October 17, 2019 – Skin cancer is the most common type of cancer in the United States. According to the Skin Cancer Foundation “1 out of 5 Americans will develop skin cancer by age 70.” Dermatologists are trained to diagnose and treat skin cancer early. But knowledge is the best defense for your patient.

On October 8, MDedge Dermatology hosted a conversation on Twitter at #MDedgeChats with three dermatologists, Dr. Candrice Heath, Dr. Anthony Rossi, and Dr. Julie Amthor Croley. The conversation covered trending dermatology topics such as sunscreen, melanoma, and treating skin of color patients. 

Throughout the conversation, physicians encouraged participants to use sunscreen daily. “SPF of 15 for daily use! Daily means all seasons! Nonmelanoma cancers are associated with cumulative sun exposure. Melanomas tend to be associated with intense, intermittent sun exposure/sunburns,” said Dr. David Henry, a clinical professor of medicine at the University of Pennsylvania and vice chairman of the department of medicine at Pennsylvania Hospital in Philadelphia.  He is also the host of the MDedge podcast Blood & Cancer. 

“One common misconception amongst patients is that there is only one type of skin cancer. Oftentimes, this singular skin cancer is referred to as ‘melanoma.’ In reality, there are dozens of types of skin cancers, originating from different cell types within the skin,” said Dr. Julie Amthor Croley, Chief Dermatology Resident at the University of Texas Medical Branch in Galveston, Texas, and recurring host of the resident takeover edition of the MDedge podcast Dermatology Weekly. 

Read more of the physicians' responses on page 2. The following is an edited version of the discussion.

“One common misconception amongst patients is that there is only one type of skin cancer.”~ Dr. Julie Amthor Croley

“Melanoma incidence is associated with increased UV index and lower latitude in non-Hispanic whites. UVA and UVB protection is important because of this.”~ Dr. Anthony Rossi

“Melanoma commonly occurs in sun-exposed areas in whites but in non-sun-exposed areas in people of color.”~ Dr. Candrice Heath

“When BCC and SCC occur in people of color, the lesions may be pigmented and thus look different. #Skinofcolor education for dermatologists is important.”~ Dr. Candrice Heath

“SPF of 15 for daily use! Daily means all seasons! Nonmelanoma cancers are associated with cumulative sun exposure. Melanomas tend to be associated with intense, intermittent sun exposure/sunburns.”~ Dr. David Henry

October 17, 2019 – Skin cancer is the most common type of cancer in the United States. According to the Skin Cancer Foundation “1 out of 5 Americans will develop skin cancer by age 70.” Dermatologists are trained to diagnose and treat skin cancer early. But knowledge is the best defense for your patient.

On October 8, MDedge Dermatology hosted a conversation on Twitter at #MDedgeChats with three dermatologists, Dr. Candrice Heath, Dr. Anthony Rossi, and Dr. Julie Amthor Croley. The conversation covered trending dermatology topics such as sunscreen, melanoma, and treating skin of color patients. 

Throughout the conversation, physicians encouraged participants to use sunscreen daily. “SPF of 15 for daily use! Daily means all seasons! Nonmelanoma cancers are associated with cumulative sun exposure. Melanomas tend to be associated with intense, intermittent sun exposure/sunburns,” said Dr. David Henry, a clinical professor of medicine at the University of Pennsylvania and vice chairman of the department of medicine at Pennsylvania Hospital in Philadelphia.  He is also the host of the MDedge podcast Blood & Cancer. 

“One common misconception amongst patients is that there is only one type of skin cancer. Oftentimes, this singular skin cancer is referred to as ‘melanoma.’ In reality, there are dozens of types of skin cancers, originating from different cell types within the skin,” said Dr. Julie Amthor Croley, Chief Dermatology Resident at the University of Texas Medical Branch in Galveston, Texas, and recurring host of the resident takeover edition of the MDedge podcast Dermatology Weekly. 

Read more of the physicians' responses on page 2. The following is an edited version of the discussion.

“One common misconception amongst patients is that there is only one type of skin cancer.”~ Dr. Julie Amthor Croley

“Melanoma incidence is associated with increased UV index and lower latitude in non-Hispanic whites. UVA and UVB protection is important because of this.”~ Dr. Anthony Rossi

“Melanoma commonly occurs in sun-exposed areas in whites but in non-sun-exposed areas in people of color.”~ Dr. Candrice Heath

“When BCC and SCC occur in people of color, the lesions may be pigmented and thus look different. #Skinofcolor education for dermatologists is important.”~ Dr. Candrice Heath

“SPF of 15 for daily use! Daily means all seasons! Nonmelanoma cancers are associated with cumulative sun exposure. Melanomas tend to be associated with intense, intermittent sun exposure/sunburns.”~ Dr. David Henry

October 17, 2019 – Skin cancer is the most common type of cancer in the United States. According to the Skin Cancer Foundation “1 out of 5 Americans will develop skin cancer by age 70.” Dermatologists are trained to diagnose and treat skin cancer early. But knowledge is the best defense for your patient.

On October 8, MDedge Dermatology hosted a conversation on Twitter at #MDedgeChats with three dermatologists, Dr. Candrice Heath, Dr. Anthony Rossi, and Dr. Julie Amthor Croley. The conversation covered trending dermatology topics such as sunscreen, melanoma, and treating skin of color patients. 

Throughout the conversation, physicians encouraged participants to use sunscreen daily. “SPF of 15 for daily use! Daily means all seasons! Nonmelanoma cancers are associated with cumulative sun exposure. Melanomas tend to be associated with intense, intermittent sun exposure/sunburns,” said Dr. David Henry, a clinical professor of medicine at the University of Pennsylvania and vice chairman of the department of medicine at Pennsylvania Hospital in Philadelphia.  He is also the host of the MDedge podcast Blood & Cancer. 

“One common misconception amongst patients is that there is only one type of skin cancer. Oftentimes, this singular skin cancer is referred to as ‘melanoma.’ In reality, there are dozens of types of skin cancers, originating from different cell types within the skin,” said Dr. Julie Amthor Croley, Chief Dermatology Resident at the University of Texas Medical Branch in Galveston, Texas, and recurring host of the resident takeover edition of the MDedge podcast Dermatology Weekly. 

Read more of the physicians' responses on page 2. The following is an edited version of the discussion.

“One common misconception amongst patients is that there is only one type of skin cancer.”~ Dr. Julie Amthor Croley

“Melanoma incidence is associated with increased UV index and lower latitude in non-Hispanic whites. UVA and UVB protection is important because of this.”~ Dr. Anthony Rossi

“Melanoma commonly occurs in sun-exposed areas in whites but in non-sun-exposed areas in people of color.”~ Dr. Candrice Heath

“When BCC and SCC occur in people of color, the lesions may be pigmented and thus look different. #Skinofcolor education for dermatologists is important.”~ Dr. Candrice Heath

“SPF of 15 for daily use! Daily means all seasons! Nonmelanoma cancers are associated with cumulative sun exposure. Melanomas tend to be associated with intense, intermittent sun exposure/sunburns.”~ Dr. David Henry

Vaccination rates among kindergartners during the 2018-2019 school year and children aged 24 months during 2016-2018 remained high, but several gaps in coverage remained, new research found.

MarianVejcik/Getty Images

The national vaccination rate for the almost 4 million kindergartners reported as enrolled in 2018-2019 was 94.9% for DTaP, 94.7% for 2 doses of MMR, and 94.8% for state-required doses of varicella. The MMR vaccination rate fell just short of the recommended 95% vaccination rate threshold, according to Ranee Seither, MPH, of the immunization services division at the National Center for Immunization and Respiratory Diseases (NCIRD), and associates.

By state, Mississippi had the highest vaccination rate, achieving at least 99.2% coverage for DTaP, MMR, and varicella. Colorado had the lowest vaccination rate for MMR and varicella at 87.4% and 86.5%, respectively; Idaho had the lowest DTaP vaccination rate at 88.8%.

A total of 20 states had at least 95% MMR coverage while 2 had under 90%, 21 states had at least 95% DTaP coverage with only Idaho having below 90%, and 20 states had at least 95% varicella coverage with 4 states having below 90%.

Nationally, 2.5% of kindergartners had an exemption from at least one vaccine, and 2.8% were not up to date for MMR and did not have a vaccine exemption. The investigators noted that, if all nonexempt kindergartners were vaccinated in accordance with local and state vaccination policies, nearly all states could achieve the 95% MMR vaccination threshold.

“Recent measles outbreaks in states with high overall MMR coverage, such as New York, highlight the need for assessing vaccination coverage at the local level. [The Centers for Disease Control and Prevention] encourage programs to use their local-level school assessment data to identify populations of undervaccinated students and to partner with schools and providers to reduce barriers to vaccination and improve coverage,” Dr. Seither and associates wrote.

In a study published in the same issue of the Morbidity and Mortality Weekly Report, Holly A. Hill, MD, PhD, and associates from the immunization services division at NCIRD, found that, according to data collected from 25,059 participants in the National Immunization Survey–Child, national vaccination coverage in children aged 24 months was generally strong and stable.

The vaccines with coverage of at least 90% were poliovirus (92.7%), MMR (90.4%), hepatitis B (91%), and varicella (90%). Complete hepatitis A (74%), rotavirus (72.4%), influenza (53%), and combined seven-vaccine series (68.4%) rates were below 80%. Only 1.3% of children received no vaccinations.

In general, the highest rates of coverage were seen in children with private insurance, followed by those with other insurance, those with Medicaid, and finally those without insurance. Disparities also were seen depending on race/ethnicity, poverty level, and rural/urban location. Vaccination rates also varied by state; for example, 20 states had vaccination coverage for one dose of MMR below 90%, with 6 having coverage above 94% (Arkansas, Maine, Massachusetts, Mississippi, Rhode Island, Wisconsin).

“Improvements in childhood vaccination coverage will require that parents and other caregivers have access to vaccination providers and believe in the safety and effectiveness of vaccines. Increased opportunity for vaccination can be facilitated through expanded access to health insurance, greater promotion of available vaccines through the Vaccines for Children program, and solutions to logistical challenges such as transportation, child care, and time off from work. Providers can improve vaccination coverage overall and reduce disparities by administering all recommended vaccines during office visits,” Dr. Hill and associates wrote.

No conflicts of interest were reported by the investigators of either study.

lfranki@mdedge.com

SOURCES: Seither R et al. MMWR Morb Mortal Wkly Rep 2019;68:905-12; Hill HA et al. MMWR Morb Mortal Wkly Rep 2019;68:913-8.

Vaccination rates among kindergartners during the 2018-2019 school year and children aged 24 months during 2016-2018 remained high, but several gaps in coverage remained, new research found.

MarianVejcik/Getty Images

The national vaccination rate for the almost 4 million kindergartners reported as enrolled in 2018-2019 was 94.9% for DTaP, 94.7% for 2 doses of MMR, and 94.8% for state-required doses of varicella. The MMR vaccination rate fell just short of the recommended 95% vaccination rate threshold, according to Ranee Seither, MPH, of the immunization services division at the National Center for Immunization and Respiratory Diseases (NCIRD), and associates.

By state, Mississippi had the highest vaccination rate, achieving at least 99.2% coverage for DTaP, MMR, and varicella. Colorado had the lowest vaccination rate for MMR and varicella at 87.4% and 86.5%, respectively; Idaho had the lowest DTaP vaccination rate at 88.8%.

A total of 20 states had at least 95% MMR coverage while 2 had under 90%, 21 states had at least 95% DTaP coverage with only Idaho having below 90%, and 20 states had at least 95% varicella coverage with 4 states having below 90%.

Nationally, 2.5% of kindergartners had an exemption from at least one vaccine, and 2.8% were not up to date for MMR and did not have a vaccine exemption. The investigators noted that, if all nonexempt kindergartners were vaccinated in accordance with local and state vaccination policies, nearly all states could achieve the 95% MMR vaccination threshold.

“Recent measles outbreaks in states with high overall MMR coverage, such as New York, highlight the need for assessing vaccination coverage at the local level. [The Centers for Disease Control and Prevention] encourage programs to use their local-level school assessment data to identify populations of undervaccinated students and to partner with schools and providers to reduce barriers to vaccination and improve coverage,” Dr. Seither and associates wrote.

In a study published in the same issue of the Morbidity and Mortality Weekly Report, Holly A. Hill, MD, PhD, and associates from the immunization services division at NCIRD, found that, according to data collected from 25,059 participants in the National Immunization Survey–Child, national vaccination coverage in children aged 24 months was generally strong and stable.

The vaccines with coverage of at least 90% were poliovirus (92.7%), MMR (90.4%), hepatitis B (91%), and varicella (90%). Complete hepatitis A (74%), rotavirus (72.4%), influenza (53%), and combined seven-vaccine series (68.4%) rates were below 80%. Only 1.3% of children received no vaccinations.

In general, the highest rates of coverage were seen in children with private insurance, followed by those with other insurance, those with Medicaid, and finally those without insurance. Disparities also were seen depending on race/ethnicity, poverty level, and rural/urban location. Vaccination rates also varied by state; for example, 20 states had vaccination coverage for one dose of MMR below 90%, with 6 having coverage above 94% (Arkansas, Maine, Massachusetts, Mississippi, Rhode Island, Wisconsin).

“Improvements in childhood vaccination coverage will require that parents and other caregivers have access to vaccination providers and believe in the safety and effectiveness of vaccines. Increased opportunity for vaccination can be facilitated through expanded access to health insurance, greater promotion of available vaccines through the Vaccines for Children program, and solutions to logistical challenges such as transportation, child care, and time off from work. Providers can improve vaccination coverage overall and reduce disparities by administering all recommended vaccines during office visits,” Dr. Hill and associates wrote.

No conflicts of interest were reported by the investigators of either study.

lfranki@mdedge.com

SOURCES: Seither R et al. MMWR Morb Mortal Wkly Rep 2019;68:905-12; Hill HA et al. MMWR Morb Mortal Wkly Rep 2019;68:913-8.

Vaccination rates among kindergartners during the 2018-2019 school year and children aged 24 months during 2016-2018 remained high, but several gaps in coverage remained, new research found.

MarianVejcik/Getty Images

The national vaccination rate for the almost 4 million kindergartners reported as enrolled in 2018-2019 was 94.9% for DTaP, 94.7% for 2 doses of MMR, and 94.8% for state-required doses of varicella. The MMR vaccination rate fell just short of the recommended 95% vaccination rate threshold, according to Ranee Seither, MPH, of the immunization services division at the National Center for Immunization and Respiratory Diseases (NCIRD), and associates.

By state, Mississippi had the highest vaccination rate, achieving at least 99.2% coverage for DTaP, MMR, and varicella. Colorado had the lowest vaccination rate for MMR and varicella at 87.4% and 86.5%, respectively; Idaho had the lowest DTaP vaccination rate at 88.8%.

A total of 20 states had at least 95% MMR coverage while 2 had under 90%, 21 states had at least 95% DTaP coverage with only Idaho having below 90%, and 20 states had at least 95% varicella coverage with 4 states having below 90%.

Nationally, 2.5% of kindergartners had an exemption from at least one vaccine, and 2.8% were not up to date for MMR and did not have a vaccine exemption. The investigators noted that, if all nonexempt kindergartners were vaccinated in accordance with local and state vaccination policies, nearly all states could achieve the 95% MMR vaccination threshold.

“Recent measles outbreaks in states with high overall MMR coverage, such as New York, highlight the need for assessing vaccination coverage at the local level. [The Centers for Disease Control and Prevention] encourage programs to use their local-level school assessment data to identify populations of undervaccinated students and to partner with schools and providers to reduce barriers to vaccination and improve coverage,” Dr. Seither and associates wrote.

In a study published in the same issue of the Morbidity and Mortality Weekly Report, Holly A. Hill, MD, PhD, and associates from the immunization services division at NCIRD, found that, according to data collected from 25,059 participants in the National Immunization Survey–Child, national vaccination coverage in children aged 24 months was generally strong and stable.

The vaccines with coverage of at least 90% were poliovirus (92.7%), MMR (90.4%), hepatitis B (91%), and varicella (90%). Complete hepatitis A (74%), rotavirus (72.4%), influenza (53%), and combined seven-vaccine series (68.4%) rates were below 80%. Only 1.3% of children received no vaccinations.

In general, the highest rates of coverage were seen in children with private insurance, followed by those with other insurance, those with Medicaid, and finally those without insurance. Disparities also were seen depending on race/ethnicity, poverty level, and rural/urban location. Vaccination rates also varied by state; for example, 20 states had vaccination coverage for one dose of MMR below 90%, with 6 having coverage above 94% (Arkansas, Maine, Massachusetts, Mississippi, Rhode Island, Wisconsin).

“Improvements in childhood vaccination coverage will require that parents and other caregivers have access to vaccination providers and believe in the safety and effectiveness of vaccines. Increased opportunity for vaccination can be facilitated through expanded access to health insurance, greater promotion of available vaccines through the Vaccines for Children program, and solutions to logistical challenges such as transportation, child care, and time off from work. Providers can improve vaccination coverage overall and reduce disparities by administering all recommended vaccines during office visits,” Dr. Hill and associates wrote.

No conflicts of interest were reported by the investigators of either study.

lfranki@mdedge.com

SOURCES: Seither R et al. MMWR Morb Mortal Wkly Rep 2019;68:905-12; Hill HA et al. MMWR Morb Mortal Wkly Rep 2019;68:913-8.

Gastroenterology

Pantoprazole to prevent gastroduodenal events in patients receiving rivaroxaban and/or aspirin in a randomized, double-blind, placebo-controlled trial. Moayyedi P et al. 2019 Aug;157(2):403-12. doi. org/10.1053/j.gastro.2019.04.04.



How to foster academic promotion and career advancement of women in gastroenterology. Zimmermann EM. 2019 Sep;157(3):598-601. doi: 10.1053/j.gastro.2019.07.041.



AGA Clinical Practice Guidelines on the laboratory evaluation of functional diarrhea and diarrhea-predominant irritable bowel syndrome in adults (IBS-D). Smalley W et al. 2019 Sep;157(3):851-4. doi: 10.1053/j.gastro.2019.07.004.



Gluten does not induce gastrointestinal symptoms in healthy volunteers: A double-blind randomized placebo trial. Croall ID et al. 2019 Sep;157(3):881-883. doi: 10.1053/j.gastro.2019.05.015.



How to advance research, education, and training in the study of rare diseases. Groft SC et al. 2019 Oct;157(4):917-21. doi. org/10.1053/j.gastro.2019.08.010.



Clip closure prevents bleeding after endoscopic resection of large colon polyps in a randomized trial. Pohl H et al. 2019 Oct;157(4):977-984.e3. doi: 10.1053/j.gastro.2019.03.019.


 

Clinical Gastroenterology and Hepatology

Fibroscan for the rest of us – How to incorporate Fibroscan into management of patients with liver disease. Sozio MS. 2019 Aug;17(9):1714-7 doi. org/10.1016/j.cgh.2019.02.014.



Physician practice management and private equity: Market forces drive change. Gilreath M et al. 2019 Sep;17(10):1924-8.e2. doi: 10.1016/j.cgh.2019.05.001.

Migration of patients for liver transplantation and waitlist outcomes. Kwong AJ et al. 2019 Oct;17(11):2347-55.e5. doi: 10.1016/j.cgh.2019.04.060.

Gastroenterology

Pantoprazole to prevent gastroduodenal events in patients receiving rivaroxaban and/or aspirin in a randomized, double-blind, placebo-controlled trial. Moayyedi P et al. 2019 Aug;157(2):403-12. doi. org/10.1053/j.gastro.2019.04.04.



How to foster academic promotion and career advancement of women in gastroenterology. Zimmermann EM. 2019 Sep;157(3):598-601. doi: 10.1053/j.gastro.2019.07.041.



AGA Clinical Practice Guidelines on the laboratory evaluation of functional diarrhea and diarrhea-predominant irritable bowel syndrome in adults (IBS-D). Smalley W et al. 2019 Sep;157(3):851-4. doi: 10.1053/j.gastro.2019.07.004.



Gluten does not induce gastrointestinal symptoms in healthy volunteers: A double-blind randomized placebo trial. Croall ID et al. 2019 Sep;157(3):881-883. doi: 10.1053/j.gastro.2019.05.015.



How to advance research, education, and training in the study of rare diseases. Groft SC et al. 2019 Oct;157(4):917-21. doi. org/10.1053/j.gastro.2019.08.010.



Clip closure prevents bleeding after endoscopic resection of large colon polyps in a randomized trial. Pohl H et al. 2019 Oct;157(4):977-984.e3. doi: 10.1053/j.gastro.2019.03.019.


 

Clinical Gastroenterology and Hepatology

Fibroscan for the rest of us – How to incorporate Fibroscan into management of patients with liver disease. Sozio MS. 2019 Aug;17(9):1714-7 doi. org/10.1016/j.cgh.2019.02.014.



Physician practice management and private equity: Market forces drive change. Gilreath M et al. 2019 Sep;17(10):1924-8.e2. doi: 10.1016/j.cgh.2019.05.001.

Migration of patients for liver transplantation and waitlist outcomes. Kwong AJ et al. 2019 Oct;17(11):2347-55.e5. doi: 10.1016/j.cgh.2019.04.060.

Gastroenterology

Pantoprazole to prevent gastroduodenal events in patients receiving rivaroxaban and/or aspirin in a randomized, double-blind, placebo-controlled trial. Moayyedi P et al. 2019 Aug;157(2):403-12. doi. org/10.1053/j.gastro.2019.04.04.



How to foster academic promotion and career advancement of women in gastroenterology. Zimmermann EM. 2019 Sep;157(3):598-601. doi: 10.1053/j.gastro.2019.07.041.



AGA Clinical Practice Guidelines on the laboratory evaluation of functional diarrhea and diarrhea-predominant irritable bowel syndrome in adults (IBS-D). Smalley W et al. 2019 Sep;157(3):851-4. doi: 10.1053/j.gastro.2019.07.004.



Gluten does not induce gastrointestinal symptoms in healthy volunteers: A double-blind randomized placebo trial. Croall ID et al. 2019 Sep;157(3):881-883. doi: 10.1053/j.gastro.2019.05.015.



How to advance research, education, and training in the study of rare diseases. Groft SC et al. 2019 Oct;157(4):917-21. doi. org/10.1053/j.gastro.2019.08.010.



Clip closure prevents bleeding after endoscopic resection of large colon polyps in a randomized trial. Pohl H et al. 2019 Oct;157(4):977-984.e3. doi: 10.1053/j.gastro.2019.03.019.


 

Clinical Gastroenterology and Hepatology

Fibroscan for the rest of us – How to incorporate Fibroscan into management of patients with liver disease. Sozio MS. 2019 Aug;17(9):1714-7 doi. org/10.1016/j.cgh.2019.02.014.



Physician practice management and private equity: Market forces drive change. Gilreath M et al. 2019 Sep;17(10):1924-8.e2. doi: 10.1016/j.cgh.2019.05.001.

Migration of patients for liver transplantation and waitlist outcomes. Kwong AJ et al. 2019 Oct;17(11):2347-55.e5. doi: 10.1016/j.cgh.2019.04.060.

PHILADELPHIA – Factors such as primary fibroid volume, fibroid stage, and uterine volume did not appear to affect the efficacy of elagolix in improving heavy menstrual bleeding associated with uterine fibroids, according to results presented at the annual meeting of the American Society for Reproductive Medicine.

Ayman Al-Hendy, MD, PhD, director of translational research at the University of Illinois at Chicago, and associates, analyzed a pooled subgroup of 790 patients from the Elaris UF-1 and UF-2 trials who received elagolix twice daily at a dose of 300 mg (199 patients), elagolix 300 mg twice daily with add-back therapy (1 mg of estradiol plus 0.5 mg of norethindrone acetate; 395 patients), and a placebo group (196 patients) for treatment of heavy menstrual bleeding. Patients were premenopausal women aged 18-51 years with more than 80 mL of menstrual blood loss per cycle. The study design included a washout period, followed by a 2.5-month to 3.5-month screening period, and patients were randomized to 6 months of treatment with placebo, elagolix alone, or elagolix with add-back therapy in a 1:1:2 ratio. Researchers evaluated whether patients had less than 80 mL of menstrual blood loss per cycle and a 50% or more reduction in menstrual blood loss per cycle by the end of the study.

In a subgroup analysis, they also analyzed primary fibroid volume, fibroid stage, and uterine volume. The median primary fibroid volume was 36.2 cm³ (range, 1.0-1,081.5 cm³). Fibroid location was classified using the International Federation of Gynecology and Obstetrics (FIGO) staging system, and researchers placed fibroids into FIGO 0-3, FIGO 4, and FIGO 5-8 groups. At baseline, characteristics between groups were similar, but the patients who received elagolix alone had a lower number of fibroids classified as FIGO 0-3 and had a greater percentage of fibroids less than 36.2 cm³. The median uterine volume was 356.5 cm³ (range, 71.6-3,347.9 cm³).

At final follow-up, 81% of patients receiving elagolix alone and 72% of patients receiving elagolix with add-back therapy responded to treatment, compared with placebo (9%).

Patients receiving elagolix plus add-back therapy responded to treatment better than placebo, and there were no significant differences in outcomes in terms of FIGO stage: Response was as follows for patients with FIGO 0-3 classified fibroids (78% of 47 patients vs. 9% of 25 patients), FIGO 4 fibroids (68% of 177 patients vs. 15% of 85 patients) and FIGO 5-8 fibroids (74% of 165 patients vs. 4% of 82 patients). The same was true in terms of both primary fibroid volume and uterine volume in patients who received elagolix plus add-back therapy, compared with those who received placebo: Patients with a primary fibroid volume of less than 36.2 cm³ (74% of 189 patients vs. 15% of 92 patients) responded similarly to elagolix plus add-back therapy as did patients with a primary fibroid volume greater than 36.2 cm³ (70% of 200 patients vs. 5% of 100 patients), and there were no significant differences between the treatment response of patients with a uterine volume less than 365.5 cm³ (75% of 203 patients vs. 15% of 88 patients) and a uterine volume greater than 365.5 cm³ (70% of 192 patients vs. 5% of 108 patients).

“These really are very encouraging results and suggests that, in women with different fibroids, elagolix with add-back therapy would be an effective treatment option despite uterine and fibroid volume and location of fibroids,” said Dr. Al-Hendy.

Dr. Al-Hendy noted there are ongoing studies analyzing elagolix with add-back in women with fibroids, in women with endometriosis, and elagolix in women with polycystic ovary syndrome.

AbbVie recently submitted a new drug application to the Food and Drug Administration for elagolix based on results from these two trials. Elagolix, an oral GnRh receptor antagonist, is an FDA-approved oral medication for the management of endometriosis with associated moderate to severe pain.

This study was funded by AbbVie, and the company was involved in the study design, research, data collection, analysis and interpretation of the data, as well as the writing, reviewing and approving of the study for publication. The authors reported various relationships with industry, pharmaceutical companies, government entities, and other organizations.
 

SOURCE: Al-Hendy A et al. ASRM 2019, Abstract O-205.

PHILADELPHIA – Factors such as primary fibroid volume, fibroid stage, and uterine volume did not appear to affect the efficacy of elagolix in improving heavy menstrual bleeding associated with uterine fibroids, according to results presented at the annual meeting of the American Society for Reproductive Medicine.

Ayman Al-Hendy, MD, PhD, director of translational research at the University of Illinois at Chicago, and associates, analyzed a pooled subgroup of 790 patients from the Elaris UF-1 and UF-2 trials who received elagolix twice daily at a dose of 300 mg (199 patients), elagolix 300 mg twice daily with add-back therapy (1 mg of estradiol plus 0.5 mg of norethindrone acetate; 395 patients), and a placebo group (196 patients) for treatment of heavy menstrual bleeding. Patients were premenopausal women aged 18-51 years with more than 80 mL of menstrual blood loss per cycle. The study design included a washout period, followed by a 2.5-month to 3.5-month screening period, and patients were randomized to 6 months of treatment with placebo, elagolix alone, or elagolix with add-back therapy in a 1:1:2 ratio. Researchers evaluated whether patients had less than 80 mL of menstrual blood loss per cycle and a 50% or more reduction in menstrual blood loss per cycle by the end of the study.

In a subgroup analysis, they also analyzed primary fibroid volume, fibroid stage, and uterine volume. The median primary fibroid volume was 36.2 cm³ (range, 1.0-1,081.5 cm³). Fibroid location was classified using the International Federation of Gynecology and Obstetrics (FIGO) staging system, and researchers placed fibroids into FIGO 0-3, FIGO 4, and FIGO 5-8 groups. At baseline, characteristics between groups were similar, but the patients who received elagolix alone had a lower number of fibroids classified as FIGO 0-3 and had a greater percentage of fibroids less than 36.2 cm³. The median uterine volume was 356.5 cm³ (range, 71.6-3,347.9 cm³).

At final follow-up, 81% of patients receiving elagolix alone and 72% of patients receiving elagolix with add-back therapy responded to treatment, compared with placebo (9%).

Patients receiving elagolix plus add-back therapy responded to treatment better than placebo, and there were no significant differences in outcomes in terms of FIGO stage: Response was as follows for patients with FIGO 0-3 classified fibroids (78% of 47 patients vs. 9% of 25 patients), FIGO 4 fibroids (68% of 177 patients vs. 15% of 85 patients) and FIGO 5-8 fibroids (74% of 165 patients vs. 4% of 82 patients). The same was true in terms of both primary fibroid volume and uterine volume in patients who received elagolix plus add-back therapy, compared with those who received placebo: Patients with a primary fibroid volume of less than 36.2 cm³ (74% of 189 patients vs. 15% of 92 patients) responded similarly to elagolix plus add-back therapy as did patients with a primary fibroid volume greater than 36.2 cm³ (70% of 200 patients vs. 5% of 100 patients), and there were no significant differences between the treatment response of patients with a uterine volume less than 365.5 cm³ (75% of 203 patients vs. 15% of 88 patients) and a uterine volume greater than 365.5 cm³ (70% of 192 patients vs. 5% of 108 patients).

“These really are very encouraging results and suggests that, in women with different fibroids, elagolix with add-back therapy would be an effective treatment option despite uterine and fibroid volume and location of fibroids,” said Dr. Al-Hendy.

Dr. Al-Hendy noted there are ongoing studies analyzing elagolix with add-back in women with fibroids, in women with endometriosis, and elagolix in women with polycystic ovary syndrome.

AbbVie recently submitted a new drug application to the Food and Drug Administration for elagolix based on results from these two trials. Elagolix, an oral GnRh receptor antagonist, is an FDA-approved oral medication for the management of endometriosis with associated moderate to severe pain.

This study was funded by AbbVie, and the company was involved in the study design, research, data collection, analysis and interpretation of the data, as well as the writing, reviewing and approving of the study for publication. The authors reported various relationships with industry, pharmaceutical companies, government entities, and other organizations.
 

SOURCE: Al-Hendy A et al. ASRM 2019, Abstract O-205.

PHILADELPHIA – Factors such as primary fibroid volume, fibroid stage, and uterine volume did not appear to affect the efficacy of elagolix in improving heavy menstrual bleeding associated with uterine fibroids, according to results presented at the annual meeting of the American Society for Reproductive Medicine.

Ayman Al-Hendy, MD, PhD, director of translational research at the University of Illinois at Chicago, and associates, analyzed a pooled subgroup of 790 patients from the Elaris UF-1 and UF-2 trials who received elagolix twice daily at a dose of 300 mg (199 patients), elagolix 300 mg twice daily with add-back therapy (1 mg of estradiol plus 0.5 mg of norethindrone acetate; 395 patients), and a placebo group (196 patients) for treatment of heavy menstrual bleeding. Patients were premenopausal women aged 18-51 years with more than 80 mL of menstrual blood loss per cycle. The study design included a washout period, followed by a 2.5-month to 3.5-month screening period, and patients were randomized to 6 months of treatment with placebo, elagolix alone, or elagolix with add-back therapy in a 1:1:2 ratio. Researchers evaluated whether patients had less than 80 mL of menstrual blood loss per cycle and a 50% or more reduction in menstrual blood loss per cycle by the end of the study.

In a subgroup analysis, they also analyzed primary fibroid volume, fibroid stage, and uterine volume. The median primary fibroid volume was 36.2 cm³ (range, 1.0-1,081.5 cm³). Fibroid location was classified using the International Federation of Gynecology and Obstetrics (FIGO) staging system, and researchers placed fibroids into FIGO 0-3, FIGO 4, and FIGO 5-8 groups. At baseline, characteristics between groups were similar, but the patients who received elagolix alone had a lower number of fibroids classified as FIGO 0-3 and had a greater percentage of fibroids less than 36.2 cm³. The median uterine volume was 356.5 cm³ (range, 71.6-3,347.9 cm³).

At final follow-up, 81% of patients receiving elagolix alone and 72% of patients receiving elagolix with add-back therapy responded to treatment, compared with placebo (9%).

Patients receiving elagolix plus add-back therapy responded to treatment better than placebo, and there were no significant differences in outcomes in terms of FIGO stage: Response was as follows for patients with FIGO 0-3 classified fibroids (78% of 47 patients vs. 9% of 25 patients), FIGO 4 fibroids (68% of 177 patients vs. 15% of 85 patients) and FIGO 5-8 fibroids (74% of 165 patients vs. 4% of 82 patients). The same was true in terms of both primary fibroid volume and uterine volume in patients who received elagolix plus add-back therapy, compared with those who received placebo: Patients with a primary fibroid volume of less than 36.2 cm³ (74% of 189 patients vs. 15% of 92 patients) responded similarly to elagolix plus add-back therapy as did patients with a primary fibroid volume greater than 36.2 cm³ (70% of 200 patients vs. 5% of 100 patients), and there were no significant differences between the treatment response of patients with a uterine volume less than 365.5 cm³ (75% of 203 patients vs. 15% of 88 patients) and a uterine volume greater than 365.5 cm³ (70% of 192 patients vs. 5% of 108 patients).

“These really are very encouraging results and suggests that, in women with different fibroids, elagolix with add-back therapy would be an effective treatment option despite uterine and fibroid volume and location of fibroids,” said Dr. Al-Hendy.

Dr. Al-Hendy noted there are ongoing studies analyzing elagolix with add-back in women with fibroids, in women with endometriosis, and elagolix in women with polycystic ovary syndrome.

AbbVie recently submitted a new drug application to the Food and Drug Administration for elagolix based on results from these two trials. Elagolix, an oral GnRh receptor antagonist, is an FDA-approved oral medication for the management of endometriosis with associated moderate to severe pain.

This study was funded by AbbVie, and the company was involved in the study design, research, data collection, analysis and interpretation of the data, as well as the writing, reviewing and approving of the study for publication. The authors reported various relationships with industry, pharmaceutical companies, government entities, and other organizations.
 

SOURCE: Al-Hendy A et al. ASRM 2019, Abstract O-205.

I love empty storefronts. The realtor headshot in the window is a sign of hope. What was here is no more. What is coming will be better.

anyaberkut/Getty Images

I’ve waited a year for one such sign to come down and scaffolding to go up. Just one block from my condo, my curiosity has been slaked: a yoga studio! At first, disappointment; so many potentials unrealized: a coffee shop, cleaners, speakeasy! Yet, I decided to make the best of it. I bought Rainbow sandals, a Lululemon mat, and a pack of 10 classes. As it turns out, yoga can transform your life.

I didn’t realize how beautifully yoga combines physical exertion, meditation, and spirituality. It is both a model for understanding and a ritualistic training for life. Take resting pigeon for example. (Yogis reading this will forgive my imperfect explanation.) This moderately difficult pose opens your hip and stretches your glutes. Imagine doing a split but with your front knee bent and your forehead and arms resting on the floor in front of you. Done correctly, it puts a stretch deep into the hip of the forward leg. It is uncomfortable. Holding it for a minute or 2 is hard. But rather than just focusing on releasing, with each breath you find yourself deepening the stretch. Sweat streams down your arms and the discomfort builds as you hold. All you can think about is your breath. Then, it’s over. You feel freer, lighter than you were before. The deeper the discomfort, the deeper the delight that arises afterward. You are wise, yogis would say, to have chosen “the good over the pleasant.”

We have many opportunities for resting pigeon in everyday life. The patient to be added to your Monday morning clinic – which already had added patients. The Friday afternoon Mohs case that went to periosteum and still needs a flap to close. The “yet another” GI bleed patient that needs to be scoped tonight. These are all deep stretches, uncomfortable hip openings. Part of what I learned from yoga is to not give in to fear of what is ahead. Rather, when you must be uncomfortable, breathe and lean into it. Choosing the good sometimes means choosing suffering, but it isn’t the pain that makes it hard to bear. It is a lack of significance for that difficulty. By choosing what is good, you answer the question: “Who am I?” I am the one able and willing to endure inconvenience or disquiet to help others. This is my job, what I’m here to do. The pose, the call, the case will be over quickly. The freedom you feel after, along with the satisfaction you have served your purpose, will sustain you.

There are many poses and endless lessons from yoga. In fact, doing yoga is called “practicing.” Each time you learn and try. Each time you are imperfect and uncomfortable and reemerge sweaty and satisfied, just a little better human than you were before.
 

Dr. Benabio is director of health care transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

I love empty storefronts. The realtor headshot in the window is a sign of hope. What was here is no more. What is coming will be better.

anyaberkut/Getty Images

I’ve waited a year for one such sign to come down and scaffolding to go up. Just one block from my condo, my curiosity has been slaked: a yoga studio! At first, disappointment; so many potentials unrealized: a coffee shop, cleaners, speakeasy! Yet, I decided to make the best of it. I bought Rainbow sandals, a Lululemon mat, and a pack of 10 classes. As it turns out, yoga can transform your life.

I didn’t realize how beautifully yoga combines physical exertion, meditation, and spirituality. It is both a model for understanding and a ritualistic training for life. Take resting pigeon for example. (Yogis reading this will forgive my imperfect explanation.) This moderately difficult pose opens your hip and stretches your glutes. Imagine doing a split but with your front knee bent and your forehead and arms resting on the floor in front of you. Done correctly, it puts a stretch deep into the hip of the forward leg. It is uncomfortable. Holding it for a minute or 2 is hard. But rather than just focusing on releasing, with each breath you find yourself deepening the stretch. Sweat streams down your arms and the discomfort builds as you hold. All you can think about is your breath. Then, it’s over. You feel freer, lighter than you were before. The deeper the discomfort, the deeper the delight that arises afterward. You are wise, yogis would say, to have chosen “the good over the pleasant.”

We have many opportunities for resting pigeon in everyday life. The patient to be added to your Monday morning clinic – which already had added patients. The Friday afternoon Mohs case that went to periosteum and still needs a flap to close. The “yet another” GI bleed patient that needs to be scoped tonight. These are all deep stretches, uncomfortable hip openings. Part of what I learned from yoga is to not give in to fear of what is ahead. Rather, when you must be uncomfortable, breathe and lean into it. Choosing the good sometimes means choosing suffering, but it isn’t the pain that makes it hard to bear. It is a lack of significance for that difficulty. By choosing what is good, you answer the question: “Who am I?” I am the one able and willing to endure inconvenience or disquiet to help others. This is my job, what I’m here to do. The pose, the call, the case will be over quickly. The freedom you feel after, along with the satisfaction you have served your purpose, will sustain you.

There are many poses and endless lessons from yoga. In fact, doing yoga is called “practicing.” Each time you learn and try. Each time you are imperfect and uncomfortable and reemerge sweaty and satisfied, just a little better human than you were before.
 

Dr. Benabio is director of health care transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

I love empty storefronts. The realtor headshot in the window is a sign of hope. What was here is no more. What is coming will be better.

anyaberkut/Getty Images

I’ve waited a year for one such sign to come down and scaffolding to go up. Just one block from my condo, my curiosity has been slaked: a yoga studio! At first, disappointment; so many potentials unrealized: a coffee shop, cleaners, speakeasy! Yet, I decided to make the best of it. I bought Rainbow sandals, a Lululemon mat, and a pack of 10 classes. As it turns out, yoga can transform your life.

I didn’t realize how beautifully yoga combines physical exertion, meditation, and spirituality. It is both a model for understanding and a ritualistic training for life. Take resting pigeon for example. (Yogis reading this will forgive my imperfect explanation.) This moderately difficult pose opens your hip and stretches your glutes. Imagine doing a split but with your front knee bent and your forehead and arms resting on the floor in front of you. Done correctly, it puts a stretch deep into the hip of the forward leg. It is uncomfortable. Holding it for a minute or 2 is hard. But rather than just focusing on releasing, with each breath you find yourself deepening the stretch. Sweat streams down your arms and the discomfort builds as you hold. All you can think about is your breath. Then, it’s over. You feel freer, lighter than you were before. The deeper the discomfort, the deeper the delight that arises afterward. You are wise, yogis would say, to have chosen “the good over the pleasant.”

We have many opportunities for resting pigeon in everyday life. The patient to be added to your Monday morning clinic – which already had added patients. The Friday afternoon Mohs case that went to periosteum and still needs a flap to close. The “yet another” GI bleed patient that needs to be scoped tonight. These are all deep stretches, uncomfortable hip openings. Part of what I learned from yoga is to not give in to fear of what is ahead. Rather, when you must be uncomfortable, breathe and lean into it. Choosing the good sometimes means choosing suffering, but it isn’t the pain that makes it hard to bear. It is a lack of significance for that difficulty. By choosing what is good, you answer the question: “Who am I?” I am the one able and willing to endure inconvenience or disquiet to help others. This is my job, what I’m here to do. The pose, the call, the case will be over quickly. The freedom you feel after, along with the satisfaction you have served your purpose, will sustain you.

There are many poses and endless lessons from yoga. In fact, doing yoga is called “practicing.” Each time you learn and try. Each time you are imperfect and uncomfortable and reemerge sweaty and satisfied, just a little better human than you were before.
 

Dr. Benabio is director of health care transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at dermnews@mdedge.com.

PHILADELPHIA – Women with ovarian torsion had a lower rate of perioperative complications when treated with conservative surgery, compared with oophorectomy, according to results from a retrospective study presented at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

The effectiveness of laparoscopy and conservative surgery has increased in recent years, but over 75% of women with ovarian torsion in the study were treated with oophorectomy and 60% underwent a laparotomy, said Rachel S. Mandelbaum, MD, of the department of obstetrics & gynecology at the University of Southern California, Los Angeles.

“We believe that conservative surgery should be performed whenever possible in young women with ovarian torsion regardless of the appearance of the ovary intraoperatively,” said Dr. Mandelbaum.

The researchers performed a retrospective, observational study of 89,801 women in the Nationwide Inpatient Sample who were younger than age 50 years, were diagnosed with ovarian torsion during Jan. 2001–Sept. 2015, and were treated with conservative surgery or oophorectomy. Patients were excluded if they had malignancy, were older than 50 years of age, or their surgery information was unavailable. The majority of patients in the study were white (46%), nonobese (91%), without comorbidities, privately insured (59%), and were seen at a large (61%) urban hospital (51% teaching; 38% nonteaching).

Dr. Mandelbaum and colleagues found 78% of patients received a cystectomy, 19% had cyst drainage, 11% had detorsion alone, and 0.5% had an oophoropexy, with less than 10% of patients having a combination of cystectomy, cyst drainage, and oophoropexy. According to a multivariable analysis, patients who were treated with conservative surgery were more likely to be young, have a high income, live in the northeastern United States, be treated with laparoscopy, and be seen at a large hospital or teaching hospital (P less than .001). Oophorectomy was more common in patients with a high number of comorbidities and in patients with morbid obesity (P less than .001).

Between 2001 and 2015, the rate of conservative surgery increased from 19% to 25% (P less than .001); however, the rate of conservative surgery by age was nearly 40% in pediatric patients up to 15 years old, while the rate of conservative surgery declined by almost half until 35 years, followed by a further decline until age 50 years, said Dr. Mandelbaum. Use of laparoscopy also increased from 31% in 2001 to 42% in 2015 (P less than .001).

Overall, 20,643 patients underwent conservative surgery and 69,157 patients received an oophorectomy. Patients in the conservative surgery group were more likely to undergo a conservative surgery with a laparoscopic surgical approach (51%) than a laparotomy (41%), while patients receiving an oophorectomy were more likely to have a laparotomy (67%) than a laparoscopic surgical approach (33%). In 1,663 conservative surgeries (8%), the approach was unknown.

Postoperative complications were higher in the oophorectomy group (12%) than the conservative surgery (8%) group (odds ratio, 0.57; 95% confidence interval, 0.57-0.78; P less than .001), but there was a similar rate of venous thromboembolism (0.3% vs. 0.2%; P equals .568) and sepsis (0.3% vs. 0.3%; P equals .865) in each group.

Dr. Mandelbaum attributed the high rate of oophorectomies in the study to “differential uptake of evidence” in different areas of the United States, fear of complications from leaving an infected ovary in situ, or the surgeon’s belief that the ovary is not viable because of its color intraoperatively. “We know from animal and human studies that the intraoperative appearance of the ovary does not correlate to viability, and that 90% of black or blue ovaries regain function and subsequently appear normal on both transvaginal ultrasound or on a second look grossly,” she said. Oophorectomy rates also vary by surgeon, and gynecologists are more likely to perform conservative surgery, she added.

The researchers said they were unable to obtain data on specific surgical variables such as the size of the mass, time to surgery, intraoperative appearance, laterality, fertility wishes of the patient, and surgeon type. There were also no postdischarge data, or information on the timing of complications.

Dr. Mandelbaum reported no relevant conflicts of interest.

SOURCE: Mandelbaum RS et al. ASRM 2019. Abstract O-96.

PHILADELPHIA – Women with ovarian torsion had a lower rate of perioperative complications when treated with conservative surgery, compared with oophorectomy, according to results from a retrospective study presented at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

The effectiveness of laparoscopy and conservative surgery has increased in recent years, but over 75% of women with ovarian torsion in the study were treated with oophorectomy and 60% underwent a laparotomy, said Rachel S. Mandelbaum, MD, of the department of obstetrics & gynecology at the University of Southern California, Los Angeles.

“We believe that conservative surgery should be performed whenever possible in young women with ovarian torsion regardless of the appearance of the ovary intraoperatively,” said Dr. Mandelbaum.

The researchers performed a retrospective, observational study of 89,801 women in the Nationwide Inpatient Sample who were younger than age 50 years, were diagnosed with ovarian torsion during Jan. 2001–Sept. 2015, and were treated with conservative surgery or oophorectomy. Patients were excluded if they had malignancy, were older than 50 years of age, or their surgery information was unavailable. The majority of patients in the study were white (46%), nonobese (91%), without comorbidities, privately insured (59%), and were seen at a large (61%) urban hospital (51% teaching; 38% nonteaching).

Dr. Mandelbaum and colleagues found 78% of patients received a cystectomy, 19% had cyst drainage, 11% had detorsion alone, and 0.5% had an oophoropexy, with less than 10% of patients having a combination of cystectomy, cyst drainage, and oophoropexy. According to a multivariable analysis, patients who were treated with conservative surgery were more likely to be young, have a high income, live in the northeastern United States, be treated with laparoscopy, and be seen at a large hospital or teaching hospital (P less than .001). Oophorectomy was more common in patients with a high number of comorbidities and in patients with morbid obesity (P less than .001).

Between 2001 and 2015, the rate of conservative surgery increased from 19% to 25% (P less than .001); however, the rate of conservative surgery by age was nearly 40% in pediatric patients up to 15 years old, while the rate of conservative surgery declined by almost half until 35 years, followed by a further decline until age 50 years, said Dr. Mandelbaum. Use of laparoscopy also increased from 31% in 2001 to 42% in 2015 (P less than .001).

Overall, 20,643 patients underwent conservative surgery and 69,157 patients received an oophorectomy. Patients in the conservative surgery group were more likely to undergo a conservative surgery with a laparoscopic surgical approach (51%) than a laparotomy (41%), while patients receiving an oophorectomy were more likely to have a laparotomy (67%) than a laparoscopic surgical approach (33%). In 1,663 conservative surgeries (8%), the approach was unknown.

Postoperative complications were higher in the oophorectomy group (12%) than the conservative surgery (8%) group (odds ratio, 0.57; 95% confidence interval, 0.57-0.78; P less than .001), but there was a similar rate of venous thromboembolism (0.3% vs. 0.2%; P equals .568) and sepsis (0.3% vs. 0.3%; P equals .865) in each group.

Dr. Mandelbaum attributed the high rate of oophorectomies in the study to “differential uptake of evidence” in different areas of the United States, fear of complications from leaving an infected ovary in situ, or the surgeon’s belief that the ovary is not viable because of its color intraoperatively. “We know from animal and human studies that the intraoperative appearance of the ovary does not correlate to viability, and that 90% of black or blue ovaries regain function and subsequently appear normal on both transvaginal ultrasound or on a second look grossly,” she said. Oophorectomy rates also vary by surgeon, and gynecologists are more likely to perform conservative surgery, she added.

The researchers said they were unable to obtain data on specific surgical variables such as the size of the mass, time to surgery, intraoperative appearance, laterality, fertility wishes of the patient, and surgeon type. There were also no postdischarge data, or information on the timing of complications.

Dr. Mandelbaum reported no relevant conflicts of interest.

SOURCE: Mandelbaum RS et al. ASRM 2019. Abstract O-96.

PHILADELPHIA – Women with ovarian torsion had a lower rate of perioperative complications when treated with conservative surgery, compared with oophorectomy, according to results from a retrospective study presented at the annual meeting of the American Society for Reproductive Medicine.

Jeff Craven/MDedge News

The effectiveness of laparoscopy and conservative surgery has increased in recent years, but over 75% of women with ovarian torsion in the study were treated with oophorectomy and 60% underwent a laparotomy, said Rachel S. Mandelbaum, MD, of the department of obstetrics & gynecology at the University of Southern California, Los Angeles.

“We believe that conservative surgery should be performed whenever possible in young women with ovarian torsion regardless of the appearance of the ovary intraoperatively,” said Dr. Mandelbaum.

The researchers performed a retrospective, observational study of 89,801 women in the Nationwide Inpatient Sample who were younger than age 50 years, were diagnosed with ovarian torsion during Jan. 2001–Sept. 2015, and were treated with conservative surgery or oophorectomy. Patients were excluded if they had malignancy, were older than 50 years of age, or their surgery information was unavailable. The majority of patients in the study were white (46%), nonobese (91%), without comorbidities, privately insured (59%), and were seen at a large (61%) urban hospital (51% teaching; 38% nonteaching).

Dr. Mandelbaum and colleagues found 78% of patients received a cystectomy, 19% had cyst drainage, 11% had detorsion alone, and 0.5% had an oophoropexy, with less than 10% of patients having a combination of cystectomy, cyst drainage, and oophoropexy. According to a multivariable analysis, patients who were treated with conservative surgery were more likely to be young, have a high income, live in the northeastern United States, be treated with laparoscopy, and be seen at a large hospital or teaching hospital (P less than .001). Oophorectomy was more common in patients with a high number of comorbidities and in patients with morbid obesity (P less than .001).

Between 2001 and 2015, the rate of conservative surgery increased from 19% to 25% (P less than .001); however, the rate of conservative surgery by age was nearly 40% in pediatric patients up to 15 years old, while the rate of conservative surgery declined by almost half until 35 years, followed by a further decline until age 50 years, said Dr. Mandelbaum. Use of laparoscopy also increased from 31% in 2001 to 42% in 2015 (P less than .001).

Overall, 20,643 patients underwent conservative surgery and 69,157 patients received an oophorectomy. Patients in the conservative surgery group were more likely to undergo a conservative surgery with a laparoscopic surgical approach (51%) than a laparotomy (41%), while patients receiving an oophorectomy were more likely to have a laparotomy (67%) than a laparoscopic surgical approach (33%). In 1,663 conservative surgeries (8%), the approach was unknown.

Postoperative complications were higher in the oophorectomy group (12%) than the conservative surgery (8%) group (odds ratio, 0.57; 95% confidence interval, 0.57-0.78; P less than .001), but there was a similar rate of venous thromboembolism (0.3% vs. 0.2%; P equals .568) and sepsis (0.3% vs. 0.3%; P equals .865) in each group.

Dr. Mandelbaum attributed the high rate of oophorectomies in the study to “differential uptake of evidence” in different areas of the United States, fear of complications from leaving an infected ovary in situ, or the surgeon’s belief that the ovary is not viable because of its color intraoperatively. “We know from animal and human studies that the intraoperative appearance of the ovary does not correlate to viability, and that 90% of black or blue ovaries regain function and subsequently appear normal on both transvaginal ultrasound or on a second look grossly,” she said. Oophorectomy rates also vary by surgeon, and gynecologists are more likely to perform conservative surgery, she added.

The researchers said they were unable to obtain data on specific surgical variables such as the size of the mass, time to surgery, intraoperative appearance, laterality, fertility wishes of the patient, and surgeon type. There were also no postdischarge data, or information on the timing of complications.

Dr. Mandelbaum reported no relevant conflicts of interest.

SOURCE: Mandelbaum RS et al. ASRM 2019. Abstract O-96.

AUSTIN, TEX. – Among patients with acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis, rituximab and placebo may have a similar glucocorticoid-sparing effect regardless of disease severity, according to research presented at the annual meeting of the American Association of Neuromuscular and Electrodiagnostic Medicine.

Jake Remaly/MDedge News

B Cell Targeted Treatment In Myasthenia Gravis (BeatMG) was a 52-week, randomized, double-blind, placebo-controlled clinical trial. The phase 2 study’s primary outcomes were safety and the glucocorticoid-sparing effect assessed by the percentage of patients who reduced their mean daily prednisone dose by at least 75% and maintained clinical stability. Secondary outcomes were change in Myasthenia Gravis Composite (MGC) score and change in Quantitative Myasthenia Gravis (QMG) score from baseline to 52 weeks.

Investigators randomized 52 participants 1:1 to rituximab (Rituxan) or placebo. Patients were taking at least 15 mg/day of prednisone and were a mean of about age 50 years. About two-thirds were treated with glucocorticoids alone at baseline, and nearly two-thirds had a Myasthenia Gravis Foundation of America (MGFA) clinical classification of II. “It was a mildly symptomatic group of individuals in terms of disease severity,” said Richard Nowak, MD, assistant professor of neurology and director of the Yale Myasthenia Gravis Clinic in New Haven, Conn.

During the study, 60% of patients who received rituximab had a 75% or greater reduction in their mean daily prednisone dose and maintained clinical stability. “However, what surprised us is that we had a significantly high placebo response rate of 56%,” he said. The difference between groups was not significant.

Patients who received rituximab had “directionally favorable reductions” in MGC and QMG scores over 52 weeks, compared with patients who received placebo. Nevertheless, “after correcting for baseline differences, there was no significant difference between the two groups,” Dr. Nowak said.

Rituximab had good safety and tolerability, and the placebo group had a threefold higher rate of clinical relapse requiring IV immunoglobulin or plasmapheresis. “While the placebo arm did achieve a similar rate of reduction in their steroid dose, at 52 weeks the patients may have been doing less well, reflected by the higher rate of relapse,” he said.

Subgroup analysis

To explore whether rituximab might benefit patients who were treatment resistant or had more symptomatic disease, Dr. Nowak and his colleagues conducted a post hoc subgroup analysis of 20 participants – 10 in the rituximab arm and 10 in the placebo arm – who were MGFA class III-IV. In each group, 70% were on glucocorticoid treatment alone, and 90% were MGFA class III.

As in the overall study, the glucocorticoid-sparing effect was not significant (60% of the rituximab group vs. 50% of the placebo group).

Mean change in QMG score was –3.9 in the rituximab group and –0.5 in the placebo group, and mean change in MGC score was –7.0 in the rituximab group and –4.8 in the placebo group. These secondary outcomes again show “directional favorability” with rituximab, Dr. Nowak said. The researchers saw similar trends for scores that assess quality of life and activities of daily living.

In the subgroup analysis, myasthenia gravis relapses requiring rescue therapy occurred in 20% of patients in the rituximab arm and in 30% of the placebo arm. Overall, the researchers did not see a difference in treatment response between those with moderate to severe disease and those with mild disease, Dr. Nowak said.

Suggestions from the data

The post hoc subgroup analysis should be interpreted with caution, and the study does not provide firm conclusions, Dr. Nowak noted. In addition, the trial population does not reflect all patients with myasthenia gravis. Dr. Nowak routinely uses rituximab in patients with muscle-specific kinase antibody-positive disease, he said. For acetylcholine receptor antibody-positive generalized myasthenia gravis, which has approved therapies available, Dr. Nowak presents rituximab as an option for some patients. Further research may clarify where B-cell depletion therapy may fit into the treatment paradigm.

Nonetheless, BeatMG and the subgroup analysis may help physicians better understand the disease and the role of various therapies. Investigators successfully lowered prednisone dose “at a pretty high rate in the placebo arm,” he said. “It suggests that many of our patients potentially may be on higher than required prednisone doses.”

Finally, the BeatMG findings emphasize the need for placebo-controlled trials to understand potential therapies. “We need to pause when we see a lot of retrospective and uncontrolled studies that are very promising,” Dr. Nowak said.

The study was supported by the National Institute of Neurological Disorders and Stroke. Genentech provided the study drug and placebo through an investigator-sponsored study agreement. Dr. Nowak has received research support from Alexion Pharmaceuticals, Genentech, Grifols, and Ra Pharmaceuticals. He has served as a paid consultant for Alexion, Momenta, Ra, Roivant, Shire, Grifols, and CSL Behring.

jremaly@mdedge.com

SOURCE: Nowak R et al. AANEM 2019. Unnumbered Abstract: Rituximab in patients with moderate to severe myasthenia gravis: a subgroup analysis of the BeatMG study

AUSTIN, TEX. – Among patients with acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis, rituximab and placebo may have a similar glucocorticoid-sparing effect regardless of disease severity, according to research presented at the annual meeting of the American Association of Neuromuscular and Electrodiagnostic Medicine.

Jake Remaly/MDedge News

B Cell Targeted Treatment In Myasthenia Gravis (BeatMG) was a 52-week, randomized, double-blind, placebo-controlled clinical trial. The phase 2 study’s primary outcomes were safety and the glucocorticoid-sparing effect assessed by the percentage of patients who reduced their mean daily prednisone dose by at least 75% and maintained clinical stability. Secondary outcomes were change in Myasthenia Gravis Composite (MGC) score and change in Quantitative Myasthenia Gravis (QMG) score from baseline to 52 weeks.

Investigators randomized 52 participants 1:1 to rituximab (Rituxan) or placebo. Patients were taking at least 15 mg/day of prednisone and were a mean of about age 50 years. About two-thirds were treated with glucocorticoids alone at baseline, and nearly two-thirds had a Myasthenia Gravis Foundation of America (MGFA) clinical classification of II. “It was a mildly symptomatic group of individuals in terms of disease severity,” said Richard Nowak, MD, assistant professor of neurology and director of the Yale Myasthenia Gravis Clinic in New Haven, Conn.

During the study, 60% of patients who received rituximab had a 75% or greater reduction in their mean daily prednisone dose and maintained clinical stability. “However, what surprised us is that we had a significantly high placebo response rate of 56%,” he said. The difference between groups was not significant.

Patients who received rituximab had “directionally favorable reductions” in MGC and QMG scores over 52 weeks, compared with patients who received placebo. Nevertheless, “after correcting for baseline differences, there was no significant difference between the two groups,” Dr. Nowak said.

Rituximab had good safety and tolerability, and the placebo group had a threefold higher rate of clinical relapse requiring IV immunoglobulin or plasmapheresis. “While the placebo arm did achieve a similar rate of reduction in their steroid dose, at 52 weeks the patients may have been doing less well, reflected by the higher rate of relapse,” he said.

Subgroup analysis

To explore whether rituximab might benefit patients who were treatment resistant or had more symptomatic disease, Dr. Nowak and his colleagues conducted a post hoc subgroup analysis of 20 participants – 10 in the rituximab arm and 10 in the placebo arm – who were MGFA class III-IV. In each group, 70% were on glucocorticoid treatment alone, and 90% were MGFA class III.

As in the overall study, the glucocorticoid-sparing effect was not significant (60% of the rituximab group vs. 50% of the placebo group).

Mean change in QMG score was –3.9 in the rituximab group and –0.5 in the placebo group, and mean change in MGC score was –7.0 in the rituximab group and –4.8 in the placebo group. These secondary outcomes again show “directional favorability” with rituximab, Dr. Nowak said. The researchers saw similar trends for scores that assess quality of life and activities of daily living.

In the subgroup analysis, myasthenia gravis relapses requiring rescue therapy occurred in 20% of patients in the rituximab arm and in 30% of the placebo arm. Overall, the researchers did not see a difference in treatment response between those with moderate to severe disease and those with mild disease, Dr. Nowak said.

Suggestions from the data

The post hoc subgroup analysis should be interpreted with caution, and the study does not provide firm conclusions, Dr. Nowak noted. In addition, the trial population does not reflect all patients with myasthenia gravis. Dr. Nowak routinely uses rituximab in patients with muscle-specific kinase antibody-positive disease, he said. For acetylcholine receptor antibody-positive generalized myasthenia gravis, which has approved therapies available, Dr. Nowak presents rituximab as an option for some patients. Further research may clarify where B-cell depletion therapy may fit into the treatment paradigm.

Nonetheless, BeatMG and the subgroup analysis may help physicians better understand the disease and the role of various therapies. Investigators successfully lowered prednisone dose “at a pretty high rate in the placebo arm,” he said. “It suggests that many of our patients potentially may be on higher than required prednisone doses.”

Finally, the BeatMG findings emphasize the need for placebo-controlled trials to understand potential therapies. “We need to pause when we see a lot of retrospective and uncontrolled studies that are very promising,” Dr. Nowak said.

The study was supported by the National Institute of Neurological Disorders and Stroke. Genentech provided the study drug and placebo through an investigator-sponsored study agreement. Dr. Nowak has received research support from Alexion Pharmaceuticals, Genentech, Grifols, and Ra Pharmaceuticals. He has served as a paid consultant for Alexion, Momenta, Ra, Roivant, Shire, Grifols, and CSL Behring.

jremaly@mdedge.com

SOURCE: Nowak R et al. AANEM 2019. Unnumbered Abstract: Rituximab in patients with moderate to severe myasthenia gravis: a subgroup analysis of the BeatMG study

AUSTIN, TEX. – Among patients with acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis, rituximab and placebo may have a similar glucocorticoid-sparing effect regardless of disease severity, according to research presented at the annual meeting of the American Association of Neuromuscular and Electrodiagnostic Medicine.

Jake Remaly/MDedge News

B Cell Targeted Treatment In Myasthenia Gravis (BeatMG) was a 52-week, randomized, double-blind, placebo-controlled clinical trial. The phase 2 study’s primary outcomes were safety and the glucocorticoid-sparing effect assessed by the percentage of patients who reduced their mean daily prednisone dose by at least 75% and maintained clinical stability. Secondary outcomes were change in Myasthenia Gravis Composite (MGC) score and change in Quantitative Myasthenia Gravis (QMG) score from baseline to 52 weeks.

Investigators randomized 52 participants 1:1 to rituximab (Rituxan) or placebo. Patients were taking at least 15 mg/day of prednisone and were a mean of about age 50 years. About two-thirds were treated with glucocorticoids alone at baseline, and nearly two-thirds had a Myasthenia Gravis Foundation of America (MGFA) clinical classification of II. “It was a mildly symptomatic group of individuals in terms of disease severity,” said Richard Nowak, MD, assistant professor of neurology and director of the Yale Myasthenia Gravis Clinic in New Haven, Conn.

During the study, 60% of patients who received rituximab had a 75% or greater reduction in their mean daily prednisone dose and maintained clinical stability. “However, what surprised us is that we had a significantly high placebo response rate of 56%,” he said. The difference between groups was not significant.

Patients who received rituximab had “directionally favorable reductions” in MGC and QMG scores over 52 weeks, compared with patients who received placebo. Nevertheless, “after correcting for baseline differences, there was no significant difference between the two groups,” Dr. Nowak said.

Rituximab had good safety and tolerability, and the placebo group had a threefold higher rate of clinical relapse requiring IV immunoglobulin or plasmapheresis. “While the placebo arm did achieve a similar rate of reduction in their steroid dose, at 52 weeks the patients may have been doing less well, reflected by the higher rate of relapse,” he said.

Subgroup analysis

To explore whether rituximab might benefit patients who were treatment resistant or had more symptomatic disease, Dr. Nowak and his colleagues conducted a post hoc subgroup analysis of 20 participants – 10 in the rituximab arm and 10 in the placebo arm – who were MGFA class III-IV. In each group, 70% were on glucocorticoid treatment alone, and 90% were MGFA class III.

As in the overall study, the glucocorticoid-sparing effect was not significant (60% of the rituximab group vs. 50% of the placebo group).

Mean change in QMG score was –3.9 in the rituximab group and –0.5 in the placebo group, and mean change in MGC score was –7.0 in the rituximab group and –4.8 in the placebo group. These secondary outcomes again show “directional favorability” with rituximab, Dr. Nowak said. The researchers saw similar trends for scores that assess quality of life and activities of daily living.

In the subgroup analysis, myasthenia gravis relapses requiring rescue therapy occurred in 20% of patients in the rituximab arm and in 30% of the placebo arm. Overall, the researchers did not see a difference in treatment response between those with moderate to severe disease and those with mild disease, Dr. Nowak said.

Suggestions from the data

The post hoc subgroup analysis should be interpreted with caution, and the study does not provide firm conclusions, Dr. Nowak noted. In addition, the trial population does not reflect all patients with myasthenia gravis. Dr. Nowak routinely uses rituximab in patients with muscle-specific kinase antibody-positive disease, he said. For acetylcholine receptor antibody-positive generalized myasthenia gravis, which has approved therapies available, Dr. Nowak presents rituximab as an option for some patients. Further research may clarify where B-cell depletion therapy may fit into the treatment paradigm.

Nonetheless, BeatMG and the subgroup analysis may help physicians better understand the disease and the role of various therapies. Investigators successfully lowered prednisone dose “at a pretty high rate in the placebo arm,” he said. “It suggests that many of our patients potentially may be on higher than required prednisone doses.”

Finally, the BeatMG findings emphasize the need for placebo-controlled trials to understand potential therapies. “We need to pause when we see a lot of retrospective and uncontrolled studies that are very promising,” Dr. Nowak said.

The study was supported by the National Institute of Neurological Disorders and Stroke. Genentech provided the study drug and placebo through an investigator-sponsored study agreement. Dr. Nowak has received research support from Alexion Pharmaceuticals, Genentech, Grifols, and Ra Pharmaceuticals. He has served as a paid consultant for Alexion, Momenta, Ra, Roivant, Shire, Grifols, and CSL Behring.

jremaly@mdedge.com

SOURCE: Nowak R et al. AANEM 2019. Unnumbered Abstract: Rituximab in patients with moderate to severe myasthenia gravis: a subgroup analysis of the BeatMG study

Hold the peas, pass the spiders

There’s an old saying – and by “old,” we mean that we just made it up – in the medical-humor business: When in doubt, find a survey.

Barcin/iStock/Getty Images Plus

Some group is always surveying somebody about something and coming up with a wacky assumption or misguided opinion held by a minority of the respondents. It’s a classic go-to move for the desperate writer.

And look, here’s one now. According to a recent survey conducted by OnePoll for VeggieTracker.com, 83% of Americans like – and this makes us feel oogie just thinking about it – peas. Blecch. Even more amazing? About a quarter of the 2,000 respondents said that they had never even eaten a vegetable. That might explain a good bit of the country’s obesity problem.

And then there’s the survey that OnePoll did for Mattress Advisor, which questioned 2,000 Americans about sleep science and myth. Among the results: 23% believe that an hour of sleep before midnight is worth more than two after, 25% think that sleeping on your left side helps digestion, and 15% said that circadian rhythm was the proper term for the body’s blood flow.

Our favorite, though, was the myth that you swallow eight spiders a year while you sleep. We’ve never heard that one, but 20% of respondents thought it was true.

We’re glad that it’s just a myth, but even spiders would be better than peas.
 

The politics of pretty

It’s an age-old political question: Did a majority of U.S. voters back Martin Van Buren in the 1836 presidential election because he pushed the popular policies of his boss, fellow Democrat Andrew Jackson? Or was it the suave sideburns of Jackson’s stylish vice president that trumped (see what we did there?) the clean-shaven Whig William Henry Harrison?

Robert Daly/OJO Images

The evidence-backed answer: Probably both.

Researchers at the University of Freiburg in Germany conducted two style-or-substance studies to determine how much political advantage a pretty face confers. The first study examined the impact attractive looks and the ability to appear competent riding atop an Abrams tank (ooooh, sorry, Dukakis fans), er, the ability to look competent in photos had in Germany’s 2017 Bundestag elections.

The study’s precise answer: 3.8 percentage points. That’s the polling advantage candidates gained by being judged more attractive than their competitors. Admittedly, the researchers also found it helped to be more than just a pretty face – the unaesthetic quality of relative competence also played a positive role.

The second study took the same approach to U.S. House of Representatives races. In that research beauty contest, America’s aesthetically attuned voters delivered up to an 11-point advantage to the prettiest person.

Now, as anyone will tell you who’s watched congressional TMZ – a.k.a. C-SPAN – beauty in politics is a relative matter. As one of our colleagues noted after visiting the Bureau of LOTME’s Washington hometown and seeing several political stars up close and personal: “Washington is Hollywood for the not so good lookin’.”
 

Grate idea, or greatest idea?

Tattoo removal is a big part of business for quite a few dermatologists out there. In 2011, more than 100,000 tattoo removal procedures were performed, according to the American Society for Dermatologic Surgery.

JoeGough/iStock/Getty Images Plus

But dermatologists beware, because an Argentinian man may have found a far cheaper method for getting rid of unwanted tattoos, one that would make all those fancy lasers obsolete.

And it all hinges on a humble kitchen utensil: the cheese grater.

The story began when our intrepid hero found out that he wouldn’t be able to work as airport police with a visible tattoo. Simultaneously, he decided that the detail on the week-old tattoo was not up to his standard. So, the man took to the Internet, searching for a cheap way to remove the offending mark. He tried a pumice stone but had no luck. So, next came the cheese grater.

And credit where credit’s due – he did get rid of the tattoo. He washed the wound, applied disinfectant, and everything was good.

Okay, he MAY have required a trip to his local emergency department because he needed a tetanus shot. And while the man isn’t sorry that he did what he did, he wouldn’t recommend the procedure to anyone else.

But consider yourselves on notice, dermatologists. There are always new ways to innovate.

Hold the peas, pass the spiders

There’s an old saying – and by “old,” we mean that we just made it up – in the medical-humor business: When in doubt, find a survey.

Barcin/iStock/Getty Images Plus

Some group is always surveying somebody about something and coming up with a wacky assumption or misguided opinion held by a minority of the respondents. It’s a classic go-to move for the desperate writer.

And look, here’s one now. According to a recent survey conducted by OnePoll for VeggieTracker.com, 83% of Americans like – and this makes us feel oogie just thinking about it – peas. Blecch. Even more amazing? About a quarter of the 2,000 respondents said that they had never even eaten a vegetable. That might explain a good bit of the country’s obesity problem.

And then there’s the survey that OnePoll did for Mattress Advisor, which questioned 2,000 Americans about sleep science and myth. Among the results: 23% believe that an hour of sleep before midnight is worth more than two after, 25% think that sleeping on your left side helps digestion, and 15% said that circadian rhythm was the proper term for the body’s blood flow.

Our favorite, though, was the myth that you swallow eight spiders a year while you sleep. We’ve never heard that one, but 20% of respondents thought it was true.

We’re glad that it’s just a myth, but even spiders would be better than peas.
 

The politics of pretty

It’s an age-old political question: Did a majority of U.S. voters back Martin Van Buren in the 1836 presidential election because he pushed the popular policies of his boss, fellow Democrat Andrew Jackson? Or was it the suave sideburns of Jackson’s stylish vice president that trumped (see what we did there?) the clean-shaven Whig William Henry Harrison?

Robert Daly/OJO Images

The evidence-backed answer: Probably both.

Researchers at the University of Freiburg in Germany conducted two style-or-substance studies to determine how much political advantage a pretty face confers. The first study examined the impact attractive looks and the ability to appear competent riding atop an Abrams tank (ooooh, sorry, Dukakis fans), er, the ability to look competent in photos had in Germany’s 2017 Bundestag elections.

The study’s precise answer: 3.8 percentage points. That’s the polling advantage candidates gained by being judged more attractive than their competitors. Admittedly, the researchers also found it helped to be more than just a pretty face – the unaesthetic quality of relative competence also played a positive role.

The second study took the same approach to U.S. House of Representatives races. In that research beauty contest, America’s aesthetically attuned voters delivered up to an 11-point advantage to the prettiest person.

Now, as anyone will tell you who’s watched congressional TMZ – a.k.a. C-SPAN – beauty in politics is a relative matter. As one of our colleagues noted after visiting the Bureau of LOTME’s Washington hometown and seeing several political stars up close and personal: “Washington is Hollywood for the not so good lookin’.”
 

Grate idea, or greatest idea?

Tattoo removal is a big part of business for quite a few dermatologists out there. In 2011, more than 100,000 tattoo removal procedures were performed, according to the American Society for Dermatologic Surgery.

JoeGough/iStock/Getty Images Plus

But dermatologists beware, because an Argentinian man may have found a far cheaper method for getting rid of unwanted tattoos, one that would make all those fancy lasers obsolete.

And it all hinges on a humble kitchen utensil: the cheese grater.

The story began when our intrepid hero found out that he wouldn’t be able to work as airport police with a visible tattoo. Simultaneously, he decided that the detail on the week-old tattoo was not up to his standard. So, the man took to the Internet, searching for a cheap way to remove the offending mark. He tried a pumice stone but had no luck. So, next came the cheese grater.

And credit where credit’s due – he did get rid of the tattoo. He washed the wound, applied disinfectant, and everything was good.

Okay, he MAY have required a trip to his local emergency department because he needed a tetanus shot. And while the man isn’t sorry that he did what he did, he wouldn’t recommend the procedure to anyone else.

But consider yourselves on notice, dermatologists. There are always new ways to innovate.

Hold the peas, pass the spiders

There’s an old saying – and by “old,” we mean that we just made it up – in the medical-humor business: When in doubt, find a survey.

Barcin/iStock/Getty Images Plus

Some group is always surveying somebody about something and coming up with a wacky assumption or misguided opinion held by a minority of the respondents. It’s a classic go-to move for the desperate writer.

And look, here’s one now. According to a recent survey conducted by OnePoll for VeggieTracker.com, 83% of Americans like – and this makes us feel oogie just thinking about it – peas. Blecch. Even more amazing? About a quarter of the 2,000 respondents said that they had never even eaten a vegetable. That might explain a good bit of the country’s obesity problem.

And then there’s the survey that OnePoll did for Mattress Advisor, which questioned 2,000 Americans about sleep science and myth. Among the results: 23% believe that an hour of sleep before midnight is worth more than two after, 25% think that sleeping on your left side helps digestion, and 15% said that circadian rhythm was the proper term for the body’s blood flow.

Our favorite, though, was the myth that you swallow eight spiders a year while you sleep. We’ve never heard that one, but 20% of respondents thought it was true.

We’re glad that it’s just a myth, but even spiders would be better than peas.
 

The politics of pretty

It’s an age-old political question: Did a majority of U.S. voters back Martin Van Buren in the 1836 presidential election because he pushed the popular policies of his boss, fellow Democrat Andrew Jackson? Or was it the suave sideburns of Jackson’s stylish vice president that trumped (see what we did there?) the clean-shaven Whig William Henry Harrison?

Robert Daly/OJO Images

The evidence-backed answer: Probably both.

Researchers at the University of Freiburg in Germany conducted two style-or-substance studies to determine how much political advantage a pretty face confers. The first study examined the impact attractive looks and the ability to appear competent riding atop an Abrams tank (ooooh, sorry, Dukakis fans), er, the ability to look competent in photos had in Germany’s 2017 Bundestag elections.

The study’s precise answer: 3.8 percentage points. That’s the polling advantage candidates gained by being judged more attractive than their competitors. Admittedly, the researchers also found it helped to be more than just a pretty face – the unaesthetic quality of relative competence also played a positive role.

The second study took the same approach to U.S. House of Representatives races. In that research beauty contest, America’s aesthetically attuned voters delivered up to an 11-point advantage to the prettiest person.

Now, as anyone will tell you who’s watched congressional TMZ – a.k.a. C-SPAN – beauty in politics is a relative matter. As one of our colleagues noted after visiting the Bureau of LOTME’s Washington hometown and seeing several political stars up close and personal: “Washington is Hollywood for the not so good lookin’.”
 

Grate idea, or greatest idea?

Tattoo removal is a big part of business for quite a few dermatologists out there. In 2011, more than 100,000 tattoo removal procedures were performed, according to the American Society for Dermatologic Surgery.

JoeGough/iStock/Getty Images Plus

But dermatologists beware, because an Argentinian man may have found a far cheaper method for getting rid of unwanted tattoos, one that would make all those fancy lasers obsolete.

And it all hinges on a humble kitchen utensil: the cheese grater.

The story began when our intrepid hero found out that he wouldn’t be able to work as airport police with a visible tattoo. Simultaneously, he decided that the detail on the week-old tattoo was not up to his standard. So, the man took to the Internet, searching for a cheap way to remove the offending mark. He tried a pumice stone but had no luck. So, next came the cheese grater.

And credit where credit’s due – he did get rid of the tattoo. He washed the wound, applied disinfectant, and everything was good.

Okay, he MAY have required a trip to his local emergency department because he needed a tetanus shot. And while the man isn’t sorry that he did what he did, he wouldn’t recommend the procedure to anyone else.

But consider yourselves on notice, dermatologists. There are always new ways to innovate.

AUSTIN, TEX. – The use of both repetitive stimulation (RS) and jitter analysis are important for accurate diagnosis of congenital myasthenic syndrome (CMS) suggests newly presented research.

“In case RS is negative, SFEMG [single fiber electromyography] alone is not very specific and cannot distinguish CMS from mitochondrial myopathies, even in the presence of impulse blocking,” Vitor Marques Caldas, MD, a neurologist at the Syrian Libanes Hospital in Brasilia, Brazil, and a PhD student at the University of São Paulo, told attendees at the annual meeting of the American Association for Neuromuscular and Electrodiagnostic Medicine. “An isolated SFEMG test can lead to a misdiagnosis of myasthenia syndrome if not interpreted in the right clinical context.”

The researchers sought to understand the relative sensitivity and specificity of low-frequency RS versus jitter analysis using disposable concentric needle electrodes (CNE).

The study involved 69 patients, of whom 19 had mitochondrial myopathy, 18 had congenital myopathy, 18 had CMS, and 14 were asymptomatic controls. The control group all tested normal with both RS and jitter analysis.

The 18 participants with CMS, average age 24 years, received low-frequency RS in at least six different muscles: two distal muscles (abductor digiti minimi and tibialis anterior), two proximal muscles (deltoid and trapezius) and two facial muscles (nasalis and orbicularis oculi). They also underwent jitter analysis of their orbicularis oculi muscle under voluntary activation using CNE.

These patients had heterogeneous genetic profiles: 11 had the CHRNE gene mutation, 2 had the RAPSN gene mutation, 2 had the COLQ gene mutation, 2 had the DOK-7 gene mutation, and 1 had the COL13A1 mutation.

All but two patients with congenital CMS tested positive (88.9%) with RS: one female with CHRNE mutation and one male with RAPSN mutation. Using mean jitter, all but one patient tested positive (94.4%): a female with DOK-7 mutation who had tested abnormal on RS.

All patients with CMS tested positive with at least one of the two tests, but only 83.3% tested positive with both tests, resulting in a sensitivity of 83.3%, a specificity of 100%, and overall accuracy of 95.6% using both tests.

Among the 19 patients with mitochondrial myopathy, 5 had abnormal jitter analysis.

When the researchers looked only at participants with abnormal jitter analysis but normal RS, two of these were patients with CMS, but another seven had congenital or mitochondrial myopathies. Using abnormal jitter alone therefore resulted in a sensitivity of 100% but a specificity of only 86%, for overall 86.5% accuracy.

“It’s important to notice that if you have an abnormal jitter, we have to look at the clinical symptoms of the patients,” Dr. Marques Caldas said in an interview. “Jitter abnormalities are not enough to distinguish between myasthenic disorder and a myopathic disorder.”

The research used no external funding, and Dr. Marques Caldas had no disclosures.
 

SOURCE: Caldas VM et al. AANEM 2019. Unnumbered Abstract: Sensitivity of neurophysiologic tests regarding the neuromuscular junction in patients with congenital myasthenic syndromes.

AUSTIN, TEX. – The use of both repetitive stimulation (RS) and jitter analysis are important for accurate diagnosis of congenital myasthenic syndrome (CMS) suggests newly presented research.

“In case RS is negative, SFEMG [single fiber electromyography] alone is not very specific and cannot distinguish CMS from mitochondrial myopathies, even in the presence of impulse blocking,” Vitor Marques Caldas, MD, a neurologist at the Syrian Libanes Hospital in Brasilia, Brazil, and a PhD student at the University of São Paulo, told attendees at the annual meeting of the American Association for Neuromuscular and Electrodiagnostic Medicine. “An isolated SFEMG test can lead to a misdiagnosis of myasthenia syndrome if not interpreted in the right clinical context.”

The researchers sought to understand the relative sensitivity and specificity of low-frequency RS versus jitter analysis using disposable concentric needle electrodes (CNE).

The study involved 69 patients, of whom 19 had mitochondrial myopathy, 18 had congenital myopathy, 18 had CMS, and 14 were asymptomatic controls. The control group all tested normal with both RS and jitter analysis.

The 18 participants with CMS, average age 24 years, received low-frequency RS in at least six different muscles: two distal muscles (abductor digiti minimi and tibialis anterior), two proximal muscles (deltoid and trapezius) and two facial muscles (nasalis and orbicularis oculi). They also underwent jitter analysis of their orbicularis oculi muscle under voluntary activation using CNE.

These patients had heterogeneous genetic profiles: 11 had the CHRNE gene mutation, 2 had the RAPSN gene mutation, 2 had the COLQ gene mutation, 2 had the DOK-7 gene mutation, and 1 had the COL13A1 mutation.

All but two patients with congenital CMS tested positive (88.9%) with RS: one female with CHRNE mutation and one male with RAPSN mutation. Using mean jitter, all but one patient tested positive (94.4%): a female with DOK-7 mutation who had tested abnormal on RS.

All patients with CMS tested positive with at least one of the two tests, but only 83.3% tested positive with both tests, resulting in a sensitivity of 83.3%, a specificity of 100%, and overall accuracy of 95.6% using both tests.

Among the 19 patients with mitochondrial myopathy, 5 had abnormal jitter analysis.

When the researchers looked only at participants with abnormal jitter analysis but normal RS, two of these were patients with CMS, but another seven had congenital or mitochondrial myopathies. Using abnormal jitter alone therefore resulted in a sensitivity of 100% but a specificity of only 86%, for overall 86.5% accuracy.

“It’s important to notice that if you have an abnormal jitter, we have to look at the clinical symptoms of the patients,” Dr. Marques Caldas said in an interview. “Jitter abnormalities are not enough to distinguish between myasthenic disorder and a myopathic disorder.”

The research used no external funding, and Dr. Marques Caldas had no disclosures.
 

SOURCE: Caldas VM et al. AANEM 2019. Unnumbered Abstract: Sensitivity of neurophysiologic tests regarding the neuromuscular junction in patients with congenital myasthenic syndromes.

AUSTIN, TEX. – The use of both repetitive stimulation (RS) and jitter analysis are important for accurate diagnosis of congenital myasthenic syndrome (CMS) suggests newly presented research.

“In case RS is negative, SFEMG [single fiber electromyography] alone is not very specific and cannot distinguish CMS from mitochondrial myopathies, even in the presence of impulse blocking,” Vitor Marques Caldas, MD, a neurologist at the Syrian Libanes Hospital in Brasilia, Brazil, and a PhD student at the University of São Paulo, told attendees at the annual meeting of the American Association for Neuromuscular and Electrodiagnostic Medicine. “An isolated SFEMG test can lead to a misdiagnosis of myasthenia syndrome if not interpreted in the right clinical context.”

The researchers sought to understand the relative sensitivity and specificity of low-frequency RS versus jitter analysis using disposable concentric needle electrodes (CNE).

The study involved 69 patients, of whom 19 had mitochondrial myopathy, 18 had congenital myopathy, 18 had CMS, and 14 were asymptomatic controls. The control group all tested normal with both RS and jitter analysis.

The 18 participants with CMS, average age 24 years, received low-frequency RS in at least six different muscles: two distal muscles (abductor digiti minimi and tibialis anterior), two proximal muscles (deltoid and trapezius) and two facial muscles (nasalis and orbicularis oculi). They also underwent jitter analysis of their orbicularis oculi muscle under voluntary activation using CNE.

These patients had heterogeneous genetic profiles: 11 had the CHRNE gene mutation, 2 had the RAPSN gene mutation, 2 had the COLQ gene mutation, 2 had the DOK-7 gene mutation, and 1 had the COL13A1 mutation.

All but two patients with congenital CMS tested positive (88.9%) with RS: one female with CHRNE mutation and one male with RAPSN mutation. Using mean jitter, all but one patient tested positive (94.4%): a female with DOK-7 mutation who had tested abnormal on RS.

All patients with CMS tested positive with at least one of the two tests, but only 83.3% tested positive with both tests, resulting in a sensitivity of 83.3%, a specificity of 100%, and overall accuracy of 95.6% using both tests.

Among the 19 patients with mitochondrial myopathy, 5 had abnormal jitter analysis.

When the researchers looked only at participants with abnormal jitter analysis but normal RS, two of these were patients with CMS, but another seven had congenital or mitochondrial myopathies. Using abnormal jitter alone therefore resulted in a sensitivity of 100% but a specificity of only 86%, for overall 86.5% accuracy.

“It’s important to notice that if you have an abnormal jitter, we have to look at the clinical symptoms of the patients,” Dr. Marques Caldas said in an interview. “Jitter abnormalities are not enough to distinguish between myasthenic disorder and a myopathic disorder.”

The research used no external funding, and Dr. Marques Caldas had no disclosures.
 

SOURCE: Caldas VM et al. AANEM 2019. Unnumbered Abstract: Sensitivity of neurophysiologic tests regarding the neuromuscular junction in patients with congenital myasthenic syndromes.

BARCELONA – Adding veliparib to frontline chemotherapy and maintenance therapy significantly extended progression-free survival in women with high-grade serous epithelial ovarian cancer (HGSC) in the phase 3 VELIA/GOG-3005 trial.

The benefit associated with the oral poly (ADP-ribose) polymerase (PARP) inhibitor was seen in all women with newly diagnosed HGSC included in the randomized, placebo-controlled trial, regardless of BRCA mutation (BRCAm) status or homologous recombination deficiency (HRD) status, Robert L. Coleman, MD, reported at the European Society for Medical Oncology Congress.

Of 1,140 patients enrolled in the international, multicenter trial, 26% had a BRCAm and 55% were HRD positive. In the intent-to-treat population, median progression-free survival (PFS) was 23.5 months in 382 patients who received carboplatin/paclitaxel (CP) plus veliparib followed by veliparib maintenance (veliparib group 1) versus 17.3 months in 375 patients treated with CP alone followed by placebo maintenance (the control group) (hazard ratio, 0.68), according to Dr. Coleman, professor and Ann Rife Cox Chair in Gynecology in the department of gynecologic oncology and reproductive medicine in the division of surgery at the University of Texas MD Anderson Cancer Center, Houston.

Among 200 patients with a deleterious BRCAm, including 108 in the veliparib 1 group and 92 in the control group, median PFS was 34.7 and 22.0 months, respectively (HR, 0.44), and among 421 patients with HRD and BRCAm, including 214 in the veliparib 1 group and 207 in the control group, median PFS was 31.9 versus 20.5 months (HR, 0.57).

In the non-HRD population of 249 patients (125 in the veliparib 1 arm and 124 in the control arm), median PFS was 15.0 and 11.5 months, respectively.

The PFS for an additional group of 383 patients treated with CP plus veliparib followed by placebo maintenance (veliparib group 2) didn’t differ significantly from either the veliparib 1 or the control group (HR, 1.07 vs. the control group in the intent-to-treat population), and the PFS rates were also similar for the BRCAm and HRD-positive patients in the veliparib 2 group and control group, he noted, explaining that the main focus of his presentation was the primary study endpoint of median PFS in the veliparib 1 versus control group.

The overall response rates at the end of treatment in the intent-to-treat populations were 84% in the veliparib 1 group, 74% in the control group, and 79% in the veliparib 2 group, Dr. Coleman said, adding that response rates were numerically higher in both veliparib-containing arms.

Additional analyses, including overall survival, will be reported at a future date, he noted.

Study participants were adults with a mean age of 62 years who had previously untreated stage III-IV HGSC. Treatment included six cycles of CP at 21-day intervals, with paclitaxel given either weekly or every 3 weeks following primary cytoreduction or neoadjuvant chemotherapy with interval cytoreduction. The veliparib dose when given with CP was 150 mg twice daily, and the veliparib maintenance dose was 400 mg twice daily for 30 cycles.

Relative CP dose intensities were similar between arms, and grade 3-4 adverse events were similar in the veliparib 1 and control groups during CP – with the exception of thrombocytopenia, which occurred in 27% and 8% of patients in the groups, respectively. During maintenance, the rates of any grade 3-4 adverse events were higher in the veliparib 1 group versus the control group (45% vs. 32%), but serious adverse event rates were similar in the groups (17% and 19%).

Observed toxicities were consistent with the known veliparib safety profile, Dr. Coleman said.

The findings are notable, as PARP inhibitors have proven effective in ovarian cancer, but their use in combination with chemotherapy has been challenging because of hematologic toxicity, he added, explaining, however, that veliparib has not only been shown to have single agent activity in germline BRCAm recurrent ovarian cancer patients, but also has binding characteristics – namely increased protein poly ADP-ribosylation and decreased PARP trapping – that could allow for its use in combination with chemotherapy.

VELIA/GOG-3005 is the first randomized trial designed to enroll only untreated patients with advanced-stage HGSC regardless of BRCA status, surgical management, or response to treatment, and the findings suggest that veliparib can be safely administered with CP and should be considered a new treatment option for women with newly diagnosed, advanced-stage serous ovarian cancer, he concluded.

In an ESMO press release, Ana Oaknin, MD, PhD, head of the gynecologic cancer program at Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona, said that this trial, along with others such as the SOLO-1 trial, the PAOLA-1/ENGOT-Ov25 trial, and the PRIMA/ENGOT-OV26/GOG-3012 trial, which each looked at integrating PARP inhibitors into first-line treatment, represents “a milestone for patients.”

“After decades studying different chemotherapy approaches, it is the first time we have meaningfully prolonged progression free survival and hopefully we will improve long-term outcome,” she said.

The study was sponsored by AbbVie. Dr. Coleman and Dr. Oaknin reported relationships with numerous pharmaceutical companies.

SOURCE: Coleman RL et al. ESMO 2019, Abstract LBA3-PR.

BARCELONA – Adding veliparib to frontline chemotherapy and maintenance therapy significantly extended progression-free survival in women with high-grade serous epithelial ovarian cancer (HGSC) in the phase 3 VELIA/GOG-3005 trial.

The benefit associated with the oral poly (ADP-ribose) polymerase (PARP) inhibitor was seen in all women with newly diagnosed HGSC included in the randomized, placebo-controlled trial, regardless of BRCA mutation (BRCAm) status or homologous recombination deficiency (HRD) status, Robert L. Coleman, MD, reported at the European Society for Medical Oncology Congress.

Of 1,140 patients enrolled in the international, multicenter trial, 26% had a BRCAm and 55% were HRD positive. In the intent-to-treat population, median progression-free survival (PFS) was 23.5 months in 382 patients who received carboplatin/paclitaxel (CP) plus veliparib followed by veliparib maintenance (veliparib group 1) versus 17.3 months in 375 patients treated with CP alone followed by placebo maintenance (the control group) (hazard ratio, 0.68), according to Dr. Coleman, professor and Ann Rife Cox Chair in Gynecology in the department of gynecologic oncology and reproductive medicine in the division of surgery at the University of Texas MD Anderson Cancer Center, Houston.

Among 200 patients with a deleterious BRCAm, including 108 in the veliparib 1 group and 92 in the control group, median PFS was 34.7 and 22.0 months, respectively (HR, 0.44), and among 421 patients with HRD and BRCAm, including 214 in the veliparib 1 group and 207 in the control group, median PFS was 31.9 versus 20.5 months (HR, 0.57).

In the non-HRD population of 249 patients (125 in the veliparib 1 arm and 124 in the control arm), median PFS was 15.0 and 11.5 months, respectively.

The PFS for an additional group of 383 patients treated with CP plus veliparib followed by placebo maintenance (veliparib group 2) didn’t differ significantly from either the veliparib 1 or the control group (HR, 1.07 vs. the control group in the intent-to-treat population), and the PFS rates were also similar for the BRCAm and HRD-positive patients in the veliparib 2 group and control group, he noted, explaining that the main focus of his presentation was the primary study endpoint of median PFS in the veliparib 1 versus control group.

The overall response rates at the end of treatment in the intent-to-treat populations were 84% in the veliparib 1 group, 74% in the control group, and 79% in the veliparib 2 group, Dr. Coleman said, adding that response rates were numerically higher in both veliparib-containing arms.

Additional analyses, including overall survival, will be reported at a future date, he noted.

Study participants were adults with a mean age of 62 years who had previously untreated stage III-IV HGSC. Treatment included six cycles of CP at 21-day intervals, with paclitaxel given either weekly or every 3 weeks following primary cytoreduction or neoadjuvant chemotherapy with interval cytoreduction. The veliparib dose when given with CP was 150 mg twice daily, and the veliparib maintenance dose was 400 mg twice daily for 30 cycles.

Relative CP dose intensities were similar between arms, and grade 3-4 adverse events were similar in the veliparib 1 and control groups during CP – with the exception of thrombocytopenia, which occurred in 27% and 8% of patients in the groups, respectively. During maintenance, the rates of any grade 3-4 adverse events were higher in the veliparib 1 group versus the control group (45% vs. 32%), but serious adverse event rates were similar in the groups (17% and 19%).

Observed toxicities were consistent with the known veliparib safety profile, Dr. Coleman said.

The findings are notable, as PARP inhibitors have proven effective in ovarian cancer, but their use in combination with chemotherapy has been challenging because of hematologic toxicity, he added, explaining, however, that veliparib has not only been shown to have single agent activity in germline BRCAm recurrent ovarian cancer patients, but also has binding characteristics – namely increased protein poly ADP-ribosylation and decreased PARP trapping – that could allow for its use in combination with chemotherapy.

VELIA/GOG-3005 is the first randomized trial designed to enroll only untreated patients with advanced-stage HGSC regardless of BRCA status, surgical management, or response to treatment, and the findings suggest that veliparib can be safely administered with CP and should be considered a new treatment option for women with newly diagnosed, advanced-stage serous ovarian cancer, he concluded.

In an ESMO press release, Ana Oaknin, MD, PhD, head of the gynecologic cancer program at Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona, said that this trial, along with others such as the SOLO-1 trial, the PAOLA-1/ENGOT-Ov25 trial, and the PRIMA/ENGOT-OV26/GOG-3012 trial, which each looked at integrating PARP inhibitors into first-line treatment, represents “a milestone for patients.”

“After decades studying different chemotherapy approaches, it is the first time we have meaningfully prolonged progression free survival and hopefully we will improve long-term outcome,” she said.

The study was sponsored by AbbVie. Dr. Coleman and Dr. Oaknin reported relationships with numerous pharmaceutical companies.

SOURCE: Coleman RL et al. ESMO 2019, Abstract LBA3-PR.

BARCELONA – Adding veliparib to frontline chemotherapy and maintenance therapy significantly extended progression-free survival in women with high-grade serous epithelial ovarian cancer (HGSC) in the phase 3 VELIA/GOG-3005 trial.

The benefit associated with the oral poly (ADP-ribose) polymerase (PARP) inhibitor was seen in all women with newly diagnosed HGSC included in the randomized, placebo-controlled trial, regardless of BRCA mutation (BRCAm) status or homologous recombination deficiency (HRD) status, Robert L. Coleman, MD, reported at the European Society for Medical Oncology Congress.

Of 1,140 patients enrolled in the international, multicenter trial, 26% had a BRCAm and 55% were HRD positive. In the intent-to-treat population, median progression-free survival (PFS) was 23.5 months in 382 patients who received carboplatin/paclitaxel (CP) plus veliparib followed by veliparib maintenance (veliparib group 1) versus 17.3 months in 375 patients treated with CP alone followed by placebo maintenance (the control group) (hazard ratio, 0.68), according to Dr. Coleman, professor and Ann Rife Cox Chair in Gynecology in the department of gynecologic oncology and reproductive medicine in the division of surgery at the University of Texas MD Anderson Cancer Center, Houston.

Among 200 patients with a deleterious BRCAm, including 108 in the veliparib 1 group and 92 in the control group, median PFS was 34.7 and 22.0 months, respectively (HR, 0.44), and among 421 patients with HRD and BRCAm, including 214 in the veliparib 1 group and 207 in the control group, median PFS was 31.9 versus 20.5 months (HR, 0.57).

In the non-HRD population of 249 patients (125 in the veliparib 1 arm and 124 in the control arm), median PFS was 15.0 and 11.5 months, respectively.

The PFS for an additional group of 383 patients treated with CP plus veliparib followed by placebo maintenance (veliparib group 2) didn’t differ significantly from either the veliparib 1 or the control group (HR, 1.07 vs. the control group in the intent-to-treat population), and the PFS rates were also similar for the BRCAm and HRD-positive patients in the veliparib 2 group and control group, he noted, explaining that the main focus of his presentation was the primary study endpoint of median PFS in the veliparib 1 versus control group.

The overall response rates at the end of treatment in the intent-to-treat populations were 84% in the veliparib 1 group, 74% in the control group, and 79% in the veliparib 2 group, Dr. Coleman said, adding that response rates were numerically higher in both veliparib-containing arms.

Additional analyses, including overall survival, will be reported at a future date, he noted.

Study participants were adults with a mean age of 62 years who had previously untreated stage III-IV HGSC. Treatment included six cycles of CP at 21-day intervals, with paclitaxel given either weekly or every 3 weeks following primary cytoreduction or neoadjuvant chemotherapy with interval cytoreduction. The veliparib dose when given with CP was 150 mg twice daily, and the veliparib maintenance dose was 400 mg twice daily for 30 cycles.

Relative CP dose intensities were similar between arms, and grade 3-4 adverse events were similar in the veliparib 1 and control groups during CP – with the exception of thrombocytopenia, which occurred in 27% and 8% of patients in the groups, respectively. During maintenance, the rates of any grade 3-4 adverse events were higher in the veliparib 1 group versus the control group (45% vs. 32%), but serious adverse event rates were similar in the groups (17% and 19%).

Observed toxicities were consistent with the known veliparib safety profile, Dr. Coleman said.

The findings are notable, as PARP inhibitors have proven effective in ovarian cancer, but their use in combination with chemotherapy has been challenging because of hematologic toxicity, he added, explaining, however, that veliparib has not only been shown to have single agent activity in germline BRCAm recurrent ovarian cancer patients, but also has binding characteristics – namely increased protein poly ADP-ribosylation and decreased PARP trapping – that could allow for its use in combination with chemotherapy.

VELIA/GOG-3005 is the first randomized trial designed to enroll only untreated patients with advanced-stage HGSC regardless of BRCA status, surgical management, or response to treatment, and the findings suggest that veliparib can be safely administered with CP and should be considered a new treatment option for women with newly diagnosed, advanced-stage serous ovarian cancer, he concluded.

In an ESMO press release, Ana Oaknin, MD, PhD, head of the gynecologic cancer program at Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona, said that this trial, along with others such as the SOLO-1 trial, the PAOLA-1/ENGOT-Ov25 trial, and the PRIMA/ENGOT-OV26/GOG-3012 trial, which each looked at integrating PARP inhibitors into first-line treatment, represents “a milestone for patients.”

“After decades studying different chemotherapy approaches, it is the first time we have meaningfully prolonged progression free survival and hopefully we will improve long-term outcome,” she said.

The study was sponsored by AbbVie. Dr. Coleman and Dr. Oaknin reported relationships with numerous pharmaceutical companies.

SOURCE: Coleman RL et al. ESMO 2019, Abstract LBA3-PR.