Studies gauge toll of pausing fertility treatment during pandemic

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More than 60% of patients at a center for reproductive medicine in Utah who had fertility treatments canceled because of the COVID-19 pandemic opted to resume treatment once the suspension was lifted about 7 weeks later.

At another fertility center in New York, a survey found that 96% of respondents who had a cycle canceled because of the pandemic found it upsetting, and 22% found it extremely upsetting, with extremely upsetting defined as equivalent to the loss of a child.

The indefinite time frame for resuming treatment when the New York survey was conducted may have been a major source of distress for patients, one of the researchers said at the American Society for Reproductive Medicine’s 2020 annual meeting, held virtually this year.

“They don’t know when they might have that chance again,” said Jenna M. Turocy, MD, of Columbia University Fertility Center, New York.

COVID-19 guidelines published by ASRM on March 17 recommended the suspension of new treatment cycles, including ovulation induction, intrauterine inseminations, and in vitro fertilization (IVF).

An ASRM COVID-19 task force has since supported “the measured resumption of fertility care following the easing of restrictions,” said Paul C. Lin, MD, president of the Society for Assisted Reproductive Technology and a member of the task force.

“Over the past several months, significant knowledge has been gained regarding the COVID-19 virus and its impact on patients and the medical system,” he said in a news release about the two studies that assessed the pandemic’s effects.

Certain precautions remain. “It has become clear that we will need to be practicing COVID-19 protocols at least until an effective and safe vaccine or broadly effective treatment becomes widely available,” Dr. Lin said.
 

Desire to proceed during a pandemic

The Utah Center for Reproductive Medicine on March 15 suspended new IVF cycles and frozen embryo transfers. The center continued to offer IVF cycles for oncofertility patients on an urgent basis.

In early May, patients whose cycles had been suspended had the option to receive treatment.

“Upon reopening, every patient received standardized counseling from their primary IVF physician,” Lauren Verrilli, MD, a reproductive endocrinology and infertility fellow at the University of Utah, Salt Lake City, said at the virtual meeting.

Doctors explained that much remained unknown about COVID-19 in pregnancy, and that it was unclear whether the clinic would need to shut down again. In addition, patients had to undergo COVID-19 testing.

To identify factors associated with proceeding with treatment after the suspension, the researchers compared patients who resumed treatment with patients who did not.

Their analysis included 278 patients who had planned an IVF cycle or frozen embryo transfer (FET) prior to the shutdown. The researchers examined factors such as age, parity, anti-Müllerian hormone, antral follicle count, history of prior IVF cycles or FET, number of frozen blastocysts, gamete source, and use of a gestational carrier.

In all, 62% of patients opted to receive treatment once restrictions were lifted, including 69 of the 133 (52%) patients with planned fresh cycles and 104 of the 145 (72%) patients with planned FET cycles.

Among those with planned fresh cycles, those who opted to resume treatment tended to be older than those who did not resume treatment, with a median age of 37 years versus 35 years, but the difference was not statistically significant.

Among patients with planned FET cycles, those who did not resume treatment were more likely to have a gestational carrier, compared with those who resumed treatment (7% vs. 1%). In some cases, gestational carriers lived in another state and the pandemic complicated travel arrangements, which contributed to delays, Dr. Verrilli said.

The analysis did not include information about income or socioeconomic status, which may play a role in patients’ decisions, Dr. Verrilli said.
 

 

 

Emotional impact of indefinite delay

Fertility treatment is often time sensitive, particularly for patients with advanced reproductive age or diminished ovarian reserve, and indefinite postponement of fertility treatment potentially could lead some patients to lose the ability to conceive with their own gametes, Dr. Turocy said.

In early April, Dr. Turocy and colleagues surveyed patients at their academic fertility center in New York City to assess patients’ reactions to the ASRM recommendations. They decided to conduct the study after they realized that treatment cancellations were having a significant emotional effect.

Investigators emailed an 18-item survey to more than 3,000 patients.

In all, 518 patients completed the survey, a response rate of 17%. Patients had an average age of 37 years (range, 23-52 years), and 92% were female. About 24% had children, and 66% had received at least one fertility treatment.

Half had a cycle canceled because of the COVID-19 pandemic, including timed intercourse cycles (5%), intrauterine insemination cycles (23%), IVF cycles with a planned fresh embryo transfer (10%), IVF with all frozen embryos (27%), egg freeze cycles (3%), and FET cycles (30%).

In response to survey questions about whether they agreed with ASRM recommendations, “the reactions were mixed,” Dr. Turocy said.

About 36% of patients agreed all fertility cycles should be canceled, 22% were unsure, and 43% disagreed with the recommendation. Patients who had a cycle canceled were slightly more likely to agree with the cancellations (40% agreed) than those who did not have a cycle canceled (30% agreed), Dr. Turocy said.

Most respondents would have preferred an option to start a treatment cycle in consultation with their doctor. Half “would have chosen to start a new cycle during the height of the pandemic in New York City,” Dr. Turocy said.

Patient opinions may vary by region and depend on the severity of COVID-19 outbreaks there, and they also might change over time, Dr. Turocy suggested. In addition, the opinions and characteristics of patients who responded to the anonymous survey may differ from those of patients who did not respond.

Dr. Verrilli, Dr. Turocy, and Dr. Lin had no relevant financial disclosures.

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More than 60% of patients at a center for reproductive medicine in Utah who had fertility treatments canceled because of the COVID-19 pandemic opted to resume treatment once the suspension was lifted about 7 weeks later.

At another fertility center in New York, a survey found that 96% of respondents who had a cycle canceled because of the pandemic found it upsetting, and 22% found it extremely upsetting, with extremely upsetting defined as equivalent to the loss of a child.

The indefinite time frame for resuming treatment when the New York survey was conducted may have been a major source of distress for patients, one of the researchers said at the American Society for Reproductive Medicine’s 2020 annual meeting, held virtually this year.

“They don’t know when they might have that chance again,” said Jenna M. Turocy, MD, of Columbia University Fertility Center, New York.

COVID-19 guidelines published by ASRM on March 17 recommended the suspension of new treatment cycles, including ovulation induction, intrauterine inseminations, and in vitro fertilization (IVF).

An ASRM COVID-19 task force has since supported “the measured resumption of fertility care following the easing of restrictions,” said Paul C. Lin, MD, president of the Society for Assisted Reproductive Technology and a member of the task force.

“Over the past several months, significant knowledge has been gained regarding the COVID-19 virus and its impact on patients and the medical system,” he said in a news release about the two studies that assessed the pandemic’s effects.

Certain precautions remain. “It has become clear that we will need to be practicing COVID-19 protocols at least until an effective and safe vaccine or broadly effective treatment becomes widely available,” Dr. Lin said.
 

Desire to proceed during a pandemic

The Utah Center for Reproductive Medicine on March 15 suspended new IVF cycles and frozen embryo transfers. The center continued to offer IVF cycles for oncofertility patients on an urgent basis.

In early May, patients whose cycles had been suspended had the option to receive treatment.

“Upon reopening, every patient received standardized counseling from their primary IVF physician,” Lauren Verrilli, MD, a reproductive endocrinology and infertility fellow at the University of Utah, Salt Lake City, said at the virtual meeting.

Doctors explained that much remained unknown about COVID-19 in pregnancy, and that it was unclear whether the clinic would need to shut down again. In addition, patients had to undergo COVID-19 testing.

To identify factors associated with proceeding with treatment after the suspension, the researchers compared patients who resumed treatment with patients who did not.

Their analysis included 278 patients who had planned an IVF cycle or frozen embryo transfer (FET) prior to the shutdown. The researchers examined factors such as age, parity, anti-Müllerian hormone, antral follicle count, history of prior IVF cycles or FET, number of frozen blastocysts, gamete source, and use of a gestational carrier.

In all, 62% of patients opted to receive treatment once restrictions were lifted, including 69 of the 133 (52%) patients with planned fresh cycles and 104 of the 145 (72%) patients with planned FET cycles.

Among those with planned fresh cycles, those who opted to resume treatment tended to be older than those who did not resume treatment, with a median age of 37 years versus 35 years, but the difference was not statistically significant.

Among patients with planned FET cycles, those who did not resume treatment were more likely to have a gestational carrier, compared with those who resumed treatment (7% vs. 1%). In some cases, gestational carriers lived in another state and the pandemic complicated travel arrangements, which contributed to delays, Dr. Verrilli said.

The analysis did not include information about income or socioeconomic status, which may play a role in patients’ decisions, Dr. Verrilli said.
 

 

 

Emotional impact of indefinite delay

Fertility treatment is often time sensitive, particularly for patients with advanced reproductive age or diminished ovarian reserve, and indefinite postponement of fertility treatment potentially could lead some patients to lose the ability to conceive with their own gametes, Dr. Turocy said.

In early April, Dr. Turocy and colleagues surveyed patients at their academic fertility center in New York City to assess patients’ reactions to the ASRM recommendations. They decided to conduct the study after they realized that treatment cancellations were having a significant emotional effect.

Investigators emailed an 18-item survey to more than 3,000 patients.

In all, 518 patients completed the survey, a response rate of 17%. Patients had an average age of 37 years (range, 23-52 years), and 92% were female. About 24% had children, and 66% had received at least one fertility treatment.

Half had a cycle canceled because of the COVID-19 pandemic, including timed intercourse cycles (5%), intrauterine insemination cycles (23%), IVF cycles with a planned fresh embryo transfer (10%), IVF with all frozen embryos (27%), egg freeze cycles (3%), and FET cycles (30%).

In response to survey questions about whether they agreed with ASRM recommendations, “the reactions were mixed,” Dr. Turocy said.

About 36% of patients agreed all fertility cycles should be canceled, 22% were unsure, and 43% disagreed with the recommendation. Patients who had a cycle canceled were slightly more likely to agree with the cancellations (40% agreed) than those who did not have a cycle canceled (30% agreed), Dr. Turocy said.

Most respondents would have preferred an option to start a treatment cycle in consultation with their doctor. Half “would have chosen to start a new cycle during the height of the pandemic in New York City,” Dr. Turocy said.

Patient opinions may vary by region and depend on the severity of COVID-19 outbreaks there, and they also might change over time, Dr. Turocy suggested. In addition, the opinions and characteristics of patients who responded to the anonymous survey may differ from those of patients who did not respond.

Dr. Verrilli, Dr. Turocy, and Dr. Lin had no relevant financial disclosures.

More than 60% of patients at a center for reproductive medicine in Utah who had fertility treatments canceled because of the COVID-19 pandemic opted to resume treatment once the suspension was lifted about 7 weeks later.

At another fertility center in New York, a survey found that 96% of respondents who had a cycle canceled because of the pandemic found it upsetting, and 22% found it extremely upsetting, with extremely upsetting defined as equivalent to the loss of a child.

The indefinite time frame for resuming treatment when the New York survey was conducted may have been a major source of distress for patients, one of the researchers said at the American Society for Reproductive Medicine’s 2020 annual meeting, held virtually this year.

“They don’t know when they might have that chance again,” said Jenna M. Turocy, MD, of Columbia University Fertility Center, New York.

COVID-19 guidelines published by ASRM on March 17 recommended the suspension of new treatment cycles, including ovulation induction, intrauterine inseminations, and in vitro fertilization (IVF).

An ASRM COVID-19 task force has since supported “the measured resumption of fertility care following the easing of restrictions,” said Paul C. Lin, MD, president of the Society for Assisted Reproductive Technology and a member of the task force.

“Over the past several months, significant knowledge has been gained regarding the COVID-19 virus and its impact on patients and the medical system,” he said in a news release about the two studies that assessed the pandemic’s effects.

Certain precautions remain. “It has become clear that we will need to be practicing COVID-19 protocols at least until an effective and safe vaccine or broadly effective treatment becomes widely available,” Dr. Lin said.
 

Desire to proceed during a pandemic

The Utah Center for Reproductive Medicine on March 15 suspended new IVF cycles and frozen embryo transfers. The center continued to offer IVF cycles for oncofertility patients on an urgent basis.

In early May, patients whose cycles had been suspended had the option to receive treatment.

“Upon reopening, every patient received standardized counseling from their primary IVF physician,” Lauren Verrilli, MD, a reproductive endocrinology and infertility fellow at the University of Utah, Salt Lake City, said at the virtual meeting.

Doctors explained that much remained unknown about COVID-19 in pregnancy, and that it was unclear whether the clinic would need to shut down again. In addition, patients had to undergo COVID-19 testing.

To identify factors associated with proceeding with treatment after the suspension, the researchers compared patients who resumed treatment with patients who did not.

Their analysis included 278 patients who had planned an IVF cycle or frozen embryo transfer (FET) prior to the shutdown. The researchers examined factors such as age, parity, anti-Müllerian hormone, antral follicle count, history of prior IVF cycles or FET, number of frozen blastocysts, gamete source, and use of a gestational carrier.

In all, 62% of patients opted to receive treatment once restrictions were lifted, including 69 of the 133 (52%) patients with planned fresh cycles and 104 of the 145 (72%) patients with planned FET cycles.

Among those with planned fresh cycles, those who opted to resume treatment tended to be older than those who did not resume treatment, with a median age of 37 years versus 35 years, but the difference was not statistically significant.

Among patients with planned FET cycles, those who did not resume treatment were more likely to have a gestational carrier, compared with those who resumed treatment (7% vs. 1%). In some cases, gestational carriers lived in another state and the pandemic complicated travel arrangements, which contributed to delays, Dr. Verrilli said.

The analysis did not include information about income or socioeconomic status, which may play a role in patients’ decisions, Dr. Verrilli said.
 

 

 

Emotional impact of indefinite delay

Fertility treatment is often time sensitive, particularly for patients with advanced reproductive age or diminished ovarian reserve, and indefinite postponement of fertility treatment potentially could lead some patients to lose the ability to conceive with their own gametes, Dr. Turocy said.

In early April, Dr. Turocy and colleagues surveyed patients at their academic fertility center in New York City to assess patients’ reactions to the ASRM recommendations. They decided to conduct the study after they realized that treatment cancellations were having a significant emotional effect.

Investigators emailed an 18-item survey to more than 3,000 patients.

In all, 518 patients completed the survey, a response rate of 17%. Patients had an average age of 37 years (range, 23-52 years), and 92% were female. About 24% had children, and 66% had received at least one fertility treatment.

Half had a cycle canceled because of the COVID-19 pandemic, including timed intercourse cycles (5%), intrauterine insemination cycles (23%), IVF cycles with a planned fresh embryo transfer (10%), IVF with all frozen embryos (27%), egg freeze cycles (3%), and FET cycles (30%).

In response to survey questions about whether they agreed with ASRM recommendations, “the reactions were mixed,” Dr. Turocy said.

About 36% of patients agreed all fertility cycles should be canceled, 22% were unsure, and 43% disagreed with the recommendation. Patients who had a cycle canceled were slightly more likely to agree with the cancellations (40% agreed) than those who did not have a cycle canceled (30% agreed), Dr. Turocy said.

Most respondents would have preferred an option to start a treatment cycle in consultation with their doctor. Half “would have chosen to start a new cycle during the height of the pandemic in New York City,” Dr. Turocy said.

Patient opinions may vary by region and depend on the severity of COVID-19 outbreaks there, and they also might change over time, Dr. Turocy suggested. In addition, the opinions and characteristics of patients who responded to the anonymous survey may differ from those of patients who did not respond.

Dr. Verrilli, Dr. Turocy, and Dr. Lin had no relevant financial disclosures.

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Dermatologists and the history of skin care and beauty devices: Part 4

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Thu, 11/19/2020 - 10:12

In this series on the role dermatologists have played in the history of skin care, I have covered dermatologists who developed cosmeceutical ingredients, dermatologists who consulted for the skin care industry, and those who developed a novel and successful skin care line. In this column, part 4 of the series, I will continue to discuss the role that dermatologists have played in developing skin care products and devices used in the skin care and beauty industry.
 

Dermatologists and Stiefel Laboratories

The Stiefel Medicinal Soap Company, founded in 1847, later became Stiefel Laboratories and was sold to GlaxoSmithKline in 2009. Stiefel Laboratories made many contributions over the years to the field of dermatology as chronicled in the excellent book, Skin Saga” written by Charles Stiefel and published in 2018. The company was first known for soaps and groundbreaking products, such as “Freckle Soap” that sped epidermal turnover, resulting in a more even toned complexion.

Courtesy of Dr. Leslie Baumann
The Stiefel Medicinal Soap Company was first known for soaps and groundbreaking products, such as 'Freckle Soap' that sped epidermal turnover, resulting in a more even toned complexion.


Many dermatologists were involved in developing products and providing advice to the company. Herman Sharlit, MD, in New York, had the idea for a moisturizing soap (Oilatum), a detergent soap (Acne Aid detergent soap), and a coal tar soap (Polytar). Eugene Farber, MD, who was professor and chairman of the department of dermatology at Stanford (Calif.) University, consulted for Stiefel Laboratories and helped them identify and develop many products over the years.1 Stiefel Labs came out with the first facial scrub called Brasivol, an abrasive cream with aluminum oxide particles – the predecessor to modern day microdermabrasion. This facial scrub was conceived by dermatologist Rose Saperstein, MD, Los Angeles, who published a report2 on this in 1960 and also received a patent for it in 1963.3 Brasivol became the company’s first million dollar product.1

Stiefel Laboratories worked with many dermatologists to help them develop their ideas. They included Cleveland White, MD, who patented a highly absorbent foot and body powder known as Zeasorb powder. William Pace, MD, was a Canadian dermatologist who patented an acne treatment containing benzoyl peroxide and sulfur that Stiefel Labs marketed as Sulfoxyl Lotion. Dr. Pace is lovingly referred to as “the father of benzoyl peroxide” because his idea led Stiefel Labs to develop more benzoyl peroxide products. Benzoyl peroxide remains the most popular OTC ingredient to treat acne.

Comedone extractors

Many dermatologists have developed ways to extract comedones. There are publications on using paper clips,4,5safety pins,6 and medicine droppers,7 but some dermatologists have developed special comedone extractors, which include the following: Jay Schamberg, MD, developed a comedone extractor with a loop at each end. He disapproved of cutting a comedone, so did not include a needle or scalpel in his extractor.8

  • Leonard Savitt, MD,9 attached a scalpel to one end of the Schamberg extractor.
  • Alan Shalita, MD, developed a comedone extractor with a large, keyhole-shaped extracting orifice that made the tool easier to clean.10

The Saalfield comedone extractor combines a fixed pointed blade at one end and a small spoon-shaped expressor foot at the other end. (However, I have not been able to determine if Saalfield was a dermatologist.)
 

 

 

Dermatologist who developed methods for lesion excisions

Robert Segal, MD, a dermatologist at the University of Arizona, Tucson, invented the Dermablade. Although this is technically not a beauty device, I am including it because it has made the removal of unsightly moles and lesions much easier. He holds six patents on this device.

Dermatologists developed dermabrasion and microneedling

Ernst Kromayer, MD,11 a dermatologist in Germany, first described microneedling in 1905 when he mounted dental burrs on motor-driven flexible cord equipment to treat scars. Abner Kurtin, MD, a New York dermatologist, learned about Dr. Kromayer’s technique and modified it using stainless wireless brushes. Dr. Kurtin is known as the “father of dermabrasion.” His work was noted by Nobel Laureate Alexis Carrel, MD, who moved to New York City and began using the technique. Dr. Carrel’s protege, New York dermatologist, Norman Orentreich, MD, began using hypodermic needles instead of wire brushes. Microneedling has gained much popularity over the last decade and has been combined with platelet rich plasma injections.

Dermatologist-developed injection to shrink fat

Adam Rotunda, MD, was a dermatology resident at the University of California, Los Angeles, when he and his professor Michael Kolodney, MD, PhD, had the idea to develop deoxycholate as an injectable to reduce fat deposits. They filed a patent in 2004, conducted clinical trials, and it worked! In 2009, the patent for deoxycholic acid (ATX-10), marketed as Kybella, was granted. The rights to the drug were purchased by Aestherx, which later became Kythera Biopharmaceuticals. Kybella received Food and Drug Administration approval in 2015, and 6 months later, Kythera was acquired by Allergan.

Development of FDA-approved drugs to improve skin appearance

In 2004, dermatologists Stuart Shanler, MD, and Andrew Ondo, MD, filed a patent for the use of topical oxymetazoline for the treatment of the erythema of rosacea. They published their observations in 2007, noting that oxymetazoline improved facial flushing and erythema.11 Dr. Shanler then teamed up with dermatologist Neal Walker, MD, to form a start-up pharmaceutical company, Vicept Therapeutics, and took this compound through phase 2 clinical trials, while Dr. Shanler filed additional patents on oxymetazoline compositions and their uses. Once they successfully demonstrated the efficacy of topical oxymetazoline for rosacea, Allergan acquired the rights of the drug, successfully completed the phase 3 clinical trials, and Rhofade was approved by the FDA in 2017. It is the only topical drug invented and developed by a dermatologist to receive FDA approval since tretinoin (Renova) was developed by Albert Kligman, MD, and approved by the FDA for the improvement in appearance of fine wrinkling, mottled hyperpigmentation and roughness associated with photodamage in 1992.

The development of lasers

The last dermatologist I will discuss in this history series is R. Rox Anderson, MD, professor of dermatology at Harvard University, and director of the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston. It is impossible to list all his contributions in such a limited space. It would take a book. Building on efforts pioneered by Leon Goldman, MD, Dr. Anderson and his associates pioneered the use of lasers in dermatology and invented the idea of photothermolysis when they filed a patent on using light to remove hair in 1995.Dieter Manstein, MD, PhD,Dr. Anderson and others filed many patents that led to devices such as hair removal lasers, resurfacing lasers, and Fraxel lasers. They also made discoveries related to using cold to shrink fat. One of their inventions is known as CoolSculpting. They were so influential in the development of cosmetic dermatology that it is hard to imagine the field without their contributions.

This concludes my four-part series on the history of dermatologists’ role in the development of the skin care industry. I hope I have not forgotten anyone; if I did, I apologize. I have asked for ideas on Dermchat, Facebook and LinkedIn. Feel free to reach out if I missed one of your contributions. I will be giving lectures on this topic in the future and would be happy to include anyone I missed.

Dr. Leslie S. Baumann


As the year 2020 ends, I want to say, Happy 50th Anniversary Dermatology News! I hope you enjoyed this historical series in honor of this anniversary.
 

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Revance, Evolus, and Burt’s Bees. She is the CEO of Skin Type Solutions Inc., a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].

References

1. Stiefel, CW. (n.d.). Skin Saga: How a Tiny Family Soap Business Evolved Over Six Generations Into the #1 Dermatology Company in the World. United States: Smart Business Network.

2. Saperstein, RB. Arch Dermatol. 1960 Apr;81:601.

3. Saperstein, RB, and Stiefel, WK (1963). U.S. Patent No. 3,092,111. Washington, DC: U.S. Patent and Trademark Office.

4. George DE et al. J Am Acad Dermatol. 2006 Feb;54(2):326.

5. Cvancara JL, Meffert JJ. J Am Acad Dermatol. 1999 Mar;40(3):477-8.

6. Mukhtar M., Sharma R. Int J Dermatol. 2004 Dec;43(12):967-8.

7. Shellow, H. JAMA. 1951;147(18):1777.

8. Wright CS. Arch Dermatol. 1961;84(3):515.

9. Savitt LE. Arch Dermatol. 1961 Apr;83:660-1.

10. Shalita AR, Harris H. Arch Dermatol. 1972 May;105(5):759-60.

11. Shanler SD, Ondo AL. Arch Dermatol. 2007 Nov;143(11):1369-71.

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In this series on the role dermatologists have played in the history of skin care, I have covered dermatologists who developed cosmeceutical ingredients, dermatologists who consulted for the skin care industry, and those who developed a novel and successful skin care line. In this column, part 4 of the series, I will continue to discuss the role that dermatologists have played in developing skin care products and devices used in the skin care and beauty industry.
 

Dermatologists and Stiefel Laboratories

The Stiefel Medicinal Soap Company, founded in 1847, later became Stiefel Laboratories and was sold to GlaxoSmithKline in 2009. Stiefel Laboratories made many contributions over the years to the field of dermatology as chronicled in the excellent book, Skin Saga” written by Charles Stiefel and published in 2018. The company was first known for soaps and groundbreaking products, such as “Freckle Soap” that sped epidermal turnover, resulting in a more even toned complexion.

Courtesy of Dr. Leslie Baumann
The Stiefel Medicinal Soap Company was first known for soaps and groundbreaking products, such as 'Freckle Soap' that sped epidermal turnover, resulting in a more even toned complexion.


Many dermatologists were involved in developing products and providing advice to the company. Herman Sharlit, MD, in New York, had the idea for a moisturizing soap (Oilatum), a detergent soap (Acne Aid detergent soap), and a coal tar soap (Polytar). Eugene Farber, MD, who was professor and chairman of the department of dermatology at Stanford (Calif.) University, consulted for Stiefel Laboratories and helped them identify and develop many products over the years.1 Stiefel Labs came out with the first facial scrub called Brasivol, an abrasive cream with aluminum oxide particles – the predecessor to modern day microdermabrasion. This facial scrub was conceived by dermatologist Rose Saperstein, MD, Los Angeles, who published a report2 on this in 1960 and also received a patent for it in 1963.3 Brasivol became the company’s first million dollar product.1

Stiefel Laboratories worked with many dermatologists to help them develop their ideas. They included Cleveland White, MD, who patented a highly absorbent foot and body powder known as Zeasorb powder. William Pace, MD, was a Canadian dermatologist who patented an acne treatment containing benzoyl peroxide and sulfur that Stiefel Labs marketed as Sulfoxyl Lotion. Dr. Pace is lovingly referred to as “the father of benzoyl peroxide” because his idea led Stiefel Labs to develop more benzoyl peroxide products. Benzoyl peroxide remains the most popular OTC ingredient to treat acne.

Comedone extractors

Many dermatologists have developed ways to extract comedones. There are publications on using paper clips,4,5safety pins,6 and medicine droppers,7 but some dermatologists have developed special comedone extractors, which include the following: Jay Schamberg, MD, developed a comedone extractor with a loop at each end. He disapproved of cutting a comedone, so did not include a needle or scalpel in his extractor.8

  • Leonard Savitt, MD,9 attached a scalpel to one end of the Schamberg extractor.
  • Alan Shalita, MD, developed a comedone extractor with a large, keyhole-shaped extracting orifice that made the tool easier to clean.10

The Saalfield comedone extractor combines a fixed pointed blade at one end and a small spoon-shaped expressor foot at the other end. (However, I have not been able to determine if Saalfield was a dermatologist.)
 

 

 

Dermatologist who developed methods for lesion excisions

Robert Segal, MD, a dermatologist at the University of Arizona, Tucson, invented the Dermablade. Although this is technically not a beauty device, I am including it because it has made the removal of unsightly moles and lesions much easier. He holds six patents on this device.

Dermatologists developed dermabrasion and microneedling

Ernst Kromayer, MD,11 a dermatologist in Germany, first described microneedling in 1905 when he mounted dental burrs on motor-driven flexible cord equipment to treat scars. Abner Kurtin, MD, a New York dermatologist, learned about Dr. Kromayer’s technique and modified it using stainless wireless brushes. Dr. Kurtin is known as the “father of dermabrasion.” His work was noted by Nobel Laureate Alexis Carrel, MD, who moved to New York City and began using the technique. Dr. Carrel’s protege, New York dermatologist, Norman Orentreich, MD, began using hypodermic needles instead of wire brushes. Microneedling has gained much popularity over the last decade and has been combined with platelet rich plasma injections.

Dermatologist-developed injection to shrink fat

Adam Rotunda, MD, was a dermatology resident at the University of California, Los Angeles, when he and his professor Michael Kolodney, MD, PhD, had the idea to develop deoxycholate as an injectable to reduce fat deposits. They filed a patent in 2004, conducted clinical trials, and it worked! In 2009, the patent for deoxycholic acid (ATX-10), marketed as Kybella, was granted. The rights to the drug were purchased by Aestherx, which later became Kythera Biopharmaceuticals. Kybella received Food and Drug Administration approval in 2015, and 6 months later, Kythera was acquired by Allergan.

Development of FDA-approved drugs to improve skin appearance

In 2004, dermatologists Stuart Shanler, MD, and Andrew Ondo, MD, filed a patent for the use of topical oxymetazoline for the treatment of the erythema of rosacea. They published their observations in 2007, noting that oxymetazoline improved facial flushing and erythema.11 Dr. Shanler then teamed up with dermatologist Neal Walker, MD, to form a start-up pharmaceutical company, Vicept Therapeutics, and took this compound through phase 2 clinical trials, while Dr. Shanler filed additional patents on oxymetazoline compositions and their uses. Once they successfully demonstrated the efficacy of topical oxymetazoline for rosacea, Allergan acquired the rights of the drug, successfully completed the phase 3 clinical trials, and Rhofade was approved by the FDA in 2017. It is the only topical drug invented and developed by a dermatologist to receive FDA approval since tretinoin (Renova) was developed by Albert Kligman, MD, and approved by the FDA for the improvement in appearance of fine wrinkling, mottled hyperpigmentation and roughness associated with photodamage in 1992.

The development of lasers

The last dermatologist I will discuss in this history series is R. Rox Anderson, MD, professor of dermatology at Harvard University, and director of the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston. It is impossible to list all his contributions in such a limited space. It would take a book. Building on efforts pioneered by Leon Goldman, MD, Dr. Anderson and his associates pioneered the use of lasers in dermatology and invented the idea of photothermolysis when they filed a patent on using light to remove hair in 1995.Dieter Manstein, MD, PhD,Dr. Anderson and others filed many patents that led to devices such as hair removal lasers, resurfacing lasers, and Fraxel lasers. They also made discoveries related to using cold to shrink fat. One of their inventions is known as CoolSculpting. They were so influential in the development of cosmetic dermatology that it is hard to imagine the field without their contributions.

This concludes my four-part series on the history of dermatologists’ role in the development of the skin care industry. I hope I have not forgotten anyone; if I did, I apologize. I have asked for ideas on Dermchat, Facebook and LinkedIn. Feel free to reach out if I missed one of your contributions. I will be giving lectures on this topic in the future and would be happy to include anyone I missed.

Dr. Leslie S. Baumann


As the year 2020 ends, I want to say, Happy 50th Anniversary Dermatology News! I hope you enjoyed this historical series in honor of this anniversary.
 

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Revance, Evolus, and Burt’s Bees. She is the CEO of Skin Type Solutions Inc., a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].

References

1. Stiefel, CW. (n.d.). Skin Saga: How a Tiny Family Soap Business Evolved Over Six Generations Into the #1 Dermatology Company in the World. United States: Smart Business Network.

2. Saperstein, RB. Arch Dermatol. 1960 Apr;81:601.

3. Saperstein, RB, and Stiefel, WK (1963). U.S. Patent No. 3,092,111. Washington, DC: U.S. Patent and Trademark Office.

4. George DE et al. J Am Acad Dermatol. 2006 Feb;54(2):326.

5. Cvancara JL, Meffert JJ. J Am Acad Dermatol. 1999 Mar;40(3):477-8.

6. Mukhtar M., Sharma R. Int J Dermatol. 2004 Dec;43(12):967-8.

7. Shellow, H. JAMA. 1951;147(18):1777.

8. Wright CS. Arch Dermatol. 1961;84(3):515.

9. Savitt LE. Arch Dermatol. 1961 Apr;83:660-1.

10. Shalita AR, Harris H. Arch Dermatol. 1972 May;105(5):759-60.

11. Shanler SD, Ondo AL. Arch Dermatol. 2007 Nov;143(11):1369-71.

In this series on the role dermatologists have played in the history of skin care, I have covered dermatologists who developed cosmeceutical ingredients, dermatologists who consulted for the skin care industry, and those who developed a novel and successful skin care line. In this column, part 4 of the series, I will continue to discuss the role that dermatologists have played in developing skin care products and devices used in the skin care and beauty industry.
 

Dermatologists and Stiefel Laboratories

The Stiefel Medicinal Soap Company, founded in 1847, later became Stiefel Laboratories and was sold to GlaxoSmithKline in 2009. Stiefel Laboratories made many contributions over the years to the field of dermatology as chronicled in the excellent book, Skin Saga” written by Charles Stiefel and published in 2018. The company was first known for soaps and groundbreaking products, such as “Freckle Soap” that sped epidermal turnover, resulting in a more even toned complexion.

Courtesy of Dr. Leslie Baumann
The Stiefel Medicinal Soap Company was first known for soaps and groundbreaking products, such as 'Freckle Soap' that sped epidermal turnover, resulting in a more even toned complexion.


Many dermatologists were involved in developing products and providing advice to the company. Herman Sharlit, MD, in New York, had the idea for a moisturizing soap (Oilatum), a detergent soap (Acne Aid detergent soap), and a coal tar soap (Polytar). Eugene Farber, MD, who was professor and chairman of the department of dermatology at Stanford (Calif.) University, consulted for Stiefel Laboratories and helped them identify and develop many products over the years.1 Stiefel Labs came out with the first facial scrub called Brasivol, an abrasive cream with aluminum oxide particles – the predecessor to modern day microdermabrasion. This facial scrub was conceived by dermatologist Rose Saperstein, MD, Los Angeles, who published a report2 on this in 1960 and also received a patent for it in 1963.3 Brasivol became the company’s first million dollar product.1

Stiefel Laboratories worked with many dermatologists to help them develop their ideas. They included Cleveland White, MD, who patented a highly absorbent foot and body powder known as Zeasorb powder. William Pace, MD, was a Canadian dermatologist who patented an acne treatment containing benzoyl peroxide and sulfur that Stiefel Labs marketed as Sulfoxyl Lotion. Dr. Pace is lovingly referred to as “the father of benzoyl peroxide” because his idea led Stiefel Labs to develop more benzoyl peroxide products. Benzoyl peroxide remains the most popular OTC ingredient to treat acne.

Comedone extractors

Many dermatologists have developed ways to extract comedones. There are publications on using paper clips,4,5safety pins,6 and medicine droppers,7 but some dermatologists have developed special comedone extractors, which include the following: Jay Schamberg, MD, developed a comedone extractor with a loop at each end. He disapproved of cutting a comedone, so did not include a needle or scalpel in his extractor.8

  • Leonard Savitt, MD,9 attached a scalpel to one end of the Schamberg extractor.
  • Alan Shalita, MD, developed a comedone extractor with a large, keyhole-shaped extracting orifice that made the tool easier to clean.10

The Saalfield comedone extractor combines a fixed pointed blade at one end and a small spoon-shaped expressor foot at the other end. (However, I have not been able to determine if Saalfield was a dermatologist.)
 

 

 

Dermatologist who developed methods for lesion excisions

Robert Segal, MD, a dermatologist at the University of Arizona, Tucson, invented the Dermablade. Although this is technically not a beauty device, I am including it because it has made the removal of unsightly moles and lesions much easier. He holds six patents on this device.

Dermatologists developed dermabrasion and microneedling

Ernst Kromayer, MD,11 a dermatologist in Germany, first described microneedling in 1905 when he mounted dental burrs on motor-driven flexible cord equipment to treat scars. Abner Kurtin, MD, a New York dermatologist, learned about Dr. Kromayer’s technique and modified it using stainless wireless brushes. Dr. Kurtin is known as the “father of dermabrasion.” His work was noted by Nobel Laureate Alexis Carrel, MD, who moved to New York City and began using the technique. Dr. Carrel’s protege, New York dermatologist, Norman Orentreich, MD, began using hypodermic needles instead of wire brushes. Microneedling has gained much popularity over the last decade and has been combined with platelet rich plasma injections.

Dermatologist-developed injection to shrink fat

Adam Rotunda, MD, was a dermatology resident at the University of California, Los Angeles, when he and his professor Michael Kolodney, MD, PhD, had the idea to develop deoxycholate as an injectable to reduce fat deposits. They filed a patent in 2004, conducted clinical trials, and it worked! In 2009, the patent for deoxycholic acid (ATX-10), marketed as Kybella, was granted. The rights to the drug were purchased by Aestherx, which later became Kythera Biopharmaceuticals. Kybella received Food and Drug Administration approval in 2015, and 6 months later, Kythera was acquired by Allergan.

Development of FDA-approved drugs to improve skin appearance

In 2004, dermatologists Stuart Shanler, MD, and Andrew Ondo, MD, filed a patent for the use of topical oxymetazoline for the treatment of the erythema of rosacea. They published their observations in 2007, noting that oxymetazoline improved facial flushing and erythema.11 Dr. Shanler then teamed up with dermatologist Neal Walker, MD, to form a start-up pharmaceutical company, Vicept Therapeutics, and took this compound through phase 2 clinical trials, while Dr. Shanler filed additional patents on oxymetazoline compositions and their uses. Once they successfully demonstrated the efficacy of topical oxymetazoline for rosacea, Allergan acquired the rights of the drug, successfully completed the phase 3 clinical trials, and Rhofade was approved by the FDA in 2017. It is the only topical drug invented and developed by a dermatologist to receive FDA approval since tretinoin (Renova) was developed by Albert Kligman, MD, and approved by the FDA for the improvement in appearance of fine wrinkling, mottled hyperpigmentation and roughness associated with photodamage in 1992.

The development of lasers

The last dermatologist I will discuss in this history series is R. Rox Anderson, MD, professor of dermatology at Harvard University, and director of the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston. It is impossible to list all his contributions in such a limited space. It would take a book. Building on efforts pioneered by Leon Goldman, MD, Dr. Anderson and his associates pioneered the use of lasers in dermatology and invented the idea of photothermolysis when they filed a patent on using light to remove hair in 1995.Dieter Manstein, MD, PhD,Dr. Anderson and others filed many patents that led to devices such as hair removal lasers, resurfacing lasers, and Fraxel lasers. They also made discoveries related to using cold to shrink fat. One of their inventions is known as CoolSculpting. They were so influential in the development of cosmetic dermatology that it is hard to imagine the field without their contributions.

This concludes my four-part series on the history of dermatologists’ role in the development of the skin care industry. I hope I have not forgotten anyone; if I did, I apologize. I have asked for ideas on Dermchat, Facebook and LinkedIn. Feel free to reach out if I missed one of your contributions. I will be giving lectures on this topic in the future and would be happy to include anyone I missed.

Dr. Leslie S. Baumann


As the year 2020 ends, I want to say, Happy 50th Anniversary Dermatology News! I hope you enjoyed this historical series in honor of this anniversary.
 

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Revance, Evolus, and Burt’s Bees. She is the CEO of Skin Type Solutions Inc., a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].

References

1. Stiefel, CW. (n.d.). Skin Saga: How a Tiny Family Soap Business Evolved Over Six Generations Into the #1 Dermatology Company in the World. United States: Smart Business Network.

2. Saperstein, RB. Arch Dermatol. 1960 Apr;81:601.

3. Saperstein, RB, and Stiefel, WK (1963). U.S. Patent No. 3,092,111. Washington, DC: U.S. Patent and Trademark Office.

4. George DE et al. J Am Acad Dermatol. 2006 Feb;54(2):326.

5. Cvancara JL, Meffert JJ. J Am Acad Dermatol. 1999 Mar;40(3):477-8.

6. Mukhtar M., Sharma R. Int J Dermatol. 2004 Dec;43(12):967-8.

7. Shellow, H. JAMA. 1951;147(18):1777.

8. Wright CS. Arch Dermatol. 1961;84(3):515.

9. Savitt LE. Arch Dermatol. 1961 Apr;83:660-1.

10. Shalita AR, Harris H. Arch Dermatol. 1972 May;105(5):759-60.

11. Shanler SD, Ondo AL. Arch Dermatol. 2007 Nov;143(11):1369-71.

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Breast Cancer Journal Scans: November 2020

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Dr. Erin Roesch: Ongoing research in the field of tumor genomics will help advance the field of personalized treatment for breast cancer
Dr. Roesch scans the journals so you don't have to

Erin Roesch, MD
Racial disparities in health care are complex and involve factors related to biology, socioeconomic status, literacy, co-morbid health conditions and access to care. Kong and colleagues studied the patterns of various breast cancer subtypes and clinicopathologic variables among nearly 240,000 women from the SEER database. Tumors characterized by higher grade and more aggressive subtypes, specifically, ERBB2-positive and triple-negative, were found to have higher incidence in black women. Studies have also shown that although neoadjuvant chemotherapy is more frequently administered to black, Hispanic and Asian women than to white women, response rates for HER2-positive and triple-negative subtypes are lower for black compared to white women. These findings suggest possible inherent differences in the tumor biology, and further research is warranted to better understand these findings to optimize treatment and outcomes for all women.

The utilization of neoadjuvant chemotherapy is increasing, and is considered standard of care for the majority of patients with HER2-positive and triple-negative breast cancer subtypes. A significant benefit of neoadjuvant systemic therapy is assessment of the tumor biology via chemotherapy response, which has prognostic implications and additionally can help tailor therapy in the adjuvant setting. In the era of precision medicine, de-escalation strategies are considered to provide patients with efficacious treatment and spare toxicity. Tasoulis et al assessed the accuracy of image-guided biopsy after neoadjuvant therapy to predict residual disease, and found a false negative rate (FNR) of 3.2% and negative predictive value (NPV) of 97.4% when the residual imaging abnormality was 2cm or smaller with a minimum of 6 vacuum-assisted biopsies performed. They also demonstrated a FNR of 4.2% and NPV of 97.2% in the subgroup of patients with ERBB2-positive and triple-negative subtypes, those most likely to achieve a pathologic complete response. These findings suggest that local therapy de-escalation may be a relevant strategy for those patients who have excellent responses to neoadjuvant chemotherapy.

Estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) have historically been, and still are, considered important prognostic and predictive factors. Beyond these, the role of genomic assays in breast cancer is evolving, and the 21-gene recurrence score is a valuable prognostic tool to assess chemotherapy benefit in women with early-stage ER-positive, HER2-negative breast cancer. Precision medicine in oncology strives to identify and apply an individualized approach to cancer care based on strong scientific data. Zhang and colleagues demonstrated the prognostic ability of an 8 DNA repair-related gene signature that was constructed from gene expression profiles from over 1,000 women diagnosed with breast cancer. These genes have roles in ER-mediated transactivation, DNA damage repair and cell adhesion processes. Additionally, Kudela et al showed that microRNAs (mRNAs), which are small RNAs that regulate gene expression, are able to classify intrinsic breast cancer subtype, play a role in endocrine resistance, and may also enhance the function of predictive models such as the 21-gene recurrence score (Kudela). Ongoing research in the field of tumor genomics will help advance the field of personalized treatment for breast cancer.

 

Erin Roesch, MD
The Cleveland Clinic

 

References:

Killelea BK, Yang VQ, Wang SY, Hayse B, Mougalian S, Horowitz NR, Chagpar AB, Pusztai L, Lannin DR. Racial differences in the use and outcome of neoadjuvant chemotherapy for breast cancer: results from the National Cancer Data Base. J Clin Oncol. 2015;33:4267-76.

Heil J, Schaefgen B, Sinn P, Harcos A, Gomez C, Stieber A, Hennings A, Schuetz F, Sohn C, Schneeweiss A, Golatta M. Diagnosis of pathological complete response to neoadjuvant chemotherapy in breast cancer by minimal invasive biopsy techniques. Br J Cancer. 2015;113:1565-70.

Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, Geyer CE Jr, Dees EC, Goetz MP, Olson JA Jr, Lively T, Badve SS, Saphner TJ, Wagner LI, Whelan TJ, Ellis MJ, Paik S, Wood WC, Ravdin PM, Keane MM, Gomez Moreno HL, Reddy PS, Goggins TF, Mayer IA, Brufsky AM, Toppmeyer DL, Kaklamani VG, Berenberg JL, Abrams J, Sledge GW Jr. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med. 2018;379:111-21.

Emmadi R, Canestrari E, Arbieva ZH, Mu W, Dai Y, Frasor J, Wiley E. Correlative analysis of miRNA expression and Oncotype Dx Recurrence Score in estrogen receptor positive breast carcinomas. PLoS One. 2015;10:e0145346.

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Dr. Roesch scans the journals so you don't have to
Dr. Roesch scans the journals so you don't have to

Erin Roesch, MD
Racial disparities in health care are complex and involve factors related to biology, socioeconomic status, literacy, co-morbid health conditions and access to care. Kong and colleagues studied the patterns of various breast cancer subtypes and clinicopathologic variables among nearly 240,000 women from the SEER database. Tumors characterized by higher grade and more aggressive subtypes, specifically, ERBB2-positive and triple-negative, were found to have higher incidence in black women. Studies have also shown that although neoadjuvant chemotherapy is more frequently administered to black, Hispanic and Asian women than to white women, response rates for HER2-positive and triple-negative subtypes are lower for black compared to white women. These findings suggest possible inherent differences in the tumor biology, and further research is warranted to better understand these findings to optimize treatment and outcomes for all women.

The utilization of neoadjuvant chemotherapy is increasing, and is considered standard of care for the majority of patients with HER2-positive and triple-negative breast cancer subtypes. A significant benefit of neoadjuvant systemic therapy is assessment of the tumor biology via chemotherapy response, which has prognostic implications and additionally can help tailor therapy in the adjuvant setting. In the era of precision medicine, de-escalation strategies are considered to provide patients with efficacious treatment and spare toxicity. Tasoulis et al assessed the accuracy of image-guided biopsy after neoadjuvant therapy to predict residual disease, and found a false negative rate (FNR) of 3.2% and negative predictive value (NPV) of 97.4% when the residual imaging abnormality was 2cm or smaller with a minimum of 6 vacuum-assisted biopsies performed. They also demonstrated a FNR of 4.2% and NPV of 97.2% in the subgroup of patients with ERBB2-positive and triple-negative subtypes, those most likely to achieve a pathologic complete response. These findings suggest that local therapy de-escalation may be a relevant strategy for those patients who have excellent responses to neoadjuvant chemotherapy.

Estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) have historically been, and still are, considered important prognostic and predictive factors. Beyond these, the role of genomic assays in breast cancer is evolving, and the 21-gene recurrence score is a valuable prognostic tool to assess chemotherapy benefit in women with early-stage ER-positive, HER2-negative breast cancer. Precision medicine in oncology strives to identify and apply an individualized approach to cancer care based on strong scientific data. Zhang and colleagues demonstrated the prognostic ability of an 8 DNA repair-related gene signature that was constructed from gene expression profiles from over 1,000 women diagnosed with breast cancer. These genes have roles in ER-mediated transactivation, DNA damage repair and cell adhesion processes. Additionally, Kudela et al showed that microRNAs (mRNAs), which are small RNAs that regulate gene expression, are able to classify intrinsic breast cancer subtype, play a role in endocrine resistance, and may also enhance the function of predictive models such as the 21-gene recurrence score (Kudela). Ongoing research in the field of tumor genomics will help advance the field of personalized treatment for breast cancer.

 

Erin Roesch, MD
The Cleveland Clinic

 

References:

Killelea BK, Yang VQ, Wang SY, Hayse B, Mougalian S, Horowitz NR, Chagpar AB, Pusztai L, Lannin DR. Racial differences in the use and outcome of neoadjuvant chemotherapy for breast cancer: results from the National Cancer Data Base. J Clin Oncol. 2015;33:4267-76.

Heil J, Schaefgen B, Sinn P, Harcos A, Gomez C, Stieber A, Hennings A, Schuetz F, Sohn C, Schneeweiss A, Golatta M. Diagnosis of pathological complete response to neoadjuvant chemotherapy in breast cancer by minimal invasive biopsy techniques. Br J Cancer. 2015;113:1565-70.

Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, Geyer CE Jr, Dees EC, Goetz MP, Olson JA Jr, Lively T, Badve SS, Saphner TJ, Wagner LI, Whelan TJ, Ellis MJ, Paik S, Wood WC, Ravdin PM, Keane MM, Gomez Moreno HL, Reddy PS, Goggins TF, Mayer IA, Brufsky AM, Toppmeyer DL, Kaklamani VG, Berenberg JL, Abrams J, Sledge GW Jr. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med. 2018;379:111-21.

Emmadi R, Canestrari E, Arbieva ZH, Mu W, Dai Y, Frasor J, Wiley E. Correlative analysis of miRNA expression and Oncotype Dx Recurrence Score in estrogen receptor positive breast carcinomas. PLoS One. 2015;10:e0145346.

Erin Roesch, MD
Racial disparities in health care are complex and involve factors related to biology, socioeconomic status, literacy, co-morbid health conditions and access to care. Kong and colleagues studied the patterns of various breast cancer subtypes and clinicopathologic variables among nearly 240,000 women from the SEER database. Tumors characterized by higher grade and more aggressive subtypes, specifically, ERBB2-positive and triple-negative, were found to have higher incidence in black women. Studies have also shown that although neoadjuvant chemotherapy is more frequently administered to black, Hispanic and Asian women than to white women, response rates for HER2-positive and triple-negative subtypes are lower for black compared to white women. These findings suggest possible inherent differences in the tumor biology, and further research is warranted to better understand these findings to optimize treatment and outcomes for all women.

The utilization of neoadjuvant chemotherapy is increasing, and is considered standard of care for the majority of patients with HER2-positive and triple-negative breast cancer subtypes. A significant benefit of neoadjuvant systemic therapy is assessment of the tumor biology via chemotherapy response, which has prognostic implications and additionally can help tailor therapy in the adjuvant setting. In the era of precision medicine, de-escalation strategies are considered to provide patients with efficacious treatment and spare toxicity. Tasoulis et al assessed the accuracy of image-guided biopsy after neoadjuvant therapy to predict residual disease, and found a false negative rate (FNR) of 3.2% and negative predictive value (NPV) of 97.4% when the residual imaging abnormality was 2cm or smaller with a minimum of 6 vacuum-assisted biopsies performed. They also demonstrated a FNR of 4.2% and NPV of 97.2% in the subgroup of patients with ERBB2-positive and triple-negative subtypes, those most likely to achieve a pathologic complete response. These findings suggest that local therapy de-escalation may be a relevant strategy for those patients who have excellent responses to neoadjuvant chemotherapy.

Estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) have historically been, and still are, considered important prognostic and predictive factors. Beyond these, the role of genomic assays in breast cancer is evolving, and the 21-gene recurrence score is a valuable prognostic tool to assess chemotherapy benefit in women with early-stage ER-positive, HER2-negative breast cancer. Precision medicine in oncology strives to identify and apply an individualized approach to cancer care based on strong scientific data. Zhang and colleagues demonstrated the prognostic ability of an 8 DNA repair-related gene signature that was constructed from gene expression profiles from over 1,000 women diagnosed with breast cancer. These genes have roles in ER-mediated transactivation, DNA damage repair and cell adhesion processes. Additionally, Kudela et al showed that microRNAs (mRNAs), which are small RNAs that regulate gene expression, are able to classify intrinsic breast cancer subtype, play a role in endocrine resistance, and may also enhance the function of predictive models such as the 21-gene recurrence score (Kudela). Ongoing research in the field of tumor genomics will help advance the field of personalized treatment for breast cancer.

 

Erin Roesch, MD
The Cleveland Clinic

 

References:

Killelea BK, Yang VQ, Wang SY, Hayse B, Mougalian S, Horowitz NR, Chagpar AB, Pusztai L, Lannin DR. Racial differences in the use and outcome of neoadjuvant chemotherapy for breast cancer: results from the National Cancer Data Base. J Clin Oncol. 2015;33:4267-76.

Heil J, Schaefgen B, Sinn P, Harcos A, Gomez C, Stieber A, Hennings A, Schuetz F, Sohn C, Schneeweiss A, Golatta M. Diagnosis of pathological complete response to neoadjuvant chemotherapy in breast cancer by minimal invasive biopsy techniques. Br J Cancer. 2015;113:1565-70.

Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, Geyer CE Jr, Dees EC, Goetz MP, Olson JA Jr, Lively T, Badve SS, Saphner TJ, Wagner LI, Whelan TJ, Ellis MJ, Paik S, Wood WC, Ravdin PM, Keane MM, Gomez Moreno HL, Reddy PS, Goggins TF, Mayer IA, Brufsky AM, Toppmeyer DL, Kaklamani VG, Berenberg JL, Abrams J, Sledge GW Jr. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med. 2018;379:111-21.

Emmadi R, Canestrari E, Arbieva ZH, Mu W, Dai Y, Frasor J, Wiley E. Correlative analysis of miRNA expression and Oncotype Dx Recurrence Score in estrogen receptor positive breast carcinomas. PLoS One. 2015;10:e0145346.

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MicroRNAs show promising predictive value for early breast cancer

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Key clinical point: Differences in microRNAs (mRNAs), a group of small RNAs that regulate gene expression, can be used to distinguish among breast cancer subtypes.

Major finding: Altered expression of microRNAs distinguished between cancer and healthy samples, and also identified breast cancer subtypes including HER2, Luminal A, Luminal B, and triple negative breast cancer, according to a retrospective study of 740 breast cancer cases included in the review.

Study details: The data come from a review of the latest research on the prognostic and predictive value of microRNAs in patients with luminal A breast cancer.

Disclosures: The study was supported by the Scientific Grant Agency of the Ministry of Education of the Slovak Republic, the Slovak Research and Development Agency, and the Operational Programme Research and Innovation funded by the ERDF.

Citation: Kudela E et al. Int J Mol Sci. 2020 Oct 17. doi: 10.3390/ijms21207691.

 

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Key clinical point: Differences in microRNAs (mRNAs), a group of small RNAs that regulate gene expression, can be used to distinguish among breast cancer subtypes.

Major finding: Altered expression of microRNAs distinguished between cancer and healthy samples, and also identified breast cancer subtypes including HER2, Luminal A, Luminal B, and triple negative breast cancer, according to a retrospective study of 740 breast cancer cases included in the review.

Study details: The data come from a review of the latest research on the prognostic and predictive value of microRNAs in patients with luminal A breast cancer.

Disclosures: The study was supported by the Scientific Grant Agency of the Ministry of Education of the Slovak Republic, the Slovak Research and Development Agency, and the Operational Programme Research and Innovation funded by the ERDF.

Citation: Kudela E et al. Int J Mol Sci. 2020 Oct 17. doi: 10.3390/ijms21207691.

 

Key clinical point: Differences in microRNAs (mRNAs), a group of small RNAs that regulate gene expression, can be used to distinguish among breast cancer subtypes.

Major finding: Altered expression of microRNAs distinguished between cancer and healthy samples, and also identified breast cancer subtypes including HER2, Luminal A, Luminal B, and triple negative breast cancer, according to a retrospective study of 740 breast cancer cases included in the review.

Study details: The data come from a review of the latest research on the prognostic and predictive value of microRNAs in patients with luminal A breast cancer.

Disclosures: The study was supported by the Scientific Grant Agency of the Ministry of Education of the Slovak Republic, the Slovak Research and Development Agency, and the Operational Programme Research and Innovation funded by the ERDF.

Citation: Kudela E et al. Int J Mol Sci. 2020 Oct 17. doi: 10.3390/ijms21207691.

 

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Income loss shows no link to stress levels in young women with breast cancer

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Key clinical point: Over a 12-month period, 15.4% of women with early breast cancer reported losing income. Although stress, anxiety, and depression were not association with household income changes (risk ratios 2.42, 1.12, and 1.41, respectively), the proportion of women reporting high stress was greatest among those who lost income (13.2%, compared to 3.1% among women maintaining an income of $100,000 or higher).

Major finding: Women with a household income below $50,000 had a higher risk of losing household income compared to those with incomes of $50,000 or higher, suggesting that lower income women may be more vulnerable to income loss after diagnosis with breast cancer.

Study details: The data come from a prospective, longitudinal cohort study including 467 women with early breast cancer enrolled in the Young and Strong cohort trial from 2012 to 2013.

Disclosures: The study was supported by an ASCO Improving Cancer Care grant, the National Institutes of Health, an NIH training grants. The researchers had no financial conflicts to disclose.

Citation: Cook EE et al. BMC Public Health. 2020 Oct 6. doi: 10.1186/s12889-020-09562-z.

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Key clinical point: Over a 12-month period, 15.4% of women with early breast cancer reported losing income. Although stress, anxiety, and depression were not association with household income changes (risk ratios 2.42, 1.12, and 1.41, respectively), the proportion of women reporting high stress was greatest among those who lost income (13.2%, compared to 3.1% among women maintaining an income of $100,000 or higher).

Major finding: Women with a household income below $50,000 had a higher risk of losing household income compared to those with incomes of $50,000 or higher, suggesting that lower income women may be more vulnerable to income loss after diagnosis with breast cancer.

Study details: The data come from a prospective, longitudinal cohort study including 467 women with early breast cancer enrolled in the Young and Strong cohort trial from 2012 to 2013.

Disclosures: The study was supported by an ASCO Improving Cancer Care grant, the National Institutes of Health, an NIH training grants. The researchers had no financial conflicts to disclose.

Citation: Cook EE et al. BMC Public Health. 2020 Oct 6. doi: 10.1186/s12889-020-09562-z.

Key clinical point: Over a 12-month period, 15.4% of women with early breast cancer reported losing income. Although stress, anxiety, and depression were not association with household income changes (risk ratios 2.42, 1.12, and 1.41, respectively), the proportion of women reporting high stress was greatest among those who lost income (13.2%, compared to 3.1% among women maintaining an income of $100,000 or higher).

Major finding: Women with a household income below $50,000 had a higher risk of losing household income compared to those with incomes of $50,000 or higher, suggesting that lower income women may be more vulnerable to income loss after diagnosis with breast cancer.

Study details: The data come from a prospective, longitudinal cohort study including 467 women with early breast cancer enrolled in the Young and Strong cohort trial from 2012 to 2013.

Disclosures: The study was supported by an ASCO Improving Cancer Care grant, the National Institutes of Health, an NIH training grants. The researchers had no financial conflicts to disclose.

Citation: Cook EE et al. BMC Public Health. 2020 Oct 6. doi: 10.1186/s12889-020-09562-z.

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Exercise and diet intervention fail to improve fatigue in breast cancer patients on chemotherapy

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Key clinical point: An exercise and diet intervention had no significant impact on fatigue in women with breast cancer who were undergoing chemotherapy or radiotherapy.

Major finding: Based on the general cancer-related fatigue score using the MFI-20 questionnaire, general fatigue levels were not significantly different between groups of breast cancer patients randomized to an Adapted Physical Activity Diet (APAD) program and controls (P = 0.274).

Study details: The data come from a randomized, controlled trial of 360 adult women with early breast cancer designed to evaluate the impact of an exercise and nutrition intervention on fatigue during 6 months of chemotherapy and radiotherapy.

Disclosures: The study was supported by the INCa-DGOS and by a Montpellier Cancer SIRIC grant. The researchers had no financial conflicts to disclose. 

Citation: Jacot W et al. Nutrients. 2020 Oct 9. doi: 10.3390/nu12103081.

 

 

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Key clinical point: An exercise and diet intervention had no significant impact on fatigue in women with breast cancer who were undergoing chemotherapy or radiotherapy.

Major finding: Based on the general cancer-related fatigue score using the MFI-20 questionnaire, general fatigue levels were not significantly different between groups of breast cancer patients randomized to an Adapted Physical Activity Diet (APAD) program and controls (P = 0.274).

Study details: The data come from a randomized, controlled trial of 360 adult women with early breast cancer designed to evaluate the impact of an exercise and nutrition intervention on fatigue during 6 months of chemotherapy and radiotherapy.

Disclosures: The study was supported by the INCa-DGOS and by a Montpellier Cancer SIRIC grant. The researchers had no financial conflicts to disclose. 

Citation: Jacot W et al. Nutrients. 2020 Oct 9. doi: 10.3390/nu12103081.

 

 

Key clinical point: An exercise and diet intervention had no significant impact on fatigue in women with breast cancer who were undergoing chemotherapy or radiotherapy.

Major finding: Based on the general cancer-related fatigue score using the MFI-20 questionnaire, general fatigue levels were not significantly different between groups of breast cancer patients randomized to an Adapted Physical Activity Diet (APAD) program and controls (P = 0.274).

Study details: The data come from a randomized, controlled trial of 360 adult women with early breast cancer designed to evaluate the impact of an exercise and nutrition intervention on fatigue during 6 months of chemotherapy and radiotherapy.

Disclosures: The study was supported by the INCa-DGOS and by a Montpellier Cancer SIRIC grant. The researchers had no financial conflicts to disclose. 

Citation: Jacot W et al. Nutrients. 2020 Oct 9. doi: 10.3390/nu12103081.

 

 

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DNA-based model predicts overall survival in breast cancer

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Key clinical point: A prognostic signature including 8 DNA repair-related genes (MDC1, RPA3, MED17, DDB2, SFPQ, XRCC4, CYP19A1, and PARP3) predicted overall survival in breast cancer patients

Major finding: The areas under the curve were for 3-year survival and 5-year survival were 0.717 and 0.772, respectively, in the GSE9893 data set, and 0.691 and 0.718, respectively, in the GSE42568 data set.

Study details: The data come from 1,096 women with breast cancer; gene expression profiles and clinical data were collected from a Chinese health database between October 9, 2019, and February 3, 2020.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Citation: Zhang D et al. JAMA Netw Open. 2020 Oct 5. doi:10.1001/jamanetworkopen.2020.14622.

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Key clinical point: A prognostic signature including 8 DNA repair-related genes (MDC1, RPA3, MED17, DDB2, SFPQ, XRCC4, CYP19A1, and PARP3) predicted overall survival in breast cancer patients

Major finding: The areas under the curve were for 3-year survival and 5-year survival were 0.717 and 0.772, respectively, in the GSE9893 data set, and 0.691 and 0.718, respectively, in the GSE42568 data set.

Study details: The data come from 1,096 women with breast cancer; gene expression profiles and clinical data were collected from a Chinese health database between October 9, 2019, and February 3, 2020.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Citation: Zhang D et al. JAMA Netw Open. 2020 Oct 5. doi:10.1001/jamanetworkopen.2020.14622.

Key clinical point: A prognostic signature including 8 DNA repair-related genes (MDC1, RPA3, MED17, DDB2, SFPQ, XRCC4, CYP19A1, and PARP3) predicted overall survival in breast cancer patients

Major finding: The areas under the curve were for 3-year survival and 5-year survival were 0.717 and 0.772, respectively, in the GSE9893 data set, and 0.691 and 0.718, respectively, in the GSE42568 data set.

Study details: The data come from 1,096 women with breast cancer; gene expression profiles and clinical data were collected from a Chinese health database between October 9, 2019, and February 3, 2020.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Citation: Zhang D et al. JAMA Netw Open. 2020 Oct 5. doi:10.1001/jamanetworkopen.2020.14622.

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Textured breast implants may raise risk of cancer relapse

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Key clinical point: The use of textured implants in reconstructive surgery after breast cancer mastectomy was significantly associated with lower rates of disease-free survival compared to smooth implants, but no difference was noted in local and regional recurrence-free survival based on implant texture.

Major finding: Rates of disease-free survival were significantly lower among breast cancer patients who received textured breast implants compared to those who received smooth implants (hazard ratio 3.054); the association was even stronger among patients with stage II or III tumors (HR 8.874).

Study details: The data come from a cohort study of 650 women representing 687 cases of breast cancer who were treated at a single center in South Korea between January 1, 2011, and December 31, 2016.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Citation: Lee K-T et al. JAMA Surg. 2020 Oct 7. doi: 10.1001/jamasurg.2020.4124.

 

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Key clinical point: The use of textured implants in reconstructive surgery after breast cancer mastectomy was significantly associated with lower rates of disease-free survival compared to smooth implants, but no difference was noted in local and regional recurrence-free survival based on implant texture.

Major finding: Rates of disease-free survival were significantly lower among breast cancer patients who received textured breast implants compared to those who received smooth implants (hazard ratio 3.054); the association was even stronger among patients with stage II or III tumors (HR 8.874).

Study details: The data come from a cohort study of 650 women representing 687 cases of breast cancer who were treated at a single center in South Korea between January 1, 2011, and December 31, 2016.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Citation: Lee K-T et al. JAMA Surg. 2020 Oct 7. doi: 10.1001/jamasurg.2020.4124.

 

Key clinical point: The use of textured implants in reconstructive surgery after breast cancer mastectomy was significantly associated with lower rates of disease-free survival compared to smooth implants, but no difference was noted in local and regional recurrence-free survival based on implant texture.

Major finding: Rates of disease-free survival were significantly lower among breast cancer patients who received textured breast implants compared to those who received smooth implants (hazard ratio 3.054); the association was even stronger among patients with stage II or III tumors (HR 8.874).

Study details: The data come from a cohort study of 650 women representing 687 cases of breast cancer who were treated at a single center in South Korea between January 1, 2011, and December 31, 2016.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Citation: Lee K-T et al. JAMA Surg. 2020 Oct 7. doi: 10.1001/jamasurg.2020.4124.

 

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Vacuum-assisted biopsy predicts post-treatment residual disease in breast cancer

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Key clinical point: Vacuum-assisted biopsy accurately predicted residual disease in breast cancer patients after neoadjuvant chemotherapy.

Major finding: The overall false negative rate using vacuum-assisted biopsy (VAB) was 18.7%; in a subgroup of patients with a complete/partial response and imaging abnormalities of 2 cm or smaller, the false negative rate was 3.2% and the negative predictive value was 97.4% for an overall accuracy of 89.5% with VAB.

Study details: The data come from a diagnostic study of 166 women with breast cancer who received neoadjuvant chemotherapy followed by image-guided biopsy.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.  

Citation: Tasoulis MK et al. JAMA Surg. 2020 Oct 7. doi: 10.1001/jamasurg.2020.4103.

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Key clinical point: Vacuum-assisted biopsy accurately predicted residual disease in breast cancer patients after neoadjuvant chemotherapy.

Major finding: The overall false negative rate using vacuum-assisted biopsy (VAB) was 18.7%; in a subgroup of patients with a complete/partial response and imaging abnormalities of 2 cm or smaller, the false negative rate was 3.2% and the negative predictive value was 97.4% for an overall accuracy of 89.5% with VAB.

Study details: The data come from a diagnostic study of 166 women with breast cancer who received neoadjuvant chemotherapy followed by image-guided biopsy.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.  

Citation: Tasoulis MK et al. JAMA Surg. 2020 Oct 7. doi: 10.1001/jamasurg.2020.4103.

Key clinical point: Vacuum-assisted biopsy accurately predicted residual disease in breast cancer patients after neoadjuvant chemotherapy.

Major finding: The overall false negative rate using vacuum-assisted biopsy (VAB) was 18.7%; in a subgroup of patients with a complete/partial response and imaging abnormalities of 2 cm or smaller, the false negative rate was 3.2% and the negative predictive value was 97.4% for an overall accuracy of 89.5% with VAB.

Study details: The data come from a diagnostic study of 166 women with breast cancer who received neoadjuvant chemotherapy followed by image-guided biopsy.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.  

Citation: Tasoulis MK et al. JAMA Surg. 2020 Oct 7. doi: 10.1001/jamasurg.2020.4103.

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Immediate breast reconstruction after chemotherapy doesn’t hurt survival

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Key clinical point: Outcomes including recurrence, disease-free survival, and overall survival were similar for breast cancer patients who underwent immediate breast reconstruction (IBR) with nipple-sparing mastectomy (NSM) or skin-sparing mastectomy (SSM) following neoadjuvant chemotherapy. 

Major finding: Breast cancer patients who underwent IBR with NSM/SSM as surgical treatment showed similar rates of overall survival at 5 years compared to those who underwent conventional mastectomy (92.0% vs. 89.3%).

Study details: The data come from a retrospective, case-control study of 1,266 breast cancer patients who underwent neoadjuvant chemotherapy followed by immediate breast reconstruction or conventional mastectomy at a single center between January 1, 2010, and November 30, 2016.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Citation: Wu Z-Y et al. JAMA Surg. 2020 Oct 14. doi: 10.1001/jamasurg.2020.4132.

 

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Key clinical point: Outcomes including recurrence, disease-free survival, and overall survival were similar for breast cancer patients who underwent immediate breast reconstruction (IBR) with nipple-sparing mastectomy (NSM) or skin-sparing mastectomy (SSM) following neoadjuvant chemotherapy. 

Major finding: Breast cancer patients who underwent IBR with NSM/SSM as surgical treatment showed similar rates of overall survival at 5 years compared to those who underwent conventional mastectomy (92.0% vs. 89.3%).

Study details: The data come from a retrospective, case-control study of 1,266 breast cancer patients who underwent neoadjuvant chemotherapy followed by immediate breast reconstruction or conventional mastectomy at a single center between January 1, 2010, and November 30, 2016.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Citation: Wu Z-Y et al. JAMA Surg. 2020 Oct 14. doi: 10.1001/jamasurg.2020.4132.

 

Key clinical point: Outcomes including recurrence, disease-free survival, and overall survival were similar for breast cancer patients who underwent immediate breast reconstruction (IBR) with nipple-sparing mastectomy (NSM) or skin-sparing mastectomy (SSM) following neoadjuvant chemotherapy. 

Major finding: Breast cancer patients who underwent IBR with NSM/SSM as surgical treatment showed similar rates of overall survival at 5 years compared to those who underwent conventional mastectomy (92.0% vs. 89.3%).

Study details: The data come from a retrospective, case-control study of 1,266 breast cancer patients who underwent neoadjuvant chemotherapy followed by immediate breast reconstruction or conventional mastectomy at a single center between January 1, 2010, and November 30, 2016.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Citation: Wu Z-Y et al. JAMA Surg. 2020 Oct 14. doi: 10.1001/jamasurg.2020.4132.

 

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