The proportion of U.S. outpatient visits for influenza-like illness (ILI) crept up from 2.1% to 2.2% for the week ending Jan. 23 – week 15 of the 2015-2016 flu season, the Centers for Disease Control and Prevention reported.

That increase put the proportion of visits involving ILI back above the national baseline level of 2.1% for the first time since the week ending Jan. 2, when it reached a season-high 2.8%, the CDC said.

Puerto Rico was the nation’s influenza hotspot at level 8 on the CDC’s 1-10 scale of ILI activity, but the states with the most activity were Connecticut, Maryland, and South Carolina, which were categorized in the “moderate” range at level 6. Connecticut was up from level 2 the week before; the other two states were unchanged.

There were five states in the “low” range: Arizona, New Jersey, and Oklahoma at level 5 and Illinois and Virginia at level 4. Arizona (down from level 7) and Oklahoma (up from level 3) were the biggest movers in this group from the previous week. There were 12 states at level 3 and four states at level 2, putting the total at 24 states at level 2 or higher, according to data from the CDC’s Outpatient Influenza-like Illness Surveillance Network.

There were no pediatric deaths reported in week 15, keeping the total for the season at seven, the CDC said, which is well below the number of deaths reported by week 15 in each of the last three flu seasons.

The ILI hospitalization rate for the season so far is 2.1 per 100,000 population, with 575 laboratory-confirmed, influenza-associated hospitalizations reported between Oct. 1, 2015, and Jan. 23, 2016. The highest hospitalization rates are among adults aged 65 years and older (7.0 per 100,000 population) and children aged 0-4 years (3.4 per 100,000), the CDC reported.

[email protected]

The proportion of U.S. outpatient visits for influenza-like illness (ILI) crept up from 2.1% to 2.2% for the week ending Jan. 23 – week 15 of the 2015-2016 flu season, the Centers for Disease Control and Prevention reported.

That increase put the proportion of visits involving ILI back above the national baseline level of 2.1% for the first time since the week ending Jan. 2, when it reached a season-high 2.8%, the CDC said.

Puerto Rico was the nation’s influenza hotspot at level 8 on the CDC’s 1-10 scale of ILI activity, but the states with the most activity were Connecticut, Maryland, and South Carolina, which were categorized in the “moderate” range at level 6. Connecticut was up from level 2 the week before; the other two states were unchanged.

There were five states in the “low” range: Arizona, New Jersey, and Oklahoma at level 5 and Illinois and Virginia at level 4. Arizona (down from level 7) and Oklahoma (up from level 3) were the biggest movers in this group from the previous week. There were 12 states at level 3 and four states at level 2, putting the total at 24 states at level 2 or higher, according to data from the CDC’s Outpatient Influenza-like Illness Surveillance Network.

There were no pediatric deaths reported in week 15, keeping the total for the season at seven, the CDC said, which is well below the number of deaths reported by week 15 in each of the last three flu seasons.

The ILI hospitalization rate for the season so far is 2.1 per 100,000 population, with 575 laboratory-confirmed, influenza-associated hospitalizations reported between Oct. 1, 2015, and Jan. 23, 2016. The highest hospitalization rates are among adults aged 65 years and older (7.0 per 100,000 population) and children aged 0-4 years (3.4 per 100,000), the CDC reported.

[email protected]

The proportion of U.S. outpatient visits for influenza-like illness (ILI) crept up from 2.1% to 2.2% for the week ending Jan. 23 – week 15 of the 2015-2016 flu season, the Centers for Disease Control and Prevention reported.

That increase put the proportion of visits involving ILI back above the national baseline level of 2.1% for the first time since the week ending Jan. 2, when it reached a season-high 2.8%, the CDC said.

Puerto Rico was the nation’s influenza hotspot at level 8 on the CDC’s 1-10 scale of ILI activity, but the states with the most activity were Connecticut, Maryland, and South Carolina, which were categorized in the “moderate” range at level 6. Connecticut was up from level 2 the week before; the other two states were unchanged.

There were five states in the “low” range: Arizona, New Jersey, and Oklahoma at level 5 and Illinois and Virginia at level 4. Arizona (down from level 7) and Oklahoma (up from level 3) were the biggest movers in this group from the previous week. There were 12 states at level 3 and four states at level 2, putting the total at 24 states at level 2 or higher, according to data from the CDC’s Outpatient Influenza-like Illness Surveillance Network.

There were no pediatric deaths reported in week 15, keeping the total for the season at seven, the CDC said, which is well below the number of deaths reported by week 15 in each of the last three flu seasons.

The ILI hospitalization rate for the season so far is 2.1 per 100,000 population, with 575 laboratory-confirmed, influenza-associated hospitalizations reported between Oct. 1, 2015, and Jan. 23, 2016. The highest hospitalization rates are among adults aged 65 years and older (7.0 per 100,000 population) and children aged 0-4 years (3.4 per 100,000), the CDC reported.

[email protected]

Endometrial cancer after unopposed estrogen: $7.5M
A 42-year-old woman took unopposed estrogen as treatment for reported perimenopausal symptoms from October 2010 through October 2012, although she still had her uterus.

In December 2013, the patient was diagnosed with Stage 3 endometrial cancer. She underwent a radical hysterectomy followed by several rounds of chemotherapy. Despite treatment, the cancer metastasized, leaving the patient with a decreased life expectancy.

Patient’s claim Use of unopposed estrogens by a woman who still has her uterus significantly increases her risk of developing endometrial cancer. The gynecologist was negligent for prescribing the drug.

Physician’s defense The case was settled during the trial.

Verdict A $7.5 million Illinois settlement was reached

Preeclampsia treatment delayed because BP machine failed: $5M
At 31 4/7 weeks’ gestation, a woman went to the hospital. She reported burning pain in her chest, headache, and vomiting.

Two nurses cared for the mother: one who was completing her shift (Nurse A) and another who was beginning her shift (Nurse B). Nurse A stated that the blood pressure (BP) machine was not working correctly when she attempted to assess the patient at admission. When Nurse B took the patient’s BP, it indicated preeclampsia. Shortly thereafter, fetal heart-rate monitoring showed a concerning pattern. Nurse B notified the ObGyn 75 minutes after the mother’s arrival. The ObGyn ordered intervention to treat the baby’s concerning heart rate and, when those efforts failed, an emergency cesarean delivery was performed. The baby was found to have brain damage caused by hypoxia.

Parents’ claim Because the BP machine was not working properly when the mother arrived at the hospital, intervention for preeclampsia was delayed. Preeclampsia caused the baby’s injuries. An earlier cesarean delivery should have been performed.

Defendant’s defense The patient was adequately treated. The injury likely occurred before the mother arrived at the hospital. The case was settled during the trial.

Verdict A $5 million Massachusetts settlement was reached with the hospital and ObGyn.

Standard prenatal scan missed congenital syndrome: $3.75M
A woman receiving prenatal care at a medical center requested an ultrasonographic anatomical fetal scan. A limited ultrasound (US) was performed, and no abnormalities were detected.

Upon birth, the child was found to have Dandy Walker syndrome, a malformation of the brain affecting mobility. The child requires full-time nursing care.

Parents’ claim If a complete prenatal anatomical survey had been performed when requested, the abnormality would have been detected. The mother would have terminated the pregnancy.

Defendant’s defense It is the medical center’s policy to perform complete anatomical surveys only on women with high-risk pregnancies, which this was not. The woman switched health care providers during her pregnancy. A subsequent US performed by the new health care provider did not show a fetal abnormality. The case was settled during the trial.

Verdict A $3.75 million New Jersey settlement was reached with the medical center.
 

Should mother have been discharged? $700,000 settlement
Due to elevated fetal heart rate, a woman was admitted to the hospital for fetal heart-rate monitoring and then discharged a few hours later. After 2 days, the mother was readmitted for induction of labor, but she was discharged the following day. The next day, she was readmitted when she noticed lack of fetal movement. The infant was stillborn.

Parents’ claim The mother and fetus were not properly monitored; she should not have been sent home after induction of labor. The hospital was negligent for not properly monitoring labor, for not assigning an ObGyn to care for the mother, and for not performing cesarean delivery.

Hospital’s defense The case was settled during the trial.

Verdict A $700,000 Illinois settlement was reached with the hospital.

Endometrial cancer after unopposed estrogen: $7.5M
A 42-year-old woman took unopposed estrogen as treatment for reported perimenopausal symptoms from October 2010 through October 2012, although she still had her uterus.

In December 2013, the patient was diagnosed with Stage 3 endometrial cancer. She underwent a radical hysterectomy followed by several rounds of chemotherapy. Despite treatment, the cancer metastasized, leaving the patient with a decreased life expectancy.

Patient’s claim Use of unopposed estrogens by a woman who still has her uterus significantly increases her risk of developing endometrial cancer. The gynecologist was negligent for prescribing the drug.

Physician’s defense The case was settled during the trial.

Verdict A $7.5 million Illinois settlement was reached

Preeclampsia treatment delayed because BP machine failed: $5M
At 31 4/7 weeks’ gestation, a woman went to the hospital. She reported burning pain in her chest, headache, and vomiting.

Two nurses cared for the mother: one who was completing her shift (Nurse A) and another who was beginning her shift (Nurse B). Nurse A stated that the blood pressure (BP) machine was not working correctly when she attempted to assess the patient at admission. When Nurse B took the patient’s BP, it indicated preeclampsia. Shortly thereafter, fetal heart-rate monitoring showed a concerning pattern. Nurse B notified the ObGyn 75 minutes after the mother’s arrival. The ObGyn ordered intervention to treat the baby’s concerning heart rate and, when those efforts failed, an emergency cesarean delivery was performed. The baby was found to have brain damage caused by hypoxia.

Parents’ claim Because the BP machine was not working properly when the mother arrived at the hospital, intervention for preeclampsia was delayed. Preeclampsia caused the baby’s injuries. An earlier cesarean delivery should have been performed.

Defendant’s defense The patient was adequately treated. The injury likely occurred before the mother arrived at the hospital. The case was settled during the trial.

Verdict A $5 million Massachusetts settlement was reached with the hospital and ObGyn.

Standard prenatal scan missed congenital syndrome: $3.75M
A woman receiving prenatal care at a medical center requested an ultrasonographic anatomical fetal scan. A limited ultrasound (US) was performed, and no abnormalities were detected.

Upon birth, the child was found to have Dandy Walker syndrome, a malformation of the brain affecting mobility. The child requires full-time nursing care.

Parents’ claim If a complete prenatal anatomical survey had been performed when requested, the abnormality would have been detected. The mother would have terminated the pregnancy.

Defendant’s defense It is the medical center’s policy to perform complete anatomical surveys only on women with high-risk pregnancies, which this was not. The woman switched health care providers during her pregnancy. A subsequent US performed by the new health care provider did not show a fetal abnormality. The case was settled during the trial.

Verdict A $3.75 million New Jersey settlement was reached with the medical center.
 

Should mother have been discharged? $700,000 settlement
Due to elevated fetal heart rate, a woman was admitted to the hospital for fetal heart-rate monitoring and then discharged a few hours later. After 2 days, the mother was readmitted for induction of labor, but she was discharged the following day. The next day, she was readmitted when she noticed lack of fetal movement. The infant was stillborn.

Parents’ claim The mother and fetus were not properly monitored; she should not have been sent home after induction of labor. The hospital was negligent for not properly monitoring labor, for not assigning an ObGyn to care for the mother, and for not performing cesarean delivery.

Hospital’s defense The case was settled during the trial.

Verdict A $700,000 Illinois settlement was reached with the hospital.

Endometrial cancer after unopposed estrogen: $7.5M
A 42-year-old woman took unopposed estrogen as treatment for reported perimenopausal symptoms from October 2010 through October 2012, although she still had her uterus.

In December 2013, the patient was diagnosed with Stage 3 endometrial cancer. She underwent a radical hysterectomy followed by several rounds of chemotherapy. Despite treatment, the cancer metastasized, leaving the patient with a decreased life expectancy.

Patient’s claim Use of unopposed estrogens by a woman who still has her uterus significantly increases her risk of developing endometrial cancer. The gynecologist was negligent for prescribing the drug.

Physician’s defense The case was settled during the trial.

Verdict A $7.5 million Illinois settlement was reached

Preeclampsia treatment delayed because BP machine failed: $5M
At 31 4/7 weeks’ gestation, a woman went to the hospital. She reported burning pain in her chest, headache, and vomiting.

Two nurses cared for the mother: one who was completing her shift (Nurse A) and another who was beginning her shift (Nurse B). Nurse A stated that the blood pressure (BP) machine was not working correctly when she attempted to assess the patient at admission. When Nurse B took the patient’s BP, it indicated preeclampsia. Shortly thereafter, fetal heart-rate monitoring showed a concerning pattern. Nurse B notified the ObGyn 75 minutes after the mother’s arrival. The ObGyn ordered intervention to treat the baby’s concerning heart rate and, when those efforts failed, an emergency cesarean delivery was performed. The baby was found to have brain damage caused by hypoxia.

Parents’ claim Because the BP machine was not working properly when the mother arrived at the hospital, intervention for preeclampsia was delayed. Preeclampsia caused the baby’s injuries. An earlier cesarean delivery should have been performed.

Defendant’s defense The patient was adequately treated. The injury likely occurred before the mother arrived at the hospital. The case was settled during the trial.

Verdict A $5 million Massachusetts settlement was reached with the hospital and ObGyn.

Standard prenatal scan missed congenital syndrome: $3.75M
A woman receiving prenatal care at a medical center requested an ultrasonographic anatomical fetal scan. A limited ultrasound (US) was performed, and no abnormalities were detected.

Upon birth, the child was found to have Dandy Walker syndrome, a malformation of the brain affecting mobility. The child requires full-time nursing care.

Parents’ claim If a complete prenatal anatomical survey had been performed when requested, the abnormality would have been detected. The mother would have terminated the pregnancy.

Defendant’s defense It is the medical center’s policy to perform complete anatomical surveys only on women with high-risk pregnancies, which this was not. The woman switched health care providers during her pregnancy. A subsequent US performed by the new health care provider did not show a fetal abnormality. The case was settled during the trial.

Verdict A $3.75 million New Jersey settlement was reached with the medical center.
 

Should mother have been discharged? $700,000 settlement
Due to elevated fetal heart rate, a woman was admitted to the hospital for fetal heart-rate monitoring and then discharged a few hours later. After 2 days, the mother was readmitted for induction of labor, but she was discharged the following day. The next day, she was readmitted when she noticed lack of fetal movement. The infant was stillborn.

Parents’ claim The mother and fetus were not properly monitored; she should not have been sent home after induction of labor. The hospital was negligent for not properly monitoring labor, for not assigning an ObGyn to care for the mother, and for not performing cesarean delivery.

Hospital’s defense The case was settled during the trial.

Verdict A $700,000 Illinois settlement was reached with the hospital.

GRAND CAYMAN – What impact do treatments for gastroesophageal reflux disease (GERD), hypertension, hyperlipidemia, and menopausal flushing have in patients with erythematotelangiectatic and papulopustular rosacea?

In a video interview at the Caribbean Dermatology Symposium, Dr. Jonathan K. Wilkin, who is in private practice in Grand Cayman and is a former director of the Food and Drug Administration’s Division of Dermatologic and Dental Drug Products, refers to recent studies that have linked rosacea to these and other comorbidities. He shares his insights into how addressing these four comorbidities into your treatment calculus can improve outcomes in patients who have rosacea with flushing.

The meeting is provided by Global Academy for Medical Education. Global Academy and this news organization are owned by the same parent company.

[email protected]

On Twitter @whitneymcknight

GRAND CAYMAN – What impact do treatments for gastroesophageal reflux disease (GERD), hypertension, hyperlipidemia, and menopausal flushing have in patients with erythematotelangiectatic and papulopustular rosacea?

In a video interview at the Caribbean Dermatology Symposium, Dr. Jonathan K. Wilkin, who is in private practice in Grand Cayman and is a former director of the Food and Drug Administration’s Division of Dermatologic and Dental Drug Products, refers to recent studies that have linked rosacea to these and other comorbidities. He shares his insights into how addressing these four comorbidities into your treatment calculus can improve outcomes in patients who have rosacea with flushing.

The meeting is provided by Global Academy for Medical Education. Global Academy and this news organization are owned by the same parent company.

[email protected]

On Twitter @whitneymcknight

GRAND CAYMAN – What impact do treatments for gastroesophageal reflux disease (GERD), hypertension, hyperlipidemia, and menopausal flushing have in patients with erythematotelangiectatic and papulopustular rosacea?

In a video interview at the Caribbean Dermatology Symposium, Dr. Jonathan K. Wilkin, who is in private practice in Grand Cayman and is a former director of the Food and Drug Administration’s Division of Dermatologic and Dental Drug Products, refers to recent studies that have linked rosacea to these and other comorbidities. He shares his insights into how addressing these four comorbidities into your treatment calculus can improve outcomes in patients who have rosacea with flushing.

The meeting is provided by Global Academy for Medical Education. Global Academy and this news organization are owned by the same parent company.

[email protected]

On Twitter @whitneymcknight

In 2009, the US Preventive Services Task Force (USPSTF) recommended that biennial mammography screening in average-risk women begin at age 50.¹ New guidelines, that take into account reviews and modeling studies, clarify the earlier USPSTF recommendations, paying particular attention to individualized screening for women aged 40 to 49, use of tomosynthesis, and supplemental evaluation for women with radiologically dense breasts.

The new guidance only applies to women at average risk for breast cancer (not to those at substantially higher-than-average risk), including those with prior breast cancer or biopsy-confirmed high-risk lesions (eg, atypical hyperplasia), certain genetic conditions (such as BRCA1 or BRCA2 mutation), or histories of chest irradiation (eg, Hodgkin lymphoma).

Major statements:

The Task Force generated controversy with its 2009 recommendation that screening begin at age 50 in average-risk women. The current guidance clarifies that repetitive screening of women through 10 years reduces breast cancer deaths by 4 (aged 40–49), 8 (aged 50–59), and 21 (aged 60–69) per 10,000 women, respectively.²

The term “overdiagnosis” refers to detection and treatment of invasive and noninvasive (usually ductal carcinoma in situ) lesions that would have gone undetected without screening and would not have caused health problems. The USPSTF acknowledges that, while overdiagnosis represents the principal harm from screening, estimating overdiagnosis rates is challenging (best estimates range from 1 in 5 to 1 in 8 breast cancers diagnosed in screened women).^2–4 False-positive results, which lead to unnecessary additional imaging and biopsies,^3,4 can represent an additional harm of screening mammography.

The rationale for recommending that average-risk women begin screening at age 50 is based on the relatively smaller benefits and greater harms incurred when younger women are screened;^3,4 however, in noting that most of the screening benefits for women in their 40s are realized starting at age 45, the USPSTF guidance opens the door to average-risk women to begin screening at that age (congruent with the November 2015 American Cancer Society recommendations⁵). Also, women with a first-degree relative with breast cancer may want to initiate screening at age 40.

Regarding screening frequency, annual screening generates minimal if any benefit while increasing the potential for harm^3,4; thus, for most women at average risk for breast cancer, biennial screening provides the best benefit–harm balance.

What about use of tomosynthesis and women with dense breasts?
Tomosynthesis, which can be performed along with conventional digital screening mammography, seems to diminish the need for follow-up imaging while also increasing cancer detection rates.⁶ However, whether these additional cancers represent overdiagnosis remains unknown. Furthermore, tomosynthesis can expose women to about twice the radiation as conventional digital screening.⁷

Twenty-four states currently mandate that patients with dense breasts identified at screening be notified. Although increased breast density is a common independent risk factor for breast cancer, the degree of radiographic density can vary substantially from one screen to the next in the same woman. Evidence for or against adjunctive imaging is very limited in women found to have dense breasts in an otherwise negative mammogram, and suggests that ultrasonography and MRI (as well as tomosynthesis) can detect additional breast cancers while also generating more false-positive results.⁸ Thus, the USPSTF does not recommend specific screening strategies for women with dense breasts.

How I counsel my patients
I plan to continue recommending screening based on USPSTF guidance. However, I also will continue to support the preferences of many of my patients to:

You and your patients alike may find the USPSTF’s Summary for Patients⁹ (http://annals.org/article.aspx?articleid=2480981&resultClick=3) to be helpful when navigating this territory.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

In 2009, the US Preventive Services Task Force (USPSTF) recommended that biennial mammography screening in average-risk women begin at age 50.¹ New guidelines, that take into account reviews and modeling studies, clarify the earlier USPSTF recommendations, paying particular attention to individualized screening for women aged 40 to 49, use of tomosynthesis, and supplemental evaluation for women with radiologically dense breasts.

The new guidance only applies to women at average risk for breast cancer (not to those at substantially higher-than-average risk), including those with prior breast cancer or biopsy-confirmed high-risk lesions (eg, atypical hyperplasia), certain genetic conditions (such as BRCA1 or BRCA2 mutation), or histories of chest irradiation (eg, Hodgkin lymphoma).

Major statements:

The Task Force generated controversy with its 2009 recommendation that screening begin at age 50 in average-risk women. The current guidance clarifies that repetitive screening of women through 10 years reduces breast cancer deaths by 4 (aged 40–49), 8 (aged 50–59), and 21 (aged 60–69) per 10,000 women, respectively.²

The term “overdiagnosis” refers to detection and treatment of invasive and noninvasive (usually ductal carcinoma in situ) lesions that would have gone undetected without screening and would not have caused health problems. The USPSTF acknowledges that, while overdiagnosis represents the principal harm from screening, estimating overdiagnosis rates is challenging (best estimates range from 1 in 5 to 1 in 8 breast cancers diagnosed in screened women).^2–4 False-positive results, which lead to unnecessary additional imaging and biopsies,^3,4 can represent an additional harm of screening mammography.

The rationale for recommending that average-risk women begin screening at age 50 is based on the relatively smaller benefits and greater harms incurred when younger women are screened;^3,4 however, in noting that most of the screening benefits for women in their 40s are realized starting at age 45, the USPSTF guidance opens the door to average-risk women to begin screening at that age (congruent with the November 2015 American Cancer Society recommendations⁵). Also, women with a first-degree relative with breast cancer may want to initiate screening at age 40.

Regarding screening frequency, annual screening generates minimal if any benefit while increasing the potential for harm^3,4; thus, for most women at average risk for breast cancer, biennial screening provides the best benefit–harm balance.

What about use of tomosynthesis and women with dense breasts?
Tomosynthesis, which can be performed along with conventional digital screening mammography, seems to diminish the need for follow-up imaging while also increasing cancer detection rates.⁶ However, whether these additional cancers represent overdiagnosis remains unknown. Furthermore, tomosynthesis can expose women to about twice the radiation as conventional digital screening.⁷

Twenty-four states currently mandate that patients with dense breasts identified at screening be notified. Although increased breast density is a common independent risk factor for breast cancer, the degree of radiographic density can vary substantially from one screen to the next in the same woman. Evidence for or against adjunctive imaging is very limited in women found to have dense breasts in an otherwise negative mammogram, and suggests that ultrasonography and MRI (as well as tomosynthesis) can detect additional breast cancers while also generating more false-positive results.⁸ Thus, the USPSTF does not recommend specific screening strategies for women with dense breasts.

How I counsel my patients
I plan to continue recommending screening based on USPSTF guidance. However, I also will continue to support the preferences of many of my patients to:

You and your patients alike may find the USPSTF’s Summary for Patients⁹ (http://annals.org/article.aspx?articleid=2480981&resultClick=3) to be helpful when navigating this territory.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

In 2009, the US Preventive Services Task Force (USPSTF) recommended that biennial mammography screening in average-risk women begin at age 50.¹ New guidelines, that take into account reviews and modeling studies, clarify the earlier USPSTF recommendations, paying particular attention to individualized screening for women aged 40 to 49, use of tomosynthesis, and supplemental evaluation for women with radiologically dense breasts.

The new guidance only applies to women at average risk for breast cancer (not to those at substantially higher-than-average risk), including those with prior breast cancer or biopsy-confirmed high-risk lesions (eg, atypical hyperplasia), certain genetic conditions (such as BRCA1 or BRCA2 mutation), or histories of chest irradiation (eg, Hodgkin lymphoma).

Major statements:

The Task Force generated controversy with its 2009 recommendation that screening begin at age 50 in average-risk women. The current guidance clarifies that repetitive screening of women through 10 years reduces breast cancer deaths by 4 (aged 40–49), 8 (aged 50–59), and 21 (aged 60–69) per 10,000 women, respectively.²

The term “overdiagnosis” refers to detection and treatment of invasive and noninvasive (usually ductal carcinoma in situ) lesions that would have gone undetected without screening and would not have caused health problems. The USPSTF acknowledges that, while overdiagnosis represents the principal harm from screening, estimating overdiagnosis rates is challenging (best estimates range from 1 in 5 to 1 in 8 breast cancers diagnosed in screened women).^2–4 False-positive results, which lead to unnecessary additional imaging and biopsies,^3,4 can represent an additional harm of screening mammography.

The rationale for recommending that average-risk women begin screening at age 50 is based on the relatively smaller benefits and greater harms incurred when younger women are screened;^3,4 however, in noting that most of the screening benefits for women in their 40s are realized starting at age 45, the USPSTF guidance opens the door to average-risk women to begin screening at that age (congruent with the November 2015 American Cancer Society recommendations⁵). Also, women with a first-degree relative with breast cancer may want to initiate screening at age 40.

Regarding screening frequency, annual screening generates minimal if any benefit while increasing the potential for harm^3,4; thus, for most women at average risk for breast cancer, biennial screening provides the best benefit–harm balance.

What about use of tomosynthesis and women with dense breasts?
Tomosynthesis, which can be performed along with conventional digital screening mammography, seems to diminish the need for follow-up imaging while also increasing cancer detection rates.⁶ However, whether these additional cancers represent overdiagnosis remains unknown. Furthermore, tomosynthesis can expose women to about twice the radiation as conventional digital screening.⁷

Twenty-four states currently mandate that patients with dense breasts identified at screening be notified. Although increased breast density is a common independent risk factor for breast cancer, the degree of radiographic density can vary substantially from one screen to the next in the same woman. Evidence for or against adjunctive imaging is very limited in women found to have dense breasts in an otherwise negative mammogram, and suggests that ultrasonography and MRI (as well as tomosynthesis) can detect additional breast cancers while also generating more false-positive results.⁸ Thus, the USPSTF does not recommend specific screening strategies for women with dense breasts.

How I counsel my patients
I plan to continue recommending screening based on USPSTF guidance. However, I also will continue to support the preferences of many of my patients to:

You and your patients alike may find the USPSTF’s Summary for Patients⁹ (http://annals.org/article.aspx?articleid=2480981&resultClick=3) to be helpful when navigating this territory.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The Food and Drug Administration has approved eribulin for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

The approval was based on improved overall survival (OS) in an open-label, randomized, multicenter trial of 446 patients with unresectable, locally advanced or metastatic liposarcoma or leiomyosarcoma who had received at least two prior systemic chemotherapies (one of which must have included an anthracycline) and had experienced disease progression within 6 months of randomization, according to the Jan. 28 statement issued by the FDA.

Patients were randomized to receive either eribulin 1.4 mg/m² on days 1 and 8 of a 21-day cycle or dacarbazine (at a dose of 850 mg/m², 1,000 mg/m², or 1,200 mg/m² chosen by the investigator prior to randomization) on day 1 of a 21-day cycle.

Eribulin benefit was limited to the subgroup of patients with liposarcoma. The median OS was 15.6 vs. 8.4 months (HR 0.51 [95% CI: 0.35, 0.75]) and the median progression-free survival (PFS) was 2.9 vs. 1.7 months (HR 0.52 [95% CI: 0.35, 0.78]) in patients with liposarcoma treated with eribulin compared to dacarbazine, respectively. There was no evidence of efficacy for eribulin in patients with leiomyosarcoma.

The most common adverse reactions among those who received eribulin in the trial were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia. The most common grade 3-4 laboratory abnormalities were neutropenia, hypokalemia, and hypocalcemia.

The most common serious adverse reactions were neutropenia (4.9%) and pyrexia (4.5%). Febrile neutropenia occurred in 0.9% and fatal neutropenic sepsis in 0.9% of patients treated with eribulin. The most frequent adverse reactions leading to discontinuation were fatigue (0.9%) and thrombocytopenia (0.9%), according to the FDA statement.

Eribulin is marketed as Halaven injection by Eisai. The recommended dose and schedule for eribulin is 1.4 mg/m2 on days 1 and 8 of a 21-day cycle.

[email protected]

On Twitter @nikolaideslaura

The Food and Drug Administration has approved eribulin for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

The approval was based on improved overall survival (OS) in an open-label, randomized, multicenter trial of 446 patients with unresectable, locally advanced or metastatic liposarcoma or leiomyosarcoma who had received at least two prior systemic chemotherapies (one of which must have included an anthracycline) and had experienced disease progression within 6 months of randomization, according to the Jan. 28 statement issued by the FDA.

Patients were randomized to receive either eribulin 1.4 mg/m² on days 1 and 8 of a 21-day cycle or dacarbazine (at a dose of 850 mg/m², 1,000 mg/m², or 1,200 mg/m² chosen by the investigator prior to randomization) on day 1 of a 21-day cycle.

Eribulin benefit was limited to the subgroup of patients with liposarcoma. The median OS was 15.6 vs. 8.4 months (HR 0.51 [95% CI: 0.35, 0.75]) and the median progression-free survival (PFS) was 2.9 vs. 1.7 months (HR 0.52 [95% CI: 0.35, 0.78]) in patients with liposarcoma treated with eribulin compared to dacarbazine, respectively. There was no evidence of efficacy for eribulin in patients with leiomyosarcoma.

The most common adverse reactions among those who received eribulin in the trial were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia. The most common grade 3-4 laboratory abnormalities were neutropenia, hypokalemia, and hypocalcemia.

The most common serious adverse reactions were neutropenia (4.9%) and pyrexia (4.5%). Febrile neutropenia occurred in 0.9% and fatal neutropenic sepsis in 0.9% of patients treated with eribulin. The most frequent adverse reactions leading to discontinuation were fatigue (0.9%) and thrombocytopenia (0.9%), according to the FDA statement.

Eribulin is marketed as Halaven injection by Eisai. The recommended dose and schedule for eribulin is 1.4 mg/m2 on days 1 and 8 of a 21-day cycle.

[email protected]

On Twitter @nikolaideslaura

The Food and Drug Administration has approved eribulin for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

The approval was based on improved overall survival (OS) in an open-label, randomized, multicenter trial of 446 patients with unresectable, locally advanced or metastatic liposarcoma or leiomyosarcoma who had received at least two prior systemic chemotherapies (one of which must have included an anthracycline) and had experienced disease progression within 6 months of randomization, according to the Jan. 28 statement issued by the FDA.

Patients were randomized to receive either eribulin 1.4 mg/m² on days 1 and 8 of a 21-day cycle or dacarbazine (at a dose of 850 mg/m², 1,000 mg/m², or 1,200 mg/m² chosen by the investigator prior to randomization) on day 1 of a 21-day cycle.

Eribulin benefit was limited to the subgroup of patients with liposarcoma. The median OS was 15.6 vs. 8.4 months (HR 0.51 [95% CI: 0.35, 0.75]) and the median progression-free survival (PFS) was 2.9 vs. 1.7 months (HR 0.52 [95% CI: 0.35, 0.78]) in patients with liposarcoma treated with eribulin compared to dacarbazine, respectively. There was no evidence of efficacy for eribulin in patients with leiomyosarcoma.

The most common adverse reactions among those who received eribulin in the trial were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia. The most common grade 3-4 laboratory abnormalities were neutropenia, hypokalemia, and hypocalcemia.

The most common serious adverse reactions were neutropenia (4.9%) and pyrexia (4.5%). Febrile neutropenia occurred in 0.9% and fatal neutropenic sepsis in 0.9% of patients treated with eribulin. The most frequent adverse reactions leading to discontinuation were fatigue (0.9%) and thrombocytopenia (0.9%), according to the FDA statement.

Eribulin is marketed as Halaven injection by Eisai. The recommended dose and schedule for eribulin is 1.4 mg/m2 on days 1 and 8 of a 21-day cycle.

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On Twitter @nikolaideslaura

In the midst of the cold and flu season, we should reflect on the fact that our patients are laying down billions of dollars annually on preventions and cures for respiratory tract infections.

An aside: I am frequently turned down on my offer of the influenza vaccine, for which we probably have the best evidence. But $60 per month for a completely unproven preventive/curative agent made in some random factory in some random foreign land with no guarantee of good manufacturing practices (never mind the lack of active ingredients)? Stores can’t keep it in stock.

But I digress.

Our patients may lack the awareness of where to access evidence-based information when seeking answers about efficacy for cold remedies. So, it’s up to us to have at least some sense of where to get reliable information.

Truth be told, I am an enormous fan of safe and effective nonmedication therapies for the treatment and prevention of disease. So, when time permits, I will do a quick PubMed.gov search limiting my articles to randomized trials or systematic reviews on the latest and greatest home remedy.

Probiotics have been around for a while, and I think of them as a cure in search of a disease. The Cochrane Collaboration conducted a systematic review evaluating probiotics for the prevention of upper respiratory tract infection. In this review, 13 randomized, controlled trials were included (Explore [NY]. 2015 Sep-Oct;11[5]:418-20).

Probiotics were observed to be significantly better than placebo for reducing episodes of upper respiratory tract infection, the mean duration of episodes, antibiotic prescription rates, and cold-related absences. The evidence was of moderate to low quality.

Some may wonder how an ingested probiotic helps the respiratory tract stave off or fight infection. The prevailing theory appears to be that probiotics may function by mobilizing cells from the intestine to immunomodulate respiratory mucosa.

As for what probiotic/organism to prescribe? On this issue, there is a lot of smoke and not a lot of heat.

In general, the product should be encapsulated, and the label should include the genus and species of the strains (e.g., Lactobacillus acidophilus), the number of organisms (e.g., 5 billion), storage conditions (e.g., refrigerated or room temperature), and the shelf life. Pharmacy chain house brands may be cheaper. Gummy and chewable products tend to have 92% fewer beneficial bacteria than standard formulations.

How can we ensure purity?

That is tough, because supplements like probiotics are not regulated by the Food and Drug Administration above and beyond the agency’s trying to ensure good manufacturing practices. However, companies such as LabDoor (which generates revenue through affiliate links) test and grade supplements for label accuracy and purity. Websites like this might be the best place to start.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no financial disclosures relevant to this article.

In the midst of the cold and flu season, we should reflect on the fact that our patients are laying down billions of dollars annually on preventions and cures for respiratory tract infections.

An aside: I am frequently turned down on my offer of the influenza vaccine, for which we probably have the best evidence. But $60 per month for a completely unproven preventive/curative agent made in some random factory in some random foreign land with no guarantee of good manufacturing practices (never mind the lack of active ingredients)? Stores can’t keep it in stock.

But I digress.

Our patients may lack the awareness of where to access evidence-based information when seeking answers about efficacy for cold remedies. So, it’s up to us to have at least some sense of where to get reliable information.

Truth be told, I am an enormous fan of safe and effective nonmedication therapies for the treatment and prevention of disease. So, when time permits, I will do a quick PubMed.gov search limiting my articles to randomized trials or systematic reviews on the latest and greatest home remedy.

Probiotics have been around for a while, and I think of them as a cure in search of a disease. The Cochrane Collaboration conducted a systematic review evaluating probiotics for the prevention of upper respiratory tract infection. In this review, 13 randomized, controlled trials were included (Explore [NY]. 2015 Sep-Oct;11[5]:418-20).

Probiotics were observed to be significantly better than placebo for reducing episodes of upper respiratory tract infection, the mean duration of episodes, antibiotic prescription rates, and cold-related absences. The evidence was of moderate to low quality.

Some may wonder how an ingested probiotic helps the respiratory tract stave off or fight infection. The prevailing theory appears to be that probiotics may function by mobilizing cells from the intestine to immunomodulate respiratory mucosa.

As for what probiotic/organism to prescribe? On this issue, there is a lot of smoke and not a lot of heat.

In general, the product should be encapsulated, and the label should include the genus and species of the strains (e.g., Lactobacillus acidophilus), the number of organisms (e.g., 5 billion), storage conditions (e.g., refrigerated or room temperature), and the shelf life. Pharmacy chain house brands may be cheaper. Gummy and chewable products tend to have 92% fewer beneficial bacteria than standard formulations.

How can we ensure purity?

That is tough, because supplements like probiotics are not regulated by the Food and Drug Administration above and beyond the agency’s trying to ensure good manufacturing practices. However, companies such as LabDoor (which generates revenue through affiliate links) test and grade supplements for label accuracy and purity. Websites like this might be the best place to start.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no financial disclosures relevant to this article.

In the midst of the cold and flu season, we should reflect on the fact that our patients are laying down billions of dollars annually on preventions and cures for respiratory tract infections.

An aside: I am frequently turned down on my offer of the influenza vaccine, for which we probably have the best evidence. But $60 per month for a completely unproven preventive/curative agent made in some random factory in some random foreign land with no guarantee of good manufacturing practices (never mind the lack of active ingredients)? Stores can’t keep it in stock.

But I digress.

Our patients may lack the awareness of where to access evidence-based information when seeking answers about efficacy for cold remedies. So, it’s up to us to have at least some sense of where to get reliable information.

Truth be told, I am an enormous fan of safe and effective nonmedication therapies for the treatment and prevention of disease. So, when time permits, I will do a quick PubMed.gov search limiting my articles to randomized trials or systematic reviews on the latest and greatest home remedy.

Probiotics have been around for a while, and I think of them as a cure in search of a disease. The Cochrane Collaboration conducted a systematic review evaluating probiotics for the prevention of upper respiratory tract infection. In this review, 13 randomized, controlled trials were included (Explore [NY]. 2015 Sep-Oct;11[5]:418-20).

Probiotics were observed to be significantly better than placebo for reducing episodes of upper respiratory tract infection, the mean duration of episodes, antibiotic prescription rates, and cold-related absences. The evidence was of moderate to low quality.

Some may wonder how an ingested probiotic helps the respiratory tract stave off or fight infection. The prevailing theory appears to be that probiotics may function by mobilizing cells from the intestine to immunomodulate respiratory mucosa.

As for what probiotic/organism to prescribe? On this issue, there is a lot of smoke and not a lot of heat.

In general, the product should be encapsulated, and the label should include the genus and species of the strains (e.g., Lactobacillus acidophilus), the number of organisms (e.g., 5 billion), storage conditions (e.g., refrigerated or room temperature), and the shelf life. Pharmacy chain house brands may be cheaper. Gummy and chewable products tend to have 92% fewer beneficial bacteria than standard formulations.

How can we ensure purity?

That is tough, because supplements like probiotics are not regulated by the Food and Drug Administration above and beyond the agency’s trying to ensure good manufacturing practices. However, companies such as LabDoor (which generates revenue through affiliate links) test and grade supplements for label accuracy and purity. Websites like this might be the best place to start.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no financial disclosures relevant to this article.

Doctor consults with cancer

patient and her father

Photo by Rhoda Baer

A new study indicates that race, insurance status, and socioeconomic status (SES) impact survival in adolescents and young adults (AYAs) with Hodgkin lymphoma (HL).

Researchers found evidence to suggest that patients diagnosed with HL between the ages of 15 and 39 are less likely to survive the disease if they are black, Hispanic, have no insurance or public health insurance, or live in a neighborhood with low SES.

Theresa H.M. Keegan, PhD, MS, of the UC Davis Comprehensive Cancer Center in Sacramento, California, and her colleagues conducted this research and reported the results in Cancer Epidemiology, Biomarkers & Prevention.

Dr Keegan and her colleagues studied data from 9353 patients in the California Cancer Registry who were between 15 and 39 years old when they were diagnosed with HL between 1988 and 2011.

The team examined the impact of race/ethnicity, neighborhood SES, and health insurance on mortality.

The researchers found that AYAs diagnosed with early stage HL were twice as likely to die if they resided in a lower SES neighborhood.

Subjects were also twice as likely to die from HL if they had public health insurance or were uninsured, regardless of whether they were diagnosed at an early stage or a late stage.

Black AYA patients were 68% more likely to die of HL than non-Hispanic white patients, whether they were diagnosed at an early stage or a late stage.

And Hispanic AYA patients diagnosed at a late stage were 58% more likely than non-Hispanic white patients to die of HL, but there was no significant disparity for Hispanic patients diagnosed at an early stage.

“Identifying and reducing barriers to recommended treatment and surveillance in these AYAs at much higher risk of mortality is essential to ameliorating these survival disparities,” Dr Keegan said.

However, she and her colleagues noted that this study had limitations. The researchers were able to identify the first course of treatment but did not have specific details on the treatment that followed the initial period.

In addition, health insurance status at the time of diagnosis was not available for patients who were diagnosed before 2001, and the researchers did not have information on changes in patients’ insurance status that may have occurred after their initial treatment.

Doctor consults with cancer

patient and her father

Photo by Rhoda Baer

A new study indicates that race, insurance status, and socioeconomic status (SES) impact survival in adolescents and young adults (AYAs) with Hodgkin lymphoma (HL).

Researchers found evidence to suggest that patients diagnosed with HL between the ages of 15 and 39 are less likely to survive the disease if they are black, Hispanic, have no insurance or public health insurance, or live in a neighborhood with low SES.

Theresa H.M. Keegan, PhD, MS, of the UC Davis Comprehensive Cancer Center in Sacramento, California, and her colleagues conducted this research and reported the results in Cancer Epidemiology, Biomarkers & Prevention.

Dr Keegan and her colleagues studied data from 9353 patients in the California Cancer Registry who were between 15 and 39 years old when they were diagnosed with HL between 1988 and 2011.

The team examined the impact of race/ethnicity, neighborhood SES, and health insurance on mortality.

The researchers found that AYAs diagnosed with early stage HL were twice as likely to die if they resided in a lower SES neighborhood.

Subjects were also twice as likely to die from HL if they had public health insurance or were uninsured, regardless of whether they were diagnosed at an early stage or a late stage.

Black AYA patients were 68% more likely to die of HL than non-Hispanic white patients, whether they were diagnosed at an early stage or a late stage.

And Hispanic AYA patients diagnosed at a late stage were 58% more likely than non-Hispanic white patients to die of HL, but there was no significant disparity for Hispanic patients diagnosed at an early stage.

“Identifying and reducing barriers to recommended treatment and surveillance in these AYAs at much higher risk of mortality is essential to ameliorating these survival disparities,” Dr Keegan said.

However, she and her colleagues noted that this study had limitations. The researchers were able to identify the first course of treatment but did not have specific details on the treatment that followed the initial period.

In addition, health insurance status at the time of diagnosis was not available for patients who were diagnosed before 2001, and the researchers did not have information on changes in patients’ insurance status that may have occurred after their initial treatment.

Doctor consults with cancer

patient and her father

Photo by Rhoda Baer

A new study indicates that race, insurance status, and socioeconomic status (SES) impact survival in adolescents and young adults (AYAs) with Hodgkin lymphoma (HL).

Researchers found evidence to suggest that patients diagnosed with HL between the ages of 15 and 39 are less likely to survive the disease if they are black, Hispanic, have no insurance or public health insurance, or live in a neighborhood with low SES.

Theresa H.M. Keegan, PhD, MS, of the UC Davis Comprehensive Cancer Center in Sacramento, California, and her colleagues conducted this research and reported the results in Cancer Epidemiology, Biomarkers & Prevention.

Dr Keegan and her colleagues studied data from 9353 patients in the California Cancer Registry who were between 15 and 39 years old when they were diagnosed with HL between 1988 and 2011.

The team examined the impact of race/ethnicity, neighborhood SES, and health insurance on mortality.

The researchers found that AYAs diagnosed with early stage HL were twice as likely to die if they resided in a lower SES neighborhood.

Subjects were also twice as likely to die from HL if they had public health insurance or were uninsured, regardless of whether they were diagnosed at an early stage or a late stage.

Black AYA patients were 68% more likely to die of HL than non-Hispanic white patients, whether they were diagnosed at an early stage or a late stage.

And Hispanic AYA patients diagnosed at a late stage were 58% more likely than non-Hispanic white patients to die of HL, but there was no significant disparity for Hispanic patients diagnosed at an early stage.

“Identifying and reducing barriers to recommended treatment and surveillance in these AYAs at much higher risk of mortality is essential to ameliorating these survival disparities,” Dr Keegan said.

However, she and her colleagues noted that this study had limitations. The researchers were able to identify the first course of treatment but did not have specific details on the treatment that followed the initial period.

In addition, health insurance status at the time of diagnosis was not available for patients who were diagnosed before 2001, and the researchers did not have information on changes in patients’ insurance status that may have occurred after their initial treatment.

Carfilzomib (Kyprolis)

Photo courtesy of Amgen

Health Canada has approved the proteasome inhibitor carfilzomib (Kyprolis) for use in combination with lenalidomide and dexamethasone to treat patients with relapsed multiple myeloma (MM) who have received 1 to 3 prior lines of therapy.

Carfilzomib, a product of Amgen Canada, is also approved for use in the US, the European Union, Argentina, Israel, Kuwait, Mexico, Thailand, and Colombia.

Health Canada’s approval is based on results of the phase 3 ASPIRE trial, which were presented at ASH 2014 and published in NEJM.

The trial enrolled 792 patients with relapsed or refractory MM who had received 1 to 3 prior lines of therapy. The patients were randomized (1:1) to receive carfilzomib plus lenalidomide and dexamethasone (KRd) or just lenalidomide and dexamethasone (Rd) for 18 cycles.

Lenalidomide and dexamethasone were continued thereafter until disease progression. There was no planned cross-over from the control arm to treatment with carfilzomib.

The study’s primary endpoint was progression-free survival. The median progression-free survival was significantly longer in the KRd arm than the Rd arm—26.3 months and 17.6 months, respectively (hazard ratio=0.69, P=0.0001).

At the time of analysis, the difference in overall survival did not reach the prespecified boundary for statistical significance.

The overall response rate was 87% in the KRd arm and 67% in the Rd arm. The median duration of response was 28.6 months and 21.2 months, respectively.

The rates of death due to adverse events (AEs) within 30 days of the last dose were similar between the treatment arms.

The most common causes of death not due to progressive disease occurring in patients in the KRd arm and the Rd arm, respectively, were cardiac disorders (3% vs 2%), infection (2% vs 3%), renal events (0% vs less than 1%), and other AEs (2% vs 3%).

Serious AEs were reported in 60% of patients in the KRd arm and 54% in the Rd arm. The most common serious AEs reported in the KRd arm and the Rd arm, respectively, were pneumonia (14% vs 11%), respiratory tract infection (4% vs 2%), pyrexia (4% vs 2%), and pulmonary embolism (3% vs 2%).

Carfilzomib (Kyprolis)

Photo courtesy of Amgen

Health Canada has approved the proteasome inhibitor carfilzomib (Kyprolis) for use in combination with lenalidomide and dexamethasone to treat patients with relapsed multiple myeloma (MM) who have received 1 to 3 prior lines of therapy.

Carfilzomib, a product of Amgen Canada, is also approved for use in the US, the European Union, Argentina, Israel, Kuwait, Mexico, Thailand, and Colombia.

Health Canada’s approval is based on results of the phase 3 ASPIRE trial, which were presented at ASH 2014 and published in NEJM.

The trial enrolled 792 patients with relapsed or refractory MM who had received 1 to 3 prior lines of therapy. The patients were randomized (1:1) to receive carfilzomib plus lenalidomide and dexamethasone (KRd) or just lenalidomide and dexamethasone (Rd) for 18 cycles.

Lenalidomide and dexamethasone were continued thereafter until disease progression. There was no planned cross-over from the control arm to treatment with carfilzomib.

The study’s primary endpoint was progression-free survival. The median progression-free survival was significantly longer in the KRd arm than the Rd arm—26.3 months and 17.6 months, respectively (hazard ratio=0.69, P=0.0001).

At the time of analysis, the difference in overall survival did not reach the prespecified boundary for statistical significance.

The overall response rate was 87% in the KRd arm and 67% in the Rd arm. The median duration of response was 28.6 months and 21.2 months, respectively.

The rates of death due to adverse events (AEs) within 30 days of the last dose were similar between the treatment arms.

The most common causes of death not due to progressive disease occurring in patients in the KRd arm and the Rd arm, respectively, were cardiac disorders (3% vs 2%), infection (2% vs 3%), renal events (0% vs less than 1%), and other AEs (2% vs 3%).

Serious AEs were reported in 60% of patients in the KRd arm and 54% in the Rd arm. The most common serious AEs reported in the KRd arm and the Rd arm, respectively, were pneumonia (14% vs 11%), respiratory tract infection (4% vs 2%), pyrexia (4% vs 2%), and pulmonary embolism (3% vs 2%).

Carfilzomib (Kyprolis)

Photo courtesy of Amgen

Health Canada has approved the proteasome inhibitor carfilzomib (Kyprolis) for use in combination with lenalidomide and dexamethasone to treat patients with relapsed multiple myeloma (MM) who have received 1 to 3 prior lines of therapy.

Carfilzomib, a product of Amgen Canada, is also approved for use in the US, the European Union, Argentina, Israel, Kuwait, Mexico, Thailand, and Colombia.

Health Canada’s approval is based on results of the phase 3 ASPIRE trial, which were presented at ASH 2014 and published in NEJM.

The trial enrolled 792 patients with relapsed or refractory MM who had received 1 to 3 prior lines of therapy. The patients were randomized (1:1) to receive carfilzomib plus lenalidomide and dexamethasone (KRd) or just lenalidomide and dexamethasone (Rd) for 18 cycles.

Lenalidomide and dexamethasone were continued thereafter until disease progression. There was no planned cross-over from the control arm to treatment with carfilzomib.

The study’s primary endpoint was progression-free survival. The median progression-free survival was significantly longer in the KRd arm than the Rd arm—26.3 months and 17.6 months, respectively (hazard ratio=0.69, P=0.0001).

At the time of analysis, the difference in overall survival did not reach the prespecified boundary for statistical significance.

The overall response rate was 87% in the KRd arm and 67% in the Rd arm. The median duration of response was 28.6 months and 21.2 months, respectively.

The rates of death due to adverse events (AEs) within 30 days of the last dose were similar between the treatment arms.

The most common causes of death not due to progressive disease occurring in patients in the KRd arm and the Rd arm, respectively, were cardiac disorders (3% vs 2%), infection (2% vs 3%), renal events (0% vs less than 1%), and other AEs (2% vs 3%).

Serious AEs were reported in 60% of patients in the KRd arm and 54% in the Rd arm. The most common serious AEs reported in the KRd arm and the Rd arm, respectively, were pneumonia (14% vs 11%), respiratory tract infection (4% vs 2%), pyrexia (4% vs 2%), and pulmonary embolism (3% vs 2%).

Doctor using a smartphone

Photo by Daniel Sone

Understanding and integrating patients’ cultural beliefs into cancer treatment plans may help improve their acceptance of and adherence to treatment in multicultural settings, according to research published in the Journal of Global Oncology.

Researchers examined traditional Maya healers’ understanding of cancer and found that, although there are key differences between Maya and Western medicine perspectives, they also share many fundamental concepts.

“Maya healers understand cancer in remarkably similar ways to Western doctors,” said lead study author Mónica Berger-González, PhD, of the Institute for Environmental Decisions at ETH Zurich in Switzerland.

“Recognizing this is the first step to bridging the gap between cultures and ultimately providing better, more effective services for indigenous populations.”

Nearly half of the population in Guatemala (approximately 5.4 million people) relies on Maya medicine. Traditional healers have practiced in Guatemala for more than 2000 years, with the healing tradition passed down orally and through apprenticeship.

According to the authors, this is one of the first studies to explore the subject of Maya healers and cancer across several ethno-linguistic groups, and limited data exist on survival outcomes.

Dr Berger-González and her colleagues conducted in-depth interviews with 67 healers across various ethnic and language groups in Guatemala, exploring how its indigenous people define and treat cancer.

Of the Maya healers interviewed, 46% were illiterate. Although only 36% were able to define the word cancer, most (85%) were familiar with the term and identified malignancy as a core characteristic of the disease, explaining the concept of metastasis clearly.

The analysis also revealed that Maya healers understand the origins of cancer in ways that align closely with Western medical concepts.

When asked to identify the physical causes of cancer, 10 of 17 causes provided correlated directly with cancer risk factors as understood in Western medicine. Healers cited causes such as the consumption of harmful foods (46.3%), hereditary conditions (29.6%), and lifestyle factors such as smoking or working with toxic substances (29.6%).

One notable difference identified between the 2 perspectives is that Maya healers’ view of cancer is not limited to the physical body, but rather includes a complex imbalance of the emotions, mind, and spirit.

The Maya treatment of cancer is consequently holistic and seeks to restore that balance. This is achieved through a combination of methods—such as regulating diet, plant therapy, detoxifying baths—as well as social, psychological, and spiritual methods, the latter of which, the authors note, is harder to grasp in Western medicine.

“If healthcare professionals do not understand indigenous peoples’ conception of cancer, these patients are far less likely to accept and adhere to treatment in the public healthcare system,” Dr Berger-González said.

Many indigenous people in Guatemala do not have access to Western medicine services, cannot afford them, or prefer Maya medicine even when Western medical treatment is available. Yet Western medicine practitioners have little to no training in multicultural management or traditional indigenous medicine.

The authors offer 3 key recommendations to help address the challenges of providing care in multicultural settings:

• Adequate training of healthcare professionals on cultural and social perceptions of cancer
• Increasing evidence-based research on traditional medicine
• Establishing national regulations on integrating traditional and Western medicine—following other countries like Peru, Brazil, and Ecuador, which have successfully incorporated these aspects of care.

The authors plan to continue their transdisciplinary research with the goal of providing biomedical evidence that advances different aspects of Maya medicine.

Doctor using a smartphone

Photo by Daniel Sone

Understanding and integrating patients’ cultural beliefs into cancer treatment plans may help improve their acceptance of and adherence to treatment in multicultural settings, according to research published in the Journal of Global Oncology.

Researchers examined traditional Maya healers’ understanding of cancer and found that, although there are key differences between Maya and Western medicine perspectives, they also share many fundamental concepts.

“Maya healers understand cancer in remarkably similar ways to Western doctors,” said lead study author Mónica Berger-González, PhD, of the Institute for Environmental Decisions at ETH Zurich in Switzerland.

“Recognizing this is the first step to bridging the gap between cultures and ultimately providing better, more effective services for indigenous populations.”

Nearly half of the population in Guatemala (approximately 5.4 million people) relies on Maya medicine. Traditional healers have practiced in Guatemala for more than 2000 years, with the healing tradition passed down orally and through apprenticeship.

According to the authors, this is one of the first studies to explore the subject of Maya healers and cancer across several ethno-linguistic groups, and limited data exist on survival outcomes.

Dr Berger-González and her colleagues conducted in-depth interviews with 67 healers across various ethnic and language groups in Guatemala, exploring how its indigenous people define and treat cancer.

Of the Maya healers interviewed, 46% were illiterate. Although only 36% were able to define the word cancer, most (85%) were familiar with the term and identified malignancy as a core characteristic of the disease, explaining the concept of metastasis clearly.

The analysis also revealed that Maya healers understand the origins of cancer in ways that align closely with Western medical concepts.

When asked to identify the physical causes of cancer, 10 of 17 causes provided correlated directly with cancer risk factors as understood in Western medicine. Healers cited causes such as the consumption of harmful foods (46.3%), hereditary conditions (29.6%), and lifestyle factors such as smoking or working with toxic substances (29.6%).

One notable difference identified between the 2 perspectives is that Maya healers’ view of cancer is not limited to the physical body, but rather includes a complex imbalance of the emotions, mind, and spirit.

The Maya treatment of cancer is consequently holistic and seeks to restore that balance. This is achieved through a combination of methods—such as regulating diet, plant therapy, detoxifying baths—as well as social, psychological, and spiritual methods, the latter of which, the authors note, is harder to grasp in Western medicine.

“If healthcare professionals do not understand indigenous peoples’ conception of cancer, these patients are far less likely to accept and adhere to treatment in the public healthcare system,” Dr Berger-González said.

Many indigenous people in Guatemala do not have access to Western medicine services, cannot afford them, or prefer Maya medicine even when Western medical treatment is available. Yet Western medicine practitioners have little to no training in multicultural management or traditional indigenous medicine.

The authors offer 3 key recommendations to help address the challenges of providing care in multicultural settings:

• Adequate training of healthcare professionals on cultural and social perceptions of cancer
• Increasing evidence-based research on traditional medicine
• Establishing national regulations on integrating traditional and Western medicine—following other countries like Peru, Brazil, and Ecuador, which have successfully incorporated these aspects of care.

The authors plan to continue their transdisciplinary research with the goal of providing biomedical evidence that advances different aspects of Maya medicine.

Doctor using a smartphone

Photo by Daniel Sone

Understanding and integrating patients’ cultural beliefs into cancer treatment plans may help improve their acceptance of and adherence to treatment in multicultural settings, according to research published in the Journal of Global Oncology.

Researchers examined traditional Maya healers’ understanding of cancer and found that, although there are key differences between Maya and Western medicine perspectives, they also share many fundamental concepts.

“Maya healers understand cancer in remarkably similar ways to Western doctors,” said lead study author Mónica Berger-González, PhD, of the Institute for Environmental Decisions at ETH Zurich in Switzerland.

“Recognizing this is the first step to bridging the gap between cultures and ultimately providing better, more effective services for indigenous populations.”

Nearly half of the population in Guatemala (approximately 5.4 million people) relies on Maya medicine. Traditional healers have practiced in Guatemala for more than 2000 years, with the healing tradition passed down orally and through apprenticeship.

According to the authors, this is one of the first studies to explore the subject of Maya healers and cancer across several ethno-linguistic groups, and limited data exist on survival outcomes.

Dr Berger-González and her colleagues conducted in-depth interviews with 67 healers across various ethnic and language groups in Guatemala, exploring how its indigenous people define and treat cancer.

Of the Maya healers interviewed, 46% were illiterate. Although only 36% were able to define the word cancer, most (85%) were familiar with the term and identified malignancy as a core characteristic of the disease, explaining the concept of metastasis clearly.

The analysis also revealed that Maya healers understand the origins of cancer in ways that align closely with Western medical concepts.

When asked to identify the physical causes of cancer, 10 of 17 causes provided correlated directly with cancer risk factors as understood in Western medicine. Healers cited causes such as the consumption of harmful foods (46.3%), hereditary conditions (29.6%), and lifestyle factors such as smoking or working with toxic substances (29.6%).

One notable difference identified between the 2 perspectives is that Maya healers’ view of cancer is not limited to the physical body, but rather includes a complex imbalance of the emotions, mind, and spirit.

The Maya treatment of cancer is consequently holistic and seeks to restore that balance. This is achieved through a combination of methods—such as regulating diet, plant therapy, detoxifying baths—as well as social, psychological, and spiritual methods, the latter of which, the authors note, is harder to grasp in Western medicine.

“If healthcare professionals do not understand indigenous peoples’ conception of cancer, these patients are far less likely to accept and adhere to treatment in the public healthcare system,” Dr Berger-González said.

Many indigenous people in Guatemala do not have access to Western medicine services, cannot afford them, or prefer Maya medicine even when Western medical treatment is available. Yet Western medicine practitioners have little to no training in multicultural management or traditional indigenous medicine.

The authors offer 3 key recommendations to help address the challenges of providing care in multicultural settings:

• Adequate training of healthcare professionals on cultural and social perceptions of cancer
• Increasing evidence-based research on traditional medicine
• Establishing national regulations on integrating traditional and Western medicine—following other countries like Peru, Brazil, and Ecuador, which have successfully incorporated these aspects of care.

The authors plan to continue their transdisciplinary research with the goal of providing biomedical evidence that advances different aspects of Maya medicine.

Micrograph showing AML

Image by Lance Liotta

The US Food and Drug Administration (FDA) has granted a third breakthrough therapy designation for the BCL-2 inhibitor venetoclax (ABT-199).

This time, the designation is for venetoclax in combination with hypomethylating agents to treat patients with treatment-naïve acute myeloid leukemia (AML) who are ineligible for standard induction therapy.

Venetoclax previously received breakthrough designation as a single agent for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and in combination with rituximab to treat patients with relapsed or refractory CLL and 17p deletion.

Breakthrough therapy designation is designed to accelerate the development and review of medicines that demonstrate early clinical evidence of a substantial improvement over current treatment options for serious diseases.

Venetoclax is currently under investigation in a phase 1/2 trial in combination with low-dose cytarabine for treatment-naïve patients with AML and in a phase 1b study in combination with decitabine or azacitidine for treatment-naïve AML patients.

A phase 2 study of single-agent venetoclax in AML has been completed. The results were presented at ASH 2014.

At that time, the trial had enrolled 32 patients, 30 of whom had relapsed or refractory disease. Patients had a median age of 71 (range, 19 to 84), and half were male.

The overall response rate was 15.5%, with 1 patient achieving a complete response (CR) and 4 patients achieving a CR with incomplete count recovery (CRi).

The researchers noted that 3 of the patients who had a CR/CRi had IDH mutations. Two of these patients also achieved minimal residual disease negativity.

The median bone marrow blast count in evaluable patients decreased 36% after treatment, and 6 patients (19%) had at least a 50% reduction in bone marrow blasts.

Common adverse events following treatment (occurring in at least 25% of patients) included nausea, diarrhea, fatigue, neutropenia, and vomiting.

Grade 3 and 4 adverse events (occurring in 3 or more patients) included febrile neutropenia, anemia, and pneumonia. No patient died as a result of treatment-related adverse events.

Venetoclax is being developed by AbbVie in partnership with Genentech and Roche.

Micrograph showing AML

Image by Lance Liotta

The US Food and Drug Administration (FDA) has granted a third breakthrough therapy designation for the BCL-2 inhibitor venetoclax (ABT-199).

This time, the designation is for venetoclax in combination with hypomethylating agents to treat patients with treatment-naïve acute myeloid leukemia (AML) who are ineligible for standard induction therapy.

Venetoclax previously received breakthrough designation as a single agent for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and in combination with rituximab to treat patients with relapsed or refractory CLL and 17p deletion.

Breakthrough therapy designation is designed to accelerate the development and review of medicines that demonstrate early clinical evidence of a substantial improvement over current treatment options for serious diseases.

Venetoclax is currently under investigation in a phase 1/2 trial in combination with low-dose cytarabine for treatment-naïve patients with AML and in a phase 1b study in combination with decitabine or azacitidine for treatment-naïve AML patients.

A phase 2 study of single-agent venetoclax in AML has been completed. The results were presented at ASH 2014.

At that time, the trial had enrolled 32 patients, 30 of whom had relapsed or refractory disease. Patients had a median age of 71 (range, 19 to 84), and half were male.

The overall response rate was 15.5%, with 1 patient achieving a complete response (CR) and 4 patients achieving a CR with incomplete count recovery (CRi).

The researchers noted that 3 of the patients who had a CR/CRi had IDH mutations. Two of these patients also achieved minimal residual disease negativity.

The median bone marrow blast count in evaluable patients decreased 36% after treatment, and 6 patients (19%) had at least a 50% reduction in bone marrow blasts.

Common adverse events following treatment (occurring in at least 25% of patients) included nausea, diarrhea, fatigue, neutropenia, and vomiting.

Grade 3 and 4 adverse events (occurring in 3 or more patients) included febrile neutropenia, anemia, and pneumonia. No patient died as a result of treatment-related adverse events.

Venetoclax is being developed by AbbVie in partnership with Genentech and Roche.

Micrograph showing AML

Image by Lance Liotta

The US Food and Drug Administration (FDA) has granted a third breakthrough therapy designation for the BCL-2 inhibitor venetoclax (ABT-199).

This time, the designation is for venetoclax in combination with hypomethylating agents to treat patients with treatment-naïve acute myeloid leukemia (AML) who are ineligible for standard induction therapy.

Venetoclax previously received breakthrough designation as a single agent for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and in combination with rituximab to treat patients with relapsed or refractory CLL and 17p deletion.

Breakthrough therapy designation is designed to accelerate the development and review of medicines that demonstrate early clinical evidence of a substantial improvement over current treatment options for serious diseases.

Venetoclax is currently under investigation in a phase 1/2 trial in combination with low-dose cytarabine for treatment-naïve patients with AML and in a phase 1b study in combination with decitabine or azacitidine for treatment-naïve AML patients.

A phase 2 study of single-agent venetoclax in AML has been completed. The results were presented at ASH 2014.

At that time, the trial had enrolled 32 patients, 30 of whom had relapsed or refractory disease. Patients had a median age of 71 (range, 19 to 84), and half were male.

The overall response rate was 15.5%, with 1 patient achieving a complete response (CR) and 4 patients achieving a CR with incomplete count recovery (CRi).

The researchers noted that 3 of the patients who had a CR/CRi had IDH mutations. Two of these patients also achieved minimal residual disease negativity.

The median bone marrow blast count in evaluable patients decreased 36% after treatment, and 6 patients (19%) had at least a 50% reduction in bone marrow blasts.

Common adverse events following treatment (occurring in at least 25% of patients) included nausea, diarrhea, fatigue, neutropenia, and vomiting.

Grade 3 and 4 adverse events (occurring in 3 or more patients) included febrile neutropenia, anemia, and pneumonia. No patient died as a result of treatment-related adverse events.

Venetoclax is being developed by AbbVie in partnership with Genentech and Roche.