NEW YORK – Treated with chimeric antigen receptor (CAR) T-cell therapy, most patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL) achieved better outcomes than those receiving autologous stem cell transplants (ASCT), according to evidence presented at the 2023 Lymphoma, Leukemia, and Myeloma Congress.

DLBCL is characterized by the National Institutes of Health as an aggressive malignancy and the most common lymphoma. Research presented at the conference indicated that 60%70% of patients were cured with six to eight cycles of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone (R-CHOP).

courtesy MD Anderson Cancer Center

“In the past, if a relapsed of refractory DLBCL patient couldn’t get a transplant, they were likely headed for palliative care. CAR T-cell therapy is no longer experimental. Not only can we offer it to patients who are ineligible for transplant (and manage the side effects), the treatment has proven to offer better overall survival and cure rates, even in patients who eligible for ASCT,” said presenter Jason Westin, MD, director of the lymphoma clinical research program at the University of Texas MD Anderson Cancer Center, Houston.

The ZUMA-7 phase 3trial among patients with early r/r DLBCL demonstrated the superiority of CAR T-cell therapy with the agent, axicabtagene ciloleucel (YESCARTA, Kita Pharma) versus standard of care (chemoimmunotherapy followed by high-dose chemotherapy and ASCT). Those in the axicabtagene ciloleucel (axi-cel) group had a median progression free survival (PFS) of 14.7 months and an estimated 4-year overall survival (OS) rate of 54.6% compared to 3.7 months and 46% in the control group.

Patients treated with axi-cel experienced a higher rate of adverse events (AE) grade 3 of higher, compared with the ACST group (91% vs. 83%) Furthermore, patients who received axi-cel had cytokine release syndrome (6%) and neurologic events in (21%) grade 3 or higher, compared with 0% and less than 1% in the ASCT group.

At the conference, Dr. Westin’s copanelist Jennifer Amengual, MD, of Columbia University Irving Medical Center, New York, interpreted the data on adverse events (AEs) from ZUMA-7 to mean that if a patient is especially susceptible to CAR T side effects, then ASCT could be preferred. She also outlined a second strategy that shows promise when a patient has either failed CAR T and ASCT or whose frailty demands an approach that avoids AEs.

Dr. Amengual cited a study in which patients with r/r DLBCL were treated with the bispecific antibody glofitamab (Columvi/Roche), which induced a complete response in 39% of patients at a median follow-up of 12.6 months and a 12-month PFS rate of 37%. Those treated with the agent experienced cytokine release syndrome and neurologic events grade 3 or higher, at a rate of 4% and 3% respectively.

“Efforts to make off-the-shelf CAR T therapy are ongoing. With some fine-tuning the PFS and OS with bispecific antibodies will likely approach or exceed both CAR T and ACST. The fact that they could come right off the shelf, rather than having to be tailor made for each patient, gives them a huge advantage in terms of cost and availability, while maintaining what appears to be an excellent safety profile” said Morton Colman, MD, professor of medicine at Weill Cornell Medicine, New York, and chair of the 2023 Lymphoma, Leukemia, and Myeloma Congress.

Dr. Amengual disclosed ties with Astra Zeneca and Incyte. Dr. Westin reported ties with Abbie, ADC therapeutics, AstraZeneca, Bristol-Myers Squibb, Genentech, GenMad, Hanssen, Kite/Gilead, Morphosys/Incyte, Novartis, Nurix, Regeneron, and SeaGen. Dr. Coleman had no disclosures.

NEW YORK – Treated with chimeric antigen receptor (CAR) T-cell therapy, most patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL) achieved better outcomes than those receiving autologous stem cell transplants (ASCT), according to evidence presented at the 2023 Lymphoma, Leukemia, and Myeloma Congress.

DLBCL is characterized by the National Institutes of Health as an aggressive malignancy and the most common lymphoma. Research presented at the conference indicated that 60%70% of patients were cured with six to eight cycles of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone (R-CHOP).

courtesy MD Anderson Cancer Center

“In the past, if a relapsed of refractory DLBCL patient couldn’t get a transplant, they were likely headed for palliative care. CAR T-cell therapy is no longer experimental. Not only can we offer it to patients who are ineligible for transplant (and manage the side effects), the treatment has proven to offer better overall survival and cure rates, even in patients who eligible for ASCT,” said presenter Jason Westin, MD, director of the lymphoma clinical research program at the University of Texas MD Anderson Cancer Center, Houston.

The ZUMA-7 phase 3trial among patients with early r/r DLBCL demonstrated the superiority of CAR T-cell therapy with the agent, axicabtagene ciloleucel (YESCARTA, Kita Pharma) versus standard of care (chemoimmunotherapy followed by high-dose chemotherapy and ASCT). Those in the axicabtagene ciloleucel (axi-cel) group had a median progression free survival (PFS) of 14.7 months and an estimated 4-year overall survival (OS) rate of 54.6% compared to 3.7 months and 46% in the control group.

Patients treated with axi-cel experienced a higher rate of adverse events (AE) grade 3 of higher, compared with the ACST group (91% vs. 83%) Furthermore, patients who received axi-cel had cytokine release syndrome (6%) and neurologic events in (21%) grade 3 or higher, compared with 0% and less than 1% in the ASCT group.

At the conference, Dr. Westin’s copanelist Jennifer Amengual, MD, of Columbia University Irving Medical Center, New York, interpreted the data on adverse events (AEs) from ZUMA-7 to mean that if a patient is especially susceptible to CAR T side effects, then ASCT could be preferred. She also outlined a second strategy that shows promise when a patient has either failed CAR T and ASCT or whose frailty demands an approach that avoids AEs.

Dr. Amengual cited a study in which patients with r/r DLBCL were treated with the bispecific antibody glofitamab (Columvi/Roche), which induced a complete response in 39% of patients at a median follow-up of 12.6 months and a 12-month PFS rate of 37%. Those treated with the agent experienced cytokine release syndrome and neurologic events grade 3 or higher, at a rate of 4% and 3% respectively.

“Efforts to make off-the-shelf CAR T therapy are ongoing. With some fine-tuning the PFS and OS with bispecific antibodies will likely approach or exceed both CAR T and ACST. The fact that they could come right off the shelf, rather than having to be tailor made for each patient, gives them a huge advantage in terms of cost and availability, while maintaining what appears to be an excellent safety profile” said Morton Colman, MD, professor of medicine at Weill Cornell Medicine, New York, and chair of the 2023 Lymphoma, Leukemia, and Myeloma Congress.

Dr. Amengual disclosed ties with Astra Zeneca and Incyte. Dr. Westin reported ties with Abbie, ADC therapeutics, AstraZeneca, Bristol-Myers Squibb, Genentech, GenMad, Hanssen, Kite/Gilead, Morphosys/Incyte, Novartis, Nurix, Regeneron, and SeaGen. Dr. Coleman had no disclosures.

NEW YORK – Treated with chimeric antigen receptor (CAR) T-cell therapy, most patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL) achieved better outcomes than those receiving autologous stem cell transplants (ASCT), according to evidence presented at the 2023 Lymphoma, Leukemia, and Myeloma Congress.

DLBCL is characterized by the National Institutes of Health as an aggressive malignancy and the most common lymphoma. Research presented at the conference indicated that 60%70% of patients were cured with six to eight cycles of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone (R-CHOP).

courtesy MD Anderson Cancer Center

“In the past, if a relapsed of refractory DLBCL patient couldn’t get a transplant, they were likely headed for palliative care. CAR T-cell therapy is no longer experimental. Not only can we offer it to patients who are ineligible for transplant (and manage the side effects), the treatment has proven to offer better overall survival and cure rates, even in patients who eligible for ASCT,” said presenter Jason Westin, MD, director of the lymphoma clinical research program at the University of Texas MD Anderson Cancer Center, Houston.

The ZUMA-7 phase 3trial among patients with early r/r DLBCL demonstrated the superiority of CAR T-cell therapy with the agent, axicabtagene ciloleucel (YESCARTA, Kita Pharma) versus standard of care (chemoimmunotherapy followed by high-dose chemotherapy and ASCT). Those in the axicabtagene ciloleucel (axi-cel) group had a median progression free survival (PFS) of 14.7 months and an estimated 4-year overall survival (OS) rate of 54.6% compared to 3.7 months and 46% in the control group.

Patients treated with axi-cel experienced a higher rate of adverse events (AE) grade 3 of higher, compared with the ACST group (91% vs. 83%) Furthermore, patients who received axi-cel had cytokine release syndrome (6%) and neurologic events in (21%) grade 3 or higher, compared with 0% and less than 1% in the ASCT group.

At the conference, Dr. Westin’s copanelist Jennifer Amengual, MD, of Columbia University Irving Medical Center, New York, interpreted the data on adverse events (AEs) from ZUMA-7 to mean that if a patient is especially susceptible to CAR T side effects, then ASCT could be preferred. She also outlined a second strategy that shows promise when a patient has either failed CAR T and ASCT or whose frailty demands an approach that avoids AEs.

Dr. Amengual cited a study in which patients with r/r DLBCL were treated with the bispecific antibody glofitamab (Columvi/Roche), which induced a complete response in 39% of patients at a median follow-up of 12.6 months and a 12-month PFS rate of 37%. Those treated with the agent experienced cytokine release syndrome and neurologic events grade 3 or higher, at a rate of 4% and 3% respectively.

“Efforts to make off-the-shelf CAR T therapy are ongoing. With some fine-tuning the PFS and OS with bispecific antibodies will likely approach or exceed both CAR T and ACST. The fact that they could come right off the shelf, rather than having to be tailor made for each patient, gives them a huge advantage in terms of cost and availability, while maintaining what appears to be an excellent safety profile” said Morton Colman, MD, professor of medicine at Weill Cornell Medicine, New York, and chair of the 2023 Lymphoma, Leukemia, and Myeloma Congress.

Dr. Amengual disclosed ties with Astra Zeneca and Incyte. Dr. Westin reported ties with Abbie, ADC therapeutics, AstraZeneca, Bristol-Myers Squibb, Genentech, GenMad, Hanssen, Kite/Gilead, Morphosys/Incyte, Novartis, Nurix, Regeneron, and SeaGen. Dr. Coleman had no disclosures.

Dear Friends,

It’s been a year since I have become editor-in-chief of The New Gastroenterologist and I am so grateful for our readers and contributors. Thank you for being a part of the TNG family. This issue highlights topics that may be overwhelming for trainees and early faculty, including the increasing armamentarium of inflammatory bowel disease treatments, taking on leadership roles in diversity, equity, and inclusion, and tackling financial planning.

In this issue’s In Focus, Drs. Ariela K. Holmer, Shannon Chang, and Lisa Malter break down the factors that contribute to selecting therapies for moderate to severe IBD, such as disease activity and severity, extraintestinal manifestations, safety, prior anti–tumor necrosis factor exposure, perianal disease, and patient preference.

Drs. Michael G. Rubeiz, Kemmian D. Johnson, and Juan Reyes Genere continue our journey with IBD in the Short Clinical Review section, describing advances in endoscopic therapies in IBD. They review the resection of colitis dysplasia and management of luminal strictures with dilation and stricturotomy.

Early-career faculty are being requested to spearhead diversity, equity, and inclusion (DEI) efforts at their institutions or for their groups. Drs. Cassandra D.L. Fritz and Nicolette Juliana Rodriguez highlight important aspects that should be considered prior to taking on DEI roles.

In the Finance section, Dr. Animesh Jain answers five common questions for young gastroenterologists. He addresses student loans, disability insurance, life insurance, retirement, and buying a first house.

If you are interested in contributing or have ideas for future TNG topics, please contact me ([email protected]), or Jillian Schweitzer ([email protected]), managing editor of TNG.

Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: The first biologic therapy for IBD, infliximab, was only approved 25 years ago in 1998.

Yours truly,

Judy A Trieu, MD, MPH
Editor-in-Chief
Interventional Endoscopy, Division of Gastroenterology
Washington University in St. Louis

Dear Friends,

It’s been a year since I have become editor-in-chief of The New Gastroenterologist and I am so grateful for our readers and contributors. Thank you for being a part of the TNG family. This issue highlights topics that may be overwhelming for trainees and early faculty, including the increasing armamentarium of inflammatory bowel disease treatments, taking on leadership roles in diversity, equity, and inclusion, and tackling financial planning.

In this issue’s In Focus, Drs. Ariela K. Holmer, Shannon Chang, and Lisa Malter break down the factors that contribute to selecting therapies for moderate to severe IBD, such as disease activity and severity, extraintestinal manifestations, safety, prior anti–tumor necrosis factor exposure, perianal disease, and patient preference.

Drs. Michael G. Rubeiz, Kemmian D. Johnson, and Juan Reyes Genere continue our journey with IBD in the Short Clinical Review section, describing advances in endoscopic therapies in IBD. They review the resection of colitis dysplasia and management of luminal strictures with dilation and stricturotomy.

Early-career faculty are being requested to spearhead diversity, equity, and inclusion (DEI) efforts at their institutions or for their groups. Drs. Cassandra D.L. Fritz and Nicolette Juliana Rodriguez highlight important aspects that should be considered prior to taking on DEI roles.

In the Finance section, Dr. Animesh Jain answers five common questions for young gastroenterologists. He addresses student loans, disability insurance, life insurance, retirement, and buying a first house.

If you are interested in contributing or have ideas for future TNG topics, please contact me ([email protected]), or Jillian Schweitzer ([email protected]), managing editor of TNG.

Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: The first biologic therapy for IBD, infliximab, was only approved 25 years ago in 1998.

Yours truly,

Judy A Trieu, MD, MPH
Editor-in-Chief
Interventional Endoscopy, Division of Gastroenterology
Washington University in St. Louis

Dear Friends,

It’s been a year since I have become editor-in-chief of The New Gastroenterologist and I am so grateful for our readers and contributors. Thank you for being a part of the TNG family. This issue highlights topics that may be overwhelming for trainees and early faculty, including the increasing armamentarium of inflammatory bowel disease treatments, taking on leadership roles in diversity, equity, and inclusion, and tackling financial planning.

In this issue’s In Focus, Drs. Ariela K. Holmer, Shannon Chang, and Lisa Malter break down the factors that contribute to selecting therapies for moderate to severe IBD, such as disease activity and severity, extraintestinal manifestations, safety, prior anti–tumor necrosis factor exposure, perianal disease, and patient preference.

Drs. Michael G. Rubeiz, Kemmian D. Johnson, and Juan Reyes Genere continue our journey with IBD in the Short Clinical Review section, describing advances in endoscopic therapies in IBD. They review the resection of colitis dysplasia and management of luminal strictures with dilation and stricturotomy.

Early-career faculty are being requested to spearhead diversity, equity, and inclusion (DEI) efforts at their institutions or for their groups. Drs. Cassandra D.L. Fritz and Nicolette Juliana Rodriguez highlight important aspects that should be considered prior to taking on DEI roles.

In the Finance section, Dr. Animesh Jain answers five common questions for young gastroenterologists. He addresses student loans, disability insurance, life insurance, retirement, and buying a first house.

If you are interested in contributing or have ideas for future TNG topics, please contact me ([email protected]), or Jillian Schweitzer ([email protected]), managing editor of TNG.

Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: The first biologic therapy for IBD, infliximab, was only approved 25 years ago in 1998.

Yours truly,

Judy A Trieu, MD, MPH
Editor-in-Chief
Interventional Endoscopy, Division of Gastroenterology
Washington University in St. Louis

Are you a gastroenterology fellow settling into a new role and wondering what else you can do to make the most of your fellowship experience? The AGA Gastro Squad is excited you’re here and we’re here to help.

AGA has resources and programs specifically for fellows. Whether you’re embarking on your first year or your last one, these tools can be used at any point to help you during your training.

Start here:

Review and bookmark these guides to make the most out of fellowship.

10 tips for new GI fellows

First year fellows guide
 

Small talk, big topics

A podcast for trainees and early career GIs from fellow early career GIs. Join our hosts for conversations with leaders in gastroenterology. They offer guidance for training and dissect the changing landscape of GI and what it means for you. Check out recent episodes and download and subscribe wherever podcasts are available.

AGA university

Get your clinical questions answered or take a deeper dive into different topic areas with AGA University. Courses include Gastro Bites sessions about topics such as examining new guideline recommendations for managing chronic idiopathic constipation in adults. CME is available. Access AGA University here.

AGA young delegates program

Get plugged in with your fellow engaged early career GIs and learn about volunteer opportunities to represent AGA. The only criteria to participate is to be an AGA member. Join now.

Get more advice

Interested in receiving additional career guidance or professional development opportunities? Connect with the AGA Gastro Squad at @AmerGastroAssn on X and on Instagram.

Are you a gastroenterology fellow settling into a new role and wondering what else you can do to make the most of your fellowship experience? The AGA Gastro Squad is excited you’re here and we’re here to help.

AGA has resources and programs specifically for fellows. Whether you’re embarking on your first year or your last one, these tools can be used at any point to help you during your training.

Start here:

Review and bookmark these guides to make the most out of fellowship.

10 tips for new GI fellows

First year fellows guide
 

Small talk, big topics

A podcast for trainees and early career GIs from fellow early career GIs. Join our hosts for conversations with leaders in gastroenterology. They offer guidance for training and dissect the changing landscape of GI and what it means for you. Check out recent episodes and download and subscribe wherever podcasts are available.

AGA university

Get your clinical questions answered or take a deeper dive into different topic areas with AGA University. Courses include Gastro Bites sessions about topics such as examining new guideline recommendations for managing chronic idiopathic constipation in adults. CME is available. Access AGA University here.

AGA young delegates program

Get plugged in with your fellow engaged early career GIs and learn about volunteer opportunities to represent AGA. The only criteria to participate is to be an AGA member. Join now.

Get more advice

Interested in receiving additional career guidance or professional development opportunities? Connect with the AGA Gastro Squad at @AmerGastroAssn on X and on Instagram.

Are you a gastroenterology fellow settling into a new role and wondering what else you can do to make the most of your fellowship experience? The AGA Gastro Squad is excited you’re here and we’re here to help.

AGA has resources and programs specifically for fellows. Whether you’re embarking on your first year or your last one, these tools can be used at any point to help you during your training.

Start here:

Review and bookmark these guides to make the most out of fellowship.

10 tips for new GI fellows

First year fellows guide
 

Small talk, big topics

A podcast for trainees and early career GIs from fellow early career GIs. Join our hosts for conversations with leaders in gastroenterology. They offer guidance for training and dissect the changing landscape of GI and what it means for you. Check out recent episodes and download and subscribe wherever podcasts are available.

AGA university

Get your clinical questions answered or take a deeper dive into different topic areas with AGA University. Courses include Gastro Bites sessions about topics such as examining new guideline recommendations for managing chronic idiopathic constipation in adults. CME is available. Access AGA University here.

AGA young delegates program

Get plugged in with your fellow engaged early career GIs and learn about volunteer opportunities to represent AGA. The only criteria to participate is to be an AGA member. Join now.

Get more advice

Interested in receiving additional career guidance or professional development opportunities? Connect with the AGA Gastro Squad at @AmerGastroAssn on X and on Instagram.

The Fostering Opportunities Resulting in Workforce and Research Diversity (FORWARD) Program is now accepting applications for its 2023-2025 cohort. The FORWARD program supports and facilitates a unique pathway for physician-scientists from underrepresented populations to advance their careers and make a meaningful impact as leaders within AGA and in academic medicine. Here’s how the AGA FORWARD program creates a supportive environment that fosters career advancement, leadership development and a growing community:

• Learn important skills critical for a successful research career, expert grant writing training and coaching from esteemed GI mentors.
• Connect with a community of GI leaders through one-on-one mentorship and near-peer mentors in medicine from underrepresented populations.
• Develop leadership skills vital to directing your lab, your institution, the field, and AGA, partnering with an executive coach to assess, identify and work on key strengths and areas of improvement.

Embark on a transformative journey toward a successful and fulfilling career in academic medicine.

Apply today.

The Fostering Opportunities Resulting in Workforce and Research Diversity (FORWARD) Program is now accepting applications for its 2023-2025 cohort. The FORWARD program supports and facilitates a unique pathway for physician-scientists from underrepresented populations to advance their careers and make a meaningful impact as leaders within AGA and in academic medicine. Here’s how the AGA FORWARD program creates a supportive environment that fosters career advancement, leadership development and a growing community:

• Learn important skills critical for a successful research career, expert grant writing training and coaching from esteemed GI mentors.
• Connect with a community of GI leaders through one-on-one mentorship and near-peer mentors in medicine from underrepresented populations.
• Develop leadership skills vital to directing your lab, your institution, the field, and AGA, partnering with an executive coach to assess, identify and work on key strengths and areas of improvement.

Embark on a transformative journey toward a successful and fulfilling career in academic medicine.

Apply today.

The Fostering Opportunities Resulting in Workforce and Research Diversity (FORWARD) Program is now accepting applications for its 2023-2025 cohort. The FORWARD program supports and facilitates a unique pathway for physician-scientists from underrepresented populations to advance their careers and make a meaningful impact as leaders within AGA and in academic medicine. Here’s how the AGA FORWARD program creates a supportive environment that fosters career advancement, leadership development and a growing community:

• Learn important skills critical for a successful research career, expert grant writing training and coaching from esteemed GI mentors.
• Connect with a community of GI leaders through one-on-one mentorship and near-peer mentors in medicine from underrepresented populations.
• Develop leadership skills vital to directing your lab, your institution, the field, and AGA, partnering with an executive coach to assess, identify and work on key strengths and areas of improvement.

Embark on a transformative journey toward a successful and fulfilling career in academic medicine.

Apply today.

Lawrence Faucette, the 58-year-old man with terminal heart disease who received the world’s second genetically modified pig heart transplant, died on Oct. 30, 2023, the University of Maryland Medical Center (UMMC), Baltimore, reported in a statement.

Mr. Faucette, a former lab tech who was turned down repeatedly for a standard allograft transplantation because of his various medical conditions, received the pig heart transplant on Sept. 20, 2023.

He first came to UMMC as a patient on Sept. 14. When he was admitted, he was in end-stage heart failure. Shortly before the surgery, his heart stopped, and he required resuscitation.

On Sept. 15, the Food and Drug Administration granted an emergency authorization for the surgery through its single-patient investigational new drug compassionate use pathway. 

“My only real hope left is to go with the pig heart, the xenotransplant,” Mr. Faucette said in an interview from his hospital room a few days before his surgery. “At least now I have hope, and I have a chance.” He made “significant progress” in the month after the surgery, participating in physical therapy and spending time with family, according to the university. But in the days before his death, the heart showed signs of rejection.

“Mr. Faucette’s last wish was for us to make the most of what we have learned from our experience, so others may be guaranteed a chance for a new heart when a human organ is unavailable,” said Bartley P. Griffith, MD, who transplanted the pig heart into Mr. Faucette at UMMC. “He then told the team of doctors and nurses who gathered around him that he loved us. We will miss him tremendously.”

Muhammad M. Mohiuddin, MD, professor of surgery and scientific/program director of the Cardiac Xenotransplantation Program at the University of Maryland School of Medicine, said that “Mr. Faucette was a scientist who not only read and interpreted his own biopsies, but who understood the important contribution he was making in advancing the field.

“As with the first patient, David Bennett Sr., we intend to conduct an extensive analysis to identify factors that can be prevented in future transplants; this will allow us to continue to move forward and educate our colleagues in the field on our experience,” Dr. Mohiuddin added.

The researchers don’t plan to make further comments until their investigation is complete, a university spokesperson said in an interview.

UMMC performed the first transplant of a genetically modified pig heart in January 2022. Mr. Bennett, the recipient of that heart, survived for 60 days. The researchers published their initial findings in The New England Journal of Medicine, and then the results of their follow-up investigation in The Lancet.
 

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

Lawrence Faucette, the 58-year-old man with terminal heart disease who received the world’s second genetically modified pig heart transplant, died on Oct. 30, 2023, the University of Maryland Medical Center (UMMC), Baltimore, reported in a statement.

Mr. Faucette, a former lab tech who was turned down repeatedly for a standard allograft transplantation because of his various medical conditions, received the pig heart transplant on Sept. 20, 2023.

He first came to UMMC as a patient on Sept. 14. When he was admitted, he was in end-stage heart failure. Shortly before the surgery, his heart stopped, and he required resuscitation.

On Sept. 15, the Food and Drug Administration granted an emergency authorization for the surgery through its single-patient investigational new drug compassionate use pathway. 

“My only real hope left is to go with the pig heart, the xenotransplant,” Mr. Faucette said in an interview from his hospital room a few days before his surgery. “At least now I have hope, and I have a chance.” He made “significant progress” in the month after the surgery, participating in physical therapy and spending time with family, according to the university. But in the days before his death, the heart showed signs of rejection.

“Mr. Faucette’s last wish was for us to make the most of what we have learned from our experience, so others may be guaranteed a chance for a new heart when a human organ is unavailable,” said Bartley P. Griffith, MD, who transplanted the pig heart into Mr. Faucette at UMMC. “He then told the team of doctors and nurses who gathered around him that he loved us. We will miss him tremendously.”

Muhammad M. Mohiuddin, MD, professor of surgery and scientific/program director of the Cardiac Xenotransplantation Program at the University of Maryland School of Medicine, said that “Mr. Faucette was a scientist who not only read and interpreted his own biopsies, but who understood the important contribution he was making in advancing the field.

“As with the first patient, David Bennett Sr., we intend to conduct an extensive analysis to identify factors that can be prevented in future transplants; this will allow us to continue to move forward and educate our colleagues in the field on our experience,” Dr. Mohiuddin added.

The researchers don’t plan to make further comments until their investigation is complete, a university spokesperson said in an interview.

UMMC performed the first transplant of a genetically modified pig heart in January 2022. Mr. Bennett, the recipient of that heart, survived for 60 days. The researchers published their initial findings in The New England Journal of Medicine, and then the results of their follow-up investigation in The Lancet.
 

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

Lawrence Faucette, the 58-year-old man with terminal heart disease who received the world’s second genetically modified pig heart transplant, died on Oct. 30, 2023, the University of Maryland Medical Center (UMMC), Baltimore, reported in a statement.

Mr. Faucette, a former lab tech who was turned down repeatedly for a standard allograft transplantation because of his various medical conditions, received the pig heart transplant on Sept. 20, 2023.

He first came to UMMC as a patient on Sept. 14. When he was admitted, he was in end-stage heart failure. Shortly before the surgery, his heart stopped, and he required resuscitation.

On Sept. 15, the Food and Drug Administration granted an emergency authorization for the surgery through its single-patient investigational new drug compassionate use pathway. 

“My only real hope left is to go with the pig heart, the xenotransplant,” Mr. Faucette said in an interview from his hospital room a few days before his surgery. “At least now I have hope, and I have a chance.” He made “significant progress” in the month after the surgery, participating in physical therapy and spending time with family, according to the university. But in the days before his death, the heart showed signs of rejection.

“Mr. Faucette’s last wish was for us to make the most of what we have learned from our experience, so others may be guaranteed a chance for a new heart when a human organ is unavailable,” said Bartley P. Griffith, MD, who transplanted the pig heart into Mr. Faucette at UMMC. “He then told the team of doctors and nurses who gathered around him that he loved us. We will miss him tremendously.”

Muhammad M. Mohiuddin, MD, professor of surgery and scientific/program director of the Cardiac Xenotransplantation Program at the University of Maryland School of Medicine, said that “Mr. Faucette was a scientist who not only read and interpreted his own biopsies, but who understood the important contribution he was making in advancing the field.

“As with the first patient, David Bennett Sr., we intend to conduct an extensive analysis to identify factors that can be prevented in future transplants; this will allow us to continue to move forward and educate our colleagues in the field on our experience,” Dr. Mohiuddin added.

The researchers don’t plan to make further comments until their investigation is complete, a university spokesperson said in an interview.

UMMC performed the first transplant of a genetically modified pig heart in January 2022. Mr. Bennett, the recipient of that heart, survived for 60 days. The researchers published their initial findings in The New England Journal of Medicine, and then the results of their follow-up investigation in The Lancet.
 

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

Roughly 2% of prescriptions to older patients appear to be inappropriate – but the figure does not appear to differ between physicians and nurse practitioners, according to a study published in Annals of Internal Medicine.

Older adults are “especially vulnerable to adverse drug events from inappropriate prescribing due to comorbidities and aging-related physiological changes,” said Johnny Huynh, MA, doctoral candidate in economics at UCLA and lead author of the study. “Considering the volume of prescriptions for older adults, even a small percentage can translate to a big impact on adverse drug events and spending.”

In recent years, more states have granted prescriptive authority to NPs, while professional medical organizations have opposed the reforms and made claims about differences in quality of care.

The medical community must focus on the prescribing performance of individual clinicians rather than whether an NP has prescriptive authority, said David Studdert, LLB, ScD, MPH, professor of health policy at Stanford (Calif.) University and a co-author of the study.

“Don’t fixate on whether nurse practitioners have prescriptive authority or don’t,” said Mr. Studdert. “Just try to identify those practitioners who need to boost their performance.”

The investigators found that rates of potentially inappropriate prescribing were “virtually identical.” Adjusted rates were 1.66 per 100 prescriptions for NPs versus 1.68 per 100 prescriptions for physicians (adjusted odds ratio, 0.99; 95% confidence interval, 0.97-1.01).

“Older adults often have more than one chronic condition and are prescribed multiple medications to manage these conditions, putting them at risk for adverse events,” said Paula Rochon, MD, MPH, founding director of the Women’s Age Lab and professor in the Division of Geriatric Medicine at Dalla Lana School of Public Health in Toronto. “Furthermore, older women are more likely than men to have multiple medical problems and experience adverse drug events.”

Dr. Rochon led a 2021 research review on polypharmacy and inappropriate prescribing among older adults in both the United States and abroad. She and her team noted that while women are physiologically more susceptible to drug-related harm, rates of inappropriate prescribing also tend to be higher for women, such as in the case of senior U.S. veterans and older adults in Canada. 

The researchers analyzed data over a 7-year period starting in 2013 from 23,669 primary care NPs and 50,060 physicians who wrote prescriptions for at least 100 patients with Medicare Part D coverage. Data from 29 states, which had all expanded prescriptive authority to NPs, was included. 

Prescriptive quality was defined by the American Geriatrics Society’s Beers Criteria, a list of potentially inappropriate medications (PIMs) for adults ages 65 and over. Mr. Studdert said it’s important to note the nuance in the Beers Criteria.

“It’s not to say that there may not be certain clinical circumstances where it’s appropriate to” prescribe these drugs, Mr. Studdert said,  “But generally, it’s not appropriate.”

Ten medications accounted for 99.5% of the PIMs prescribed, including drugs that were antidepressants, muscle relaxants, hypnotics, antihistamines (generation 1), antispasmodics, sulfonylureas, barbiturates, antineoplastics, thyroid medications, and nonsteroidal anti-inflammatory drugs.

The top three most frequently potentially inappropriately prescribed were antidepressants (0.393 NPs vs. 0.481 PCPs per 100 prescriptions), muscle relaxants (0.372 NPs vs. 0.305 PCPs per 100), and hypnotics (0.364 NPs vs. 0.440 PCPs per 100). Both antidepressants and hypnotics are associated with an increased risk for falls and fractures among older adults, while muscle relaxants have been shown to increase the risk for hospitalization in this population. 

Despite the overall similar PIM rates, NPs were more present in the “tails,” or highest and lowest end of the quality bell curve. The higher variation among NPs means these patients are at a higher risk of receiving a prescription for an inappropriate medication, said David Chan, MD, PhD, associate professor of health policy at Stanford (Calif.) School of Medicine, and a co-author of the study.

Other studies have shown “high-intensity prescribers” were more likely to dispense drugs like benzodiazepines and opioids, which can be harmful to older patients.

According to Dr. Rochon, clinicians should use the Beers Criteria and STOPP/START Criteria to guide decision-making, along with the DRUGS framework, which follows a geriatric medicine approach that advises clinicians to discuss goals of care with their patients and conduct routine reviews of medications. 

Prescribers should also avoid prescribing cascades, which “occur when a drug is prescribed, an adverse event occurs that is misinterpreted as a new medical condition, and a further drug is prescribed to treat that medical condition,” Dr. Rochon said. 

To reduce cascades, “it’s important to document when a medication was started, why it was started, and who started it so that this information is available when evaluating if a medication continues to be needed,” she said. 

The study was funded by grants from Robert Wood Johnson Foundation and National Science Foundation. The authors report no relevant financial relationships.

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

Roughly 2% of prescriptions to older patients appear to be inappropriate – but the figure does not appear to differ between physicians and nurse practitioners, according to a study published in Annals of Internal Medicine.

Older adults are “especially vulnerable to adverse drug events from inappropriate prescribing due to comorbidities and aging-related physiological changes,” said Johnny Huynh, MA, doctoral candidate in economics at UCLA and lead author of the study. “Considering the volume of prescriptions for older adults, even a small percentage can translate to a big impact on adverse drug events and spending.”

In recent years, more states have granted prescriptive authority to NPs, while professional medical organizations have opposed the reforms and made claims about differences in quality of care.

The medical community must focus on the prescribing performance of individual clinicians rather than whether an NP has prescriptive authority, said David Studdert, LLB, ScD, MPH, professor of health policy at Stanford (Calif.) University and a co-author of the study.

“Don’t fixate on whether nurse practitioners have prescriptive authority or don’t,” said Mr. Studdert. “Just try to identify those practitioners who need to boost their performance.”

The investigators found that rates of potentially inappropriate prescribing were “virtually identical.” Adjusted rates were 1.66 per 100 prescriptions for NPs versus 1.68 per 100 prescriptions for physicians (adjusted odds ratio, 0.99; 95% confidence interval, 0.97-1.01).

“Older adults often have more than one chronic condition and are prescribed multiple medications to manage these conditions, putting them at risk for adverse events,” said Paula Rochon, MD, MPH, founding director of the Women’s Age Lab and professor in the Division of Geriatric Medicine at Dalla Lana School of Public Health in Toronto. “Furthermore, older women are more likely than men to have multiple medical problems and experience adverse drug events.”

Dr. Rochon led a 2021 research review on polypharmacy and inappropriate prescribing among older adults in both the United States and abroad. She and her team noted that while women are physiologically more susceptible to drug-related harm, rates of inappropriate prescribing also tend to be higher for women, such as in the case of senior U.S. veterans and older adults in Canada. 

The researchers analyzed data over a 7-year period starting in 2013 from 23,669 primary care NPs and 50,060 physicians who wrote prescriptions for at least 100 patients with Medicare Part D coverage. Data from 29 states, which had all expanded prescriptive authority to NPs, was included. 

Prescriptive quality was defined by the American Geriatrics Society’s Beers Criteria, a list of potentially inappropriate medications (PIMs) for adults ages 65 and over. Mr. Studdert said it’s important to note the nuance in the Beers Criteria.

“It’s not to say that there may not be certain clinical circumstances where it’s appropriate to” prescribe these drugs, Mr. Studdert said,  “But generally, it’s not appropriate.”

Ten medications accounted for 99.5% of the PIMs prescribed, including drugs that were antidepressants, muscle relaxants, hypnotics, antihistamines (generation 1), antispasmodics, sulfonylureas, barbiturates, antineoplastics, thyroid medications, and nonsteroidal anti-inflammatory drugs.

The top three most frequently potentially inappropriately prescribed were antidepressants (0.393 NPs vs. 0.481 PCPs per 100 prescriptions), muscle relaxants (0.372 NPs vs. 0.305 PCPs per 100), and hypnotics (0.364 NPs vs. 0.440 PCPs per 100). Both antidepressants and hypnotics are associated with an increased risk for falls and fractures among older adults, while muscle relaxants have been shown to increase the risk for hospitalization in this population. 

Despite the overall similar PIM rates, NPs were more present in the “tails,” or highest and lowest end of the quality bell curve. The higher variation among NPs means these patients are at a higher risk of receiving a prescription for an inappropriate medication, said David Chan, MD, PhD, associate professor of health policy at Stanford (Calif.) School of Medicine, and a co-author of the study.

Other studies have shown “high-intensity prescribers” were more likely to dispense drugs like benzodiazepines and opioids, which can be harmful to older patients.

According to Dr. Rochon, clinicians should use the Beers Criteria and STOPP/START Criteria to guide decision-making, along with the DRUGS framework, which follows a geriatric medicine approach that advises clinicians to discuss goals of care with their patients and conduct routine reviews of medications. 

Prescribers should also avoid prescribing cascades, which “occur when a drug is prescribed, an adverse event occurs that is misinterpreted as a new medical condition, and a further drug is prescribed to treat that medical condition,” Dr. Rochon said. 

To reduce cascades, “it’s important to document when a medication was started, why it was started, and who started it so that this information is available when evaluating if a medication continues to be needed,” she said. 

The study was funded by grants from Robert Wood Johnson Foundation and National Science Foundation. The authors report no relevant financial relationships.

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

Roughly 2% of prescriptions to older patients appear to be inappropriate – but the figure does not appear to differ between physicians and nurse practitioners, according to a study published in Annals of Internal Medicine.

Older adults are “especially vulnerable to adverse drug events from inappropriate prescribing due to comorbidities and aging-related physiological changes,” said Johnny Huynh, MA, doctoral candidate in economics at UCLA and lead author of the study. “Considering the volume of prescriptions for older adults, even a small percentage can translate to a big impact on adverse drug events and spending.”

In recent years, more states have granted prescriptive authority to NPs, while professional medical organizations have opposed the reforms and made claims about differences in quality of care.

The medical community must focus on the prescribing performance of individual clinicians rather than whether an NP has prescriptive authority, said David Studdert, LLB, ScD, MPH, professor of health policy at Stanford (Calif.) University and a co-author of the study.

“Don’t fixate on whether nurse practitioners have prescriptive authority or don’t,” said Mr. Studdert. “Just try to identify those practitioners who need to boost their performance.”

The investigators found that rates of potentially inappropriate prescribing were “virtually identical.” Adjusted rates were 1.66 per 100 prescriptions for NPs versus 1.68 per 100 prescriptions for physicians (adjusted odds ratio, 0.99; 95% confidence interval, 0.97-1.01).

“Older adults often have more than one chronic condition and are prescribed multiple medications to manage these conditions, putting them at risk for adverse events,” said Paula Rochon, MD, MPH, founding director of the Women’s Age Lab and professor in the Division of Geriatric Medicine at Dalla Lana School of Public Health in Toronto. “Furthermore, older women are more likely than men to have multiple medical problems and experience adverse drug events.”

Dr. Rochon led a 2021 research review on polypharmacy and inappropriate prescribing among older adults in both the United States and abroad. She and her team noted that while women are physiologically more susceptible to drug-related harm, rates of inappropriate prescribing also tend to be higher for women, such as in the case of senior U.S. veterans and older adults in Canada. 

The researchers analyzed data over a 7-year period starting in 2013 from 23,669 primary care NPs and 50,060 physicians who wrote prescriptions for at least 100 patients with Medicare Part D coverage. Data from 29 states, which had all expanded prescriptive authority to NPs, was included. 

Prescriptive quality was defined by the American Geriatrics Society’s Beers Criteria, a list of potentially inappropriate medications (PIMs) for adults ages 65 and over. Mr. Studdert said it’s important to note the nuance in the Beers Criteria.

“It’s not to say that there may not be certain clinical circumstances where it’s appropriate to” prescribe these drugs, Mr. Studdert said,  “But generally, it’s not appropriate.”

Ten medications accounted for 99.5% of the PIMs prescribed, including drugs that were antidepressants, muscle relaxants, hypnotics, antihistamines (generation 1), antispasmodics, sulfonylureas, barbiturates, antineoplastics, thyroid medications, and nonsteroidal anti-inflammatory drugs.

The top three most frequently potentially inappropriately prescribed were antidepressants (0.393 NPs vs. 0.481 PCPs per 100 prescriptions), muscle relaxants (0.372 NPs vs. 0.305 PCPs per 100), and hypnotics (0.364 NPs vs. 0.440 PCPs per 100). Both antidepressants and hypnotics are associated with an increased risk for falls and fractures among older adults, while muscle relaxants have been shown to increase the risk for hospitalization in this population. 

Despite the overall similar PIM rates, NPs were more present in the “tails,” or highest and lowest end of the quality bell curve. The higher variation among NPs means these patients are at a higher risk of receiving a prescription for an inappropriate medication, said David Chan, MD, PhD, associate professor of health policy at Stanford (Calif.) School of Medicine, and a co-author of the study.

Other studies have shown “high-intensity prescribers” were more likely to dispense drugs like benzodiazepines and opioids, which can be harmful to older patients.

According to Dr. Rochon, clinicians should use the Beers Criteria and STOPP/START Criteria to guide decision-making, along with the DRUGS framework, which follows a geriatric medicine approach that advises clinicians to discuss goals of care with their patients and conduct routine reviews of medications. 

Prescribers should also avoid prescribing cascades, which “occur when a drug is prescribed, an adverse event occurs that is misinterpreted as a new medical condition, and a further drug is prescribed to treat that medical condition,” Dr. Rochon said. 

To reduce cascades, “it’s important to document when a medication was started, why it was started, and who started it so that this information is available when evaluating if a medication continues to be needed,” she said. 

The study was funded by grants from Robert Wood Johnson Foundation and National Science Foundation. The authors report no relevant financial relationships.

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

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.