cancer.

The study enrolled 132 outpatients with a life expectancy of at least 4 weeks with three or more cancer-related symptoms (fatigue, pain, nausea, loss of appetite, depression, anxiety, or sleep disturbance), and randomly assigned them to oral dexamethasone 4 mg twice daily or placebo for 14 days.

The most common diagnosis was head and neck/lung cancer in 45 patients, followed by gastrointestinal cancer in 39, breast cancer in 13, and genitourinary in 10. Median patient age was 60; 81 patients were white, and the average FACIT fatigue score was 19.6, where 52 denotes no fatigue and 0 is severe fatigue.

Among 84 evaluable patients, total scores on FACIT favored the dexamethasone group (18.16 vs. 7.87; P = .03), as did scores on its physical subscale (5.25 vs. 1.32; P = .002), said Dr. Yennu of the department of palliative care and rehabilitation medicine, University of Texas MD Anderson Cancer Center, Houston.

Scores on the physical domain of the Edmonton Symptom Assessment Scale (ESAS) were better in the dexamethasone group than in the placebo group (–10.15 vs. –5.39; P = .04), according to the study, which earned Dr. Yennu a young investigator award.

Notably, scores were similar between the dexamethasone and placebo groups on the emotional subscale of FACIT (1.85 vs. 1.18; P = .49) and the ESAS psychological subscale (–1.48 vs. –2.08; P = .76). The emotional domain of the FACIT-F is measured by six items using a 0-4 scale where 0 is "not at all" and 4 includes statements like "I am losing hope in the fight against my illness." The finding suggests that the improvement in fatigue was likely not just a euphoric effect, as observed before in other steroid trials, Dr. Yennu said.

He expressed concern that corticosteroid use would increase toxicity, particularly insomnia, but no significant differences were observed between the dexamethasone and placebo groups regarding insomnia (3 vs. 4), overall adverse events (41 vs. 44) or serious adverse events (17 vs. 11).

Larger, long-term safety and efficacy studies are needed to address steroid dose and duration, and whether dexamethasone should be coupled with interventions targeting the psychological domain, he said. A 3-point difference in the FACIT is considered clinically important, but research in press in the Journal of Clinical Oncology, by Dr. Yennu and his colleagues, suggests a 10-point difference is more meaningful.

The American Cancer Society supported the study. Dr. Yennu reported having no financial disclosures.

pwendling@frontlinemedcom.com

NEW ORLEANS – Dexamethasone was more effective than was placebo in relieving cancer-related fatigue in a double-blind randomized trial of patients with advanced cancer.

After 14 days of treatment, scores on the Functional Assessment of Chronic Illness Therapy (FACIT) fatigue subscale improved by nearly 6 points in the dexamethasone group (9.0 vs. 3.1; P = .008).

Patrice Wendling/IMNG Medical Media

"[Treatment] duration is very important in our patient population because when they are referred to us, it’s very late. They typically have a survival of just 28 to 7 days," Dr. Sriram Yennu said at the annual meeting of the American Academy of Hospice and Palliative Medicine.

Although 20%-50% of palliative care patients receive some form of corticosteroid, no steroid study to date has used cancer-related fatigue (CRF) as a primary outcome or assessed CRF with a validated outcome measure, he said. Fatigue is ubiquitous, however, contributing up to one-third of symptom distress in patients with advanced cancer.

The study enrolled 132 outpatients with a life expectancy of at least 4 weeks with three or more cancer-related symptoms (fatigue, pain, nausea, loss of appetite, depression, anxiety, or sleep disturbance), and randomly assigned them to oral dexamethasone 4 mg twice daily or placebo for 14 days.

The most common diagnosis was head and neck/lung cancer in 45 patients, followed by gastrointestinal cancer in 39, breast cancer in 13, and genitourinary in 10. Median patient age was 60; 81 patients were white, and the average FACIT fatigue score was 19.6, where 52 denotes no fatigue and 0 is severe fatigue.

Among 84 evaluable patients, total scores on FACIT favored the dexamethasone group (18.16 vs. 7.87; P = .03), as did scores on its physical subscale (5.25 vs. 1.32; P = .002), said Dr. Yennu of the department of palliative care and rehabilitation medicine, University of Texas MD Anderson Cancer Center, Houston.

Scores on the physical domain of the Edmonton Symptom Assessment Scale (ESAS) were better in the dexamethasone group than in the placebo group (–10.15 vs. –5.39; P = .04), according to the study, which earned Dr. Yennu a young investigator award.

Notably, scores were similar between the dexamethasone and placebo groups on the emotional subscale of FACIT (1.85 vs. 1.18; P = .49) and the ESAS psychological subscale (–1.48 vs. –2.08; P = .76). The emotional domain of the FACIT-F is measured by six items using a 0-4 scale where 0 is "not at all" and 4 includes statements like "I am losing hope in the fight against my illness." The finding suggests that the improvement in fatigue was likely not just a euphoric effect, as observed before in other steroid trials, Dr. Yennu said.

He expressed concern that corticosteroid use would increase toxicity, particularly insomnia, but no significant differences were observed between the dexamethasone and placebo groups regarding insomnia (3 vs. 4), overall adverse events (41 vs. 44) or serious adverse events (17 vs. 11).

Larger, long-term safety and efficacy studies are needed to address steroid dose and duration, and whether dexamethasone should be coupled with interventions targeting the psychological domain, he said. A 3-point difference in the FACIT is considered clinically important, but research in press in the Journal of Clinical Oncology, by Dr. Yennu and his colleagues, suggests a 10-point difference is more meaningful.

The American Cancer Society supported the study. Dr. Yennu reported having no financial disclosures.

pwendling@frontlinemedcom.com

NEW ORLEANS – That which we call a rose by any other name would smell as sweet. Perhaps not, if the conversation turns to palliative care.

A telephone survey of 169 patients with advanced cancer found that those randomized to hear the term "supportive care" instead of "palliative care" rated their understanding, overall impressions and future perceived need for those services significantly higher.

Patrice Wendling/IMNG Medical Media

In contrast, there was no significant difference in outcomes when patients heard either a "patient-centered" or "traditional" description of palliative/supportive care services, Rachael Maciasz said at the annual meeting of the American Association of Hospice and Palliative Medicine.

"It may be that ‘palliative care’ is so loaded with advanced cancer patients because of family members’ or friends’ experiences with this in the past that [they think] their family member is going to die," she said. "Perhaps what comes after that, no matter how you describe it, you can’t change that impression."

Patients with stage IV solid tumors or refractory/recurrent hematologic malignancies were recruited from 20 oncologists at two comprehensive cancer centers in Pittsburgh, and randomized to one of four survey groups: "palliative care/patient-centered," "palliative care/traditional," "supportive care/patient-centered," and "supportive care/traditional." Outcomes were measured using 10-point Likert scales, with 0 meaning "do not understand at all," or impression "not favorable at all" or "strongly disagree with" a need for services.

The most common cancer diagnoses were breast (32%), lung (18%), and gastrointestinal (13%).

The majority (63%) of patients were female, 95% were white, 88% were Catholic/Christian, 4% Jewish, and 7% other religion or agnostic. The most common cancer diagnoses were breast (32%), lung (18%), and gastrointestinal (13%). Their average age was 62 and roughly 11% had prior exposure to palliative care services.

The supportive care groups had significantly higher mean ratings than did the palliative care groups for overall understanding of what the service had to offer (7.7 vs. 6.8) and for overall favorable impressions (8.4 vs. 7.3), said Ms. Maciasz, a fourth-year medical student and a Doris Duke Clinical Research Fellow at the University of Pittsburgh.

Patients rated their current need for supportive and palliative care services equally, but were significantly more likely to perceive a future need for supportive services for themselves or family (8.6 vs. 7.7).

All patients rated their willingness to see a supportive/palliative care specialist as higher if their oncologist recommended it rather than if they had to ask their oncologist whether they could see a specialist on their own (8.6 vs. 6.0).

In a robust multivariable regression model that adjusted for term, description, and all significant variables in univariate analyses, the term supportive care was again significantly associated with more favorable impressions (correlation coefficient 1.24) and higher future perceived need (correlation coefficient 0.93), Ms. Maciasz said.

The qualitative results also paralleled the quantitative results.

"I had the impression that fewer patients went in with an impression of palliative care and that if you could explain it in ways that made perfect sense and described how awesome it is, that it wouldn’t matter if it was [called] palliative or supportive," Ms. Maciasz said in an interview. "I think it’s just loaded, but I don’t think it’s unique to patients."

Research data have shown that some oncologists don’t like the term palliative care. "I think there’s something about the term palliative care that means I can’t give you everything you need," she suggested.

Ms. Maciasz and her coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

NEW ORLEANS – That which we call a rose by any other name would smell as sweet. Perhaps not, if the conversation turns to palliative care.

A telephone survey of 169 patients with advanced cancer found that those randomized to hear the term "supportive care" instead of "palliative care" rated their understanding, overall impressions and future perceived need for those services significantly higher.

Patrice Wendling/IMNG Medical Media

In contrast, there was no significant difference in outcomes when patients heard either a "patient-centered" or "traditional" description of palliative/supportive care services, Rachael Maciasz said at the annual meeting of the American Association of Hospice and Palliative Medicine.

"It may be that ‘palliative care’ is so loaded with advanced cancer patients because of family members’ or friends’ experiences with this in the past that [they think] their family member is going to die," she said. "Perhaps what comes after that, no matter how you describe it, you can’t change that impression."

Patients with stage IV solid tumors or refractory/recurrent hematologic malignancies were recruited from 20 oncologists at two comprehensive cancer centers in Pittsburgh, and randomized to one of four survey groups: "palliative care/patient-centered," "palliative care/traditional," "supportive care/patient-centered," and "supportive care/traditional." Outcomes were measured using 10-point Likert scales, with 0 meaning "do not understand at all," or impression "not favorable at all" or "strongly disagree with" a need for services.

The most common cancer diagnoses were breast (32%), lung (18%), and gastrointestinal (13%).

The majority (63%) of patients were female, 95% were white, 88% were Catholic/Christian, 4% Jewish, and 7% other religion or agnostic. The most common cancer diagnoses were breast (32%), lung (18%), and gastrointestinal (13%). Their average age was 62 and roughly 11% had prior exposure to palliative care services.

The supportive care groups had significantly higher mean ratings than did the palliative care groups for overall understanding of what the service had to offer (7.7 vs. 6.8) and for overall favorable impressions (8.4 vs. 7.3), said Ms. Maciasz, a fourth-year medical student and a Doris Duke Clinical Research Fellow at the University of Pittsburgh.

Patients rated their current need for supportive and palliative care services equally, but were significantly more likely to perceive a future need for supportive services for themselves or family (8.6 vs. 7.7).

All patients rated their willingness to see a supportive/palliative care specialist as higher if their oncologist recommended it rather than if they had to ask their oncologist whether they could see a specialist on their own (8.6 vs. 6.0).

In a robust multivariable regression model that adjusted for term, description, and all significant variables in univariate analyses, the term supportive care was again significantly associated with more favorable impressions (correlation coefficient 1.24) and higher future perceived need (correlation coefficient 0.93), Ms. Maciasz said.

The qualitative results also paralleled the quantitative results.

"I had the impression that fewer patients went in with an impression of palliative care and that if you could explain it in ways that made perfect sense and described how awesome it is, that it wouldn’t matter if it was [called] palliative or supportive," Ms. Maciasz said in an interview. "I think it’s just loaded, but I don’t think it’s unique to patients."

Research data have shown that some oncologists don’t like the term palliative care. "I think there’s something about the term palliative care that means I can’t give you everything you need," she suggested.

Ms. Maciasz and her coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

NEW ORLEANS – That which we call a rose by any other name would smell as sweet. Perhaps not, if the conversation turns to palliative care.

A telephone survey of 169 patients with advanced cancer found that those randomized to hear the term "supportive care" instead of "palliative care" rated their understanding, overall impressions and future perceived need for those services significantly higher.

Patrice Wendling/IMNG Medical Media

In contrast, there was no significant difference in outcomes when patients heard either a "patient-centered" or "traditional" description of palliative/supportive care services, Rachael Maciasz said at the annual meeting of the American Association of Hospice and Palliative Medicine.

"It may be that ‘palliative care’ is so loaded with advanced cancer patients because of family members’ or friends’ experiences with this in the past that [they think] their family member is going to die," she said. "Perhaps what comes after that, no matter how you describe it, you can’t change that impression."

Patients with stage IV solid tumors or refractory/recurrent hematologic malignancies were recruited from 20 oncologists at two comprehensive cancer centers in Pittsburgh, and randomized to one of four survey groups: "palliative care/patient-centered," "palliative care/traditional," "supportive care/patient-centered," and "supportive care/traditional." Outcomes were measured using 10-point Likert scales, with 0 meaning "do not understand at all," or impression "not favorable at all" or "strongly disagree with" a need for services.

The most common cancer diagnoses were breast (32%), lung (18%), and gastrointestinal (13%).

The majority (63%) of patients were female, 95% were white, 88% were Catholic/Christian, 4% Jewish, and 7% other religion or agnostic. The most common cancer diagnoses were breast (32%), lung (18%), and gastrointestinal (13%). Their average age was 62 and roughly 11% had prior exposure to palliative care services.

The supportive care groups had significantly higher mean ratings than did the palliative care groups for overall understanding of what the service had to offer (7.7 vs. 6.8) and for overall favorable impressions (8.4 vs. 7.3), said Ms. Maciasz, a fourth-year medical student and a Doris Duke Clinical Research Fellow at the University of Pittsburgh.

Patients rated their current need for supportive and palliative care services equally, but were significantly more likely to perceive a future need for supportive services for themselves or family (8.6 vs. 7.7).

All patients rated their willingness to see a supportive/palliative care specialist as higher if their oncologist recommended it rather than if they had to ask their oncologist whether they could see a specialist on their own (8.6 vs. 6.0).

In a robust multivariable regression model that adjusted for term, description, and all significant variables in univariate analyses, the term supportive care was again significantly associated with more favorable impressions (correlation coefficient 1.24) and higher future perceived need (correlation coefficient 0.93), Ms. Maciasz said.

The qualitative results also paralleled the quantitative results.

"I had the impression that fewer patients went in with an impression of palliative care and that if you could explain it in ways that made perfect sense and described how awesome it is, that it wouldn’t matter if it was [called] palliative or supportive," Ms. Maciasz said in an interview. "I think it’s just loaded, but I don’t think it’s unique to patients."

Research data have shown that some oncologists don’t like the term palliative care. "I think there’s something about the term palliative care that means I can’t give you everything you need," she suggested.

Ms. Maciasz and her coauthors reported having no financial disclosures.

pwendling@frontlinemedcom.com

WASHINGTON – For women aged 75 years and older, a span of 5 or more years between mammograms translated into a threefold increased risk of death from breast cancer, compared with women in the same age group who had yearly exams.

While the exact reasons for the finding can’t be pinpointed, it should at least reawaken the discussion about whether older women should get a regular mammogram, Dr. Michael Simon noted at the annual meeting of the American Association for Cancer Research.

In 2009, the U.S. Preventive Services Task Force changed its recommendation on screening exams for women aged 75 and older, noting that there was insufficient evidence to recommend for or against breast cancer screening in this population (Ann. Intern. Med. 2009;151:716-26).

However, the absence of evidence does not automatically translate into absence of benefit, Dr. Simon said in an interview. "You can’t assume that at 75, it’s not worth screening anymore. Yes, there’s no evidence from randomized trials of women older than 75, and the recommendations are based on this kind of evidence. But just because there are no trials doesn’t mean there is no benefit."

Dr. Simon and his coinvestigators extracted data from the 15-year Women’s Health Initiative study. The cohort comprised 9,057 women who had been diagnosed with breast cancer over a 12-year period.

The multivariate analysis examined the relationship between death from breast cancer and mammography screening intervals. The screening intervals studied were from 6 months to 1 year, 1 to 2 years, 2 to 5 years, and more than 5 years or never. The study cohort was divided into women by age: 50-74 years (6,497) and 75 years or older (2,560).

Baseline characteristics showed that the older group of women presented with dangerous breast cancers almost as often as did the younger group, including moderately differentiated (22% vs. 21%, respectively) and poorly differentiated tumors (28% vs. 31%). Older women were more likely to have hormone receptor–positive tumors (75% vs. 67%), and just as likely to have hormone receptor–negative tumors (12% of each group).

Stage was also similar between the older and younger groups: in situ (18% vs. 20%, respectively); localized (62% vs. 59%); regional (17% vs. 19%); and distant (1% in both groups).

Significant differences occurred when the investigators broke the group of more than 9,000 women out by mammogram intervals.

Overall, an interval of 5 or more years between a woman’s last mammogram and breast cancer diagnosis was associated with advanced-stage disease in 23%, compared with 20% in women with an interval of 1 year or less – a statistically significant difference, which could affect large numbers of women, said Dr. Simon, head of the breast multidisciplinary team at Barbara Ann Karmanos Cancer Institute in Detroit.

"We also saw significantly more aggressive cancers that were hormone receptor negative in the group with the longest interval between mammograms," he said (22% vs. 16%).

The multivariate analysis adjusted for age at enrollment in the WHI study and the trial component in which subjects enrolled, age at diagnosis, race and ethnicity, insurance and marital status, comorbidities, and body mass index at baseline.

In this analysis, women aged 75 years and older who went at least 5 years between mammograms were 67% more likely to die from a breast cancer than were those who had yearly exams. Older women who went 5 or more years between mammograms were three times more likely to die than were those who had yearly screening, Dr. Simon said.

The results show a need for stronger emphasis on regular mammograms for older women, he said. "Women are living longer and living vitally longer. If we have a test that can identify an early cancer ... we should take advantage of it."

For women of any age, mammograms have their downsides, including anxiety while waiting for results, overdiagnosis, and treatment of indolent, in situ tumors that may never progress to serious cancers – especially in women with a shorter lifespan ahead of them. Dr. Simon said those risks are small compared with the benefit of finding and treating a potentially lethal tumor.

Cost, however, is the sticking point, admitted Dr. Simon, who is also a public health expert.

"Resource allocation is something we can’t ignore. We know that it takes 1,700 mammograms to benefit one woman. That sounds like a lot, but when you think about it in a global perspective – how many women there are in this country – you see it in a different light. What we’re paying for mammograms is small potatoes."

Dr. Simon had no financial disclosures.

msullivan@frontlinemedcom.com

WASHINGTON – For women aged 75 years and older, a span of 5 or more years between mammograms translated into a threefold increased risk of death from breast cancer, compared with women in the same age group who had yearly exams.

While the exact reasons for the finding can’t be pinpointed, it should at least reawaken the discussion about whether older women should get a regular mammogram, Dr. Michael Simon noted at the annual meeting of the American Association for Cancer Research.

In 2009, the U.S. Preventive Services Task Force changed its recommendation on screening exams for women aged 75 and older, noting that there was insufficient evidence to recommend for or against breast cancer screening in this population (Ann. Intern. Med. 2009;151:716-26).

However, the absence of evidence does not automatically translate into absence of benefit, Dr. Simon said in an interview. "You can’t assume that at 75, it’s not worth screening anymore. Yes, there’s no evidence from randomized trials of women older than 75, and the recommendations are based on this kind of evidence. But just because there are no trials doesn’t mean there is no benefit."

Dr. Simon and his coinvestigators extracted data from the 15-year Women’s Health Initiative study. The cohort comprised 9,057 women who had been diagnosed with breast cancer over a 12-year period.

The multivariate analysis examined the relationship between death from breast cancer and mammography screening intervals. The screening intervals studied were from 6 months to 1 year, 1 to 2 years, 2 to 5 years, and more than 5 years or never. The study cohort was divided into women by age: 50-74 years (6,497) and 75 years or older (2,560).

Baseline characteristics showed that the older group of women presented with dangerous breast cancers almost as often as did the younger group, including moderately differentiated (22% vs. 21%, respectively) and poorly differentiated tumors (28% vs. 31%). Older women were more likely to have hormone receptor–positive tumors (75% vs. 67%), and just as likely to have hormone receptor–negative tumors (12% of each group).

Stage was also similar between the older and younger groups: in situ (18% vs. 20%, respectively); localized (62% vs. 59%); regional (17% vs. 19%); and distant (1% in both groups).

Significant differences occurred when the investigators broke the group of more than 9,000 women out by mammogram intervals.

Overall, an interval of 5 or more years between a woman’s last mammogram and breast cancer diagnosis was associated with advanced-stage disease in 23%, compared with 20% in women with an interval of 1 year or less – a statistically significant difference, which could affect large numbers of women, said Dr. Simon, head of the breast multidisciplinary team at Barbara Ann Karmanos Cancer Institute in Detroit.

"We also saw significantly more aggressive cancers that were hormone receptor negative in the group with the longest interval between mammograms," he said (22% vs. 16%).

The multivariate analysis adjusted for age at enrollment in the WHI study and the trial component in which subjects enrolled, age at diagnosis, race and ethnicity, insurance and marital status, comorbidities, and body mass index at baseline.

In this analysis, women aged 75 years and older who went at least 5 years between mammograms were 67% more likely to die from a breast cancer than were those who had yearly exams. Older women who went 5 or more years between mammograms were three times more likely to die than were those who had yearly screening, Dr. Simon said.

The results show a need for stronger emphasis on regular mammograms for older women, he said. "Women are living longer and living vitally longer. If we have a test that can identify an early cancer ... we should take advantage of it."

For women of any age, mammograms have their downsides, including anxiety while waiting for results, overdiagnosis, and treatment of indolent, in situ tumors that may never progress to serious cancers – especially in women with a shorter lifespan ahead of them. Dr. Simon said those risks are small compared with the benefit of finding and treating a potentially lethal tumor.

Cost, however, is the sticking point, admitted Dr. Simon, who is also a public health expert.

"Resource allocation is something we can’t ignore. We know that it takes 1,700 mammograms to benefit one woman. That sounds like a lot, but when you think about it in a global perspective – how many women there are in this country – you see it in a different light. What we’re paying for mammograms is small potatoes."

Dr. Simon had no financial disclosures.

msullivan@frontlinemedcom.com

WASHINGTON – For women aged 75 years and older, a span of 5 or more years between mammograms translated into a threefold increased risk of death from breast cancer, compared with women in the same age group who had yearly exams.

While the exact reasons for the finding can’t be pinpointed, it should at least reawaken the discussion about whether older women should get a regular mammogram, Dr. Michael Simon noted at the annual meeting of the American Association for Cancer Research.

In 2009, the U.S. Preventive Services Task Force changed its recommendation on screening exams for women aged 75 and older, noting that there was insufficient evidence to recommend for or against breast cancer screening in this population (Ann. Intern. Med. 2009;151:716-26).

However, the absence of evidence does not automatically translate into absence of benefit, Dr. Simon said in an interview. "You can’t assume that at 75, it’s not worth screening anymore. Yes, there’s no evidence from randomized trials of women older than 75, and the recommendations are based on this kind of evidence. But just because there are no trials doesn’t mean there is no benefit."

Dr. Simon and his coinvestigators extracted data from the 15-year Women’s Health Initiative study. The cohort comprised 9,057 women who had been diagnosed with breast cancer over a 12-year period.

The multivariate analysis examined the relationship between death from breast cancer and mammography screening intervals. The screening intervals studied were from 6 months to 1 year, 1 to 2 years, 2 to 5 years, and more than 5 years or never. The study cohort was divided into women by age: 50-74 years (6,497) and 75 years or older (2,560).

Baseline characteristics showed that the older group of women presented with dangerous breast cancers almost as often as did the younger group, including moderately differentiated (22% vs. 21%, respectively) and poorly differentiated tumors (28% vs. 31%). Older women were more likely to have hormone receptor–positive tumors (75% vs. 67%), and just as likely to have hormone receptor–negative tumors (12% of each group).

Stage was also similar between the older and younger groups: in situ (18% vs. 20%, respectively); localized (62% vs. 59%); regional (17% vs. 19%); and distant (1% in both groups).

Significant differences occurred when the investigators broke the group of more than 9,000 women out by mammogram intervals.

Overall, an interval of 5 or more years between a woman’s last mammogram and breast cancer diagnosis was associated with advanced-stage disease in 23%, compared with 20% in women with an interval of 1 year or less – a statistically significant difference, which could affect large numbers of women, said Dr. Simon, head of the breast multidisciplinary team at Barbara Ann Karmanos Cancer Institute in Detroit.

"We also saw significantly more aggressive cancers that were hormone receptor negative in the group with the longest interval between mammograms," he said (22% vs. 16%).

The multivariate analysis adjusted for age at enrollment in the WHI study and the trial component in which subjects enrolled, age at diagnosis, race and ethnicity, insurance and marital status, comorbidities, and body mass index at baseline.

In this analysis, women aged 75 years and older who went at least 5 years between mammograms were 67% more likely to die from a breast cancer than were those who had yearly exams. Older women who went 5 or more years between mammograms were three times more likely to die than were those who had yearly screening, Dr. Simon said.

The results show a need for stronger emphasis on regular mammograms for older women, he said. "Women are living longer and living vitally longer. If we have a test that can identify an early cancer ... we should take advantage of it."

For women of any age, mammograms have their downsides, including anxiety while waiting for results, overdiagnosis, and treatment of indolent, in situ tumors that may never progress to serious cancers – especially in women with a shorter lifespan ahead of them. Dr. Simon said those risks are small compared with the benefit of finding and treating a potentially lethal tumor.

Cost, however, is the sticking point, admitted Dr. Simon, who is also a public health expert.

"Resource allocation is something we can’t ignore. We know that it takes 1,700 mammograms to benefit one woman. That sounds like a lot, but when you think about it in a global perspective – how many women there are in this country – you see it in a different light. What we’re paying for mammograms is small potatoes."

Dr. Simon had no financial disclosures.

msullivan@frontlinemedcom.com

The American Society of Clinical Oncology has unveiled its prototype for an ambitious computer network that allows physicians to search patient records and clinical evidence in real time.

The network, called CancerLinQ, promises to ultimately give oncologists access to millions of patient records, expert guidelines, and scientific literature all through a single computer interface.

The development of CancerLinQ comes as more oncologists are embracing health information technology. A recent ASCO survey shows that more than 60% of oncologists are using advanced electronic health records. Only 8% of the oncologists surveyed by ASCO said they aren’t using an EHR now and don’t plan to implement a system.

The prototype, which is the first major step in developing CancerLinQ, focuses on breast cancer. Through the prototype, oncologists are using their EHR systems to contribute everything from genomic data to physician notes related to their breast cancer patients. They can then search CancerLinQ’s database of about 130,000 de-identified patient records to look for trends and associations in treatment responses or patient characteristics.

The prototype also allows physicians to get individualized treatment advice based on breast cancer guidelines and to measure their performance against quality measures in ASCO’s Quality Oncology Practice Initiative (QOPI).

Once complete, the CancerLinQ system will include patients with all types of cancers.

"We’re developing a knowledge-generating computer network that will help us unlock that 97% of data that [are] currently beyond our reach," Dr. Sandra M. Swain, ASCO president, said during a demo of the CancerLinQ network on March 27.

Currently, about 3% of cancer patients participate in clinical trials, leaving the rest of the patient experience untapped for research purposes, Dr. Swain said. The development of CancerLinQ aims to bring that information directly to physicians.

For instance, if an oncologist is planning to start a patient on an aromatase inhibitor to treat a hormone-sensitive breast cancer, they might want to know how long similar patients stay on the treatment. CancerLinQ allows physicians to generate reports showing the typical treatment duration in patients with similar characteristics and to see what their outcomes were at various durations.

For individual patients and physicians, CancerLinQ will be "like having the whole medical community available for an opinion," Dr. Swain said. "It redefines what a second opinion is."

And the health care system as a whole could benefit, too. CancerLinQ has the potential to reduce fragmentation of care, decrease duplicative testing, and reduce costs, she said.

"The result will be higher-quality, higher-value care with better outcomes for patients," said Dr. Swain, who is medical director of the Washington Cancer Institute at MedStar Washington Hospital Center.

ASCO developed the prototype as a "proof of concept" that this type of "learning health system" could be developed, said Dr. Clifford A. Hudis, ASCO president-elect and an oncologist at Memorial Sloan-Kettering Cancer Center in New York. The prototype uses mostly open source software, along with some proprietary programs. But the prototype is able to import and aggregate information from a wide variety of electronic health record systems, he said.

Over the next year, ASCO officials will publish a series of white papers on their experience with the prototype. At the same time, they will continue to develop the system for an eventual rollout that will include patient data across all types of cancer. But that will be a multiyear effort, Dr. Hudis said. "This (demonstration) proves that what we want to do can be done."

Dr. W. Charles Penley, director of ASCO’s Conquer Cancer Foundation and an oncologist at a large group practice in Nashville, Tenn., has been participating in testing of the prototype. The process of linking to the prototype was fairly simple, he said. It took only about a day of work by the practice’s IT staff in to connect their EHR to the CancerLinQ system.

Lynn Etheredge, director of the Rapid Learning Project at George Washington University, Washington, and a member of the Institute of Medicine committee that proposed the concept of the "learning health care system," praised ASCO officials for their leadership in developing the CancerLinQ system and in helping to get better information into the hands of physicians.

"For the last 20 years roughly, we’ve been missing physician leadership," Mr. Etheredge said. "I want to credit ASCO with regaining leadership by physicians for what physicians and patients know needs to be the center of health policy."

CancerLinQ is supported by the Conquer Cancer Foundation, which has received funding from Susan G. Komen for the Cure, Helsinn Group, and by Genentech.

mschneider@frontlinemedcom.com

Twitter @MaryEllenNY

The American Society of Clinical Oncology has unveiled its prototype for an ambitious computer network that allows physicians to search patient records and clinical evidence in real time.

The network, called CancerLinQ, promises to ultimately give oncologists access to millions of patient records, expert guidelines, and scientific literature all through a single computer interface.

The development of CancerLinQ comes as more oncologists are embracing health information technology. A recent ASCO survey shows that more than 60% of oncologists are using advanced electronic health records. Only 8% of the oncologists surveyed by ASCO said they aren’t using an EHR now and don’t plan to implement a system.

The prototype, which is the first major step in developing CancerLinQ, focuses on breast cancer. Through the prototype, oncologists are using their EHR systems to contribute everything from genomic data to physician notes related to their breast cancer patients. They can then search CancerLinQ’s database of about 130,000 de-identified patient records to look for trends and associations in treatment responses or patient characteristics.

The prototype also allows physicians to get individualized treatment advice based on breast cancer guidelines and to measure their performance against quality measures in ASCO’s Quality Oncology Practice Initiative (QOPI).

Once complete, the CancerLinQ system will include patients with all types of cancers.

"We’re developing a knowledge-generating computer network that will help us unlock that 97% of data that [are] currently beyond our reach," Dr. Sandra M. Swain, ASCO president, said during a demo of the CancerLinQ network on March 27.

Currently, about 3% of cancer patients participate in clinical trials, leaving the rest of the patient experience untapped for research purposes, Dr. Swain said. The development of CancerLinQ aims to bring that information directly to physicians.

For instance, if an oncologist is planning to start a patient on an aromatase inhibitor to treat a hormone-sensitive breast cancer, they might want to know how long similar patients stay on the treatment. CancerLinQ allows physicians to generate reports showing the typical treatment duration in patients with similar characteristics and to see what their outcomes were at various durations.

For individual patients and physicians, CancerLinQ will be "like having the whole medical community available for an opinion," Dr. Swain said. "It redefines what a second opinion is."

And the health care system as a whole could benefit, too. CancerLinQ has the potential to reduce fragmentation of care, decrease duplicative testing, and reduce costs, she said.

"The result will be higher-quality, higher-value care with better outcomes for patients," said Dr. Swain, who is medical director of the Washington Cancer Institute at MedStar Washington Hospital Center.

ASCO developed the prototype as a "proof of concept" that this type of "learning health system" could be developed, said Dr. Clifford A. Hudis, ASCO president-elect and an oncologist at Memorial Sloan-Kettering Cancer Center in New York. The prototype uses mostly open source software, along with some proprietary programs. But the prototype is able to import and aggregate information from a wide variety of electronic health record systems, he said.

Over the next year, ASCO officials will publish a series of white papers on their experience with the prototype. At the same time, they will continue to develop the system for an eventual rollout that will include patient data across all types of cancer. But that will be a multiyear effort, Dr. Hudis said. "This (demonstration) proves that what we want to do can be done."

Dr. W. Charles Penley, director of ASCO’s Conquer Cancer Foundation and an oncologist at a large group practice in Nashville, Tenn., has been participating in testing of the prototype. The process of linking to the prototype was fairly simple, he said. It took only about a day of work by the practice’s IT staff in to connect their EHR to the CancerLinQ system.

Lynn Etheredge, director of the Rapid Learning Project at George Washington University, Washington, and a member of the Institute of Medicine committee that proposed the concept of the "learning health care system," praised ASCO officials for their leadership in developing the CancerLinQ system and in helping to get better information into the hands of physicians.

"For the last 20 years roughly, we’ve been missing physician leadership," Mr. Etheredge said. "I want to credit ASCO with regaining leadership by physicians for what physicians and patients know needs to be the center of health policy."

CancerLinQ is supported by the Conquer Cancer Foundation, which has received funding from Susan G. Komen for the Cure, Helsinn Group, and by Genentech.

mschneider@frontlinemedcom.com

Twitter @MaryEllenNY

The American Society of Clinical Oncology has unveiled its prototype for an ambitious computer network that allows physicians to search patient records and clinical evidence in real time.

The network, called CancerLinQ, promises to ultimately give oncologists access to millions of patient records, expert guidelines, and scientific literature all through a single computer interface.

The development of CancerLinQ comes as more oncologists are embracing health information technology. A recent ASCO survey shows that more than 60% of oncologists are using advanced electronic health records. Only 8% of the oncologists surveyed by ASCO said they aren’t using an EHR now and don’t plan to implement a system.

The prototype, which is the first major step in developing CancerLinQ, focuses on breast cancer. Through the prototype, oncologists are using their EHR systems to contribute everything from genomic data to physician notes related to their breast cancer patients. They can then search CancerLinQ’s database of about 130,000 de-identified patient records to look for trends and associations in treatment responses or patient characteristics.

The prototype also allows physicians to get individualized treatment advice based on breast cancer guidelines and to measure their performance against quality measures in ASCO’s Quality Oncology Practice Initiative (QOPI).

Once complete, the CancerLinQ system will include patients with all types of cancers.

"We’re developing a knowledge-generating computer network that will help us unlock that 97% of data that [are] currently beyond our reach," Dr. Sandra M. Swain, ASCO president, said during a demo of the CancerLinQ network on March 27.

Currently, about 3% of cancer patients participate in clinical trials, leaving the rest of the patient experience untapped for research purposes, Dr. Swain said. The development of CancerLinQ aims to bring that information directly to physicians.

For instance, if an oncologist is planning to start a patient on an aromatase inhibitor to treat a hormone-sensitive breast cancer, they might want to know how long similar patients stay on the treatment. CancerLinQ allows physicians to generate reports showing the typical treatment duration in patients with similar characteristics and to see what their outcomes were at various durations.

For individual patients and physicians, CancerLinQ will be "like having the whole medical community available for an opinion," Dr. Swain said. "It redefines what a second opinion is."

And the health care system as a whole could benefit, too. CancerLinQ has the potential to reduce fragmentation of care, decrease duplicative testing, and reduce costs, she said.

"The result will be higher-quality, higher-value care with better outcomes for patients," said Dr. Swain, who is medical director of the Washington Cancer Institute at MedStar Washington Hospital Center.

ASCO developed the prototype as a "proof of concept" that this type of "learning health system" could be developed, said Dr. Clifford A. Hudis, ASCO president-elect and an oncologist at Memorial Sloan-Kettering Cancer Center in New York. The prototype uses mostly open source software, along with some proprietary programs. But the prototype is able to import and aggregate information from a wide variety of electronic health record systems, he said.

Over the next year, ASCO officials will publish a series of white papers on their experience with the prototype. At the same time, they will continue to develop the system for an eventual rollout that will include patient data across all types of cancer. But that will be a multiyear effort, Dr. Hudis said. "This (demonstration) proves that what we want to do can be done."

Dr. W. Charles Penley, director of ASCO’s Conquer Cancer Foundation and an oncologist at a large group practice in Nashville, Tenn., has been participating in testing of the prototype. The process of linking to the prototype was fairly simple, he said. It took only about a day of work by the practice’s IT staff in to connect their EHR to the CancerLinQ system.

Lynn Etheredge, director of the Rapid Learning Project at George Washington University, Washington, and a member of the Institute of Medicine committee that proposed the concept of the "learning health care system," praised ASCO officials for their leadership in developing the CancerLinQ system and in helping to get better information into the hands of physicians.

"For the last 20 years roughly, we’ve been missing physician leadership," Mr. Etheredge said. "I want to credit ASCO with regaining leadership by physicians for what physicians and patients know needs to be the center of health policy."

CancerLinQ is supported by the Conquer Cancer Foundation, which has received funding from Susan G. Komen for the Cure, Helsinn Group, and by Genentech.

mschneider@frontlinemedcom.com

Twitter @MaryEllenNY

Editor-in-Chief Dr. David Henry highlights articles on T-DM1 for advanced HER2-positive breast cancer and an original research report from US Oncology on treatment patterns in women with HER2-/HR-positive breast cancer. He also looks at two case letters, one on plasmablastic lymphoma in the ileum, and a second on methotrexate-induced erythema multiforme, as well as a column by an oncology fellow on being a first-year fellow and first-year mom.

Editor-in-Chief Dr. David Henry highlights articles on T-DM1 for advanced HER2-positive breast cancer and an original research report from US Oncology on treatment patterns in women with HER2-/HR-positive breast cancer. He also looks at two case letters, one on plasmablastic lymphoma in the ileum, and a second on methotrexate-induced erythema multiforme, as well as a column by an oncology fellow on being a first-year fellow and first-year mom.

Editor-in-Chief Dr. David Henry highlights articles on T-DM1 for advanced HER2-positive breast cancer and an original research report from US Oncology on treatment patterns in women with HER2-/HR-positive breast cancer. He also looks at two case letters, one on plasmablastic lymphoma in the ileum, and a second on methotrexate-induced erythema multiforme, as well as a column by an oncology fellow on being a first-year fellow and first-year mom.

NATIONAL HARBOR, MD. – The rate of contralateral prophylactic mastectomies is rising, even though there is no evidence for a survival benefit.

From 1998 through 2007, contralateral prophylactic mastectomies (CPM) were performed within 1 year of unilateral mastectomies in 21% of those with ductal carcinoma in situ (DCIS) and in 17% of those with stage I-III breast cancer who were treated at one of 10 National Comprehensive Cancer Network (NCCN) centers.

But in an analysis of overall survival for patients with stages I-III invasive breast cancer, there was so significant difference in overall survival for patients who underwent a CPM, compared with those who underwent only unilateral mastectomy, regardless of whether they had received neoadjuvant chemotherapy, reported Dr. William E. Carson III, professor of surgery at the Ohio State University Comprehensive Cancer Center in Columbus.

In addition, CPMs are associated with a significantly greater risk of complications than unilateral mastectomies, including increased risk for major complications requiring reoperation and rehospitalization, said Dr. Megan Miller, a surgery resident at the University of Chicago, Illinois.

"CPM patients are 1.5 times more likely to have any complication, and 2.6 times more likely to have a major complication than unilateral mastectomy patients," she said at the annual Society of Surgical Oncology Cancer Symposium.

Among patients who underwent CPM, almost 40% of the complications occurred on the side of the body without cancer, she noted.

SSO position statement

A 2007 position statement from the Society of Surgical Oncology (SSO) states that in patients with a current or prior diagnosis, CPM may be indicated for risk reduction in cases where surveillance is difficult or for reconstructive issues such as symmetry and balance, Dr. Carson noted.

Two studies using Surveillance, Epidemiology, and End Results (SEER) data (Tuttle et al. [J. Clin. Oncology 2009;27:1362-7]); Bedrosian et al. [J. Natl. Cancer Inst. 2010;102:401-9]) and one from his own center (Jones et al. [Ann. Surg. Oncol. 2009;16:2691-6]) showed about a 10% increase in the rate of CPM over a decade. Younger women with higher levels of education were more likely to seek CPM.

To see whether this trend extended to NCCN centers, Dr. Carson and his colleagues reviewed data on 1,309 women with DCIS, and 7,044 with stage I-III breast cancer who underwent unilateral mastectomy from 1998 through 2007 at one of 10 designated centers.

In all, 273 of the women diagnosed with DCIS (21%) had a contralateral prophylactic mastectomy, as did 1,199 (17%) of the women with a diagnosis of stage I-III invasive disease. Median follow-up was more than 4 years for both groups.

In a multivariate analysis, factors that significantly predicted the likelihood of CPM included age younger than 50 years, Caucasian race, MRI as the method of detection, and tumor size of 1 cm or smaller. In women with invasive disease, years of education, node-negative status, and no immediate reconstruction were also significant predictors of CPM (P less than .0001 for all variables).

Use of CPM varied widely by institution from 8.2%-34.7% of women with DCIS, and from 3.6%-30.8% of patients with stage I-III disease. As other studies have shown, the use of CPM increased over time, from 15% for DCIS in 1998 to 27% in 2007. For patients with invasive breast cancer, the respective increase was from 8% to 26%. The most pronounced increases were among patients younger than 50 years, Dr. Carson noted.

When they looked at overall survival in a multivariate Cox regression model adjusted for age, race, tumor size, nodal status, tumor grade, histology, and treatment, they found that there was no significant survival advantage for unilateral mastectomy plus CPM, compared with unilateral mastectomy alone.

Complications, complications

Dr. Miller and her colleagues retrospectively reviewed 600 patients who underwent either unilateral mastectomy (391) or CPM (209) at their center from January 2009 through March 2012. They looked at major complications such as seroma or hematoma requiring reoperations, infections requiring hospital admission, total nipple or flap necrosis, and bleeding requiring transfusion; and minor complications such as seromas and hematomas requiring aspiration, infections requiring oral antibiotics, partial nipple or flap necrosis, minor bleeding, and delayed wound healing.

The percentage of patients experiencing any complications was 29% for patients who had a unilateral mastectomy, compared with 42% of those who underwent CPM (P less than .001). Major complications occurred in 4.1% and 14%, respectively (P less than .001). Rates of minor complications were identical between the groups, at 15% each.

Multiple major complications were seen in 4.9% of unilateral patients, compared with 9.1% of CPM patients (P = .043).

Among the CPM patients, 40% of complications occurred on the CPM side.

In a multivariate analysis controlling for age, body mass index, diabetes, previous radiation, smoking history and reconstruction type, CPM was associated with an odds ratio for any complication of 1.5 (P = .029) and 2.6 for major complications (P = .007).

"We believe that patients considering CPM should be made aware of these risks, and certainly more research is needed on patient decision pathways and shared decision making," Dr. Miller said.

Both Dr. Carson’s and Dr. Miller’s studies were internally funded. Dr. Carson disclosed serving on the NCCN Board of Directors. Dr. Miller reported having no financial disclosures.

NATIONAL HARBOR, MD. – The rate of contralateral prophylactic mastectomies is rising, even though there is no evidence for a survival benefit.

From 1998 through 2007, contralateral prophylactic mastectomies (CPM) were performed within 1 year of unilateral mastectomies in 21% of those with ductal carcinoma in situ (DCIS) and in 17% of those with stage I-III breast cancer who were treated at one of 10 National Comprehensive Cancer Network (NCCN) centers.

But in an analysis of overall survival for patients with stages I-III invasive breast cancer, there was so significant difference in overall survival for patients who underwent a CPM, compared with those who underwent only unilateral mastectomy, regardless of whether they had received neoadjuvant chemotherapy, reported Dr. William E. Carson III, professor of surgery at the Ohio State University Comprehensive Cancer Center in Columbus.

In addition, CPMs are associated with a significantly greater risk of complications than unilateral mastectomies, including increased risk for major complications requiring reoperation and rehospitalization, said Dr. Megan Miller, a surgery resident at the University of Chicago, Illinois.

"CPM patients are 1.5 times more likely to have any complication, and 2.6 times more likely to have a major complication than unilateral mastectomy patients," she said at the annual Society of Surgical Oncology Cancer Symposium.

Among patients who underwent CPM, almost 40% of the complications occurred on the side of the body without cancer, she noted.

SSO position statement

A 2007 position statement from the Society of Surgical Oncology (SSO) states that in patients with a current or prior diagnosis, CPM may be indicated for risk reduction in cases where surveillance is difficult or for reconstructive issues such as symmetry and balance, Dr. Carson noted.

Two studies using Surveillance, Epidemiology, and End Results (SEER) data (Tuttle et al. [J. Clin. Oncology 2009;27:1362-7]); Bedrosian et al. [J. Natl. Cancer Inst. 2010;102:401-9]) and one from his own center (Jones et al. [Ann. Surg. Oncol. 2009;16:2691-6]) showed about a 10% increase in the rate of CPM over a decade. Younger women with higher levels of education were more likely to seek CPM.

To see whether this trend extended to NCCN centers, Dr. Carson and his colleagues reviewed data on 1,309 women with DCIS, and 7,044 with stage I-III breast cancer who underwent unilateral mastectomy from 1998 through 2007 at one of 10 designated centers.

In all, 273 of the women diagnosed with DCIS (21%) had a contralateral prophylactic mastectomy, as did 1,199 (17%) of the women with a diagnosis of stage I-III invasive disease. Median follow-up was more than 4 years for both groups.

In a multivariate analysis, factors that significantly predicted the likelihood of CPM included age younger than 50 years, Caucasian race, MRI as the method of detection, and tumor size of 1 cm or smaller. In women with invasive disease, years of education, node-negative status, and no immediate reconstruction were also significant predictors of CPM (P less than .0001 for all variables).

Use of CPM varied widely by institution from 8.2%-34.7% of women with DCIS, and from 3.6%-30.8% of patients with stage I-III disease. As other studies have shown, the use of CPM increased over time, from 15% for DCIS in 1998 to 27% in 2007. For patients with invasive breast cancer, the respective increase was from 8% to 26%. The most pronounced increases were among patients younger than 50 years, Dr. Carson noted.

When they looked at overall survival in a multivariate Cox regression model adjusted for age, race, tumor size, nodal status, tumor grade, histology, and treatment, they found that there was no significant survival advantage for unilateral mastectomy plus CPM, compared with unilateral mastectomy alone.

Complications, complications

Dr. Miller and her colleagues retrospectively reviewed 600 patients who underwent either unilateral mastectomy (391) or CPM (209) at their center from January 2009 through March 2012. They looked at major complications such as seroma or hematoma requiring reoperations, infections requiring hospital admission, total nipple or flap necrosis, and bleeding requiring transfusion; and minor complications such as seromas and hematomas requiring aspiration, infections requiring oral antibiotics, partial nipple or flap necrosis, minor bleeding, and delayed wound healing.

The percentage of patients experiencing any complications was 29% for patients who had a unilateral mastectomy, compared with 42% of those who underwent CPM (P less than .001). Major complications occurred in 4.1% and 14%, respectively (P less than .001). Rates of minor complications were identical between the groups, at 15% each.

Multiple major complications were seen in 4.9% of unilateral patients, compared with 9.1% of CPM patients (P = .043).

Among the CPM patients, 40% of complications occurred on the CPM side.

In a multivariate analysis controlling for age, body mass index, diabetes, previous radiation, smoking history and reconstruction type, CPM was associated with an odds ratio for any complication of 1.5 (P = .029) and 2.6 for major complications (P = .007).

"We believe that patients considering CPM should be made aware of these risks, and certainly more research is needed on patient decision pathways and shared decision making," Dr. Miller said.

Both Dr. Carson’s and Dr. Miller’s studies were internally funded. Dr. Carson disclosed serving on the NCCN Board of Directors. Dr. Miller reported having no financial disclosures.

NATIONAL HARBOR, MD. – The rate of contralateral prophylactic mastectomies is rising, even though there is no evidence for a survival benefit.

From 1998 through 2007, contralateral prophylactic mastectomies (CPM) were performed within 1 year of unilateral mastectomies in 21% of those with ductal carcinoma in situ (DCIS) and in 17% of those with stage I-III breast cancer who were treated at one of 10 National Comprehensive Cancer Network (NCCN) centers.

But in an analysis of overall survival for patients with stages I-III invasive breast cancer, there was so significant difference in overall survival for patients who underwent a CPM, compared with those who underwent only unilateral mastectomy, regardless of whether they had received neoadjuvant chemotherapy, reported Dr. William E. Carson III, professor of surgery at the Ohio State University Comprehensive Cancer Center in Columbus.

In addition, CPMs are associated with a significantly greater risk of complications than unilateral mastectomies, including increased risk for major complications requiring reoperation and rehospitalization, said Dr. Megan Miller, a surgery resident at the University of Chicago, Illinois.

"CPM patients are 1.5 times more likely to have any complication, and 2.6 times more likely to have a major complication than unilateral mastectomy patients," she said at the annual Society of Surgical Oncology Cancer Symposium.

Among patients who underwent CPM, almost 40% of the complications occurred on the side of the body without cancer, she noted.

SSO position statement

A 2007 position statement from the Society of Surgical Oncology (SSO) states that in patients with a current or prior diagnosis, CPM may be indicated for risk reduction in cases where surveillance is difficult or for reconstructive issues such as symmetry and balance, Dr. Carson noted.

Two studies using Surveillance, Epidemiology, and End Results (SEER) data (Tuttle et al. [J. Clin. Oncology 2009;27:1362-7]); Bedrosian et al. [J. Natl. Cancer Inst. 2010;102:401-9]) and one from his own center (Jones et al. [Ann. Surg. Oncol. 2009;16:2691-6]) showed about a 10% increase in the rate of CPM over a decade. Younger women with higher levels of education were more likely to seek CPM.

To see whether this trend extended to NCCN centers, Dr. Carson and his colleagues reviewed data on 1,309 women with DCIS, and 7,044 with stage I-III breast cancer who underwent unilateral mastectomy from 1998 through 2007 at one of 10 designated centers.

In all, 273 of the women diagnosed with DCIS (21%) had a contralateral prophylactic mastectomy, as did 1,199 (17%) of the women with a diagnosis of stage I-III invasive disease. Median follow-up was more than 4 years for both groups.

In a multivariate analysis, factors that significantly predicted the likelihood of CPM included age younger than 50 years, Caucasian race, MRI as the method of detection, and tumor size of 1 cm or smaller. In women with invasive disease, years of education, node-negative status, and no immediate reconstruction were also significant predictors of CPM (P less than .0001 for all variables).

Use of CPM varied widely by institution from 8.2%-34.7% of women with DCIS, and from 3.6%-30.8% of patients with stage I-III disease. As other studies have shown, the use of CPM increased over time, from 15% for DCIS in 1998 to 27% in 2007. For patients with invasive breast cancer, the respective increase was from 8% to 26%. The most pronounced increases were among patients younger than 50 years, Dr. Carson noted.

When they looked at overall survival in a multivariate Cox regression model adjusted for age, race, tumor size, nodal status, tumor grade, histology, and treatment, they found that there was no significant survival advantage for unilateral mastectomy plus CPM, compared with unilateral mastectomy alone.

Complications, complications

Dr. Miller and her colleagues retrospectively reviewed 600 patients who underwent either unilateral mastectomy (391) or CPM (209) at their center from January 2009 through March 2012. They looked at major complications such as seroma or hematoma requiring reoperations, infections requiring hospital admission, total nipple or flap necrosis, and bleeding requiring transfusion; and minor complications such as seromas and hematomas requiring aspiration, infections requiring oral antibiotics, partial nipple or flap necrosis, minor bleeding, and delayed wound healing.

The percentage of patients experiencing any complications was 29% for patients who had a unilateral mastectomy, compared with 42% of those who underwent CPM (P less than .001). Major complications occurred in 4.1% and 14%, respectively (P less than .001). Rates of minor complications were identical between the groups, at 15% each.

Multiple major complications were seen in 4.9% of unilateral patients, compared with 9.1% of CPM patients (P = .043).

Among the CPM patients, 40% of complications occurred on the CPM side.

In a multivariate analysis controlling for age, body mass index, diabetes, previous radiation, smoking history and reconstruction type, CPM was associated with an odds ratio for any complication of 1.5 (P = .029) and 2.6 for major complications (P = .007).

"We believe that patients considering CPM should be made aware of these risks, and certainly more research is needed on patient decision pathways and shared decision making," Dr. Miller said.

Both Dr. Carson’s and Dr. Miller’s studies were internally funded. Dr. Carson disclosed serving on the NCCN Board of Directors. Dr. Miller reported having no financial disclosures.