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Antibiotic awareness tops ID agenda
Antibiotic resistance is “one of the greatest problems we face,” according to Jennifer A. Hanrahan, DO, MSc, of MetroHealth Medical Center in Cleveland. Dr. Hanrahan led the education session, “A Bug’s Life: Infectious Disease Pearls,” and she called the topic “timely and timeless.”
Antibiotic resistance stems from several problems, Dr. Hanrahan said in her Monday presentation. “One of these is overuse of antibiotics, specifically overuse of broad-spectrum antibiotics, and the other problem is overuse of testing.”
Data from the Centers for Disease Control and Prevention show that at least 2 million people in the United States develop antibiotic-resistant bacterial infections each year. At least 23,000 of these patients die each year because of these infections.
In 2013, the CDC published a report on drug-resistant threats in the United States. The three offenders deemed most serious – Clostridium difficile, Carbapenem-resistant Enterobacteriaceae, and Neisseria gonorrhoeae, continue to challenge clinicians.
Clinicians can help curb antibiotic resistance by practicing good stewardship, said Dr. Hanrahan. “Antimicrobial stewardship and laboratory stewardship are two things that can greatly improve patient care and outcomes for patients,” she said.
“Testing stewardship means ordering tests that are necessary based on signs and symptoms,” said Dr. Hanrahan. “For example, people often order urine cultures when there are no symptoms of urinary tract infection, and then end up treating positive cultures with antibiotics even when there are no symptoms of infection. This leads to unnecessary antibiotic exposure,” she noted.
The CDC’s core plans to fight antimicrobial resistance include:
- Preventing infections in the first place: The CDC emphasizes the importance of prevention through hand washing, safe food handling practices, and immunizations.
- Tracking data: The CDC collects and uses data on resistant infections to identify risk factors for resistance and develop strategies to prevent the spread of resistant bacteria.
- Practicing antibiotic stewardship: As Dr. Hanrahan noted, judicious use of antibiotics can help cut down on resistant bacteria.
- Developing alternatives: The CDC supports the development of new antibiotics and new tests to track antibacterial resistance.
Dr. Hanrahan discussed the Top 10 things hospitalists can do to improve lab testing and antimicrobial use.
“Hospitalists must recognize the need to decrease antibiotic use, utilize laboratory testing appropriately, and improve patient safety,” she said.
“There are a wide range of resources available on the Internet that can help you delve further into this topic and to find the appropriate balance for testing and treatment,” Dr. Hanrahan concluded.
Antibiotic resistance is “one of the greatest problems we face,” according to Jennifer A. Hanrahan, DO, MSc, of MetroHealth Medical Center in Cleveland. Dr. Hanrahan led the education session, “A Bug’s Life: Infectious Disease Pearls,” and she called the topic “timely and timeless.”
Antibiotic resistance stems from several problems, Dr. Hanrahan said in her Monday presentation. “One of these is overuse of antibiotics, specifically overuse of broad-spectrum antibiotics, and the other problem is overuse of testing.”
Data from the Centers for Disease Control and Prevention show that at least 2 million people in the United States develop antibiotic-resistant bacterial infections each year. At least 23,000 of these patients die each year because of these infections.
In 2013, the CDC published a report on drug-resistant threats in the United States. The three offenders deemed most serious – Clostridium difficile, Carbapenem-resistant Enterobacteriaceae, and Neisseria gonorrhoeae, continue to challenge clinicians.
Clinicians can help curb antibiotic resistance by practicing good stewardship, said Dr. Hanrahan. “Antimicrobial stewardship and laboratory stewardship are two things that can greatly improve patient care and outcomes for patients,” she said.
“Testing stewardship means ordering tests that are necessary based on signs and symptoms,” said Dr. Hanrahan. “For example, people often order urine cultures when there are no symptoms of urinary tract infection, and then end up treating positive cultures with antibiotics even when there are no symptoms of infection. This leads to unnecessary antibiotic exposure,” she noted.
The CDC’s core plans to fight antimicrobial resistance include:
- Preventing infections in the first place: The CDC emphasizes the importance of prevention through hand washing, safe food handling practices, and immunizations.
- Tracking data: The CDC collects and uses data on resistant infections to identify risk factors for resistance and develop strategies to prevent the spread of resistant bacteria.
- Practicing antibiotic stewardship: As Dr. Hanrahan noted, judicious use of antibiotics can help cut down on resistant bacteria.
- Developing alternatives: The CDC supports the development of new antibiotics and new tests to track antibacterial resistance.
Dr. Hanrahan discussed the Top 10 things hospitalists can do to improve lab testing and antimicrobial use.
“Hospitalists must recognize the need to decrease antibiotic use, utilize laboratory testing appropriately, and improve patient safety,” she said.
“There are a wide range of resources available on the Internet that can help you delve further into this topic and to find the appropriate balance for testing and treatment,” Dr. Hanrahan concluded.
Antibiotic resistance is “one of the greatest problems we face,” according to Jennifer A. Hanrahan, DO, MSc, of MetroHealth Medical Center in Cleveland. Dr. Hanrahan led the education session, “A Bug’s Life: Infectious Disease Pearls,” and she called the topic “timely and timeless.”
Antibiotic resistance stems from several problems, Dr. Hanrahan said in her Monday presentation. “One of these is overuse of antibiotics, specifically overuse of broad-spectrum antibiotics, and the other problem is overuse of testing.”
Data from the Centers for Disease Control and Prevention show that at least 2 million people in the United States develop antibiotic-resistant bacterial infections each year. At least 23,000 of these patients die each year because of these infections.
In 2013, the CDC published a report on drug-resistant threats in the United States. The three offenders deemed most serious – Clostridium difficile, Carbapenem-resistant Enterobacteriaceae, and Neisseria gonorrhoeae, continue to challenge clinicians.
Clinicians can help curb antibiotic resistance by practicing good stewardship, said Dr. Hanrahan. “Antimicrobial stewardship and laboratory stewardship are two things that can greatly improve patient care and outcomes for patients,” she said.
“Testing stewardship means ordering tests that are necessary based on signs and symptoms,” said Dr. Hanrahan. “For example, people often order urine cultures when there are no symptoms of urinary tract infection, and then end up treating positive cultures with antibiotics even when there are no symptoms of infection. This leads to unnecessary antibiotic exposure,” she noted.
The CDC’s core plans to fight antimicrobial resistance include:
- Preventing infections in the first place: The CDC emphasizes the importance of prevention through hand washing, safe food handling practices, and immunizations.
- Tracking data: The CDC collects and uses data on resistant infections to identify risk factors for resistance and develop strategies to prevent the spread of resistant bacteria.
- Practicing antibiotic stewardship: As Dr. Hanrahan noted, judicious use of antibiotics can help cut down on resistant bacteria.
- Developing alternatives: The CDC supports the development of new antibiotics and new tests to track antibacterial resistance.
Dr. Hanrahan discussed the Top 10 things hospitalists can do to improve lab testing and antimicrobial use.
“Hospitalists must recognize the need to decrease antibiotic use, utilize laboratory testing appropriately, and improve patient safety,” she said.
“There are a wide range of resources available on the Internet that can help you delve further into this topic and to find the appropriate balance for testing and treatment,” Dr. Hanrahan concluded.
Myriad career options for hospitalists
The “Hospitalist Career Options” education session provided future and early-career hospitalists with information about the diversity of potential career tracks within hospital medicine.
“There are so many different things that people do and that’s what so amazing about hospital medicine,” said Dennis Chang, MD, FHM, associate professor in Mount Sinai Hospital’s division of hospital medicine, New York, in his talk on Monday. “You never really know where its going to go, and it’s really a matter of keeping your eye out for opportunities.”
Hospital medicine offers a diverse and interesting career that presents a variety of professional opportunities to those who practice it, Dr. Chang said. He noted that many hospitalists are gravitating toward careers in improving patient safety and quality improvement.
“They are working on the systems that are in the hospital and trying to make them more efficient and safer for patients,” he said.
Keeping with the theme of the talk, Dr. Chang pointed out that there a number of other specialty areas that hospitalists can explore.
“A lot of hospitalists also get into education, educating students and residents,” he said. If teaching is not your desired area of practice, you can also try your hand at “becoming CMO [chief medical officer] of a hospital” or other areas of administrative leadership or “informatics and electronic health records.” Most importantly, there are a variety of professional avenues available within hospital medicine, he added.
Dr. Chang said that the design of the session was intended to help early-career hospitalists navigate their professional path and indicated that it definitely would have provided him with some guidance. “When I was a resident thinking about what I wanted to do after residency, I didn’t necessarily know what hospital medicine was,” he said. “I think I thought it was a cool clinical job, but I didn’t understand that there were so many other things that you could do with it that are not clinical, but still really interesting.”
Dr. Chang emphasized that early-career hospitalists do not need to have a fully formed idea of the professional track they wish to pursue.
“It’s okay if you don’t know what you want to do, just do what you think is interesting and it’s amazing the things you can end up doing,” he said, noting that the best thing for residents and early-career hospitalists is “to get experience and training.”
At the end of the talk, Dr. Chang and his copresenter Daniel Ricotta, MD, offered attendees tips about other events that they might attend to advance their careers. Dr. Chang noted that SHM offers many smaller conferences that offer career development skills such as leadership.
The “Hospitalist Career Options” education session provided future and early-career hospitalists with information about the diversity of potential career tracks within hospital medicine.
“There are so many different things that people do and that’s what so amazing about hospital medicine,” said Dennis Chang, MD, FHM, associate professor in Mount Sinai Hospital’s division of hospital medicine, New York, in his talk on Monday. “You never really know where its going to go, and it’s really a matter of keeping your eye out for opportunities.”
Hospital medicine offers a diverse and interesting career that presents a variety of professional opportunities to those who practice it, Dr. Chang said. He noted that many hospitalists are gravitating toward careers in improving patient safety and quality improvement.
“They are working on the systems that are in the hospital and trying to make them more efficient and safer for patients,” he said.
Keeping with the theme of the talk, Dr. Chang pointed out that there a number of other specialty areas that hospitalists can explore.
“A lot of hospitalists also get into education, educating students and residents,” he said. If teaching is not your desired area of practice, you can also try your hand at “becoming CMO [chief medical officer] of a hospital” or other areas of administrative leadership or “informatics and electronic health records.” Most importantly, there are a variety of professional avenues available within hospital medicine, he added.
Dr. Chang said that the design of the session was intended to help early-career hospitalists navigate their professional path and indicated that it definitely would have provided him with some guidance. “When I was a resident thinking about what I wanted to do after residency, I didn’t necessarily know what hospital medicine was,” he said. “I think I thought it was a cool clinical job, but I didn’t understand that there were so many other things that you could do with it that are not clinical, but still really interesting.”
Dr. Chang emphasized that early-career hospitalists do not need to have a fully formed idea of the professional track they wish to pursue.
“It’s okay if you don’t know what you want to do, just do what you think is interesting and it’s amazing the things you can end up doing,” he said, noting that the best thing for residents and early-career hospitalists is “to get experience and training.”
At the end of the talk, Dr. Chang and his copresenter Daniel Ricotta, MD, offered attendees tips about other events that they might attend to advance their careers. Dr. Chang noted that SHM offers many smaller conferences that offer career development skills such as leadership.
The “Hospitalist Career Options” education session provided future and early-career hospitalists with information about the diversity of potential career tracks within hospital medicine.
“There are so many different things that people do and that’s what so amazing about hospital medicine,” said Dennis Chang, MD, FHM, associate professor in Mount Sinai Hospital’s division of hospital medicine, New York, in his talk on Monday. “You never really know where its going to go, and it’s really a matter of keeping your eye out for opportunities.”
Hospital medicine offers a diverse and interesting career that presents a variety of professional opportunities to those who practice it, Dr. Chang said. He noted that many hospitalists are gravitating toward careers in improving patient safety and quality improvement.
“They are working on the systems that are in the hospital and trying to make them more efficient and safer for patients,” he said.
Keeping with the theme of the talk, Dr. Chang pointed out that there a number of other specialty areas that hospitalists can explore.
“A lot of hospitalists also get into education, educating students and residents,” he said. If teaching is not your desired area of practice, you can also try your hand at “becoming CMO [chief medical officer] of a hospital” or other areas of administrative leadership or “informatics and electronic health records.” Most importantly, there are a variety of professional avenues available within hospital medicine, he added.
Dr. Chang said that the design of the session was intended to help early-career hospitalists navigate their professional path and indicated that it definitely would have provided him with some guidance. “When I was a resident thinking about what I wanted to do after residency, I didn’t necessarily know what hospital medicine was,” he said. “I think I thought it was a cool clinical job, but I didn’t understand that there were so many other things that you could do with it that are not clinical, but still really interesting.”
Dr. Chang emphasized that early-career hospitalists do not need to have a fully formed idea of the professional track they wish to pursue.
“It’s okay if you don’t know what you want to do, just do what you think is interesting and it’s amazing the things you can end up doing,” he said, noting that the best thing for residents and early-career hospitalists is “to get experience and training.”
At the end of the talk, Dr. Chang and his copresenter Daniel Ricotta, MD, offered attendees tips about other events that they might attend to advance their careers. Dr. Chang noted that SHM offers many smaller conferences that offer career development skills such as leadership.
Session tackles oncology emergencies
Hospitalists are on the front lines of diagnosis and management of patients with cancer, the second-leading cause of death in the United States. The session on Oncology Emergencies addressed the enormous number of clinical issues that must be considered within this patient population.
“The real challenge in managing sick cancer patients lies in the data-free zones,” presenter Benjamin L. Schlechter, MD, of Beth Israel Deaconess Medical Center in Boston, said in an interview. “I think the oncologic emergency we forget to talk about most often is the early diagnostic period,” he noted. The focus of Dr. Schlechter’s Monday talk was on this time frame and the process of getting patients with an advanced malignancy from diagnosis to treatment safely, which remains a clinical challenge.
“These patients often present with vague symptoms that do not point to any particular diagnosis,” stated Dr. Schlechter. “Once we identify that a patient has a symptomatic new malignancy, it is critical to determine who needs a rapid work-up as an inpatient on a hospital medicine service and who can be managed as an outpatient.”
Dr. Schlechter explained that there are no randomized trials to guide diagnostic work-up of malignancy or even define an expedited work-up. On the other hand, there are extensive data on treatment of newly diagnosed cancers. Clinical trials that guide first-line cancer therapy have clear eligibility criteria, which should inform hospitalists’ work-ups. “These include torso imaging, biopsy of a metastatic site, and assessment of liver and kidney function,” Dr. Schlechter continued. “The reason kidney and liver function are so critical is that patients who have organ dysfunction cannot receive effective chemotherapy.”
During the presentation, Dr. Schlechter reminded attendees that two-thirds of all cancers are cured, and there are clear data showing that chemotherapy in the first-line setting improves quality and length of life in virtually all cases. He underscored how critical it is to get patients treated before they develop organ dysfunction. “We can also use fairly basic clinical and laboratory assessment to determine who has a hyperaggressive malignancy and who doesn’t,” he added. “If LDH [lactate dehydrogenase] or uric acid are elevated, something really dangerous is happening. If the transaminases and alkaline phosphatase are rising, liver function is in danger. If the kidneys are failing, we need to act quickly.”
Dr. Schlechter closed by saying, “There are huge challenges in studying this time frame in a patient’s illness, which is why the initial work-up of cancer remains a high-risk period.”
Hospitalists are on the front lines of diagnosis and management of patients with cancer, the second-leading cause of death in the United States. The session on Oncology Emergencies addressed the enormous number of clinical issues that must be considered within this patient population.
“The real challenge in managing sick cancer patients lies in the data-free zones,” presenter Benjamin L. Schlechter, MD, of Beth Israel Deaconess Medical Center in Boston, said in an interview. “I think the oncologic emergency we forget to talk about most often is the early diagnostic period,” he noted. The focus of Dr. Schlechter’s Monday talk was on this time frame and the process of getting patients with an advanced malignancy from diagnosis to treatment safely, which remains a clinical challenge.
“These patients often present with vague symptoms that do not point to any particular diagnosis,” stated Dr. Schlechter. “Once we identify that a patient has a symptomatic new malignancy, it is critical to determine who needs a rapid work-up as an inpatient on a hospital medicine service and who can be managed as an outpatient.”
Dr. Schlechter explained that there are no randomized trials to guide diagnostic work-up of malignancy or even define an expedited work-up. On the other hand, there are extensive data on treatment of newly diagnosed cancers. Clinical trials that guide first-line cancer therapy have clear eligibility criteria, which should inform hospitalists’ work-ups. “These include torso imaging, biopsy of a metastatic site, and assessment of liver and kidney function,” Dr. Schlechter continued. “The reason kidney and liver function are so critical is that patients who have organ dysfunction cannot receive effective chemotherapy.”
During the presentation, Dr. Schlechter reminded attendees that two-thirds of all cancers are cured, and there are clear data showing that chemotherapy in the first-line setting improves quality and length of life in virtually all cases. He underscored how critical it is to get patients treated before they develop organ dysfunction. “We can also use fairly basic clinical and laboratory assessment to determine who has a hyperaggressive malignancy and who doesn’t,” he added. “If LDH [lactate dehydrogenase] or uric acid are elevated, something really dangerous is happening. If the transaminases and alkaline phosphatase are rising, liver function is in danger. If the kidneys are failing, we need to act quickly.”
Dr. Schlechter closed by saying, “There are huge challenges in studying this time frame in a patient’s illness, which is why the initial work-up of cancer remains a high-risk period.”
Hospitalists are on the front lines of diagnosis and management of patients with cancer, the second-leading cause of death in the United States. The session on Oncology Emergencies addressed the enormous number of clinical issues that must be considered within this patient population.
“The real challenge in managing sick cancer patients lies in the data-free zones,” presenter Benjamin L. Schlechter, MD, of Beth Israel Deaconess Medical Center in Boston, said in an interview. “I think the oncologic emergency we forget to talk about most often is the early diagnostic period,” he noted. The focus of Dr. Schlechter’s Monday talk was on this time frame and the process of getting patients with an advanced malignancy from diagnosis to treatment safely, which remains a clinical challenge.
“These patients often present with vague symptoms that do not point to any particular diagnosis,” stated Dr. Schlechter. “Once we identify that a patient has a symptomatic new malignancy, it is critical to determine who needs a rapid work-up as an inpatient on a hospital medicine service and who can be managed as an outpatient.”
Dr. Schlechter explained that there are no randomized trials to guide diagnostic work-up of malignancy or even define an expedited work-up. On the other hand, there are extensive data on treatment of newly diagnosed cancers. Clinical trials that guide first-line cancer therapy have clear eligibility criteria, which should inform hospitalists’ work-ups. “These include torso imaging, biopsy of a metastatic site, and assessment of liver and kidney function,” Dr. Schlechter continued. “The reason kidney and liver function are so critical is that patients who have organ dysfunction cannot receive effective chemotherapy.”
During the presentation, Dr. Schlechter reminded attendees that two-thirds of all cancers are cured, and there are clear data showing that chemotherapy in the first-line setting improves quality and length of life in virtually all cases. He underscored how critical it is to get patients treated before they develop organ dysfunction. “We can also use fairly basic clinical and laboratory assessment to determine who has a hyperaggressive malignancy and who doesn’t,” he added. “If LDH [lactate dehydrogenase] or uric acid are elevated, something really dangerous is happening. If the transaminases and alkaline phosphatase are rising, liver function is in danger. If the kidneys are failing, we need to act quickly.”
Dr. Schlechter closed by saying, “There are huge challenges in studying this time frame in a patient’s illness, which is why the initial work-up of cancer remains a high-risk period.”
What’s new in the latest melanoma guidelines
KAUAI, HAWAII – Melanoma , resulting in an evidence-based improved prognosis for many of them, Laura Korb Ferris, MD, PhD, said at the Hawaii Dermatology Seminar provided by Skin Disease Education Foundation/Global Academy for Medical Education.
Dr. Ferris, of the department of dermatology, University of Pittsburgh, highlighted some of the key changes in the eighth edition of the AJCC staging manual, which is now in effect. She also described the clinical implications of important updates introduced in the 2018 National Comprehensive Cancer Network (NCCN) guidelines for the diagnosis and management of melanoma.
The AJCC eighth edition
The eighth edition is built upon an AJCC database of more than 46,000 patients with stage I-III melanoma diagnosed since 1998 at 10 academic medical centers. The AJCC panel made no changes in stage IV melanoma guidance because the newer targeted therapies have rapidly changed treatment outcomes in that setting and longer follow-up is needed to assess the full impact. 
The current edition of the AJCC melanoma staging manual creates a new subcategory within pathologic stage III. In the melanoma staging world, that’s exciting news, especially because this change has important implications for prognosis.
This fourth subcategory, stage IIID, is for melanomas, which in the Tumor, Nodes, Metastasis (TNM) classification scheme, are primary tumor stage T4b, meaning greater than 4.0 mm in thickness and with ulceration; regional lymph node N3a, b, or c, based upon the number of metastatic nodes involved and whether they were clinically occult nodal metastases detected by sentinel lymph node biopsy (SLNB) or clinically detected; and M0, meaning no distant metastatic disease. In the 8th edition, the AJCC staging system can be applied in patients with T2 through T4 primary melanoma only if they have undergone SLNB.
This new approach to stage III disease makes for more homogeneous patient subgroups, which in turn provides much better stratification of prognosis than was possible in the seventh edition of the AJCC staging manual, which dates back to 2010. Most strikingly, the 5-year melanoma-specific survival rate for patients with stage IIIA disease was 78% in the seventh edition of AJCC, but it climbs to 93% in the eighth edition. For patients with stage IIIB melanoma, 5-year melanoma-specific survival improved from 59% in the seventh edition to 83% in the current iteration, while in stage IIIC, the jump is from 40% to 69%. All this is made possible because the eighth edition separates out patients with the new stage IIID, whose 5-year melanoma-specific survival is only 32%, Dr. Ferris explained.
Among the other key points to remember about the eighth edition of AJCC:
- Tumor thickness is now measured to the nearest 0.1 mm rather than to the nearest 0.01 mm, as previously. Thus, a 0.75-mm-thick melanoma is now rounded up to 0.8 mm, while a 0.74-mm melanoma becomes a 0.7-mm tumor.
- Based upon recent evidence, tumors that are 0.8-1.0 mm thick, with or without ulceration, are now classified at T1b. So are ulcerated lesions that are less than 0.8 mm.
- Dermal mitotic rate is no longer used in staging T1 tumors, although it’s still supposed to be included in pathology reports.
- The T category definitions of primary tumors have been clarified in the eighth edition. A tumor is now classified as T0 only if there is no evidence of a primary tumor. Tx is employed when the primary tumor thickness can’t be determined, as for example when the biopsy specimen was obtained by curettage. Tis is utilized for melanoma in situ.
- The N subcategory definitions of regional nodal status have been revised. Microsatellites, clinical satellites, and in-transit metastases are now categorized as N1c, N2c, or N3c based upon the number of tumor-involved regional lymph nodes. These features are no longer defined by their size or distance from the primary tumor.
2018 NCCN melanoma guidelines
The guidelines have been revised to recommend against SLNB if a patient’s pretest probability of finding a positive SLN is less than 5%. This includes patients who have a clinical stage IA/T1a melanoma with a Breslow thickness of less than 0.8 mm without ulceration.
There is to be no SLNB in patients with microsatellites, clinical satellites, or in-transit metastases because SLN status has no prognostic significance in this situation.
Routine ordering of prognostic genetic tests for BRAF or the multigene test panels that are now commercially available is not recommended except to guide systemic therapy or to determine if a patient is a candidate for a specific clinical trial. “Basically, there is not a place to use this information in the NCCN guidelines,” according to the dermatologist.
What about completion lymphadenectomy in the SLN-positive melanoma patient?
Completion lymph node dissection looks increasingly like a procedure in search of an indication. Results of the National Cancer Institute–sponsored Multicenter Selective Lymphadenectomy Trial–II (MSLT-II) demonstrated not even a hint of a difference in 3-year melanoma-specific survival in 1,934 melanoma patients with sentinel lymph node metastases regardless of whether they were randomized to immediate completion lymph node dissection or ultrasound-based nodal monitoring. Moreover, completion lymphadenectomy was associated with significant morbidity: a 24.1% incidence of lymphedema, compared with a 6.3% rate in the observation group (N Engl J Med. 2017 Jun 8;376[23]:2211-22).
On the other hand, Dr. Ferris noted that many newer drugs are being approved for the treatment of stage III melanoma, and in all the pivotal clinical trials, patients had to have undergone completion lymph node dissection as a condition of participation. So the surgery becomes a consideration if physicians want to use the newer agents the way they were used successfully in the trials.
The full eighth edition of the AJCC cancer staging manual is available for purchase. For physicians with a specific interest in melanoma, Dr. Ferris recommended as an extremely useful alternative the AJCC expert writing panel’s free downloadable summary of the evidence-based changes made in melanoma staging (CA Cancer J Clin. 2017 Nov;67[6]:472-92). The 2018 NCCN guidelines (Melanoma. Version 1.2018 Oct. 11, 2017) are available for free (www.NCCN.org).
Dr. Ferris reported serving as a consultant to DermTech.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – Melanoma , resulting in an evidence-based improved prognosis for many of them, Laura Korb Ferris, MD, PhD, said at the Hawaii Dermatology Seminar provided by Skin Disease Education Foundation/Global Academy for Medical Education.
Dr. Ferris, of the department of dermatology, University of Pittsburgh, highlighted some of the key changes in the eighth edition of the AJCC staging manual, which is now in effect. She also described the clinical implications of important updates introduced in the 2018 National Comprehensive Cancer Network (NCCN) guidelines for the diagnosis and management of melanoma.
The AJCC eighth edition
The eighth edition is built upon an AJCC database of more than 46,000 patients with stage I-III melanoma diagnosed since 1998 at 10 academic medical centers. The AJCC panel made no changes in stage IV melanoma guidance because the newer targeted therapies have rapidly changed treatment outcomes in that setting and longer follow-up is needed to assess the full impact.
The current edition of the AJCC melanoma staging manual creates a new subcategory within pathologic stage III. In the melanoma staging world, that’s exciting news, especially because this change has important implications for prognosis.
This fourth subcategory, stage IIID, is for melanomas, which in the Tumor, Nodes, Metastasis (TNM) classification scheme, are primary tumor stage T4b, meaning greater than 4.0 mm in thickness and with ulceration; regional lymph node N3a, b, or c, based upon the number of metastatic nodes involved and whether they were clinically occult nodal metastases detected by sentinel lymph node biopsy (SLNB) or clinically detected; and M0, meaning no distant metastatic disease. In the 8th edition, the AJCC staging system can be applied in patients with T2 through T4 primary melanoma only if they have undergone SLNB.
This new approach to stage III disease makes for more homogeneous patient subgroups, which in turn provides much better stratification of prognosis than was possible in the seventh edition of the AJCC staging manual, which dates back to 2010. Most strikingly, the 5-year melanoma-specific survival rate for patients with stage IIIA disease was 78% in the seventh edition of AJCC, but it climbs to 93% in the eighth edition. For patients with stage IIIB melanoma, 5-year melanoma-specific survival improved from 59% in the seventh edition to 83% in the current iteration, while in stage IIIC, the jump is from 40% to 69%. All this is made possible because the eighth edition separates out patients with the new stage IIID, whose 5-year melanoma-specific survival is only 32%, Dr. Ferris explained.
Among the other key points to remember about the eighth edition of AJCC:
- Tumor thickness is now measured to the nearest 0.1 mm rather than to the nearest 0.01 mm, as previously. Thus, a 0.75-mm-thick melanoma is now rounded up to 0.8 mm, while a 0.74-mm melanoma becomes a 0.7-mm tumor.
- Based upon recent evidence, tumors that are 0.8-1.0 mm thick, with or without ulceration, are now classified at T1b. So are ulcerated lesions that are less than 0.8 mm.
- Dermal mitotic rate is no longer used in staging T1 tumors, although it’s still supposed to be included in pathology reports.
- The T category definitions of primary tumors have been clarified in the eighth edition. A tumor is now classified as T0 only if there is no evidence of a primary tumor. Tx is employed when the primary tumor thickness can’t be determined, as for example when the biopsy specimen was obtained by curettage. Tis is utilized for melanoma in situ.
- The N subcategory definitions of regional nodal status have been revised. Microsatellites, clinical satellites, and in-transit metastases are now categorized as N1c, N2c, or N3c based upon the number of tumor-involved regional lymph nodes. These features are no longer defined by their size or distance from the primary tumor.
2018 NCCN melanoma guidelines
The guidelines have been revised to recommend against SLNB if a patient’s pretest probability of finding a positive SLN is less than 5%. This includes patients who have a clinical stage IA/T1a melanoma with a Breslow thickness of less than 0.8 mm without ulceration.
There is to be no SLNB in patients with microsatellites, clinical satellites, or in-transit metastases because SLN status has no prognostic significance in this situation.
Routine ordering of prognostic genetic tests for BRAF or the multigene test panels that are now commercially available is not recommended except to guide systemic therapy or to determine if a patient is a candidate for a specific clinical trial. “Basically, there is not a place to use this information in the NCCN guidelines,” according to the dermatologist.
What about completion lymphadenectomy in the SLN-positive melanoma patient?
Completion lymph node dissection looks increasingly like a procedure in search of an indication. Results of the National Cancer Institute–sponsored Multicenter Selective Lymphadenectomy Trial–II (MSLT-II) demonstrated not even a hint of a difference in 3-year melanoma-specific survival in 1,934 melanoma patients with sentinel lymph node metastases regardless of whether they were randomized to immediate completion lymph node dissection or ultrasound-based nodal monitoring. Moreover, completion lymphadenectomy was associated with significant morbidity: a 24.1% incidence of lymphedema, compared with a 6.3% rate in the observation group (N Engl J Med. 2017 Jun 8;376[23]:2211-22).
On the other hand, Dr. Ferris noted that many newer drugs are being approved for the treatment of stage III melanoma, and in all the pivotal clinical trials, patients had to have undergone completion lymph node dissection as a condition of participation. So the surgery becomes a consideration if physicians want to use the newer agents the way they were used successfully in the trials.
The full eighth edition of the AJCC cancer staging manual is available for purchase. For physicians with a specific interest in melanoma, Dr. Ferris recommended as an extremely useful alternative the AJCC expert writing panel’s free downloadable summary of the evidence-based changes made in melanoma staging (CA Cancer J Clin. 2017 Nov;67[6]:472-92). The 2018 NCCN guidelines (Melanoma. Version 1.2018 Oct. 11, 2017) are available for free (www.NCCN.org).
Dr. Ferris reported serving as a consultant to DermTech.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
KAUAI, HAWAII – Melanoma , resulting in an evidence-based improved prognosis for many of them, Laura Korb Ferris, MD, PhD, said at the Hawaii Dermatology Seminar provided by Skin Disease Education Foundation/Global Academy for Medical Education.
Dr. Ferris, of the department of dermatology, University of Pittsburgh, highlighted some of the key changes in the eighth edition of the AJCC staging manual, which is now in effect. She also described the clinical implications of important updates introduced in the 2018 National Comprehensive Cancer Network (NCCN) guidelines for the diagnosis and management of melanoma.
The AJCC eighth edition
The eighth edition is built upon an AJCC database of more than 46,000 patients with stage I-III melanoma diagnosed since 1998 at 10 academic medical centers. The AJCC panel made no changes in stage IV melanoma guidance because the newer targeted therapies have rapidly changed treatment outcomes in that setting and longer follow-up is needed to assess the full impact.
The current edition of the AJCC melanoma staging manual creates a new subcategory within pathologic stage III. In the melanoma staging world, that’s exciting news, especially because this change has important implications for prognosis.
This fourth subcategory, stage IIID, is for melanomas, which in the Tumor, Nodes, Metastasis (TNM) classification scheme, are primary tumor stage T4b, meaning greater than 4.0 mm in thickness and with ulceration; regional lymph node N3a, b, or c, based upon the number of metastatic nodes involved and whether they were clinically occult nodal metastases detected by sentinel lymph node biopsy (SLNB) or clinically detected; and M0, meaning no distant metastatic disease. In the 8th edition, the AJCC staging system can be applied in patients with T2 through T4 primary melanoma only if they have undergone SLNB.
This new approach to stage III disease makes for more homogeneous patient subgroups, which in turn provides much better stratification of prognosis than was possible in the seventh edition of the AJCC staging manual, which dates back to 2010. Most strikingly, the 5-year melanoma-specific survival rate for patients with stage IIIA disease was 78% in the seventh edition of AJCC, but it climbs to 93% in the eighth edition. For patients with stage IIIB melanoma, 5-year melanoma-specific survival improved from 59% in the seventh edition to 83% in the current iteration, while in stage IIIC, the jump is from 40% to 69%. All this is made possible because the eighth edition separates out patients with the new stage IIID, whose 5-year melanoma-specific survival is only 32%, Dr. Ferris explained.
Among the other key points to remember about the eighth edition of AJCC:
- Tumor thickness is now measured to the nearest 0.1 mm rather than to the nearest 0.01 mm, as previously. Thus, a 0.75-mm-thick melanoma is now rounded up to 0.8 mm, while a 0.74-mm melanoma becomes a 0.7-mm tumor.
- Based upon recent evidence, tumors that are 0.8-1.0 mm thick, with or without ulceration, are now classified at T1b. So are ulcerated lesions that are less than 0.8 mm.
- Dermal mitotic rate is no longer used in staging T1 tumors, although it’s still supposed to be included in pathology reports.
- The T category definitions of primary tumors have been clarified in the eighth edition. A tumor is now classified as T0 only if there is no evidence of a primary tumor. Tx is employed when the primary tumor thickness can’t be determined, as for example when the biopsy specimen was obtained by curettage. Tis is utilized for melanoma in situ.
- The N subcategory definitions of regional nodal status have been revised. Microsatellites, clinical satellites, and in-transit metastases are now categorized as N1c, N2c, or N3c based upon the number of tumor-involved regional lymph nodes. These features are no longer defined by their size or distance from the primary tumor.
2018 NCCN melanoma guidelines
The guidelines have been revised to recommend against SLNB if a patient’s pretest probability of finding a positive SLN is less than 5%. This includes patients who have a clinical stage IA/T1a melanoma with a Breslow thickness of less than 0.8 mm without ulceration.
There is to be no SLNB in patients with microsatellites, clinical satellites, or in-transit metastases because SLN status has no prognostic significance in this situation.
Routine ordering of prognostic genetic tests for BRAF or the multigene test panels that are now commercially available is not recommended except to guide systemic therapy or to determine if a patient is a candidate for a specific clinical trial. “Basically, there is not a place to use this information in the NCCN guidelines,” according to the dermatologist.
What about completion lymphadenectomy in the SLN-positive melanoma patient?
Completion lymph node dissection looks increasingly like a procedure in search of an indication. Results of the National Cancer Institute–sponsored Multicenter Selective Lymphadenectomy Trial–II (MSLT-II) demonstrated not even a hint of a difference in 3-year melanoma-specific survival in 1,934 melanoma patients with sentinel lymph node metastases regardless of whether they were randomized to immediate completion lymph node dissection or ultrasound-based nodal monitoring. Moreover, completion lymphadenectomy was associated with significant morbidity: a 24.1% incidence of lymphedema, compared with a 6.3% rate in the observation group (N Engl J Med. 2017 Jun 8;376[23]:2211-22).
On the other hand, Dr. Ferris noted that many newer drugs are being approved for the treatment of stage III melanoma, and in all the pivotal clinical trials, patients had to have undergone completion lymph node dissection as a condition of participation. So the surgery becomes a consideration if physicians want to use the newer agents the way they were used successfully in the trials.
The full eighth edition of the AJCC cancer staging manual is available for purchase. For physicians with a specific interest in melanoma, Dr. Ferris recommended as an extremely useful alternative the AJCC expert writing panel’s free downloadable summary of the evidence-based changes made in melanoma staging (CA Cancer J Clin. 2017 Nov;67[6]:472-92). The 2018 NCCN guidelines (Melanoma. Version 1.2018 Oct. 11, 2017) are available for free (www.NCCN.org).
Dr. Ferris reported serving as a consultant to DermTech.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR
A Peek at Our April 2018 Issue
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Empiric fluid restriction cuts transsphenoidal surgery readmissions
CHICAGO – A 70% drop in 30-day was achieved at the University of Colorado, Aurora, after endocrinologists there restricted fluid for the first 2 weeks postop, according to a report at the Endocrine Society annual meeting.
The antidiuretic hormone (ADH) rebound following pituitary adenoma resection often leads to fluid retention, and potentially dangerous hyponatremia, in about 25% of patients. It’s the leading cause of readmission for this procedure, occurring in up to 15% of patients.
To counter the problem, endocrinology fellow Kelsi Deaver, MD, and her colleagues limited patients to 1.5 L of fluid for 2 weeks after discharge, with a serum sodium check at day 7. If the sodium level was normal, patients remained on 1.5 L until the 2-week postop visit. If levels trended upward – a sign of dehydration – restrictions were eased to 2 or even 3 L, which is about the normal daily intake. If sodium levels trended downward, fluids were tightened to 1-1.2 L, or patients were brought in for further workup. The discharge packet included a 1.5-L cup so patients could track their intake.
Among 118 patients studied before the protocol was implemented in September 2015, 9 (7.6%) were readmitted for symptomatic hyponatremia within 30 days. Among 169 studied after the implementation of the fluid restriction protocol, just 4 (2.4%) were readmitted for hyponatremia (P = .044).
At present, there are no widely accepted postop fluid management guidelines for transsphenoidal surgery, but some hospitals have taken similar steps, she said.
It was the fluid restriction, not the 7-day sodium check, that drove the results. Among the four readmissions after the protocol took effect, two patients had their sodium checked, and two did not because their sodium drop was so precipitous that they were back in the hospital before the week was out. Overall, only about 70% of patients got their sodium checked as instructed.
Fluid restriction isn’t easy for patients. “The last day before discharge, we try to coach them through it,” with tips about sucking on ice chips and other strategies; “anything really to help them through it,” Dr. Deaver said.
Readmitted patients were no different from others in terms of pituitary tumor subtype, tumor size, gender, and other factors. “We couldn’t find any predictors,” she said. There were a higher percentage of macroadenomas in the preimplementation patients (91.5% versus 81.7%), but they were otherwise similar to postimplementation patients.
Those with evidence of diabetes insipidus at discharge were excluded from the study.
The National Institutes of Health funded the study. The investigators did not have any disclosures.
SOURCE: Deaver KE et al. Endocrine Society 2018 annual meeting abstract SUN-572.
CHICAGO – A 70% drop in 30-day was achieved at the University of Colorado, Aurora, after endocrinologists there restricted fluid for the first 2 weeks postop, according to a report at the Endocrine Society annual meeting.
The antidiuretic hormone (ADH) rebound following pituitary adenoma resection often leads to fluid retention, and potentially dangerous hyponatremia, in about 25% of patients. It’s the leading cause of readmission for this procedure, occurring in up to 15% of patients.
To counter the problem, endocrinology fellow Kelsi Deaver, MD, and her colleagues limited patients to 1.5 L of fluid for 2 weeks after discharge, with a serum sodium check at day 7. If the sodium level was normal, patients remained on 1.5 L until the 2-week postop visit. If levels trended upward – a sign of dehydration – restrictions were eased to 2 or even 3 L, which is about the normal daily intake. If sodium levels trended downward, fluids were tightened to 1-1.2 L, or patients were brought in for further workup. The discharge packet included a 1.5-L cup so patients could track their intake.
Among 118 patients studied before the protocol was implemented in September 2015, 9 (7.6%) were readmitted for symptomatic hyponatremia within 30 days. Among 169 studied after the implementation of the fluid restriction protocol, just 4 (2.4%) were readmitted for hyponatremia (P = .044).
At present, there are no widely accepted postop fluid management guidelines for transsphenoidal surgery, but some hospitals have taken similar steps, she said.
It was the fluid restriction, not the 7-day sodium check, that drove the results. Among the four readmissions after the protocol took effect, two patients had their sodium checked, and two did not because their sodium drop was so precipitous that they were back in the hospital before the week was out. Overall, only about 70% of patients got their sodium checked as instructed.
Fluid restriction isn’t easy for patients. “The last day before discharge, we try to coach them through it,” with tips about sucking on ice chips and other strategies; “anything really to help them through it,” Dr. Deaver said.
Readmitted patients were no different from others in terms of pituitary tumor subtype, tumor size, gender, and other factors. “We couldn’t find any predictors,” she said. There were a higher percentage of macroadenomas in the preimplementation patients (91.5% versus 81.7%), but they were otherwise similar to postimplementation patients.
Those with evidence of diabetes insipidus at discharge were excluded from the study.
The National Institutes of Health funded the study. The investigators did not have any disclosures.
SOURCE: Deaver KE et al. Endocrine Society 2018 annual meeting abstract SUN-572.
CHICAGO – A 70% drop in 30-day was achieved at the University of Colorado, Aurora, after endocrinologists there restricted fluid for the first 2 weeks postop, according to a report at the Endocrine Society annual meeting.
The antidiuretic hormone (ADH) rebound following pituitary adenoma resection often leads to fluid retention, and potentially dangerous hyponatremia, in about 25% of patients. It’s the leading cause of readmission for this procedure, occurring in up to 15% of patients.
To counter the problem, endocrinology fellow Kelsi Deaver, MD, and her colleagues limited patients to 1.5 L of fluid for 2 weeks after discharge, with a serum sodium check at day 7. If the sodium level was normal, patients remained on 1.5 L until the 2-week postop visit. If levels trended upward – a sign of dehydration – restrictions were eased to 2 or even 3 L, which is about the normal daily intake. If sodium levels trended downward, fluids were tightened to 1-1.2 L, or patients were brought in for further workup. The discharge packet included a 1.5-L cup so patients could track their intake.
Among 118 patients studied before the protocol was implemented in September 2015, 9 (7.6%) were readmitted for symptomatic hyponatremia within 30 days. Among 169 studied after the implementation of the fluid restriction protocol, just 4 (2.4%) were readmitted for hyponatremia (P = .044).
At present, there are no widely accepted postop fluid management guidelines for transsphenoidal surgery, but some hospitals have taken similar steps, she said.
It was the fluid restriction, not the 7-day sodium check, that drove the results. Among the four readmissions after the protocol took effect, two patients had their sodium checked, and two did not because their sodium drop was so precipitous that they were back in the hospital before the week was out. Overall, only about 70% of patients got their sodium checked as instructed.
Fluid restriction isn’t easy for patients. “The last day before discharge, we try to coach them through it,” with tips about sucking on ice chips and other strategies; “anything really to help them through it,” Dr. Deaver said.
Readmitted patients were no different from others in terms of pituitary tumor subtype, tumor size, gender, and other factors. “We couldn’t find any predictors,” she said. There were a higher percentage of macroadenomas in the preimplementation patients (91.5% versus 81.7%), but they were otherwise similar to postimplementation patients.
Those with evidence of diabetes insipidus at discharge were excluded from the study.
The National Institutes of Health funded the study. The investigators did not have any disclosures.
SOURCE: Deaver KE et al. Endocrine Society 2018 annual meeting abstract SUN-572.
REPORTING FROM ENDO 2018
Key clinical point: A simple fluid restriction protocol cuts readmissions 70% following transsphenoidal surgery.
Major finding: The readmission rate among the transsphenoidal surgery patients was 7.6% before the fluid restriction protocol was implemented, compared with 2.4% (P = .044) afterward.
Study details: Review of 287 transsphenoidal surgery patients.
Disclosures: The National Institutes of Health supported the work. The investigators did not have any disclosures.
Source: Deaver KE et al. Abstract SUN-572
Ten-step trauma intervention offers help for foster families
WASHINGTON – Trauma-Informed Parenting Skills for Resource Parents, a new intervention program, might be an answer to addressing trauma symptoms in foster homes, according to a presentation at the annual conference of the Anxiety and Depression Association of America.
Rates of trauma exposure range from 80% to 93% in child welfare populations. In light of those statistics, foster parents are left to deal with the effects of traumatic stress symptoms without proper preparation or tools. Trauma-Informed Parenting Skills for Resource Parents targets different aspects of the way in which trauma can affect both the foster child and other members of the family.
The program is structured over the course of 10 weekly, 60- to 90-minute sessions for parents with foster children or those who plan to begin fostering. It is designed for caregivers of children aged 0-17 years. In addition, the intervention uses four key components: trauma awareness, caregiver relationships as the context for healing, trauma-informed parenting strategies, and creating physical and psychological safety, according to the program’s website.
“Trauma awareness is a large part of this intervention [in order to] help resource parents understand what’s happening,” Dr. Eslinger said. “There is trauma 101, orientation to what happens in the body when a child is exposed to a traumatic event, and this is followed by learning how to use the caregiver relationship.”
The 10 sessions were structured carefully, starting by addressing end goals, moving to education on the effects of early childhood trauma, transitioning to relaxation and coping skills, followed by teaching how to deal with challenging behaviors, and finishing with a final session where participants have a chance to bring it all together.
Caregivers also are instructed on using the cognitive triangle to understand their children’s feelings and build the framework to develop healthy reactions to behavior caused by traumatic stress.
“We work to help parents learn how to instill safety messages that the child needs to hear, creating a sense of safety in the home, and operating in the relationship in such a way to create psychological safety for their child,” Dr. Sprang said. “For many of [the parents], they’ve never understood that their disappointment and their hopelessness were a danger to the child – that children pick up on this.”
Neither Dr. Eslinger nor Dr. Sprang reported financial disclosures.
WASHINGTON – Trauma-Informed Parenting Skills for Resource Parents, a new intervention program, might be an answer to addressing trauma symptoms in foster homes, according to a presentation at the annual conference of the Anxiety and Depression Association of America.
Rates of trauma exposure range from 80% to 93% in child welfare populations. In light of those statistics, foster parents are left to deal with the effects of traumatic stress symptoms without proper preparation or tools. Trauma-Informed Parenting Skills for Resource Parents targets different aspects of the way in which trauma can affect both the foster child and other members of the family.
The program is structured over the course of 10 weekly, 60- to 90-minute sessions for parents with foster children or those who plan to begin fostering. It is designed for caregivers of children aged 0-17 years. In addition, the intervention uses four key components: trauma awareness, caregiver relationships as the context for healing, trauma-informed parenting strategies, and creating physical and psychological safety, according to the program’s website.
“Trauma awareness is a large part of this intervention [in order to] help resource parents understand what’s happening,” Dr. Eslinger said. “There is trauma 101, orientation to what happens in the body when a child is exposed to a traumatic event, and this is followed by learning how to use the caregiver relationship.”
The 10 sessions were structured carefully, starting by addressing end goals, moving to education on the effects of early childhood trauma, transitioning to relaxation and coping skills, followed by teaching how to deal with challenging behaviors, and finishing with a final session where participants have a chance to bring it all together.
Caregivers also are instructed on using the cognitive triangle to understand their children’s feelings and build the framework to develop healthy reactions to behavior caused by traumatic stress.
“We work to help parents learn how to instill safety messages that the child needs to hear, creating a sense of safety in the home, and operating in the relationship in such a way to create psychological safety for their child,” Dr. Sprang said. “For many of [the parents], they’ve never understood that their disappointment and their hopelessness were a danger to the child – that children pick up on this.”
Neither Dr. Eslinger nor Dr. Sprang reported financial disclosures.
WASHINGTON – Trauma-Informed Parenting Skills for Resource Parents, a new intervention program, might be an answer to addressing trauma symptoms in foster homes, according to a presentation at the annual conference of the Anxiety and Depression Association of America.
Rates of trauma exposure range from 80% to 93% in child welfare populations. In light of those statistics, foster parents are left to deal with the effects of traumatic stress symptoms without proper preparation or tools. Trauma-Informed Parenting Skills for Resource Parents targets different aspects of the way in which trauma can affect both the foster child and other members of the family.
The program is structured over the course of 10 weekly, 60- to 90-minute sessions for parents with foster children or those who plan to begin fostering. It is designed for caregivers of children aged 0-17 years. In addition, the intervention uses four key components: trauma awareness, caregiver relationships as the context for healing, trauma-informed parenting strategies, and creating physical and psychological safety, according to the program’s website.
“Trauma awareness is a large part of this intervention [in order to] help resource parents understand what’s happening,” Dr. Eslinger said. “There is trauma 101, orientation to what happens in the body when a child is exposed to a traumatic event, and this is followed by learning how to use the caregiver relationship.”
The 10 sessions were structured carefully, starting by addressing end goals, moving to education on the effects of early childhood trauma, transitioning to relaxation and coping skills, followed by teaching how to deal with challenging behaviors, and finishing with a final session where participants have a chance to bring it all together.
Caregivers also are instructed on using the cognitive triangle to understand their children’s feelings and build the framework to develop healthy reactions to behavior caused by traumatic stress.
“We work to help parents learn how to instill safety messages that the child needs to hear, creating a sense of safety in the home, and operating in the relationship in such a way to create psychological safety for their child,” Dr. Sprang said. “For many of [the parents], they’ve never understood that their disappointment and their hopelessness were a danger to the child – that children pick up on this.”
Neither Dr. Eslinger nor Dr. Sprang reported financial disclosures.
REPORTING FROM THE ANXIETY AND DEPRESSION CONFERENCE 2018
Rosacea tied to physical and psychological comorbidities
according to a review of 29 studies.
The recognition of rosacea as an inflammatory condition similar to psoriasis suggests that, as with psoriasis, rosacea may be associated with a range of systemic diseases, but data on such an association are limited, wrote Roger Haber, MD, from the department of dermatology at Saint George Hospital University Medical Center, Beirut, Lebanon.
“To the best of our knowledge, our study is the first review analyzing available data regarding the diseases associated with rosacea,” they said.
Overall, the most common comorbidities associated with rosacea were depression (reported in 117,848 patients), hypertension (18,176 patients), cardiovascular disease (9,739 patients), anxiety disorder (9,079 patients), dyslipidemia (7,004 patients), diabetes mellitus (6,306 patients), and migraine (6,136 patients). All associations were statistically significant.
Psychological problems significantly associated with rosacea include depression and anxiety, which may be related to similar inflammatory pathways among these conditions, the researchers noted.
Cardiovascular disease risk factors significantly associated with rosacea included coronary artery disease, cardiovascular disease, peripheral artery disease, heart failure, diabetes mellitus, hypertension, dyslipidemia, and metabolic syndrome. The association with coronary artery disease remained significant after adjusting for multiple variables, as has been shown with psoriasis, which supports consideration of rosacea as an independent risk factor for CAD, the researchers said.
In terms of gastrointestinal comorbidities, the studies reviewed found an association between rosacea and several GI disorders, including celiac disease, Crohn’s disease, and ulcerative colitis, and Helicobacter pylori infection, they wrote. Although the current data do not imply causality, clinicians should screen rosacea patients for GI disorders, they noted.
The link between rosacea and migraine may stem from the similar vascular abnormalities and triggers common to both conditions, such as stress and alcohol, the researchers added.
The review does not establish causality between rosacea and any of the comorbidities examined in part because of the inclusion of observational studies, the researchers noted. “It is also possible that the observed association with rosacea is explained by shared environmental or lifestyle factors rather than by a common genetic disposition or pathophysiologic pathways,” they said. Controlled and prospective studies are needed to better identify associations, but general physicians and dermatologists who recognize the potential risk of comorbidities in rosacea patients may be better able to manage and treat them, they added.
The researchers had no financial conflicts to disclose. There was no funding source for the study.
SOURCE: Haber R et al. J Am Acad Dermatol. 2018 April;78(4):786-92.
according to a review of 29 studies.
The recognition of rosacea as an inflammatory condition similar to psoriasis suggests that, as with psoriasis, rosacea may be associated with a range of systemic diseases, but data on such an association are limited, wrote Roger Haber, MD, from the department of dermatology at Saint George Hospital University Medical Center, Beirut, Lebanon.
“To the best of our knowledge, our study is the first review analyzing available data regarding the diseases associated with rosacea,” they said.
Overall, the most common comorbidities associated with rosacea were depression (reported in 117,848 patients), hypertension (18,176 patients), cardiovascular disease (9,739 patients), anxiety disorder (9,079 patients), dyslipidemia (7,004 patients), diabetes mellitus (6,306 patients), and migraine (6,136 patients). All associations were statistically significant.
Psychological problems significantly associated with rosacea include depression and anxiety, which may be related to similar inflammatory pathways among these conditions, the researchers noted.
Cardiovascular disease risk factors significantly associated with rosacea included coronary artery disease, cardiovascular disease, peripheral artery disease, heart failure, diabetes mellitus, hypertension, dyslipidemia, and metabolic syndrome. The association with coronary artery disease remained significant after adjusting for multiple variables, as has been shown with psoriasis, which supports consideration of rosacea as an independent risk factor for CAD, the researchers said.
In terms of gastrointestinal comorbidities, the studies reviewed found an association between rosacea and several GI disorders, including celiac disease, Crohn’s disease, and ulcerative colitis, and Helicobacter pylori infection, they wrote. Although the current data do not imply causality, clinicians should screen rosacea patients for GI disorders, they noted.
The link between rosacea and migraine may stem from the similar vascular abnormalities and triggers common to both conditions, such as stress and alcohol, the researchers added.
The review does not establish causality between rosacea and any of the comorbidities examined in part because of the inclusion of observational studies, the researchers noted. “It is also possible that the observed association with rosacea is explained by shared environmental or lifestyle factors rather than by a common genetic disposition or pathophysiologic pathways,” they said. Controlled and prospective studies are needed to better identify associations, but general physicians and dermatologists who recognize the potential risk of comorbidities in rosacea patients may be better able to manage and treat them, they added.
The researchers had no financial conflicts to disclose. There was no funding source for the study.
SOURCE: Haber R et al. J Am Acad Dermatol. 2018 April;78(4):786-92.
according to a review of 29 studies.
The recognition of rosacea as an inflammatory condition similar to psoriasis suggests that, as with psoriasis, rosacea may be associated with a range of systemic diseases, but data on such an association are limited, wrote Roger Haber, MD, from the department of dermatology at Saint George Hospital University Medical Center, Beirut, Lebanon.
“To the best of our knowledge, our study is the first review analyzing available data regarding the diseases associated with rosacea,” they said.
Overall, the most common comorbidities associated with rosacea were depression (reported in 117,848 patients), hypertension (18,176 patients), cardiovascular disease (9,739 patients), anxiety disorder (9,079 patients), dyslipidemia (7,004 patients), diabetes mellitus (6,306 patients), and migraine (6,136 patients). All associations were statistically significant.
Psychological problems significantly associated with rosacea include depression and anxiety, which may be related to similar inflammatory pathways among these conditions, the researchers noted.
Cardiovascular disease risk factors significantly associated with rosacea included coronary artery disease, cardiovascular disease, peripheral artery disease, heart failure, diabetes mellitus, hypertension, dyslipidemia, and metabolic syndrome. The association with coronary artery disease remained significant after adjusting for multiple variables, as has been shown with psoriasis, which supports consideration of rosacea as an independent risk factor for CAD, the researchers said.
In terms of gastrointestinal comorbidities, the studies reviewed found an association between rosacea and several GI disorders, including celiac disease, Crohn’s disease, and ulcerative colitis, and Helicobacter pylori infection, they wrote. Although the current data do not imply causality, clinicians should screen rosacea patients for GI disorders, they noted.
The link between rosacea and migraine may stem from the similar vascular abnormalities and triggers common to both conditions, such as stress and alcohol, the researchers added.
The review does not establish causality between rosacea and any of the comorbidities examined in part because of the inclusion of observational studies, the researchers noted. “It is also possible that the observed association with rosacea is explained by shared environmental or lifestyle factors rather than by a common genetic disposition or pathophysiologic pathways,” they said. Controlled and prospective studies are needed to better identify associations, but general physicians and dermatologists who recognize the potential risk of comorbidities in rosacea patients may be better able to manage and treat them, they added.
The researchers had no financial conflicts to disclose. There was no funding source for the study.
SOURCE: Haber R et al. J Am Acad Dermatol. 2018 April;78(4):786-92.
FROM JAAD
Key clinical point: Rosacea is significantly associated with several comorbidities, including depression, hypertension, cardiovascular disease, and anxiety.
Major finding: Approximately 75% of studies on depression and rosacea showed a positive correlation between these conditions.
Study details: A systematic review of 29 studies: 14 case-control, 8 cross-sectional, and 7 cohort.
Disclosures: The researchers had no financial conflicts to disclose.
Source: Haber R et al. J Am Acad Dermatol. 2018 April;78(4):786-92.
ACOG welcomes over 600 attendees to white coat Capitol Hill
The American College of Obstetricians and Gynecologists’ 36th annual Congressional Leadership Conference was held in Washington March 11-13 with the theme “Facts are important: Women’s health is no exception.”
Approximately 630 fellows, junior fellows, and medical students attended, with 50% of those present being junior fellows. Another 50% were at the CLC for the first time. Forty-nine states were represented. There were a total of 359 meetings with members of Congress, including senators and representatives.
The first day and a half was spent learning about advocacy and current women’s health issues that should be addressed by Congress. Rep. Jaime Herrera Beutler (R-Wash.) discussed her cosponsorship of the House bill, H.R. 1318, the “Preventing Maternal Deaths Act.” The bill authorizes the CDC to provide $7 million annually for grants to states for Maternal Mortality Review Committees (MMRC) in order to create, expand, or support a committee that will collect data so the causes of maternal mortality can be determined and reviewed in each state.
One of the two “asks” for the CLC attendees was to discuss maternal mortality and ask their representatives to cosponsor H.R. 1318 and their senators to cosponsor S. 1112, the “Maternal Health Accountability Act.”
With more women dying from pregnancy complications in the United States than any other developed country, maternal mortality needs to be assessed. Currently 33 states have MMRC while 11 states and the District of Columbia are in the process of establishing the committee.
The rate of maternal mortality has increased from 18.8 maternal deaths per 100,000 live births in 2000 to 23.8 per 100,000 in 2014. African American women are three to four times more likely than non-Hispanic white women to die of pregnancy-related or associated complications in the United States. Causes of maternal death include preeclampsia, hemorrhage, overdosage, and suicide with the leading cause varying from one state to the next.
Sara Rosenbaum, professor of health law and policy at George Washington University, Washington, presented “Medicaid. Facts Matter to Women’s Health.” Rebekah Gee, MD, secretary of the Louisiana Department of Health discussed health care from a state’s perspective.
These and other presenters provided facts that were used for the second ask to the senators and representatives: Medicaid is a women’s health success story. Don’t turn the clock back on women’s health. There was not a specific bill to endorse, but the goal was to endorse continued Medicaid funding for women’s health. Medicaid covers 42.6% of U.S. births and around 75% of public family planning dollars. For every $1 spent for family planning by Medicaid there is a savings of $7.09. Medicaid expansion reduced the uninsured rate among women aged 18-64 years by nearly half from 19.3% to 10.8% in 5 years.
It has been documented that girls enrolled in Medicaid as children are more likely to attend college and experience upward mobility than their peers with the same socioeconomic status who did not have Medicaid. Medicaid helps to provide financial stability and serve as the pathway to jobs for women and girls. Nearly 80% of Medicaid beneficiaries live in working families, and 60% themselves work. Of those who don’t work, 36% do not work because of disability or illness, 30% care for home or family, 15% are in school, 9% are retired, and 6% could not find work. Work requirements add administrative complexity for states and women without long-term gains in employment.
Qualified providers should not be prevented from participating in Medicaid because they perform abortions or provide counseling or refer patients for abortion. Politicians should not select among qualified providers at the expense of women’s access to care. Very often, there are no other providers who can fill the gap, leaving low-income women without access to care.
Willie Parker, MD, addressed reproductive rights and access to care at the President’s Luncheon.
Prior to the Hill visits, attendees were given advice by fellow physicians, Rep. Ami Bera, MD (D-Calif.), and Rep. Raul Ruiz, MD (D-Calif.).
As stated by ACOG President Haywood Brown, MD, “This is a critical moment in our nation’s history. People are engaging like we haven’t seen in our lifetime, and politicians are paying attention. Advocacy efforts around the country are already creating change, in policy and in elections. ... Let’s remind America of what ob.gyns. know best: Facts are important. Women’s health is no exception.”
Dr. Bohon is an ob.gyn. in private practice in Washington. She is an ACOG state legislative chair from the District of Columbia and a member of the Ob.Gyn. News Editorial Advisory Board. She reported having no relevant financial disclosures. Dr. Cuff of the Medical University of South Carolina, Charleston, is the current chair of the Junior Fellow Congress Advisory Council of ACOG.
The American College of Obstetricians and Gynecologists’ 36th annual Congressional Leadership Conference was held in Washington March 11-13 with the theme “Facts are important: Women’s health is no exception.”
Approximately 630 fellows, junior fellows, and medical students attended, with 50% of those present being junior fellows. Another 50% were at the CLC for the first time. Forty-nine states were represented. There were a total of 359 meetings with members of Congress, including senators and representatives.
The first day and a half was spent learning about advocacy and current women’s health issues that should be addressed by Congress. Rep. Jaime Herrera Beutler (R-Wash.) discussed her cosponsorship of the House bill, H.R. 1318, the “Preventing Maternal Deaths Act.” The bill authorizes the CDC to provide $7 million annually for grants to states for Maternal Mortality Review Committees (MMRC) in order to create, expand, or support a committee that will collect data so the causes of maternal mortality can be determined and reviewed in each state.
One of the two “asks” for the CLC attendees was to discuss maternal mortality and ask their representatives to cosponsor H.R. 1318 and their senators to cosponsor S. 1112, the “Maternal Health Accountability Act.”
With more women dying from pregnancy complications in the United States than any other developed country, maternal mortality needs to be assessed. Currently 33 states have MMRC while 11 states and the District of Columbia are in the process of establishing the committee.
The rate of maternal mortality has increased from 18.8 maternal deaths per 100,000 live births in 2000 to 23.8 per 100,000 in 2014. African American women are three to four times more likely than non-Hispanic white women to die of pregnancy-related or associated complications in the United States. Causes of maternal death include preeclampsia, hemorrhage, overdosage, and suicide with the leading cause varying from one state to the next.
Sara Rosenbaum, professor of health law and policy at George Washington University, Washington, presented “Medicaid. Facts Matter to Women’s Health.” Rebekah Gee, MD, secretary of the Louisiana Department of Health discussed health care from a state’s perspective.
These and other presenters provided facts that were used for the second ask to the senators and representatives: Medicaid is a women’s health success story. Don’t turn the clock back on women’s health. There was not a specific bill to endorse, but the goal was to endorse continued Medicaid funding for women’s health. Medicaid covers 42.6% of U.S. births and around 75% of public family planning dollars. For every $1 spent for family planning by Medicaid there is a savings of $7.09. Medicaid expansion reduced the uninsured rate among women aged 18-64 years by nearly half from 19.3% to 10.8% in 5 years.
It has been documented that girls enrolled in Medicaid as children are more likely to attend college and experience upward mobility than their peers with the same socioeconomic status who did not have Medicaid. Medicaid helps to provide financial stability and serve as the pathway to jobs for women and girls. Nearly 80% of Medicaid beneficiaries live in working families, and 60% themselves work. Of those who don’t work, 36% do not work because of disability or illness, 30% care for home or family, 15% are in school, 9% are retired, and 6% could not find work. Work requirements add administrative complexity for states and women without long-term gains in employment.
Qualified providers should not be prevented from participating in Medicaid because they perform abortions or provide counseling or refer patients for abortion. Politicians should not select among qualified providers at the expense of women’s access to care. Very often, there are no other providers who can fill the gap, leaving low-income women without access to care.
Willie Parker, MD, addressed reproductive rights and access to care at the President’s Luncheon.
Prior to the Hill visits, attendees were given advice by fellow physicians, Rep. Ami Bera, MD (D-Calif.), and Rep. Raul Ruiz, MD (D-Calif.).
As stated by ACOG President Haywood Brown, MD, “This is a critical moment in our nation’s history. People are engaging like we haven’t seen in our lifetime, and politicians are paying attention. Advocacy efforts around the country are already creating change, in policy and in elections. ... Let’s remind America of what ob.gyns. know best: Facts are important. Women’s health is no exception.”
Dr. Bohon is an ob.gyn. in private practice in Washington. She is an ACOG state legislative chair from the District of Columbia and a member of the Ob.Gyn. News Editorial Advisory Board. She reported having no relevant financial disclosures. Dr. Cuff of the Medical University of South Carolina, Charleston, is the current chair of the Junior Fellow Congress Advisory Council of ACOG.
The American College of Obstetricians and Gynecologists’ 36th annual Congressional Leadership Conference was held in Washington March 11-13 with the theme “Facts are important: Women’s health is no exception.”
Approximately 630 fellows, junior fellows, and medical students attended, with 50% of those present being junior fellows. Another 50% were at the CLC for the first time. Forty-nine states were represented. There were a total of 359 meetings with members of Congress, including senators and representatives.
The first day and a half was spent learning about advocacy and current women’s health issues that should be addressed by Congress. Rep. Jaime Herrera Beutler (R-Wash.) discussed her cosponsorship of the House bill, H.R. 1318, the “Preventing Maternal Deaths Act.” The bill authorizes the CDC to provide $7 million annually for grants to states for Maternal Mortality Review Committees (MMRC) in order to create, expand, or support a committee that will collect data so the causes of maternal mortality can be determined and reviewed in each state.
One of the two “asks” for the CLC attendees was to discuss maternal mortality and ask their representatives to cosponsor H.R. 1318 and their senators to cosponsor S. 1112, the “Maternal Health Accountability Act.”
With more women dying from pregnancy complications in the United States than any other developed country, maternal mortality needs to be assessed. Currently 33 states have MMRC while 11 states and the District of Columbia are in the process of establishing the committee.
The rate of maternal mortality has increased from 18.8 maternal deaths per 100,000 live births in 2000 to 23.8 per 100,000 in 2014. African American women are three to four times more likely than non-Hispanic white women to die of pregnancy-related or associated complications in the United States. Causes of maternal death include preeclampsia, hemorrhage, overdosage, and suicide with the leading cause varying from one state to the next.
Sara Rosenbaum, professor of health law and policy at George Washington University, Washington, presented “Medicaid. Facts Matter to Women’s Health.” Rebekah Gee, MD, secretary of the Louisiana Department of Health discussed health care from a state’s perspective.
These and other presenters provided facts that were used for the second ask to the senators and representatives: Medicaid is a women’s health success story. Don’t turn the clock back on women’s health. There was not a specific bill to endorse, but the goal was to endorse continued Medicaid funding for women’s health. Medicaid covers 42.6% of U.S. births and around 75% of public family planning dollars. For every $1 spent for family planning by Medicaid there is a savings of $7.09. Medicaid expansion reduced the uninsured rate among women aged 18-64 years by nearly half from 19.3% to 10.8% in 5 years.
It has been documented that girls enrolled in Medicaid as children are more likely to attend college and experience upward mobility than their peers with the same socioeconomic status who did not have Medicaid. Medicaid helps to provide financial stability and serve as the pathway to jobs for women and girls. Nearly 80% of Medicaid beneficiaries live in working families, and 60% themselves work. Of those who don’t work, 36% do not work because of disability or illness, 30% care for home or family, 15% are in school, 9% are retired, and 6% could not find work. Work requirements add administrative complexity for states and women without long-term gains in employment.
Qualified providers should not be prevented from participating in Medicaid because they perform abortions or provide counseling or refer patients for abortion. Politicians should not select among qualified providers at the expense of women’s access to care. Very often, there are no other providers who can fill the gap, leaving low-income women without access to care.
Willie Parker, MD, addressed reproductive rights and access to care at the President’s Luncheon.
Prior to the Hill visits, attendees were given advice by fellow physicians, Rep. Ami Bera, MD (D-Calif.), and Rep. Raul Ruiz, MD (D-Calif.).
As stated by ACOG President Haywood Brown, MD, “This is a critical moment in our nation’s history. People are engaging like we haven’t seen in our lifetime, and politicians are paying attention. Advocacy efforts around the country are already creating change, in policy and in elections. ... Let’s remind America of what ob.gyns. know best: Facts are important. Women’s health is no exception.”
Dr. Bohon is an ob.gyn. in private practice in Washington. She is an ACOG state legislative chair from the District of Columbia and a member of the Ob.Gyn. News Editorial Advisory Board. She reported having no relevant financial disclosures. Dr. Cuff of the Medical University of South Carolina, Charleston, is the current chair of the Junior Fellow Congress Advisory Council of ACOG.
Surgery after immunotherapy effective in advanced melanoma
CHICAGO – Surgical resection is an effective treatment in selected patients with advanced melanoma treated with checkpoint blockade immunotherapy, according to a study of an institutional database at Memorial Sloan Kettering Cancer Center in New York presented at the Society of Surgical Oncology Annual Cancer Symposium.
“In the era of improved systemic therapy, checkpoint blockade for metastatic melanoma and the ability to surgically resect all disease after treatment is associated with an estimated survival of 75%, better than what’s been previously reported,” said Danielle M. Bello, MD, of Memorial Sloan Kettering.
The study analyzed a cohort of 237 patients who had unresectable stage III and IV melanoma and were treated with checkpoint blockade, including CTLA-4, programmed cell death protein 1 (PD-1), and programmed death-ligand 1 inhibitors, and then had surgical resection during 2003-2017.
Dr. Bello noted two previous studies that had reported encouraging outcomes in advanced melanoma. The first highlighted the role for surgery in stage IV melanoma. In that phase 3 clinical trial, patients had resection of up to five sites of metastatic disease and were then randomized to one of two treatment arms: bacillus Calmette-Guérin and allogeneic whole-cell vaccine (Canvaxin) or bacillus Calmette-Guérin and placebo. While this trial found no difference in overall survival between groups, it did report a 5-year overall survival exceeding 40% in both treatment arms, which highlighted that Stage IV patients who underwent resection of all their disease had survival outcomes superior to outcomes previously reported (Ann Surg Onc. 2017 Dec;24[13]:3991-4000). The second trial, the recent Checkmate 067 trial, emphasized the role of effective systemic checkpoint blockade in advanced stage III and IV melanoma. It reported that patients treated with combined nivolumab/ipilimumab therapy had not reached median overall survival at minimum 36 months of follow-up (N Engl J Med. 2017 Oct 5;377[14]:1345-56).
“We know that checkpoint inhibitor therapy has revolutionized the landscape of unresectable stage III and IV melanoma,” Dr. Bello said. However, despite encouraging trial readouts of overall survival, progression-free survival is a different story. “We know that the median progression-free survival even in our best combination therapy is 11.5 months, meaning that 50% of patients will go on to progress in a year and many will go on to surgical resection of their disease and do quite well,” she said.
Dr. Bello and her coauthors set out to describe outcomes of a “highly selective group” of patients who had surgical resection after checkpoint inhibitor therapy. “The majority of patients in our study had a cutaneous primary melanoma,” she said. Median age was 63 years, and 88% had stage IV disease. Regarding checkpoint blockade regimen, 62% received anti–CTLA-4, and 29% received combination anti–PD-1 and anti–CLTA-4 either sequentially or concomitantly prior to resection.
The median time from the start of immunotherapy to the first operation was 7 months. Forty-six percent had no further postoperative treatment after resection. In those, who did require further treatment, the majority received anti–PD-1 followed by targeted BRAF/MEK therapy, she said.
The analysis stratified patients into the following three categories based on radiological response to immunotherapy:
- Overall response to checkpoint blockade and the index lesion was either smaller since initiation of therapy or stabilized (12; 5.1%). Half of this group had a pathological complete response.
- Isolated site of progressive disease with residual stable disease elsewhere or as the only site of progressive disease (106; 44.7%).
- Multiple sites of progressive and palliative operations (119; 50.2%).
Median overall survival was 21 months in the entire study cohort with a median follow-up of 23 months, Dr. Bello said. “Those resected to no evidence of disease (NED) – 87 patients – had an estimated 5-year overall survival of 75%.” The NED group did not reach median OS.
The analysis also stratified overall survival by response to immunotherapy. “Patients with responding or stable disease had an estimated 90% 5-year overall survival,” Dr. Bellow said. “Those with one isolated progressive lesion that was resected had a 60% 5-year overall survival.” A more detailed analysis of the latter group found that those who had a resection to NED had an improved overall survival of 75% at 5 years. Resected patients who had residual remaining disease had a 30% 5-year overall survival.
“Further follow-up is needed to assess the durability and contributions of surgery, and further studies are underway to identify biomarkers associated with improved survival after immunotherapy and surgery,” Dr. Bello said.
SOURCE: Bello DM et al. SSO 2018, Abstract 5.
CHICAGO – Surgical resection is an effective treatment in selected patients with advanced melanoma treated with checkpoint blockade immunotherapy, according to a study of an institutional database at Memorial Sloan Kettering Cancer Center in New York presented at the Society of Surgical Oncology Annual Cancer Symposium.
“In the era of improved systemic therapy, checkpoint blockade for metastatic melanoma and the ability to surgically resect all disease after treatment is associated with an estimated survival of 75%, better than what’s been previously reported,” said Danielle M. Bello, MD, of Memorial Sloan Kettering.
The study analyzed a cohort of 237 patients who had unresectable stage III and IV melanoma and were treated with checkpoint blockade, including CTLA-4, programmed cell death protein 1 (PD-1), and programmed death-ligand 1 inhibitors, and then had surgical resection during 2003-2017.
Dr. Bello noted two previous studies that had reported encouraging outcomes in advanced melanoma. The first highlighted the role for surgery in stage IV melanoma. In that phase 3 clinical trial, patients had resection of up to five sites of metastatic disease and were then randomized to one of two treatment arms: bacillus Calmette-Guérin and allogeneic whole-cell vaccine (Canvaxin) or bacillus Calmette-Guérin and placebo. While this trial found no difference in overall survival between groups, it did report a 5-year overall survival exceeding 40% in both treatment arms, which highlighted that Stage IV patients who underwent resection of all their disease had survival outcomes superior to outcomes previously reported (Ann Surg Onc. 2017 Dec;24[13]:3991-4000). The second trial, the recent Checkmate 067 trial, emphasized the role of effective systemic checkpoint blockade in advanced stage III and IV melanoma. It reported that patients treated with combined nivolumab/ipilimumab therapy had not reached median overall survival at minimum 36 months of follow-up (N Engl J Med. 2017 Oct 5;377[14]:1345-56).
“We know that checkpoint inhibitor therapy has revolutionized the landscape of unresectable stage III and IV melanoma,” Dr. Bello said. However, despite encouraging trial readouts of overall survival, progression-free survival is a different story. “We know that the median progression-free survival even in our best combination therapy is 11.5 months, meaning that 50% of patients will go on to progress in a year and many will go on to surgical resection of their disease and do quite well,” she said.
Dr. Bello and her coauthors set out to describe outcomes of a “highly selective group” of patients who had surgical resection after checkpoint inhibitor therapy. “The majority of patients in our study had a cutaneous primary melanoma,” she said. Median age was 63 years, and 88% had stage IV disease. Regarding checkpoint blockade regimen, 62% received anti–CTLA-4, and 29% received combination anti–PD-1 and anti–CLTA-4 either sequentially or concomitantly prior to resection.
The median time from the start of immunotherapy to the first operation was 7 months. Forty-six percent had no further postoperative treatment after resection. In those, who did require further treatment, the majority received anti–PD-1 followed by targeted BRAF/MEK therapy, she said.
The analysis stratified patients into the following three categories based on radiological response to immunotherapy:
- Overall response to checkpoint blockade and the index lesion was either smaller since initiation of therapy or stabilized (12; 5.1%). Half of this group had a pathological complete response.
- Isolated site of progressive disease with residual stable disease elsewhere or as the only site of progressive disease (106; 44.7%).
- Multiple sites of progressive and palliative operations (119; 50.2%).
Median overall survival was 21 months in the entire study cohort with a median follow-up of 23 months, Dr. Bello said. “Those resected to no evidence of disease (NED) – 87 patients – had an estimated 5-year overall survival of 75%.” The NED group did not reach median OS.
The analysis also stratified overall survival by response to immunotherapy. “Patients with responding or stable disease had an estimated 90% 5-year overall survival,” Dr. Bellow said. “Those with one isolated progressive lesion that was resected had a 60% 5-year overall survival.” A more detailed analysis of the latter group found that those who had a resection to NED had an improved overall survival of 75% at 5 years. Resected patients who had residual remaining disease had a 30% 5-year overall survival.
“Further follow-up is needed to assess the durability and contributions of surgery, and further studies are underway to identify biomarkers associated with improved survival after immunotherapy and surgery,” Dr. Bello said.
SOURCE: Bello DM et al. SSO 2018, Abstract 5.
CHICAGO – Surgical resection is an effective treatment in selected patients with advanced melanoma treated with checkpoint blockade immunotherapy, according to a study of an institutional database at Memorial Sloan Kettering Cancer Center in New York presented at the Society of Surgical Oncology Annual Cancer Symposium.
“In the era of improved systemic therapy, checkpoint blockade for metastatic melanoma and the ability to surgically resect all disease after treatment is associated with an estimated survival of 75%, better than what’s been previously reported,” said Danielle M. Bello, MD, of Memorial Sloan Kettering.
The study analyzed a cohort of 237 patients who had unresectable stage III and IV melanoma and were treated with checkpoint blockade, including CTLA-4, programmed cell death protein 1 (PD-1), and programmed death-ligand 1 inhibitors, and then had surgical resection during 2003-2017.
Dr. Bello noted two previous studies that had reported encouraging outcomes in advanced melanoma. The first highlighted the role for surgery in stage IV melanoma. In that phase 3 clinical trial, patients had resection of up to five sites of metastatic disease and were then randomized to one of two treatment arms: bacillus Calmette-Guérin and allogeneic whole-cell vaccine (Canvaxin) or bacillus Calmette-Guérin and placebo. While this trial found no difference in overall survival between groups, it did report a 5-year overall survival exceeding 40% in both treatment arms, which highlighted that Stage IV patients who underwent resection of all their disease had survival outcomes superior to outcomes previously reported (Ann Surg Onc. 2017 Dec;24[13]:3991-4000). The second trial, the recent Checkmate 067 trial, emphasized the role of effective systemic checkpoint blockade in advanced stage III and IV melanoma. It reported that patients treated with combined nivolumab/ipilimumab therapy had not reached median overall survival at minimum 36 months of follow-up (N Engl J Med. 2017 Oct 5;377[14]:1345-56).
“We know that checkpoint inhibitor therapy has revolutionized the landscape of unresectable stage III and IV melanoma,” Dr. Bello said. However, despite encouraging trial readouts of overall survival, progression-free survival is a different story. “We know that the median progression-free survival even in our best combination therapy is 11.5 months, meaning that 50% of patients will go on to progress in a year and many will go on to surgical resection of their disease and do quite well,” she said.
Dr. Bello and her coauthors set out to describe outcomes of a “highly selective group” of patients who had surgical resection after checkpoint inhibitor therapy. “The majority of patients in our study had a cutaneous primary melanoma,” she said. Median age was 63 years, and 88% had stage IV disease. Regarding checkpoint blockade regimen, 62% received anti–CTLA-4, and 29% received combination anti–PD-1 and anti–CLTA-4 either sequentially or concomitantly prior to resection.
The median time from the start of immunotherapy to the first operation was 7 months. Forty-six percent had no further postoperative treatment after resection. In those, who did require further treatment, the majority received anti–PD-1 followed by targeted BRAF/MEK therapy, she said.
The analysis stratified patients into the following three categories based on radiological response to immunotherapy:
- Overall response to checkpoint blockade and the index lesion was either smaller since initiation of therapy or stabilized (12; 5.1%). Half of this group had a pathological complete response.
- Isolated site of progressive disease with residual stable disease elsewhere or as the only site of progressive disease (106; 44.7%).
- Multiple sites of progressive and palliative operations (119; 50.2%).
Median overall survival was 21 months in the entire study cohort with a median follow-up of 23 months, Dr. Bello said. “Those resected to no evidence of disease (NED) – 87 patients – had an estimated 5-year overall survival of 75%.” The NED group did not reach median OS.
The analysis also stratified overall survival by response to immunotherapy. “Patients with responding or stable disease had an estimated 90% 5-year overall survival,” Dr. Bellow said. “Those with one isolated progressive lesion that was resected had a 60% 5-year overall survival.” A more detailed analysis of the latter group found that those who had a resection to NED had an improved overall survival of 75% at 5 years. Resected patients who had residual remaining disease had a 30% 5-year overall survival.
“Further follow-up is needed to assess the durability and contributions of surgery, and further studies are underway to identify biomarkers associated with improved survival after immunotherapy and surgery,” Dr. Bello said.
SOURCE: Bello DM et al. SSO 2018, Abstract 5.
REPORTING FROM SSO 2018
Key clinical point: Surgery after immunotherapy can achieve good outcomes in advanced melanoma.
Major findings: Complete resection achieved an estimated 5-year overall survival of 75%.
Study details: Analysis of a cohort of 237 patients from a prospectively maintained institutional melanoma database who had surgery after immunotherapy for unresectable stage III and IV melanoma during 2003-2017.
Disclosures: Dr. Bello reported having no financial disclosures. Some coauthors reported financial relationships with various pharmaceutical companies.
Source: Bello DM et al. SSO 2018, Abstract 5.