A small trial headed by MD Anderson Cancer Center, Houston, has helped to further identify women who can safely skip surgery after neoadjuvant therapy for early breast cancer.

Among 50 women in the study with cT1-2N0-1M0 triple negative or HER2-positive disease, 31 (62%) had a complete pathologic response (pCR) to neoadjuvant therapy on image-guided vacuum-assisted core biopsy (VACB).

They went onto whole breast radiation with a boost, but given their response to neoadjuvant treatment and the accuracy of VACB, the women did not have surgery.

So far, it seems to have been the right call: At 3 years, there’s been no tumor recurrences and disease-free and overall survival are both 100%.

Eliminating “breast surgery in highly-selected patients with image-guided VACB-determined pCR following” neoadjuvant systemic therapy has “very promising 3-year results,” lead investigator Henry M. Kuerer, MD, PhD, a breast cancer surgeon at MD Anderson, who presented the findings at the European Society for Medical Oncology (ESMO) 2023 annual meeting.

The study speaks to a trend in breast cancer toward deescalation of treatment – particularly surgery – to save women from the side effects of treatments they don’t need.

With the success of modern systemic therapy, “it’s only natural that we think this way,” said Ava Kwong, PhD, chief of breast surgery at the University of Hong Kong, who discussed Dr. Kuerer’s presentation at the meeting.

“This study is really important,” she said. “It’s addressing a very important question whether we can omit surgery in certain groups of patients ... We do want to deescalate surgery,” and the study results are “very good,” she said.

However, larger trials with longer follow-up are needed to draw any firm conclusions, she said.

Dr. Kuerer agreed. He and his team will continue to follow the study subjects, and they have opened up a new trial with 100 patients. A similar study is ongoing in Korea, as well, he noted.
 

Study details

Women in the trial were a median of 60.4 years old; 58% had HER2-positive and the rest triple-negative unicentric breast cancer. Mean baseline tumor size was 2.8 cm. Just 12% of the participants had lymph node involvement. Neoadjuvant systemic therapy was clinician’s choice.

Breast lesions had to shrink to less than 2 cm on imaging after systemic therapy to be eligible for the study, and a minimum of 12 cores had to be obtained on VACB.

The 38% of women in the study with residual disease after systemic treatment went on to surgery.

Two patients were circulating tumor cell (CTC)-positive at baseline, two were positive at 6 months, and one at 12 months. No patients had CTCs detected at more than one timepoint.

The work was funded by the National Cancer Institute. Dr. Kuerer is an adviser for Merck. Dr. Kwong is an adviser/speaker/reviewer/author for Stryker, AstraZeneca, Merck, and Roche. She also disclosed research funding from Merck, Roche, and Gilead and funding for genetic testing from AstraZeneca.

A small trial headed by MD Anderson Cancer Center, Houston, has helped to further identify women who can safely skip surgery after neoadjuvant therapy for early breast cancer.

Among 50 women in the study with cT1-2N0-1M0 triple negative or HER2-positive disease, 31 (62%) had a complete pathologic response (pCR) to neoadjuvant therapy on image-guided vacuum-assisted core biopsy (VACB).

They went onto whole breast radiation with a boost, but given their response to neoadjuvant treatment and the accuracy of VACB, the women did not have surgery.

So far, it seems to have been the right call: At 3 years, there’s been no tumor recurrences and disease-free and overall survival are both 100%.

Eliminating “breast surgery in highly-selected patients with image-guided VACB-determined pCR following” neoadjuvant systemic therapy has “very promising 3-year results,” lead investigator Henry M. Kuerer, MD, PhD, a breast cancer surgeon at MD Anderson, who presented the findings at the European Society for Medical Oncology (ESMO) 2023 annual meeting.

The study speaks to a trend in breast cancer toward deescalation of treatment – particularly surgery – to save women from the side effects of treatments they don’t need.

With the success of modern systemic therapy, “it’s only natural that we think this way,” said Ava Kwong, PhD, chief of breast surgery at the University of Hong Kong, who discussed Dr. Kuerer’s presentation at the meeting.

“This study is really important,” she said. “It’s addressing a very important question whether we can omit surgery in certain groups of patients ... We do want to deescalate surgery,” and the study results are “very good,” she said.

However, larger trials with longer follow-up are needed to draw any firm conclusions, she said.

Dr. Kuerer agreed. He and his team will continue to follow the study subjects, and they have opened up a new trial with 100 patients. A similar study is ongoing in Korea, as well, he noted.
 

Study details

Women in the trial were a median of 60.4 years old; 58% had HER2-positive and the rest triple-negative unicentric breast cancer. Mean baseline tumor size was 2.8 cm. Just 12% of the participants had lymph node involvement. Neoadjuvant systemic therapy was clinician’s choice.

Breast lesions had to shrink to less than 2 cm on imaging after systemic therapy to be eligible for the study, and a minimum of 12 cores had to be obtained on VACB.

The 38% of women in the study with residual disease after systemic treatment went on to surgery.

Two patients were circulating tumor cell (CTC)-positive at baseline, two were positive at 6 months, and one at 12 months. No patients had CTCs detected at more than one timepoint.

The work was funded by the National Cancer Institute. Dr. Kuerer is an adviser for Merck. Dr. Kwong is an adviser/speaker/reviewer/author for Stryker, AstraZeneca, Merck, and Roche. She also disclosed research funding from Merck, Roche, and Gilead and funding for genetic testing from AstraZeneca.

A small trial headed by MD Anderson Cancer Center, Houston, has helped to further identify women who can safely skip surgery after neoadjuvant therapy for early breast cancer.

Among 50 women in the study with cT1-2N0-1M0 triple negative or HER2-positive disease, 31 (62%) had a complete pathologic response (pCR) to neoadjuvant therapy on image-guided vacuum-assisted core biopsy (VACB).

They went onto whole breast radiation with a boost, but given their response to neoadjuvant treatment and the accuracy of VACB, the women did not have surgery.

So far, it seems to have been the right call: At 3 years, there’s been no tumor recurrences and disease-free and overall survival are both 100%.

Eliminating “breast surgery in highly-selected patients with image-guided VACB-determined pCR following” neoadjuvant systemic therapy has “very promising 3-year results,” lead investigator Henry M. Kuerer, MD, PhD, a breast cancer surgeon at MD Anderson, who presented the findings at the European Society for Medical Oncology (ESMO) 2023 annual meeting.

The study speaks to a trend in breast cancer toward deescalation of treatment – particularly surgery – to save women from the side effects of treatments they don’t need.

With the success of modern systemic therapy, “it’s only natural that we think this way,” said Ava Kwong, PhD, chief of breast surgery at the University of Hong Kong, who discussed Dr. Kuerer’s presentation at the meeting.

“This study is really important,” she said. “It’s addressing a very important question whether we can omit surgery in certain groups of patients ... We do want to deescalate surgery,” and the study results are “very good,” she said.

However, larger trials with longer follow-up are needed to draw any firm conclusions, she said.

Dr. Kuerer agreed. He and his team will continue to follow the study subjects, and they have opened up a new trial with 100 patients. A similar study is ongoing in Korea, as well, he noted.
 

Study details

Women in the trial were a median of 60.4 years old; 58% had HER2-positive and the rest triple-negative unicentric breast cancer. Mean baseline tumor size was 2.8 cm. Just 12% of the participants had lymph node involvement. Neoadjuvant systemic therapy was clinician’s choice.

Breast lesions had to shrink to less than 2 cm on imaging after systemic therapy to be eligible for the study, and a minimum of 12 cores had to be obtained on VACB.

The 38% of women in the study with residual disease after systemic treatment went on to surgery.

Two patients were circulating tumor cell (CTC)-positive at baseline, two were positive at 6 months, and one at 12 months. No patients had CTCs detected at more than one timepoint.

The work was funded by the National Cancer Institute. Dr. Kuerer is an adviser for Merck. Dr. Kwong is an adviser/speaker/reviewer/author for Stryker, AstraZeneca, Merck, and Roche. She also disclosed research funding from Merck, Roche, and Gilead and funding for genetic testing from AstraZeneca.

COPENHAGEN – People with precancerous colonic lesions show significant differences in their gut microbiome, compared with the general population up to 5 years before the lesions develop, according to a large, 22-year analysis from the Dutch Microbiome Project cohort study.

The findings suggest a possible role for gut microbiota in the development of colorectal lesions and cancer, said study lead Ranko Gacesa, PhD, from the department of gastroenterology, University of Groningen (the Netherlands), who presented the results at the annual United European Gastroenterology Week.

“It [also] suggests that gut bacteria might enhance currently used noninvasive fecal tests for the detection of colorectal polyps, and even that microbiome-modulating therapies might play a role in prevention of colorectal cancer,” said Dr. Gacesa, who won the award for best abstract in the meeting session.

The gut microbiome is known to be linked to colorectal cancer (CRC); in particular, the bacteria Bacteroides fragilis and Alistipes finegoldii have been found to cause CRC in mouse models, explained Dr. Gacesa.

In the current study, Dr. Gacesa and colleagues looked at the potential for the gut microbiome in humans to play a role in the detection of precancerous colonic lesions. The noninvasive fecal immunochemical test (FIT), recently shown to be a preference among patients, produces a high number of false-positive results, leading to many unnecessary colonoscopies.

“It has been calculated that the use of a fecal microbiota analysis combined with FIT in the early-stage prediction of CRC could result in a high true-positive rate and a low false-positive rate,” said Dr. Gacesa. “In this way, we might reduce the false-positive rate by around 50%. 

“Ideally, we don’t want to detect cancer when it is already established and is hard to treat. We want to detect it as early in its development as possible,” he said.
 

Longitudinal analysis using large Dutch databases

To determine the direction of the relationship between CRC and the gut microbiome, the Dutch researchers conducted a longitudinal analysis from 2000 to 2022, looking at whether CRC alters the gut microbiome, as well as whether changes in the microbiome contribute to the development of precancerous lesions and CRC.

They drew on data from the Dutch colorectal cancer screening program, comprising FIT results in people aged 55 years and older, and colonoscopy if referred. They recorded cases of colonic biopsies from the extensive Dutch national database of medical biopsies. These were then linked with Dutch microbiome project data sourced from fecal samples of 8208 individuals taken between 2012 and 2015.

“This allowed us to associate gut microbiome compositions and functions to detailed histological information about precancerous lesions and CRC, including when lesions were detected relative to fecal sampling [and a reading of the gut microbiome],” Dr. Gacesa explained. 

The analysis determined the composition, function, and genomic profiles of gut microbiota in participants who developed precancerous colorectal lesions before fecal sampling from 2000 to 2015, and in those participants who developed lesions after fecal sampling, between 2015 and 2022. Clinical phenotypes, comprising the type and size of lesions, were noted. The control group included 2123 individuals from the general population with normal colonoscopy findings.
 

More precancerous lesions found after fecal sampling

There were more cases of precancerous lesions found after fecal sampling, reported Dr. Gacesa.

Before fecal sampling, 219 participants had colonic lesions, including low-grade dysplasia, high-grade dysplasia, and serrated polyps, and 26 cases of CRC. A total of 315 participants developed assorted colonic lesions after fecal sampling, with a total of 29 cases of CRC.

When the researchers looked at microbiome diversity in people who had experienced precancerous colonic lesions 1-5 years before fecal sampling, they found that diversity was lower, compared with controls. Microbiome diversity was also decreased in participants who developed colonic lesions after sampling.

The microbiome composition and function were different between patients with preexisting and future lesions, and varied based on the types of lesion.

“We saw a drop in some commensal bacteria, including Faecalibacterium, in both those with recent pathologies and those who developed them in the future. We also saw a massive spike in Alistipes finegoldii in those who had CRC, strongly suggesting it is closely linked to CRC in people,” reported Dr. Gacesa.

Among bacterial species linked with the future development of precancerous lesions were those from the family of Lachnospiraceae, and the genera Roseburia and Eubacterium. Microbiome composition had a moderate predictive power for future lesions and CRC.

“Precancerous lesions are linked to the gut microbiome,” Dr. Gacesa said. “Adenomas – both preexisting ones (before fecal sampling), and ones that came after fecal sampling – are significantly linked to the microbiome composition.”
 

More time needed

Loris Lopetuso, MD, gastroenterologist, from Fondazione Policlinico Universitario Agostino Gemelli, Rome, who comoderated the session, remarked that the data were intriguing and important.

“We really need to find new predictors of tumorigenesis,” he said. “We already have some good predictors, mainly FIT, but these are not enough. These gut microbiota look promising.”

He added that the study by Dr. Gacesa’s team was one of the largest he had seen. “But I would note that, methodologically, we need to remember that the time between a fecal sample and the development of polyps can be very large,” Dr. Lopetuso emphasized. “This study looked at around 5 years only. Also, the microbiota can change from one day to the other in response to stress, diet, and many other things.” 

However, “this could be the beginning of a longitudinal study between cases and controls because many years are needed,” he added.

Dr. Gacesa has received funding from Janssen Pharmaceuticals for an unrelated research project. He is a paid R&D consultant for Esox Biologics Ltd for topics unrelated to this project. Dr. Lopetuso reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

COPENHAGEN – People with precancerous colonic lesions show significant differences in their gut microbiome, compared with the general population up to 5 years before the lesions develop, according to a large, 22-year analysis from the Dutch Microbiome Project cohort study.

The findings suggest a possible role for gut microbiota in the development of colorectal lesions and cancer, said study lead Ranko Gacesa, PhD, from the department of gastroenterology, University of Groningen (the Netherlands), who presented the results at the annual United European Gastroenterology Week.

“It [also] suggests that gut bacteria might enhance currently used noninvasive fecal tests for the detection of colorectal polyps, and even that microbiome-modulating therapies might play a role in prevention of colorectal cancer,” said Dr. Gacesa, who won the award for best abstract in the meeting session.

The gut microbiome is known to be linked to colorectal cancer (CRC); in particular, the bacteria Bacteroides fragilis and Alistipes finegoldii have been found to cause CRC in mouse models, explained Dr. Gacesa.

In the current study, Dr. Gacesa and colleagues looked at the potential for the gut microbiome in humans to play a role in the detection of precancerous colonic lesions. The noninvasive fecal immunochemical test (FIT), recently shown to be a preference among patients, produces a high number of false-positive results, leading to many unnecessary colonoscopies.

“It has been calculated that the use of a fecal microbiota analysis combined with FIT in the early-stage prediction of CRC could result in a high true-positive rate and a low false-positive rate,” said Dr. Gacesa. “In this way, we might reduce the false-positive rate by around 50%. 

“Ideally, we don’t want to detect cancer when it is already established and is hard to treat. We want to detect it as early in its development as possible,” he said.
 

Longitudinal analysis using large Dutch databases

To determine the direction of the relationship between CRC and the gut microbiome, the Dutch researchers conducted a longitudinal analysis from 2000 to 2022, looking at whether CRC alters the gut microbiome, as well as whether changes in the microbiome contribute to the development of precancerous lesions and CRC.

They drew on data from the Dutch colorectal cancer screening program, comprising FIT results in people aged 55 years and older, and colonoscopy if referred. They recorded cases of colonic biopsies from the extensive Dutch national database of medical biopsies. These were then linked with Dutch microbiome project data sourced from fecal samples of 8208 individuals taken between 2012 and 2015.

“This allowed us to associate gut microbiome compositions and functions to detailed histological information about precancerous lesions and CRC, including when lesions were detected relative to fecal sampling [and a reading of the gut microbiome],” Dr. Gacesa explained. 

The analysis determined the composition, function, and genomic profiles of gut microbiota in participants who developed precancerous colorectal lesions before fecal sampling from 2000 to 2015, and in those participants who developed lesions after fecal sampling, between 2015 and 2022. Clinical phenotypes, comprising the type and size of lesions, were noted. The control group included 2123 individuals from the general population with normal colonoscopy findings.
 

More precancerous lesions found after fecal sampling

There were more cases of precancerous lesions found after fecal sampling, reported Dr. Gacesa.

Before fecal sampling, 219 participants had colonic lesions, including low-grade dysplasia, high-grade dysplasia, and serrated polyps, and 26 cases of CRC. A total of 315 participants developed assorted colonic lesions after fecal sampling, with a total of 29 cases of CRC.

When the researchers looked at microbiome diversity in people who had experienced precancerous colonic lesions 1-5 years before fecal sampling, they found that diversity was lower, compared with controls. Microbiome diversity was also decreased in participants who developed colonic lesions after sampling.

The microbiome composition and function were different between patients with preexisting and future lesions, and varied based on the types of lesion.

“We saw a drop in some commensal bacteria, including Faecalibacterium, in both those with recent pathologies and those who developed them in the future. We also saw a massive spike in Alistipes finegoldii in those who had CRC, strongly suggesting it is closely linked to CRC in people,” reported Dr. Gacesa.

Among bacterial species linked with the future development of precancerous lesions were those from the family of Lachnospiraceae, and the genera Roseburia and Eubacterium. Microbiome composition had a moderate predictive power for future lesions and CRC.

“Precancerous lesions are linked to the gut microbiome,” Dr. Gacesa said. “Adenomas – both preexisting ones (before fecal sampling), and ones that came after fecal sampling – are significantly linked to the microbiome composition.”
 

More time needed

Loris Lopetuso, MD, gastroenterologist, from Fondazione Policlinico Universitario Agostino Gemelli, Rome, who comoderated the session, remarked that the data were intriguing and important.

“We really need to find new predictors of tumorigenesis,” he said. “We already have some good predictors, mainly FIT, but these are not enough. These gut microbiota look promising.”

He added that the study by Dr. Gacesa’s team was one of the largest he had seen. “But I would note that, methodologically, we need to remember that the time between a fecal sample and the development of polyps can be very large,” Dr. Lopetuso emphasized. “This study looked at around 5 years only. Also, the microbiota can change from one day to the other in response to stress, diet, and many other things.” 

However, “this could be the beginning of a longitudinal study between cases and controls because many years are needed,” he added.

Dr. Gacesa has received funding from Janssen Pharmaceuticals for an unrelated research project. He is a paid R&D consultant for Esox Biologics Ltd for topics unrelated to this project. Dr. Lopetuso reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

COPENHAGEN – People with precancerous colonic lesions show significant differences in their gut microbiome, compared with the general population up to 5 years before the lesions develop, according to a large, 22-year analysis from the Dutch Microbiome Project cohort study.

The findings suggest a possible role for gut microbiota in the development of colorectal lesions and cancer, said study lead Ranko Gacesa, PhD, from the department of gastroenterology, University of Groningen (the Netherlands), who presented the results at the annual United European Gastroenterology Week.

“It [also] suggests that gut bacteria might enhance currently used noninvasive fecal tests for the detection of colorectal polyps, and even that microbiome-modulating therapies might play a role in prevention of colorectal cancer,” said Dr. Gacesa, who won the award for best abstract in the meeting session.

The gut microbiome is known to be linked to colorectal cancer (CRC); in particular, the bacteria Bacteroides fragilis and Alistipes finegoldii have been found to cause CRC in mouse models, explained Dr. Gacesa.

In the current study, Dr. Gacesa and colleagues looked at the potential for the gut microbiome in humans to play a role in the detection of precancerous colonic lesions. The noninvasive fecal immunochemical test (FIT), recently shown to be a preference among patients, produces a high number of false-positive results, leading to many unnecessary colonoscopies.

“It has been calculated that the use of a fecal microbiota analysis combined with FIT in the early-stage prediction of CRC could result in a high true-positive rate and a low false-positive rate,” said Dr. Gacesa. “In this way, we might reduce the false-positive rate by around 50%. 

“Ideally, we don’t want to detect cancer when it is already established and is hard to treat. We want to detect it as early in its development as possible,” he said.
 

Longitudinal analysis using large Dutch databases

To determine the direction of the relationship between CRC and the gut microbiome, the Dutch researchers conducted a longitudinal analysis from 2000 to 2022, looking at whether CRC alters the gut microbiome, as well as whether changes in the microbiome contribute to the development of precancerous lesions and CRC.

They drew on data from the Dutch colorectal cancer screening program, comprising FIT results in people aged 55 years and older, and colonoscopy if referred. They recorded cases of colonic biopsies from the extensive Dutch national database of medical biopsies. These were then linked with Dutch microbiome project data sourced from fecal samples of 8208 individuals taken between 2012 and 2015.

“This allowed us to associate gut microbiome compositions and functions to detailed histological information about precancerous lesions and CRC, including when lesions were detected relative to fecal sampling [and a reading of the gut microbiome],” Dr. Gacesa explained. 

The analysis determined the composition, function, and genomic profiles of gut microbiota in participants who developed precancerous colorectal lesions before fecal sampling from 2000 to 2015, and in those participants who developed lesions after fecal sampling, between 2015 and 2022. Clinical phenotypes, comprising the type and size of lesions, were noted. The control group included 2123 individuals from the general population with normal colonoscopy findings.
 

More precancerous lesions found after fecal sampling

There were more cases of precancerous lesions found after fecal sampling, reported Dr. Gacesa.

Before fecal sampling, 219 participants had colonic lesions, including low-grade dysplasia, high-grade dysplasia, and serrated polyps, and 26 cases of CRC. A total of 315 participants developed assorted colonic lesions after fecal sampling, with a total of 29 cases of CRC.

When the researchers looked at microbiome diversity in people who had experienced precancerous colonic lesions 1-5 years before fecal sampling, they found that diversity was lower, compared with controls. Microbiome diversity was also decreased in participants who developed colonic lesions after sampling.

The microbiome composition and function were different between patients with preexisting and future lesions, and varied based on the types of lesion.

“We saw a drop in some commensal bacteria, including Faecalibacterium, in both those with recent pathologies and those who developed them in the future. We also saw a massive spike in Alistipes finegoldii in those who had CRC, strongly suggesting it is closely linked to CRC in people,” reported Dr. Gacesa.

Among bacterial species linked with the future development of precancerous lesions were those from the family of Lachnospiraceae, and the genera Roseburia and Eubacterium. Microbiome composition had a moderate predictive power for future lesions and CRC.

“Precancerous lesions are linked to the gut microbiome,” Dr. Gacesa said. “Adenomas – both preexisting ones (before fecal sampling), and ones that came after fecal sampling – are significantly linked to the microbiome composition.”
 

More time needed

Loris Lopetuso, MD, gastroenterologist, from Fondazione Policlinico Universitario Agostino Gemelli, Rome, who comoderated the session, remarked that the data were intriguing and important.

“We really need to find new predictors of tumorigenesis,” he said. “We already have some good predictors, mainly FIT, but these are not enough. These gut microbiota look promising.”

He added that the study by Dr. Gacesa’s team was one of the largest he had seen. “But I would note that, methodologically, we need to remember that the time between a fecal sample and the development of polyps can be very large,” Dr. Lopetuso emphasized. “This study looked at around 5 years only. Also, the microbiota can change from one day to the other in response to stress, diet, and many other things.” 

However, “this could be the beginning of a longitudinal study between cases and controls because many years are needed,” he added.

Dr. Gacesa has received funding from Janssen Pharmaceuticals for an unrelated research project. He is a paid R&D consultant for Esox Biologics Ltd for topics unrelated to this project. Dr. Lopetuso reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

TOPLINE:

A novel handheld tool may hold promise for reducing anxiety and pain and improving sleep quality, according to research presented at Lifestyle Medicine 2023, the annual meeting of the American College of Lifestyle Medicine.

METHODOLOGY:

• Franklin Somchith Ly, a PhD candidate in mechanical engineering at the University of California, Santa Barbara, developed , a product that assesses blood flow to the hand with an infrared temperature sensor and changes color as blood vessels expand during relaxation.
• Exercises such as intentional breathwork, visualization, and muscle relaxation change the color displayed by the device.
• Mr. Ly examined how measures of anxiety, sleep quality, and chronic pain changed after participants used the instrument. Ten participants completed a study assessing anxiety. Eight participants were enrolled in a sleep study where they completed biofeedback sessions before bed for 2 weeks, and 15 participants performed biofeedback twice daily and reported their levels of anxiety and pain.

TAKEAWAY:

• Anxiety scores decreased by about 22% on average (P < .001).
• Seven of the eight participants in the sleep study had improved scores on the Pittsburgh Sleep Quality Index, with an average improvement of nearly 30% (P < .05). Daytime dysfunction improved by 58% (P < .01).
• In the chronic pain study, about 60% of the 350 biofeedback sessions led to reduced pain.

IN PRACTICE:

“These portable devices may aid lifestyle management by alleviating anxiety, chronic pain, and enhancing daytime energy,” Mr. Ly said. “The results support their integration into lifestyle medicine and integrative medicine.”

SOURCE:

Mr. Ly presented the findings as a poster at Lifestyle Medicine 2023, which took place Oct. 29 to Nov. 1 in Denver and online.

LIMITATIONS:

The studies were open label and did not include control groups.

DISCLOSURES:

Mr. Ly is the founder of CalmStone, which markets a thermal biofeedback device. The research was supported by the Bill and Melinda Gates Foundation and the U.S. Army Research Office and Institute for Collaborative Biotechnologies.

A version of this article first appeared on Medscape.com.

TOPLINE:

A novel handheld tool may hold promise for reducing anxiety and pain and improving sleep quality, according to research presented at Lifestyle Medicine 2023, the annual meeting of the American College of Lifestyle Medicine.

METHODOLOGY:

• Franklin Somchith Ly, a PhD candidate in mechanical engineering at the University of California, Santa Barbara, developed , a product that assesses blood flow to the hand with an infrared temperature sensor and changes color as blood vessels expand during relaxation.
• Exercises such as intentional breathwork, visualization, and muscle relaxation change the color displayed by the device.
• Mr. Ly examined how measures of anxiety, sleep quality, and chronic pain changed after participants used the instrument. Ten participants completed a study assessing anxiety. Eight participants were enrolled in a sleep study where they completed biofeedback sessions before bed for 2 weeks, and 15 participants performed biofeedback twice daily and reported their levels of anxiety and pain.

TAKEAWAY:

• Anxiety scores decreased by about 22% on average (P < .001).
• Seven of the eight participants in the sleep study had improved scores on the Pittsburgh Sleep Quality Index, with an average improvement of nearly 30% (P < .05). Daytime dysfunction improved by 58% (P < .01).
• In the chronic pain study, about 60% of the 350 biofeedback sessions led to reduced pain.

IN PRACTICE:

“These portable devices may aid lifestyle management by alleviating anxiety, chronic pain, and enhancing daytime energy,” Mr. Ly said. “The results support their integration into lifestyle medicine and integrative medicine.”

SOURCE:

Mr. Ly presented the findings as a poster at Lifestyle Medicine 2023, which took place Oct. 29 to Nov. 1 in Denver and online.

LIMITATIONS:

The studies were open label and did not include control groups.

DISCLOSURES:

Mr. Ly is the founder of CalmStone, which markets a thermal biofeedback device. The research was supported by the Bill and Melinda Gates Foundation and the U.S. Army Research Office and Institute for Collaborative Biotechnologies.

A version of this article first appeared on Medscape.com.

TOPLINE:

A novel handheld tool may hold promise for reducing anxiety and pain and improving sleep quality, according to research presented at Lifestyle Medicine 2023, the annual meeting of the American College of Lifestyle Medicine.

METHODOLOGY:

• Franklin Somchith Ly, a PhD candidate in mechanical engineering at the University of California, Santa Barbara, developed , a product that assesses blood flow to the hand with an infrared temperature sensor and changes color as blood vessels expand during relaxation.
• Exercises such as intentional breathwork, visualization, and muscle relaxation change the color displayed by the device.
• Mr. Ly examined how measures of anxiety, sleep quality, and chronic pain changed after participants used the instrument. Ten participants completed a study assessing anxiety. Eight participants were enrolled in a sleep study where they completed biofeedback sessions before bed for 2 weeks, and 15 participants performed biofeedback twice daily and reported their levels of anxiety and pain.

TAKEAWAY:

• Anxiety scores decreased by about 22% on average (P < .001).
• Seven of the eight participants in the sleep study had improved scores on the Pittsburgh Sleep Quality Index, with an average improvement of nearly 30% (P < .05). Daytime dysfunction improved by 58% (P < .01).
• In the chronic pain study, about 60% of the 350 biofeedback sessions led to reduced pain.

IN PRACTICE:

“These portable devices may aid lifestyle management by alleviating anxiety, chronic pain, and enhancing daytime energy,” Mr. Ly said. “The results support their integration into lifestyle medicine and integrative medicine.”

SOURCE:

Mr. Ly presented the findings as a poster at Lifestyle Medicine 2023, which took place Oct. 29 to Nov. 1 in Denver and online.

LIMITATIONS:

The studies were open label and did not include control groups.

DISCLOSURES:

Mr. Ly is the founder of CalmStone, which markets a thermal biofeedback device. The research was supported by the Bill and Melinda Gates Foundation and the U.S. Army Research Office and Institute for Collaborative Biotechnologies.

A version of this article first appeared on Medscape.com.

TOPLINE:

The Immunoscore biopsy, which quantifies immune cell tumor infiltration in tumor biopsies at baseline, is a strong predictor for rectal cancer recurrence for both local regrowth and distant metastasis during watchful waiting.

METHODOLOGY:

• Currently, oncologists do not have a biomarker that can help select patients with rectal cancer for watchful waiting after neoadjuvant chemoradiotherapy as well as help monitor them over time. And about 25% of patients on watchful waiting will eventually relapse.
• The Immunoscore biopsy quantifies the degree of immune infiltration on pretreatment tumor biopsies, looking at the density of CD3- and CD8-positive T cells at baseline, given that greater infiltration has been associated with prolonged treatment response.
• To determine whether the Immunoscore can help select patients for watchful waiting, investigators correlated Immunoscore with time to recurrence in 249 patients with stage I-III rectal cancer who were undergoing watchful waiting after complete clinical responses to neoadjuvant chemoradiotherapy.
• CD3- and CD8-positive T-cell densities were converted into percentiles and then translated into scores of Immunoscore biopsy: low (0%-25%), intermediate (> 25%-70%), and high (> 70%-100%).

TAKEAWAY:

• The Immunoscore biopsy significantly improved predictions of recurrence: 5-year recurrence-free survival was 91.3% among patients with high scores, 62.5% among those with intermediate scores, and 53.1% among those with low scores.
• The Immunoscore was significantly associated with disease-free survival (log-rank P = .0002) and predicted both local regrowth and distant metastasis.
• On multivariate analysis, the Immunoscore’s predictive ability was independent of age, sex, tumor location, cT stage, and cN stage, and was the strongest predictor of time to recurrence (hazard ratio, high vs. low, 6.93; P = .0017).

IN PRACTICE:

This validation study confirms that the Immunoscore biopsy “is an independent parameter predicting time to recurrence” and can help physicians and patients decide whether to opt for watchful waiting, the study authors wrote.

SOURCE:

The study, led by Carine El Sissy of the Laboratory of Integrative Cancer Immunology, Paris, was published Oct. 3 in the Journal of Clinical Oncology.

LIMITATIONS:

Mismatch repair gene expression status was not assessed.

DISCLOSURES:

The work was supported by the L’Institut National de la Santé et de la Recherche Médicale and others. Investigators disclosed patents related to the work and ties to many companies, including Amgen, AstraZeneca, and Merck. One investigator is an employee of Novo Nordisk, and another is employed by Veracyte.

A version of this article first appeared on Medscape.com.

TOPLINE:

The Immunoscore biopsy, which quantifies immune cell tumor infiltration in tumor biopsies at baseline, is a strong predictor for rectal cancer recurrence for both local regrowth and distant metastasis during watchful waiting.

METHODOLOGY:

• Currently, oncologists do not have a biomarker that can help select patients with rectal cancer for watchful waiting after neoadjuvant chemoradiotherapy as well as help monitor them over time. And about 25% of patients on watchful waiting will eventually relapse.
• The Immunoscore biopsy quantifies the degree of immune infiltration on pretreatment tumor biopsies, looking at the density of CD3- and CD8-positive T cells at baseline, given that greater infiltration has been associated with prolonged treatment response.
• To determine whether the Immunoscore can help select patients for watchful waiting, investigators correlated Immunoscore with time to recurrence in 249 patients with stage I-III rectal cancer who were undergoing watchful waiting after complete clinical responses to neoadjuvant chemoradiotherapy.
• CD3- and CD8-positive T-cell densities were converted into percentiles and then translated into scores of Immunoscore biopsy: low (0%-25%), intermediate (> 25%-70%), and high (> 70%-100%).

TAKEAWAY:

• The Immunoscore biopsy significantly improved predictions of recurrence: 5-year recurrence-free survival was 91.3% among patients with high scores, 62.5% among those with intermediate scores, and 53.1% among those with low scores.
• The Immunoscore was significantly associated with disease-free survival (log-rank P = .0002) and predicted both local regrowth and distant metastasis.
• On multivariate analysis, the Immunoscore’s predictive ability was independent of age, sex, tumor location, cT stage, and cN stage, and was the strongest predictor of time to recurrence (hazard ratio, high vs. low, 6.93; P = .0017).

IN PRACTICE:

This validation study confirms that the Immunoscore biopsy “is an independent parameter predicting time to recurrence” and can help physicians and patients decide whether to opt for watchful waiting, the study authors wrote.

SOURCE:

The study, led by Carine El Sissy of the Laboratory of Integrative Cancer Immunology, Paris, was published Oct. 3 in the Journal of Clinical Oncology.

LIMITATIONS:

Mismatch repair gene expression status was not assessed.

DISCLOSURES:

The work was supported by the L’Institut National de la Santé et de la Recherche Médicale and others. Investigators disclosed patents related to the work and ties to many companies, including Amgen, AstraZeneca, and Merck. One investigator is an employee of Novo Nordisk, and another is employed by Veracyte.

A version of this article first appeared on Medscape.com.

TOPLINE:

The Immunoscore biopsy, which quantifies immune cell tumor infiltration in tumor biopsies at baseline, is a strong predictor for rectal cancer recurrence for both local regrowth and distant metastasis during watchful waiting.

METHODOLOGY:

• Currently, oncologists do not have a biomarker that can help select patients with rectal cancer for watchful waiting after neoadjuvant chemoradiotherapy as well as help monitor them over time. And about 25% of patients on watchful waiting will eventually relapse.
• The Immunoscore biopsy quantifies the degree of immune infiltration on pretreatment tumor biopsies, looking at the density of CD3- and CD8-positive T cells at baseline, given that greater infiltration has been associated with prolonged treatment response.
• To determine whether the Immunoscore can help select patients for watchful waiting, investigators correlated Immunoscore with time to recurrence in 249 patients with stage I-III rectal cancer who were undergoing watchful waiting after complete clinical responses to neoadjuvant chemoradiotherapy.
• CD3- and CD8-positive T-cell densities were converted into percentiles and then translated into scores of Immunoscore biopsy: low (0%-25%), intermediate (> 25%-70%), and high (> 70%-100%).

TAKEAWAY:

• The Immunoscore biopsy significantly improved predictions of recurrence: 5-year recurrence-free survival was 91.3% among patients with high scores, 62.5% among those with intermediate scores, and 53.1% among those with low scores.
• The Immunoscore was significantly associated with disease-free survival (log-rank P = .0002) and predicted both local regrowth and distant metastasis.
• On multivariate analysis, the Immunoscore’s predictive ability was independent of age, sex, tumor location, cT stage, and cN stage, and was the strongest predictor of time to recurrence (hazard ratio, high vs. low, 6.93; P = .0017).

IN PRACTICE:

This validation study confirms that the Immunoscore biopsy “is an independent parameter predicting time to recurrence” and can help physicians and patients decide whether to opt for watchful waiting, the study authors wrote.

SOURCE:

The study, led by Carine El Sissy of the Laboratory of Integrative Cancer Immunology, Paris, was published Oct. 3 in the Journal of Clinical Oncology.

LIMITATIONS:

Mismatch repair gene expression status was not assessed.

DISCLOSURES:

The work was supported by the L’Institut National de la Santé et de la Recherche Médicale and others. Investigators disclosed patents related to the work and ties to many companies, including Amgen, AstraZeneca, and Merck. One investigator is an employee of Novo Nordisk, and another is employed by Veracyte.

A version of this article first appeared on Medscape.com.

The American Cancer Society has updated its screening guidelines for lung cancer, the leading cause of cancer-specific deaths in the United States and the largest driver of potential years of life lost from cancer.

The 2023 screening guidance, aimed principally at reducing lung cancer mortality in asymptomatic but high-risk, tobacco-exposed individuals, expands the age eligibility and lowers both the former smoking history and the years since quitting threshold for screening with low-dose CT (LDCT).

It is based on the most recent evidence on the efficacy and effectiveness of screening and lung cancer risk in persons who formerly smoked, wrote the ACS’s Guideline Development Group led by Robert A. Smith, PhD, senior vice president of early cancer detection science. The new guidelines, which replace the 2013 statement, appear in CA: A Cancer Journal for Physicians.

The primary evidence source for the update was a systematic review of LDCT lung cancer screening conducted for the U.S. Preventive Services Task Force and published in 2021.

The new guideline continues a trend of expanding eligibility for lung cancer screening, which has had low uptake, to prevent more deaths. “Recent studies have shown that extending the age for persons who smoked and formerly smoked, eliminating the ‘years since quitting’ requirement, and lowering the pack-per-year recommendation could make a real difference in saving lives,” Dr. Smith said. “The relative risk of developing lung cancer in people who have smoked most of their life compared to people who never smoked is very high – about 70 times the risk.” Although lung cancer is the third most common malignancy in the United States, it accounts for more deaths than colorectal, breast, prostate, and cervical cancers combined.

The recommendation for annual LDCT for at-risk persons remains unchanged from 2013.

Among the 2023 eligibility changes:

• Age: Expanded to 50-80 years from 55-74 years.
• Smoking status: Changed to current or previous smoker from current smoker or smoker who quit within past 15 years (number of years since quitting no longer a criterion to start or stop screening). Dr. Smith noted that both the 2013 guidelines and other groups’ updated recommendations retained the eligibility cutoff of 15 years since smoking cessation. “But had their risk declined to a level that just did not justify continuing screening?” he asked. “There wasn’t an answer to that question, so we needed to look carefully at the absolute risk of lung cancer in persons who formerly smoked compared with people who currently smoked and people who never smoked.”
• Smoking history: Reduced to 20 or more pack-years (average of 20 cigarettes a day) versus 30 or more pack-years.
• Exclusions: Expanded to health conditions that may increase harm or hinder further evaluation, surgery, or treatment; comorbidities limiting life expectancy to fewer than 5 years; unwillingness to accept treatment for screen‐detected cancer, which was changed from 2013’s life‐limiting comorbid conditions, metallic implants or devices in the chest or back, home oxygen supplementation.

In addition, decision-making should be a shared process with a health professional providing the patient with information on the benefits, limitations, and harms of LDCT screening, as well as prescreening advice on smoking cessation and the offer of assistive counseling and pharmocotherapy.

“Overall, lung cancer screening remains one of the least used early cancer detection modalities in clinical practice. The new guidance opens up lung cancer screening to all former smokers regardless of time of cessation,” said internist William E. Golden, MD, MACP, a professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock. “This may promote greater uptake in concert with greater availability of low-radiation CT scanning.”

While agreeing the expanded criteria will enfranchise nearly 5 million current and former U.S. smokers for screening and may reduce deaths, internist Aarati D. Didwania, MD, MMSCI, MACP, a professor of medicine and medical education at Northwestern University, Chicago, warned that increasing actual uptake may be an uphill battle. “The practical part of the equation is seeing that the scans get done. There is often a lag between a recommendation of a yearly test and getting insurance coverage for it, and many disadvantaged people face barriers.” Then there’s the knowledge gap. “Patients and doctors have to know what the new guidelines are and who has access,” she said.

Reaching the target population in rural areas is particularly challenging with the greater distances to imaging centers. Another barrier is that most electronic health records do not identify eligible patients based on smoking and pack‐year history.

In Dr. Didwania’s view, professional medical societies have an important role to play in educating their members, and through them, patients. “Disseminating information about the new recommendations is the first step and would be incredibly helpful.”
 

A brief history of lung cancer screening

1950s: By mid-20th century, the causal association between tobacco exposure and lung cancer became clear and by the late 1950s attempts were made to develop a lung cancer screening strategy for high‐risk individuals, commonly with the combination of sputum cytology and chest x-ray.

1970s: The ACS recommended annual testing for current or former smokers with chest x-ray (and sometimes sputum cytology).

1980: The ACS withdrew the above recommendation for regular radiographic screening after randomized controlled trials failed to yield convincing evidence that such screening saved lives.

2013: After the National Lung Screening Trial found three annual LDCT screenings were associated with a 20% relative mortality reduction, compared with annual chest x-ray, the ACS issued a recommendation for annual screening with LDCT: in persons 55-74 years with a pack‐year history of 30 or more who currently smoke or formerly smoked but had not exceeded 15 years since quitting and had no life-limiting morbidity.
 

Future mortality

Although tobacco controls are expected to reduce age‐adjusted lung cancer mortality in the United States by 79% from 2015 to 2065, 4.4 million lung cancer deaths are projected to occur in this period, the authors stated. “A large fraction of these deaths can be prevented if we embrace the urgent challenge to improve our ability to identify the population at risk and apply our knowledge to achieve high rates of participation in regular [lung cancer screening].”

The study was funded by the American Cancer Society Guideline Development Group and the National Comprehensive Cancer Network. The authors disclosed no relevant competing interests. Dr. Golden and Dr. Didwania had no relevant conflicts of interest to declare with regard to their comments.

The American Cancer Society has updated its screening guidelines for lung cancer, the leading cause of cancer-specific deaths in the United States and the largest driver of potential years of life lost from cancer.

The 2023 screening guidance, aimed principally at reducing lung cancer mortality in asymptomatic but high-risk, tobacco-exposed individuals, expands the age eligibility and lowers both the former smoking history and the years since quitting threshold for screening with low-dose CT (LDCT).

It is based on the most recent evidence on the efficacy and effectiveness of screening and lung cancer risk in persons who formerly smoked, wrote the ACS’s Guideline Development Group led by Robert A. Smith, PhD, senior vice president of early cancer detection science. The new guidelines, which replace the 2013 statement, appear in CA: A Cancer Journal for Physicians.

The primary evidence source for the update was a systematic review of LDCT lung cancer screening conducted for the U.S. Preventive Services Task Force and published in 2021.

The new guideline continues a trend of expanding eligibility for lung cancer screening, which has had low uptake, to prevent more deaths. “Recent studies have shown that extending the age for persons who smoked and formerly smoked, eliminating the ‘years since quitting’ requirement, and lowering the pack-per-year recommendation could make a real difference in saving lives,” Dr. Smith said. “The relative risk of developing lung cancer in people who have smoked most of their life compared to people who never smoked is very high – about 70 times the risk.” Although lung cancer is the third most common malignancy in the United States, it accounts for more deaths than colorectal, breast, prostate, and cervical cancers combined.

The recommendation for annual LDCT for at-risk persons remains unchanged from 2013.

Among the 2023 eligibility changes:

• Age: Expanded to 50-80 years from 55-74 years.
• Smoking status: Changed to current or previous smoker from current smoker or smoker who quit within past 15 years (number of years since quitting no longer a criterion to start or stop screening). Dr. Smith noted that both the 2013 guidelines and other groups’ updated recommendations retained the eligibility cutoff of 15 years since smoking cessation. “But had their risk declined to a level that just did not justify continuing screening?” he asked. “There wasn’t an answer to that question, so we needed to look carefully at the absolute risk of lung cancer in persons who formerly smoked compared with people who currently smoked and people who never smoked.”
• Smoking history: Reduced to 20 or more pack-years (average of 20 cigarettes a day) versus 30 or more pack-years.
• Exclusions: Expanded to health conditions that may increase harm or hinder further evaluation, surgery, or treatment; comorbidities limiting life expectancy to fewer than 5 years; unwillingness to accept treatment for screen‐detected cancer, which was changed from 2013’s life‐limiting comorbid conditions, metallic implants or devices in the chest or back, home oxygen supplementation.

In addition, decision-making should be a shared process with a health professional providing the patient with information on the benefits, limitations, and harms of LDCT screening, as well as prescreening advice on smoking cessation and the offer of assistive counseling and pharmocotherapy.

“Overall, lung cancer screening remains one of the least used early cancer detection modalities in clinical practice. The new guidance opens up lung cancer screening to all former smokers regardless of time of cessation,” said internist William E. Golden, MD, MACP, a professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock. “This may promote greater uptake in concert with greater availability of low-radiation CT scanning.”

While agreeing the expanded criteria will enfranchise nearly 5 million current and former U.S. smokers for screening and may reduce deaths, internist Aarati D. Didwania, MD, MMSCI, MACP, a professor of medicine and medical education at Northwestern University, Chicago, warned that increasing actual uptake may be an uphill battle. “The practical part of the equation is seeing that the scans get done. There is often a lag between a recommendation of a yearly test and getting insurance coverage for it, and many disadvantaged people face barriers.” Then there’s the knowledge gap. “Patients and doctors have to know what the new guidelines are and who has access,” she said.

Reaching the target population in rural areas is particularly challenging with the greater distances to imaging centers. Another barrier is that most electronic health records do not identify eligible patients based on smoking and pack‐year history.

In Dr. Didwania’s view, professional medical societies have an important role to play in educating their members, and through them, patients. “Disseminating information about the new recommendations is the first step and would be incredibly helpful.”
 

A brief history of lung cancer screening

1950s: By mid-20th century, the causal association between tobacco exposure and lung cancer became clear and by the late 1950s attempts were made to develop a lung cancer screening strategy for high‐risk individuals, commonly with the combination of sputum cytology and chest x-ray.

1970s: The ACS recommended annual testing for current or former smokers with chest x-ray (and sometimes sputum cytology).

1980: The ACS withdrew the above recommendation for regular radiographic screening after randomized controlled trials failed to yield convincing evidence that such screening saved lives.

2013: After the National Lung Screening Trial found three annual LDCT screenings were associated with a 20% relative mortality reduction, compared with annual chest x-ray, the ACS issued a recommendation for annual screening with LDCT: in persons 55-74 years with a pack‐year history of 30 or more who currently smoke or formerly smoked but had not exceeded 15 years since quitting and had no life-limiting morbidity.
 

Future mortality

Although tobacco controls are expected to reduce age‐adjusted lung cancer mortality in the United States by 79% from 2015 to 2065, 4.4 million lung cancer deaths are projected to occur in this period, the authors stated. “A large fraction of these deaths can be prevented if we embrace the urgent challenge to improve our ability to identify the population at risk and apply our knowledge to achieve high rates of participation in regular [lung cancer screening].”

The study was funded by the American Cancer Society Guideline Development Group and the National Comprehensive Cancer Network. The authors disclosed no relevant competing interests. Dr. Golden and Dr. Didwania had no relevant conflicts of interest to declare with regard to their comments.

The American Cancer Society has updated its screening guidelines for lung cancer, the leading cause of cancer-specific deaths in the United States and the largest driver of potential years of life lost from cancer.

The 2023 screening guidance, aimed principally at reducing lung cancer mortality in asymptomatic but high-risk, tobacco-exposed individuals, expands the age eligibility and lowers both the former smoking history and the years since quitting threshold for screening with low-dose CT (LDCT).

It is based on the most recent evidence on the efficacy and effectiveness of screening and lung cancer risk in persons who formerly smoked, wrote the ACS’s Guideline Development Group led by Robert A. Smith, PhD, senior vice president of early cancer detection science. The new guidelines, which replace the 2013 statement, appear in CA: A Cancer Journal for Physicians.

The primary evidence source for the update was a systematic review of LDCT lung cancer screening conducted for the U.S. Preventive Services Task Force and published in 2021.

The new guideline continues a trend of expanding eligibility for lung cancer screening, which has had low uptake, to prevent more deaths. “Recent studies have shown that extending the age for persons who smoked and formerly smoked, eliminating the ‘years since quitting’ requirement, and lowering the pack-per-year recommendation could make a real difference in saving lives,” Dr. Smith said. “The relative risk of developing lung cancer in people who have smoked most of their life compared to people who never smoked is very high – about 70 times the risk.” Although lung cancer is the third most common malignancy in the United States, it accounts for more deaths than colorectal, breast, prostate, and cervical cancers combined.

The recommendation for annual LDCT for at-risk persons remains unchanged from 2013.

Among the 2023 eligibility changes:

• Age: Expanded to 50-80 years from 55-74 years.
• Smoking status: Changed to current or previous smoker from current smoker or smoker who quit within past 15 years (number of years since quitting no longer a criterion to start or stop screening). Dr. Smith noted that both the 2013 guidelines and other groups’ updated recommendations retained the eligibility cutoff of 15 years since smoking cessation. “But had their risk declined to a level that just did not justify continuing screening?” he asked. “There wasn’t an answer to that question, so we needed to look carefully at the absolute risk of lung cancer in persons who formerly smoked compared with people who currently smoked and people who never smoked.”
• Smoking history: Reduced to 20 or more pack-years (average of 20 cigarettes a day) versus 30 or more pack-years.
• Exclusions: Expanded to health conditions that may increase harm or hinder further evaluation, surgery, or treatment; comorbidities limiting life expectancy to fewer than 5 years; unwillingness to accept treatment for screen‐detected cancer, which was changed from 2013’s life‐limiting comorbid conditions, metallic implants or devices in the chest or back, home oxygen supplementation.

In addition, decision-making should be a shared process with a health professional providing the patient with information on the benefits, limitations, and harms of LDCT screening, as well as prescreening advice on smoking cessation and the offer of assistive counseling and pharmocotherapy.

“Overall, lung cancer screening remains one of the least used early cancer detection modalities in clinical practice. The new guidance opens up lung cancer screening to all former smokers regardless of time of cessation,” said internist William E. Golden, MD, MACP, a professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock. “This may promote greater uptake in concert with greater availability of low-radiation CT scanning.”

While agreeing the expanded criteria will enfranchise nearly 5 million current and former U.S. smokers for screening and may reduce deaths, internist Aarati D. Didwania, MD, MMSCI, MACP, a professor of medicine and medical education at Northwestern University, Chicago, warned that increasing actual uptake may be an uphill battle. “The practical part of the equation is seeing that the scans get done. There is often a lag between a recommendation of a yearly test and getting insurance coverage for it, and many disadvantaged people face barriers.” Then there’s the knowledge gap. “Patients and doctors have to know what the new guidelines are and who has access,” she said.

Reaching the target population in rural areas is particularly challenging with the greater distances to imaging centers. Another barrier is that most electronic health records do not identify eligible patients based on smoking and pack‐year history.

In Dr. Didwania’s view, professional medical societies have an important role to play in educating their members, and through them, patients. “Disseminating information about the new recommendations is the first step and would be incredibly helpful.”
 

A brief history of lung cancer screening

1950s: By mid-20th century, the causal association between tobacco exposure and lung cancer became clear and by the late 1950s attempts were made to develop a lung cancer screening strategy for high‐risk individuals, commonly with the combination of sputum cytology and chest x-ray.

1970s: The ACS recommended annual testing for current or former smokers with chest x-ray (and sometimes sputum cytology).

1980: The ACS withdrew the above recommendation for regular radiographic screening after randomized controlled trials failed to yield convincing evidence that such screening saved lives.

2013: After the National Lung Screening Trial found three annual LDCT screenings were associated with a 20% relative mortality reduction, compared with annual chest x-ray, the ACS issued a recommendation for annual screening with LDCT: in persons 55-74 years with a pack‐year history of 30 or more who currently smoke or formerly smoked but had not exceeded 15 years since quitting and had no life-limiting morbidity.
 

Future mortality

Although tobacco controls are expected to reduce age‐adjusted lung cancer mortality in the United States by 79% from 2015 to 2065, 4.4 million lung cancer deaths are projected to occur in this period, the authors stated. “A large fraction of these deaths can be prevented if we embrace the urgent challenge to improve our ability to identify the population at risk and apply our knowledge to achieve high rates of participation in regular [lung cancer screening].”

The study was funded by the American Cancer Society Guideline Development Group and the National Comprehensive Cancer Network. The authors disclosed no relevant competing interests. Dr. Golden and Dr. Didwania had no relevant conflicts of interest to declare with regard to their comments.

Gastroenterology

July

Newberry C et al. Enhancing Nutrition and Obesity Education in GI Fellowship Through Universal Curriculum Development. Gastroenterology. 2023 Jul;165(1):16-19. doi: 10.1053/j.gastro.2023.04.004. Epub 2023 Apr 13. PMID: 37061170.

Han H et al. Macrophage-derived Osteopontin (SPP1) Protects From Nonalcoholic Steatohepatitis. Gastroenterology. 2023 Jul;165(1):201-17. doi: 10.1053/j.gastro.2023.03.228. Epub 2023 Apr 5. PMID: 37028770.

Deepak P et al. Health Disparities in Inflammatory Bowel Disease Care Driven by Rural Versus Urban Residence: Challenges and Potential Solutions. Gastroenterology. 2023 Jul;165(1):11-15. doi: 10.1053/j.gastro.2023.05.017. PMID: 37349061.

August

Guo L et al. Molecular Profiling Provides Clinical Insights Into Targeted and Immunotherapies as Well as Colorectal Cancer Prognosis. Gastroenterology. 2023 Aug;165(2):414-28.e7. doi: 10.1053/j.gastro.2023.04.029. Epub 2023 May 3. PMID: 37146911.

Huang DQ et al. Fibrosis Progression Rate in Biopsy-Proven Nonalcoholic Fatty Liver Disease Among People With Diabetes Versus People Without Diabetes: A Multicenter Study. Gastroenterology. 2023 Aug;165(2):463-72.e5. doi: 10.1053/j.gastro.2023.04.025. Epub 2023 Apr 29. PMID: 37127100.

Teoh AYB et al. EUS-Guided Choledocho-duodenostomy Using Lumen Apposing Stent Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Trial (DRA-MBO Trial). Gastroenterology. 2023 Aug;165(2):473-82.e2. doi: 10.1053/j.gastro.2023.04.016. Epub 2023 Apr 28. PMID: 37121331.

September

Mehta RS et al. Association of Proton Pump Inhibitor Use With Incident Dementia and Cognitive Decline in Older Adults: A Prospective Cohort Study. Gastroenterology. 2023 Sep;165(3):564-72.e1. doi: 10.1053/j.gastro.2023.05.052. Epub 2023 Jun 12. PMID: 37315867; PMCID: PMC10527011.

Ballou S et al. Prevalence and Associated Factors of Bloating: Results From the Rome Foundation Global Epidemiology Study. Gastroenterology. 2023 Sep;165(3):647-55.e4. doi: 10.1053/j.gastro.2023.05.049. Epub 2023 Jun 13. PMID: 37315866; PMCID: PMC10527500.

CGH

July

Chang JW et al. Development of a Practical Guide to Implement and Monitor Diet Therapy for Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2023 Jul;21(7):1690-8. doi: 10.1016/j.cgh.2023.03.006. Epub 2023 Mar 16. PMID: 36933603; PMCID: PMC10293042.

Siboni S et al. Improving the Diagnostic Yield of High-Resolution Esophageal Manometry for GERD: The “Straight Leg-Raise” International Study. Clin Gastroenterol Hepatol. 2023 Jul;21(7):1761-70.e1. doi: 10.1016/j.cgh.2022.10.008. Epub 2022 Oct 19. PMID: 36270615.
 

August

Wechsler EV et al. Up-Front Endoscopy Maximizes Cost-Effectiveness and Cost-Satisfaction in Uninvestigated Dyspepsia. Clin Gastroenterol Hepatol. 2023 Aug;21(9):2378-88.e28. doi: 10.1016/j.cgh.2023.01.003. Epub 2023 Jan 13. PMID: 36646234; PMCID: PMC10542651.

Frederiks CN et al. Clinical Relevance of Random Biopsies From the Esophagogastric Junction After Complete Eradication of Barrett’s Esophagus is Low. Clin Gastroenterol Hepatol. 2023 Aug;21(9):2260-9.e9. doi: 10.1016/j.cgh.2022.11.012. Epub 2022 Nov 22. PMID: 36423874.



Rustgi SD et al. Management of Gastric Intestinal Metaplasia. Clin Gastroenterol Hepatol. 2023 Aug;21(9):2178-82. doi: 10.1016/j.cgh.2023.03.010. Epub 2023 Apr 19. PMID: 37086748; PMCID: PMC10526696.
 

September

Baroud S et al. A Protocolized Management of Walled-Off Necrosis (WON) Reduces Time to WON Resolution and Improves Outcomes. Clin Gastroenterol Hepatol. 2023 Sep;21(10):2543-50.e1. doi: 10.1016/j.cgh.2023.04.029. Epub 2023 May 8. PMID: 37164115.

Arnim UV et al. Monitoring Patients With Eosinophilic Esophagitis in Routine Clinical Practice - International Expert Recommendations. Clin Gastroenterol Hepatol. 2023 Sep;21(10):2526-33. doi: 10.1016/j.cgh.2022.12.018. Epub 2022 Dec 24. PMID: 36572109.
 

TIGE

Kaila V et al. Does the Absence of Contrast Passage Into the Duodenum During Intraoperative Cholangiogram Truly Predict Choledocholithiasis? Techniques and Innovations in Gastrointestinal Endoscopy. 2023. https://doi.org/10.1016/j.tige.2023.05.002.

O’Keefe SJD et al. Early Enteral Feeding in Severe Acute Pancreatitis: A Randomized Clinical Trial Between Gastric vs Distal Jejunal Feeding. Techniques and Innovations in Gastrointestinal Endoscopy. 2023. https://doi.org/10.1016/j.tige.2023.06.002.
 

Gastro Hep Advances

Mukherjee S et al. Assessing ChatGPT’s ability to reply to queries regarding colon cancer screening based on Multi-Society Guidelines. Gastro Hep Advances. 2023. https://doi.org/10.1016/j.gastha.2023.07.008.

Lopes EW et al. Lochhead P. Improving the Consent Process with an Informed Consent Video Prior to Outpatient Colonoscopy. Gastro Hep Advances. 2023. https://doi.org/10.1016/j.gastha.2023.07.016.

Gastroenterology

July

Newberry C et al. Enhancing Nutrition and Obesity Education in GI Fellowship Through Universal Curriculum Development. Gastroenterology. 2023 Jul;165(1):16-19. doi: 10.1053/j.gastro.2023.04.004. Epub 2023 Apr 13. PMID: 37061170.

Han H et al. Macrophage-derived Osteopontin (SPP1) Protects From Nonalcoholic Steatohepatitis. Gastroenterology. 2023 Jul;165(1):201-17. doi: 10.1053/j.gastro.2023.03.228. Epub 2023 Apr 5. PMID: 37028770.

Deepak P et al. Health Disparities in Inflammatory Bowel Disease Care Driven by Rural Versus Urban Residence: Challenges and Potential Solutions. Gastroenterology. 2023 Jul;165(1):11-15. doi: 10.1053/j.gastro.2023.05.017. PMID: 37349061.

August

Guo L et al. Molecular Profiling Provides Clinical Insights Into Targeted and Immunotherapies as Well as Colorectal Cancer Prognosis. Gastroenterology. 2023 Aug;165(2):414-28.e7. doi: 10.1053/j.gastro.2023.04.029. Epub 2023 May 3. PMID: 37146911.

Huang DQ et al. Fibrosis Progression Rate in Biopsy-Proven Nonalcoholic Fatty Liver Disease Among People With Diabetes Versus People Without Diabetes: A Multicenter Study. Gastroenterology. 2023 Aug;165(2):463-72.e5. doi: 10.1053/j.gastro.2023.04.025. Epub 2023 Apr 29. PMID: 37127100.

Teoh AYB et al. EUS-Guided Choledocho-duodenostomy Using Lumen Apposing Stent Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Trial (DRA-MBO Trial). Gastroenterology. 2023 Aug;165(2):473-82.e2. doi: 10.1053/j.gastro.2023.04.016. Epub 2023 Apr 28. PMID: 37121331.

September

Mehta RS et al. Association of Proton Pump Inhibitor Use With Incident Dementia and Cognitive Decline in Older Adults: A Prospective Cohort Study. Gastroenterology. 2023 Sep;165(3):564-72.e1. doi: 10.1053/j.gastro.2023.05.052. Epub 2023 Jun 12. PMID: 37315867; PMCID: PMC10527011.

Ballou S et al. Prevalence and Associated Factors of Bloating: Results From the Rome Foundation Global Epidemiology Study. Gastroenterology. 2023 Sep;165(3):647-55.e4. doi: 10.1053/j.gastro.2023.05.049. Epub 2023 Jun 13. PMID: 37315866; PMCID: PMC10527500.

CGH

July

Chang JW et al. Development of a Practical Guide to Implement and Monitor Diet Therapy for Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2023 Jul;21(7):1690-8. doi: 10.1016/j.cgh.2023.03.006. Epub 2023 Mar 16. PMID: 36933603; PMCID: PMC10293042.

Siboni S et al. Improving the Diagnostic Yield of High-Resolution Esophageal Manometry for GERD: The “Straight Leg-Raise” International Study. Clin Gastroenterol Hepatol. 2023 Jul;21(7):1761-70.e1. doi: 10.1016/j.cgh.2022.10.008. Epub 2022 Oct 19. PMID: 36270615.
 

August

Wechsler EV et al. Up-Front Endoscopy Maximizes Cost-Effectiveness and Cost-Satisfaction in Uninvestigated Dyspepsia. Clin Gastroenterol Hepatol. 2023 Aug;21(9):2378-88.e28. doi: 10.1016/j.cgh.2023.01.003. Epub 2023 Jan 13. PMID: 36646234; PMCID: PMC10542651.

Frederiks CN et al. Clinical Relevance of Random Biopsies From the Esophagogastric Junction After Complete Eradication of Barrett’s Esophagus is Low. Clin Gastroenterol Hepatol. 2023 Aug;21(9):2260-9.e9. doi: 10.1016/j.cgh.2022.11.012. Epub 2022 Nov 22. PMID: 36423874.



Rustgi SD et al. Management of Gastric Intestinal Metaplasia. Clin Gastroenterol Hepatol. 2023 Aug;21(9):2178-82. doi: 10.1016/j.cgh.2023.03.010. Epub 2023 Apr 19. PMID: 37086748; PMCID: PMC10526696.
 

September

Baroud S et al. A Protocolized Management of Walled-Off Necrosis (WON) Reduces Time to WON Resolution and Improves Outcomes. Clin Gastroenterol Hepatol. 2023 Sep;21(10):2543-50.e1. doi: 10.1016/j.cgh.2023.04.029. Epub 2023 May 8. PMID: 37164115.

Arnim UV et al. Monitoring Patients With Eosinophilic Esophagitis in Routine Clinical Practice - International Expert Recommendations. Clin Gastroenterol Hepatol. 2023 Sep;21(10):2526-33. doi: 10.1016/j.cgh.2022.12.018. Epub 2022 Dec 24. PMID: 36572109.
 

TIGE

Kaila V et al. Does the Absence of Contrast Passage Into the Duodenum During Intraoperative Cholangiogram Truly Predict Choledocholithiasis? Techniques and Innovations in Gastrointestinal Endoscopy. 2023. https://doi.org/10.1016/j.tige.2023.05.002.

O’Keefe SJD et al. Early Enteral Feeding in Severe Acute Pancreatitis: A Randomized Clinical Trial Between Gastric vs Distal Jejunal Feeding. Techniques and Innovations in Gastrointestinal Endoscopy. 2023. https://doi.org/10.1016/j.tige.2023.06.002.
 

Gastro Hep Advances

Mukherjee S et al. Assessing ChatGPT’s ability to reply to queries regarding colon cancer screening based on Multi-Society Guidelines. Gastro Hep Advances. 2023. https://doi.org/10.1016/j.gastha.2023.07.008.

Lopes EW et al. Lochhead P. Improving the Consent Process with an Informed Consent Video Prior to Outpatient Colonoscopy. Gastro Hep Advances. 2023. https://doi.org/10.1016/j.gastha.2023.07.016.

Gastroenterology

July

Newberry C et al. Enhancing Nutrition and Obesity Education in GI Fellowship Through Universal Curriculum Development. Gastroenterology. 2023 Jul;165(1):16-19. doi: 10.1053/j.gastro.2023.04.004. Epub 2023 Apr 13. PMID: 37061170.

Han H et al. Macrophage-derived Osteopontin (SPP1) Protects From Nonalcoholic Steatohepatitis. Gastroenterology. 2023 Jul;165(1):201-17. doi: 10.1053/j.gastro.2023.03.228. Epub 2023 Apr 5. PMID: 37028770.

Deepak P et al. Health Disparities in Inflammatory Bowel Disease Care Driven by Rural Versus Urban Residence: Challenges and Potential Solutions. Gastroenterology. 2023 Jul;165(1):11-15. doi: 10.1053/j.gastro.2023.05.017. PMID: 37349061.

August

Guo L et al. Molecular Profiling Provides Clinical Insights Into Targeted and Immunotherapies as Well as Colorectal Cancer Prognosis. Gastroenterology. 2023 Aug;165(2):414-28.e7. doi: 10.1053/j.gastro.2023.04.029. Epub 2023 May 3. PMID: 37146911.

Huang DQ et al. Fibrosis Progression Rate in Biopsy-Proven Nonalcoholic Fatty Liver Disease Among People With Diabetes Versus People Without Diabetes: A Multicenter Study. Gastroenterology. 2023 Aug;165(2):463-72.e5. doi: 10.1053/j.gastro.2023.04.025. Epub 2023 Apr 29. PMID: 37127100.

Teoh AYB et al. EUS-Guided Choledocho-duodenostomy Using Lumen Apposing Stent Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Trial (DRA-MBO Trial). Gastroenterology. 2023 Aug;165(2):473-82.e2. doi: 10.1053/j.gastro.2023.04.016. Epub 2023 Apr 28. PMID: 37121331.

September

Mehta RS et al. Association of Proton Pump Inhibitor Use With Incident Dementia and Cognitive Decline in Older Adults: A Prospective Cohort Study. Gastroenterology. 2023 Sep;165(3):564-72.e1. doi: 10.1053/j.gastro.2023.05.052. Epub 2023 Jun 12. PMID: 37315867; PMCID: PMC10527011.

Ballou S et al. Prevalence and Associated Factors of Bloating: Results From the Rome Foundation Global Epidemiology Study. Gastroenterology. 2023 Sep;165(3):647-55.e4. doi: 10.1053/j.gastro.2023.05.049. Epub 2023 Jun 13. PMID: 37315866; PMCID: PMC10527500.

CGH

July

Chang JW et al. Development of a Practical Guide to Implement and Monitor Diet Therapy for Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2023 Jul;21(7):1690-8. doi: 10.1016/j.cgh.2023.03.006. Epub 2023 Mar 16. PMID: 36933603; PMCID: PMC10293042.

Siboni S et al. Improving the Diagnostic Yield of High-Resolution Esophageal Manometry for GERD: The “Straight Leg-Raise” International Study. Clin Gastroenterol Hepatol. 2023 Jul;21(7):1761-70.e1. doi: 10.1016/j.cgh.2022.10.008. Epub 2022 Oct 19. PMID: 36270615.
 

August

Wechsler EV et al. Up-Front Endoscopy Maximizes Cost-Effectiveness and Cost-Satisfaction in Uninvestigated Dyspepsia. Clin Gastroenterol Hepatol. 2023 Aug;21(9):2378-88.e28. doi: 10.1016/j.cgh.2023.01.003. Epub 2023 Jan 13. PMID: 36646234; PMCID: PMC10542651.

Frederiks CN et al. Clinical Relevance of Random Biopsies From the Esophagogastric Junction After Complete Eradication of Barrett’s Esophagus is Low. Clin Gastroenterol Hepatol. 2023 Aug;21(9):2260-9.e9. doi: 10.1016/j.cgh.2022.11.012. Epub 2022 Nov 22. PMID: 36423874.



Rustgi SD et al. Management of Gastric Intestinal Metaplasia. Clin Gastroenterol Hepatol. 2023 Aug;21(9):2178-82. doi: 10.1016/j.cgh.2023.03.010. Epub 2023 Apr 19. PMID: 37086748; PMCID: PMC10526696.
 

September

Baroud S et al. A Protocolized Management of Walled-Off Necrosis (WON) Reduces Time to WON Resolution and Improves Outcomes. Clin Gastroenterol Hepatol. 2023 Sep;21(10):2543-50.e1. doi: 10.1016/j.cgh.2023.04.029. Epub 2023 May 8. PMID: 37164115.

Arnim UV et al. Monitoring Patients With Eosinophilic Esophagitis in Routine Clinical Practice - International Expert Recommendations. Clin Gastroenterol Hepatol. 2023 Sep;21(10):2526-33. doi: 10.1016/j.cgh.2022.12.018. Epub 2022 Dec 24. PMID: 36572109.
 

TIGE

Kaila V et al. Does the Absence of Contrast Passage Into the Duodenum During Intraoperative Cholangiogram Truly Predict Choledocholithiasis? Techniques and Innovations in Gastrointestinal Endoscopy. 2023. https://doi.org/10.1016/j.tige.2023.05.002.

O’Keefe SJD et al. Early Enteral Feeding in Severe Acute Pancreatitis: A Randomized Clinical Trial Between Gastric vs Distal Jejunal Feeding. Techniques and Innovations in Gastrointestinal Endoscopy. 2023. https://doi.org/10.1016/j.tige.2023.06.002.
 

Gastro Hep Advances

Mukherjee S et al. Assessing ChatGPT’s ability to reply to queries regarding colon cancer screening based on Multi-Society Guidelines. Gastro Hep Advances. 2023. https://doi.org/10.1016/j.gastha.2023.07.008.

Lopes EW et al. Lochhead P. Improving the Consent Process with an Informed Consent Video Prior to Outpatient Colonoscopy. Gastro Hep Advances. 2023. https://doi.org/10.1016/j.gastha.2023.07.016.

TOPLINE:

Among patients with colorectal cancer (CRC), those with complicated diabetes were at higher risk of poor survival than their peers without diabetes, while those with uncomplicated diabetes had insignificantly worse cancer outcomes.

METHODOLOGY:

• This population-based retrospective cohort study used 2007-2015 data from the Taiwan Cancer Registry, which is linked to national insurance and death registry data.
• The analysis included 59,202 adults with stage I-III CRC who underwent potentially curative surgery: 44,944 without diabetes, 8,864 with uncomplicated diabetes, and 5,394 with complicated diabetes.
• The association between diabetes severity and CRC survival, overall survival (OS), disease-free survival (DFS), time to recurrence, and cancer-specific survival (CSS) was examined.
•  

TAKEAWAY:

• Patients with uncomplicated diabetes had insignificantly worse OS (hazard ratio, 1.05), DFS (HR, 1.08), and CSS (HR, 0.98), compared with peers who did not have diabetes.
• Patients with complicated diabetes were at significantly higher risk of poor OS (HR, 1.85), DFS (HR, 1.75), and CSS (HR, 1.41), compared with those without diabetes.
• Patients with diabetes were also at higher risk for CRC recurrence than those without diabetes.
• Except for recurrence risk, the impact of complicated diabetes on CRC survival – that is, OS, DFS, and CSS – was more pronounced among women and those with early-stage cancer.

IN PRACTICE:

“These findings indicate that preventing diabetes complications may help improve survival in patients with CRC, especially [in] female patients and those in the early stages of the disease. Thus, a multidisciplinary approach is recommended for patients with CRC,” the authors conclude.

SOURCE:

The study, with first author Hsin-Yin Hsu, MD, National Taiwan University, Taipei, was published online in the journal Cancer.

LIMITATIONS:

Only patients from Taiwan were included, which limits generalizability, because CRC prognosis may vary in accordance with race or cancer treatment strategy – factors that may differ among countries. Data on glucose levels and diabetes duration were unavailable, potentially leading to misclassification of diabetes status.

DISCLOSURES:

Funding was provided by the Ministry of Science and Technology and the Ministry of Health and Welfare. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

TOPLINE:

Among patients with colorectal cancer (CRC), those with complicated diabetes were at higher risk of poor survival than their peers without diabetes, while those with uncomplicated diabetes had insignificantly worse cancer outcomes.

METHODOLOGY:

• This population-based retrospective cohort study used 2007-2015 data from the Taiwan Cancer Registry, which is linked to national insurance and death registry data.
• The analysis included 59,202 adults with stage I-III CRC who underwent potentially curative surgery: 44,944 without diabetes, 8,864 with uncomplicated diabetes, and 5,394 with complicated diabetes.
• The association between diabetes severity and CRC survival, overall survival (OS), disease-free survival (DFS), time to recurrence, and cancer-specific survival (CSS) was examined.
•  

TAKEAWAY:

• Patients with uncomplicated diabetes had insignificantly worse OS (hazard ratio, 1.05), DFS (HR, 1.08), and CSS (HR, 0.98), compared with peers who did not have diabetes.
• Patients with complicated diabetes were at significantly higher risk of poor OS (HR, 1.85), DFS (HR, 1.75), and CSS (HR, 1.41), compared with those without diabetes.
• Patients with diabetes were also at higher risk for CRC recurrence than those without diabetes.
• Except for recurrence risk, the impact of complicated diabetes on CRC survival – that is, OS, DFS, and CSS – was more pronounced among women and those with early-stage cancer.

IN PRACTICE:

“These findings indicate that preventing diabetes complications may help improve survival in patients with CRC, especially [in] female patients and those in the early stages of the disease. Thus, a multidisciplinary approach is recommended for patients with CRC,” the authors conclude.

SOURCE:

The study, with first author Hsin-Yin Hsu, MD, National Taiwan University, Taipei, was published online in the journal Cancer.

LIMITATIONS:

Only patients from Taiwan were included, which limits generalizability, because CRC prognosis may vary in accordance with race or cancer treatment strategy – factors that may differ among countries. Data on glucose levels and diabetes duration were unavailable, potentially leading to misclassification of diabetes status.

DISCLOSURES:

Funding was provided by the Ministry of Science and Technology and the Ministry of Health and Welfare. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

TOPLINE:

Among patients with colorectal cancer (CRC), those with complicated diabetes were at higher risk of poor survival than their peers without diabetes, while those with uncomplicated diabetes had insignificantly worse cancer outcomes.

METHODOLOGY:

• This population-based retrospective cohort study used 2007-2015 data from the Taiwan Cancer Registry, which is linked to national insurance and death registry data.
• The analysis included 59,202 adults with stage I-III CRC who underwent potentially curative surgery: 44,944 without diabetes, 8,864 with uncomplicated diabetes, and 5,394 with complicated diabetes.
• The association between diabetes severity and CRC survival, overall survival (OS), disease-free survival (DFS), time to recurrence, and cancer-specific survival (CSS) was examined.
•  

TAKEAWAY:

• Patients with uncomplicated diabetes had insignificantly worse OS (hazard ratio, 1.05), DFS (HR, 1.08), and CSS (HR, 0.98), compared with peers who did not have diabetes.
• Patients with complicated diabetes were at significantly higher risk of poor OS (HR, 1.85), DFS (HR, 1.75), and CSS (HR, 1.41), compared with those without diabetes.
• Patients with diabetes were also at higher risk for CRC recurrence than those without diabetes.
• Except for recurrence risk, the impact of complicated diabetes on CRC survival – that is, OS, DFS, and CSS – was more pronounced among women and those with early-stage cancer.

IN PRACTICE:

“These findings indicate that preventing diabetes complications may help improve survival in patients with CRC, especially [in] female patients and those in the early stages of the disease. Thus, a multidisciplinary approach is recommended for patients with CRC,” the authors conclude.

SOURCE:

The study, with first author Hsin-Yin Hsu, MD, National Taiwan University, Taipei, was published online in the journal Cancer.

LIMITATIONS:

Only patients from Taiwan were included, which limits generalizability, because CRC prognosis may vary in accordance with race or cancer treatment strategy – factors that may differ among countries. Data on glucose levels and diabetes duration were unavailable, potentially leading to misclassification of diabetes status.

DISCLOSURES:

Funding was provided by the Ministry of Science and Technology and the Ministry of Health and Welfare. The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

I informally surveyed several young gastroenterologists to understand their biggest personal finance questions and we will tackle the top five here. While this article will get you started, these are complex topics, and each could warrant several standalone articles. I strongly encourage you to develop some basic understanding of personal finance through books, websites, and podcasts. If you can manage Barrett’s esophagus, Crohn’s, and cirrhosis, you can understand the basics of personal finance.

For trainees debating an academic/501(c)(3) position vs. private practice, I would generally not advise making a career choice based purely on PSLF eligibility. However, borrowers with very high federal student loan burdens (e.g., debt to income ratio of > 2:1), or who are very close to the PSLF 10-year requirement may want to consider choosing a qualifying position for a few years to receive PSLF student loan forgiveness. Please see TNG’s 2020 article³ for a deeper discussion. Consultation with a company specializing in student loan advice for physicians may be well worth the upfront cost.
 

2. Do I need disability insurance? What should I look for?

I would strongly advise getting disability insurance as soon as possible (including while in training). While disability insurance is not cheap, it is one of the first steps you should take and one of the most important ways to protect your financial future. It is essential to look for a specialty-specific own occupation policy. Such a policy will provide disability payments if you are no longer able to work as a gastroenterologist/hepatologist (including an injury which prevents you from doing endoscopies).

There are two major types of disability policies: group policies and individual policies. See table 1 for a detailed comparison.

3. Do I need life insurance? What type should I get?

If anyone is dependent on your income (partner, child, etc.), you should have life insurance. Moreover, if you expect to have dependents in the near future (e.g., children), you could consider getting life insurance now while you are younger and healthier. For a young GI with multiple financial obligations, term life insurance is generally the right product. Term life insurance is a straightforward, affordable product that can be purchased from multiple high-quality insurance carriers. There are two major considerations: The amount of coverage ($2 million, $3 million, etc.) and the length of coverage (20 years, 30 years, etc.). To estimate the appropriate amount of coverage, start with your expected annual household living expenses, and multiply by 25-30. While this is a rule of thumb, it will get you in the ballpark. For many young physicians, a $2-$5 million policy with 20- to 30-year coverage is reasonable.

Many financial advisers may suggest whole life insurance policies. These are typically not the ideal policy for young GIs who are just starting their careers. While whole life insurance may be the right choice in select cases, term life insurance will be the best product for most of TNG’s audience. As an example, a $3 million, 25-year term policy for a healthy, nonsmoking 35-year-old male would cost approximately $175 per month. A similar $3 million whole life policy could cost $2,000 per month or more.
 

4. What do I need to know about retirement accounts and investing?

The alphabet soup of retirement accounts can be confusing – IRA, 401k, 457. Retirement accounts provide a tax break to incentivize saving for retirement. Traditional (“non-Roth”) accounts provide a tax break today, but you will pay taxes when withdrawing the money in retirement. Roth accounts provide no tax break now but provide tax-free growth for decades, and no taxes are due when withdrawing money. See table 2 for a detailed comparison of retirement accounts.

Once you place money into a retirement account, you will need to choose specific investments to grow your money. The two most common asset classes are stocks and bonds, though there are many other reasonable assets, such as real estate, commodities, and alternative currencies. It is generally recommended to have a higher proportion of stock-based investments early on (60%-90%) and then increase the ratio of bonds closer to retirement. Using low cost, passive index funds (or exchange traded funds) is a good way to get stock exposure. Target date retirement funds can be a nice tool for beginning investors since they will automatically adjust the stock/bond ratio for you.

Calculating the amount needed for retirement is beyond the scope of this article. However, saving at least 20% of your gross income specifically for retirement is a good starting point and should set you up for a reasonable retirement in about 30 years. For the average GI physician, this would mean saving $4,000 or more per month for retirement. If you aim to retire earlier, consider investing a higher percentage.
 

5. What do I need to know about buying a house?

The first question to ask is whether it makes sense to rent or buy a house. This is a personal and lifestyle decision, not just a financial decision. Today’s market is difficult with both high home prices and high rent costs. If there is a reasonable chance that you will be moving within 3-5 years, I would consider not buying until your long-term plans are more stable. Moreover, a high proportion of physicians change jobs.^4,5,6 If you are just starting a new job, it is often wise to wait at least 6-12 months before buying a house to ensure the new job is a good fit. If you are in a stable long-term situation, it may be reasonable to buy a house. While it is commonly believed that buying a house is a “good financial move,” there are many hidden costs to home ownership, including big ticket repairs, property taxes, and real estate fees when selling a home.

First-time physician home buyers can often secure a physician mortgage with competitive interest rates and a low down payment of 0%-10% instead of the traditional 20% down payment. Moreover, a good physician mortgage should not have private mortgage insurance (PMI). Given the variation between mortgage companies, my most important piece of advice is to shop around for a good mortgage. An independent mortgage broker can be very valuable.
 

Dr. Jain is associate professor of medicine in the division of gastroenterology and hepatology, University of North Carolina School of Medicine, Chapel Hill. He has no conflicts of interest. The information in this article is meant for general educational purposes only. For individualized personal finance advice, please seek your own financial advisor, tax accountant, insurance broker, attorney, or other financial professional. Follow Dr. Jain @AJainMD on X.

References

1. Future of PSLF Fact Sheet

2. The Loophole That Can Get Thousands of Doctors into PSLF

3. Student loan management: An introduction for the young gastroenterologist

4. Study Shows First Job after Medical Residency Often Doesn’t Last

5. More physicians want to leave their jobs as pay rates fall, survey finds

6. Physician turnover rates are climbing as they clamor for better work-life balance

I informally surveyed several young gastroenterologists to understand their biggest personal finance questions and we will tackle the top five here. While this article will get you started, these are complex topics, and each could warrant several standalone articles. I strongly encourage you to develop some basic understanding of personal finance through books, websites, and podcasts. If you can manage Barrett’s esophagus, Crohn’s, and cirrhosis, you can understand the basics of personal finance.

For trainees debating an academic/501(c)(3) position vs. private practice, I would generally not advise making a career choice based purely on PSLF eligibility. However, borrowers with very high federal student loan burdens (e.g., debt to income ratio of > 2:1), or who are very close to the PSLF 10-year requirement may want to consider choosing a qualifying position for a few years to receive PSLF student loan forgiveness. Please see TNG’s 2020 article³ for a deeper discussion. Consultation with a company specializing in student loan advice for physicians may be well worth the upfront cost.
 

2. Do I need disability insurance? What should I look for?

I would strongly advise getting disability insurance as soon as possible (including while in training). While disability insurance is not cheap, it is one of the first steps you should take and one of the most important ways to protect your financial future. It is essential to look for a specialty-specific own occupation policy. Such a policy will provide disability payments if you are no longer able to work as a gastroenterologist/hepatologist (including an injury which prevents you from doing endoscopies).

There are two major types of disability policies: group policies and individual policies. See table 1 for a detailed comparison.

3. Do I need life insurance? What type should I get?

If anyone is dependent on your income (partner, child, etc.), you should have life insurance. Moreover, if you expect to have dependents in the near future (e.g., children), you could consider getting life insurance now while you are younger and healthier. For a young GI with multiple financial obligations, term life insurance is generally the right product. Term life insurance is a straightforward, affordable product that can be purchased from multiple high-quality insurance carriers. There are two major considerations: The amount of coverage ($2 million, $3 million, etc.) and the length of coverage (20 years, 30 years, etc.). To estimate the appropriate amount of coverage, start with your expected annual household living expenses, and multiply by 25-30. While this is a rule of thumb, it will get you in the ballpark. For many young physicians, a $2-$5 million policy with 20- to 30-year coverage is reasonable.

Many financial advisers may suggest whole life insurance policies. These are typically not the ideal policy for young GIs who are just starting their careers. While whole life insurance may be the right choice in select cases, term life insurance will be the best product for most of TNG’s audience. As an example, a $3 million, 25-year term policy for a healthy, nonsmoking 35-year-old male would cost approximately $175 per month. A similar $3 million whole life policy could cost $2,000 per month or more.
 

4. What do I need to know about retirement accounts and investing?

The alphabet soup of retirement accounts can be confusing – IRA, 401k, 457. Retirement accounts provide a tax break to incentivize saving for retirement. Traditional (“non-Roth”) accounts provide a tax break today, but you will pay taxes when withdrawing the money in retirement. Roth accounts provide no tax break now but provide tax-free growth for decades, and no taxes are due when withdrawing money. See table 2 for a detailed comparison of retirement accounts.

Once you place money into a retirement account, you will need to choose specific investments to grow your money. The two most common asset classes are stocks and bonds, though there are many other reasonable assets, such as real estate, commodities, and alternative currencies. It is generally recommended to have a higher proportion of stock-based investments early on (60%-90%) and then increase the ratio of bonds closer to retirement. Using low cost, passive index funds (or exchange traded funds) is a good way to get stock exposure. Target date retirement funds can be a nice tool for beginning investors since they will automatically adjust the stock/bond ratio for you.

Calculating the amount needed for retirement is beyond the scope of this article. However, saving at least 20% of your gross income specifically for retirement is a good starting point and should set you up for a reasonable retirement in about 30 years. For the average GI physician, this would mean saving $4,000 or more per month for retirement. If you aim to retire earlier, consider investing a higher percentage.
 

5. What do I need to know about buying a house?

The first question to ask is whether it makes sense to rent or buy a house. This is a personal and lifestyle decision, not just a financial decision. Today’s market is difficult with both high home prices and high rent costs. If there is a reasonable chance that you will be moving within 3-5 years, I would consider not buying until your long-term plans are more stable. Moreover, a high proportion of physicians change jobs.^4,5,6 If you are just starting a new job, it is often wise to wait at least 6-12 months before buying a house to ensure the new job is a good fit. If you are in a stable long-term situation, it may be reasonable to buy a house. While it is commonly believed that buying a house is a “good financial move,” there are many hidden costs to home ownership, including big ticket repairs, property taxes, and real estate fees when selling a home.

First-time physician home buyers can often secure a physician mortgage with competitive interest rates and a low down payment of 0%-10% instead of the traditional 20% down payment. Moreover, a good physician mortgage should not have private mortgage insurance (PMI). Given the variation between mortgage companies, my most important piece of advice is to shop around for a good mortgage. An independent mortgage broker can be very valuable.
 

Dr. Jain is associate professor of medicine in the division of gastroenterology and hepatology, University of North Carolina School of Medicine, Chapel Hill. He has no conflicts of interest. The information in this article is meant for general educational purposes only. For individualized personal finance advice, please seek your own financial advisor, tax accountant, insurance broker, attorney, or other financial professional. Follow Dr. Jain @AJainMD on X.

References

1. Future of PSLF Fact Sheet

2. The Loophole That Can Get Thousands of Doctors into PSLF

3. Student loan management: An introduction for the young gastroenterologist

4. Study Shows First Job after Medical Residency Often Doesn’t Last

5. More physicians want to leave their jobs as pay rates fall, survey finds

6. Physician turnover rates are climbing as they clamor for better work-life balance

I informally surveyed several young gastroenterologists to understand their biggest personal finance questions and we will tackle the top five here. While this article will get you started, these are complex topics, and each could warrant several standalone articles. I strongly encourage you to develop some basic understanding of personal finance through books, websites, and podcasts. If you can manage Barrett’s esophagus, Crohn’s, and cirrhosis, you can understand the basics of personal finance.

For trainees debating an academic/501(c)(3) position vs. private practice, I would generally not advise making a career choice based purely on PSLF eligibility. However, borrowers with very high federal student loan burdens (e.g., debt to income ratio of > 2:1), or who are very close to the PSLF 10-year requirement may want to consider choosing a qualifying position for a few years to receive PSLF student loan forgiveness. Please see TNG’s 2020 article³ for a deeper discussion. Consultation with a company specializing in student loan advice for physicians may be well worth the upfront cost.
 

2. Do I need disability insurance? What should I look for?

I would strongly advise getting disability insurance as soon as possible (including while in training). While disability insurance is not cheap, it is one of the first steps you should take and one of the most important ways to protect your financial future. It is essential to look for a specialty-specific own occupation policy. Such a policy will provide disability payments if you are no longer able to work as a gastroenterologist/hepatologist (including an injury which prevents you from doing endoscopies).

There are two major types of disability policies: group policies and individual policies. See table 1 for a detailed comparison.

3. Do I need life insurance? What type should I get?

If anyone is dependent on your income (partner, child, etc.), you should have life insurance. Moreover, if you expect to have dependents in the near future (e.g., children), you could consider getting life insurance now while you are younger and healthier. For a young GI with multiple financial obligations, term life insurance is generally the right product. Term life insurance is a straightforward, affordable product that can be purchased from multiple high-quality insurance carriers. There are two major considerations: The amount of coverage ($2 million, $3 million, etc.) and the length of coverage (20 years, 30 years, etc.). To estimate the appropriate amount of coverage, start with your expected annual household living expenses, and multiply by 25-30. While this is a rule of thumb, it will get you in the ballpark. For many young physicians, a $2-$5 million policy with 20- to 30-year coverage is reasonable.

Many financial advisers may suggest whole life insurance policies. These are typically not the ideal policy for young GIs who are just starting their careers. While whole life insurance may be the right choice in select cases, term life insurance will be the best product for most of TNG’s audience. As an example, a $3 million, 25-year term policy for a healthy, nonsmoking 35-year-old male would cost approximately $175 per month. A similar $3 million whole life policy could cost $2,000 per month or more.
 

4. What do I need to know about retirement accounts and investing?

The alphabet soup of retirement accounts can be confusing – IRA, 401k, 457. Retirement accounts provide a tax break to incentivize saving for retirement. Traditional (“non-Roth”) accounts provide a tax break today, but you will pay taxes when withdrawing the money in retirement. Roth accounts provide no tax break now but provide tax-free growth for decades, and no taxes are due when withdrawing money. See table 2 for a detailed comparison of retirement accounts.

Once you place money into a retirement account, you will need to choose specific investments to grow your money. The two most common asset classes are stocks and bonds, though there are many other reasonable assets, such as real estate, commodities, and alternative currencies. It is generally recommended to have a higher proportion of stock-based investments early on (60%-90%) and then increase the ratio of bonds closer to retirement. Using low cost, passive index funds (or exchange traded funds) is a good way to get stock exposure. Target date retirement funds can be a nice tool for beginning investors since they will automatically adjust the stock/bond ratio for you.

Calculating the amount needed for retirement is beyond the scope of this article. However, saving at least 20% of your gross income specifically for retirement is a good starting point and should set you up for a reasonable retirement in about 30 years. For the average GI physician, this would mean saving $4,000 or more per month for retirement. If you aim to retire earlier, consider investing a higher percentage.
 

5. What do I need to know about buying a house?

The first question to ask is whether it makes sense to rent or buy a house. This is a personal and lifestyle decision, not just a financial decision. Today’s market is difficult with both high home prices and high rent costs. If there is a reasonable chance that you will be moving within 3-5 years, I would consider not buying until your long-term plans are more stable. Moreover, a high proportion of physicians change jobs.^4,5,6 If you are just starting a new job, it is often wise to wait at least 6-12 months before buying a house to ensure the new job is a good fit. If you are in a stable long-term situation, it may be reasonable to buy a house. While it is commonly believed that buying a house is a “good financial move,” there are many hidden costs to home ownership, including big ticket repairs, property taxes, and real estate fees when selling a home.

First-time physician home buyers can often secure a physician mortgage with competitive interest rates and a low down payment of 0%-10% instead of the traditional 20% down payment. Moreover, a good physician mortgage should not have private mortgage insurance (PMI). Given the variation between mortgage companies, my most important piece of advice is to shop around for a good mortgage. An independent mortgage broker can be very valuable.
 

Dr. Jain is associate professor of medicine in the division of gastroenterology and hepatology, University of North Carolina School of Medicine, Chapel Hill. He has no conflicts of interest. The information in this article is meant for general educational purposes only. For individualized personal finance advice, please seek your own financial advisor, tax accountant, insurance broker, attorney, or other financial professional. Follow Dr. Jain @AJainMD on X.

References

1. Future of PSLF Fact Sheet

2. The Loophole That Can Get Thousands of Doctors into PSLF

3. Student loan management: An introduction for the young gastroenterologist

4. Study Shows First Job after Medical Residency Often Doesn’t Last

5. More physicians want to leave their jobs as pay rates fall, survey finds

6. Physician turnover rates are climbing as they clamor for better work-life balance

Introduction

Inflammatory bowel disease (IBD) is a chronic, relapsing and remitting disorder that is becoming increasingly prevalent worldwide.¹ Despite major advances in this area, many patients with moderate to severe IBD do not achieve disease remission with immunosuppressive therapy.² Dysplasia and fibrostenosis are two common consequences of uncontrolled chronic inflammation and these structural complications are often the primary reasons for surgical interventions.³ While there is certainly a time and a place for surgery in IBD, this approach is invasive and postoperative recrudescence of disease is common.⁴ Moreover patients with complex surgical or medical histories may not make optimal surgical candidates.

Thanks to advancements in a variety of endoscopic technologies, nonoperative therapies are now available and provide a solution for patients who would otherwise fall outside of conventional treatment options. Over the last several years, applications of endoscopic therapies in IBD have been gaining traction and the need for these therapies is expected to continue to rise over time. As such, understanding the domains of available endoscopic options in IBD is important for the modern-day gastroenterologist. In this article, we will discuss some of the recent advancements in endoscopic therapies for IBD and how we may position these in clinical practice.
 

Protecting against colitis dysplasia and colon cancer

IBD is a risk factor for colorectal cancer because of the dysplasia-carcinoma sequence arising from chronic colitis. Endoscopic resection is the first-line treatment for conventional colitis-associated dysplasia (CAD).^5,6 However, larger or complex lesions may not have been previously amenable to this organ-preserving approach. The application of newer techniques has extended the indication for endoscopic resection to include most CAD lesions, as an alternative to proctocolectomy. Endoscopic mucosal resection (EMR) is the most commonly used technique and its outcomes for CAD greater than 2 cm have been excellent (Figure 1).⁷ However, employing EMR for lesions greater than 2 cm in size may require piecemeal resection and this has been associated with a small risk of local recurrence.⁸ Endoscopic submucosal dissection (ESD) is an alternate method of endoscopic tissue resection that can reliably achieve en bloc (single specimen) resections even in larger lesions.⁹

Courtesy Dr. Genere and colleagues

Restoring gastrointestinal tract transit

Crohn’s strictures may lead to acute intestinal obstructions or facilitate the onset of penetrating disease, such as fistula formation or abscess. These strictures are often characterized by a combination of inflammation and layered fibrosis, which requires the application of medical therapies alongside structural remodeling to successfully manage. Not all strictures may be clinically overt due to variances in visceral sensitivity, yet experts believe that treatment of all strictures should be considered to avoid occurrence of delayed complications.¹⁴ Endoscopic balloon dilation (EBD) is a well-established treatment for Crohn’s strictures up to 4-5 cm in length (Figure 2). This treatment involves inflating a balloon within the narrowed section of intestine, thereby stretching and disrupting the layered fibrotic bands to widen the stricture. EBD improves symptoms 70% of the time and successfully avoids the medium-term need for surgery in most, although it often requires repeat endoscopic procedures.¹⁵ In fact, up to 74% of patients will require repeat dilation over 2 years and 43% will require salvage surgery after EBD.¹⁶

Courtesy Dr. Genere and colleagues

The future for endoscopic therapy is bright

Structural complications of IBD are common and can pose a significant detriment to quality of life and general well-being for patients. From mucosal resection of CAD to surgery-sparing therapies for intestinal strictures, endoscopic therapies are valuable and effective options for managing disease-related sequelae within the scope of interventional IBD practice. We can expect the availability of these options to grow as the scope of endoscopy training incorporates principles of interventional IBD, along with the concurrent development of additional therapeutic applications beyond the categories discussed here (including perianal disease, fistulas, and abscess formation). It is noteworthy to mention that while endoscopic therapies are separate treatment modalities, should not be considered mutually exclusive; endotherapies are best viewed as a complement to existing medical and surgical approaches. Thus, Interventional IBD endoscopy can serve as an integral part of the multidisciplinary IBD framework to provide comprehensive care for our patients with IBD.

Juan Reyes Genere, MD, is an assistant professor of medicine in gastroenterology at Washington University in St. Louis. He served as the corresponding author of this article. Michael Rubeiz, MD, is a physician in the internal medicine residency program at Washington University in St. Louis. Kemmian Johnson, MD, MPH, is a gastroenterologist at Washington University in St. Louis specializing in inflammatory bowel disease. Dr. Genere is a consultant for Edulis Therapeutics. Dr. Rubeiz and Dr. Johnson had no personal or financial conflicts of interest. Dr. Johnson can be reached on Instagram @KJ.1906; Dr. Rubeiz is on X @MichaelRubeiz1 and Dr. Genere can be reached via X @JPGenereMD.

References

1. Ng SC et al. Lancet. 2017;390(10114):2769-78.

2. Gordon JP et al. Eur J Gastroenterol Hepatol. 2015;27(7):804-12.

3. Sica GS and Biancone L. World J Gastroenterol. 2013;19(16):2445-8.

4. Iborra M et al. Gastroenterol Rep (Oxf). 2019;7(6):411-8.

5. Annese V et al. J Crohns Colitis. 2013;7(12):982-1018.

6. Laine L et al. Gastrointest Endosc. 2015;81(3):489-501.e426.

7. Mohan BP et al. Gastrointest Endosc. 2021;93(1):59-67.e10.

8. Briedigkeit A et al. World J Gastrointest Endosc. 2016;8(5):276-81.

9. Manta R et al. J Crohns Colitis. 2021;15(1):165-8.

10. Mohapatra S et al. Endosc Int Open. 2022;10(5):E593-601.

11. Ngamruengphong S et al. Endosc Int Open. 2022;10(4):E354-60.

12. Baker G et al. Cureus. 2022 May 3;14(5):e24688.

13. Yadav S et al. Endosc Int Open. 2019;7(8):E994-1001.

14. Schwartz DA. Gastrointestinal Endoscopy. 2023;97(5):974-6.

15. Morar PS et al. Aliment Pharmacol Ther. 2015;42(10):1137-48.

16. Bettenworth D et al. Inflamm Bowel Dis. 2017;23(1):133-42.

17. Lan N and Shen B. Inflamm Bowel Dis. 2018;24(4):897-907.

18. Loras C et al. Lancet Gastroenterol Hepatol. 2022;7(4):332-41.

19. Genere JR et al. Lancet Gastroenterol Hepatol. 2022;7(6):503-4.

Introduction

Inflammatory bowel disease (IBD) is a chronic, relapsing and remitting disorder that is becoming increasingly prevalent worldwide.¹ Despite major advances in this area, many patients with moderate to severe IBD do not achieve disease remission with immunosuppressive therapy.² Dysplasia and fibrostenosis are two common consequences of uncontrolled chronic inflammation and these structural complications are often the primary reasons for surgical interventions.³ While there is certainly a time and a place for surgery in IBD, this approach is invasive and postoperative recrudescence of disease is common.⁴ Moreover patients with complex surgical or medical histories may not make optimal surgical candidates.

Thanks to advancements in a variety of endoscopic technologies, nonoperative therapies are now available and provide a solution for patients who would otherwise fall outside of conventional treatment options. Over the last several years, applications of endoscopic therapies in IBD have been gaining traction and the need for these therapies is expected to continue to rise over time. As such, understanding the domains of available endoscopic options in IBD is important for the modern-day gastroenterologist. In this article, we will discuss some of the recent advancements in endoscopic therapies for IBD and how we may position these in clinical practice.
 

Protecting against colitis dysplasia and colon cancer

IBD is a risk factor for colorectal cancer because of the dysplasia-carcinoma sequence arising from chronic colitis. Endoscopic resection is the first-line treatment for conventional colitis-associated dysplasia (CAD).^5,6 However, larger or complex lesions may not have been previously amenable to this organ-preserving approach. The application of newer techniques has extended the indication for endoscopic resection to include most CAD lesions, as an alternative to proctocolectomy. Endoscopic mucosal resection (EMR) is the most commonly used technique and its outcomes for CAD greater than 2 cm have been excellent (Figure 1).⁷ However, employing EMR for lesions greater than 2 cm in size may require piecemeal resection and this has been associated with a small risk of local recurrence.⁸ Endoscopic submucosal dissection (ESD) is an alternate method of endoscopic tissue resection that can reliably achieve en bloc (single specimen) resections even in larger lesions.⁹

Courtesy Dr. Genere and colleagues

Restoring gastrointestinal tract transit

Crohn’s strictures may lead to acute intestinal obstructions or facilitate the onset of penetrating disease, such as fistula formation or abscess. These strictures are often characterized by a combination of inflammation and layered fibrosis, which requires the application of medical therapies alongside structural remodeling to successfully manage. Not all strictures may be clinically overt due to variances in visceral sensitivity, yet experts believe that treatment of all strictures should be considered to avoid occurrence of delayed complications.¹⁴ Endoscopic balloon dilation (EBD) is a well-established treatment for Crohn’s strictures up to 4-5 cm in length (Figure 2). This treatment involves inflating a balloon within the narrowed section of intestine, thereby stretching and disrupting the layered fibrotic bands to widen the stricture. EBD improves symptoms 70% of the time and successfully avoids the medium-term need for surgery in most, although it often requires repeat endoscopic procedures.¹⁵ In fact, up to 74% of patients will require repeat dilation over 2 years and 43% will require salvage surgery after EBD.¹⁶

Courtesy Dr. Genere and colleagues

The future for endoscopic therapy is bright

Structural complications of IBD are common and can pose a significant detriment to quality of life and general well-being for patients. From mucosal resection of CAD to surgery-sparing therapies for intestinal strictures, endoscopic therapies are valuable and effective options for managing disease-related sequelae within the scope of interventional IBD practice. We can expect the availability of these options to grow as the scope of endoscopy training incorporates principles of interventional IBD, along with the concurrent development of additional therapeutic applications beyond the categories discussed here (including perianal disease, fistulas, and abscess formation). It is noteworthy to mention that while endoscopic therapies are separate treatment modalities, should not be considered mutually exclusive; endotherapies are best viewed as a complement to existing medical and surgical approaches. Thus, Interventional IBD endoscopy can serve as an integral part of the multidisciplinary IBD framework to provide comprehensive care for our patients with IBD.

Juan Reyes Genere, MD, is an assistant professor of medicine in gastroenterology at Washington University in St. Louis. He served as the corresponding author of this article. Michael Rubeiz, MD, is a physician in the internal medicine residency program at Washington University in St. Louis. Kemmian Johnson, MD, MPH, is a gastroenterologist at Washington University in St. Louis specializing in inflammatory bowel disease. Dr. Genere is a consultant for Edulis Therapeutics. Dr. Rubeiz and Dr. Johnson had no personal or financial conflicts of interest. Dr. Johnson can be reached on Instagram @KJ.1906; Dr. Rubeiz is on X @MichaelRubeiz1 and Dr. Genere can be reached via X @JPGenereMD.

References

1. Ng SC et al. Lancet. 2017;390(10114):2769-78.

2. Gordon JP et al. Eur J Gastroenterol Hepatol. 2015;27(7):804-12.

3. Sica GS and Biancone L. World J Gastroenterol. 2013;19(16):2445-8.

4. Iborra M et al. Gastroenterol Rep (Oxf). 2019;7(6):411-8.

5. Annese V et al. J Crohns Colitis. 2013;7(12):982-1018.

6. Laine L et al. Gastrointest Endosc. 2015;81(3):489-501.e426.

7. Mohan BP et al. Gastrointest Endosc. 2021;93(1):59-67.e10.

8. Briedigkeit A et al. World J Gastrointest Endosc. 2016;8(5):276-81.

9. Manta R et al. J Crohns Colitis. 2021;15(1):165-8.

10. Mohapatra S et al. Endosc Int Open. 2022;10(5):E593-601.

11. Ngamruengphong S et al. Endosc Int Open. 2022;10(4):E354-60.

12. Baker G et al. Cureus. 2022 May 3;14(5):e24688.

13. Yadav S et al. Endosc Int Open. 2019;7(8):E994-1001.

14. Schwartz DA. Gastrointestinal Endoscopy. 2023;97(5):974-6.

15. Morar PS et al. Aliment Pharmacol Ther. 2015;42(10):1137-48.

16. Bettenworth D et al. Inflamm Bowel Dis. 2017;23(1):133-42.

17. Lan N and Shen B. Inflamm Bowel Dis. 2018;24(4):897-907.

18. Loras C et al. Lancet Gastroenterol Hepatol. 2022;7(4):332-41.

19. Genere JR et al. Lancet Gastroenterol Hepatol. 2022;7(6):503-4.

Introduction

Inflammatory bowel disease (IBD) is a chronic, relapsing and remitting disorder that is becoming increasingly prevalent worldwide.¹ Despite major advances in this area, many patients with moderate to severe IBD do not achieve disease remission with immunosuppressive therapy.² Dysplasia and fibrostenosis are two common consequences of uncontrolled chronic inflammation and these structural complications are often the primary reasons for surgical interventions.³ While there is certainly a time and a place for surgery in IBD, this approach is invasive and postoperative recrudescence of disease is common.⁴ Moreover patients with complex surgical or medical histories may not make optimal surgical candidates.

Thanks to advancements in a variety of endoscopic technologies, nonoperative therapies are now available and provide a solution for patients who would otherwise fall outside of conventional treatment options. Over the last several years, applications of endoscopic therapies in IBD have been gaining traction and the need for these therapies is expected to continue to rise over time. As such, understanding the domains of available endoscopic options in IBD is important for the modern-day gastroenterologist. In this article, we will discuss some of the recent advancements in endoscopic therapies for IBD and how we may position these in clinical practice.
 

Protecting against colitis dysplasia and colon cancer

IBD is a risk factor for colorectal cancer because of the dysplasia-carcinoma sequence arising from chronic colitis. Endoscopic resection is the first-line treatment for conventional colitis-associated dysplasia (CAD).^5,6 However, larger or complex lesions may not have been previously amenable to this organ-preserving approach. The application of newer techniques has extended the indication for endoscopic resection to include most CAD lesions, as an alternative to proctocolectomy. Endoscopic mucosal resection (EMR) is the most commonly used technique and its outcomes for CAD greater than 2 cm have been excellent (Figure 1).⁷ However, employing EMR for lesions greater than 2 cm in size may require piecemeal resection and this has been associated with a small risk of local recurrence.⁸ Endoscopic submucosal dissection (ESD) is an alternate method of endoscopic tissue resection that can reliably achieve en bloc (single specimen) resections even in larger lesions.⁹

Courtesy Dr. Genere and colleagues

Restoring gastrointestinal tract transit

Crohn’s strictures may lead to acute intestinal obstructions or facilitate the onset of penetrating disease, such as fistula formation or abscess. These strictures are often characterized by a combination of inflammation and layered fibrosis, which requires the application of medical therapies alongside structural remodeling to successfully manage. Not all strictures may be clinically overt due to variances in visceral sensitivity, yet experts believe that treatment of all strictures should be considered to avoid occurrence of delayed complications.¹⁴ Endoscopic balloon dilation (EBD) is a well-established treatment for Crohn’s strictures up to 4-5 cm in length (Figure 2). This treatment involves inflating a balloon within the narrowed section of intestine, thereby stretching and disrupting the layered fibrotic bands to widen the stricture. EBD improves symptoms 70% of the time and successfully avoids the medium-term need for surgery in most, although it often requires repeat endoscopic procedures.¹⁵ In fact, up to 74% of patients will require repeat dilation over 2 years and 43% will require salvage surgery after EBD.¹⁶

Courtesy Dr. Genere and colleagues

The future for endoscopic therapy is bright

Structural complications of IBD are common and can pose a significant detriment to quality of life and general well-being for patients. From mucosal resection of CAD to surgery-sparing therapies for intestinal strictures, endoscopic therapies are valuable and effective options for managing disease-related sequelae within the scope of interventional IBD practice. We can expect the availability of these options to grow as the scope of endoscopy training incorporates principles of interventional IBD, along with the concurrent development of additional therapeutic applications beyond the categories discussed here (including perianal disease, fistulas, and abscess formation). It is noteworthy to mention that while endoscopic therapies are separate treatment modalities, should not be considered mutually exclusive; endotherapies are best viewed as a complement to existing medical and surgical approaches. Thus, Interventional IBD endoscopy can serve as an integral part of the multidisciplinary IBD framework to provide comprehensive care for our patients with IBD.

Juan Reyes Genere, MD, is an assistant professor of medicine in gastroenterology at Washington University in St. Louis. He served as the corresponding author of this article. Michael Rubeiz, MD, is a physician in the internal medicine residency program at Washington University in St. Louis. Kemmian Johnson, MD, MPH, is a gastroenterologist at Washington University in St. Louis specializing in inflammatory bowel disease. Dr. Genere is a consultant for Edulis Therapeutics. Dr. Rubeiz and Dr. Johnson had no personal or financial conflicts of interest. Dr. Johnson can be reached on Instagram @KJ.1906; Dr. Rubeiz is on X @MichaelRubeiz1 and Dr. Genere can be reached via X @JPGenereMD.

References

1. Ng SC et al. Lancet. 2017;390(10114):2769-78.

2. Gordon JP et al. Eur J Gastroenterol Hepatol. 2015;27(7):804-12.

3. Sica GS and Biancone L. World J Gastroenterol. 2013;19(16):2445-8.

4. Iborra M et al. Gastroenterol Rep (Oxf). 2019;7(6):411-8.

5. Annese V et al. J Crohns Colitis. 2013;7(12):982-1018.

6. Laine L et al. Gastrointest Endosc. 2015;81(3):489-501.e426.

7. Mohan BP et al. Gastrointest Endosc. 2021;93(1):59-67.e10.

8. Briedigkeit A et al. World J Gastrointest Endosc. 2016;8(5):276-81.

9. Manta R et al. J Crohns Colitis. 2021;15(1):165-8.

10. Mohapatra S et al. Endosc Int Open. 2022;10(5):E593-601.

11. Ngamruengphong S et al. Endosc Int Open. 2022;10(4):E354-60.

12. Baker G et al. Cureus. 2022 May 3;14(5):e24688.

13. Yadav S et al. Endosc Int Open. 2019;7(8):E994-1001.

14. Schwartz DA. Gastrointestinal Endoscopy. 2023;97(5):974-6.

15. Morar PS et al. Aliment Pharmacol Ther. 2015;42(10):1137-48.

16. Bettenworth D et al. Inflamm Bowel Dis. 2017;23(1):133-42.

17. Lan N and Shen B. Inflamm Bowel Dis. 2018;24(4):897-907.

18. Loras C et al. Lancet Gastroenterol Hepatol. 2022;7(4):332-41.

19. Genere JR et al. Lancet Gastroenterol Hepatol. 2022;7(6):503-4.

Community oncologists across the United States are concerned about a recent lawsuit in Philadelphia between the Jefferson Health hospital system and the largest independent oncology and hematology practice in southeastern Pennsylvania, Alliance Cancer Specialists.

The outcome, some community oncologists say, could set a new precedent in how far large health care organizations will go to take their patients or drive them out of business.
 

The case

On Sept. 5, Alliance sued Jefferson Health after Jefferson canceled the inpatient oncology/hematology privileges of five Alliance oncologists at three Jefferson Health-Northeast hospitals, primarily alleging that Jefferson was attempting to monopolize cancer care in the area.

Jefferson – one of the largest health care systems in the Philadelphia area that includes the NCI-designated Sidney Kimmel Cancer Center – made the move because it had entered into an exclusive agreement with its own medical group to provide inpatient and outpatient oncology/hematology services at the hospitals.

In its court filings, Jefferson said it entered into the exclusive agreement because doing so was in “the best interest of patients, as it would ensure better integration and availability of care and help ensure that Jefferson consistently provides high-quality medical care in accordance with evidence-based standards.”

Tensions had been building between Alliance and Jefferson for years, ever since, according to Alliance, the community practice declined a buyout offer from Jefferson almost a decade ago.

But the revocation of privileges ultimately tipped the scales for Alliance, sparking the lawsuit.

“For us, that crossed a line,” said Moshe Chasky, MD, one of the five Alliance oncologists and a plaintiff in the suit.

Dr. Chasky and his colleagues had provided care at the hospitals for years, with about 10-15 patients admitted at any one time. The quality of their care is not in dispute. Dr. Chasky, for instance, routinely makes Philadelphia Magazine’s Top Doc List.

Under the new arrangement, the five Alliance oncologists have to hand over care of their admitted patients to Jefferson oncologists or send their patients to another hospital farther away where they do have admitting privileges.

“Without having admitting privileges,” community oncologists “can’t look a patient in the eye and say, ‘No matter what, I’ve got you,’ ” explained Nicolas Ferreyros, managing director of policy, advocacy, and communications at the Community Oncology Alliance, a DC-based lobbying group for independent oncologists.

“A doctor doesn’t want to tell a patient that ‘once you go in the hospital, I have to hand you off.’ ” It undermines their practice, Mr. Ferreyros said.

The situation has caught the attention of other community oncologists who are worried that hospitals canceling admitting privileges might become a new tactic in what they characterize as an ongoing effort to elbow-out independent practitioners and corner the oncology market.

Dr. Chasky said he is getting “calls every day from independent oncologists throughout the country” who “are very concerned. People are watching this for sure.”   

Alliance attorney Daniel Frier said that there is nothing unusual about hospitals entering into exclusive contracts with hospital-based practices.

But Mr. Frier said he’s never heard of a hospital entering into an exclusive contract and then terminating the privileges of community oncologists.  

“There’s no direct precedent” for the move, he said.

Jefferson Health did not respond to requests for comment. 
 

The ruling

U.S. District Court Judge Kai Scott, who ruled on Alliance’s motion to block the contract and preserve its oncologists’ admitting privileges, ultimately sided with Jefferson and allowed the contract to go forward.

Judge Scott wrote that, “while the court understands the plaintiffs’ concerns and desires to maintain the continuity of care for their own patients,” the court “is not persuaded that either of the two threshold elements for a temporary restraining order or preliminary injunction are met” – first, that Jefferson’s actions violate antitrust laws and second that the plaintiffs “will suffer immediate, irreparable harm” from having their admitting privileges rescinded.

Alliance argued that Jefferson’s contract violated federal antitrust laws and would allow Jefferson to monopolize the local oncology market.

However, Judge Scott called Alliance’s antitrust argument “lifeless” under the strict requirements for antitrust violations, explaining that, among other reasons, a monopoly is unlikely given that Jefferson competes with several high-profile oncology programs in the Philadelphia area, including the Fox Chase Cancer Center.

Judge Scott also expressed doubt that the Jefferson’s actions would cause irreparable harm to Alliance’s business. Alliance employs more than thirty oncologists affiliated with over a dozen hospitals in the greater Philadelphia area, and the inpatient services provided at Jefferson Health-Northeast did not represent a major part of its business. 

Despite her ruling, Judge Scott did voice skepticism about some of Jefferson’s arguments.

“The court notes that the Jefferson defendants have briefly argued that Jefferson will be better able to ensure that its own patients receive fully integrated and coordinated care” under the exclusive provider agreement, but “it is unclear how the cooperation of ACS [Alliance Cancer Specialists] and JNE [Jefferson Health-Northeast] hospitalists really caused any problems for the coordinated care of” patients in the many years that they worked together.

It also “does not seem to necessarily serve the community to quickly sever the artery between the services that ACS provides and the services that JNE provides,” Judge Scott wrote.

She added that she would consider another motion from Alliance if the practice makes stronger arguments illustrating antitrust violations and demonstrating irreparable harm.

Currently, Dr. Chasky and Mr. Frier are considering their next steps in the case. The oncologists said they can appeal the judge’s decision or file a new complaint.

Meanwhile, Dr. Chasky and his four colleagues requested and were granted internal medicine privileges at Jefferson Health-Northeast, but given the considerable overlap between oncology and internal medicine, the line between what they can and cannot do remains unclear.

“It’s a mess,” he said.
 

A familiar story

Large health care entities have increasingly worked to push out or swallow up smaller, independent practices for years.

“What Dr. Chasky and his practice are going through is a little bit more of an aggressive version of what’s going on in the rest of the country,” said Michael Diaz, MD, a community oncologist at Florida Cancer Specialists, the largest independent medical oncology/hematology group in the United States. “The larger institutional hospitals try to make it a closed system so they can keep everything in-house and refer to their own physicians.”

The incentive, Dr. Diaz said, is the financial windfall that Section 340B of the 1992 Public Health Service Act generates for hospital-based oncology services at nonprofit hospitals, such as the Jefferson Health-Northeast facilities.

The 340B program allows nonprofit hospitals to buy primarily outpatient oncology drugs at steep discounts, sometimes 50% or more, and be reimbursed at full price.

When launched in 1992, the program was meant to help a handful of safety-net hospitals cover the cost of charity care, and now approximately more than half of U.S. hospitals participate in the program, particularly after requirements were loosened by the Affordable Care Act. But there’s little transparency on how the money is spent.

Critics say the incentives have created a feeding frenzy among 340B hospitals to either acquire outpatient oncology practices or take their business because of the particularly high margins on oncology drugs. There are similar incentives for hospital-based infusion centers.

In its lawsuit, Alliance alleged that such incentives are what motivated Jefferson’s recent actions.

“It’s all about the money at the end of the day,” said Christian Thomas, MD, a community oncologist with New England Cancer Specialists, Scarborough, Maine, who, like Dr. Diaz, said he’s seen the dynamic play out repeatedly in his career. 

The American Hospital Association has been a vigorous defender of 340B in the courts and elsewhere, but the Association’s communications staff had little to say when this news organization reached out about the Jefferson-Alliance situation, except that they do not comment on “specific hospital circumstance.”
 

Reverberations around the country

Many community oncologists are keeping close tabs on the Jefferson-Alliance situation.

“Our group has been watching Jefferson closely because our [local] hospital is following the same playbook, but they have not yet gone after our privileges,” said Scott Herbert, MD, a community oncologist with the independent Nexus Health system, Sante Fe, N.M.

Dr. Herbert was referring to what has happened since he and his colleagues declined to renew an exclusive provider agreement early this year with St. Vincent Regional Medical Center, a nonprofit hospital in Sante Fe. The agreement allowed the hospital to take advantage of the 340B program because Nexus oncologists acted on its behalf.

St. Vincent’s owner, Christus Health, did not respond to inquiries from this news organization.

Nexus let the contract lapse because its oncologists wanted to provide services at a second, newer hospital in Santa Fe where some of their patients had begun seeking treatment.

The nonprofit hospital in Sante Fe is now building its own oncology practice. Similar to Dr. Chasky’s experience in Philadelphia, Dr. Herbert said his group has seen referrals from the hospital dry up and existing patients rechanneled to the hospital’s oncologists.  

“We found over 109 patients in January and February that were referred to one of our docs that got rerouted to one of their docs,” he said.

Dr. Herbert has sent cease-and-desist letters, but “after we saw what Jefferson did, my group said, ‘You better back off of the hospital, or it’s going to take our privileges.’ ”

The Jefferson situation “is sending a message,” he said. “Frankly, we’ve been terrified” at the thought of losing privileges there. “It’s the busiest hospital in our area.”
 

The future of community oncology

Despite the challenges, Mr. Ferreyros at the Community Oncology Alliance remains optimistic about the future of independent oncology.

Under the competitive pressures, a lot of independent oncology practices have folded in recent years, but the ones that remain are strong. Payers are also increasingly noticing that community oncology practices are less expensive than hospital-based practices for comparable care, he said.

Relationships with hospitals aren’t always adversarial, either. “A lot of practices have collaborative agreements with local hospitals” that work out well, Mr. Ferreyros said, adding that sometimes hospitals even hand over oncology care to local independents after finding that starting and maintaining an oncology service is harder than they imagined.

“The last two decades have been difficult,” but the remaining community oncology practices “are going strong,” he said, and “we’ve never seen more engagement on our issues,” particularly around the issue of cost savings.

A version of this article first appeared on Medscape.com.

Community oncologists across the United States are concerned about a recent lawsuit in Philadelphia between the Jefferson Health hospital system and the largest independent oncology and hematology practice in southeastern Pennsylvania, Alliance Cancer Specialists.

The outcome, some community oncologists say, could set a new precedent in how far large health care organizations will go to take their patients or drive them out of business.
 

The case

On Sept. 5, Alliance sued Jefferson Health after Jefferson canceled the inpatient oncology/hematology privileges of five Alliance oncologists at three Jefferson Health-Northeast hospitals, primarily alleging that Jefferson was attempting to monopolize cancer care in the area.

Jefferson – one of the largest health care systems in the Philadelphia area that includes the NCI-designated Sidney Kimmel Cancer Center – made the move because it had entered into an exclusive agreement with its own medical group to provide inpatient and outpatient oncology/hematology services at the hospitals.

In its court filings, Jefferson said it entered into the exclusive agreement because doing so was in “the best interest of patients, as it would ensure better integration and availability of care and help ensure that Jefferson consistently provides high-quality medical care in accordance with evidence-based standards.”

Tensions had been building between Alliance and Jefferson for years, ever since, according to Alliance, the community practice declined a buyout offer from Jefferson almost a decade ago.

But the revocation of privileges ultimately tipped the scales for Alliance, sparking the lawsuit.

“For us, that crossed a line,” said Moshe Chasky, MD, one of the five Alliance oncologists and a plaintiff in the suit.

Dr. Chasky and his colleagues had provided care at the hospitals for years, with about 10-15 patients admitted at any one time. The quality of their care is not in dispute. Dr. Chasky, for instance, routinely makes Philadelphia Magazine’s Top Doc List.

Under the new arrangement, the five Alliance oncologists have to hand over care of their admitted patients to Jefferson oncologists or send their patients to another hospital farther away where they do have admitting privileges.

“Without having admitting privileges,” community oncologists “can’t look a patient in the eye and say, ‘No matter what, I’ve got you,’ ” explained Nicolas Ferreyros, managing director of policy, advocacy, and communications at the Community Oncology Alliance, a DC-based lobbying group for independent oncologists.

“A doctor doesn’t want to tell a patient that ‘once you go in the hospital, I have to hand you off.’ ” It undermines their practice, Mr. Ferreyros said.

The situation has caught the attention of other community oncologists who are worried that hospitals canceling admitting privileges might become a new tactic in what they characterize as an ongoing effort to elbow-out independent practitioners and corner the oncology market.

Dr. Chasky said he is getting “calls every day from independent oncologists throughout the country” who “are very concerned. People are watching this for sure.”   

Alliance attorney Daniel Frier said that there is nothing unusual about hospitals entering into exclusive contracts with hospital-based practices.

But Mr. Frier said he’s never heard of a hospital entering into an exclusive contract and then terminating the privileges of community oncologists.  

“There’s no direct precedent” for the move, he said.

Jefferson Health did not respond to requests for comment. 
 

The ruling

U.S. District Court Judge Kai Scott, who ruled on Alliance’s motion to block the contract and preserve its oncologists’ admitting privileges, ultimately sided with Jefferson and allowed the contract to go forward.

Judge Scott wrote that, “while the court understands the plaintiffs’ concerns and desires to maintain the continuity of care for their own patients,” the court “is not persuaded that either of the two threshold elements for a temporary restraining order or preliminary injunction are met” – first, that Jefferson’s actions violate antitrust laws and second that the plaintiffs “will suffer immediate, irreparable harm” from having their admitting privileges rescinded.

Alliance argued that Jefferson’s contract violated federal antitrust laws and would allow Jefferson to monopolize the local oncology market.

However, Judge Scott called Alliance’s antitrust argument “lifeless” under the strict requirements for antitrust violations, explaining that, among other reasons, a monopoly is unlikely given that Jefferson competes with several high-profile oncology programs in the Philadelphia area, including the Fox Chase Cancer Center.

Judge Scott also expressed doubt that the Jefferson’s actions would cause irreparable harm to Alliance’s business. Alliance employs more than thirty oncologists affiliated with over a dozen hospitals in the greater Philadelphia area, and the inpatient services provided at Jefferson Health-Northeast did not represent a major part of its business. 

Despite her ruling, Judge Scott did voice skepticism about some of Jefferson’s arguments.

“The court notes that the Jefferson defendants have briefly argued that Jefferson will be better able to ensure that its own patients receive fully integrated and coordinated care” under the exclusive provider agreement, but “it is unclear how the cooperation of ACS [Alliance Cancer Specialists] and JNE [Jefferson Health-Northeast] hospitalists really caused any problems for the coordinated care of” patients in the many years that they worked together.

It also “does not seem to necessarily serve the community to quickly sever the artery between the services that ACS provides and the services that JNE provides,” Judge Scott wrote.

She added that she would consider another motion from Alliance if the practice makes stronger arguments illustrating antitrust violations and demonstrating irreparable harm.

Currently, Dr. Chasky and Mr. Frier are considering their next steps in the case. The oncologists said they can appeal the judge’s decision or file a new complaint.

Meanwhile, Dr. Chasky and his four colleagues requested and were granted internal medicine privileges at Jefferson Health-Northeast, but given the considerable overlap between oncology and internal medicine, the line between what they can and cannot do remains unclear.

“It’s a mess,” he said.
 

A familiar story

Large health care entities have increasingly worked to push out or swallow up smaller, independent practices for years.

“What Dr. Chasky and his practice are going through is a little bit more of an aggressive version of what’s going on in the rest of the country,” said Michael Diaz, MD, a community oncologist at Florida Cancer Specialists, the largest independent medical oncology/hematology group in the United States. “The larger institutional hospitals try to make it a closed system so they can keep everything in-house and refer to their own physicians.”

The incentive, Dr. Diaz said, is the financial windfall that Section 340B of the 1992 Public Health Service Act generates for hospital-based oncology services at nonprofit hospitals, such as the Jefferson Health-Northeast facilities.

The 340B program allows nonprofit hospitals to buy primarily outpatient oncology drugs at steep discounts, sometimes 50% or more, and be reimbursed at full price.

When launched in 1992, the program was meant to help a handful of safety-net hospitals cover the cost of charity care, and now approximately more than half of U.S. hospitals participate in the program, particularly after requirements were loosened by the Affordable Care Act. But there’s little transparency on how the money is spent.

Critics say the incentives have created a feeding frenzy among 340B hospitals to either acquire outpatient oncology practices or take their business because of the particularly high margins on oncology drugs. There are similar incentives for hospital-based infusion centers.

In its lawsuit, Alliance alleged that such incentives are what motivated Jefferson’s recent actions.

“It’s all about the money at the end of the day,” said Christian Thomas, MD, a community oncologist with New England Cancer Specialists, Scarborough, Maine, who, like Dr. Diaz, said he’s seen the dynamic play out repeatedly in his career. 

The American Hospital Association has been a vigorous defender of 340B in the courts and elsewhere, but the Association’s communications staff had little to say when this news organization reached out about the Jefferson-Alliance situation, except that they do not comment on “specific hospital circumstance.”
 

Reverberations around the country

Many community oncologists are keeping close tabs on the Jefferson-Alliance situation.

“Our group has been watching Jefferson closely because our [local] hospital is following the same playbook, but they have not yet gone after our privileges,” said Scott Herbert, MD, a community oncologist with the independent Nexus Health system, Sante Fe, N.M.

Dr. Herbert was referring to what has happened since he and his colleagues declined to renew an exclusive provider agreement early this year with St. Vincent Regional Medical Center, a nonprofit hospital in Sante Fe. The agreement allowed the hospital to take advantage of the 340B program because Nexus oncologists acted on its behalf.

St. Vincent’s owner, Christus Health, did not respond to inquiries from this news organization.

Nexus let the contract lapse because its oncologists wanted to provide services at a second, newer hospital in Santa Fe where some of their patients had begun seeking treatment.

The nonprofit hospital in Sante Fe is now building its own oncology practice. Similar to Dr. Chasky’s experience in Philadelphia, Dr. Herbert said his group has seen referrals from the hospital dry up and existing patients rechanneled to the hospital’s oncologists.  

“We found over 109 patients in January and February that were referred to one of our docs that got rerouted to one of their docs,” he said.

Dr. Herbert has sent cease-and-desist letters, but “after we saw what Jefferson did, my group said, ‘You better back off of the hospital, or it’s going to take our privileges.’ ”

The Jefferson situation “is sending a message,” he said. “Frankly, we’ve been terrified” at the thought of losing privileges there. “It’s the busiest hospital in our area.”
 

The future of community oncology

Despite the challenges, Mr. Ferreyros at the Community Oncology Alliance remains optimistic about the future of independent oncology.

Under the competitive pressures, a lot of independent oncology practices have folded in recent years, but the ones that remain are strong. Payers are also increasingly noticing that community oncology practices are less expensive than hospital-based practices for comparable care, he said.

Relationships with hospitals aren’t always adversarial, either. “A lot of practices have collaborative agreements with local hospitals” that work out well, Mr. Ferreyros said, adding that sometimes hospitals even hand over oncology care to local independents after finding that starting and maintaining an oncology service is harder than they imagined.

“The last two decades have been difficult,” but the remaining community oncology practices “are going strong,” he said, and “we’ve never seen more engagement on our issues,” particularly around the issue of cost savings.

A version of this article first appeared on Medscape.com.

Community oncologists across the United States are concerned about a recent lawsuit in Philadelphia between the Jefferson Health hospital system and the largest independent oncology and hematology practice in southeastern Pennsylvania, Alliance Cancer Specialists.

The outcome, some community oncologists say, could set a new precedent in how far large health care organizations will go to take their patients or drive them out of business.
 

The case

On Sept. 5, Alliance sued Jefferson Health after Jefferson canceled the inpatient oncology/hematology privileges of five Alliance oncologists at three Jefferson Health-Northeast hospitals, primarily alleging that Jefferson was attempting to monopolize cancer care in the area.

Jefferson – one of the largest health care systems in the Philadelphia area that includes the NCI-designated Sidney Kimmel Cancer Center – made the move because it had entered into an exclusive agreement with its own medical group to provide inpatient and outpatient oncology/hematology services at the hospitals.

In its court filings, Jefferson said it entered into the exclusive agreement because doing so was in “the best interest of patients, as it would ensure better integration and availability of care and help ensure that Jefferson consistently provides high-quality medical care in accordance with evidence-based standards.”

Tensions had been building between Alliance and Jefferson for years, ever since, according to Alliance, the community practice declined a buyout offer from Jefferson almost a decade ago.

But the revocation of privileges ultimately tipped the scales for Alliance, sparking the lawsuit.

“For us, that crossed a line,” said Moshe Chasky, MD, one of the five Alliance oncologists and a plaintiff in the suit.

Dr. Chasky and his colleagues had provided care at the hospitals for years, with about 10-15 patients admitted at any one time. The quality of their care is not in dispute. Dr. Chasky, for instance, routinely makes Philadelphia Magazine’s Top Doc List.

Under the new arrangement, the five Alliance oncologists have to hand over care of their admitted patients to Jefferson oncologists or send their patients to another hospital farther away where they do have admitting privileges.

“Without having admitting privileges,” community oncologists “can’t look a patient in the eye and say, ‘No matter what, I’ve got you,’ ” explained Nicolas Ferreyros, managing director of policy, advocacy, and communications at the Community Oncology Alliance, a DC-based lobbying group for independent oncologists.

“A doctor doesn’t want to tell a patient that ‘once you go in the hospital, I have to hand you off.’ ” It undermines their practice, Mr. Ferreyros said.

The situation has caught the attention of other community oncologists who are worried that hospitals canceling admitting privileges might become a new tactic in what they characterize as an ongoing effort to elbow-out independent practitioners and corner the oncology market.

Dr. Chasky said he is getting “calls every day from independent oncologists throughout the country” who “are very concerned. People are watching this for sure.”   

Alliance attorney Daniel Frier said that there is nothing unusual about hospitals entering into exclusive contracts with hospital-based practices.

But Mr. Frier said he’s never heard of a hospital entering into an exclusive contract and then terminating the privileges of community oncologists.  

“There’s no direct precedent” for the move, he said.

Jefferson Health did not respond to requests for comment. 
 

The ruling

U.S. District Court Judge Kai Scott, who ruled on Alliance’s motion to block the contract and preserve its oncologists’ admitting privileges, ultimately sided with Jefferson and allowed the contract to go forward.

Judge Scott wrote that, “while the court understands the plaintiffs’ concerns and desires to maintain the continuity of care for their own patients,” the court “is not persuaded that either of the two threshold elements for a temporary restraining order or preliminary injunction are met” – first, that Jefferson’s actions violate antitrust laws and second that the plaintiffs “will suffer immediate, irreparable harm” from having their admitting privileges rescinded.

Alliance argued that Jefferson’s contract violated federal antitrust laws and would allow Jefferson to monopolize the local oncology market.

However, Judge Scott called Alliance’s antitrust argument “lifeless” under the strict requirements for antitrust violations, explaining that, among other reasons, a monopoly is unlikely given that Jefferson competes with several high-profile oncology programs in the Philadelphia area, including the Fox Chase Cancer Center.

Judge Scott also expressed doubt that the Jefferson’s actions would cause irreparable harm to Alliance’s business. Alliance employs more than thirty oncologists affiliated with over a dozen hospitals in the greater Philadelphia area, and the inpatient services provided at Jefferson Health-Northeast did not represent a major part of its business. 

Despite her ruling, Judge Scott did voice skepticism about some of Jefferson’s arguments.

“The court notes that the Jefferson defendants have briefly argued that Jefferson will be better able to ensure that its own patients receive fully integrated and coordinated care” under the exclusive provider agreement, but “it is unclear how the cooperation of ACS [Alliance Cancer Specialists] and JNE [Jefferson Health-Northeast] hospitalists really caused any problems for the coordinated care of” patients in the many years that they worked together.

It also “does not seem to necessarily serve the community to quickly sever the artery between the services that ACS provides and the services that JNE provides,” Judge Scott wrote.

She added that she would consider another motion from Alliance if the practice makes stronger arguments illustrating antitrust violations and demonstrating irreparable harm.

Currently, Dr. Chasky and Mr. Frier are considering their next steps in the case. The oncologists said they can appeal the judge’s decision or file a new complaint.

Meanwhile, Dr. Chasky and his four colleagues requested and were granted internal medicine privileges at Jefferson Health-Northeast, but given the considerable overlap between oncology and internal medicine, the line between what they can and cannot do remains unclear.

“It’s a mess,” he said.
 

A familiar story

Large health care entities have increasingly worked to push out or swallow up smaller, independent practices for years.

“What Dr. Chasky and his practice are going through is a little bit more of an aggressive version of what’s going on in the rest of the country,” said Michael Diaz, MD, a community oncologist at Florida Cancer Specialists, the largest independent medical oncology/hematology group in the United States. “The larger institutional hospitals try to make it a closed system so they can keep everything in-house and refer to their own physicians.”

The incentive, Dr. Diaz said, is the financial windfall that Section 340B of the 1992 Public Health Service Act generates for hospital-based oncology services at nonprofit hospitals, such as the Jefferson Health-Northeast facilities.

The 340B program allows nonprofit hospitals to buy primarily outpatient oncology drugs at steep discounts, sometimes 50% or more, and be reimbursed at full price.

When launched in 1992, the program was meant to help a handful of safety-net hospitals cover the cost of charity care, and now approximately more than half of U.S. hospitals participate in the program, particularly after requirements were loosened by the Affordable Care Act. But there’s little transparency on how the money is spent.

Critics say the incentives have created a feeding frenzy among 340B hospitals to either acquire outpatient oncology practices or take their business because of the particularly high margins on oncology drugs. There are similar incentives for hospital-based infusion centers.

In its lawsuit, Alliance alleged that such incentives are what motivated Jefferson’s recent actions.

“It’s all about the money at the end of the day,” said Christian Thomas, MD, a community oncologist with New England Cancer Specialists, Scarborough, Maine, who, like Dr. Diaz, said he’s seen the dynamic play out repeatedly in his career. 

The American Hospital Association has been a vigorous defender of 340B in the courts and elsewhere, but the Association’s communications staff had little to say when this news organization reached out about the Jefferson-Alliance situation, except that they do not comment on “specific hospital circumstance.”
 

Reverberations around the country

Many community oncologists are keeping close tabs on the Jefferson-Alliance situation.

“Our group has been watching Jefferson closely because our [local] hospital is following the same playbook, but they have not yet gone after our privileges,” said Scott Herbert, MD, a community oncologist with the independent Nexus Health system, Sante Fe, N.M.

Dr. Herbert was referring to what has happened since he and his colleagues declined to renew an exclusive provider agreement early this year with St. Vincent Regional Medical Center, a nonprofit hospital in Sante Fe. The agreement allowed the hospital to take advantage of the 340B program because Nexus oncologists acted on its behalf.

St. Vincent’s owner, Christus Health, did not respond to inquiries from this news organization.

Nexus let the contract lapse because its oncologists wanted to provide services at a second, newer hospital in Santa Fe where some of their patients had begun seeking treatment.

The nonprofit hospital in Sante Fe is now building its own oncology practice. Similar to Dr. Chasky’s experience in Philadelphia, Dr. Herbert said his group has seen referrals from the hospital dry up and existing patients rechanneled to the hospital’s oncologists.  

“We found over 109 patients in January and February that were referred to one of our docs that got rerouted to one of their docs,” he said.

Dr. Herbert has sent cease-and-desist letters, but “after we saw what Jefferson did, my group said, ‘You better back off of the hospital, or it’s going to take our privileges.’ ”

The Jefferson situation “is sending a message,” he said. “Frankly, we’ve been terrified” at the thought of losing privileges there. “It’s the busiest hospital in our area.”
 

The future of community oncology

Despite the challenges, Mr. Ferreyros at the Community Oncology Alliance remains optimistic about the future of independent oncology.

Under the competitive pressures, a lot of independent oncology practices have folded in recent years, but the ones that remain are strong. Payers are also increasingly noticing that community oncology practices are less expensive than hospital-based practices for comparable care, he said.

Relationships with hospitals aren’t always adversarial, either. “A lot of practices have collaborative agreements with local hospitals” that work out well, Mr. Ferreyros said, adding that sometimes hospitals even hand over oncology care to local independents after finding that starting and maintaining an oncology service is harder than they imagined.

“The last two decades have been difficult,” but the remaining community oncology practices “are going strong,” he said, and “we’ve never seen more engagement on our issues,” particularly around the issue of cost savings.

A version of this article first appeared on Medscape.com.