Commentary

Along with resigning as chairman of the department of hematology and medical oncology at the Cleveland Clinic (Reunion), I am also resigning as editor in chief of Hematology News. In contrast to the drawn out process of choosing the next department chairman, however, I was in the enviable position of being able to hand pick my successor as editor in chief. I am proud to announce that Ifeyinwa (Ify) Osunkwo, MD, MPH, will be the new editor in chief of Hematology News. Dr. Osunkwo’s new perspective and energy will guide the further development of Hematology News for the benefit of our readers.

As editor in chief, I have had the opportunity to write essays for Hematology News that reflect my experience as a leader in an academic medical department. By doing so, I was trying to summarize some of what I learned along my career path. In my final essay, I want to direct some of these nuggets of wisdom directly to aspiring leaders who are closer to the beginning of their career journey than I am.

My junior colleagues are very interested in developing their careers to maximize opportunities in leadership, and I have coached many to try to understand that the path to leadership is not always straight, may be difficult, and does not always end comfortably. While the goal may seem to be in one direction, the path may lead to another. That is what has happened to me.

I did not seek to be Chairman. The opportunity came to me while I was busy doing other things. As I expressed in an earlier editorial (Seeking the chair), those who are diligent about their work without actively trying to rise through the leadership hierarchy are the ones who seem to rise more often.

Ambition is overrated. The ambitious find it harder to accept failure, and some degree of failure is likely. In his book “Falling Upward: A Spirituality for the Two Halves of Life,” Father Richard Rohr suggests that failure is required in order to mature from someone whose life centers on self to someone whose self centers on life.

Junior faculty tend to focus on self. They try to excel at whatever they attempt as they always have. Whether that is teaching, performing research, or treating patients, they try to be the absolute best teacher, researcher, or practitioner they can be. Many try to do all three well. Rare are those who can perfectly balance all three endeavors. Tension results, both at work and at home. Here is where failure often happens. The student disappoints, the paper is rejected, the grant isn’t funded, the patient relapses, and the family wishes you were home more. This confluence of difficulties challenges our concept of self. Maybe we aren’t perfect after all. Perhaps for the first time, failure looms.

In my experience, the usual solution to the possibility of failure is a desire to reduce patient care responsibilities. Academic faculty cherish their protected time and usually look for ways to increase it rather than to balance it (Professional time). Academic careers require thick CVs, not satisfied patients. A talk on leukemia at a major conference is more valued than talking to a patient about their leukemia. The cognitive dissonance between what we think is important and what is actually important challenges our personal sense of identity. The resulting burnout represents the necessary failure required to then mature spiritually and reprioritize our ambitions.

On some level, then, the path most of us are on is the time-honored – but painful – journey that must be traveled in order to attain peace.

I also recommend planning a career path with quality work, not a future title, as the goal. Quality work implies measurable objectives. For teachers, work could be measured by teaching scores and student accomplishments. For researchers, work could be measured by published papers, grants received, and invited lectures. For practitioners, work could be measured by outcomes, particularly patient-reported outcomes. Once work is measured, continuous improvements can be made and tracked. Highly reliable teachers, researchers, and practitioners who value quality work will be rewarded both personally and professionally (Defining high reliability).

There is a difference, however, between trying to be the best and trying to improve. The former implies competition with someone else, while the latter involves only one person. Competition can be motivating, but can also undermine interpersonal relationships while causing unhealthy behaviors like overworking and sleep deprivation. If the position sought requires selfish and destructive behaviors, it is not a position worth seeking (Rat race).

By doing quality work – not just more work – leadership positions will inevitably follow. Once a position is obtained, the work increases because a leader is now responsible for others. There are some easy-to-learn tools that can help with that responsibility. I find them very useful for helping colleagues work through interpersonal struggles and resource issues (Leadership hacks: The drama triangle; Leadership hacks: Structural tension).

Success as a leader is harder to measure, but many institutions employ engagement surveys similar to job satisfaction surveys. Leadership scores are generally accurate reflections of leader effectiveness, as are 360-degree surveys of those who work with you. Of course, being a leader also means holding those in your charge accountable for their behaviors (The white wall; Full disclosure). Leadership is no place for someone unwilling to hold crucial and difficult conversations with colleagues.

Success, of course, begets success and additional leadership roles are offered to successful leaders. Meanwhile, the work you started in order to get to the leadership position will probably need to be scaled back as excellence in teaching, research, patient care, and leadership is daunting, difficult to manage, and threatens work-life balance. The ability to say “no” is a valuable skill to learn as leadership roles increase.

Even though none of us work alone, academic medicine generally rewards only the individual. Yet, the camaraderie developed over time working together helps balance work and life roles. To advance as a leader, learning to work in a team is a critical ability. There is a science behind teamwork and aspiring leaders should acquaint themselves with it (Successful teams). While you may be rewarded as an individual, your success will be dependent on your ability to work on a team.

Finally, at least for clinicians, our obligation to our patients largely supersedes all our other commitments. Knowing the most, or being the most technically gifted, is not what patients value. They value empathy and relationships. We need to develop care designed for them, not us (Timed perfectly). We need to communicate with them on their terms, not ours (Pathologic superstition). We must walk with patients on their path, not ours. A patient-centered approach to care and career can take you far. Good luck on your journey.

Dr. Kalaycio is the outgoing editor in chief of Hematology News. He is a hematologist-oncologist at the Cleveland Clinic Taussig Cancer Institute. Contact him at [email protected].

Along with resigning as chairman of the department of hematology and medical oncology at the Cleveland Clinic (Reunion), I am also resigning as editor in chief of Hematology News. In contrast to the drawn out process of choosing the next department chairman, however, I was in the enviable position of being able to hand pick my successor as editor in chief. I am proud to announce that Ifeyinwa (Ify) Osunkwo, MD, MPH, will be the new editor in chief of Hematology News. Dr. Osunkwo’s new perspective and energy will guide the further development of Hematology News for the benefit of our readers.

As editor in chief, I have had the opportunity to write essays for Hematology News that reflect my experience as a leader in an academic medical department. By doing so, I was trying to summarize some of what I learned along my career path. In my final essay, I want to direct some of these nuggets of wisdom directly to aspiring leaders who are closer to the beginning of their career journey than I am.

My junior colleagues are very interested in developing their careers to maximize opportunities in leadership, and I have coached many to try to understand that the path to leadership is not always straight, may be difficult, and does not always end comfortably. While the goal may seem to be in one direction, the path may lead to another. That is what has happened to me.

I did not seek to be Chairman. The opportunity came to me while I was busy doing other things. As I expressed in an earlier editorial (Seeking the chair), those who are diligent about their work without actively trying to rise through the leadership hierarchy are the ones who seem to rise more often.

Ambition is overrated. The ambitious find it harder to accept failure, and some degree of failure is likely. In his book “Falling Upward: A Spirituality for the Two Halves of Life,” Father Richard Rohr suggests that failure is required in order to mature from someone whose life centers on self to someone whose self centers on life.

Junior faculty tend to focus on self. They try to excel at whatever they attempt as they always have. Whether that is teaching, performing research, or treating patients, they try to be the absolute best teacher, researcher, or practitioner they can be. Many try to do all three well. Rare are those who can perfectly balance all three endeavors. Tension results, both at work and at home. Here is where failure often happens. The student disappoints, the paper is rejected, the grant isn’t funded, the patient relapses, and the family wishes you were home more. This confluence of difficulties challenges our concept of self. Maybe we aren’t perfect after all. Perhaps for the first time, failure looms.

In my experience, the usual solution to the possibility of failure is a desire to reduce patient care responsibilities. Academic faculty cherish their protected time and usually look for ways to increase it rather than to balance it (Professional time). Academic careers require thick CVs, not satisfied patients. A talk on leukemia at a major conference is more valued than talking to a patient about their leukemia. The cognitive dissonance between what we think is important and what is actually important challenges our personal sense of identity. The resulting burnout represents the necessary failure required to then mature spiritually and reprioritize our ambitions.

On some level, then, the path most of us are on is the time-honored – but painful – journey that must be traveled in order to attain peace.

I also recommend planning a career path with quality work, not a future title, as the goal. Quality work implies measurable objectives. For teachers, work could be measured by teaching scores and student accomplishments. For researchers, work could be measured by published papers, grants received, and invited lectures. For practitioners, work could be measured by outcomes, particularly patient-reported outcomes. Once work is measured, continuous improvements can be made and tracked. Highly reliable teachers, researchers, and practitioners who value quality work will be rewarded both personally and professionally (Defining high reliability).

There is a difference, however, between trying to be the best and trying to improve. The former implies competition with someone else, while the latter involves only one person. Competition can be motivating, but can also undermine interpersonal relationships while causing unhealthy behaviors like overworking and sleep deprivation. If the position sought requires selfish and destructive behaviors, it is not a position worth seeking (Rat race).

By doing quality work – not just more work – leadership positions will inevitably follow. Once a position is obtained, the work increases because a leader is now responsible for others. There are some easy-to-learn tools that can help with that responsibility. I find them very useful for helping colleagues work through interpersonal struggles and resource issues (Leadership hacks: The drama triangle; Leadership hacks: Structural tension).

Success as a leader is harder to measure, but many institutions employ engagement surveys similar to job satisfaction surveys. Leadership scores are generally accurate reflections of leader effectiveness, as are 360-degree surveys of those who work with you. Of course, being a leader also means holding those in your charge accountable for their behaviors (The white wall; Full disclosure). Leadership is no place for someone unwilling to hold crucial and difficult conversations with colleagues.

Success, of course, begets success and additional leadership roles are offered to successful leaders. Meanwhile, the work you started in order to get to the leadership position will probably need to be scaled back as excellence in teaching, research, patient care, and leadership is daunting, difficult to manage, and threatens work-life balance. The ability to say “no” is a valuable skill to learn as leadership roles increase.

Even though none of us work alone, academic medicine generally rewards only the individual. Yet, the camaraderie developed over time working together helps balance work and life roles. To advance as a leader, learning to work in a team is a critical ability. There is a science behind teamwork and aspiring leaders should acquaint themselves with it (Successful teams). While you may be rewarded as an individual, your success will be dependent on your ability to work on a team.

Finally, at least for clinicians, our obligation to our patients largely supersedes all our other commitments. Knowing the most, or being the most technically gifted, is not what patients value. They value empathy and relationships. We need to develop care designed for them, not us (Timed perfectly). We need to communicate with them on their terms, not ours (Pathologic superstition). We must walk with patients on their path, not ours. A patient-centered approach to care and career can take you far. Good luck on your journey.

Dr. Kalaycio is the outgoing editor in chief of Hematology News. He is a hematologist-oncologist at the Cleveland Clinic Taussig Cancer Institute. Contact him at [email protected].

Along with resigning as chairman of the department of hematology and medical oncology at the Cleveland Clinic (Reunion), I am also resigning as editor in chief of Hematology News. In contrast to the drawn out process of choosing the next department chairman, however, I was in the enviable position of being able to hand pick my successor as editor in chief. I am proud to announce that Ifeyinwa (Ify) Osunkwo, MD, MPH, will be the new editor in chief of Hematology News. Dr. Osunkwo’s new perspective and energy will guide the further development of Hematology News for the benefit of our readers.

As editor in chief, I have had the opportunity to write essays for Hematology News that reflect my experience as a leader in an academic medical department. By doing so, I was trying to summarize some of what I learned along my career path. In my final essay, I want to direct some of these nuggets of wisdom directly to aspiring leaders who are closer to the beginning of their career journey than I am.

My junior colleagues are very interested in developing their careers to maximize opportunities in leadership, and I have coached many to try to understand that the path to leadership is not always straight, may be difficult, and does not always end comfortably. While the goal may seem to be in one direction, the path may lead to another. That is what has happened to me.

I did not seek to be Chairman. The opportunity came to me while I was busy doing other things. As I expressed in an earlier editorial (Seeking the chair), those who are diligent about their work without actively trying to rise through the leadership hierarchy are the ones who seem to rise more often.

Ambition is overrated. The ambitious find it harder to accept failure, and some degree of failure is likely. In his book “Falling Upward: A Spirituality for the Two Halves of Life,” Father Richard Rohr suggests that failure is required in order to mature from someone whose life centers on self to someone whose self centers on life.

Junior faculty tend to focus on self. They try to excel at whatever they attempt as they always have. Whether that is teaching, performing research, or treating patients, they try to be the absolute best teacher, researcher, or practitioner they can be. Many try to do all three well. Rare are those who can perfectly balance all three endeavors. Tension results, both at work and at home. Here is where failure often happens. The student disappoints, the paper is rejected, the grant isn’t funded, the patient relapses, and the family wishes you were home more. This confluence of difficulties challenges our concept of self. Maybe we aren’t perfect after all. Perhaps for the first time, failure looms.

In my experience, the usual solution to the possibility of failure is a desire to reduce patient care responsibilities. Academic faculty cherish their protected time and usually look for ways to increase it rather than to balance it (Professional time). Academic careers require thick CVs, not satisfied patients. A talk on leukemia at a major conference is more valued than talking to a patient about their leukemia. The cognitive dissonance between what we think is important and what is actually important challenges our personal sense of identity. The resulting burnout represents the necessary failure required to then mature spiritually and reprioritize our ambitions.

On some level, then, the path most of us are on is the time-honored – but painful – journey that must be traveled in order to attain peace.

I also recommend planning a career path with quality work, not a future title, as the goal. Quality work implies measurable objectives. For teachers, work could be measured by teaching scores and student accomplishments. For researchers, work could be measured by published papers, grants received, and invited lectures. For practitioners, work could be measured by outcomes, particularly patient-reported outcomes. Once work is measured, continuous improvements can be made and tracked. Highly reliable teachers, researchers, and practitioners who value quality work will be rewarded both personally and professionally (Defining high reliability).

There is a difference, however, between trying to be the best and trying to improve. The former implies competition with someone else, while the latter involves only one person. Competition can be motivating, but can also undermine interpersonal relationships while causing unhealthy behaviors like overworking and sleep deprivation. If the position sought requires selfish and destructive behaviors, it is not a position worth seeking (Rat race).

By doing quality work – not just more work – leadership positions will inevitably follow. Once a position is obtained, the work increases because a leader is now responsible for others. There are some easy-to-learn tools that can help with that responsibility. I find them very useful for helping colleagues work through interpersonal struggles and resource issues (Leadership hacks: The drama triangle; Leadership hacks: Structural tension).

Success as a leader is harder to measure, but many institutions employ engagement surveys similar to job satisfaction surveys. Leadership scores are generally accurate reflections of leader effectiveness, as are 360-degree surveys of those who work with you. Of course, being a leader also means holding those in your charge accountable for their behaviors (The white wall; Full disclosure). Leadership is no place for someone unwilling to hold crucial and difficult conversations with colleagues.

Success, of course, begets success and additional leadership roles are offered to successful leaders. Meanwhile, the work you started in order to get to the leadership position will probably need to be scaled back as excellence in teaching, research, patient care, and leadership is daunting, difficult to manage, and threatens work-life balance. The ability to say “no” is a valuable skill to learn as leadership roles increase.

Even though none of us work alone, academic medicine generally rewards only the individual. Yet, the camaraderie developed over time working together helps balance work and life roles. To advance as a leader, learning to work in a team is a critical ability. There is a science behind teamwork and aspiring leaders should acquaint themselves with it (Successful teams). While you may be rewarded as an individual, your success will be dependent on your ability to work on a team.

Finally, at least for clinicians, our obligation to our patients largely supersedes all our other commitments. Knowing the most, or being the most technically gifted, is not what patients value. They value empathy and relationships. We need to develop care designed for them, not us (Timed perfectly). We need to communicate with them on their terms, not ours (Pathologic superstition). We must walk with patients on their path, not ours. A patient-centered approach to care and career can take you far. Good luck on your journey.

Dr. Kalaycio is the outgoing editor in chief of Hematology News. He is a hematologist-oncologist at the Cleveland Clinic Taussig Cancer Institute. Contact him at [email protected].

Julia Brennan sings about inner demons. They just won’t go away and they don’t play fair with angels. We have marveled at the miracles of fecal microbiome transplants (FMT), but this month we read about an inner demon. Two patients developed bacteremia from extended-spectrum beta-lactamase (ESBL)–producing Escherichia coli transmitted during FMT from stool derived from a single donor. One patient, with cirrhosis, who received FMT as part of a trial to treat hepatic encephalopathy, recovered. A second patient with myelodysplastic syndrome underwent allogeneic hematopoietic stem cell transplantation and received FMT as part of a phase 2 trial. This severely immunocompromised patient succumbed to sepsis related to the E. coli bacteremia. Both organisms were genetically traced to the donor stool. The AGA has NIH funding to develop and maintain an FMT registry (see https://www.gastrojournal.org/article/S0016-5085(17)30088-4/pdf) so we can understand long-term risks and benefits.

These rare experiences will lead to increased scrutiny and likely further FDA regulations. Gastroenterologists should be careful about choosing patients for FMT.

This month, we again feature an article about incorporating telehealth into your practice – this month’s article highlights the potential for private practices to incorporate this emerging technology. There are interesting articles about treatment of eosinophilic esophagitis, acute liver failure, and postcolonoscopy interval cancers. Finally, we are cautioned about the vulnerability of our biosimilar market. This market may wither despite the great potential to reduce therapeutic costs.

Last week, I taught an undergraduate course about health care economics. After recounting current challenges, one student said, “I am a first-year medical student, what should I do?” I was caught off guard. The future is too overwhelming. As we enter the 12-month countdown to a national election, I would suggest that we continue to advocate for our patients and educate our political leaders about verifiable root causes of our major problems. Despite current antipathy to science and data, we are scientists and eventually truth will prevail. “The arc of the moral universe is long, but it bends towards justice” (Dr. Martin Luther King, Jr.).
 

John I. Allen, MD, MBA, AGAF
Editor in Chief

Julia Brennan sings about inner demons. They just won’t go away and they don’t play fair with angels. We have marveled at the miracles of fecal microbiome transplants (FMT), but this month we read about an inner demon. Two patients developed bacteremia from extended-spectrum beta-lactamase (ESBL)–producing Escherichia coli transmitted during FMT from stool derived from a single donor. One patient, with cirrhosis, who received FMT as part of a trial to treat hepatic encephalopathy, recovered. A second patient with myelodysplastic syndrome underwent allogeneic hematopoietic stem cell transplantation and received FMT as part of a phase 2 trial. This severely immunocompromised patient succumbed to sepsis related to the E. coli bacteremia. Both organisms were genetically traced to the donor stool. The AGA has NIH funding to develop and maintain an FMT registry (see https://www.gastrojournal.org/article/S0016-5085(17)30088-4/pdf) so we can understand long-term risks and benefits.

These rare experiences will lead to increased scrutiny and likely further FDA regulations. Gastroenterologists should be careful about choosing patients for FMT.

This month, we again feature an article about incorporating telehealth into your practice – this month’s article highlights the potential for private practices to incorporate this emerging technology. There are interesting articles about treatment of eosinophilic esophagitis, acute liver failure, and postcolonoscopy interval cancers. Finally, we are cautioned about the vulnerability of our biosimilar market. This market may wither despite the great potential to reduce therapeutic costs.

Last week, I taught an undergraduate course about health care economics. After recounting current challenges, one student said, “I am a first-year medical student, what should I do?” I was caught off guard. The future is too overwhelming. As we enter the 12-month countdown to a national election, I would suggest that we continue to advocate for our patients and educate our political leaders about verifiable root causes of our major problems. Despite current antipathy to science and data, we are scientists and eventually truth will prevail. “The arc of the moral universe is long, but it bends towards justice” (Dr. Martin Luther King, Jr.).
 

John I. Allen, MD, MBA, AGAF
Editor in Chief

Julia Brennan sings about inner demons. They just won’t go away and they don’t play fair with angels. We have marveled at the miracles of fecal microbiome transplants (FMT), but this month we read about an inner demon. Two patients developed bacteremia from extended-spectrum beta-lactamase (ESBL)–producing Escherichia coli transmitted during FMT from stool derived from a single donor. One patient, with cirrhosis, who received FMT as part of a trial to treat hepatic encephalopathy, recovered. A second patient with myelodysplastic syndrome underwent allogeneic hematopoietic stem cell transplantation and received FMT as part of a phase 2 trial. This severely immunocompromised patient succumbed to sepsis related to the E. coli bacteremia. Both organisms were genetically traced to the donor stool. The AGA has NIH funding to develop and maintain an FMT registry (see https://www.gastrojournal.org/article/S0016-5085(17)30088-4/pdf) so we can understand long-term risks and benefits.

These rare experiences will lead to increased scrutiny and likely further FDA regulations. Gastroenterologists should be careful about choosing patients for FMT.

This month, we again feature an article about incorporating telehealth into your practice – this month’s article highlights the potential for private practices to incorporate this emerging technology. There are interesting articles about treatment of eosinophilic esophagitis, acute liver failure, and postcolonoscopy interval cancers. Finally, we are cautioned about the vulnerability of our biosimilar market. This market may wither despite the great potential to reduce therapeutic costs.

Last week, I taught an undergraduate course about health care economics. After recounting current challenges, one student said, “I am a first-year medical student, what should I do?” I was caught off guard. The future is too overwhelming. As we enter the 12-month countdown to a national election, I would suggest that we continue to advocate for our patients and educate our political leaders about verifiable root causes of our major problems. Despite current antipathy to science and data, we are scientists and eventually truth will prevail. “The arc of the moral universe is long, but it bends towards justice” (Dr. Martin Luther King, Jr.).
 

John I. Allen, MD, MBA, AGAF
Editor in Chief

In the 2012 movie “Robot and Frank,” an aging ex-jewel thief named Frank receives a robotic home assistant from his well-meaning son. Frank lives alone and suffers from dementia, and his son hopes that the friendly electronic companion will help keep his father safe, assisting him with housework and improving his cognitive health. Frank initially rejects the idea but changes his mind when he realizes the robot’s talents aren’t limited to domestic chores. He begins teaching the robot new skills, and an unlikely partnership develops. With Frank’s penchant for pilfering and the robot’s digital dexterity, the two of them pull off a multimillion-dollar jewelry heist – and Frank’s outlook improves in ways his son never dreamed possible!

©koya79/Fotolia.com

“Robot and Frank” takes place “in the near future,” and while we don’t yet have robotic home companions as capable as the one in the movie, we need not look very far to realize that robotics and artificial intelligence may revolutionize the delivery of health care.

With an aging population and an industry shift toward value-based care, new research has focused on novel ways of avoiding hospitalization and reducing hospital readmission. We have seen a resurgence of home visits and the development of telemedicine and remote monitoring.

To stay healthy, patients need to be safe in their home environment and at a minimum need to be able to navigate their activities of daily living. Research published last year by Washington University’s Center for Advanced Studies in Adaptive Systems (CASAS) describes a technology that aims to help patients in their own homes.

The Robot Activity Support system, or RAS, interacts with intelligent sensors in a home environment “to detect and assist with activity errors that may occur in everyday settings.”¹ If sensors in the home indicate that a person is experiencing difficulty completing a certain task such as taking a medication or finding a bathroom, a robot can navigate to the person in need and show an instructional video, or lead the patient to the next step in the process.

Another manufacturer is taking a ‘softer’ approach to activity support in the elderly. Toymaker Hasbro has developed a line of robotic cats that provide companionship and comfort. While currently limited to tactile stimulation and simple responses, the manufacturer is working in collaboration with researchers at Brown University to add artificial intelligence capabilities. The goal of the program – Project ARIES (Affordable Robotic Intelligence for Elderly Support) – is to give the cats useful skills such as being able to provide medication and safety reminders while keeping their price point accessible to all.

Other organizations are attempting to take the robotic home health aide idea to the next level. “RUDY,” a robotic companion developed by INF Robotics, is capable of much more than just educating patients and leading them around the house. About the size of small child and wearing a huge smile, Rudy can detect falls, ensure medication adherence, provide social interaction, and even offer remote patient monitoring. According to the manufacturer, it uses natural language processing, machine learning, and a smart social interface to “facilitate trusting relationships between RUDY and older adults.” The idea is to promote acceptance from patients and offer peace of mind to their loved ones. This can be particularly valuable in assisting those with dementia, as a heavy emphasis is placed on socialization and maintaining cognitive stimulation.

Instead of developing novel artificial intelligence platforms, many groups are attempting to leverage existing technologies to assist patients in their homes. One such technology is Amazon’s Echo smart speakers, which became more attractive to health care providers on April 4 of this year with the launch of the Alexa Healthcare Skills Kit. This is Amazon’s HIPAA-compliant application programming interface (API) that allows developers to create ‘skills’ (apps for Echo devices) that can securely handle protected health information.

At launch, Amazon announced six partner organizations who have already written skills for patients. One organization, Boston Children’s Hospital, developed a skill called My Children’s Enhanced Recovery After Surgery (ERAS). According to John Brownstein, the hospital’s Chief Innovation Officer, it “allows patients and caregivers to easily share recovery progress with their care team post surgery ... it is just one example of how voice technology can extend the care and support of our patients beyond the four walls of the hospital.”

Some companies, such as HealthTap, have been working on artificial intelligence to build a platform to allow physicians and patients to interact online. HealthTap is leveraging the wisdom of those interactions to power a deep learning system called Dr. A.I. Available for Alexa and mobile devices, it attempts to assess patients’ symptoms and provide personalized medical explanations and health recommendations. In the developer’s own words: “Dr. A.I. engages with you in an empathetic conversation about your symptoms and overall health ... then gives you appropriate doctor-recommended insights as well as the best possible courses of action you can take on the road to feeling good.”

Some physicians may find this movement troubling, but we believe it represents an early glimpse of what is to come. As technology gets smarter and patients become more comfortable interacting with it, there will be greater demand for virtual caretakers and digital doctors, with no shortage of companies stepping up to meet the demand. While it’s doubtful the robots they create can be easily reprogrammed to steal jewelry, it won’t stop them from trying to steal our jobs. We as physicians will need to continue to hone our skills in compassion and empathy to provide something a computer never can: true care for our patients.

Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.

Reference

1. Robot-enabled support of daily activities in smart home environments. Cogn Syst Res. 2019 May. doi: 10.1016/j.cogsys.2018.10.032.

In the 2012 movie “Robot and Frank,” an aging ex-jewel thief named Frank receives a robotic home assistant from his well-meaning son. Frank lives alone and suffers from dementia, and his son hopes that the friendly electronic companion will help keep his father safe, assisting him with housework and improving his cognitive health. Frank initially rejects the idea but changes his mind when he realizes the robot’s talents aren’t limited to domestic chores. He begins teaching the robot new skills, and an unlikely partnership develops. With Frank’s penchant for pilfering and the robot’s digital dexterity, the two of them pull off a multimillion-dollar jewelry heist – and Frank’s outlook improves in ways his son never dreamed possible!

©koya79/Fotolia.com

“Robot and Frank” takes place “in the near future,” and while we don’t yet have robotic home companions as capable as the one in the movie, we need not look very far to realize that robotics and artificial intelligence may revolutionize the delivery of health care.

With an aging population and an industry shift toward value-based care, new research has focused on novel ways of avoiding hospitalization and reducing hospital readmission. We have seen a resurgence of home visits and the development of telemedicine and remote monitoring.

To stay healthy, patients need to be safe in their home environment and at a minimum need to be able to navigate their activities of daily living. Research published last year by Washington University’s Center for Advanced Studies in Adaptive Systems (CASAS) describes a technology that aims to help patients in their own homes.

The Robot Activity Support system, or RAS, interacts with intelligent sensors in a home environment “to detect and assist with activity errors that may occur in everyday settings.”¹ If sensors in the home indicate that a person is experiencing difficulty completing a certain task such as taking a medication or finding a bathroom, a robot can navigate to the person in need and show an instructional video, or lead the patient to the next step in the process.

Another manufacturer is taking a ‘softer’ approach to activity support in the elderly. Toymaker Hasbro has developed a line of robotic cats that provide companionship and comfort. While currently limited to tactile stimulation and simple responses, the manufacturer is working in collaboration with researchers at Brown University to add artificial intelligence capabilities. The goal of the program – Project ARIES (Affordable Robotic Intelligence for Elderly Support) – is to give the cats useful skills such as being able to provide medication and safety reminders while keeping their price point accessible to all.

Other organizations are attempting to take the robotic home health aide idea to the next level. “RUDY,” a robotic companion developed by INF Robotics, is capable of much more than just educating patients and leading them around the house. About the size of small child and wearing a huge smile, Rudy can detect falls, ensure medication adherence, provide social interaction, and even offer remote patient monitoring. According to the manufacturer, it uses natural language processing, machine learning, and a smart social interface to “facilitate trusting relationships between RUDY and older adults.” The idea is to promote acceptance from patients and offer peace of mind to their loved ones. This can be particularly valuable in assisting those with dementia, as a heavy emphasis is placed on socialization and maintaining cognitive stimulation.

Instead of developing novel artificial intelligence platforms, many groups are attempting to leverage existing technologies to assist patients in their homes. One such technology is Amazon’s Echo smart speakers, which became more attractive to health care providers on April 4 of this year with the launch of the Alexa Healthcare Skills Kit. This is Amazon’s HIPAA-compliant application programming interface (API) that allows developers to create ‘skills’ (apps for Echo devices) that can securely handle protected health information.

At launch, Amazon announced six partner organizations who have already written skills for patients. One organization, Boston Children’s Hospital, developed a skill called My Children’s Enhanced Recovery After Surgery (ERAS). According to John Brownstein, the hospital’s Chief Innovation Officer, it “allows patients and caregivers to easily share recovery progress with their care team post surgery ... it is just one example of how voice technology can extend the care and support of our patients beyond the four walls of the hospital.”

Some companies, such as HealthTap, have been working on artificial intelligence to build a platform to allow physicians and patients to interact online. HealthTap is leveraging the wisdom of those interactions to power a deep learning system called Dr. A.I. Available for Alexa and mobile devices, it attempts to assess patients’ symptoms and provide personalized medical explanations and health recommendations. In the developer’s own words: “Dr. A.I. engages with you in an empathetic conversation about your symptoms and overall health ... then gives you appropriate doctor-recommended insights as well as the best possible courses of action you can take on the road to feeling good.”

Some physicians may find this movement troubling, but we believe it represents an early glimpse of what is to come. As technology gets smarter and patients become more comfortable interacting with it, there will be greater demand for virtual caretakers and digital doctors, with no shortage of companies stepping up to meet the demand. While it’s doubtful the robots they create can be easily reprogrammed to steal jewelry, it won’t stop them from trying to steal our jobs. We as physicians will need to continue to hone our skills in compassion and empathy to provide something a computer never can: true care for our patients.

Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.

Reference

1. Robot-enabled support of daily activities in smart home environments. Cogn Syst Res. 2019 May. doi: 10.1016/j.cogsys.2018.10.032.

In the 2012 movie “Robot and Frank,” an aging ex-jewel thief named Frank receives a robotic home assistant from his well-meaning son. Frank lives alone and suffers from dementia, and his son hopes that the friendly electronic companion will help keep his father safe, assisting him with housework and improving his cognitive health. Frank initially rejects the idea but changes his mind when he realizes the robot’s talents aren’t limited to domestic chores. He begins teaching the robot new skills, and an unlikely partnership develops. With Frank’s penchant for pilfering and the robot’s digital dexterity, the two of them pull off a multimillion-dollar jewelry heist – and Frank’s outlook improves in ways his son never dreamed possible!

©koya79/Fotolia.com

“Robot and Frank” takes place “in the near future,” and while we don’t yet have robotic home companions as capable as the one in the movie, we need not look very far to realize that robotics and artificial intelligence may revolutionize the delivery of health care.

With an aging population and an industry shift toward value-based care, new research has focused on novel ways of avoiding hospitalization and reducing hospital readmission. We have seen a resurgence of home visits and the development of telemedicine and remote monitoring.

To stay healthy, patients need to be safe in their home environment and at a minimum need to be able to navigate their activities of daily living. Research published last year by Washington University’s Center for Advanced Studies in Adaptive Systems (CASAS) describes a technology that aims to help patients in their own homes.

The Robot Activity Support system, or RAS, interacts with intelligent sensors in a home environment “to detect and assist with activity errors that may occur in everyday settings.”¹ If sensors in the home indicate that a person is experiencing difficulty completing a certain task such as taking a medication or finding a bathroom, a robot can navigate to the person in need and show an instructional video, or lead the patient to the next step in the process.

Another manufacturer is taking a ‘softer’ approach to activity support in the elderly. Toymaker Hasbro has developed a line of robotic cats that provide companionship and comfort. While currently limited to tactile stimulation and simple responses, the manufacturer is working in collaboration with researchers at Brown University to add artificial intelligence capabilities. The goal of the program – Project ARIES (Affordable Robotic Intelligence for Elderly Support) – is to give the cats useful skills such as being able to provide medication and safety reminders while keeping their price point accessible to all.

Other organizations are attempting to take the robotic home health aide idea to the next level. “RUDY,” a robotic companion developed by INF Robotics, is capable of much more than just educating patients and leading them around the house. About the size of small child and wearing a huge smile, Rudy can detect falls, ensure medication adherence, provide social interaction, and even offer remote patient monitoring. According to the manufacturer, it uses natural language processing, machine learning, and a smart social interface to “facilitate trusting relationships between RUDY and older adults.” The idea is to promote acceptance from patients and offer peace of mind to their loved ones. This can be particularly valuable in assisting those with dementia, as a heavy emphasis is placed on socialization and maintaining cognitive stimulation.

Instead of developing novel artificial intelligence platforms, many groups are attempting to leverage existing technologies to assist patients in their homes. One such technology is Amazon’s Echo smart speakers, which became more attractive to health care providers on April 4 of this year with the launch of the Alexa Healthcare Skills Kit. This is Amazon’s HIPAA-compliant application programming interface (API) that allows developers to create ‘skills’ (apps for Echo devices) that can securely handle protected health information.

At launch, Amazon announced six partner organizations who have already written skills for patients. One organization, Boston Children’s Hospital, developed a skill called My Children’s Enhanced Recovery After Surgery (ERAS). According to John Brownstein, the hospital’s Chief Innovation Officer, it “allows patients and caregivers to easily share recovery progress with their care team post surgery ... it is just one example of how voice technology can extend the care and support of our patients beyond the four walls of the hospital.”

Some companies, such as HealthTap, have been working on artificial intelligence to build a platform to allow physicians and patients to interact online. HealthTap is leveraging the wisdom of those interactions to power a deep learning system called Dr. A.I. Available for Alexa and mobile devices, it attempts to assess patients’ symptoms and provide personalized medical explanations and health recommendations. In the developer’s own words: “Dr. A.I. engages with you in an empathetic conversation about your symptoms and overall health ... then gives you appropriate doctor-recommended insights as well as the best possible courses of action you can take on the road to feeling good.”

Some physicians may find this movement troubling, but we believe it represents an early glimpse of what is to come. As technology gets smarter and patients become more comfortable interacting with it, there will be greater demand for virtual caretakers and digital doctors, with no shortage of companies stepping up to meet the demand. While it’s doubtful the robots they create can be easily reprogrammed to steal jewelry, it won’t stop them from trying to steal our jobs. We as physicians will need to continue to hone our skills in compassion and empathy to provide something a computer never can: true care for our patients.

Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.

Reference

1. Robot-enabled support of daily activities in smart home environments. Cogn Syst Res. 2019 May. doi: 10.1016/j.cogsys.2018.10.032.

Several practice-changing developments in the treatment of ovarian cancer were seen in 2019, including the results of the pivotal trial Gynecologic Oncology Group (GOG)-213, which were published in November in the New England Journal of Medicine.¹ This trial randomly assigned women with ovarian cancer who had achieved a remission of more than 6 months after primary therapy (“platinum sensitive”) to either a repeat surgical cytoreduction followed by chemotherapy versus chemotherapy alone. It found that the addition of surgery provided no benefit in overall survival, challenging the notion that repeat surgical “debulking” should be routinely considered for the treatment of women with platinum-sensitive ovarian cancer.

Alexander Raths/Fotolia

The primary treatment of ovarian cancer includes a combination of surgery and chemotherapy, after which the vast majority of patients will experience a complete clinical response, a so-called “remission.” At that time patients enter surveillance care, in which their providers evaluate them, typically every 3 months in the first 2-3 years. These visits are designed to address ongoing toxicities of therapy in addition to evaluation for recurrence. At these visits, it is common for providers to assess tumor markers, such as CA 125 (cancer antigen 125), if they had been elevated at original diagnosis. As a gynecologic oncologist, I can vouch for the fact that patients “sweat” on this lab result the most. No matter how reassuring my physical exams or their symptom profiles are, there is nothing more comforting as a normal, stable CA 125 value in black and white. However, the results of GOG-213 should make us question whether drawing CA 125 in the surveillance period is of any value to patients beyond objective reassurance, and may, in fact, be harmful.

Providers have drawn tumor markers at surveillance exams under the working premise that abnormal or rising values signal the onset of asymptomatic recurrence, and that earlier treatment will be associated with better responses to salvage therapy. However, this has not been shown to be the case in randomized, controlled trials. In a large European cooperative-group trial, more than 500 patients with a history of completely treated ovarian cancer were randomized to either reinitiation of chemotherapy (salvage therapy) when CA 125 values first doubled or to reinitiation of therapy when they became symptomatic without knowledge of their CA 125 values.² In this trial the mean survival of both groups was the same (26 months for the early initiation of chemotherapy vs. 27 for late initiation). However, what did differ were the quality of life scores, which were lower for the group who initiated chemotherapy earlier, likely because they received toxic therapies for longer periods of time.

The results of this trial were challenged by those who felt that this study did not evaluate the role that surgery might play. Their argument was that surgery in the recurrent setting would improve the outcomes from chemotherapy for certain patients with long platinum-free intervals (duration of remission since last receiving a platinum-containing drug), oligometastatic disease, and good performance status, just as it had in the primary setting. Retrospective series seemed to confirm this phenomenon, particularly if surgeons were able to achieve a complete resection (no residual measurable disease).^3,4 By detecting asymptomatic patients with early elevations in CA 125, they proposed they might identify patients with lower disease burden in whom complete debulking would be more feasible. Whereas, in waiting for symptoms alone, they might “miss the boat,” and discover recurrence when it was too advanced to be completely resected.

The results of the GOG-213 study significantly challenge this line of thought, although with some caveats. Because this new trial showed no survival benefit for women with secondary debulking prior to chemotherapy, one could question whether there is any benefit in screening for asymptomatic, early recurrence. The authors of the study looked in subgroup analyses to attempt to identify groups who might benefit over others, such as women who had complete surgical cytoreduction (no residual disease) but still did not find a benefit to surgery. The trial population as a whole included women who had very favorable prognostic factors, including very long disease-free intervals (median, 20.4 months), and most women had only one or two sites of measurable recurrence. Yet it is remarkable that, in this group of patients who were predisposed to optimal outcomes, no benefit from surgery was observed.

However, it is important to recognize that the equivalent results of single-modality chemotherapy were achieved with the majority of women receiving bevacizumab with their chemotherapy regimen. An additional consideration is that the chemotherapy for platinum-sensitive, recurrent ovarian cancer has changed in recent years as we have learned the benefit of poly (ADP-ribose) polymerase (PARP) inhibitor drugs as maintenance therapy following complete or partial response to chemotherapy.⁵ It is unclear how the addition of PARP inhibitor maintenance therapy might have influenced the results of GOG-213. Further advancements in targeted therapies and consideration of hyperthermic intraperitoneal chemotherapy at the time of surgery also are being developed, and so, the answer of optimal therapy for platinum-sensitive ovarian cancer is a fluid one and might include a role for surgery for some of these patients.

However, in the meantime, before routinely ordering that tumor marker assessment in the surveillance period, it is important to remember that, if secondary cytoreduction is not beneficial and early initiation of chemotherapy is not helpful either, then these tumor marker results might provide more hindrance than help. Why search for recurrence at an earlier time point with CA 125 elevations if there isn’t a benefit to the patient in doing so? There certainly appears to be worse quality of life in doing so, and most likely also additional cost. Perhaps we should wait for clinical symptoms to confirm recurrence?

In the meantime, we will continue to have discussions with patients after primary therapy regarding how to best monitor them in the surveillance period. We will educate them about the limitations of early initiation of chemotherapy and the potentially limited role for surgery. Hopefully with individualized care and shared decision making, patients can guide us as to how they best be evaluated. While receiving a normal CA 125 result is powerfully reassuring, it is just as powerfully confusing and difficult for a patient to receive an abnormal one followed by a period of “doing nothing,” otherwise known as expectant management, if immediate treatment is not beneficial.

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She had no relevant financial disclosures. Email her at [email protected].

References

1. N Engl J Med. 2019 Nov 14;381(20):1929-39.

2. Lancet. 2010 Oct 2;376(9747):1155-63.

3. Gynecol Oncol. 2009 Jan;112(1):265-74.

4. Br J Cancer. 2011 Sep 27;105(7):890-6.

5. N Engl J Med. 2016 Dec 1;375(22):2154-64.

Several practice-changing developments in the treatment of ovarian cancer were seen in 2019, including the results of the pivotal trial Gynecologic Oncology Group (GOG)-213, which were published in November in the New England Journal of Medicine.¹ This trial randomly assigned women with ovarian cancer who had achieved a remission of more than 6 months after primary therapy (“platinum sensitive”) to either a repeat surgical cytoreduction followed by chemotherapy versus chemotherapy alone. It found that the addition of surgery provided no benefit in overall survival, challenging the notion that repeat surgical “debulking” should be routinely considered for the treatment of women with platinum-sensitive ovarian cancer.

Alexander Raths/Fotolia

The primary treatment of ovarian cancer includes a combination of surgery and chemotherapy, after which the vast majority of patients will experience a complete clinical response, a so-called “remission.” At that time patients enter surveillance care, in which their providers evaluate them, typically every 3 months in the first 2-3 years. These visits are designed to address ongoing toxicities of therapy in addition to evaluation for recurrence. At these visits, it is common for providers to assess tumor markers, such as CA 125 (cancer antigen 125), if they had been elevated at original diagnosis. As a gynecologic oncologist, I can vouch for the fact that patients “sweat” on this lab result the most. No matter how reassuring my physical exams or their symptom profiles are, there is nothing more comforting as a normal, stable CA 125 value in black and white. However, the results of GOG-213 should make us question whether drawing CA 125 in the surveillance period is of any value to patients beyond objective reassurance, and may, in fact, be harmful.

Providers have drawn tumor markers at surveillance exams under the working premise that abnormal or rising values signal the onset of asymptomatic recurrence, and that earlier treatment will be associated with better responses to salvage therapy. However, this has not been shown to be the case in randomized, controlled trials. In a large European cooperative-group trial, more than 500 patients with a history of completely treated ovarian cancer were randomized to either reinitiation of chemotherapy (salvage therapy) when CA 125 values first doubled or to reinitiation of therapy when they became symptomatic without knowledge of their CA 125 values.² In this trial the mean survival of both groups was the same (26 months for the early initiation of chemotherapy vs. 27 for late initiation). However, what did differ were the quality of life scores, which were lower for the group who initiated chemotherapy earlier, likely because they received toxic therapies for longer periods of time.

The results of this trial were challenged by those who felt that this study did not evaluate the role that surgery might play. Their argument was that surgery in the recurrent setting would improve the outcomes from chemotherapy for certain patients with long platinum-free intervals (duration of remission since last receiving a platinum-containing drug), oligometastatic disease, and good performance status, just as it had in the primary setting. Retrospective series seemed to confirm this phenomenon, particularly if surgeons were able to achieve a complete resection (no residual measurable disease).^3,4 By detecting asymptomatic patients with early elevations in CA 125, they proposed they might identify patients with lower disease burden in whom complete debulking would be more feasible. Whereas, in waiting for symptoms alone, they might “miss the boat,” and discover recurrence when it was too advanced to be completely resected.

The results of the GOG-213 study significantly challenge this line of thought, although with some caveats. Because this new trial showed no survival benefit for women with secondary debulking prior to chemotherapy, one could question whether there is any benefit in screening for asymptomatic, early recurrence. The authors of the study looked in subgroup analyses to attempt to identify groups who might benefit over others, such as women who had complete surgical cytoreduction (no residual disease) but still did not find a benefit to surgery. The trial population as a whole included women who had very favorable prognostic factors, including very long disease-free intervals (median, 20.4 months), and most women had only one or two sites of measurable recurrence. Yet it is remarkable that, in this group of patients who were predisposed to optimal outcomes, no benefit from surgery was observed.

However, it is important to recognize that the equivalent results of single-modality chemotherapy were achieved with the majority of women receiving bevacizumab with their chemotherapy regimen. An additional consideration is that the chemotherapy for platinum-sensitive, recurrent ovarian cancer has changed in recent years as we have learned the benefit of poly (ADP-ribose) polymerase (PARP) inhibitor drugs as maintenance therapy following complete or partial response to chemotherapy.⁵ It is unclear how the addition of PARP inhibitor maintenance therapy might have influenced the results of GOG-213. Further advancements in targeted therapies and consideration of hyperthermic intraperitoneal chemotherapy at the time of surgery also are being developed, and so, the answer of optimal therapy for platinum-sensitive ovarian cancer is a fluid one and might include a role for surgery for some of these patients.

However, in the meantime, before routinely ordering that tumor marker assessment in the surveillance period, it is important to remember that, if secondary cytoreduction is not beneficial and early initiation of chemotherapy is not helpful either, then these tumor marker results might provide more hindrance than help. Why search for recurrence at an earlier time point with CA 125 elevations if there isn’t a benefit to the patient in doing so? There certainly appears to be worse quality of life in doing so, and most likely also additional cost. Perhaps we should wait for clinical symptoms to confirm recurrence?

In the meantime, we will continue to have discussions with patients after primary therapy regarding how to best monitor them in the surveillance period. We will educate them about the limitations of early initiation of chemotherapy and the potentially limited role for surgery. Hopefully with individualized care and shared decision making, patients can guide us as to how they best be evaluated. While receiving a normal CA 125 result is powerfully reassuring, it is just as powerfully confusing and difficult for a patient to receive an abnormal one followed by a period of “doing nothing,” otherwise known as expectant management, if immediate treatment is not beneficial.

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She had no relevant financial disclosures. Email her at [email protected].

References

1. N Engl J Med. 2019 Nov 14;381(20):1929-39.

2. Lancet. 2010 Oct 2;376(9747):1155-63.

3. Gynecol Oncol. 2009 Jan;112(1):265-74.

4. Br J Cancer. 2011 Sep 27;105(7):890-6.

5. N Engl J Med. 2016 Dec 1;375(22):2154-64.

Several practice-changing developments in the treatment of ovarian cancer were seen in 2019, including the results of the pivotal trial Gynecologic Oncology Group (GOG)-213, which were published in November in the New England Journal of Medicine.¹ This trial randomly assigned women with ovarian cancer who had achieved a remission of more than 6 months after primary therapy (“platinum sensitive”) to either a repeat surgical cytoreduction followed by chemotherapy versus chemotherapy alone. It found that the addition of surgery provided no benefit in overall survival, challenging the notion that repeat surgical “debulking” should be routinely considered for the treatment of women with platinum-sensitive ovarian cancer.

Alexander Raths/Fotolia

The primary treatment of ovarian cancer includes a combination of surgery and chemotherapy, after which the vast majority of patients will experience a complete clinical response, a so-called “remission.” At that time patients enter surveillance care, in which their providers evaluate them, typically every 3 months in the first 2-3 years. These visits are designed to address ongoing toxicities of therapy in addition to evaluation for recurrence. At these visits, it is common for providers to assess tumor markers, such as CA 125 (cancer antigen 125), if they had been elevated at original diagnosis. As a gynecologic oncologist, I can vouch for the fact that patients “sweat” on this lab result the most. No matter how reassuring my physical exams or their symptom profiles are, there is nothing more comforting as a normal, stable CA 125 value in black and white. However, the results of GOG-213 should make us question whether drawing CA 125 in the surveillance period is of any value to patients beyond objective reassurance, and may, in fact, be harmful.

Providers have drawn tumor markers at surveillance exams under the working premise that abnormal or rising values signal the onset of asymptomatic recurrence, and that earlier treatment will be associated with better responses to salvage therapy. However, this has not been shown to be the case in randomized, controlled trials. In a large European cooperative-group trial, more than 500 patients with a history of completely treated ovarian cancer were randomized to either reinitiation of chemotherapy (salvage therapy) when CA 125 values first doubled or to reinitiation of therapy when they became symptomatic without knowledge of their CA 125 values.² In this trial the mean survival of both groups was the same (26 months for the early initiation of chemotherapy vs. 27 for late initiation). However, what did differ were the quality of life scores, which were lower for the group who initiated chemotherapy earlier, likely because they received toxic therapies for longer periods of time.

The results of this trial were challenged by those who felt that this study did not evaluate the role that surgery might play. Their argument was that surgery in the recurrent setting would improve the outcomes from chemotherapy for certain patients with long platinum-free intervals (duration of remission since last receiving a platinum-containing drug), oligometastatic disease, and good performance status, just as it had in the primary setting. Retrospective series seemed to confirm this phenomenon, particularly if surgeons were able to achieve a complete resection (no residual measurable disease).^3,4 By detecting asymptomatic patients with early elevations in CA 125, they proposed they might identify patients with lower disease burden in whom complete debulking would be more feasible. Whereas, in waiting for symptoms alone, they might “miss the boat,” and discover recurrence when it was too advanced to be completely resected.

The results of the GOG-213 study significantly challenge this line of thought, although with some caveats. Because this new trial showed no survival benefit for women with secondary debulking prior to chemotherapy, one could question whether there is any benefit in screening for asymptomatic, early recurrence. The authors of the study looked in subgroup analyses to attempt to identify groups who might benefit over others, such as women who had complete surgical cytoreduction (no residual disease) but still did not find a benefit to surgery. The trial population as a whole included women who had very favorable prognostic factors, including very long disease-free intervals (median, 20.4 months), and most women had only one or two sites of measurable recurrence. Yet it is remarkable that, in this group of patients who were predisposed to optimal outcomes, no benefit from surgery was observed.

However, it is important to recognize that the equivalent results of single-modality chemotherapy were achieved with the majority of women receiving bevacizumab with their chemotherapy regimen. An additional consideration is that the chemotherapy for platinum-sensitive, recurrent ovarian cancer has changed in recent years as we have learned the benefit of poly (ADP-ribose) polymerase (PARP) inhibitor drugs as maintenance therapy following complete or partial response to chemotherapy.⁵ It is unclear how the addition of PARP inhibitor maintenance therapy might have influenced the results of GOG-213. Further advancements in targeted therapies and consideration of hyperthermic intraperitoneal chemotherapy at the time of surgery also are being developed, and so, the answer of optimal therapy for platinum-sensitive ovarian cancer is a fluid one and might include a role for surgery for some of these patients.

However, in the meantime, before routinely ordering that tumor marker assessment in the surveillance period, it is important to remember that, if secondary cytoreduction is not beneficial and early initiation of chemotherapy is not helpful either, then these tumor marker results might provide more hindrance than help. Why search for recurrence at an earlier time point with CA 125 elevations if there isn’t a benefit to the patient in doing so? There certainly appears to be worse quality of life in doing so, and most likely also additional cost. Perhaps we should wait for clinical symptoms to confirm recurrence?

In the meantime, we will continue to have discussions with patients after primary therapy regarding how to best monitor them in the surveillance period. We will educate them about the limitations of early initiation of chemotherapy and the potentially limited role for surgery. Hopefully with individualized care and shared decision making, patients can guide us as to how they best be evaluated. While receiving a normal CA 125 result is powerfully reassuring, it is just as powerfully confusing and difficult for a patient to receive an abnormal one followed by a period of “doing nothing,” otherwise known as expectant management, if immediate treatment is not beneficial.

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She had no relevant financial disclosures. Email her at [email protected].

References

1. N Engl J Med. 2019 Nov 14;381(20):1929-39.

2. Lancet. 2010 Oct 2;376(9747):1155-63.

3. Gynecol Oncol. 2009 Jan;112(1):265-74.

4. Br J Cancer. 2011 Sep 27;105(7):890-6.

5. N Engl J Med. 2016 Dec 1;375(22):2154-64.

This abstract highlights a promising result for our younger patients diagnosed with systemic sclerosis. The fact that patients aged 44 years and younger with systemic sclerosis now have a death rate similar to that of the general population should be celebrated. Practicing clinicians can speculate why this trend has occurred. It is well known that these patients many times suffer from cardiopulmonary involvement.

Thus, the advances in the treatment of interstitial lung disease and pulmonary hypertension may account for the decreased mortality in this population.

Earlier detection has certainly helped this group. In addition, using immune modulators earlier at disease onset is likely another contributor to this positive trend. We are entering a decade and beyond filled with hope to change the course of this particular autoimmune disease.

Dr. Oberstein is a practicing rheumatologist at the University of Miami Health System and is senior medical director of musculoskeletal at Modernizing Medicine in Boca Raton, Fla. She has no relevant disclosures to report.

This abstract highlights a promising result for our younger patients diagnosed with systemic sclerosis. The fact that patients aged 44 years and younger with systemic sclerosis now have a death rate similar to that of the general population should be celebrated. Practicing clinicians can speculate why this trend has occurred. It is well known that these patients many times suffer from cardiopulmonary involvement.

Thus, the advances in the treatment of interstitial lung disease and pulmonary hypertension may account for the decreased mortality in this population.

Earlier detection has certainly helped this group. In addition, using immune modulators earlier at disease onset is likely another contributor to this positive trend. We are entering a decade and beyond filled with hope to change the course of this particular autoimmune disease.

Dr. Oberstein is a practicing rheumatologist at the University of Miami Health System and is senior medical director of musculoskeletal at Modernizing Medicine in Boca Raton, Fla. She has no relevant disclosures to report.

This abstract highlights a promising result for our younger patients diagnosed with systemic sclerosis. The fact that patients aged 44 years and younger with systemic sclerosis now have a death rate similar to that of the general population should be celebrated. Practicing clinicians can speculate why this trend has occurred. It is well known that these patients many times suffer from cardiopulmonary involvement.

Thus, the advances in the treatment of interstitial lung disease and pulmonary hypertension may account for the decreased mortality in this population.

Earlier detection has certainly helped this group. In addition, using immune modulators earlier at disease onset is likely another contributor to this positive trend. We are entering a decade and beyond filled with hope to change the course of this particular autoimmune disease.

Dr. Oberstein is a practicing rheumatologist at the University of Miami Health System and is senior medical director of musculoskeletal at Modernizing Medicine in Boca Raton, Fla. She has no relevant disclosures to report.

The VERVE study highlights a crucial topic for rheumatologists treating patients in clinical practice. The traditional thinking is to inform patients never to receive live vaccines when they are using TNF (tumor necrosis factor) inhibitors to treat their autoimmune disease. The VERVE study indicates that in the case of the Zostavax vaccine, patients on this form of biologic therapy for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis can safely receive this preventive measure. This study scratches the surface on an important topic, and other studies need to follow.

Many patients on biologic therapy want to travel. Many times, international travel requires vaccination that is only in the form of a live vaccine – for example, the yellow fever vaccine. It would be useful for us to better understand whether other live vaccines can safely be administered and better inform our patients who want to travel. In addition, many times mothers with young infants are nervous if they are on biologic therapy and their children need to receive a live vaccine. They are concerned that their children will shed the live virus and they will be in jeopardy. This study highlights that this may be more of an antiquated way of thinking. We need more studies of this kind to better understand and advise our patients properly without instilling unwarranted fear.

This study was narrow in nature and we certainly need more information on the safety of Zostavax with patients on biologics with other mechanisms of action such as B-cell depletion and interleukin-6 inhibition. Another limitation in this study was that the majority of the trial population was composed of white females. Of course, these trials, if possible, need to include the pediatric population in whom many live vaccines are lifesaving. The recent outbreak of measles in the United States highlights the importance of a better understanding of live vaccines in populations at risk for this illness. We need to congratulate the study investigators for taking the first steps to change the narrative about live vaccines with evidenced-based medicine. Hopefully more data will follow.

Dr. Oberstein is a practicing rheumatologist at the University of Miami Health System and is senior medical director of musculoskeletal at Modernizing Medicine in Boca Raton, Fla. She has no relevant disclosures to report.

 

 

The VERVE study highlights a crucial topic for rheumatologists treating patients in clinical practice. The traditional thinking is to inform patients never to receive live vaccines when they are using TNF (tumor necrosis factor) inhibitors to treat their autoimmune disease. The VERVE study indicates that in the case of the Zostavax vaccine, patients on this form of biologic therapy for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis can safely receive this preventive measure. This study scratches the surface on an important topic, and other studies need to follow.

Many patients on biologic therapy want to travel. Many times, international travel requires vaccination that is only in the form of a live vaccine – for example, the yellow fever vaccine. It would be useful for us to better understand whether other live vaccines can safely be administered and better inform our patients who want to travel. In addition, many times mothers with young infants are nervous if they are on biologic therapy and their children need to receive a live vaccine. They are concerned that their children will shed the live virus and they will be in jeopardy. This study highlights that this may be more of an antiquated way of thinking. We need more studies of this kind to better understand and advise our patients properly without instilling unwarranted fear.

This study was narrow in nature and we certainly need more information on the safety of Zostavax with patients on biologics with other mechanisms of action such as B-cell depletion and interleukin-6 inhibition. Another limitation in this study was that the majority of the trial population was composed of white females. Of course, these trials, if possible, need to include the pediatric population in whom many live vaccines are lifesaving. The recent outbreak of measles in the United States highlights the importance of a better understanding of live vaccines in populations at risk for this illness. We need to congratulate the study investigators for taking the first steps to change the narrative about live vaccines with evidenced-based medicine. Hopefully more data will follow.

Dr. Oberstein is a practicing rheumatologist at the University of Miami Health System and is senior medical director of musculoskeletal at Modernizing Medicine in Boca Raton, Fla. She has no relevant disclosures to report.

 

 

The VERVE study highlights a crucial topic for rheumatologists treating patients in clinical practice. The traditional thinking is to inform patients never to receive live vaccines when they are using TNF (tumor necrosis factor) inhibitors to treat their autoimmune disease. The VERVE study indicates that in the case of the Zostavax vaccine, patients on this form of biologic therapy for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis can safely receive this preventive measure. This study scratches the surface on an important topic, and other studies need to follow.

Many patients on biologic therapy want to travel. Many times, international travel requires vaccination that is only in the form of a live vaccine – for example, the yellow fever vaccine. It would be useful for us to better understand whether other live vaccines can safely be administered and better inform our patients who want to travel. In addition, many times mothers with young infants are nervous if they are on biologic therapy and their children need to receive a live vaccine. They are concerned that their children will shed the live virus and they will be in jeopardy. This study highlights that this may be more of an antiquated way of thinking. We need more studies of this kind to better understand and advise our patients properly without instilling unwarranted fear.

This study was narrow in nature and we certainly need more information on the safety of Zostavax with patients on biologics with other mechanisms of action such as B-cell depletion and interleukin-6 inhibition. Another limitation in this study was that the majority of the trial population was composed of white females. Of course, these trials, if possible, need to include the pediatric population in whom many live vaccines are lifesaving. The recent outbreak of measles in the United States highlights the importance of a better understanding of live vaccines in populations at risk for this illness. We need to congratulate the study investigators for taking the first steps to change the narrative about live vaccines with evidenced-based medicine. Hopefully more data will follow.

Dr. Oberstein is a practicing rheumatologist at the University of Miami Health System and is senior medical director of musculoskeletal at Modernizing Medicine in Boca Raton, Fla. She has no relevant disclosures to report.

 

 

In this edition of “How I Will Treat My Next Patient,” I highlight two articles that demonstrate the safety of established treatments – nephrectomy and stereotactic ablative body radiotherapy (SABR) – in patient populations that previously may have been excluded from those treatments at many centers.

Nephrectomy in advanced RCC

Nirmish Singla, MD, and colleagues reported a single-center retrospective cohort study, assessing outcomes of 11 nephrectomies (10 radical, 1 partial) in 10 patients with advanced renal cell carcinoma (RCC) who had received front- or later-line immune checkpoint inhibitor therapy (ICIs). Half had received nivolumab alone; the others received nivolumab plus ipilimumab. Surgery was performed laparoscopically in five cases (Urol Oncol. 2019 Dec;37[12]:924-31).

No patient experienced a major intraoperative complication. Four experienced postoperative complications, the majority of which were addressed with interventional radiology procedures. The median hospital stay was 4 days. One patient died of progressive disease more than 3 months after surgery, and another died of pulmonary embolism and sepsis. Six of the 10 patients did not have any complications or readmissions. There were no immune-related toxicities and no wound-healing issues. ICI therapy was resumed postoperatively in six patients.

At nephrectomy (plus or minus metastatectomy), one patient achieved a response to immunotherapy in the primary tumor, and three of four patients who underwent resection of hepatic, pulmonary, or adrenal metastases had no detectable cancer. All surgical margins were negative.

During a median postoperative follow-up of 180 days, nephrectomy following ICI was safe. Pathologic response in both the primary tumor and metastatic sites was encouraging.

What this means in clinical practice

In medical school, all of us are admonished not to be afraid to unlearn something and to learn something new. Historically, nephrectomy was felt to be helpful in improving overall survival in patients with advanced RCC. Effective targeted therapies and ICIs have caused us to question the role of nephrectomy and its timing, since 20%-40% of patients who have apparently localized RCC at the time of nephrectomy develop recurrences within 3 years. Preoperative therapy could mitigate potentially aggressive tumor biology, treat micrometastatic disease, and help select patients who should not be treated surgically.

In the CARMENA trial of the treatment of advanced RCC patients with the tyrosine kinase inhibitor sunitinib versus nephrectomy followed by sunitinib, most patients could avoid nephrectomy without compromising survival (N Engl J Med. 2018; 379:417-27). Results were updated at the 2019 annual meeting of the American Society of Clinical Oncology. Overall, nephrectomy was not beneficial. However, delayed nephrectomy (after sunitinib) appeared be beneficial for good responders with only one IMDC (International Metastatic RCC Database Consortium) risk factor and only one metastatic site.

The small study by Dr. Singla and colleagues illustrates that nephrectomy is feasible after ICI, plus or minus anti-CTLA4-targeted treatment, and that favorable histologic results can be achieved. With ICI plus or minus anti-CTLA4-targeted treatment, no patient had progressive disease prior to surgery. This experience is germane in view of recently updated results of the CheckMate 214 trial, showing superior overall survival, response rates, and response duration for nivolumab plus ipilimumab, in comparison with sunitinib.

There are still unresolved questions, including whether these favorable outcomes can be achieved in community practice and whether there are genomic or immunohistochemistry expression profiles to select patients who can benefit from this approach. It’s unclear whether there are practical issues that influence outcome, such as type of ICI, number of preoperative treatment cycles, and additional systemic therapies including postoperative treatment. However, the current series rings the starting bell for the study of those questions and a promising era for patients with this deadly disease.
 

 

SABR in moderately central NSCLC

SABR to peripheral, small non–small cell lung cancers (NSCLCs) produces high local control rates, with low grade 3-4 toxicity, and is an alternative to resection in patients who are unfit for surgery. In a pragmatic, community-based, prospective cohort experience in Scotland, Robert Rulach, MBChB, and colleagues, treated 50 T1-2N0M0 NSCLC patients with SABR 50-Gy in five fractions (Clin Oncol. 2019 Oct 10. doi: 10.1016/j.clon.2019.09.055). The dose and fractionation schedule was safe and effective in the phase 1/2 RTOG 0813 trial and is concordant with guidelines from the National Comprehensive Cancer Network (NCCN).

All of the tumors were moderately central, as in the RTOG trial. One patient had an additional tumor that was ultracentral. Notably, 84% of patients were deemed medically unfit for surgery.

All patients completed radiotherapy without treatment delays. Two patients died within 90 days of treatment. There were no grade 4 or grade 5 toxicities and the overall rate of grade 3 toxicity was 4%. With a median follow-up of 25.2 months, 34 patients died: 18 from causes unrelated to cancer and 16 from cancer recurrence. The median overall survival was 27 months. The 2-year overall survival rate was 67.6%, commensurate with the rate seen in RTOG 0813.

The researchers concluded that, for frail patients with centrally-located NSCLC treated uniformly in a community practice, SABR with the RTOG 0813 treatment protocol produced acceptable toxicity and overall survival comparable with the published literature.

What this means in clinical practice

The results and conclusions of the study by Dr. Rulach and colleagues are straightforward: SABR can be used for centrally-located NSCLC without producing massive hemoptysis, bronchial stricture, and fistula formation. Since the majority of patients had no histologic diagnosis, T1N0 lesions, and no routine follow-up CT scans beyond 3 months post treatment, conclusions beyond that are unjustified.

In a community-based practice, NCCN guideline–concordant SABR treatment in moderately centrally-located NSCLC was safely delivered. For the burgeoning population of medically inoperable and/or elderly NSCLC patients, this alone is reassuring for clinicians and is helpful information for patients who require and/or desire nonsurgical treatment.
 

Dr. Lyss has been a community-based medical oncologist and clinical researcher for more than 35 years, practicing in St. Louis. His clinical and research interests are in the prevention, diagnosis, and treatment of breast and lung cancers and in expanding access to clinical trials to medically underserved populations.

In this edition of “How I Will Treat My Next Patient,” I highlight two articles that demonstrate the safety of established treatments – nephrectomy and stereotactic ablative body radiotherapy (SABR) – in patient populations that previously may have been excluded from those treatments at many centers.

Nephrectomy in advanced RCC

Nirmish Singla, MD, and colleagues reported a single-center retrospective cohort study, assessing outcomes of 11 nephrectomies (10 radical, 1 partial) in 10 patients with advanced renal cell carcinoma (RCC) who had received front- or later-line immune checkpoint inhibitor therapy (ICIs). Half had received nivolumab alone; the others received nivolumab plus ipilimumab. Surgery was performed laparoscopically in five cases (Urol Oncol. 2019 Dec;37[12]:924-31).

No patient experienced a major intraoperative complication. Four experienced postoperative complications, the majority of which were addressed with interventional radiology procedures. The median hospital stay was 4 days. One patient died of progressive disease more than 3 months after surgery, and another died of pulmonary embolism and sepsis. Six of the 10 patients did not have any complications or readmissions. There were no immune-related toxicities and no wound-healing issues. ICI therapy was resumed postoperatively in six patients.

At nephrectomy (plus or minus metastatectomy), one patient achieved a response to immunotherapy in the primary tumor, and three of four patients who underwent resection of hepatic, pulmonary, or adrenal metastases had no detectable cancer. All surgical margins were negative.

During a median postoperative follow-up of 180 days, nephrectomy following ICI was safe. Pathologic response in both the primary tumor and metastatic sites was encouraging.

What this means in clinical practice

In medical school, all of us are admonished not to be afraid to unlearn something and to learn something new. Historically, nephrectomy was felt to be helpful in improving overall survival in patients with advanced RCC. Effective targeted therapies and ICIs have caused us to question the role of nephrectomy and its timing, since 20%-40% of patients who have apparently localized RCC at the time of nephrectomy develop recurrences within 3 years. Preoperative therapy could mitigate potentially aggressive tumor biology, treat micrometastatic disease, and help select patients who should not be treated surgically.

In the CARMENA trial of the treatment of advanced RCC patients with the tyrosine kinase inhibitor sunitinib versus nephrectomy followed by sunitinib, most patients could avoid nephrectomy without compromising survival (N Engl J Med. 2018; 379:417-27). Results were updated at the 2019 annual meeting of the American Society of Clinical Oncology. Overall, nephrectomy was not beneficial. However, delayed nephrectomy (after sunitinib) appeared be beneficial for good responders with only one IMDC (International Metastatic RCC Database Consortium) risk factor and only one metastatic site.

The small study by Dr. Singla and colleagues illustrates that nephrectomy is feasible after ICI, plus or minus anti-CTLA4-targeted treatment, and that favorable histologic results can be achieved. With ICI plus or minus anti-CTLA4-targeted treatment, no patient had progressive disease prior to surgery. This experience is germane in view of recently updated results of the CheckMate 214 trial, showing superior overall survival, response rates, and response duration for nivolumab plus ipilimumab, in comparison with sunitinib.

There are still unresolved questions, including whether these favorable outcomes can be achieved in community practice and whether there are genomic or immunohistochemistry expression profiles to select patients who can benefit from this approach. It’s unclear whether there are practical issues that influence outcome, such as type of ICI, number of preoperative treatment cycles, and additional systemic therapies including postoperative treatment. However, the current series rings the starting bell for the study of those questions and a promising era for patients with this deadly disease.
 

 

SABR in moderately central NSCLC

SABR to peripheral, small non–small cell lung cancers (NSCLCs) produces high local control rates, with low grade 3-4 toxicity, and is an alternative to resection in patients who are unfit for surgery. In a pragmatic, community-based, prospective cohort experience in Scotland, Robert Rulach, MBChB, and colleagues, treated 50 T1-2N0M0 NSCLC patients with SABR 50-Gy in five fractions (Clin Oncol. 2019 Oct 10. doi: 10.1016/j.clon.2019.09.055). The dose and fractionation schedule was safe and effective in the phase 1/2 RTOG 0813 trial and is concordant with guidelines from the National Comprehensive Cancer Network (NCCN).

All of the tumors were moderately central, as in the RTOG trial. One patient had an additional tumor that was ultracentral. Notably, 84% of patients were deemed medically unfit for surgery.

All patients completed radiotherapy without treatment delays. Two patients died within 90 days of treatment. There were no grade 4 or grade 5 toxicities and the overall rate of grade 3 toxicity was 4%. With a median follow-up of 25.2 months, 34 patients died: 18 from causes unrelated to cancer and 16 from cancer recurrence. The median overall survival was 27 months. The 2-year overall survival rate was 67.6%, commensurate with the rate seen in RTOG 0813.

The researchers concluded that, for frail patients with centrally-located NSCLC treated uniformly in a community practice, SABR with the RTOG 0813 treatment protocol produced acceptable toxicity and overall survival comparable with the published literature.

What this means in clinical practice

The results and conclusions of the study by Dr. Rulach and colleagues are straightforward: SABR can be used for centrally-located NSCLC without producing massive hemoptysis, bronchial stricture, and fistula formation. Since the majority of patients had no histologic diagnosis, T1N0 lesions, and no routine follow-up CT scans beyond 3 months post treatment, conclusions beyond that are unjustified.

In a community-based practice, NCCN guideline–concordant SABR treatment in moderately centrally-located NSCLC was safely delivered. For the burgeoning population of medically inoperable and/or elderly NSCLC patients, this alone is reassuring for clinicians and is helpful information for patients who require and/or desire nonsurgical treatment.
 

Dr. Lyss has been a community-based medical oncologist and clinical researcher for more than 35 years, practicing in St. Louis. His clinical and research interests are in the prevention, diagnosis, and treatment of breast and lung cancers and in expanding access to clinical trials to medically underserved populations.

In this edition of “How I Will Treat My Next Patient,” I highlight two articles that demonstrate the safety of established treatments – nephrectomy and stereotactic ablative body radiotherapy (SABR) – in patient populations that previously may have been excluded from those treatments at many centers.

Nephrectomy in advanced RCC

Nirmish Singla, MD, and colleagues reported a single-center retrospective cohort study, assessing outcomes of 11 nephrectomies (10 radical, 1 partial) in 10 patients with advanced renal cell carcinoma (RCC) who had received front- or later-line immune checkpoint inhibitor therapy (ICIs). Half had received nivolumab alone; the others received nivolumab plus ipilimumab. Surgery was performed laparoscopically in five cases (Urol Oncol. 2019 Dec;37[12]:924-31).

No patient experienced a major intraoperative complication. Four experienced postoperative complications, the majority of which were addressed with interventional radiology procedures. The median hospital stay was 4 days. One patient died of progressive disease more than 3 months after surgery, and another died of pulmonary embolism and sepsis. Six of the 10 patients did not have any complications or readmissions. There were no immune-related toxicities and no wound-healing issues. ICI therapy was resumed postoperatively in six patients.

At nephrectomy (plus or minus metastatectomy), one patient achieved a response to immunotherapy in the primary tumor, and three of four patients who underwent resection of hepatic, pulmonary, or adrenal metastases had no detectable cancer. All surgical margins were negative.

During a median postoperative follow-up of 180 days, nephrectomy following ICI was safe. Pathologic response in both the primary tumor and metastatic sites was encouraging.

What this means in clinical practice

In medical school, all of us are admonished not to be afraid to unlearn something and to learn something new. Historically, nephrectomy was felt to be helpful in improving overall survival in patients with advanced RCC. Effective targeted therapies and ICIs have caused us to question the role of nephrectomy and its timing, since 20%-40% of patients who have apparently localized RCC at the time of nephrectomy develop recurrences within 3 years. Preoperative therapy could mitigate potentially aggressive tumor biology, treat micrometastatic disease, and help select patients who should not be treated surgically.

In the CARMENA trial of the treatment of advanced RCC patients with the tyrosine kinase inhibitor sunitinib versus nephrectomy followed by sunitinib, most patients could avoid nephrectomy without compromising survival (N Engl J Med. 2018; 379:417-27). Results were updated at the 2019 annual meeting of the American Society of Clinical Oncology. Overall, nephrectomy was not beneficial. However, delayed nephrectomy (after sunitinib) appeared be beneficial for good responders with only one IMDC (International Metastatic RCC Database Consortium) risk factor and only one metastatic site.

The small study by Dr. Singla and colleagues illustrates that nephrectomy is feasible after ICI, plus or minus anti-CTLA4-targeted treatment, and that favorable histologic results can be achieved. With ICI plus or minus anti-CTLA4-targeted treatment, no patient had progressive disease prior to surgery. This experience is germane in view of recently updated results of the CheckMate 214 trial, showing superior overall survival, response rates, and response duration for nivolumab plus ipilimumab, in comparison with sunitinib.

There are still unresolved questions, including whether these favorable outcomes can be achieved in community practice and whether there are genomic or immunohistochemistry expression profiles to select patients who can benefit from this approach. It’s unclear whether there are practical issues that influence outcome, such as type of ICI, number of preoperative treatment cycles, and additional systemic therapies including postoperative treatment. However, the current series rings the starting bell for the study of those questions and a promising era for patients with this deadly disease.
 

 

SABR in moderately central NSCLC

SABR to peripheral, small non–small cell lung cancers (NSCLCs) produces high local control rates, with low grade 3-4 toxicity, and is an alternative to resection in patients who are unfit for surgery. In a pragmatic, community-based, prospective cohort experience in Scotland, Robert Rulach, MBChB, and colleagues, treated 50 T1-2N0M0 NSCLC patients with SABR 50-Gy in five fractions (Clin Oncol. 2019 Oct 10. doi: 10.1016/j.clon.2019.09.055). The dose and fractionation schedule was safe and effective in the phase 1/2 RTOG 0813 trial and is concordant with guidelines from the National Comprehensive Cancer Network (NCCN).

All of the tumors were moderately central, as in the RTOG trial. One patient had an additional tumor that was ultracentral. Notably, 84% of patients were deemed medically unfit for surgery.

All patients completed radiotherapy without treatment delays. Two patients died within 90 days of treatment. There were no grade 4 or grade 5 toxicities and the overall rate of grade 3 toxicity was 4%. With a median follow-up of 25.2 months, 34 patients died: 18 from causes unrelated to cancer and 16 from cancer recurrence. The median overall survival was 27 months. The 2-year overall survival rate was 67.6%, commensurate with the rate seen in RTOG 0813.

The researchers concluded that, for frail patients with centrally-located NSCLC treated uniformly in a community practice, SABR with the RTOG 0813 treatment protocol produced acceptable toxicity and overall survival comparable with the published literature.

What this means in clinical practice

The results and conclusions of the study by Dr. Rulach and colleagues are straightforward: SABR can be used for centrally-located NSCLC without producing massive hemoptysis, bronchial stricture, and fistula formation. Since the majority of patients had no histologic diagnosis, T1N0 lesions, and no routine follow-up CT scans beyond 3 months post treatment, conclusions beyond that are unjustified.

In a community-based practice, NCCN guideline–concordant SABR treatment in moderately centrally-located NSCLC was safely delivered. For the burgeoning population of medically inoperable and/or elderly NSCLC patients, this alone is reassuring for clinicians and is helpful information for patients who require and/or desire nonsurgical treatment.
 

Dr. Lyss has been a community-based medical oncologist and clinical researcher for more than 35 years, practicing in St. Louis. His clinical and research interests are in the prevention, diagnosis, and treatment of breast and lung cancers and in expanding access to clinical trials to medically underserved populations.

As health care providers to children, we always are learning. And with new knowledge we sometimes can be taken out of our comfort zone. One of those areas are teenagers, contraception, safe-sex counseling, and now emergency contraception (EC). In residency you have your 1-month adolescent medicine rotation to try and absorb every bit of information like a sponge, but there also will be a level of discomfort and uncertainty. However, as medical providers we cannot let the above prevent us from giving well-rounded and informed care.

Rawpixel/iStock/Getty Images

When our teens disclose the most private moment of their life, we have to be armed and ready to not only comfort them, but advise and guide them to making a decision so that they can ensure their safety. The answers regarding sexual activity are becoming more and more alarming, especially in our younger patients. Therefore, this is an important discussion to have at every visit (not just well-child checks), so that education opportunities are not missed and our patients feel a sense of normalcy about discussing reproductive health with their health care provider and or parents.

We all have our personal beliefs, but we cannot let that guide our decision on what care or education we give our patients. Unfortunately, I have heard many health care providers judge our patients for their promiscuity, when we need to educate them – not be their judge and jury. Our teens go through different stages of growth and development, and with these stages come experimentation and risk taking. So as their health care providers, we need to be up to date on the information out there.

With regards with EC, some of our patients think that they can get it only after having unprotected sex. However, they should know that the oral ECs can be given to them at any time, so should they be in the situation above, they have an immediate remedy. With the different options come different counseling and different instructions on administration and follow-up. In residency, we might not have learned the skill of inserting an IUD, which is another form of EC; that is why there are many resources available. These resources include hands-on workshops, videos on counseling, and your friendly neighborhood adolescent medicine physician or ob.gyn.

EC can give our patients that sense of relief, especially when they have unprotected sex. However, they also need to have a sense of responsibility for their actions because you do not want them to engage in high-risk behaviors. Just as we are responsible to provide up-to-date care, our patients must take ownership of their health and well-being. Also we should not discuss EC only with our female adolescents, but also with our male patients. If they are engaging in unprotected sex, they are just as responsible; therefore, they should know everything about contraception as well as EC. They should feel comfortable talking to their partners about contraception. Health care providers should make them feel comfortable receiving EC that they can give to their female partner.

We need to become knowledgeable and comfortable prescribing EC, as well as incorporating it in our routine care. This is a policy that I strongly believe should be part of every pediatrician’s and family physician’s office, especially when there is a lack of resources. Of the different options that are available, the oral forms of EC – especially Ella or Plan B step 1 (levonorgestrel) – would be the easiest to prescribe and counsel on. I would not recommend the options where multiple pills need to be taken more than once a day, because compliance becomes a factor. Also knowing that these options are available over the counter also is helpful because our community pharmacist also can help with medication administration and counseling.

In summary, I strongly recommend the discussion of EC in the office, especially the general pediatrician’s office. I recommend that, for those physicians’ who may be uncomfortable, that they should start with the “easier” options of oral progestins (Ella or Plan B step 1). As you become more comfortable with the information and counseling, you can learn skills such as IUD insertions, so you then can offer more options.

As health care providers to children, we always are learning. And with new knowledge we sometimes can be taken out of our comfort zone. One of those areas are teenagers, contraception, safe-sex counseling, and now emergency contraception (EC). In residency you have your 1-month adolescent medicine rotation to try and absorb every bit of information like a sponge, but there also will be a level of discomfort and uncertainty. However, as medical providers we cannot let the above prevent us from giving well-rounded and informed care.

Rawpixel/iStock/Getty Images

When our teens disclose the most private moment of their life, we have to be armed and ready to not only comfort them, but advise and guide them to making a decision so that they can ensure their safety. The answers regarding sexual activity are becoming more and more alarming, especially in our younger patients. Therefore, this is an important discussion to have at every visit (not just well-child checks), so that education opportunities are not missed and our patients feel a sense of normalcy about discussing reproductive health with their health care provider and or parents.

We all have our personal beliefs, but we cannot let that guide our decision on what care or education we give our patients. Unfortunately, I have heard many health care providers judge our patients for their promiscuity, when we need to educate them – not be their judge and jury. Our teens go through different stages of growth and development, and with these stages come experimentation and risk taking. So as their health care providers, we need to be up to date on the information out there.

With regards with EC, some of our patients think that they can get it only after having unprotected sex. However, they should know that the oral ECs can be given to them at any time, so should they be in the situation above, they have an immediate remedy. With the different options come different counseling and different instructions on administration and follow-up. In residency, we might not have learned the skill of inserting an IUD, which is another form of EC; that is why there are many resources available. These resources include hands-on workshops, videos on counseling, and your friendly neighborhood adolescent medicine physician or ob.gyn.

EC can give our patients that sense of relief, especially when they have unprotected sex. However, they also need to have a sense of responsibility for their actions because you do not want them to engage in high-risk behaviors. Just as we are responsible to provide up-to-date care, our patients must take ownership of their health and well-being. Also we should not discuss EC only with our female adolescents, but also with our male patients. If they are engaging in unprotected sex, they are just as responsible; therefore, they should know everything about contraception as well as EC. They should feel comfortable talking to their partners about contraception. Health care providers should make them feel comfortable receiving EC that they can give to their female partner.

We need to become knowledgeable and comfortable prescribing EC, as well as incorporating it in our routine care. This is a policy that I strongly believe should be part of every pediatrician’s and family physician’s office, especially when there is a lack of resources. Of the different options that are available, the oral forms of EC – especially Ella or Plan B step 1 (levonorgestrel) – would be the easiest to prescribe and counsel on. I would not recommend the options where multiple pills need to be taken more than once a day, because compliance becomes a factor. Also knowing that these options are available over the counter also is helpful because our community pharmacist also can help with medication administration and counseling.

In summary, I strongly recommend the discussion of EC in the office, especially the general pediatrician’s office. I recommend that, for those physicians’ who may be uncomfortable, that they should start with the “easier” options of oral progestins (Ella or Plan B step 1). As you become more comfortable with the information and counseling, you can learn skills such as IUD insertions, so you then can offer more options.

As health care providers to children, we always are learning. And with new knowledge we sometimes can be taken out of our comfort zone. One of those areas are teenagers, contraception, safe-sex counseling, and now emergency contraception (EC). In residency you have your 1-month adolescent medicine rotation to try and absorb every bit of information like a sponge, but there also will be a level of discomfort and uncertainty. However, as medical providers we cannot let the above prevent us from giving well-rounded and informed care.

Rawpixel/iStock/Getty Images

When our teens disclose the most private moment of their life, we have to be armed and ready to not only comfort them, but advise and guide them to making a decision so that they can ensure their safety. The answers regarding sexual activity are becoming more and more alarming, especially in our younger patients. Therefore, this is an important discussion to have at every visit (not just well-child checks), so that education opportunities are not missed and our patients feel a sense of normalcy about discussing reproductive health with their health care provider and or parents.

We all have our personal beliefs, but we cannot let that guide our decision on what care or education we give our patients. Unfortunately, I have heard many health care providers judge our patients for their promiscuity, when we need to educate them – not be their judge and jury. Our teens go through different stages of growth and development, and with these stages come experimentation and risk taking. So as their health care providers, we need to be up to date on the information out there.

With regards with EC, some of our patients think that they can get it only after having unprotected sex. However, they should know that the oral ECs can be given to them at any time, so should they be in the situation above, they have an immediate remedy. With the different options come different counseling and different instructions on administration and follow-up. In residency, we might not have learned the skill of inserting an IUD, which is another form of EC; that is why there are many resources available. These resources include hands-on workshops, videos on counseling, and your friendly neighborhood adolescent medicine physician or ob.gyn.

EC can give our patients that sense of relief, especially when they have unprotected sex. However, they also need to have a sense of responsibility for their actions because you do not want them to engage in high-risk behaviors. Just as we are responsible to provide up-to-date care, our patients must take ownership of their health and well-being. Also we should not discuss EC only with our female adolescents, but also with our male patients. If they are engaging in unprotected sex, they are just as responsible; therefore, they should know everything about contraception as well as EC. They should feel comfortable talking to their partners about contraception. Health care providers should make them feel comfortable receiving EC that they can give to their female partner.

We need to become knowledgeable and comfortable prescribing EC, as well as incorporating it in our routine care. This is a policy that I strongly believe should be part of every pediatrician’s and family physician’s office, especially when there is a lack of resources. Of the different options that are available, the oral forms of EC – especially Ella or Plan B step 1 (levonorgestrel) – would be the easiest to prescribe and counsel on. I would not recommend the options where multiple pills need to be taken more than once a day, because compliance becomes a factor. Also knowing that these options are available over the counter also is helpful because our community pharmacist also can help with medication administration and counseling.

In summary, I strongly recommend the discussion of EC in the office, especially the general pediatrician’s office. I recommend that, for those physicians’ who may be uncomfortable, that they should start with the “easier” options of oral progestins (Ella or Plan B step 1). As you become more comfortable with the information and counseling, you can learn skills such as IUD insertions, so you then can offer more options.

A new guideline has been published to update the 2007 guidelines for the management of adults with community-acquired pneumonia (CAP).

The practice guideline was jointly written by an ad hoc committee of the American Thoracic Society and Infectious Diseases Society of America. CAP refers to a pneumonia infection that was acquired by a patient in his or her community. Decisions about which antibiotics to use to treat this kind of infection are based on risk factors for resistant organisms and the severity of illness.
 

Pathogens

Traditionally, CAP is caused by common bacterial pathogens that include Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Staphylococcus aureus, Legionella species, Chlamydia pneumonia, and Moraxella catarrhalis. Risk factors for multidrug resistant pathogens such as methicillin-resistant S. aureus (MRSA) and Pseudomonas aeruginosa include previous infection with MRSA or P. aeruginosa, recent hospitalization, and requiring parenteral antibiotics in the last 90 days.

Defining severe community-acquired pneumonia

The health care–associated pneumonia, or HCAP, classification should no longer be used to determine empiric treatment. The recommendations for which antibiotics to use are linked to the severity of illness. Previously the site of treatment drove antibiotic selection, but since decision about the site of care can be affected by many considerations, the guidelines recommend using the CAP severity criteria. Severe CAP includes either one major or at least three minor criteria.

Major criteria are:

• Septic shock requiring vasopressors.
• Respiratory failure requiring mechanical ventilation.

Minor criteria are:

• Respiratory rate greater than or equal to 30 breaths/min.
• Ratio of arterial O₂ partial pressure to fractional inspired O₂ less than or equal to 250.
• Multilobar infiltrates.
• Confusion/disorientation.
• Uremia (blood urea nitrogen level greater than or equal to 20 mg/dL).
• Leukopenia (white blood cell count less than 4,000 cells/mcL).
• Thrombocytopenia (platelet count less than 100,000 mcL)
• Hypothermia (core temperature less than 36º C).
• Hypotension requiring aggressive fluid resuscitation.

Management and diagnostic testing

Clinicians should use the Pneumonia Severity Index (PSI) and clinical judgment to guide the site of treatment for patients. Gram stain, sputum, and blood culture should not be routinely obtained in an outpatient setting. Legionella antigen should not be routinely obtained unless indicated by epidemiological factors. During influenza season, a rapid influenza assay, preferably a nucleic acid amplification test, should be obtained to help guide treatment.

For patients with severe CAP or risk factors for MRSA or P. aeruginosa, gram stain and culture and Legionella antigen should be obtained to manage antibiotic choices. Also, blood cultures should be obtained for these patients.

Empiric antibiotic therapy should be initiated based on clinical judgment and radiographic confirmation of CAP. Serum procalcitonin should not be used to assess initiation of antibiotic therapy.
 

 

Empiric antibiotic therapy

Healthy adults without comorbidities should be treated with monotherapy of either:

• Amoxicillin 1 g three times daily.
• OR doxycycline 100 mg twice daily.
• OR a macrolide (azithromycin 500 mg on first day then 250 mg daily or clarithromycin 500 mg twice daily or clarithromycin extended release 1,000 mg daily) only in areas with pneumococcal resistance to macrolides less than 25%.

Adults with comorbidities such as chronic heart, lung, liver, or renal disease; diabetes mellitus; alcoholism; malignancy; or asplenia should be treated with:

• Amoxicillin/clavulanate 500 mg/125 mg three times daily, or amoxicillin/ clavulanate 875 mg/125 mg twice daily, or 2,000 mg/125 mg twice daily, or a cephalosporin (cefpodoxime 200 mg twice daily or cefuroxime 500 mg twice daily); and a macrolide (azithromycin 500 mg on first day then 250 mg daily, clarithromycin [500 mg twice daily or extended release 1,000 mg once daily]), or doxycycline 100 mg twice daily. (Some experts recommend that the first dose of doxycycline should be 200 mg.)
• OR monotherapy with respiratory fluoroquinolone (levofloxacin 750 mg daily, moxifloxacin 400 mg daily, or gemifloxacin 320 mg daily).

Inpatient pneumonia that is not severe, without risk factors for resistant organisms should be treated with:

• Beta-lactam (ampicillin 1 sulbactam 1.5-3 g every 6 h, cefotaxime 1-2 g every 8 h, ceftriaxone 1-2 g daily, or ceftaroline 600 mg every 12 h) and a macrolide (azithromycin 500 mg daily or clarithromycin 500 mg twice daily).
• OR monotherapy with a respiratory fluoroquinolone (levofloxacin 750 mg daily, moxifloxacin 400 mg daily).

If there is a contraindication for the use of both a macrolide and a fluoroquinolone, then doxycycline can be used instead.

Severe inpatient pneumonia without risk factors for resistant organisms should be treated with combination therapy of either (agents and doses the same as above):

• Beta-lactam and macrolide.
• OR fluoroquinolone and beta-lactam.

It is recommended to not routinely add anaerobic coverage for suspected aspiration pneumonia unless lung abscess or empyema is suspected. Clinicians should identify risk factors for MRSA or P. aeruginosa before adding additional agents.

Duration of antibiotic therapy is determined by the patient achieving clinical stability with no less than 5 days of antibiotics. In adults with symptom resolution within 5-7 days, no additional follow-up chest imaging is recommended. If patients test positive for influenza, then anti-influenza treatment such as oseltamivir should be used in addition to antibiotics regardless of length of influenza symptoms before presentation.
 

The bottom line

CAP treatment should be based on severity of illness and risk factors for resistant organisms. Blood and sputum cultures are recommended only for patients with severe pneumonia. There have been important changes in the recommendations for antibiotic treatment of CAP, with high-dose amoxicillin recommended for most patients with CAP who are treated as outpatients. Patients who exhibit clinical stability should be treated for at least 5 days and do not require follow up imaging studies.

For a podcast of this guideline, go to iTunes and download the Infectious Diseases Society of America guideline podcast.

 

Reference

Metlay JP, Waterer GW, Long AC, et al. Diagnosis and treatment of adults with community-acquired pneumonia. An official clinical practice guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019 Oct 1;200(7):e45-e67.

Tina Chuong, DO, is a second-year resident in the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.

A new guideline has been published to update the 2007 guidelines for the management of adults with community-acquired pneumonia (CAP).

The practice guideline was jointly written by an ad hoc committee of the American Thoracic Society and Infectious Diseases Society of America. CAP refers to a pneumonia infection that was acquired by a patient in his or her community. Decisions about which antibiotics to use to treat this kind of infection are based on risk factors for resistant organisms and the severity of illness.
 

Pathogens

Traditionally, CAP is caused by common bacterial pathogens that include Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Staphylococcus aureus, Legionella species, Chlamydia pneumonia, and Moraxella catarrhalis. Risk factors for multidrug resistant pathogens such as methicillin-resistant S. aureus (MRSA) and Pseudomonas aeruginosa include previous infection with MRSA or P. aeruginosa, recent hospitalization, and requiring parenteral antibiotics in the last 90 days.

Defining severe community-acquired pneumonia

The health care–associated pneumonia, or HCAP, classification should no longer be used to determine empiric treatment. The recommendations for which antibiotics to use are linked to the severity of illness. Previously the site of treatment drove antibiotic selection, but since decision about the site of care can be affected by many considerations, the guidelines recommend using the CAP severity criteria. Severe CAP includes either one major or at least three minor criteria.

Major criteria are:

• Septic shock requiring vasopressors.
• Respiratory failure requiring mechanical ventilation.

Minor criteria are:

• Respiratory rate greater than or equal to 30 breaths/min.
• Ratio of arterial O₂ partial pressure to fractional inspired O₂ less than or equal to 250.
• Multilobar infiltrates.
• Confusion/disorientation.
• Uremia (blood urea nitrogen level greater than or equal to 20 mg/dL).
• Leukopenia (white blood cell count less than 4,000 cells/mcL).
• Thrombocytopenia (platelet count less than 100,000 mcL)
• Hypothermia (core temperature less than 36º C).
• Hypotension requiring aggressive fluid resuscitation.

Management and diagnostic testing

Clinicians should use the Pneumonia Severity Index (PSI) and clinical judgment to guide the site of treatment for patients. Gram stain, sputum, and blood culture should not be routinely obtained in an outpatient setting. Legionella antigen should not be routinely obtained unless indicated by epidemiological factors. During influenza season, a rapid influenza assay, preferably a nucleic acid amplification test, should be obtained to help guide treatment.

For patients with severe CAP or risk factors for MRSA or P. aeruginosa, gram stain and culture and Legionella antigen should be obtained to manage antibiotic choices. Also, blood cultures should be obtained for these patients.

Empiric antibiotic therapy should be initiated based on clinical judgment and radiographic confirmation of CAP. Serum procalcitonin should not be used to assess initiation of antibiotic therapy.
 

 

Empiric antibiotic therapy

Healthy adults without comorbidities should be treated with monotherapy of either:

• Amoxicillin 1 g three times daily.
• OR doxycycline 100 mg twice daily.
• OR a macrolide (azithromycin 500 mg on first day then 250 mg daily or clarithromycin 500 mg twice daily or clarithromycin extended release 1,000 mg daily) only in areas with pneumococcal resistance to macrolides less than 25%.

Adults with comorbidities such as chronic heart, lung, liver, or renal disease; diabetes mellitus; alcoholism; malignancy; or asplenia should be treated with:

• Amoxicillin/clavulanate 500 mg/125 mg three times daily, or amoxicillin/ clavulanate 875 mg/125 mg twice daily, or 2,000 mg/125 mg twice daily, or a cephalosporin (cefpodoxime 200 mg twice daily or cefuroxime 500 mg twice daily); and a macrolide (azithromycin 500 mg on first day then 250 mg daily, clarithromycin [500 mg twice daily or extended release 1,000 mg once daily]), or doxycycline 100 mg twice daily. (Some experts recommend that the first dose of doxycycline should be 200 mg.)
• OR monotherapy with respiratory fluoroquinolone (levofloxacin 750 mg daily, moxifloxacin 400 mg daily, or gemifloxacin 320 mg daily).

Inpatient pneumonia that is not severe, without risk factors for resistant organisms should be treated with:

• Beta-lactam (ampicillin 1 sulbactam 1.5-3 g every 6 h, cefotaxime 1-2 g every 8 h, ceftriaxone 1-2 g daily, or ceftaroline 600 mg every 12 h) and a macrolide (azithromycin 500 mg daily or clarithromycin 500 mg twice daily).
• OR monotherapy with a respiratory fluoroquinolone (levofloxacin 750 mg daily, moxifloxacin 400 mg daily).

If there is a contraindication for the use of both a macrolide and a fluoroquinolone, then doxycycline can be used instead.

Severe inpatient pneumonia without risk factors for resistant organisms should be treated with combination therapy of either (agents and doses the same as above):

• Beta-lactam and macrolide.
• OR fluoroquinolone and beta-lactam.

It is recommended to not routinely add anaerobic coverage for suspected aspiration pneumonia unless lung abscess or empyema is suspected. Clinicians should identify risk factors for MRSA or P. aeruginosa before adding additional agents.

Duration of antibiotic therapy is determined by the patient achieving clinical stability with no less than 5 days of antibiotics. In adults with symptom resolution within 5-7 days, no additional follow-up chest imaging is recommended. If patients test positive for influenza, then anti-influenza treatment such as oseltamivir should be used in addition to antibiotics regardless of length of influenza symptoms before presentation.
 

The bottom line

CAP treatment should be based on severity of illness and risk factors for resistant organisms. Blood and sputum cultures are recommended only for patients with severe pneumonia. There have been important changes in the recommendations for antibiotic treatment of CAP, with high-dose amoxicillin recommended for most patients with CAP who are treated as outpatients. Patients who exhibit clinical stability should be treated for at least 5 days and do not require follow up imaging studies.

For a podcast of this guideline, go to iTunes and download the Infectious Diseases Society of America guideline podcast.

 

Reference

Metlay JP, Waterer GW, Long AC, et al. Diagnosis and treatment of adults with community-acquired pneumonia. An official clinical practice guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019 Oct 1;200(7):e45-e67.

Tina Chuong, DO, is a second-year resident in the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.

A new guideline has been published to update the 2007 guidelines for the management of adults with community-acquired pneumonia (CAP).

The practice guideline was jointly written by an ad hoc committee of the American Thoracic Society and Infectious Diseases Society of America. CAP refers to a pneumonia infection that was acquired by a patient in his or her community. Decisions about which antibiotics to use to treat this kind of infection are based on risk factors for resistant organisms and the severity of illness.
 

Pathogens

Traditionally, CAP is caused by common bacterial pathogens that include Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Staphylococcus aureus, Legionella species, Chlamydia pneumonia, and Moraxella catarrhalis. Risk factors for multidrug resistant pathogens such as methicillin-resistant S. aureus (MRSA) and Pseudomonas aeruginosa include previous infection with MRSA or P. aeruginosa, recent hospitalization, and requiring parenteral antibiotics in the last 90 days.

Defining severe community-acquired pneumonia

The health care–associated pneumonia, or HCAP, classification should no longer be used to determine empiric treatment. The recommendations for which antibiotics to use are linked to the severity of illness. Previously the site of treatment drove antibiotic selection, but since decision about the site of care can be affected by many considerations, the guidelines recommend using the CAP severity criteria. Severe CAP includes either one major or at least three minor criteria.

Major criteria are:

• Septic shock requiring vasopressors.
• Respiratory failure requiring mechanical ventilation.

Minor criteria are:

• Respiratory rate greater than or equal to 30 breaths/min.
• Ratio of arterial O₂ partial pressure to fractional inspired O₂ less than or equal to 250.
• Multilobar infiltrates.
• Confusion/disorientation.
• Uremia (blood urea nitrogen level greater than or equal to 20 mg/dL).
• Leukopenia (white blood cell count less than 4,000 cells/mcL).
• Thrombocytopenia (platelet count less than 100,000 mcL)
• Hypothermia (core temperature less than 36º C).
• Hypotension requiring aggressive fluid resuscitation.

Management and diagnostic testing

Clinicians should use the Pneumonia Severity Index (PSI) and clinical judgment to guide the site of treatment for patients. Gram stain, sputum, and blood culture should not be routinely obtained in an outpatient setting. Legionella antigen should not be routinely obtained unless indicated by epidemiological factors. During influenza season, a rapid influenza assay, preferably a nucleic acid amplification test, should be obtained to help guide treatment.

For patients with severe CAP or risk factors for MRSA or P. aeruginosa, gram stain and culture and Legionella antigen should be obtained to manage antibiotic choices. Also, blood cultures should be obtained for these patients.

Empiric antibiotic therapy should be initiated based on clinical judgment and radiographic confirmation of CAP. Serum procalcitonin should not be used to assess initiation of antibiotic therapy.
 

 

Empiric antibiotic therapy

Healthy adults without comorbidities should be treated with monotherapy of either:

• Amoxicillin 1 g three times daily.
• OR doxycycline 100 mg twice daily.
• OR a macrolide (azithromycin 500 mg on first day then 250 mg daily or clarithromycin 500 mg twice daily or clarithromycin extended release 1,000 mg daily) only in areas with pneumococcal resistance to macrolides less than 25%.

Adults with comorbidities such as chronic heart, lung, liver, or renal disease; diabetes mellitus; alcoholism; malignancy; or asplenia should be treated with:

• Amoxicillin/clavulanate 500 mg/125 mg three times daily, or amoxicillin/ clavulanate 875 mg/125 mg twice daily, or 2,000 mg/125 mg twice daily, or a cephalosporin (cefpodoxime 200 mg twice daily or cefuroxime 500 mg twice daily); and a macrolide (azithromycin 500 mg on first day then 250 mg daily, clarithromycin [500 mg twice daily or extended release 1,000 mg once daily]), or doxycycline 100 mg twice daily. (Some experts recommend that the first dose of doxycycline should be 200 mg.)
• OR monotherapy with respiratory fluoroquinolone (levofloxacin 750 mg daily, moxifloxacin 400 mg daily, or gemifloxacin 320 mg daily).

Inpatient pneumonia that is not severe, without risk factors for resistant organisms should be treated with:

• Beta-lactam (ampicillin 1 sulbactam 1.5-3 g every 6 h, cefotaxime 1-2 g every 8 h, ceftriaxone 1-2 g daily, or ceftaroline 600 mg every 12 h) and a macrolide (azithromycin 500 mg daily or clarithromycin 500 mg twice daily).
• OR monotherapy with a respiratory fluoroquinolone (levofloxacin 750 mg daily, moxifloxacin 400 mg daily).

If there is a contraindication for the use of both a macrolide and a fluoroquinolone, then doxycycline can be used instead.

Severe inpatient pneumonia without risk factors for resistant organisms should be treated with combination therapy of either (agents and doses the same as above):

• Beta-lactam and macrolide.
• OR fluoroquinolone and beta-lactam.

It is recommended to not routinely add anaerobic coverage for suspected aspiration pneumonia unless lung abscess or empyema is suspected. Clinicians should identify risk factors for MRSA or P. aeruginosa before adding additional agents.

Duration of antibiotic therapy is determined by the patient achieving clinical stability with no less than 5 days of antibiotics. In adults with symptom resolution within 5-7 days, no additional follow-up chest imaging is recommended. If patients test positive for influenza, then anti-influenza treatment such as oseltamivir should be used in addition to antibiotics regardless of length of influenza symptoms before presentation.
 

The bottom line

CAP treatment should be based on severity of illness and risk factors for resistant organisms. Blood and sputum cultures are recommended only for patients with severe pneumonia. There have been important changes in the recommendations for antibiotic treatment of CAP, with high-dose amoxicillin recommended for most patients with CAP who are treated as outpatients. Patients who exhibit clinical stability should be treated for at least 5 days and do not require follow up imaging studies.

For a podcast of this guideline, go to iTunes and download the Infectious Diseases Society of America guideline podcast.

 

Reference

Metlay JP, Waterer GW, Long AC, et al. Diagnosis and treatment of adults with community-acquired pneumonia. An official clinical practice guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019 Oct 1;200(7):e45-e67.

Tina Chuong, DO, is a second-year resident in the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.