Telomere maintenance mechanisms, RAS mutations, and p53 mutations can be used to mechanistically classify clinical phenotypes of neuroblastoma, according to investigators.

Genomic analysis of neuroblastomas showed that the aforementioned markers were strongly associated with outcome and other disease characteristics, reported Sandra Ackermann, MD, of the department of experimental pediatric oncology at the University Children’s Hospital of Cologne (Germany), and her colleagues.

Although previous studies have shown relationships between genetic alterations and behavior of neuroblastomas, “to date, these genomic data have not produced a coherent model of pathogenesis that can explain the extremely divergent clinical phenotypes of neuroblastoma,” the investigators wrote in Science.

The present study involved genomic sequencing of 416 pretreatment neuroblastomas, with tests for telomere maintenance mechanisms, RAS-pathway mutations, and p53-pathway mutations.

Based on existing data, the investigators first devised a panel based on 17 genes related to the RAS pathway (11 genes included ALK) and 6 related to the p53 pathway. In 198 cases, 28 tested positive for RAS- or p53-pathway abnormalities (17.8%). Positivity was more common in high-risk tumors than non–high-risk tumors (21.3% vs. 13.3%; P = .048), and in both risk groups, positivity was associated with poor outcome (hazard ratio, 2.056; P = .001).

However, because clinical courses varied widely among non–high-risk patients with RAS/p53 mutations, the investigators recognized that a piece of the puzzle was missing. They hypothesized that telomere maintenance mechanisms could also be playing a role. Following several intervening experiments, the investigators devised telomere maintenance mechanism testing, defined by MYCN amplification or TERT rearrangements, elevated TERT expression if negative for these abnormalities, or presence of ALT-associated promyelocytic leukemia nuclear bodies. Subsequent testing revealed that positivity for these parameters was associated with a HR of 5.184 (P less than .001), thereby confirming that telomere maintenance mechanisms could independently predict survival.

“Together, our findings demonstrate that the divergent clinical phenotypes of human neuroblastoma are driven by molecular alterations affecting telomere maintenance and RAS or p53 pathways, suggesting a mechanistic classification of this malignancy,” the authors concluded.

The proposed classification scheme also includes associations with other genetic features (tumor cell ploidy, segmental copy number alterations, MYCN/TERT/ATRX alterations, and gene expression favorability) and clinical characteristics (stage of disease and age at diagnosis).

The study was funded by the German Cancer Aid, the German Ministry of Science and Education, the MYC-NET, the Deutsche Forschungsgemeinschaft, the Berlin Institute of Health, the European Union, and others. One coauthor reported financial relationships with Biogazelle and pxlence, and another reported consulting fees from NEO New Oncology.

SOURCE: Ackermann S et al. Science. 2018 Dec 7. doi: 10.1126/science.aat6768.

Telomere maintenance mechanisms, RAS mutations, and p53 mutations can be used to mechanistically classify clinical phenotypes of neuroblastoma, according to investigators.

Genomic analysis of neuroblastomas showed that the aforementioned markers were strongly associated with outcome and other disease characteristics, reported Sandra Ackermann, MD, of the department of experimental pediatric oncology at the University Children’s Hospital of Cologne (Germany), and her colleagues.

Although previous studies have shown relationships between genetic alterations and behavior of neuroblastomas, “to date, these genomic data have not produced a coherent model of pathogenesis that can explain the extremely divergent clinical phenotypes of neuroblastoma,” the investigators wrote in Science.

The present study involved genomic sequencing of 416 pretreatment neuroblastomas, with tests for telomere maintenance mechanisms, RAS-pathway mutations, and p53-pathway mutations.

Based on existing data, the investigators first devised a panel based on 17 genes related to the RAS pathway (11 genes included ALK) and 6 related to the p53 pathway. In 198 cases, 28 tested positive for RAS- or p53-pathway abnormalities (17.8%). Positivity was more common in high-risk tumors than non–high-risk tumors (21.3% vs. 13.3%; P = .048), and in both risk groups, positivity was associated with poor outcome (hazard ratio, 2.056; P = .001).

However, because clinical courses varied widely among non–high-risk patients with RAS/p53 mutations, the investigators recognized that a piece of the puzzle was missing. They hypothesized that telomere maintenance mechanisms could also be playing a role. Following several intervening experiments, the investigators devised telomere maintenance mechanism testing, defined by MYCN amplification or TERT rearrangements, elevated TERT expression if negative for these abnormalities, or presence of ALT-associated promyelocytic leukemia nuclear bodies. Subsequent testing revealed that positivity for these parameters was associated with a HR of 5.184 (P less than .001), thereby confirming that telomere maintenance mechanisms could independently predict survival.

“Together, our findings demonstrate that the divergent clinical phenotypes of human neuroblastoma are driven by molecular alterations affecting telomere maintenance and RAS or p53 pathways, suggesting a mechanistic classification of this malignancy,” the authors concluded.

The proposed classification scheme also includes associations with other genetic features (tumor cell ploidy, segmental copy number alterations, MYCN/TERT/ATRX alterations, and gene expression favorability) and clinical characteristics (stage of disease and age at diagnosis).

The study was funded by the German Cancer Aid, the German Ministry of Science and Education, the MYC-NET, the Deutsche Forschungsgemeinschaft, the Berlin Institute of Health, the European Union, and others. One coauthor reported financial relationships with Biogazelle and pxlence, and another reported consulting fees from NEO New Oncology.

SOURCE: Ackermann S et al. Science. 2018 Dec 7. doi: 10.1126/science.aat6768.

Telomere maintenance mechanisms, RAS mutations, and p53 mutations can be used to mechanistically classify clinical phenotypes of neuroblastoma, according to investigators.

Genomic analysis of neuroblastomas showed that the aforementioned markers were strongly associated with outcome and other disease characteristics, reported Sandra Ackermann, MD, of the department of experimental pediatric oncology at the University Children’s Hospital of Cologne (Germany), and her colleagues.

Although previous studies have shown relationships between genetic alterations and behavior of neuroblastomas, “to date, these genomic data have not produced a coherent model of pathogenesis that can explain the extremely divergent clinical phenotypes of neuroblastoma,” the investigators wrote in Science.

The present study involved genomic sequencing of 416 pretreatment neuroblastomas, with tests for telomere maintenance mechanisms, RAS-pathway mutations, and p53-pathway mutations.

Based on existing data, the investigators first devised a panel based on 17 genes related to the RAS pathway (11 genes included ALK) and 6 related to the p53 pathway. In 198 cases, 28 tested positive for RAS- or p53-pathway abnormalities (17.8%). Positivity was more common in high-risk tumors than non–high-risk tumors (21.3% vs. 13.3%; P = .048), and in both risk groups, positivity was associated with poor outcome (hazard ratio, 2.056; P = .001).

However, because clinical courses varied widely among non–high-risk patients with RAS/p53 mutations, the investigators recognized that a piece of the puzzle was missing. They hypothesized that telomere maintenance mechanisms could also be playing a role. Following several intervening experiments, the investigators devised telomere maintenance mechanism testing, defined by MYCN amplification or TERT rearrangements, elevated TERT expression if negative for these abnormalities, or presence of ALT-associated promyelocytic leukemia nuclear bodies. Subsequent testing revealed that positivity for these parameters was associated with a HR of 5.184 (P less than .001), thereby confirming that telomere maintenance mechanisms could independently predict survival.

“Together, our findings demonstrate that the divergent clinical phenotypes of human neuroblastoma are driven by molecular alterations affecting telomere maintenance and RAS or p53 pathways, suggesting a mechanistic classification of this malignancy,” the authors concluded.

The proposed classification scheme also includes associations with other genetic features (tumor cell ploidy, segmental copy number alterations, MYCN/TERT/ATRX alterations, and gene expression favorability) and clinical characteristics (stage of disease and age at diagnosis).

The study was funded by the German Cancer Aid, the German Ministry of Science and Education, the MYC-NET, the Deutsche Forschungsgemeinschaft, the Berlin Institute of Health, the European Union, and others. One coauthor reported financial relationships with Biogazelle and pxlence, and another reported consulting fees from NEO New Oncology.

SOURCE: Ackermann S et al. Science. 2018 Dec 7. doi: 10.1126/science.aat6768.

The earth is not enough

Earthly competitors have proved to be unworthy, so this week, Bacteria vs. the World visits the International Space Station, which – and we double-checked this – is in space. It’s a pretty exclusive location, and admission is by invitation only. Unless, of, course, you happen to be the ultimate hitchhiker. Four samples taken from the toilet of the ISS (and one from a piece of exercise equipment) were found to contain unknown strains of antibiotic-resistant Enterobacter bugandensis, investigators reported (BMC Microbiol. 2018 Nov 23;18[1]:175).

3DSculptorThinkstock

These bacterial stowaways were not virulent, lead author Nitin Singh, PhD, of the Jet Propulsion Laboratory said in a separate statement. But an analysis conducted by the team “reveals that the ISS isolates have a 79% probability of being a human pathogen.”

So, what does this mean for future space exploration? Cue the “Star Trek” music: “Space … the final frontier. These are the voyages of the bacterial transport ship Enterprise.”
 

Putting the FUN in fundus photos

You just got even more dependent on your phone: The American Academy of Opthalmology has published guidelines on how to use smartphones to take fundus photography, a.k.a. photographs of the back of the eye.

r03digunawan/Thinkstock

Advancement in smartphone optical quality has turned them into an important clinical tool, especially for specialists in low-funded or rural areas who don’t have access to imaging systems. Doctors can purchase special lenses and phone software to take these photos and then can easily upload the images to their Instagram accounts. (Even doctors need likes.)

An eye hospital in India has taken fundus accessibility a step further and posted a video on YouTube showing how to make a functional fundus camera that costs only 100 rupees. All you need in some cardboard, a water bottle, and a lens. “MacGyver: Chennai Edition.”
 

I feel it in my gut

Whoever said “inside, we’re all the same” clearly wasn’t considering the gut. A study from Vanderbilt University comprising 1,700 American subjects found that differences in gut microbiomes are most consistently linked with ethnicity. Vanderbilt biologist Seth Bordenstein emphasized how changing the gut microbiome can lead to curing illness but that it’s imperative that medical professionals understand how the gut differs across ethnicities.

Tigatelu/Thinkstock

Researchers found 12 types of bacteria that vary in abundancy by ethnicity. No comment on whether this was linked to differences in cuisine, but this writer fervently hopes new research arrives proving that tacos produce the healthiest gut microbiome.
 

F-bombing blood cancer

Call it a tale of two Toms.

NWphotoguy/Getty Images

TV newsman Tom Brokaw, who has multiple myeloma, says he’s become the “poster boy” for blood cancer. At first, though, he kept his diagnosis secret from just about everyone. But occasionally he let his emotions get the best of him. Especially when he’d see a Manhattan bus stop ad spotlighting the chiseled body of another Tom: the quarterback named Brady.

As he explained in a presentation at the annual meeting of the American Society of Hematology, he found it harder to get around because of back problems, which are common in multiple myeloma. As a result, he couldn’t manage to get to the office.

Still, “every day I’d force myself to leave the walker at home,” he recalled. “In that cold and sleety fall, I’d walk half a block to the coffee shop to get a bagel. There was this enormous new bus stop, with an animated advertisement board. Looking right at me was Tom Brady, advertising Ugg boots. I’d look down 79th Street at every inch of Tom Brady, and all the little old ladies were mooning over him as they were getting on the bus.”

Brokaw knew just what to do to make himself feel better. “I’d hobble over and look at him and drop the F-bomb on him every morning. Frankly, it was therapeutic for me.”

Later, he met the New England Patriots quarterback and told him the story, replacing “F-bomb” with the real word. “He had this little posse with him, and they roared. They said nobody talks to Tom like that.”

Brokaw still resists pleas to slow down from concerned loved ones, such as his emergency physician daughter. “My birth certificate says I’m 78 years old,” he said, “but I still think I’m 38 anchoring the news.” And still tossing tight-spiral F-bombs at cancer and gridiron G.O.A.T.s alike.

The earth is not enough

Earthly competitors have proved to be unworthy, so this week, Bacteria vs. the World visits the International Space Station, which – and we double-checked this – is in space. It’s a pretty exclusive location, and admission is by invitation only. Unless, of, course, you happen to be the ultimate hitchhiker. Four samples taken from the toilet of the ISS (and one from a piece of exercise equipment) were found to contain unknown strains of antibiotic-resistant Enterobacter bugandensis, investigators reported (BMC Microbiol. 2018 Nov 23;18[1]:175).

3DSculptorThinkstock

These bacterial stowaways were not virulent, lead author Nitin Singh, PhD, of the Jet Propulsion Laboratory said in a separate statement. But an analysis conducted by the team “reveals that the ISS isolates have a 79% probability of being a human pathogen.”

So, what does this mean for future space exploration? Cue the “Star Trek” music: “Space … the final frontier. These are the voyages of the bacterial transport ship Enterprise.”
 

Putting the FUN in fundus photos

You just got even more dependent on your phone: The American Academy of Opthalmology has published guidelines on how to use smartphones to take fundus photography, a.k.a. photographs of the back of the eye.

r03digunawan/Thinkstock

Advancement in smartphone optical quality has turned them into an important clinical tool, especially for specialists in low-funded or rural areas who don’t have access to imaging systems. Doctors can purchase special lenses and phone software to take these photos and then can easily upload the images to their Instagram accounts. (Even doctors need likes.)

An eye hospital in India has taken fundus accessibility a step further and posted a video on YouTube showing how to make a functional fundus camera that costs only 100 rupees. All you need in some cardboard, a water bottle, and a lens. “MacGyver: Chennai Edition.”
 

I feel it in my gut

Whoever said “inside, we’re all the same” clearly wasn’t considering the gut. A study from Vanderbilt University comprising 1,700 American subjects found that differences in gut microbiomes are most consistently linked with ethnicity. Vanderbilt biologist Seth Bordenstein emphasized how changing the gut microbiome can lead to curing illness but that it’s imperative that medical professionals understand how the gut differs across ethnicities.

Tigatelu/Thinkstock

Researchers found 12 types of bacteria that vary in abundancy by ethnicity. No comment on whether this was linked to differences in cuisine, but this writer fervently hopes new research arrives proving that tacos produce the healthiest gut microbiome.
 

F-bombing blood cancer

Call it a tale of two Toms.

NWphotoguy/Getty Images

TV newsman Tom Brokaw, who has multiple myeloma, says he’s become the “poster boy” for blood cancer. At first, though, he kept his diagnosis secret from just about everyone. But occasionally he let his emotions get the best of him. Especially when he’d see a Manhattan bus stop ad spotlighting the chiseled body of another Tom: the quarterback named Brady.

As he explained in a presentation at the annual meeting of the American Society of Hematology, he found it harder to get around because of back problems, which are common in multiple myeloma. As a result, he couldn’t manage to get to the office.

Still, “every day I’d force myself to leave the walker at home,” he recalled. “In that cold and sleety fall, I’d walk half a block to the coffee shop to get a bagel. There was this enormous new bus stop, with an animated advertisement board. Looking right at me was Tom Brady, advertising Ugg boots. I’d look down 79th Street at every inch of Tom Brady, and all the little old ladies were mooning over him as they were getting on the bus.”

Brokaw knew just what to do to make himself feel better. “I’d hobble over and look at him and drop the F-bomb on him every morning. Frankly, it was therapeutic for me.”

Later, he met the New England Patriots quarterback and told him the story, replacing “F-bomb” with the real word. “He had this little posse with him, and they roared. They said nobody talks to Tom like that.”

Brokaw still resists pleas to slow down from concerned loved ones, such as his emergency physician daughter. “My birth certificate says I’m 78 years old,” he said, “but I still think I’m 38 anchoring the news.” And still tossing tight-spiral F-bombs at cancer and gridiron G.O.A.T.s alike.

The earth is not enough

Earthly competitors have proved to be unworthy, so this week, Bacteria vs. the World visits the International Space Station, which – and we double-checked this – is in space. It’s a pretty exclusive location, and admission is by invitation only. Unless, of, course, you happen to be the ultimate hitchhiker. Four samples taken from the toilet of the ISS (and one from a piece of exercise equipment) were found to contain unknown strains of antibiotic-resistant Enterobacter bugandensis, investigators reported (BMC Microbiol. 2018 Nov 23;18[1]:175).

3DSculptorThinkstock

These bacterial stowaways were not virulent, lead author Nitin Singh, PhD, of the Jet Propulsion Laboratory said in a separate statement. But an analysis conducted by the team “reveals that the ISS isolates have a 79% probability of being a human pathogen.”

So, what does this mean for future space exploration? Cue the “Star Trek” music: “Space … the final frontier. These are the voyages of the bacterial transport ship Enterprise.”
 

Putting the FUN in fundus photos

You just got even more dependent on your phone: The American Academy of Opthalmology has published guidelines on how to use smartphones to take fundus photography, a.k.a. photographs of the back of the eye.

r03digunawan/Thinkstock

Advancement in smartphone optical quality has turned them into an important clinical tool, especially for specialists in low-funded or rural areas who don’t have access to imaging systems. Doctors can purchase special lenses and phone software to take these photos and then can easily upload the images to their Instagram accounts. (Even doctors need likes.)

An eye hospital in India has taken fundus accessibility a step further and posted a video on YouTube showing how to make a functional fundus camera that costs only 100 rupees. All you need in some cardboard, a water bottle, and a lens. “MacGyver: Chennai Edition.”
 

I feel it in my gut

Whoever said “inside, we’re all the same” clearly wasn’t considering the gut. A study from Vanderbilt University comprising 1,700 American subjects found that differences in gut microbiomes are most consistently linked with ethnicity. Vanderbilt biologist Seth Bordenstein emphasized how changing the gut microbiome can lead to curing illness but that it’s imperative that medical professionals understand how the gut differs across ethnicities.

Tigatelu/Thinkstock

Researchers found 12 types of bacteria that vary in abundancy by ethnicity. No comment on whether this was linked to differences in cuisine, but this writer fervently hopes new research arrives proving that tacos produce the healthiest gut microbiome.
 

F-bombing blood cancer

Call it a tale of two Toms.

NWphotoguy/Getty Images

TV newsman Tom Brokaw, who has multiple myeloma, says he’s become the “poster boy” for blood cancer. At first, though, he kept his diagnosis secret from just about everyone. But occasionally he let his emotions get the best of him. Especially when he’d see a Manhattan bus stop ad spotlighting the chiseled body of another Tom: the quarterback named Brady.

As he explained in a presentation at the annual meeting of the American Society of Hematology, he found it harder to get around because of back problems, which are common in multiple myeloma. As a result, he couldn’t manage to get to the office.

Still, “every day I’d force myself to leave the walker at home,” he recalled. “In that cold and sleety fall, I’d walk half a block to the coffee shop to get a bagel. There was this enormous new bus stop, with an animated advertisement board. Looking right at me was Tom Brady, advertising Ugg boots. I’d look down 79th Street at every inch of Tom Brady, and all the little old ladies were mooning over him as they were getting on the bus.”

Brokaw knew just what to do to make himself feel better. “I’d hobble over and look at him and drop the F-bomb on him every morning. Frankly, it was therapeutic for me.”

Later, he met the New England Patriots quarterback and told him the story, replacing “F-bomb” with the real word. “He had this little posse with him, and they roared. They said nobody talks to Tom like that.”

Brokaw still resists pleas to slow down from concerned loved ones, such as his emergency physician daughter. “My birth certificate says I’m 78 years old,” he said, “but I still think I’m 38 anchoring the news.” And still tossing tight-spiral F-bombs at cancer and gridiron G.O.A.T.s alike.

SAN ANTONIO – Both axillary radiation therapy and axillary lymph node dissection provide excellent, comparable locoregional control in patients with early-stage breast cancer who have a positive sentinel node, according to updated results of the European Organisation for Research and Treatment of Cancer’s AMAROS trial.
 

The 10-year cumulative incidence rate of axillary recurrence was 1.82% with radiation and 0.93% with lymph node dissection, a nonsignificant difference (hazard ratio, 1.71; P = .365). Distant metastasis–free survival and overall survival also were statistically on par. The findings reinforce the trial’s 5-year results, which additionally showed a markedly lower incidence of lymphedema with axillary radiation therapy. Lead investigator Emiel J. T. Rutgers, MD, PhD, reflected on hesitation in the uptake of axillary radiation therapy among oncologists and discussed the AMAROS results in the context of the ACOSOG Z11 trial. Dr. Rutgers, the principal investigator of the AMAROS trial and a surgical oncologist at the Netherlands Cancer Institute in Amsterdam, also described how the trial’s findings have altered practice at his institution.

Dr. Rutgers disclosed that he had no relevant conflicts of interest. The study was supported by the EORTC Charitable Trust.

SAN ANTONIO – Both axillary radiation therapy and axillary lymph node dissection provide excellent, comparable locoregional control in patients with early-stage breast cancer who have a positive sentinel node, according to updated results of the European Organisation for Research and Treatment of Cancer’s AMAROS trial.
 

The 10-year cumulative incidence rate of axillary recurrence was 1.82% with radiation and 0.93% with lymph node dissection, a nonsignificant difference (hazard ratio, 1.71; P = .365). Distant metastasis–free survival and overall survival also were statistically on par. The findings reinforce the trial’s 5-year results, which additionally showed a markedly lower incidence of lymphedema with axillary radiation therapy. Lead investigator Emiel J. T. Rutgers, MD, PhD, reflected on hesitation in the uptake of axillary radiation therapy among oncologists and discussed the AMAROS results in the context of the ACOSOG Z11 trial. Dr. Rutgers, the principal investigator of the AMAROS trial and a surgical oncologist at the Netherlands Cancer Institute in Amsterdam, also described how the trial’s findings have altered practice at his institution.

Dr. Rutgers disclosed that he had no relevant conflicts of interest. The study was supported by the EORTC Charitable Trust.

SAN ANTONIO – Both axillary radiation therapy and axillary lymph node dissection provide excellent, comparable locoregional control in patients with early-stage breast cancer who have a positive sentinel node, according to updated results of the European Organisation for Research and Treatment of Cancer’s AMAROS trial.
 

The 10-year cumulative incidence rate of axillary recurrence was 1.82% with radiation and 0.93% with lymph node dissection, a nonsignificant difference (hazard ratio, 1.71; P = .365). Distant metastasis–free survival and overall survival also were statistically on par. The findings reinforce the trial’s 5-year results, which additionally showed a markedly lower incidence of lymphedema with axillary radiation therapy. Lead investigator Emiel J. T. Rutgers, MD, PhD, reflected on hesitation in the uptake of axillary radiation therapy among oncologists and discussed the AMAROS results in the context of the ACOSOG Z11 trial. Dr. Rutgers, the principal investigator of the AMAROS trial and a surgical oncologist at the Netherlands Cancer Institute in Amsterdam, also described how the trial’s findings have altered practice at his institution.

Dr. Rutgers disclosed that he had no relevant conflicts of interest. The study was supported by the EORTC Charitable Trust.

To the Editor:

A 22-year-old Somali woman presented to our institution with oral lesions of 2 years’ duration. The lesions started as small papules in the corners of the mouth that gradually continued to spread to the mucosal lips and gums. The lesions did not drain any material. The patient reported that they were not painful and had not regressed. She was concerned about the cosmetic appearance of the lesions. The patient believed the lesions had developed from working in a chicken factory and was concerned that they appeared possibly due to contact with a substance in the factory. Additionally, she noted that her voice had become hoarse. She was otherwise healthy and denied any sexual contact or ever having a blood transfusion.

Physical examination revealed 10 to 15 flesh-colored papules measuring 2 to 3 mm in diameter on the vermilion, mucosal surfaces of the lips, and upper and lower gingivae (Figure 1). No lesions were seen on the hard and soft palate, tongue, buccal mucosa, or posterior pharynx.

Skin biopsy of the left lower mucosal lip revealed parakeratosis, acanthosis, superficial koilocytes, and atypical keratinocytes with frequent mitoses (Figures 2A–2C). In situ hybridization testing for human papillomavirus (HPV) was negative for low-risk types 6 and 11 but positive for high-risk types 16 and 18 (Figure 2D). Laboratory investigations including complete blood cell count, electrolyte panel, and liver function studies were normal, and serum was negative for syphilis and human immunodeficiency virus antibodies.

The combined clinical and histologic findings were diagnostic of oral bowenoid papulosis. Gynecologic evaluation showed that the patient had undergone female circumcision, and she had a normal Papanicolaou test. The patient was referred to both the ear, nose, and throat clinic as well as the dermatologic surgery department to discuss treatment options, but she was lost to follow-up.

Bowenoid papulosis is triggered by HPV infection and manifests clinically as solitary or multiple verrucous papules and plaques that are usually located on the genitalia.¹ Only a few cases of bowenoid papulosis have been reported in the oral cavity.^1-5 Because this disease is sexually transmitted, the mean age of onset of bowenoid papulosis is 31 years.² There is a small risk (2%–3%) of developing invasive carcinoma in bowenoid papulosis.^1-3,6 Most lesions are associated with HPV type 16; however, bowenoid papulosis also has been associated with HPV types 18, 31, 32, 35, and 39.²

Some investigators consider bowenoid papulosis and Bowen disease (a type of squamous cell carcinoma [SCC] in situ) to be histologically identical^1,6; however, some histologic differences have been reported.^1-3,6 Bowenoid papulosis has more dilated and tortuous dermal capillaries and less atypia and dyskeratosis than Bowen disease.^1,6 In contrast to bowenoid papulosis, Bowen disease is characterized clinically as well-defined scaly plaques on sun-exposed areas of the skin in older adults. Invasive SCC can be seen in 5% of skin lesions and 30% of penile lesions associated with Bowen disease.² Risk factors for Bowen disease include sun exposure; arsenic poisoning; and infection with HPV types 2, 16, 18, 31, 33, 52, and 67.^1,6

Oral bowenoid papulosis is rare. A PubMed search of articles indexed for MEDLINE using the term oral bowenoid papulosis yielded 7 additional cases, which are summarized in the Table. In 1987 Lookingbill et al² described one of the first reported cases of oral disease in a 33-year-old immunosuppressed man receiving prednisone therapy for systemic lupus erythematosus who had both mouth and genital lesions. All lesions were positive for HPV type 16. The patient subsequently developed SCC of the tongue.² Since then, 7 other cases of oral bowenoid papulosis have been described including the current case.^1,3-5 Four (57%) cases in total were associated with immunosuppression and genital lesions.^2-5

The risk for progression of oral bowenoid papulosis to invasive SCC is not known. Our search yielded only 1 case of this occurrence.²

Two of 3 cases of solitary lip lesions in oral bowenoid papulosis were treated with surgical excision.¹ Other treatment options include CO₂ laser therapy, cryotherapy, 5-fluorouracil, bleomycin, intralesional interferon alfa, and imiquimod.^1-3,5,6

Our case represents a rare report of oral bowenoid papulosis. Recognition of this unusual presentation is important for the diagnosis and management of this disease.

To the Editor:

A 22-year-old Somali woman presented to our institution with oral lesions of 2 years’ duration. The lesions started as small papules in the corners of the mouth that gradually continued to spread to the mucosal lips and gums. The lesions did not drain any material. The patient reported that they were not painful and had not regressed. She was concerned about the cosmetic appearance of the lesions. The patient believed the lesions had developed from working in a chicken factory and was concerned that they appeared possibly due to contact with a substance in the factory. Additionally, she noted that her voice had become hoarse. She was otherwise healthy and denied any sexual contact or ever having a blood transfusion.

Physical examination revealed 10 to 15 flesh-colored papules measuring 2 to 3 mm in diameter on the vermilion, mucosal surfaces of the lips, and upper and lower gingivae (Figure 1). No lesions were seen on the hard and soft palate, tongue, buccal mucosa, or posterior pharynx.

Skin biopsy of the left lower mucosal lip revealed parakeratosis, acanthosis, superficial koilocytes, and atypical keratinocytes with frequent mitoses (Figures 2A–2C). In situ hybridization testing for human papillomavirus (HPV) was negative for low-risk types 6 and 11 but positive for high-risk types 16 and 18 (Figure 2D). Laboratory investigations including complete blood cell count, electrolyte panel, and liver function studies were normal, and serum was negative for syphilis and human immunodeficiency virus antibodies.

The combined clinical and histologic findings were diagnostic of oral bowenoid papulosis. Gynecologic evaluation showed that the patient had undergone female circumcision, and she had a normal Papanicolaou test. The patient was referred to both the ear, nose, and throat clinic as well as the dermatologic surgery department to discuss treatment options, but she was lost to follow-up.

Bowenoid papulosis is triggered by HPV infection and manifests clinically as solitary or multiple verrucous papules and plaques that are usually located on the genitalia.¹ Only a few cases of bowenoid papulosis have been reported in the oral cavity.^1-5 Because this disease is sexually transmitted, the mean age of onset of bowenoid papulosis is 31 years.² There is a small risk (2%–3%) of developing invasive carcinoma in bowenoid papulosis.^1-3,6 Most lesions are associated with HPV type 16; however, bowenoid papulosis also has been associated with HPV types 18, 31, 32, 35, and 39.²

Some investigators consider bowenoid papulosis and Bowen disease (a type of squamous cell carcinoma [SCC] in situ) to be histologically identical^1,6; however, some histologic differences have been reported.^1-3,6 Bowenoid papulosis has more dilated and tortuous dermal capillaries and less atypia and dyskeratosis than Bowen disease.^1,6 In contrast to bowenoid papulosis, Bowen disease is characterized clinically as well-defined scaly plaques on sun-exposed areas of the skin in older adults. Invasive SCC can be seen in 5% of skin lesions and 30% of penile lesions associated with Bowen disease.² Risk factors for Bowen disease include sun exposure; arsenic poisoning; and infection with HPV types 2, 16, 18, 31, 33, 52, and 67.^1,6

Oral bowenoid papulosis is rare. A PubMed search of articles indexed for MEDLINE using the term oral bowenoid papulosis yielded 7 additional cases, which are summarized in the Table. In 1987 Lookingbill et al² described one of the first reported cases of oral disease in a 33-year-old immunosuppressed man receiving prednisone therapy for systemic lupus erythematosus who had both mouth and genital lesions. All lesions were positive for HPV type 16. The patient subsequently developed SCC of the tongue.² Since then, 7 other cases of oral bowenoid papulosis have been described including the current case.^1,3-5 Four (57%) cases in total were associated with immunosuppression and genital lesions.^2-5

The risk for progression of oral bowenoid papulosis to invasive SCC is not known. Our search yielded only 1 case of this occurrence.²

Two of 3 cases of solitary lip lesions in oral bowenoid papulosis were treated with surgical excision.¹ Other treatment options include CO₂ laser therapy, cryotherapy, 5-fluorouracil, bleomycin, intralesional interferon alfa, and imiquimod.^1-3,5,6

Our case represents a rare report of oral bowenoid papulosis. Recognition of this unusual presentation is important for the diagnosis and management of this disease.

To the Editor:

A 22-year-old Somali woman presented to our institution with oral lesions of 2 years’ duration. The lesions started as small papules in the corners of the mouth that gradually continued to spread to the mucosal lips and gums. The lesions did not drain any material. The patient reported that they were not painful and had not regressed. She was concerned about the cosmetic appearance of the lesions. The patient believed the lesions had developed from working in a chicken factory and was concerned that they appeared possibly due to contact with a substance in the factory. Additionally, she noted that her voice had become hoarse. She was otherwise healthy and denied any sexual contact or ever having a blood transfusion.

Physical examination revealed 10 to 15 flesh-colored papules measuring 2 to 3 mm in diameter on the vermilion, mucosal surfaces of the lips, and upper and lower gingivae (Figure 1). No lesions were seen on the hard and soft palate, tongue, buccal mucosa, or posterior pharynx.

Skin biopsy of the left lower mucosal lip revealed parakeratosis, acanthosis, superficial koilocytes, and atypical keratinocytes with frequent mitoses (Figures 2A–2C). In situ hybridization testing for human papillomavirus (HPV) was negative for low-risk types 6 and 11 but positive for high-risk types 16 and 18 (Figure 2D). Laboratory investigations including complete blood cell count, electrolyte panel, and liver function studies were normal, and serum was negative for syphilis and human immunodeficiency virus antibodies.

The combined clinical and histologic findings were diagnostic of oral bowenoid papulosis. Gynecologic evaluation showed that the patient had undergone female circumcision, and she had a normal Papanicolaou test. The patient was referred to both the ear, nose, and throat clinic as well as the dermatologic surgery department to discuss treatment options, but she was lost to follow-up.

Bowenoid papulosis is triggered by HPV infection and manifests clinically as solitary or multiple verrucous papules and plaques that are usually located on the genitalia.¹ Only a few cases of bowenoid papulosis have been reported in the oral cavity.^1-5 Because this disease is sexually transmitted, the mean age of onset of bowenoid papulosis is 31 years.² There is a small risk (2%–3%) of developing invasive carcinoma in bowenoid papulosis.^1-3,6 Most lesions are associated with HPV type 16; however, bowenoid papulosis also has been associated with HPV types 18, 31, 32, 35, and 39.²

Some investigators consider bowenoid papulosis and Bowen disease (a type of squamous cell carcinoma [SCC] in situ) to be histologically identical^1,6; however, some histologic differences have been reported.^1-3,6 Bowenoid papulosis has more dilated and tortuous dermal capillaries and less atypia and dyskeratosis than Bowen disease.^1,6 In contrast to bowenoid papulosis, Bowen disease is characterized clinically as well-defined scaly plaques on sun-exposed areas of the skin in older adults. Invasive SCC can be seen in 5% of skin lesions and 30% of penile lesions associated with Bowen disease.² Risk factors for Bowen disease include sun exposure; arsenic poisoning; and infection with HPV types 2, 16, 18, 31, 33, 52, and 67.^1,6

Oral bowenoid papulosis is rare. A PubMed search of articles indexed for MEDLINE using the term oral bowenoid papulosis yielded 7 additional cases, which are summarized in the Table. In 1987 Lookingbill et al² described one of the first reported cases of oral disease in a 33-year-old immunosuppressed man receiving prednisone therapy for systemic lupus erythematosus who had both mouth and genital lesions. All lesions were positive for HPV type 16. The patient subsequently developed SCC of the tongue.² Since then, 7 other cases of oral bowenoid papulosis have been described including the current case.^1,3-5 Four (57%) cases in total were associated with immunosuppression and genital lesions.^2-5

The risk for progression of oral bowenoid papulosis to invasive SCC is not known. Our search yielded only 1 case of this occurrence.²

Two of 3 cases of solitary lip lesions in oral bowenoid papulosis were treated with surgical excision.¹ Other treatment options include CO₂ laser therapy, cryotherapy, 5-fluorouracil, bleomycin, intralesional interferon alfa, and imiquimod.^1-3,5,6

Our case represents a rare report of oral bowenoid papulosis. Recognition of this unusual presentation is important for the diagnosis and management of this disease.

SAN ANTONIO – Women with localized breast cancer who achieve a pathological complete response (pCR) after neoadjuvant chemotherapy may have little to gain from subsequent adjuvant chemotherapy except toxicity, according to a patient-level meta-analysis of more than 27,000 women. The analysis, reported by lead investigator Laura M. Spring, MD, at the San Antonio Breast Cancer Symposium, confirmed that, compared with residual disease, pCR was associated with significantly reduced risks of event-free survival events (hazard ratio, 0.31) and death (HR, 0.22). Moreover, the EFS benefit of a pCR was similar whether women went on to receive adjuvant chemotherapy (HR, 0.36) or not (HR, 0.36) (P = .60 for difference). Dr. Spring discussed overall and subgroup findings, implications for use of neoadjuvant chemotherapy, and how these new data may inform escalation and de-escalation of adjuvant therapy.

Dr. Spring disclosed that she has a consulting or advisory role with Novartis and that she receives institutional research funding from Tesaro. The study was supported by grants from the National Cancer Institute and Susan G. Komen.
 

SAN ANTONIO – Women with localized breast cancer who achieve a pathological complete response (pCR) after neoadjuvant chemotherapy may have little to gain from subsequent adjuvant chemotherapy except toxicity, according to a patient-level meta-analysis of more than 27,000 women. The analysis, reported by lead investigator Laura M. Spring, MD, at the San Antonio Breast Cancer Symposium, confirmed that, compared with residual disease, pCR was associated with significantly reduced risks of event-free survival events (hazard ratio, 0.31) and death (HR, 0.22). Moreover, the EFS benefit of a pCR was similar whether women went on to receive adjuvant chemotherapy (HR, 0.36) or not (HR, 0.36) (P = .60 for difference). Dr. Spring discussed overall and subgroup findings, implications for use of neoadjuvant chemotherapy, and how these new data may inform escalation and de-escalation of adjuvant therapy.

Dr. Spring disclosed that she has a consulting or advisory role with Novartis and that she receives institutional research funding from Tesaro. The study was supported by grants from the National Cancer Institute and Susan G. Komen.
 

SAN ANTONIO – Women with localized breast cancer who achieve a pathological complete response (pCR) after neoadjuvant chemotherapy may have little to gain from subsequent adjuvant chemotherapy except toxicity, according to a patient-level meta-analysis of more than 27,000 women. The analysis, reported by lead investigator Laura M. Spring, MD, at the San Antonio Breast Cancer Symposium, confirmed that, compared with residual disease, pCR was associated with significantly reduced risks of event-free survival events (hazard ratio, 0.31) and death (HR, 0.22). Moreover, the EFS benefit of a pCR was similar whether women went on to receive adjuvant chemotherapy (HR, 0.36) or not (HR, 0.36) (P = .60 for difference). Dr. Spring discussed overall and subgroup findings, implications for use of neoadjuvant chemotherapy, and how these new data may inform escalation and de-escalation of adjuvant therapy.

Dr. Spring disclosed that she has a consulting or advisory role with Novartis and that she receives institutional research funding from Tesaro. The study was supported by grants from the National Cancer Institute and Susan G. Komen.
 

Uterine cancer incidence and mortality in the United States increased significantly from 1999 to 2015, with the greatest increases among nonwhite women, according to data published in the Morbidity and Mortality Weekly Report.

Uterine cancer is the fourth most common cancer diagnosed and the seventh most common cause of cancer death among women in the United States, wrote S. Jane Henley and her colleagues from the division of cancer prevention and control at the National Center for Chronic Disease Prevention and Health Promotion. Its incidence is thought to be on the rise because of the increasing prevalence of overweight and obesity.

In this report, researchers analyzed data from population-based cancer registries to find new cases of invasive uterine cancer from 1999 to 2015.

Over that period, incidence rates of uterine cancer increased around 0.7% per year on average, with an overall 12% increase. However, among American Indian and Alaskan Native women, the incidence rate during that time increased by 53%, among black women it increased by 46%, among Asian/Pacific Island women the incidence rate increased by 38%, and among Hispanic women it increased by 32%.

Uterine cancer death rates also increased by 21% from 1999 to 2015, representing approximately a 1.1% average increase per year. Again, the greatest increases were seen in American Indian and Alaskan Native women (52%), Hispanic women (33%), and black women (29%). Death rates increased by 18% among white women but were stable among Asian/Pacific Island women.

The most common type of uterine cancer was the endometrioid carcinomas, which accounted for 68% of uterine cancers overall. However black women had a higher percentage of other carcinomas, carcinosarcomas, and sarcomas, compared with women from other ethnic groups.

Two-thirds of cancer overall were diagnosed at a localized stage, but this was less common in black women than women of other ethnicities, while the proportion of cancers diagnosed at distant stage was higher among black women.

“This report found that black women were more likely to receive a diagnosis at distant stage and with more aggressive histologic types than were other women, which might in part account for the higher death rate among black women,” the authors wrote.

Despite the increasing incidence and mortality, the authors wrote that population-based screening tests are not recommended for uterine cancer, partly because around 90% of women with uterine cancer report abnormal vaginal bleeding.

“Uterine cancer outcomes could be improved by increasing awareness among women that abnormal vagi­nal bleeding should be evaluated promptly by a health care provider,” they wrote.

No conflicts of interest were reported.

SOURCE: Henley SJ et al. MMWR Morb Mortal Wkly Rep. 2018 Dec 7;67:1333-8.
 

Uterine cancer incidence and mortality in the United States increased significantly from 1999 to 2015, with the greatest increases among nonwhite women, according to data published in the Morbidity and Mortality Weekly Report.

Uterine cancer is the fourth most common cancer diagnosed and the seventh most common cause of cancer death among women in the United States, wrote S. Jane Henley and her colleagues from the division of cancer prevention and control at the National Center for Chronic Disease Prevention and Health Promotion. Its incidence is thought to be on the rise because of the increasing prevalence of overweight and obesity.

In this report, researchers analyzed data from population-based cancer registries to find new cases of invasive uterine cancer from 1999 to 2015.

Over that period, incidence rates of uterine cancer increased around 0.7% per year on average, with an overall 12% increase. However, among American Indian and Alaskan Native women, the incidence rate during that time increased by 53%, among black women it increased by 46%, among Asian/Pacific Island women the incidence rate increased by 38%, and among Hispanic women it increased by 32%.

Uterine cancer death rates also increased by 21% from 1999 to 2015, representing approximately a 1.1% average increase per year. Again, the greatest increases were seen in American Indian and Alaskan Native women (52%), Hispanic women (33%), and black women (29%). Death rates increased by 18% among white women but were stable among Asian/Pacific Island women.

The most common type of uterine cancer was the endometrioid carcinomas, which accounted for 68% of uterine cancers overall. However black women had a higher percentage of other carcinomas, carcinosarcomas, and sarcomas, compared with women from other ethnic groups.

Two-thirds of cancer overall were diagnosed at a localized stage, but this was less common in black women than women of other ethnicities, while the proportion of cancers diagnosed at distant stage was higher among black women.

“This report found that black women were more likely to receive a diagnosis at distant stage and with more aggressive histologic types than were other women, which might in part account for the higher death rate among black women,” the authors wrote.

Despite the increasing incidence and mortality, the authors wrote that population-based screening tests are not recommended for uterine cancer, partly because around 90% of women with uterine cancer report abnormal vaginal bleeding.

“Uterine cancer outcomes could be improved by increasing awareness among women that abnormal vagi­nal bleeding should be evaluated promptly by a health care provider,” they wrote.

No conflicts of interest were reported.

SOURCE: Henley SJ et al. MMWR Morb Mortal Wkly Rep. 2018 Dec 7;67:1333-8.
 

Uterine cancer incidence and mortality in the United States increased significantly from 1999 to 2015, with the greatest increases among nonwhite women, according to data published in the Morbidity and Mortality Weekly Report.

Uterine cancer is the fourth most common cancer diagnosed and the seventh most common cause of cancer death among women in the United States, wrote S. Jane Henley and her colleagues from the division of cancer prevention and control at the National Center for Chronic Disease Prevention and Health Promotion. Its incidence is thought to be on the rise because of the increasing prevalence of overweight and obesity.

In this report, researchers analyzed data from population-based cancer registries to find new cases of invasive uterine cancer from 1999 to 2015.

Over that period, incidence rates of uterine cancer increased around 0.7% per year on average, with an overall 12% increase. However, among American Indian and Alaskan Native women, the incidence rate during that time increased by 53%, among black women it increased by 46%, among Asian/Pacific Island women the incidence rate increased by 38%, and among Hispanic women it increased by 32%.

Uterine cancer death rates also increased by 21% from 1999 to 2015, representing approximately a 1.1% average increase per year. Again, the greatest increases were seen in American Indian and Alaskan Native women (52%), Hispanic women (33%), and black women (29%). Death rates increased by 18% among white women but were stable among Asian/Pacific Island women.

The most common type of uterine cancer was the endometrioid carcinomas, which accounted for 68% of uterine cancers overall. However black women had a higher percentage of other carcinomas, carcinosarcomas, and sarcomas, compared with women from other ethnic groups.

Two-thirds of cancer overall were diagnosed at a localized stage, but this was less common in black women than women of other ethnicities, while the proportion of cancers diagnosed at distant stage was higher among black women.

“This report found that black women were more likely to receive a diagnosis at distant stage and with more aggressive histologic types than were other women, which might in part account for the higher death rate among black women,” the authors wrote.

Despite the increasing incidence and mortality, the authors wrote that population-based screening tests are not recommended for uterine cancer, partly because around 90% of women with uterine cancer report abnormal vaginal bleeding.

“Uterine cancer outcomes could be improved by increasing awareness among women that abnormal vagi­nal bleeding should be evaluated promptly by a health care provider,” they wrote.

No conflicts of interest were reported.

SOURCE: Henley SJ et al. MMWR Morb Mortal Wkly Rep. 2018 Dec 7;67:1333-8.
 

SAN ANTONIO – A phase 3 randomized NRG Oncology trial (NSABP B-39/RTOG 0413) was unable to rule out the possibility that, after lumpectomy, partial breast irradiation is inferior to whole breast irradiation when it comes to the ipsilateral breast tumor recurrences (invasive disease or ductal carcinoma in situ), reported Frank Vicini, MD, of MHP Radiation Oncology Institute, Pontiac, Mich.
 

The hazard ratio for this event with the former versus latter modality was 1.22, with the 90% confidence interval (0.94-1.58) falling just outside the predefined range to declare the two modalities equivalent (0.667-1.5). However, the absolute difference in the 10-year cumulative incidence of ipsilateral breast tumor recurrences was just 0.7% (4.6% vs. 3.9%). In a video interview, Dr. Vicini discussed whether this difference is clinically important, and the implications of the trial’s findings, taken together, for offering partial breast irradiation to patients.

Dr. Vicini disclosed that he is a research adviser for ImpediMed. The study was sponsored by the National Cancer Institute.

SAN ANTONIO – A phase 3 randomized NRG Oncology trial (NSABP B-39/RTOG 0413) was unable to rule out the possibility that, after lumpectomy, partial breast irradiation is inferior to whole breast irradiation when it comes to the ipsilateral breast tumor recurrences (invasive disease or ductal carcinoma in situ), reported Frank Vicini, MD, of MHP Radiation Oncology Institute, Pontiac, Mich.
 

The hazard ratio for this event with the former versus latter modality was 1.22, with the 90% confidence interval (0.94-1.58) falling just outside the predefined range to declare the two modalities equivalent (0.667-1.5). However, the absolute difference in the 10-year cumulative incidence of ipsilateral breast tumor recurrences was just 0.7% (4.6% vs. 3.9%). In a video interview, Dr. Vicini discussed whether this difference is clinically important, and the implications of the trial’s findings, taken together, for offering partial breast irradiation to patients.

Dr. Vicini disclosed that he is a research adviser for ImpediMed. The study was sponsored by the National Cancer Institute.

SAN ANTONIO – A phase 3 randomized NRG Oncology trial (NSABP B-39/RTOG 0413) was unable to rule out the possibility that, after lumpectomy, partial breast irradiation is inferior to whole breast irradiation when it comes to the ipsilateral breast tumor recurrences (invasive disease or ductal carcinoma in situ), reported Frank Vicini, MD, of MHP Radiation Oncology Institute, Pontiac, Mich.
 

The hazard ratio for this event with the former versus latter modality was 1.22, with the 90% confidence interval (0.94-1.58) falling just outside the predefined range to declare the two modalities equivalent (0.667-1.5). However, the absolute difference in the 10-year cumulative incidence of ipsilateral breast tumor recurrences was just 0.7% (4.6% vs. 3.9%). In a video interview, Dr. Vicini discussed whether this difference is clinically important, and the implications of the trial’s findings, taken together, for offering partial breast irradiation to patients.

Dr. Vicini disclosed that he is a research adviser for ImpediMed. The study was sponsored by the National Cancer Institute.

SAN ANTONIO – New life for old medicine: Women aged under 75 years with breast intraepithelial neoplasms (IEN) who took tamoxifen for 3 years at a dose of 5 mg per day – one-fourth the standard dose – had a 50% reduction in risk of IEN recurrence and an even more remarkable 75% reduction in the risk of contralateral breast cancer, compared with women who took placebos in the TAMO1 study.

Despite concerns about the known side effects of tamoxifen, there were no significant differences in either the rate of endometrial cancer or of deep vein thrombosis/pulmonary embolism between groups, and there was only a borderline increase in hot flashes among patients randomized to tamoxifen, reported Dr. Andrea De Censi, MD, from Ospedali Galliera in Genoa, Italy.

In a video interview, Dr. De Censi discusses how tamoxifen, a decades-old, inexpensive drug still offers real clinical benefit in day-to-day practice for patients with IEN.

The TAM01 study was supported by the Italian Ministry of Health, Italian Association for Cancer Research, and the Italian League Against Cancer. Dr. De Censi and his coauthors reported having no direct conflicts of interest.

SAN ANTONIO – New life for old medicine: Women aged under 75 years with breast intraepithelial neoplasms (IEN) who took tamoxifen for 3 years at a dose of 5 mg per day – one-fourth the standard dose – had a 50% reduction in risk of IEN recurrence and an even more remarkable 75% reduction in the risk of contralateral breast cancer, compared with women who took placebos in the TAMO1 study.

Despite concerns about the known side effects of tamoxifen, there were no significant differences in either the rate of endometrial cancer or of deep vein thrombosis/pulmonary embolism between groups, and there was only a borderline increase in hot flashes among patients randomized to tamoxifen, reported Dr. Andrea De Censi, MD, from Ospedali Galliera in Genoa, Italy.

In a video interview, Dr. De Censi discusses how tamoxifen, a decades-old, inexpensive drug still offers real clinical benefit in day-to-day practice for patients with IEN.

The TAM01 study was supported by the Italian Ministry of Health, Italian Association for Cancer Research, and the Italian League Against Cancer. Dr. De Censi and his coauthors reported having no direct conflicts of interest.

SAN ANTONIO – New life for old medicine: Women aged under 75 years with breast intraepithelial neoplasms (IEN) who took tamoxifen for 3 years at a dose of 5 mg per day – one-fourth the standard dose – had a 50% reduction in risk of IEN recurrence and an even more remarkable 75% reduction in the risk of contralateral breast cancer, compared with women who took placebos in the TAMO1 study.

Despite concerns about the known side effects of tamoxifen, there were no significant differences in either the rate of endometrial cancer or of deep vein thrombosis/pulmonary embolism between groups, and there was only a borderline increase in hot flashes among patients randomized to tamoxifen, reported Dr. Andrea De Censi, MD, from Ospedali Galliera in Genoa, Italy.

In a video interview, Dr. De Censi discusses how tamoxifen, a decades-old, inexpensive drug still offers real clinical benefit in day-to-day practice for patients with IEN.

The TAM01 study was supported by the Italian Ministry of Health, Italian Association for Cancer Research, and the Italian League Against Cancer. Dr. De Censi and his coauthors reported having no direct conflicts of interest.

SAN ANTONIO – Adjuvant capecitabine does not improve outcomes in women with early-stage triple-negative breast cancer (TNBC) who have undergone resection and received standard chemotherapy, finds a phase 3, randomized, controlled trial jointly conducted by the Spanish GEICAM group and the Central and South American CIBOMA group. But the story may not end there.

Susan London/MDedge News

Findings reported in a session and press conference at the San Antonio Breast Cancer Symposium showed that, compared with observation, eight cycles of adjuvant capecitabine (Xeloda) reduced the 5-year risks of disease-free survival events and death by a nonsignificant relative 18% and 8%, respectively, among all 876 women randomized. However, the subgroup whose tumors had the nonbasal phenotype saw large significant benefits, with 47% and 58% relative reductions in these risks, respectively.

“The trial is formally negative,” commented lead investigator Miguel Martín, MD, PhD, head of the medical oncology service at Hospital Gregorio Marañón in Madrid. However, the observation arm fared better than expected. In addition, the trial had a very low–risk patient population, which may help explain why its findings differ somewhat from the more positive findings of the similar CREATE-X trial.

“Our data don’t speak against the CREATE-X study. My personal view is that capecitabine is useful for some TNBC patients,” Dr. Martin said. “Our study is not finished because we are going to look at the genomic characteristics of this group defined as non–basal-like because we want to know more about this subgroup. We are planning also to reproduce our subset in the CREATE-X trial to see if this is a real finding because we are in the era of personalized medicine.”

TNBC is a broad group defined only by negative findings for the main markers having available treatments, he elaborated. “So if we could define a subpopulation that actually benefited from capecitabine, this will be great for the patients.” Currently, conventional pathology does not routinely report on tumor basal phenotype, so all TNBC patients receive the same drugs. “This is a mistake. We should select the right drug for the right patient. Probably not all breast cancer patients are sensitive to the same drugs. But the fact is that we don’t have funding to run trials looking at that because this kind of trial is not interesting for pharma companies.”

Susan London/MDedge News

“That’s an important message that triple-negative is really a big, very heterogeneous group,” agreed SABCS codirector and press conference moderator Carlos Arteaga, MD, director of the Harold C. Simmons Comprehensive Cancer Center and associate dean of oncology programs at the University of Texas, Dallas.

Patients and clinicians alike are largely unaware of the presence of TNBC basal and nonbasal subtypes and their potential importance, he said. “We all need some education on that, us included. It’s a very, very heterogeneous group, it is one that is very challenging. We need to start by educating all of us that there is a need to do research on that. ... We have a duty to define this phenotype better.”

Study details

“TNBC is sensitive to chemotherapy, but a significant proportion of patients will eventually relapse after conventional anthracycline and taxane combinations, so we need new approaches to this population,” Dr. Martín noted.

The trial, joint GEICAM/2003-11 and CIBOMA/2004-01, was designed in 2004. Although no information about capecitabine in breast cancer was available at the time, the investigators selected this drug because it is non–cross-resistant with anthracyclines and taxanes.

About 55% of the patients randomized had node-negative disease and roughly 80% received adjuvant chemotherapy alone because neoadjuvant chemotherapy was generally not used 14 years ago, Dr. Martín noted.

After a median follow-up of 7.34 years, the 5-year disease-free survival rate—the trial’s primary endpoint—was 79.6% with capecitabine and 76.8% with observation, a nonsignificant difference in both unadjusted analysis (hazard ratio, 0.82; P = .136) and adjusted analysis (HR, 0.79; P = .082). The 5-year overall survival rate was 86.2% with capecitabine and 85.9% with observation, another nonsignificant difference (HR, 0.92; P = .623).

However, in subgroup analyses among the 248 patients with nonbasal disease, defined as immunohistochemically negative for both EGFR and CK5/6, capecitabine conferred a significant disease-free survival advantage (HR, 0.53; P = .02) and overall survival advantage (HR, 0.420; P = .007) relative to observation.

Interaction of basal/nonbasal phenotype with treatment was marginal for disease-free survival (P = .0694) and significant for overall survival (P = .0052).

In the nonbasal subgroup, the disease-free survival benefit of capecitabine was mainly driven by a reduction in distant recurrences, particularly in the liver and the brain.

Adjuvant capecitabine had tolerability that was “exactly as expected,” according to Dr. Martín. The median dose intensity was 86.3%, and 75.2% of patients completed all of the planned eight cycles.

The trial was supported by Roche, which also provided capecitabine. Dr. Martín reported receiving speaker’s honoraria from Pfizer and Eli Lilly; honoraria for participation in advisory boards from AstraZeneca, Novartis, Roche-Genentech, Pfizer, GlaxoSmithKline, PharmaMar, Taiho Oncology, and Eli Lilly; and research grants from Novartis and Roche.

SOURCE: Martín M et al. SABCS 2018, Abstract GS2-04.

SAN ANTONIO – Adjuvant capecitabine does not improve outcomes in women with early-stage triple-negative breast cancer (TNBC) who have undergone resection and received standard chemotherapy, finds a phase 3, randomized, controlled trial jointly conducted by the Spanish GEICAM group and the Central and South American CIBOMA group. But the story may not end there.

Susan London/MDedge News

Findings reported in a session and press conference at the San Antonio Breast Cancer Symposium showed that, compared with observation, eight cycles of adjuvant capecitabine (Xeloda) reduced the 5-year risks of disease-free survival events and death by a nonsignificant relative 18% and 8%, respectively, among all 876 women randomized. However, the subgroup whose tumors had the nonbasal phenotype saw large significant benefits, with 47% and 58% relative reductions in these risks, respectively.

“The trial is formally negative,” commented lead investigator Miguel Martín, MD, PhD, head of the medical oncology service at Hospital Gregorio Marañón in Madrid. However, the observation arm fared better than expected. In addition, the trial had a very low–risk patient population, which may help explain why its findings differ somewhat from the more positive findings of the similar CREATE-X trial.

“Our data don’t speak against the CREATE-X study. My personal view is that capecitabine is useful for some TNBC patients,” Dr. Martin said. “Our study is not finished because we are going to look at the genomic characteristics of this group defined as non–basal-like because we want to know more about this subgroup. We are planning also to reproduce our subset in the CREATE-X trial to see if this is a real finding because we are in the era of personalized medicine.”

TNBC is a broad group defined only by negative findings for the main markers having available treatments, he elaborated. “So if we could define a subpopulation that actually benefited from capecitabine, this will be great for the patients.” Currently, conventional pathology does not routinely report on tumor basal phenotype, so all TNBC patients receive the same drugs. “This is a mistake. We should select the right drug for the right patient. Probably not all breast cancer patients are sensitive to the same drugs. But the fact is that we don’t have funding to run trials looking at that because this kind of trial is not interesting for pharma companies.”

Susan London/MDedge News

“That’s an important message that triple-negative is really a big, very heterogeneous group,” agreed SABCS codirector and press conference moderator Carlos Arteaga, MD, director of the Harold C. Simmons Comprehensive Cancer Center and associate dean of oncology programs at the University of Texas, Dallas.

Patients and clinicians alike are largely unaware of the presence of TNBC basal and nonbasal subtypes and their potential importance, he said. “We all need some education on that, us included. It’s a very, very heterogeneous group, it is one that is very challenging. We need to start by educating all of us that there is a need to do research on that. ... We have a duty to define this phenotype better.”

Study details

“TNBC is sensitive to chemotherapy, but a significant proportion of patients will eventually relapse after conventional anthracycline and taxane combinations, so we need new approaches to this population,” Dr. Martín noted.

The trial, joint GEICAM/2003-11 and CIBOMA/2004-01, was designed in 2004. Although no information about capecitabine in breast cancer was available at the time, the investigators selected this drug because it is non–cross-resistant with anthracyclines and taxanes.

About 55% of the patients randomized had node-negative disease and roughly 80% received adjuvant chemotherapy alone because neoadjuvant chemotherapy was generally not used 14 years ago, Dr. Martín noted.

After a median follow-up of 7.34 years, the 5-year disease-free survival rate—the trial’s primary endpoint—was 79.6% with capecitabine and 76.8% with observation, a nonsignificant difference in both unadjusted analysis (hazard ratio, 0.82; P = .136) and adjusted analysis (HR, 0.79; P = .082). The 5-year overall survival rate was 86.2% with capecitabine and 85.9% with observation, another nonsignificant difference (HR, 0.92; P = .623).

However, in subgroup analyses among the 248 patients with nonbasal disease, defined as immunohistochemically negative for both EGFR and CK5/6, capecitabine conferred a significant disease-free survival advantage (HR, 0.53; P = .02) and overall survival advantage (HR, 0.420; P = .007) relative to observation.

Interaction of basal/nonbasal phenotype with treatment was marginal for disease-free survival (P = .0694) and significant for overall survival (P = .0052).

In the nonbasal subgroup, the disease-free survival benefit of capecitabine was mainly driven by a reduction in distant recurrences, particularly in the liver and the brain.

Adjuvant capecitabine had tolerability that was “exactly as expected,” according to Dr. Martín. The median dose intensity was 86.3%, and 75.2% of patients completed all of the planned eight cycles.

The trial was supported by Roche, which also provided capecitabine. Dr. Martín reported receiving speaker’s honoraria from Pfizer and Eli Lilly; honoraria for participation in advisory boards from AstraZeneca, Novartis, Roche-Genentech, Pfizer, GlaxoSmithKline, PharmaMar, Taiho Oncology, and Eli Lilly; and research grants from Novartis and Roche.

SOURCE: Martín M et al. SABCS 2018, Abstract GS2-04.

SAN ANTONIO – Adjuvant capecitabine does not improve outcomes in women with early-stage triple-negative breast cancer (TNBC) who have undergone resection and received standard chemotherapy, finds a phase 3, randomized, controlled trial jointly conducted by the Spanish GEICAM group and the Central and South American CIBOMA group. But the story may not end there.

Susan London/MDedge News

Findings reported in a session and press conference at the San Antonio Breast Cancer Symposium showed that, compared with observation, eight cycles of adjuvant capecitabine (Xeloda) reduced the 5-year risks of disease-free survival events and death by a nonsignificant relative 18% and 8%, respectively, among all 876 women randomized. However, the subgroup whose tumors had the nonbasal phenotype saw large significant benefits, with 47% and 58% relative reductions in these risks, respectively.

“The trial is formally negative,” commented lead investigator Miguel Martín, MD, PhD, head of the medical oncology service at Hospital Gregorio Marañón in Madrid. However, the observation arm fared better than expected. In addition, the trial had a very low–risk patient population, which may help explain why its findings differ somewhat from the more positive findings of the similar CREATE-X trial.

“Our data don’t speak against the CREATE-X study. My personal view is that capecitabine is useful for some TNBC patients,” Dr. Martin said. “Our study is not finished because we are going to look at the genomic characteristics of this group defined as non–basal-like because we want to know more about this subgroup. We are planning also to reproduce our subset in the CREATE-X trial to see if this is a real finding because we are in the era of personalized medicine.”

TNBC is a broad group defined only by negative findings for the main markers having available treatments, he elaborated. “So if we could define a subpopulation that actually benefited from capecitabine, this will be great for the patients.” Currently, conventional pathology does not routinely report on tumor basal phenotype, so all TNBC patients receive the same drugs. “This is a mistake. We should select the right drug for the right patient. Probably not all breast cancer patients are sensitive to the same drugs. But the fact is that we don’t have funding to run trials looking at that because this kind of trial is not interesting for pharma companies.”

Susan London/MDedge News

“That’s an important message that triple-negative is really a big, very heterogeneous group,” agreed SABCS codirector and press conference moderator Carlos Arteaga, MD, director of the Harold C. Simmons Comprehensive Cancer Center and associate dean of oncology programs at the University of Texas, Dallas.

Patients and clinicians alike are largely unaware of the presence of TNBC basal and nonbasal subtypes and their potential importance, he said. “We all need some education on that, us included. It’s a very, very heterogeneous group, it is one that is very challenging. We need to start by educating all of us that there is a need to do research on that. ... We have a duty to define this phenotype better.”

Study details

“TNBC is sensitive to chemotherapy, but a significant proportion of patients will eventually relapse after conventional anthracycline and taxane combinations, so we need new approaches to this population,” Dr. Martín noted.

The trial, joint GEICAM/2003-11 and CIBOMA/2004-01, was designed in 2004. Although no information about capecitabine in breast cancer was available at the time, the investigators selected this drug because it is non–cross-resistant with anthracyclines and taxanes.

About 55% of the patients randomized had node-negative disease and roughly 80% received adjuvant chemotherapy alone because neoadjuvant chemotherapy was generally not used 14 years ago, Dr. Martín noted.

After a median follow-up of 7.34 years, the 5-year disease-free survival rate—the trial’s primary endpoint—was 79.6% with capecitabine and 76.8% with observation, a nonsignificant difference in both unadjusted analysis (hazard ratio, 0.82; P = .136) and adjusted analysis (HR, 0.79; P = .082). The 5-year overall survival rate was 86.2% with capecitabine and 85.9% with observation, another nonsignificant difference (HR, 0.92; P = .623).

However, in subgroup analyses among the 248 patients with nonbasal disease, defined as immunohistochemically negative for both EGFR and CK5/6, capecitabine conferred a significant disease-free survival advantage (HR, 0.53; P = .02) and overall survival advantage (HR, 0.420; P = .007) relative to observation.

Interaction of basal/nonbasal phenotype with treatment was marginal for disease-free survival (P = .0694) and significant for overall survival (P = .0052).

In the nonbasal subgroup, the disease-free survival benefit of capecitabine was mainly driven by a reduction in distant recurrences, particularly in the liver and the brain.

Adjuvant capecitabine had tolerability that was “exactly as expected,” according to Dr. Martín. The median dose intensity was 86.3%, and 75.2% of patients completed all of the planned eight cycles.

The trial was supported by Roche, which also provided capecitabine. Dr. Martín reported receiving speaker’s honoraria from Pfizer and Eli Lilly; honoraria for participation in advisory boards from AstraZeneca, Novartis, Roche-Genentech, Pfizer, GlaxoSmithKline, PharmaMar, Taiho Oncology, and Eli Lilly; and research grants from Novartis and Roche.

SOURCE: Martín M et al. SABCS 2018, Abstract GS2-04.

CASE Cost-conscious benign laparoscopic hysterectomy

A 43-year-old woman undergoes laparoscopic hysterectomy for treatment of presumed benign uterine fibroids and menorrhagia. Once she is prepped with ChloraPrep with tint, a RUMI II uterine manipulator is placed. Laparoscopic ports include a Kii Balloon Blunt Tip system, a Versaport Plus Pyramidal Bladed Trocar, and 2 Kii Fios First Entry trocars.

The surgeon uses the Harmonic ACE +7 device (a purely ultrasonic device) to perform most of the procedure. The uterus is morcellated and removed using the US Food and Drug Administration (FDA)-approved Olympus Contained Tissue Extraction System, and the vaginal cuff is closed using a series of 2-0 PDS II sutures. Skin incisions are closed using Dermabond skin adhesive.

Total cost of the products used in this case: $1,592.40. Could different product choices have reduced this figure?

Health-care costs continue to rise faster than inflation: Total health-care expenditures account for approximately 18% of gross domestic product in the United States. Physicians therefore face increasing pressure to take cost into account in their care of patients.¹ Cost-effectiveness and outcome quality continue to increase in importance as measures in many clinical trials that compare standard and alternative therapies. And women’s health—specifically, minimally invasive gynecologic surgery—invites such comparisons.

Overall, conventional laparoscopic gynecologic procedures tend to cost less than laparotomy, a consequence of shorter hospital stays, faster recovery, and fewer complications.^2-5 What is not fully appreciated, however, is how choice of laparoscopic instrumentation and associated products affects surgical costs. In this article, which revisits and updates a 2013 OBG Management examination of cost-consciousness in the selection of equipment and supplies for minimally invasive gynecologic surgery,⁶ we review these costs in 2018. Our goal is to raise awareness of the role of cost in care among minimally invasive gynecologic surgeons.

In the sections that follow, we highlight several aspects of laparoscopic gynecologic surgery that can affect your selection of instruments and products, describing differences in cost as well as some distinctive characteristics of products. Note that our comparisons focus solely on cost—not on ease of utility, effectiveness, surgical technique, risk of complications, or any other assessment. Note also that numerous other instruments and devices are commercially available besides those we list. 

Importantly, 2013 and 2018 costs are included in TABLE 1. Unless otherwise noted, costs are per unit. Changes in manufacturers and material costs and technologic advances have contributed to some, but not all, of the changes in cost between 2013 and 2018. 

Continue to: Variables to keep in mind

 

 

Variables to keep in mind

Even when taking cost into consideration, tailor your selection of instruments and supplies to your capabilities and comfort, as well as to the particular characteristics of the patient and the planned procedure. Also, remember that your institution might have arrangements with companies that supply minimally invasive instruments, and that such arrangements might limit your options, to some degree. Last, be aware that reprocessed ports and instruments are now available at a reduced cost. In short, we believe that it is crucial for surgeons to be cognizant of all products available to them prior to attending a surgical case.

Skin preparation and other preop considerations

Multiple preoperative skin preparations are available (TABLE 1). Traditionally, a povidone–iodine topical antiseptic, such as Betadine, has been used for skin and vaginal preparation prior to gynecologic surgery. Hibiclens and ChloraPrep are different combinations of chlorhexidine gluconate and isopropyl alcohol that act as broad-spectrum antiseptics. 

ChloraPrep is applied with a wand-like applicator and contains a much higher concentration of isopropyl alcohol than Hibiclens (70% and 4%, respectively), rendering it more flammable. It also requires longer drying time before surgery can be started. Clear and tinted ChloraPrep formulations are available.

Continue to: Uterine manipulators

 

 

Uterine manipulators

Cannulation of the cervical canal allows for uterine manipulation, increasing intraoperative traction and exposure as well as visualization of the adnexae and peritoneal surfaces.

The Hulka-Kenwick is a reusable uterine manipulator that is fairly standard and easy to apply. Specialized, single-use manipulators also are available, including the Advincula Delineator and VCare Plus uterine manipulator/elevator. The VCare Plus manipulator consists of 2 opposing cups: one cup (available in 4 sizes, small to extra-large) fits around the cervix and defines the site for colpotomy; the other helps maintain pneumoperitoneum once a colpotomy is created. 

The ZUMI (Zinnanti Uterine Manipulator Injector) is a rigid, curved shaft with an intrauterine balloon to help prevent expulsion. It also has an integrated injection channel to allow for intraoperative chromotubation.

The RUMI II System fits individual patient anatomy with various tip lengths and colpotomy cup sizes. The Advincula Arch Uterine Manipulator Handle is a reusable alternative to the articulating RUMI II and works with the RUMI II System Disposable Tip (TABLE 1).

Continue to: Entry style and ports

 

 

Entry style and ports

The peritoneal cavity can be entered using either a closed (Veress needle) or open (Hasson) technique.^7,8 Closed entry might allow for quicker access to the peritoneal cavity. A 2015 Cochrane review of 46 randomized, controlled trials of 7,389 patients undergoing laparoscopy compared outcomes between laparoscopic entry techniques and found no difference in major vascular or visceral injury between closed and open techniques at the umbilicus.⁹ However, open entry was associated with a greater likelihood of successful entry into the peritoneal cavity.⁹

Left upper-quadrant (Palmer’s point) entry is another option when adhesions are anticipated or abnormal anatomy is encountered at the umbilicus.

In general, complications related to laparoscopic entry are rare in gynecologic surgery, ranging from 0.18% to 0.5% of cases in studies.^8,10,11 A minimally invasive surgeon might prefer one entry technique over another but should be able to perform both methods competently and recognize when a particular technique is warranted.

--

Choosing a port

Laparoscopic ports usually range from 5 mm to 12 mm and can be fixed or variable in size. 

The primary port, usually placed through the umbilicus, can be a standard, blunt, 10-mm (Bluntport Plus Hasson) port, or it can be specialized to ease entry of the port or stabilize the port once it is introduced through the skin incision.

Optical trocars have a transparent tip that allows the surgeon to visualize the abdominal wall entry layer by layer using a 0° laparoscope, sometimes after pneumoperitoneum is created with a Veress needle. Other specialized ports include those that have balloons or foam collars, or both, to secure the port without traditional stay sutures on the fascia and to minimize leakage of pneumoperitoneum.

Continue to: Accessory ports

 

 

Accessory ports

When choosing an accessory port type and size, it is important to anticipate which instruments and devices, such as an Endo Catch bag, suture, or needle, will need to pass through it. Also, know whether 5-mm and 10-mm laparoscopes are available, and anticipate whether a second port with insufflation capabilities will be required.

The Pediport Locking Trocar is a user-friendly, 5-mm bladed port that deploys a mushroom-shaped stabilizer to prevent dislodgement. The Versaport bladed trocar has a spring-loaded entry shield, which slides over the blade to protect it once the peritoneal cavity is entered.

VersaStep Bladeless Trocars are introduced after a Step Insufflation Needle has been inserted. These trocars create a smaller fascial defect than conventional bladed trocars for an equivalent cannula size (TABLE 1).

Cutting and coagulating

Both monopolar and bipolar electrosurgical techniques are commonly employed in gynecologic laparoscopy. A wide variety of disposable and reusable instruments are available for monopolar energy, such as scissors, a hook, and a spatula.

Bipolar devices also can be disposable or reusable. Although bipolar electrosurgery minimizes injury to surrounding tissues by containing the current within the jaws of the forceps, it cannot cut or seal large vessels. As a result, several advanced bipolar devices with sealing and transecting capabilities have emerged (the LigaSure line of devices, Enseal). Ultrasonic devices, such as the Harmonic ACE, also can coagulate and cut at lower temperatures by converting electrical energy to mechanical energy (TABLE 1).

Continue to: Suture material

 

 

Suture material

Aspects of minimally invasive gynecologic surgery that require the use of suture include, but are not limited to, closure of the vaginal cuff, oophoropexy, and reapproximation of the ovarian cortex after cystectomy. Synthetic and delayed absorbable sutures, such as PDS II, are used frequently. The barbed suture also has gained popularity because it anchors to tissue without the need for intracorporeal or extracorporeal knots (TABLE 1).

Tissue removal

Adnexae and pathologic tissue, such as dermoid cysts, can be removed intact from the peritoneal cavity using an Endo Catch Single Use Specimen Pouch, a polyurethane sac. Careful use, with placement of the ovary with the cyst into the pouch prior to cystectomy, can contain or prevent spillage outside the bag.

A large uterus that cannot be extracted through a colpotomy can be manually morcellated. Appropriate candidates can undergo power morcellation using an FDA-approved device. (TABLE 1), allowing for the removal of smaller pieces through a small laparoscopic incision or the colpotomy.

Issues surrounding morcellation continue to require that gynecologic surgeons understand FDA recommendations. In 2014, the FDA issued a safety communication that morcellation is “contraindicated in gynecologic surgery if tissue is known or suspected to be malignant; it is contraindicated for uterine tissue removal with presumed benign fibroids in perimenopausal women.”¹² A black-box warning was issued that uterine tissue might contain unsuspected cancer.

A task force created by AAGL addressed key issues in this controversy. 

AAGL then provided guidelines related to morcellation¹³:

• Do not use morcellate in the setting of known malignancy.
• Provide appropriate preoperative evaluation with up-to-date Pap smear screening and image analysis.
• Increasing age significantly increases the risk of leiomyosarcoma, especially in a postmenopausal woman.
• Fibroid growth is not a reliable sign of malignancy.
• Do not use a morcellator if the patient is at high risk for malignancy.
• If leiomyosarcoma is the presumed pathology, await the final pathology report before proceeding with hysterectomy.
• Concomitant use of a bag might mitigate the risk of tissue spread.
• Obtain informed consent before proceeding with morcellation.

Continue to: Skin closure

 

 

Skin closure

Final subcuticular closure can be accomplished using sutures or skin adhesive. Sutures can be synthetic, absorbable monofilament (Caprosyn), or synthetic, absorbable, braided multifilament (Polysorb).

Skin adhesive closes incisions quickly, avoids inflammation related to foreign bodies, and can ease patients’ concerns that sometimes arise when absorbable suture persists postoperatively (TABLE 1).

The impact of physician experience

Physician experience has been shown to reduce cost while maintaining quality of care.¹⁴ That was the conclusion of researchers who undertook a retrospective study, addressing cost and clinical outcomes, of senior and junior attending physicians who performed laparoscopic-assisted vaginal hysterectomy on 120 patients. Studies such as these often lead to clinical pathways to facilitate cost-effective quality care. 

--

CASE Same outcome at lower cost

The hypothetical 43-year-old patient in the opening case undergoes laparoscopic hysterectomy for treatment of uterine fibroids and menorrhagia. In this scenario, however, the surgeon makes the following product choices:

• The patient is prepped with Hibiclens.
• A VCare Plus uterine manipulator is placed.
• Laparoscopic ports include a VersaStep Plus Bladeless Trocar with Step Insufflation Needle; Versaport Plus Pyramidal Bladed Trocar; and 2 VersaOne Bladed trocars.
• The surgeon uses the PKS LYONS Dissecting Forceps and reprocessed Endo Shears to perform the hysterectomy.
• The uterus is enclosed in an Endo Catch bag and removed through the minilaparotomy site.
• The vaginal cuff is closed using 2-0 V-Loc barbed suture. Skin incisions are closed with 4-0 Polysorb, a polyglycolic acid absorbable suture.

The cost of this set of products? $360.44 or, roughly, $1,231.96 less than the set-up described in the case at the beginning of this article (TABLE 2).

Continue to: Summing up

 

 

Summing up

Here are key points to take away from this analysis and discussion:

• As third-party payers and hospitals continue to evaluate surgeons individually and compare procedures from surgeon to surgeon, reimbursement might be stratified—thereby favoring physicians who demonstrate both quality outcomes and cost containment.
• There are many ways a minimally invasive surgeon can implement cost-conscious choices that have little or no impact on the quality of outcome.
• Surgeons who are familiar with surgical instruments and models available at their institution are better prepared to make wise cost-conscious decisions. (See “Caregivers should keep cost in mind: Here’s why,” in the Web version of this article at https://www.mdedge.com/obgyn.)
• Cost is not the only indicator of value: The surgeon must know how to apply tools correctly and be familiar with their limitations, and should choose instruments and products for their safety and ease of use. More often than not, a surgeon’s training and personal experience define—and sometimes restrict—the choice of devices.
• Last, it makes sense to have instruments and devices readily available in the operating room at the start of a case, to avoid unnecessary surgical delays. However, we recommend that you refrain from opening these tools until they are required intraoperatively. It is possible that the case will require conversion to laparotomy or that, after direct visualization of the pathology, different ports or instruments are required.

Acknowledgments
The authors would like to thank Meredith Snook, MD, who was coauthor of the original 2013 article⁶ and Kathleen Riordan, BSN, RN, for assistance in gathering specific cost-related information for this article. 

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.

CASE Cost-conscious benign laparoscopic hysterectomy

A 43-year-old woman undergoes laparoscopic hysterectomy for treatment of presumed benign uterine fibroids and menorrhagia. Once she is prepped with ChloraPrep with tint, a RUMI II uterine manipulator is placed. Laparoscopic ports include a Kii Balloon Blunt Tip system, a Versaport Plus Pyramidal Bladed Trocar, and 2 Kii Fios First Entry trocars.

The surgeon uses the Harmonic ACE +7 device (a purely ultrasonic device) to perform most of the procedure. The uterus is morcellated and removed using the US Food and Drug Administration (FDA)-approved Olympus Contained Tissue Extraction System, and the vaginal cuff is closed using a series of 2-0 PDS II sutures. Skin incisions are closed using Dermabond skin adhesive.

Total cost of the products used in this case: $1,592.40. Could different product choices have reduced this figure?

Health-care costs continue to rise faster than inflation: Total health-care expenditures account for approximately 18% of gross domestic product in the United States. Physicians therefore face increasing pressure to take cost into account in their care of patients.¹ Cost-effectiveness and outcome quality continue to increase in importance as measures in many clinical trials that compare standard and alternative therapies. And women’s health—specifically, minimally invasive gynecologic surgery—invites such comparisons.

Overall, conventional laparoscopic gynecologic procedures tend to cost less than laparotomy, a consequence of shorter hospital stays, faster recovery, and fewer complications.^2-5 What is not fully appreciated, however, is how choice of laparoscopic instrumentation and associated products affects surgical costs. In this article, which revisits and updates a 2013 OBG Management examination of cost-consciousness in the selection of equipment and supplies for minimally invasive gynecologic surgery,⁶ we review these costs in 2018. Our goal is to raise awareness of the role of cost in care among minimally invasive gynecologic surgeons.

In the sections that follow, we highlight several aspects of laparoscopic gynecologic surgery that can affect your selection of instruments and products, describing differences in cost as well as some distinctive characteristics of products. Note that our comparisons focus solely on cost—not on ease of utility, effectiveness, surgical technique, risk of complications, or any other assessment. Note also that numerous other instruments and devices are commercially available besides those we list. 

Importantly, 2013 and 2018 costs are included in TABLE 1. Unless otherwise noted, costs are per unit. Changes in manufacturers and material costs and technologic advances have contributed to some, but not all, of the changes in cost between 2013 and 2018. 

Continue to: Variables to keep in mind

 

 

Variables to keep in mind

Even when taking cost into consideration, tailor your selection of instruments and supplies to your capabilities and comfort, as well as to the particular characteristics of the patient and the planned procedure. Also, remember that your institution might have arrangements with companies that supply minimally invasive instruments, and that such arrangements might limit your options, to some degree. Last, be aware that reprocessed ports and instruments are now available at a reduced cost. In short, we believe that it is crucial for surgeons to be cognizant of all products available to them prior to attending a surgical case.

Skin preparation and other preop considerations

Multiple preoperative skin preparations are available (TABLE 1). Traditionally, a povidone–iodine topical antiseptic, such as Betadine, has been used for skin and vaginal preparation prior to gynecologic surgery. Hibiclens and ChloraPrep are different combinations of chlorhexidine gluconate and isopropyl alcohol that act as broad-spectrum antiseptics. 

ChloraPrep is applied with a wand-like applicator and contains a much higher concentration of isopropyl alcohol than Hibiclens (70% and 4%, respectively), rendering it more flammable. It also requires longer drying time before surgery can be started. Clear and tinted ChloraPrep formulations are available.

Continue to: Uterine manipulators

 

 

Uterine manipulators

Cannulation of the cervical canal allows for uterine manipulation, increasing intraoperative traction and exposure as well as visualization of the adnexae and peritoneal surfaces.

The Hulka-Kenwick is a reusable uterine manipulator that is fairly standard and easy to apply. Specialized, single-use manipulators also are available, including the Advincula Delineator and VCare Plus uterine manipulator/elevator. The VCare Plus manipulator consists of 2 opposing cups: one cup (available in 4 sizes, small to extra-large) fits around the cervix and defines the site for colpotomy; the other helps maintain pneumoperitoneum once a colpotomy is created. 

The ZUMI (Zinnanti Uterine Manipulator Injector) is a rigid, curved shaft with an intrauterine balloon to help prevent expulsion. It also has an integrated injection channel to allow for intraoperative chromotubation.

The RUMI II System fits individual patient anatomy with various tip lengths and colpotomy cup sizes. The Advincula Arch Uterine Manipulator Handle is a reusable alternative to the articulating RUMI II and works with the RUMI II System Disposable Tip (TABLE 1).

Continue to: Entry style and ports

 

 

Entry style and ports

The peritoneal cavity can be entered using either a closed (Veress needle) or open (Hasson) technique.^7,8 Closed entry might allow for quicker access to the peritoneal cavity. A 2015 Cochrane review of 46 randomized, controlled trials of 7,389 patients undergoing laparoscopy compared outcomes between laparoscopic entry techniques and found no difference in major vascular or visceral injury between closed and open techniques at the umbilicus.⁹ However, open entry was associated with a greater likelihood of successful entry into the peritoneal cavity.⁹

Left upper-quadrant (Palmer’s point) entry is another option when adhesions are anticipated or abnormal anatomy is encountered at the umbilicus.

In general, complications related to laparoscopic entry are rare in gynecologic surgery, ranging from 0.18% to 0.5% of cases in studies.^8,10,11 A minimally invasive surgeon might prefer one entry technique over another but should be able to perform both methods competently and recognize when a particular technique is warranted.

--

Choosing a port

Laparoscopic ports usually range from 5 mm to 12 mm and can be fixed or variable in size. 

The primary port, usually placed through the umbilicus, can be a standard, blunt, 10-mm (Bluntport Plus Hasson) port, or it can be specialized to ease entry of the port or stabilize the port once it is introduced through the skin incision.

Optical trocars have a transparent tip that allows the surgeon to visualize the abdominal wall entry layer by layer using a 0° laparoscope, sometimes after pneumoperitoneum is created with a Veress needle. Other specialized ports include those that have balloons or foam collars, or both, to secure the port without traditional stay sutures on the fascia and to minimize leakage of pneumoperitoneum.

Continue to: Accessory ports

 

 

Accessory ports

When choosing an accessory port type and size, it is important to anticipate which instruments and devices, such as an Endo Catch bag, suture, or needle, will need to pass through it. Also, know whether 5-mm and 10-mm laparoscopes are available, and anticipate whether a second port with insufflation capabilities will be required.

The Pediport Locking Trocar is a user-friendly, 5-mm bladed port that deploys a mushroom-shaped stabilizer to prevent dislodgement. The Versaport bladed trocar has a spring-loaded entry shield, which slides over the blade to protect it once the peritoneal cavity is entered.

VersaStep Bladeless Trocars are introduced after a Step Insufflation Needle has been inserted. These trocars create a smaller fascial defect than conventional bladed trocars for an equivalent cannula size (TABLE 1).

Cutting and coagulating

Both monopolar and bipolar electrosurgical techniques are commonly employed in gynecologic laparoscopy. A wide variety of disposable and reusable instruments are available for monopolar energy, such as scissors, a hook, and a spatula.

Bipolar devices also can be disposable or reusable. Although bipolar electrosurgery minimizes injury to surrounding tissues by containing the current within the jaws of the forceps, it cannot cut or seal large vessels. As a result, several advanced bipolar devices with sealing and transecting capabilities have emerged (the LigaSure line of devices, Enseal). Ultrasonic devices, such as the Harmonic ACE, also can coagulate and cut at lower temperatures by converting electrical energy to mechanical energy (TABLE 1).

Continue to: Suture material

 

 

Suture material

Aspects of minimally invasive gynecologic surgery that require the use of suture include, but are not limited to, closure of the vaginal cuff, oophoropexy, and reapproximation of the ovarian cortex after cystectomy. Synthetic and delayed absorbable sutures, such as PDS II, are used frequently. The barbed suture also has gained popularity because it anchors to tissue without the need for intracorporeal or extracorporeal knots (TABLE 1).

Tissue removal

Adnexae and pathologic tissue, such as dermoid cysts, can be removed intact from the peritoneal cavity using an Endo Catch Single Use Specimen Pouch, a polyurethane sac. Careful use, with placement of the ovary with the cyst into the pouch prior to cystectomy, can contain or prevent spillage outside the bag.

A large uterus that cannot be extracted through a colpotomy can be manually morcellated. Appropriate candidates can undergo power morcellation using an FDA-approved device. (TABLE 1), allowing for the removal of smaller pieces through a small laparoscopic incision or the colpotomy.

Issues surrounding morcellation continue to require that gynecologic surgeons understand FDA recommendations. In 2014, the FDA issued a safety communication that morcellation is “contraindicated in gynecologic surgery if tissue is known or suspected to be malignant; it is contraindicated for uterine tissue removal with presumed benign fibroids in perimenopausal women.”¹² A black-box warning was issued that uterine tissue might contain unsuspected cancer.

A task force created by AAGL addressed key issues in this controversy. 

AAGL then provided guidelines related to morcellation¹³:

• Do not use morcellate in the setting of known malignancy.
• Provide appropriate preoperative evaluation with up-to-date Pap smear screening and image analysis.
• Increasing age significantly increases the risk of leiomyosarcoma, especially in a postmenopausal woman.
• Fibroid growth is not a reliable sign of malignancy.
• Do not use a morcellator if the patient is at high risk for malignancy.
• If leiomyosarcoma is the presumed pathology, await the final pathology report before proceeding with hysterectomy.
• Concomitant use of a bag might mitigate the risk of tissue spread.
• Obtain informed consent before proceeding with morcellation.

Continue to: Skin closure

 

 

Skin closure

Final subcuticular closure can be accomplished using sutures or skin adhesive. Sutures can be synthetic, absorbable monofilament (Caprosyn), or synthetic, absorbable, braided multifilament (Polysorb).

Skin adhesive closes incisions quickly, avoids inflammation related to foreign bodies, and can ease patients’ concerns that sometimes arise when absorbable suture persists postoperatively (TABLE 1).

The impact of physician experience

Physician experience has been shown to reduce cost while maintaining quality of care.¹⁴ That was the conclusion of researchers who undertook a retrospective study, addressing cost and clinical outcomes, of senior and junior attending physicians who performed laparoscopic-assisted vaginal hysterectomy on 120 patients. Studies such as these often lead to clinical pathways to facilitate cost-effective quality care. 

--

CASE Same outcome at lower cost

The hypothetical 43-year-old patient in the opening case undergoes laparoscopic hysterectomy for treatment of uterine fibroids and menorrhagia. In this scenario, however, the surgeon makes the following product choices:

• The patient is prepped with Hibiclens.
• A VCare Plus uterine manipulator is placed.
• Laparoscopic ports include a VersaStep Plus Bladeless Trocar with Step Insufflation Needle; Versaport Plus Pyramidal Bladed Trocar; and 2 VersaOne Bladed trocars.
• The surgeon uses the PKS LYONS Dissecting Forceps and reprocessed Endo Shears to perform the hysterectomy.
• The uterus is enclosed in an Endo Catch bag and removed through the minilaparotomy site.
• The vaginal cuff is closed using 2-0 V-Loc barbed suture. Skin incisions are closed with 4-0 Polysorb, a polyglycolic acid absorbable suture.

The cost of this set of products? $360.44 or, roughly, $1,231.96 less than the set-up described in the case at the beginning of this article (TABLE 2).

Continue to: Summing up

 

 

Summing up

Here are key points to take away from this analysis and discussion:

• As third-party payers and hospitals continue to evaluate surgeons individually and compare procedures from surgeon to surgeon, reimbursement might be stratified—thereby favoring physicians who demonstrate both quality outcomes and cost containment.
• There are many ways a minimally invasive surgeon can implement cost-conscious choices that have little or no impact on the quality of outcome.
• Surgeons who are familiar with surgical instruments and models available at their institution are better prepared to make wise cost-conscious decisions. (See “Caregivers should keep cost in mind: Here’s why,” in the Web version of this article at https://www.mdedge.com/obgyn.)
• Cost is not the only indicator of value: The surgeon must know how to apply tools correctly and be familiar with their limitations, and should choose instruments and products for their safety and ease of use. More often than not, a surgeon’s training and personal experience define—and sometimes restrict—the choice of devices.
• Last, it makes sense to have instruments and devices readily available in the operating room at the start of a case, to avoid unnecessary surgical delays. However, we recommend that you refrain from opening these tools until they are required intraoperatively. It is possible that the case will require conversion to laparotomy or that, after direct visualization of the pathology, different ports or instruments are required.

Acknowledgments
The authors would like to thank Meredith Snook, MD, who was coauthor of the original 2013 article⁶ and Kathleen Riordan, BSN, RN, for assistance in gathering specific cost-related information for this article. 

Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.

CASE Cost-conscious benign laparoscopic hysterectomy

A 43-year-old woman undergoes laparoscopic hysterectomy for treatment of presumed benign uterine fibroids and menorrhagia. Once she is prepped with ChloraPrep with tint, a RUMI II uterine manipulator is placed. Laparoscopic ports include a Kii Balloon Blunt Tip system, a Versaport Plus Pyramidal Bladed Trocar, and 2 Kii Fios First Entry trocars.

The surgeon uses the Harmonic ACE +7 device (a purely ultrasonic device) to perform most of the procedure. The uterus is morcellated and removed using the US Food and Drug Administration (FDA)-approved Olympus Contained Tissue Extraction System, and the vaginal cuff is closed using a series of 2-0 PDS II sutures. Skin incisions are closed using Dermabond skin adhesive.

Total cost of the products used in this case: $1,592.40. Could different product choices have reduced this figure?

Health-care costs continue to rise faster than inflation: Total health-care expenditures account for approximately 18% of gross domestic product in the United States. Physicians therefore face increasing pressure to take cost into account in their care of patients.¹ Cost-effectiveness and outcome quality continue to increase in importance as measures in many clinical trials that compare standard and alternative therapies. And women’s health—specifically, minimally invasive gynecologic surgery—invites such comparisons.

Overall, conventional laparoscopic gynecologic procedures tend to cost less than laparotomy, a consequence of shorter hospital stays, faster recovery, and fewer complications.^2-5 What is not fully appreciated, however, is how choice of laparoscopic instrumentation and associated products affects surgical costs. In this article, which revisits and updates a 2013 OBG Management examination of cost-consciousness in the selection of equipment and supplies for minimally invasive gynecologic surgery,⁶ we review these costs in 2018. Our goal is to raise awareness of the role of cost in care among minimally invasive gynecologic surgeons.

In the sections that follow, we highlight several aspects of laparoscopic gynecologic surgery that can affect your selection of instruments and products, describing differences in cost as well as some distinctive characteristics of products. Note that our comparisons focus solely on cost—not on ease of utility, effectiveness, surgical technique, risk of complications, or any other assessment. Note also that numerous other instruments and devices are commercially available besides those we list. 

Importantly, 2013 and 2018 costs are included in TABLE 1. Unless otherwise noted, costs are per unit. Changes in manufacturers and material costs and technologic advances have contributed to some, but not all, of the changes in cost between 2013 and 2018. 

Continue to: Variables to keep in mind

 

 

Variables to keep in mind

Even when taking cost into consideration, tailor your selection of instruments and supplies to your capabilities and comfort, as well as to the particular characteristics of the patient and the planned procedure. Also, remember that your institution might have arrangements with companies that supply minimally invasive instruments, and that such arrangements might limit your options, to some degree. Last, be aware that reprocessed ports and instruments are now available at a reduced cost. In short, we believe that it is crucial for surgeons to be cognizant of all products available to them prior to attending a surgical case.

Skin preparation and other preop considerations

Multiple preoperative skin preparations are available (TABLE 1). Traditionally, a povidone–iodine topical antiseptic, such as Betadine, has been used for skin and vaginal preparation prior to gynecologic surgery. Hibiclens and ChloraPrep are different combinations of chlorhexidine gluconate and isopropyl alcohol that act as broad-spectrum antiseptics. 

ChloraPrep is applied with a wand-like applicator and contains a much higher concentration of isopropyl alcohol than Hibiclens (70% and 4%, respectively), rendering it more flammable. It also requires longer drying time before surgery can be started. Clear and tinted ChloraPrep formulations are available.

Continue to: Uterine manipulators

 

 

Uterine manipulators

Cannulation of the cervical canal allows for uterine manipulation, increasing intraoperative traction and exposure as well as visualization of the adnexae and peritoneal surfaces.

The Hulka-Kenwick is a reusable uterine manipulator that is fairly standard and easy to apply. Specialized, single-use manipulators also are available, including the Advincula Delineator and VCare Plus uterine manipulator/elevator. The VCare Plus manipulator consists of 2 opposing cups: one cup (available in 4 sizes, small to extra-large) fits around the cervix and defines the site for colpotomy; the other helps maintain pneumoperitoneum once a colpotomy is created. 

The ZUMI (Zinnanti Uterine Manipulator Injector) is a rigid, curved shaft with an intrauterine balloon to help prevent expulsion. It also has an integrated injection channel to allow for intraoperative chromotubation.

The RUMI II System fits individual patient anatomy with various tip lengths and colpotomy cup sizes. The Advincula Arch Uterine Manipulator Handle is a reusable alternative to the articulating RUMI II and works with the RUMI II System Disposable Tip (TABLE 1).

Continue to: Entry style and ports

 

 

Entry style and ports

The peritoneal cavity can be entered using either a closed (Veress needle) or open (Hasson) technique.^7,8 Closed entry might allow for quicker access to the peritoneal cavity. A 2015 Cochrane review of 46 randomized, controlled trials of 7,389 patients undergoing laparoscopy compared outcomes between laparoscopic entry techniques and found no difference in major vascular or visceral injury between closed and open techniques at the umbilicus.⁹ However, open entry was associated with a greater likelihood of successful entry into the peritoneal cavity.⁹

Left upper-quadrant (Palmer’s point) entry is another option when adhesions are anticipated or abnormal anatomy is encountered at the umbilicus.

In general, complications related to laparoscopic entry are rare in gynecologic surgery, ranging from 0.18% to 0.5% of cases in studies.^8,10,11 A minimally invasive surgeon might prefer one entry technique over another but should be able to perform both methods competently and recognize when a particular technique is warranted.

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Choosing a port

Laparoscopic ports usually range from 5 mm to 12 mm and can be fixed or variable in size. 

The primary port, usually placed through the umbilicus, can be a standard, blunt, 10-mm (Bluntport Plus Hasson) port, or it can be specialized to ease entry of the port or stabilize the port once it is introduced through the skin incision.

Optical trocars have a transparent tip that allows the surgeon to visualize the abdominal wall entry layer by layer using a 0° laparoscope, sometimes after pneumoperitoneum is created with a Veress needle. Other specialized ports include those that have balloons or foam collars, or both, to secure the port without traditional stay sutures on the fascia and to minimize leakage of pneumoperitoneum.

Continue to: Accessory ports

 

 

Accessory ports

When choosing an accessory port type and size, it is important to anticipate which instruments and devices, such as an Endo Catch bag, suture, or needle, will need to pass through it. Also, know whether 5-mm and 10-mm laparoscopes are available, and anticipate whether a second port with insufflation capabilities will be required.

The Pediport Locking Trocar is a user-friendly, 5-mm bladed port that deploys a mushroom-shaped stabilizer to prevent dislodgement. The Versaport bladed trocar has a spring-loaded entry shield, which slides over the blade to protect it once the peritoneal cavity is entered.

VersaStep Bladeless Trocars are introduced after a Step Insufflation Needle has been inserted. These trocars create a smaller fascial defect than conventional bladed trocars for an equivalent cannula size (TABLE 1).

Cutting and coagulating

Both monopolar and bipolar electrosurgical techniques are commonly employed in gynecologic laparoscopy. A wide variety of disposable and reusable instruments are available for monopolar energy, such as scissors, a hook, and a spatula.

Bipolar devices also can be disposable or reusable. Although bipolar electrosurgery minimizes injury to surrounding tissues by containing the current within the jaws of the forceps, it cannot cut or seal large vessels. As a result, several advanced bipolar devices with sealing and transecting capabilities have emerged (the LigaSure line of devices, Enseal). Ultrasonic devices, such as the Harmonic ACE, also can coagulate and cut at lower temperatures by converting electrical energy to mechanical energy (TABLE 1).

Continue to: Suture material

 

 

Suture material

Aspects of minimally invasive gynecologic surgery that require the use of suture include, but are not limited to, closure of the vaginal cuff, oophoropexy, and reapproximation of the ovarian cortex after cystectomy. Synthetic and delayed absorbable sutures, such as PDS II, are used frequently. The barbed suture also has gained popularity because it anchors to tissue without the need for intracorporeal or extracorporeal knots (TABLE 1).

Tissue removal

Adnexae and pathologic tissue, such as dermoid cysts, can be removed intact from the peritoneal cavity using an Endo Catch Single Use Specimen Pouch, a polyurethane sac. Careful use, with placement of the ovary with the cyst into the pouch prior to cystectomy, can contain or prevent spillage outside the bag.

A large uterus that cannot be extracted through a colpotomy can be manually morcellated. Appropriate candidates can undergo power morcellation using an FDA-approved device. (TABLE 1), allowing for the removal of smaller pieces through a small laparoscopic incision or the colpotomy.

Issues surrounding morcellation continue to require that gynecologic surgeons understand FDA recommendations. In 2014, the FDA issued a safety communication that morcellation is “contraindicated in gynecologic surgery if tissue is known or suspected to be malignant; it is contraindicated for uterine tissue removal with presumed benign fibroids in perimenopausal women.”¹² A black-box warning was issued that uterine tissue might contain unsuspected cancer.

A task force created by AAGL addressed key issues in this controversy. 

AAGL then provided guidelines related to morcellation¹³:

• Do not use morcellate in the setting of known malignancy.
• Provide appropriate preoperative evaluation with up-to-date Pap smear screening and image analysis.
• Increasing age significantly increases the risk of leiomyosarcoma, especially in a postmenopausal woman.
• Fibroid growth is not a reliable sign of malignancy.
• Do not use a morcellator if the patient is at high risk for malignancy.
• If leiomyosarcoma is the presumed pathology, await the final pathology report before proceeding with hysterectomy.
• Concomitant use of a bag might mitigate the risk of tissue spread.
• Obtain informed consent before proceeding with morcellation.

Continue to: Skin closure

 

 

Skin closure

Final subcuticular closure can be accomplished using sutures or skin adhesive. Sutures can be synthetic, absorbable monofilament (Caprosyn), or synthetic, absorbable, braided multifilament (Polysorb).

Skin adhesive closes incisions quickly, avoids inflammation related to foreign bodies, and can ease patients’ concerns that sometimes arise when absorbable suture persists postoperatively (TABLE 1).

The impact of physician experience

Physician experience has been shown to reduce cost while maintaining quality of care.¹⁴ That was the conclusion of researchers who undertook a retrospective study, addressing cost and clinical outcomes, of senior and junior attending physicians who performed laparoscopic-assisted vaginal hysterectomy on 120 patients. Studies such as these often lead to clinical pathways to facilitate cost-effective quality care. 

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CASE Same outcome at lower cost

The hypothetical 43-year-old patient in the opening case undergoes laparoscopic hysterectomy for treatment of uterine fibroids and menorrhagia. In this scenario, however, the surgeon makes the following product choices:

• The patient is prepped with Hibiclens.
• A VCare Plus uterine manipulator is placed.
• Laparoscopic ports include a VersaStep Plus Bladeless Trocar with Step Insufflation Needle; Versaport Plus Pyramidal Bladed Trocar; and 2 VersaOne Bladed trocars.
• The surgeon uses the PKS LYONS Dissecting Forceps and reprocessed Endo Shears to perform the hysterectomy.
• The uterus is enclosed in an Endo Catch bag and removed through the minilaparotomy site.
• The vaginal cuff is closed using 2-0 V-Loc barbed suture. Skin incisions are closed with 4-0 Polysorb, a polyglycolic acid absorbable suture.

The cost of this set of products? $360.44 or, roughly, $1,231.96 less than the set-up described in the case at the beginning of this article (TABLE 2).

Continue to: Summing up

 

 

Summing up

Here are key points to take away from this analysis and discussion:

• As third-party payers and hospitals continue to evaluate surgeons individually and compare procedures from surgeon to surgeon, reimbursement might be stratified—thereby favoring physicians who demonstrate both quality outcomes and cost containment.
• There are many ways a minimally invasive surgeon can implement cost-conscious choices that have little or no impact on the quality of outcome.
• Surgeons who are familiar with surgical instruments and models available at their institution are better prepared to make wise cost-conscious decisions. (See “Caregivers should keep cost in mind: Here’s why,” in the Web version of this article at https://www.mdedge.com/obgyn.)
• Cost is not the only indicator of value: The surgeon must know how to apply tools correctly and be familiar with their limitations, and should choose instruments and products for their safety and ease of use. More often than not, a surgeon’s training and personal experience define—and sometimes restrict—the choice of devices.
• Last, it makes sense to have instruments and devices readily available in the operating room at the start of a case, to avoid unnecessary surgical delays. However, we recommend that you refrain from opening these tools until they are required intraoperatively. It is possible that the case will require conversion to laparotomy or that, after direct visualization of the pathology, different ports or instruments are required.

Acknowledgments
The authors would like to thank Meredith Snook, MD, who was coauthor of the original 2013 article⁶ and Kathleen Riordan, BSN, RN, for assistance in gathering specific cost-related information for this article. 

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