The American Recovery and Reinvestment Act of 2009 introduced the Health Information Technology for Economic and Clinical Health (HITECH) Act and allocated $19.2 billion to promote the implementation of an electronic medical record (EMR) by hospitals as well as physicians in private practices.¹ The EMR stores longitudinal health information and constructs a comprehensive picture of a patient's medical history.^2,3 Following its debut, the US Department of Health & Human Services set forth meaningful use (MU) criteria,¹ which aimed to increase quality of care, safety, and efficiency. Meaningful use criteria also sought to decrease health disparities; improve coordination of care; engage patients in their care; refine population and public health measures; and finally ensure accessibility, privacy, and security of patient data.^1,2

The EMR offers potential gains at multiple levels of the patient-physician-public health hierarchy: a decrease in medical errors and duplicate services, timely access to test results and records, timely notification of patients in need for preventive services, and preservation of medical records in the event of an environmental disaster.^1-3 Furthermore, physicians can take advantage of informational reciprocity with other providers, gain remote access to medical records, be reminded of need for service, e-prescribe, monitor for drug interactions, and utilize clinical information for research purposes.^1,3 Lastly, public health organizations can use EMRs to improve outcomes by employing surveillance measures and creating patient registries that serve to protect the society at large.¹

Although it seems that the broad-scale implementation of EMRs will undoubtedly enhance the quality of patient care in the years to come, many obstacles must be overcome to reach this potential. Certification of EMR systems and implementation of confidentiality measures that are compatible with the Health Insurance Portability and Accountability Act are the forerunning concerns, and the interconnectivity of EMR systems becomes more important as MU enters its later stages (eg, increased electronic transmission of patient data during phases of care, reliance on e-prescribing, population-level analysis of patient data to improve health outcomes). Additionally, the cost to implement and maintain an EMR deters many physicians in smaller practices from shouldering the charges, as they do not necessarily see increased productivity with this technology.² Last but not least, unintended consequences of EMR implementation can involve the dangers of upcoding and overdocumentation.¹

Dermatology is a visually dominant field serving a high volume of patients that require both medical and surgical care. These factors do not preclude the implementation of EMRs in our specialty but rather necessitate the utilization of a system specifically designed to cater to the needs of specialists in dermatology. This editorial will address some fundamental considerations in implementing an EMR in dermatology; discuss what platforms and patient interfaces are most practical; reiterate the importance of interoperability; and highlight the implications of this powerful tool in education, research, training, and monitoring quality of care.

Implementation and Specific Considerations in Dermatology

One of the biggest areas of concern in adopting an EMR is the associated financial burden.^2-5 Although government incentives of MU cover a part of the initial cost of purchasing an EMR, expert maintenance costs, changes in workflow dynamics, and a steep learning curve can translate into lost productivity and revenue, discouraging many dermatologists from implementing an EMR.^3,5 Furthermore, physicians who are nearing the end of their careers may not realize the longer-term benefits of implementing an EMR and therefore may decline to do so despite the disincentives of lower Medicare reimbursements.² In fact, when juxtaposing the upfront cost of implementing an EMR against the expected increase in revenue after its implementation, there are general concerns that there will be a net loss on the part of the provider, which is a barrier to adoption of EMRs.³

Beyond the cost-benefit analysis, dermatologists often report multiple lesions in different anatomic sites or identify multiple biopsy sites that have been conveniently recorded on body templates included in their paper-based examination forms. Converting that information into words to be entered into an EMR can be excruciatingly time consuming and not easily comprehensible upon follow-up visits with the patient, which again results in decreased efficiency and productivity.⁴ Therefore, selecting a dermatology-compatible EMR that aims to make this transition easier is of utmost importance. One developer introduced an EMR with a touch interface containing a human body in all its facets that can be rotated, zoomed, and marked multiple times for accurate and convenient recording of lesions and intended procedure sites. This system automatically produces codes for examinations and procedures; facilitates e-prescription and ordering of laboratory results; prints pathology requests and consent forms; and includes information for patient education regarding their care. For example, the physical examination section of an H&P (history and physical examination) can be generated with a few taps on the screen, translating into increased efficiency and productivity.

The visual nature of dermatology demands the use of images, and as such, photographs have become integral in the diagnosis and follow-up of dermatology patients. Digital and dermatoscopic images not only help to eliminate unnecessary biopsies but also can promote early detection and management of malignancies.⁶ Thus, the capability to link photographs to a patient's medical record using an EMR is an invaluable gain. However, employing this feature in clinical practice has ethical implications that must be addressed, given that taking photographs can evoke an avoidable fear in patients regarding unlawful dissemination or unnecessary exposure of these images to physicians who do not need to access them.⁶ Thus, guidelines must be set for uploading, de-identifying, and annotating patient photographs, and only physicians involved in the care of the patient should be allocated access.^4,6

EMR Platforms

When computers were first introduced into examination rooms, many physicians were reluctant, as computers were thought to disconnect physicians from patients, arousing a sense of remoteness and further depersonalizing the encounter as physicians spent more time typing and less time making meaningful eye contact with patients.⁵ The practice of dermatology requires patient-centered communication that serves to enhance the quality of care while at the same time allowing physicians to fulfill professional competencies and reduce medical errors, which may ultimately translate into patient satisfaction.⁷ In fact, when the patient-physician relationship is interrupted, patients are more likely to pursue legal action in the wake of a bad treatment outcome.⁵

Employing a tablet-friendly EMR can help circumvent (or at least minimize) this problem by providing the physician with a light, user-friendly device that eliminates the need for laptops or desktop computers.⁴ Going one step further, the utilization of tablets eliminates the need for accessory digital cameras, as most tablets come with built-in high-resolution cameras for capturing clinical photographs and immediately linking them to the patient's medical record. Lastly, tablet technology allows physicians to access consent forms while in the examination room with the patient to more readily obtain a signature for procedural or research consent.^4,8

Interoperability, MU, and Quality of Care

The real goal in nationwide implementation of EMR technology is to accomplish MU criteria. Different EMRs should not only allow data to be imported and exported but ideally should be compatible and interoperable with one another.² The myriad of different EMR platforms available impedes maximal functionality as MU moves into its final stage. For example, if an academic dermatology program in the setting of a larger hospital is required to use the generic hospital EMR, the dermatologist's specific needs may not be effectively met; on the other hand, if a dermatology-specific EMR is implemented, access to the hospital's larger database of patient information may be sacrificed. Optimal EMR systems should be designed to allow specificity for a given specialty while being able to receive and integrate laboratory values, dermatopathology and radiology results, and notes from consultations by other physicians. Such integration may reduce duplicate services, increase patient satisfaction, and fulfill MU criteria. In fact, the fear of many physicians, especially those in a field such as dermatology, are the unwanted costs that come with implementation of an EMR system that will soon become impractical due to compatibility issues.² As a result, until a system that can meet the needs of multiple specialties is developed, dermatologists and other physicians upgrading to an EMR should consider implementing a system that is compatible with nearby hospitals, other specialists' offices, and diagnostic centers to maximize interoperability at the local level.^2,3

Electronic medical record systems that interoperate also provide the ability to set forth performance measures for physicians aimed at improving quality of care. As our health care system moves toward a pay-for-performance model, EMRs will become a tool to determine if standards of care have been met, unnecessary diagnostic tests have been avoided, and unwanted outcomes have been minimized. These measures will usher in a new era of medicine in which physicians strive to improve the care provided to their patients and receive increases in their reimbursements, while patient outcomes and satisfaction are improved.⁹

Academics, Education, Research, and Residency

The practicality of EMRs in dermatology may best be appreciated in academic settings. Electronic medical records serve as a repository of coded information that is neatly organized and can be rapidly searched, allowing for use as a powerful research tool. As an example, physicians can use EMR systems to identify patients with specific qualifications and study outcome variables over time.^2,3 Additionally, with the rise of interoperable systems, we can expect a new dawn in medical research as more information becomes available to clinical investigators, opening doors to endless possibilities for evidence-based care.^2,3,8

Another advantage of EMRs is their utility in residency programs that are charged with the task of ensuring resident competency via exposure to a comprehensive host of clinical encounters. An EMR system uniquely allows residents and attending dermatologists to monitor adequate exposure to general, pediatric, complex medical, procedural, and dermatopathologic cases, and to track the number of procedures performed by the residents by directly linking the information into the Accreditation Council for Graduate Medical Education procedure log.

Furthermore, due to the dominance of digital and dermatoscopic images in the field, interoperable EMRs could be used to construct a database of clinical and dermatopathologic specimens that not only can be used in educating residents but also may serve as a powerful reference tool in the diagnosis of complex and rare cases.8 Another often unrecognized advantage of EMRs is their utility in teledermatology. With the interoperable EMRs within academic institutions, teledermatology can be used locally and nationally for rapid consultation with high diagnostic validity,¹⁰ which has the burgeoning potential of providing patients with quicker time to diagnosis considering the dermatologist shortage in various parts of the country.

Lastly, the implementation of EMRs in residency programs has the additional benefit of exposing residents and medical students to emerging technology early on in their careers and fosters a degree of familiarity and comfort that may lead to implementation of EMRs in their future practices.² For dermatologists in-training, early exposure to these technologies also may serve as a way to develop an interactive interview style and adapt to the presence of EMRs in examination rooms without sacrificing quality of care and meaningful patient interaction.⁷

Conclusion

Electronic medical records are already becoming an integral part of many hospitals and private dermatology practices. Although EMRs provide potential benefits that can be expected to ultimately outweigh the associated costs in larger settings such as hospitals, residency programs, and multidisciplinary practices, EMRs may not be immediately beneficial to physicians in private practices or those approaching the end of their careers. Although a perfect system may be unattainable, development of interoperable systems designed to meet the needs of specialties such as dermatology are essential in attaining a comprehensive patient medical profile, improving quality of care, minimizing costs, reducing medical errors, and maximizing patient satisfaction.

The American Recovery and Reinvestment Act of 2009 introduced the Health Information Technology for Economic and Clinical Health (HITECH) Act and allocated $19.2 billion to promote the implementation of an electronic medical record (EMR) by hospitals as well as physicians in private practices.¹ The EMR stores longitudinal health information and constructs a comprehensive picture of a patient's medical history.^2,3 Following its debut, the US Department of Health & Human Services set forth meaningful use (MU) criteria,¹ which aimed to increase quality of care, safety, and efficiency. Meaningful use criteria also sought to decrease health disparities; improve coordination of care; engage patients in their care; refine population and public health measures; and finally ensure accessibility, privacy, and security of patient data.^1,2

The EMR offers potential gains at multiple levels of the patient-physician-public health hierarchy: a decrease in medical errors and duplicate services, timely access to test results and records, timely notification of patients in need for preventive services, and preservation of medical records in the event of an environmental disaster.^1-3 Furthermore, physicians can take advantage of informational reciprocity with other providers, gain remote access to medical records, be reminded of need for service, e-prescribe, monitor for drug interactions, and utilize clinical information for research purposes.^1,3 Lastly, public health organizations can use EMRs to improve outcomes by employing surveillance measures and creating patient registries that serve to protect the society at large.¹

Although it seems that the broad-scale implementation of EMRs will undoubtedly enhance the quality of patient care in the years to come, many obstacles must be overcome to reach this potential. Certification of EMR systems and implementation of confidentiality measures that are compatible with the Health Insurance Portability and Accountability Act are the forerunning concerns, and the interconnectivity of EMR systems becomes more important as MU enters its later stages (eg, increased electronic transmission of patient data during phases of care, reliance on e-prescribing, population-level analysis of patient data to improve health outcomes). Additionally, the cost to implement and maintain an EMR deters many physicians in smaller practices from shouldering the charges, as they do not necessarily see increased productivity with this technology.² Last but not least, unintended consequences of EMR implementation can involve the dangers of upcoding and overdocumentation.¹

Dermatology is a visually dominant field serving a high volume of patients that require both medical and surgical care. These factors do not preclude the implementation of EMRs in our specialty but rather necessitate the utilization of a system specifically designed to cater to the needs of specialists in dermatology. This editorial will address some fundamental considerations in implementing an EMR in dermatology; discuss what platforms and patient interfaces are most practical; reiterate the importance of interoperability; and highlight the implications of this powerful tool in education, research, training, and monitoring quality of care.

Implementation and Specific Considerations in Dermatology

One of the biggest areas of concern in adopting an EMR is the associated financial burden.^2-5 Although government incentives of MU cover a part of the initial cost of purchasing an EMR, expert maintenance costs, changes in workflow dynamics, and a steep learning curve can translate into lost productivity and revenue, discouraging many dermatologists from implementing an EMR.^3,5 Furthermore, physicians who are nearing the end of their careers may not realize the longer-term benefits of implementing an EMR and therefore may decline to do so despite the disincentives of lower Medicare reimbursements.² In fact, when juxtaposing the upfront cost of implementing an EMR against the expected increase in revenue after its implementation, there are general concerns that there will be a net loss on the part of the provider, which is a barrier to adoption of EMRs.³

Beyond the cost-benefit analysis, dermatologists often report multiple lesions in different anatomic sites or identify multiple biopsy sites that have been conveniently recorded on body templates included in their paper-based examination forms. Converting that information into words to be entered into an EMR can be excruciatingly time consuming and not easily comprehensible upon follow-up visits with the patient, which again results in decreased efficiency and productivity.⁴ Therefore, selecting a dermatology-compatible EMR that aims to make this transition easier is of utmost importance. One developer introduced an EMR with a touch interface containing a human body in all its facets that can be rotated, zoomed, and marked multiple times for accurate and convenient recording of lesions and intended procedure sites. This system automatically produces codes for examinations and procedures; facilitates e-prescription and ordering of laboratory results; prints pathology requests and consent forms; and includes information for patient education regarding their care. For example, the physical examination section of an H&P (history and physical examination) can be generated with a few taps on the screen, translating into increased efficiency and productivity.

The visual nature of dermatology demands the use of images, and as such, photographs have become integral in the diagnosis and follow-up of dermatology patients. Digital and dermatoscopic images not only help to eliminate unnecessary biopsies but also can promote early detection and management of malignancies.⁶ Thus, the capability to link photographs to a patient's medical record using an EMR is an invaluable gain. However, employing this feature in clinical practice has ethical implications that must be addressed, given that taking photographs can evoke an avoidable fear in patients regarding unlawful dissemination or unnecessary exposure of these images to physicians who do not need to access them.⁶ Thus, guidelines must be set for uploading, de-identifying, and annotating patient photographs, and only physicians involved in the care of the patient should be allocated access.^4,6

EMR Platforms

When computers were first introduced into examination rooms, many physicians were reluctant, as computers were thought to disconnect physicians from patients, arousing a sense of remoteness and further depersonalizing the encounter as physicians spent more time typing and less time making meaningful eye contact with patients.⁵ The practice of dermatology requires patient-centered communication that serves to enhance the quality of care while at the same time allowing physicians to fulfill professional competencies and reduce medical errors, which may ultimately translate into patient satisfaction.⁷ In fact, when the patient-physician relationship is interrupted, patients are more likely to pursue legal action in the wake of a bad treatment outcome.⁵

Employing a tablet-friendly EMR can help circumvent (or at least minimize) this problem by providing the physician with a light, user-friendly device that eliminates the need for laptops or desktop computers.⁴ Going one step further, the utilization of tablets eliminates the need for accessory digital cameras, as most tablets come with built-in high-resolution cameras for capturing clinical photographs and immediately linking them to the patient's medical record. Lastly, tablet technology allows physicians to access consent forms while in the examination room with the patient to more readily obtain a signature for procedural or research consent.^4,8

Interoperability, MU, and Quality of Care

The real goal in nationwide implementation of EMR technology is to accomplish MU criteria. Different EMRs should not only allow data to be imported and exported but ideally should be compatible and interoperable with one another.² The myriad of different EMR platforms available impedes maximal functionality as MU moves into its final stage. For example, if an academic dermatology program in the setting of a larger hospital is required to use the generic hospital EMR, the dermatologist's specific needs may not be effectively met; on the other hand, if a dermatology-specific EMR is implemented, access to the hospital's larger database of patient information may be sacrificed. Optimal EMR systems should be designed to allow specificity for a given specialty while being able to receive and integrate laboratory values, dermatopathology and radiology results, and notes from consultations by other physicians. Such integration may reduce duplicate services, increase patient satisfaction, and fulfill MU criteria. In fact, the fear of many physicians, especially those in a field such as dermatology, are the unwanted costs that come with implementation of an EMR system that will soon become impractical due to compatibility issues.² As a result, until a system that can meet the needs of multiple specialties is developed, dermatologists and other physicians upgrading to an EMR should consider implementing a system that is compatible with nearby hospitals, other specialists' offices, and diagnostic centers to maximize interoperability at the local level.^2,3

Electronic medical record systems that interoperate also provide the ability to set forth performance measures for physicians aimed at improving quality of care. As our health care system moves toward a pay-for-performance model, EMRs will become a tool to determine if standards of care have been met, unnecessary diagnostic tests have been avoided, and unwanted outcomes have been minimized. These measures will usher in a new era of medicine in which physicians strive to improve the care provided to their patients and receive increases in their reimbursements, while patient outcomes and satisfaction are improved.⁹

Academics, Education, Research, and Residency

The practicality of EMRs in dermatology may best be appreciated in academic settings. Electronic medical records serve as a repository of coded information that is neatly organized and can be rapidly searched, allowing for use as a powerful research tool. As an example, physicians can use EMR systems to identify patients with specific qualifications and study outcome variables over time.^2,3 Additionally, with the rise of interoperable systems, we can expect a new dawn in medical research as more information becomes available to clinical investigators, opening doors to endless possibilities for evidence-based care.^2,3,8

Another advantage of EMRs is their utility in residency programs that are charged with the task of ensuring resident competency via exposure to a comprehensive host of clinical encounters. An EMR system uniquely allows residents and attending dermatologists to monitor adequate exposure to general, pediatric, complex medical, procedural, and dermatopathologic cases, and to track the number of procedures performed by the residents by directly linking the information into the Accreditation Council for Graduate Medical Education procedure log.

Furthermore, due to the dominance of digital and dermatoscopic images in the field, interoperable EMRs could be used to construct a database of clinical and dermatopathologic specimens that not only can be used in educating residents but also may serve as a powerful reference tool in the diagnosis of complex and rare cases.8 Another often unrecognized advantage of EMRs is their utility in teledermatology. With the interoperable EMRs within academic institutions, teledermatology can be used locally and nationally for rapid consultation with high diagnostic validity,¹⁰ which has the burgeoning potential of providing patients with quicker time to diagnosis considering the dermatologist shortage in various parts of the country.

Lastly, the implementation of EMRs in residency programs has the additional benefit of exposing residents and medical students to emerging technology early on in their careers and fosters a degree of familiarity and comfort that may lead to implementation of EMRs in their future practices.² For dermatologists in-training, early exposure to these technologies also may serve as a way to develop an interactive interview style and adapt to the presence of EMRs in examination rooms without sacrificing quality of care and meaningful patient interaction.⁷

Conclusion

Electronic medical records are already becoming an integral part of many hospitals and private dermatology practices. Although EMRs provide potential benefits that can be expected to ultimately outweigh the associated costs in larger settings such as hospitals, residency programs, and multidisciplinary practices, EMRs may not be immediately beneficial to physicians in private practices or those approaching the end of their careers. Although a perfect system may be unattainable, development of interoperable systems designed to meet the needs of specialties such as dermatology are essential in attaining a comprehensive patient medical profile, improving quality of care, minimizing costs, reducing medical errors, and maximizing patient satisfaction.

The American Recovery and Reinvestment Act of 2009 introduced the Health Information Technology for Economic and Clinical Health (HITECH) Act and allocated $19.2 billion to promote the implementation of an electronic medical record (EMR) by hospitals as well as physicians in private practices.¹ The EMR stores longitudinal health information and constructs a comprehensive picture of a patient's medical history.^2,3 Following its debut, the US Department of Health & Human Services set forth meaningful use (MU) criteria,¹ which aimed to increase quality of care, safety, and efficiency. Meaningful use criteria also sought to decrease health disparities; improve coordination of care; engage patients in their care; refine population and public health measures; and finally ensure accessibility, privacy, and security of patient data.^1,2

The EMR offers potential gains at multiple levels of the patient-physician-public health hierarchy: a decrease in medical errors and duplicate services, timely access to test results and records, timely notification of patients in need for preventive services, and preservation of medical records in the event of an environmental disaster.^1-3 Furthermore, physicians can take advantage of informational reciprocity with other providers, gain remote access to medical records, be reminded of need for service, e-prescribe, monitor for drug interactions, and utilize clinical information for research purposes.^1,3 Lastly, public health organizations can use EMRs to improve outcomes by employing surveillance measures and creating patient registries that serve to protect the society at large.¹

Although it seems that the broad-scale implementation of EMRs will undoubtedly enhance the quality of patient care in the years to come, many obstacles must be overcome to reach this potential. Certification of EMR systems and implementation of confidentiality measures that are compatible with the Health Insurance Portability and Accountability Act are the forerunning concerns, and the interconnectivity of EMR systems becomes more important as MU enters its later stages (eg, increased electronic transmission of patient data during phases of care, reliance on e-prescribing, population-level analysis of patient data to improve health outcomes). Additionally, the cost to implement and maintain an EMR deters many physicians in smaller practices from shouldering the charges, as they do not necessarily see increased productivity with this technology.² Last but not least, unintended consequences of EMR implementation can involve the dangers of upcoding and overdocumentation.¹

Dermatology is a visually dominant field serving a high volume of patients that require both medical and surgical care. These factors do not preclude the implementation of EMRs in our specialty but rather necessitate the utilization of a system specifically designed to cater to the needs of specialists in dermatology. This editorial will address some fundamental considerations in implementing an EMR in dermatology; discuss what platforms and patient interfaces are most practical; reiterate the importance of interoperability; and highlight the implications of this powerful tool in education, research, training, and monitoring quality of care.

Implementation and Specific Considerations in Dermatology

One of the biggest areas of concern in adopting an EMR is the associated financial burden.^2-5 Although government incentives of MU cover a part of the initial cost of purchasing an EMR, expert maintenance costs, changes in workflow dynamics, and a steep learning curve can translate into lost productivity and revenue, discouraging many dermatologists from implementing an EMR.^3,5 Furthermore, physicians who are nearing the end of their careers may not realize the longer-term benefits of implementing an EMR and therefore may decline to do so despite the disincentives of lower Medicare reimbursements.² In fact, when juxtaposing the upfront cost of implementing an EMR against the expected increase in revenue after its implementation, there are general concerns that there will be a net loss on the part of the provider, which is a barrier to adoption of EMRs.³

Beyond the cost-benefit analysis, dermatologists often report multiple lesions in different anatomic sites or identify multiple biopsy sites that have been conveniently recorded on body templates included in their paper-based examination forms. Converting that information into words to be entered into an EMR can be excruciatingly time consuming and not easily comprehensible upon follow-up visits with the patient, which again results in decreased efficiency and productivity.⁴ Therefore, selecting a dermatology-compatible EMR that aims to make this transition easier is of utmost importance. One developer introduced an EMR with a touch interface containing a human body in all its facets that can be rotated, zoomed, and marked multiple times for accurate and convenient recording of lesions and intended procedure sites. This system automatically produces codes for examinations and procedures; facilitates e-prescription and ordering of laboratory results; prints pathology requests and consent forms; and includes information for patient education regarding their care. For example, the physical examination section of an H&P (history and physical examination) can be generated with a few taps on the screen, translating into increased efficiency and productivity.

The visual nature of dermatology demands the use of images, and as such, photographs have become integral in the diagnosis and follow-up of dermatology patients. Digital and dermatoscopic images not only help to eliminate unnecessary biopsies but also can promote early detection and management of malignancies.⁶ Thus, the capability to link photographs to a patient's medical record using an EMR is an invaluable gain. However, employing this feature in clinical practice has ethical implications that must be addressed, given that taking photographs can evoke an avoidable fear in patients regarding unlawful dissemination or unnecessary exposure of these images to physicians who do not need to access them.⁶ Thus, guidelines must be set for uploading, de-identifying, and annotating patient photographs, and only physicians involved in the care of the patient should be allocated access.^4,6

EMR Platforms

When computers were first introduced into examination rooms, many physicians were reluctant, as computers were thought to disconnect physicians from patients, arousing a sense of remoteness and further depersonalizing the encounter as physicians spent more time typing and less time making meaningful eye contact with patients.⁵ The practice of dermatology requires patient-centered communication that serves to enhance the quality of care while at the same time allowing physicians to fulfill professional competencies and reduce medical errors, which may ultimately translate into patient satisfaction.⁷ In fact, when the patient-physician relationship is interrupted, patients are more likely to pursue legal action in the wake of a bad treatment outcome.⁵

Employing a tablet-friendly EMR can help circumvent (or at least minimize) this problem by providing the physician with a light, user-friendly device that eliminates the need for laptops or desktop computers.⁴ Going one step further, the utilization of tablets eliminates the need for accessory digital cameras, as most tablets come with built-in high-resolution cameras for capturing clinical photographs and immediately linking them to the patient's medical record. Lastly, tablet technology allows physicians to access consent forms while in the examination room with the patient to more readily obtain a signature for procedural or research consent.^4,8

Interoperability, MU, and Quality of Care

The real goal in nationwide implementation of EMR technology is to accomplish MU criteria. Different EMRs should not only allow data to be imported and exported but ideally should be compatible and interoperable with one another.² The myriad of different EMR platforms available impedes maximal functionality as MU moves into its final stage. For example, if an academic dermatology program in the setting of a larger hospital is required to use the generic hospital EMR, the dermatologist's specific needs may not be effectively met; on the other hand, if a dermatology-specific EMR is implemented, access to the hospital's larger database of patient information may be sacrificed. Optimal EMR systems should be designed to allow specificity for a given specialty while being able to receive and integrate laboratory values, dermatopathology and radiology results, and notes from consultations by other physicians. Such integration may reduce duplicate services, increase patient satisfaction, and fulfill MU criteria. In fact, the fear of many physicians, especially those in a field such as dermatology, are the unwanted costs that come with implementation of an EMR system that will soon become impractical due to compatibility issues.² As a result, until a system that can meet the needs of multiple specialties is developed, dermatologists and other physicians upgrading to an EMR should consider implementing a system that is compatible with nearby hospitals, other specialists' offices, and diagnostic centers to maximize interoperability at the local level.^2,3

Electronic medical record systems that interoperate also provide the ability to set forth performance measures for physicians aimed at improving quality of care. As our health care system moves toward a pay-for-performance model, EMRs will become a tool to determine if standards of care have been met, unnecessary diagnostic tests have been avoided, and unwanted outcomes have been minimized. These measures will usher in a new era of medicine in which physicians strive to improve the care provided to their patients and receive increases in their reimbursements, while patient outcomes and satisfaction are improved.⁹

Academics, Education, Research, and Residency

The practicality of EMRs in dermatology may best be appreciated in academic settings. Electronic medical records serve as a repository of coded information that is neatly organized and can be rapidly searched, allowing for use as a powerful research tool. As an example, physicians can use EMR systems to identify patients with specific qualifications and study outcome variables over time.^2,3 Additionally, with the rise of interoperable systems, we can expect a new dawn in medical research as more information becomes available to clinical investigators, opening doors to endless possibilities for evidence-based care.^2,3,8

Another advantage of EMRs is their utility in residency programs that are charged with the task of ensuring resident competency via exposure to a comprehensive host of clinical encounters. An EMR system uniquely allows residents and attending dermatologists to monitor adequate exposure to general, pediatric, complex medical, procedural, and dermatopathologic cases, and to track the number of procedures performed by the residents by directly linking the information into the Accreditation Council for Graduate Medical Education procedure log.

Furthermore, due to the dominance of digital and dermatoscopic images in the field, interoperable EMRs could be used to construct a database of clinical and dermatopathologic specimens that not only can be used in educating residents but also may serve as a powerful reference tool in the diagnosis of complex and rare cases.8 Another often unrecognized advantage of EMRs is their utility in teledermatology. With the interoperable EMRs within academic institutions, teledermatology can be used locally and nationally for rapid consultation with high diagnostic validity,¹⁰ which has the burgeoning potential of providing patients with quicker time to diagnosis considering the dermatologist shortage in various parts of the country.

Lastly, the implementation of EMRs in residency programs has the additional benefit of exposing residents and medical students to emerging technology early on in their careers and fosters a degree of familiarity and comfort that may lead to implementation of EMRs in their future practices.² For dermatologists in-training, early exposure to these technologies also may serve as a way to develop an interactive interview style and adapt to the presence of EMRs in examination rooms without sacrificing quality of care and meaningful patient interaction.⁷

Conclusion

Electronic medical records are already becoming an integral part of many hospitals and private dermatology practices. Although EMRs provide potential benefits that can be expected to ultimately outweigh the associated costs in larger settings such as hospitals, residency programs, and multidisciplinary practices, EMRs may not be immediately beneficial to physicians in private practices or those approaching the end of their careers. Although a perfect system may be unattainable, development of interoperable systems designed to meet the needs of specialties such as dermatology are essential in attaining a comprehensive patient medical profile, improving quality of care, minimizing costs, reducing medical errors, and maximizing patient satisfaction.

I recently picked up my daughter from summer camp, and on the 5-hour drive home she kept texting people back and forth. I asked her if they were other campers or counselors she’d befriended.

cyano66/Thinkstock

She said yes, they were other campers she’d met, but was horrified that I thought some might be counselors. Counselors, understandably, aren’t allowed to have any contact with kids outside of camp. Not by text, Instagram, Facebook, or any other modern social contrivances.

That probably should have occurred to me before I even asked. It makes sense.

I keep a similar policy with patients.

Nothing against them: The majority are decent people, and there are a few I could easily see being social friends with – meeting for dinner, going to a basketball game ... but I won’t.

Like the kids and counselors at camp, I need to keep a distance between myself and patients. I don’t have any social media accounts, anyway, but I keep the relationship confined to my office.

Keeping an emotional distance with patients makes it easier to do this job. While we may genuinely care about them and are trying to help, it’s important to be objective. Seeing them through the lens of friendship might affect the decision-making process.

The divider of professionalism is there for a good reason, across many fields. It allows us to try and think clearly, to give good and bad news, and make diagnostic and treatment decisions as rationally as possible, based on scientific evidence and each individual’s circumstances.

It’s what makes good medicine possible. I wouldn’t want it to be any other way.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

I recently picked up my daughter from summer camp, and on the 5-hour drive home she kept texting people back and forth. I asked her if they were other campers or counselors she’d befriended.

cyano66/Thinkstock

She said yes, they were other campers she’d met, but was horrified that I thought some might be counselors. Counselors, understandably, aren’t allowed to have any contact with kids outside of camp. Not by text, Instagram, Facebook, or any other modern social contrivances.

That probably should have occurred to me before I even asked. It makes sense.

I keep a similar policy with patients.

Nothing against them: The majority are decent people, and there are a few I could easily see being social friends with – meeting for dinner, going to a basketball game ... but I won’t.

Like the kids and counselors at camp, I need to keep a distance between myself and patients. I don’t have any social media accounts, anyway, but I keep the relationship confined to my office.

Keeping an emotional distance with patients makes it easier to do this job. While we may genuinely care about them and are trying to help, it’s important to be objective. Seeing them through the lens of friendship might affect the decision-making process.

The divider of professionalism is there for a good reason, across many fields. It allows us to try and think clearly, to give good and bad news, and make diagnostic and treatment decisions as rationally as possible, based on scientific evidence and each individual’s circumstances.

It’s what makes good medicine possible. I wouldn’t want it to be any other way.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

I recently picked up my daughter from summer camp, and on the 5-hour drive home she kept texting people back and forth. I asked her if they were other campers or counselors she’d befriended.

cyano66/Thinkstock

She said yes, they were other campers she’d met, but was horrified that I thought some might be counselors. Counselors, understandably, aren’t allowed to have any contact with kids outside of camp. Not by text, Instagram, Facebook, or any other modern social contrivances.

That probably should have occurred to me before I even asked. It makes sense.

I keep a similar policy with patients.

Nothing against them: The majority are decent people, and there are a few I could easily see being social friends with – meeting for dinner, going to a basketball game ... but I won’t.

Like the kids and counselors at camp, I need to keep a distance between myself and patients. I don’t have any social media accounts, anyway, but I keep the relationship confined to my office.

Keeping an emotional distance with patients makes it easier to do this job. While we may genuinely care about them and are trying to help, it’s important to be objective. Seeing them through the lens of friendship might affect the decision-making process.

The divider of professionalism is there for a good reason, across many fields. It allows us to try and think clearly, to give good and bad news, and make diagnostic and treatment decisions as rationally as possible, based on scientific evidence and each individual’s circumstances.

It’s what makes good medicine possible. I wouldn’t want it to be any other way.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

In medical school, they taught us to learn the patient’s chief complaint.

Steve Debenport/Getty Images

In dermatology the presenting complaint is on the outside, where the skin is. The chief complaint is often deeper.

Sandra

“How are your parents?”

“Getting older. I’m over their house every day. It’s always something.

“My husband had a stroke this year. Our daughter – she’s a nurse – made him get help. ‘You’re not talking right,’ she said to him. You’re going to the hospital right now.’

“Stan’s at home. He can’t work construction anymore. When I get back from taking care of my parents, I take care of him.”

Sandra’s moles are normal. Who is taking care of her?

Grigoriy

“I’ve had a hard life,” says Grigoriy, apropos of nothing.

“How?”

“My father was important in the Communist party. Stalin purged him in 1938. I was a teenager. “They kept me in a cell of one room for 15 years.”

“Why did they put you in jail?”

“I was my father’s son.”

Phil

Phil is in for his annual. He looks robust, but thinner.

“Sorry I missed last year,” he says. “I was clearing my throat a lot. An ENT doctor found that I had cancer of the vocal cords. I got 39 radiation sessions. They said I would handle them OK, but afterward, I’d feel awful. They were right.

“I lost 20 pounds,” says Phil. “But now I’m getting back to myself.” His smile is broad, but uncertain.

Fred

Fred’s rash is impressive: big, purple blotches all over. Could be a drug eruption, only he takes no drugs.

“It may be viral,” I say.

“Can I visit my Dad in Providence Sunday?” he asks. “It’s Father’s Day.”

“I’m not sure …”

“Dad has cancer of the esophagus. They’re hoping that chemo may buy him a little time.”

I tell Fred to wash carefully. Some things can’t be rescheduled.

Emily

Emily’s Mom has left me a note to read before I see her daughter. It lists Emily’s five psychoactive medications.

Emily is lying on her back and does not sit up. Her gaze is vague and unfocused.

Emily has moderate papular acne on her cheeks. That is her presenting complaint. It is not her chief complaint. As for what her mother goes through, I can barely imagine.

Brenda

Brenda comes for 6-month skin checks. Usually with her husband Glen, but not today.

“Glen’s not so well,” Brenda says. The doctors diagnosed him with MS. They’re vague about how fast it will progress. I guess they don’t know.

“To tell the truth, Glen’s pretty depressed. But he doesn’t want to talk to anyone about it. Do you know a psychiatrist who specializes in MS patients? Glen might take your advice.”

Tom

“It’s been a tough year. Eddie died. You saw him years ago, I think.”

I actually remember Eddie. A troubled kid with terrible acne. He had one visit, never came back.

“I was walking in a mountain field in Cambodia when I got the word,” says Tom. “My ex called me. ‘Tom died,’ she said. ‘Drug overdose. Come home.’

“Every year I walk through Cambodia and Myanmar for a month,” says Tom. “Just to be alone. The people there are nice. They let me be.

“Eddie was a good boy. He hung with the wrong crowd. He made a mistake, and he could never get past it. I think of him every day.”

Frank

Frank doesn’t pick. Frank gouges. He’s been gouging his forearms for years. Intralesional steroids help a little. But he can’t stop.

“I guess it’s stress,” Frank says.

“How about avoiding stress?” I ask, with a smile.

Frank breaks down and weeps.

“I’m sorry,” he says. He gathers himself. “My wife has breast cancer. Mammogram showed a spot 4 years ago. Then it grew. It’s already stage four. Our kids are teenagers.”

Frank breaks down again. He apologizes again. “I’m so sorry for being like this.” Again he weeps, again he apologizes. “I shouldn’t act like this,” he says. “I’m sorry.”

I am sorry, too. Very sorry, indeed. Like all doctors, I want to help. Sometimes I can help the skin, temper the presenting complaint. But for patients’ true chief complaints, often incidental to the superficial presenting ones, all I can do is listen. It’s not much, but it’s the best I can do. For many patients, over many years, listening has been the most I’ve had to offer.


 

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected].

In medical school, they taught us to learn the patient’s chief complaint.

Steve Debenport/Getty Images

In dermatology the presenting complaint is on the outside, where the skin is. The chief complaint is often deeper.

Sandra

“How are your parents?”

“Getting older. I’m over their house every day. It’s always something.

“My husband had a stroke this year. Our daughter – she’s a nurse – made him get help. ‘You’re not talking right,’ she said to him. You’re going to the hospital right now.’

“Stan’s at home. He can’t work construction anymore. When I get back from taking care of my parents, I take care of him.”

Sandra’s moles are normal. Who is taking care of her?

Grigoriy

“I’ve had a hard life,” says Grigoriy, apropos of nothing.

“How?”

“My father was important in the Communist party. Stalin purged him in 1938. I was a teenager. “They kept me in a cell of one room for 15 years.”

“Why did they put you in jail?”

“I was my father’s son.”

Phil

Phil is in for his annual. He looks robust, but thinner.

“Sorry I missed last year,” he says. “I was clearing my throat a lot. An ENT doctor found that I had cancer of the vocal cords. I got 39 radiation sessions. They said I would handle them OK, but afterward, I’d feel awful. They were right.

“I lost 20 pounds,” says Phil. “But now I’m getting back to myself.” His smile is broad, but uncertain.

Fred

Fred’s rash is impressive: big, purple blotches all over. Could be a drug eruption, only he takes no drugs.

“It may be viral,” I say.

“Can I visit my Dad in Providence Sunday?” he asks. “It’s Father’s Day.”

“I’m not sure …”

“Dad has cancer of the esophagus. They’re hoping that chemo may buy him a little time.”

I tell Fred to wash carefully. Some things can’t be rescheduled.

Emily

Emily’s Mom has left me a note to read before I see her daughter. It lists Emily’s five psychoactive medications.

Emily is lying on her back and does not sit up. Her gaze is vague and unfocused.

Emily has moderate papular acne on her cheeks. That is her presenting complaint. It is not her chief complaint. As for what her mother goes through, I can barely imagine.

Brenda

Brenda comes for 6-month skin checks. Usually with her husband Glen, but not today.

“Glen’s not so well,” Brenda says. The doctors diagnosed him with MS. They’re vague about how fast it will progress. I guess they don’t know.

“To tell the truth, Glen’s pretty depressed. But he doesn’t want to talk to anyone about it. Do you know a psychiatrist who specializes in MS patients? Glen might take your advice.”

Tom

“It’s been a tough year. Eddie died. You saw him years ago, I think.”

I actually remember Eddie. A troubled kid with terrible acne. He had one visit, never came back.

“I was walking in a mountain field in Cambodia when I got the word,” says Tom. “My ex called me. ‘Tom died,’ she said. ‘Drug overdose. Come home.’

“Every year I walk through Cambodia and Myanmar for a month,” says Tom. “Just to be alone. The people there are nice. They let me be.

“Eddie was a good boy. He hung with the wrong crowd. He made a mistake, and he could never get past it. I think of him every day.”

Frank

Frank doesn’t pick. Frank gouges. He’s been gouging his forearms for years. Intralesional steroids help a little. But he can’t stop.

“I guess it’s stress,” Frank says.

“How about avoiding stress?” I ask, with a smile.

Frank breaks down and weeps.

“I’m sorry,” he says. He gathers himself. “My wife has breast cancer. Mammogram showed a spot 4 years ago. Then it grew. It’s already stage four. Our kids are teenagers.”

Frank breaks down again. He apologizes again. “I’m so sorry for being like this.” Again he weeps, again he apologizes. “I shouldn’t act like this,” he says. “I’m sorry.”

I am sorry, too. Very sorry, indeed. Like all doctors, I want to help. Sometimes I can help the skin, temper the presenting complaint. But for patients’ true chief complaints, often incidental to the superficial presenting ones, all I can do is listen. It’s not much, but it’s the best I can do. For many patients, over many years, listening has been the most I’ve had to offer.


 

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected].

In medical school, they taught us to learn the patient’s chief complaint.

Steve Debenport/Getty Images

In dermatology the presenting complaint is on the outside, where the skin is. The chief complaint is often deeper.

Sandra

“How are your parents?”

“Getting older. I’m over their house every day. It’s always something.

“My husband had a stroke this year. Our daughter – she’s a nurse – made him get help. ‘You’re not talking right,’ she said to him. You’re going to the hospital right now.’

“Stan’s at home. He can’t work construction anymore. When I get back from taking care of my parents, I take care of him.”

Sandra’s moles are normal. Who is taking care of her?

Grigoriy

“I’ve had a hard life,” says Grigoriy, apropos of nothing.

“How?”

“My father was important in the Communist party. Stalin purged him in 1938. I was a teenager. “They kept me in a cell of one room for 15 years.”

“Why did they put you in jail?”

“I was my father’s son.”

Phil

Phil is in for his annual. He looks robust, but thinner.

“Sorry I missed last year,” he says. “I was clearing my throat a lot. An ENT doctor found that I had cancer of the vocal cords. I got 39 radiation sessions. They said I would handle them OK, but afterward, I’d feel awful. They were right.

“I lost 20 pounds,” says Phil. “But now I’m getting back to myself.” His smile is broad, but uncertain.

Fred

Fred’s rash is impressive: big, purple blotches all over. Could be a drug eruption, only he takes no drugs.

“It may be viral,” I say.

“Can I visit my Dad in Providence Sunday?” he asks. “It’s Father’s Day.”

“I’m not sure …”

“Dad has cancer of the esophagus. They’re hoping that chemo may buy him a little time.”

I tell Fred to wash carefully. Some things can’t be rescheduled.

Emily

Emily’s Mom has left me a note to read before I see her daughter. It lists Emily’s five psychoactive medications.

Emily is lying on her back and does not sit up. Her gaze is vague and unfocused.

Emily has moderate papular acne on her cheeks. That is her presenting complaint. It is not her chief complaint. As for what her mother goes through, I can barely imagine.

Brenda

Brenda comes for 6-month skin checks. Usually with her husband Glen, but not today.

“Glen’s not so well,” Brenda says. The doctors diagnosed him with MS. They’re vague about how fast it will progress. I guess they don’t know.

“To tell the truth, Glen’s pretty depressed. But he doesn’t want to talk to anyone about it. Do you know a psychiatrist who specializes in MS patients? Glen might take your advice.”

Tom

“It’s been a tough year. Eddie died. You saw him years ago, I think.”

I actually remember Eddie. A troubled kid with terrible acne. He had one visit, never came back.

“I was walking in a mountain field in Cambodia when I got the word,” says Tom. “My ex called me. ‘Tom died,’ she said. ‘Drug overdose. Come home.’

“Every year I walk through Cambodia and Myanmar for a month,” says Tom. “Just to be alone. The people there are nice. They let me be.

“Eddie was a good boy. He hung with the wrong crowd. He made a mistake, and he could never get past it. I think of him every day.”

Frank

Frank doesn’t pick. Frank gouges. He’s been gouging his forearms for years. Intralesional steroids help a little. But he can’t stop.

“I guess it’s stress,” Frank says.

“How about avoiding stress?” I ask, with a smile.

Frank breaks down and weeps.

“I’m sorry,” he says. He gathers himself. “My wife has breast cancer. Mammogram showed a spot 4 years ago. Then it grew. It’s already stage four. Our kids are teenagers.”

Frank breaks down again. He apologizes again. “I’m so sorry for being like this.” Again he weeps, again he apologizes. “I shouldn’t act like this,” he says. “I’m sorry.”

I am sorry, too. Very sorry, indeed. Like all doctors, I want to help. Sometimes I can help the skin, temper the presenting complaint. But for patients’ true chief complaints, often incidental to the superficial presenting ones, all I can do is listen. It’s not much, but it’s the best I can do. For many patients, over many years, listening has been the most I’ve had to offer.


 

Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected].

Every cancer diagnosis starts out as anything but. That’s what I was thinking when I met Sue Marcus (not her real name) in the emergency department one Friday afternoon.

“You know,” she said in a matter of fact manner. “I think I might have the flu.”

“Yes,” I said. “You might.”

“I was in Vegas a week ago, and the person next to me was sick.”

“It’s definitely possible. That’s one of the things we’ll test for.”

“I mean ... what else can it be?”

I had information Sue didn’t yet. All her blood counts were disturbingly low. On top of that, the lab had picked up several atypical appearing cells. They could be reactive, in the setting of infection, or they could be blasts – a new diagnosis of leukemia.

I paused.

“I’m going to say this now, so you know what we are looking for. There’s a lot more information we still need.”

“But?”

“But, another possibility is that it is cancer.”

“Cancer?”

“Leukemia, maybe.”

I explained the next steps. We would have flow cytometry by that night, but it’s not a perfect test. We were limited, actually, by logistics. It was a Friday night. We would do a bone marrow biopsy on Monday. It would be several days before we’d know with certainty.

That evening, the hematology fellow and I looked at the slide under the microscope. We agreed with the lab.

“That’s a blast, isn’t it?”

“Yes, I think it is.”

But they were not completely classic, and they were sporadic. It wasn’t enough to say for sure. Meanwhile, Sue, understandably, wanted answers.

“What did you see? Is it cancer, or not?”

There was flow cytometry that night, showing an abnormal population of cells. And then, finally, there was a bone marrow biopsy clinching the diagnosis.

We explained what the path ahead looked like: Hospitalization for a month. Chemotherapy, then a repeat bone marrow biopsy to look for response. Then more chemotherapy. Chances of remission. Long-term implications.

As we gathered more information, Sue’s questions evolved.

“Is it curable?”

“Can I go back to work?”

And one day, a week into treatment, she asked, “Am I going to die?”

Over my last 3 years as an internal medicine resident, I’ve been humbled by how often patients turned to me for answers to some of the most difficult questions I could imagine. Sometimes, the questions seemed purely factual, but often, they took a more existential bent: How should I spend my last months? What should I do now? Patients have asked me if they are going to die, along with when, how, and even why.

I’ve wrestled with how to communicate candidly, treading a delicate balance between being as up-front as possible while also recognizing the uncertainty inherent in predicting. I’ve struggled with walking the tightrope of delivering bad news while also emphasizing compassion and support.

I chose hematology and oncology in part because of the gravity of these interactions. I enjoy being a primary doctor for a complex, sick, patient population who are grappling with physically and emotionally challenging illness. I value longitudinal relationships with patients I know well. I found the medicine of hematology and oncology interdisciplinary, the details high stakes, and the big questions always at play. If it was meaningful work I sought, cancer became the ultimate question that mattered.

The changing landscape of cancer care is making these conversations substantially more difficult. A central tenet of medicine is truthfulness: setting the stage for what is going on and what to anticipate. It’s explaining the nuances of the upcoming treatment options, while also addressing what a person’s life may look like down the road. It’s understanding what matters most to a patient, understanding what therapeutic choices we can offer – and then trying to reconcile them, as best as we can.

This has always been hard. But it’s getting harder. The options we have to treat cancer are expanding rapidly as immunotherapy competes with the basics of chemotherapy, radiation, and surgery. We work alongside researchers looking to change the paradigm, collecting information on outcomes and side effects as we go along. We are learning and we are applying what we learn – in real time – on real people willing to try.

How can we speak honestly about a prognosis when our data are limited and our tools are in continuous flux? How can we prepare someone for what lies ahead when we are still trying to grasp what today looks like?

All the while, medical uncertainties are amplified by a complex system with many moving parts. It’s a system in which some patients cannot afford care, in which insurance companies may deny necessary treatment, and where families may come together or fall apart in the face of incredible adversity. There are factors outside the scope of pure medicine that make the path ahead all the hazier and navigating it all the more challenging.

In July, I began my hematology and oncology fellowship. I am caring for patients with a range of cancers, and all of that goes along with the weight of those diagnoses. Learning the most up-to-date management in a constantly evolving landscape will be an ongoing skill. That my patients allow me into their most vulnerable moments – and trust me with them – is a gift.

For patients like Sue, there sometimes remain more questions than answers. She recently underwent her third round of chemotherapy and endured multiple blood clots. With her insurance covering only limited interventions, she is deciding what to focus on and where to receive her care. Her story, like many others, continues to be written.

I am deeply aware of the difficulties that are a part of the world of cancer – and the heartbreak. How can we hold up scans triumphantly showing no recurrence in some patients while others suffer one failed treatment after another? When should we push for more therapy and when should we shift our efforts toward comfort? What should we prioritize – medically and personally – if time is limited?

These questions are hard, but I cannot think of any that are more meaningful.

This is a column about patients and uncertainty as I pursue my hematology and oncology fellowship and grapple with these questions. I look forward to sharing them with you each month.

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz.

Every cancer diagnosis starts out as anything but. That’s what I was thinking when I met Sue Marcus (not her real name) in the emergency department one Friday afternoon.

“You know,” she said in a matter of fact manner. “I think I might have the flu.”

“Yes,” I said. “You might.”

“I was in Vegas a week ago, and the person next to me was sick.”

“It’s definitely possible. That’s one of the things we’ll test for.”

“I mean ... what else can it be?”

I had information Sue didn’t yet. All her blood counts were disturbingly low. On top of that, the lab had picked up several atypical appearing cells. They could be reactive, in the setting of infection, or they could be blasts – a new diagnosis of leukemia.

I paused.

“I’m going to say this now, so you know what we are looking for. There’s a lot more information we still need.”

“But?”

“But, another possibility is that it is cancer.”

“Cancer?”

“Leukemia, maybe.”

I explained the next steps. We would have flow cytometry by that night, but it’s not a perfect test. We were limited, actually, by logistics. It was a Friday night. We would do a bone marrow biopsy on Monday. It would be several days before we’d know with certainty.

That evening, the hematology fellow and I looked at the slide under the microscope. We agreed with the lab.

“That’s a blast, isn’t it?”

“Yes, I think it is.”

But they were not completely classic, and they were sporadic. It wasn’t enough to say for sure. Meanwhile, Sue, understandably, wanted answers.

“What did you see? Is it cancer, or not?”

There was flow cytometry that night, showing an abnormal population of cells. And then, finally, there was a bone marrow biopsy clinching the diagnosis.

We explained what the path ahead looked like: Hospitalization for a month. Chemotherapy, then a repeat bone marrow biopsy to look for response. Then more chemotherapy. Chances of remission. Long-term implications.

As we gathered more information, Sue’s questions evolved.

“Is it curable?”

“Can I go back to work?”

And one day, a week into treatment, she asked, “Am I going to die?”

Over my last 3 years as an internal medicine resident, I’ve been humbled by how often patients turned to me for answers to some of the most difficult questions I could imagine. Sometimes, the questions seemed purely factual, but often, they took a more existential bent: How should I spend my last months? What should I do now? Patients have asked me if they are going to die, along with when, how, and even why.

I’ve wrestled with how to communicate candidly, treading a delicate balance between being as up-front as possible while also recognizing the uncertainty inherent in predicting. I’ve struggled with walking the tightrope of delivering bad news while also emphasizing compassion and support.

I chose hematology and oncology in part because of the gravity of these interactions. I enjoy being a primary doctor for a complex, sick, patient population who are grappling with physically and emotionally challenging illness. I value longitudinal relationships with patients I know well. I found the medicine of hematology and oncology interdisciplinary, the details high stakes, and the big questions always at play. If it was meaningful work I sought, cancer became the ultimate question that mattered.

The changing landscape of cancer care is making these conversations substantially more difficult. A central tenet of medicine is truthfulness: setting the stage for what is going on and what to anticipate. It’s explaining the nuances of the upcoming treatment options, while also addressing what a person’s life may look like down the road. It’s understanding what matters most to a patient, understanding what therapeutic choices we can offer – and then trying to reconcile them, as best as we can.

This has always been hard. But it’s getting harder. The options we have to treat cancer are expanding rapidly as immunotherapy competes with the basics of chemotherapy, radiation, and surgery. We work alongside researchers looking to change the paradigm, collecting information on outcomes and side effects as we go along. We are learning and we are applying what we learn – in real time – on real people willing to try.

How can we speak honestly about a prognosis when our data are limited and our tools are in continuous flux? How can we prepare someone for what lies ahead when we are still trying to grasp what today looks like?

All the while, medical uncertainties are amplified by a complex system with many moving parts. It’s a system in which some patients cannot afford care, in which insurance companies may deny necessary treatment, and where families may come together or fall apart in the face of incredible adversity. There are factors outside the scope of pure medicine that make the path ahead all the hazier and navigating it all the more challenging.

In July, I began my hematology and oncology fellowship. I am caring for patients with a range of cancers, and all of that goes along with the weight of those diagnoses. Learning the most up-to-date management in a constantly evolving landscape will be an ongoing skill. That my patients allow me into their most vulnerable moments – and trust me with them – is a gift.

For patients like Sue, there sometimes remain more questions than answers. She recently underwent her third round of chemotherapy and endured multiple blood clots. With her insurance covering only limited interventions, she is deciding what to focus on and where to receive her care. Her story, like many others, continues to be written.

I am deeply aware of the difficulties that are a part of the world of cancer – and the heartbreak. How can we hold up scans triumphantly showing no recurrence in some patients while others suffer one failed treatment after another? When should we push for more therapy and when should we shift our efforts toward comfort? What should we prioritize – medically and personally – if time is limited?

These questions are hard, but I cannot think of any that are more meaningful.

This is a column about patients and uncertainty as I pursue my hematology and oncology fellowship and grapple with these questions. I look forward to sharing them with you each month.

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz.

Every cancer diagnosis starts out as anything but. That’s what I was thinking when I met Sue Marcus (not her real name) in the emergency department one Friday afternoon.

“You know,” she said in a matter of fact manner. “I think I might have the flu.”

“Yes,” I said. “You might.”

“I was in Vegas a week ago, and the person next to me was sick.”

“It’s definitely possible. That’s one of the things we’ll test for.”

“I mean ... what else can it be?”

I had information Sue didn’t yet. All her blood counts were disturbingly low. On top of that, the lab had picked up several atypical appearing cells. They could be reactive, in the setting of infection, or they could be blasts – a new diagnosis of leukemia.

I paused.

“I’m going to say this now, so you know what we are looking for. There’s a lot more information we still need.”

“But?”

“But, another possibility is that it is cancer.”

“Cancer?”

“Leukemia, maybe.”

I explained the next steps. We would have flow cytometry by that night, but it’s not a perfect test. We were limited, actually, by logistics. It was a Friday night. We would do a bone marrow biopsy on Monday. It would be several days before we’d know with certainty.

That evening, the hematology fellow and I looked at the slide under the microscope. We agreed with the lab.

“That’s a blast, isn’t it?”

“Yes, I think it is.”

But they were not completely classic, and they were sporadic. It wasn’t enough to say for sure. Meanwhile, Sue, understandably, wanted answers.

“What did you see? Is it cancer, or not?”

There was flow cytometry that night, showing an abnormal population of cells. And then, finally, there was a bone marrow biopsy clinching the diagnosis.

We explained what the path ahead looked like: Hospitalization for a month. Chemotherapy, then a repeat bone marrow biopsy to look for response. Then more chemotherapy. Chances of remission. Long-term implications.

As we gathered more information, Sue’s questions evolved.

“Is it curable?”

“Can I go back to work?”

And one day, a week into treatment, she asked, “Am I going to die?”

Over my last 3 years as an internal medicine resident, I’ve been humbled by how often patients turned to me for answers to some of the most difficult questions I could imagine. Sometimes, the questions seemed purely factual, but often, they took a more existential bent: How should I spend my last months? What should I do now? Patients have asked me if they are going to die, along with when, how, and even why.

I’ve wrestled with how to communicate candidly, treading a delicate balance between being as up-front as possible while also recognizing the uncertainty inherent in predicting. I’ve struggled with walking the tightrope of delivering bad news while also emphasizing compassion and support.

I chose hematology and oncology in part because of the gravity of these interactions. I enjoy being a primary doctor for a complex, sick, patient population who are grappling with physically and emotionally challenging illness. I value longitudinal relationships with patients I know well. I found the medicine of hematology and oncology interdisciplinary, the details high stakes, and the big questions always at play. If it was meaningful work I sought, cancer became the ultimate question that mattered.

The changing landscape of cancer care is making these conversations substantially more difficult. A central tenet of medicine is truthfulness: setting the stage for what is going on and what to anticipate. It’s explaining the nuances of the upcoming treatment options, while also addressing what a person’s life may look like down the road. It’s understanding what matters most to a patient, understanding what therapeutic choices we can offer – and then trying to reconcile them, as best as we can.

This has always been hard. But it’s getting harder. The options we have to treat cancer are expanding rapidly as immunotherapy competes with the basics of chemotherapy, radiation, and surgery. We work alongside researchers looking to change the paradigm, collecting information on outcomes and side effects as we go along. We are learning and we are applying what we learn – in real time – on real people willing to try.

How can we speak honestly about a prognosis when our data are limited and our tools are in continuous flux? How can we prepare someone for what lies ahead when we are still trying to grasp what today looks like?

All the while, medical uncertainties are amplified by a complex system with many moving parts. It’s a system in which some patients cannot afford care, in which insurance companies may deny necessary treatment, and where families may come together or fall apart in the face of incredible adversity. There are factors outside the scope of pure medicine that make the path ahead all the hazier and navigating it all the more challenging.

In July, I began my hematology and oncology fellowship. I am caring for patients with a range of cancers, and all of that goes along with the weight of those diagnoses. Learning the most up-to-date management in a constantly evolving landscape will be an ongoing skill. That my patients allow me into their most vulnerable moments – and trust me with them – is a gift.

For patients like Sue, there sometimes remain more questions than answers. She recently underwent her third round of chemotherapy and endured multiple blood clots. With her insurance covering only limited interventions, she is deciding what to focus on and where to receive her care. Her story, like many others, continues to be written.

I am deeply aware of the difficulties that are a part of the world of cancer – and the heartbreak. How can we hold up scans triumphantly showing no recurrence in some patients while others suffer one failed treatment after another? When should we push for more therapy and when should we shift our efforts toward comfort? What should we prioritize – medically and personally – if time is limited?

These questions are hard, but I cannot think of any that are more meaningful.

This is a column about patients and uncertainty as I pursue my hematology and oncology fellowship and grapple with these questions. I look forward to sharing them with you each month.

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz.

Click here to access August 2018 Advances In Hematology and Oncology Digital Edition.

Table of Contents

• VHA Practice Guideline Recommendations for Diffuse Gliomas
• Positivity Rates in Head and Neck Cancer in the VA
• Prevalence of Cancer in Thyroid Nodules in a Veteran Population
• Fatal Drug-Resistant Invasive Infection in a 56-Year-Old Immunosuppressed Man
• Immune Checkpoint Inhibitors for Urothelial Cancer: An Update on New Therapies
• Research News: RCC. Adrenal Tumors, Myeloma Therapy, Cancer Clusters, Hodgkin Lymphoma
• Coordination of Prostate Cance Care Between Primary Care and Oncology
• Open Clinical Trials for Patients With Lung Cancers

Click here to access August 2018 Advances In Hematology and Oncology Digital Edition.

Table of Contents

• VHA Practice Guideline Recommendations for Diffuse Gliomas
• Positivity Rates in Head and Neck Cancer in the VA
• Prevalence of Cancer in Thyroid Nodules in a Veteran Population
• Fatal Drug-Resistant Invasive Infection in a 56-Year-Old Immunosuppressed Man
• Immune Checkpoint Inhibitors for Urothelial Cancer: An Update on New Therapies
• Research News: RCC. Adrenal Tumors, Myeloma Therapy, Cancer Clusters, Hodgkin Lymphoma
• Coordination of Prostate Cance Care Between Primary Care and Oncology
• Open Clinical Trials for Patients With Lung Cancers

Click here to access August 2018 Advances In Hematology and Oncology Digital Edition.

Table of Contents

• VHA Practice Guideline Recommendations for Diffuse Gliomas
• Positivity Rates in Head and Neck Cancer in the VA
• Prevalence of Cancer in Thyroid Nodules in a Veteran Population
• Fatal Drug-Resistant Invasive Infection in a 56-Year-Old Immunosuppressed Man
• Immune Checkpoint Inhibitors for Urothelial Cancer: An Update on New Therapies
• Research News: RCC. Adrenal Tumors, Myeloma Therapy, Cancer Clusters, Hodgkin Lymphoma
• Coordination of Prostate Cance Care Between Primary Care and Oncology
• Open Clinical Trials for Patients With Lung Cancers

The rupture rate for breast implants is about 10% at 10 years after insertion. That means women aged ≥ 70 years have a greater risk of rupture. For women who had breast augmentation or reconstruction before the advent of fifth-generation implants, there are no specific recommendations regarding follow-up and very little guidance in the literature about management for those who have had implants after radiation, say clinicians from Mayo Clinic.

They report on a 74-year-old patient who was treated for breast cancer in 1987 and 1988. She underwent lumpectomy, adjuvant unilateral radiation, a right simple mastectomy, left modified radical mastectomy, and implant-based reconstruction. Nearly 30 years later, she felt an asymmetry in 1 breast. Magnetic resonance imaging and ultrasound revealed that both implants had ruptured.

It is well known, the clinicians say, that complications of postmastectomy radiotherapy include capsular contracture, infection, and loss of prosthesis in implant-based reconstruction. Studies have shown that fibrosis, a hallmark of chronic radiation therapy, can show up even several years after radiotherapy—underscoring the importance of long-term follow-up for these patients. Moreover, the fact that the consequences of silicone on irradiated mastectomy flaps is unknown posed a further challenge.

While the cause of their patient’s implant rupture is unknown, the clinicians say it is “very likely” that delayed-onset fibrosis and capsular contracture secondary to radiation played a role. Such complications, though rare, should be kept in mind, the clinicians advise, when evaluating patients who had radiation and implants.

Source:

Molinar VE, Sabbagh MD, Manrique OJ. BMJ Case Rep. 2018; pii: bcr-2018-224578.
doi: 10.1136/bcr-2018-224578.

The rupture rate for breast implants is about 10% at 10 years after insertion. That means women aged ≥ 70 years have a greater risk of rupture. For women who had breast augmentation or reconstruction before the advent of fifth-generation implants, there are no specific recommendations regarding follow-up and very little guidance in the literature about management for those who have had implants after radiation, say clinicians from Mayo Clinic.

They report on a 74-year-old patient who was treated for breast cancer in 1987 and 1988. She underwent lumpectomy, adjuvant unilateral radiation, a right simple mastectomy, left modified radical mastectomy, and implant-based reconstruction. Nearly 30 years later, she felt an asymmetry in 1 breast. Magnetic resonance imaging and ultrasound revealed that both implants had ruptured.

It is well known, the clinicians say, that complications of postmastectomy radiotherapy include capsular contracture, infection, and loss of prosthesis in implant-based reconstruction. Studies have shown that fibrosis, a hallmark of chronic radiation therapy, can show up even several years after radiotherapy—underscoring the importance of long-term follow-up for these patients. Moreover, the fact that the consequences of silicone on irradiated mastectomy flaps is unknown posed a further challenge.

While the cause of their patient’s implant rupture is unknown, the clinicians say it is “very likely” that delayed-onset fibrosis and capsular contracture secondary to radiation played a role. Such complications, though rare, should be kept in mind, the clinicians advise, when evaluating patients who had radiation and implants.

Source:

Molinar VE, Sabbagh MD, Manrique OJ. BMJ Case Rep. 2018; pii: bcr-2018-224578.
doi: 10.1136/bcr-2018-224578.

The rupture rate for breast implants is about 10% at 10 years after insertion. That means women aged ≥ 70 years have a greater risk of rupture. For women who had breast augmentation or reconstruction before the advent of fifth-generation implants, there are no specific recommendations regarding follow-up and very little guidance in the literature about management for those who have had implants after radiation, say clinicians from Mayo Clinic.

They report on a 74-year-old patient who was treated for breast cancer in 1987 and 1988. She underwent lumpectomy, adjuvant unilateral radiation, a right simple mastectomy, left modified radical mastectomy, and implant-based reconstruction. Nearly 30 years later, she felt an asymmetry in 1 breast. Magnetic resonance imaging and ultrasound revealed that both implants had ruptured.

It is well known, the clinicians say, that complications of postmastectomy radiotherapy include capsular contracture, infection, and loss of prosthesis in implant-based reconstruction. Studies have shown that fibrosis, a hallmark of chronic radiation therapy, can show up even several years after radiotherapy—underscoring the importance of long-term follow-up for these patients. Moreover, the fact that the consequences of silicone on irradiated mastectomy flaps is unknown posed a further challenge.

While the cause of their patient’s implant rupture is unknown, the clinicians say it is “very likely” that delayed-onset fibrosis and capsular contracture secondary to radiation played a role. Such complications, though rare, should be kept in mind, the clinicians advise, when evaluating patients who had radiation and implants.

Source:

Molinar VE, Sabbagh MD, Manrique OJ. BMJ Case Rep. 2018; pii: bcr-2018-224578.
doi: 10.1136/bcr-2018-224578.

Clinical question: Can a multifaceted intervention by a clinical pharmacist reduce the rate of ED visits and readmission over the subsequent 180 days?

Background: The period following an inpatient admission contains many potential risks for patients, among them the risk for adverse drug events. Approximately 45% of readmissions from adverse drug reactions are thought to be avoidable.

Study design: Multicentered, single-blinded, randomized, control trial, from September 2013 to April 2015.

Setting: Four acute inpatient hospitals in Denmark.

Synopsis: 1,467 adult patients being admitted for an acute hospitalization on a minimum of five medications were randomized to receive usual care, a basic intervention (medication review by a clinical pharmacist), or an extended intervention (medication review, three motivational interviews, and follow-up with the primary care physician, pharmacy and, if appropriate, nursing home by a clinical pharmacist). The primary endpoints were readmission within 30 days or 180 days, ED visits within 180 days, and a composite endpoint of readmission or ED visit within 180 days post discharge. For these endpoints, the basic intervention group had no statistically significant difference from the usual-care group. The extended intervention group had significantly lower rates of readmission within 30 days and 180 days, as well as the primary composite endpoint compared to the usual-care group (P less than .05 for all comparisons). For the extended intervention, the number needed to treat for the main composite endpoint was 12.

Bottom line: For patients admitted to the hospital, an extended intervention by a clinical pharmacist resulted in a significant reduction in readmissions.

Citation: Ravn-Nielsen LV et al. Effect of an in-hospital multifaceted clinical pharmacist intervention on the risk of readmission. JAMA Intern Med. 2018;178(3):375-82.

Dr. Biddick is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.

Clinical question: Can a multifaceted intervention by a clinical pharmacist reduce the rate of ED visits and readmission over the subsequent 180 days?

Background: The period following an inpatient admission contains many potential risks for patients, among them the risk for adverse drug events. Approximately 45% of readmissions from adverse drug reactions are thought to be avoidable.

Study design: Multicentered, single-blinded, randomized, control trial, from September 2013 to April 2015.

Setting: Four acute inpatient hospitals in Denmark.

Synopsis: 1,467 adult patients being admitted for an acute hospitalization on a minimum of five medications were randomized to receive usual care, a basic intervention (medication review by a clinical pharmacist), or an extended intervention (medication review, three motivational interviews, and follow-up with the primary care physician, pharmacy and, if appropriate, nursing home by a clinical pharmacist). The primary endpoints were readmission within 30 days or 180 days, ED visits within 180 days, and a composite endpoint of readmission or ED visit within 180 days post discharge. For these endpoints, the basic intervention group had no statistically significant difference from the usual-care group. The extended intervention group had significantly lower rates of readmission within 30 days and 180 days, as well as the primary composite endpoint compared to the usual-care group (P less than .05 for all comparisons). For the extended intervention, the number needed to treat for the main composite endpoint was 12.

Bottom line: For patients admitted to the hospital, an extended intervention by a clinical pharmacist resulted in a significant reduction in readmissions.

Citation: Ravn-Nielsen LV et al. Effect of an in-hospital multifaceted clinical pharmacist intervention on the risk of readmission. JAMA Intern Med. 2018;178(3):375-82.

Dr. Biddick is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.

Clinical question: Can a multifaceted intervention by a clinical pharmacist reduce the rate of ED visits and readmission over the subsequent 180 days?

Background: The period following an inpatient admission contains many potential risks for patients, among them the risk for adverse drug events. Approximately 45% of readmissions from adverse drug reactions are thought to be avoidable.

Study design: Multicentered, single-blinded, randomized, control trial, from September 2013 to April 2015.

Setting: Four acute inpatient hospitals in Denmark.

Synopsis: 1,467 adult patients being admitted for an acute hospitalization on a minimum of five medications were randomized to receive usual care, a basic intervention (medication review by a clinical pharmacist), or an extended intervention (medication review, three motivational interviews, and follow-up with the primary care physician, pharmacy and, if appropriate, nursing home by a clinical pharmacist). The primary endpoints were readmission within 30 days or 180 days, ED visits within 180 days, and a composite endpoint of readmission or ED visit within 180 days post discharge. For these endpoints, the basic intervention group had no statistically significant difference from the usual-care group. The extended intervention group had significantly lower rates of readmission within 30 days and 180 days, as well as the primary composite endpoint compared to the usual-care group (P less than .05 for all comparisons). For the extended intervention, the number needed to treat for the main composite endpoint was 12.

Bottom line: For patients admitted to the hospital, an extended intervention by a clinical pharmacist resulted in a significant reduction in readmissions.

Citation: Ravn-Nielsen LV et al. Effect of an in-hospital multifaceted clinical pharmacist intervention on the risk of readmission. JAMA Intern Med. 2018;178(3):375-82.

Dr. Biddick is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.

Micrograph showing FL

A multidrug regimen can improve upon involved-field radiotherapy (IFRT) in patients with early stage follicular lymphoma (FL), according to research published in the Journal of Clinical Oncology.

FL patients who received IFRT plus cyclophosphamide, vincristine, and prednisolone (CVP)—with or without rituximab—had a significant improvement in progression-free survival (PFS) compared to patients who received standard treatment with IFRT alone.

However, there was no significant difference in overall survival (OS) between the treatment arms.

“This is the first successful randomized study ever to be conducted in early stage follicular lymphoma comparing standard therapy to standard therapy plus effective chemotherapy or immunochemotherapy,” said Michael MacManus, MBBCh, of Peter MacCallum Cancer Centre in Melbourne, Victoria, Australia.

“It shows that the initial treatment received by patients can significantly affect their long-term chance of staying free from disease. Moving forward, we are interested in determining whether there is a benefit in overall long-term survival for patients treated with the combination with further follow-up, and if there is any way to predict if a person will benefit from combined treatment based on analyses of blood or biopsy specimens.”

Dr MacManus and his colleagues studied 150 patients with stage I to II, low-grade FL who were enrolled in this trial between 2000 and 2012.

At randomization, the patients’ median age was 57, 52% were male, 75% had stage I disease, and 48% had PET staging.

Half of patients (n=75) were randomized to receive IFRT (30-36 Gy) alone, and half were randomized to IFRT (30-36 Gy) plus 6 cycles of CVP. From 2006 on, patients in the CVP arm received rituximab (R) as well (n=31).

Baseline characteristics were well-balanced between the treatment arms.

Efficacy

The median follow-up was 9.6 years (range, 3.1 to 15.8 years).

PFS was significantly better among patients randomized to receive CVP±R (hazard ratio [HR]=0.57; P=0.033). The estimated 10-year PFS rate was 41% in the IFRT arm and 59% in the CVP±R arm.

Patients randomized to receive CVP plus R (n=31) had significantly better PFS than patients randomized to receive IFRT alone (n=31) over the same time period (HR=0.26; P=0.045).

There were 10 deaths in the IRFT arm and 5 in the CVP±R arm, but there was no significant difference in OS between the arms (HR=0.62; P=0.40). The 10-year OS rate was 86% in the IFRT arm and 95% in the CVP±R arm.

There was no significant between-arm difference in transformation to aggressive lymphoma (P=0.1). Transformation occurred in 10 patients in the IFRT arm and 4 in the CVP±R arm.

Safety

There were 148 patients from both arms who ultimately received IFRT, and 69 patients who received CVP±R.

Grade 2 toxicities occurring in more than 10% of IFRT recipients included upper gastrointestinal (n=27; 18%), skin (n=21; 14%), and mucous membrane (n=19; 12%) toxicity. One IFRT recipient had grade 3 mucositis, and 1 had grade 4 esophageal/pharyngeal mucosal toxicity.

Grade 3 toxicities occurring in at least 2 patients in the CVP±R arm included neutropenia (n=10; 14%), infection (n=8; 12%), diarrhea (n=3; 4%), elevated gamma-glutamyl transferase (n=3; 4%), fatigue (n=3; 4%), and febrile neutropenia (n=3; 4%).

Three patients (4%) in the CVP±R arm had acute grade 3 neuropathy related to vincristine. Ten patients (14%) had grade 4 neutropenia.

The most common late toxicities for the entire patient cohort were salivary gland (n=8; 5%) and skin (n=4; 3%) toxicities.

Grade 3 lung and menopausal toxicities occurred in 1 patient each. Two patients had late grade 3 vincristine neuropathy. One patient who had grade 3 neuropathy during chemotherapy progressed to grade 4.

Micrograph showing FL

A multidrug regimen can improve upon involved-field radiotherapy (IFRT) in patients with early stage follicular lymphoma (FL), according to research published in the Journal of Clinical Oncology.

FL patients who received IFRT plus cyclophosphamide, vincristine, and prednisolone (CVP)—with or without rituximab—had a significant improvement in progression-free survival (PFS) compared to patients who received standard treatment with IFRT alone.

However, there was no significant difference in overall survival (OS) between the treatment arms.

“This is the first successful randomized study ever to be conducted in early stage follicular lymphoma comparing standard therapy to standard therapy plus effective chemotherapy or immunochemotherapy,” said Michael MacManus, MBBCh, of Peter MacCallum Cancer Centre in Melbourne, Victoria, Australia.

“It shows that the initial treatment received by patients can significantly affect their long-term chance of staying free from disease. Moving forward, we are interested in determining whether there is a benefit in overall long-term survival for patients treated with the combination with further follow-up, and if there is any way to predict if a person will benefit from combined treatment based on analyses of blood or biopsy specimens.”

Dr MacManus and his colleagues studied 150 patients with stage I to II, low-grade FL who were enrolled in this trial between 2000 and 2012.

At randomization, the patients’ median age was 57, 52% were male, 75% had stage I disease, and 48% had PET staging.

Half of patients (n=75) were randomized to receive IFRT (30-36 Gy) alone, and half were randomized to IFRT (30-36 Gy) plus 6 cycles of CVP. From 2006 on, patients in the CVP arm received rituximab (R) as well (n=31).

Baseline characteristics were well-balanced between the treatment arms.

Efficacy

The median follow-up was 9.6 years (range, 3.1 to 15.8 years).

PFS was significantly better among patients randomized to receive CVP±R (hazard ratio [HR]=0.57; P=0.033). The estimated 10-year PFS rate was 41% in the IFRT arm and 59% in the CVP±R arm.

Patients randomized to receive CVP plus R (n=31) had significantly better PFS than patients randomized to receive IFRT alone (n=31) over the same time period (HR=0.26; P=0.045).

There were 10 deaths in the IRFT arm and 5 in the CVP±R arm, but there was no significant difference in OS between the arms (HR=0.62; P=0.40). The 10-year OS rate was 86% in the IFRT arm and 95% in the CVP±R arm.

There was no significant between-arm difference in transformation to aggressive lymphoma (P=0.1). Transformation occurred in 10 patients in the IFRT arm and 4 in the CVP±R arm.

Safety

There were 148 patients from both arms who ultimately received IFRT, and 69 patients who received CVP±R.

Grade 2 toxicities occurring in more than 10% of IFRT recipients included upper gastrointestinal (n=27; 18%), skin (n=21; 14%), and mucous membrane (n=19; 12%) toxicity. One IFRT recipient had grade 3 mucositis, and 1 had grade 4 esophageal/pharyngeal mucosal toxicity.

Grade 3 toxicities occurring in at least 2 patients in the CVP±R arm included neutropenia (n=10; 14%), infection (n=8; 12%), diarrhea (n=3; 4%), elevated gamma-glutamyl transferase (n=3; 4%), fatigue (n=3; 4%), and febrile neutropenia (n=3; 4%).

Three patients (4%) in the CVP±R arm had acute grade 3 neuropathy related to vincristine. Ten patients (14%) had grade 4 neutropenia.

The most common late toxicities for the entire patient cohort were salivary gland (n=8; 5%) and skin (n=4; 3%) toxicities.

Grade 3 lung and menopausal toxicities occurred in 1 patient each. Two patients had late grade 3 vincristine neuropathy. One patient who had grade 3 neuropathy during chemotherapy progressed to grade 4.

Micrograph showing FL

A multidrug regimen can improve upon involved-field radiotherapy (IFRT) in patients with early stage follicular lymphoma (FL), according to research published in the Journal of Clinical Oncology.

FL patients who received IFRT plus cyclophosphamide, vincristine, and prednisolone (CVP)—with or without rituximab—had a significant improvement in progression-free survival (PFS) compared to patients who received standard treatment with IFRT alone.

However, there was no significant difference in overall survival (OS) between the treatment arms.

“This is the first successful randomized study ever to be conducted in early stage follicular lymphoma comparing standard therapy to standard therapy plus effective chemotherapy or immunochemotherapy,” said Michael MacManus, MBBCh, of Peter MacCallum Cancer Centre in Melbourne, Victoria, Australia.

“It shows that the initial treatment received by patients can significantly affect their long-term chance of staying free from disease. Moving forward, we are interested in determining whether there is a benefit in overall long-term survival for patients treated with the combination with further follow-up, and if there is any way to predict if a person will benefit from combined treatment based on analyses of blood or biopsy specimens.”

Dr MacManus and his colleagues studied 150 patients with stage I to II, low-grade FL who were enrolled in this trial between 2000 and 2012.

At randomization, the patients’ median age was 57, 52% were male, 75% had stage I disease, and 48% had PET staging.

Half of patients (n=75) were randomized to receive IFRT (30-36 Gy) alone, and half were randomized to IFRT (30-36 Gy) plus 6 cycles of CVP. From 2006 on, patients in the CVP arm received rituximab (R) as well (n=31).

Baseline characteristics were well-balanced between the treatment arms.

Efficacy

The median follow-up was 9.6 years (range, 3.1 to 15.8 years).

PFS was significantly better among patients randomized to receive CVP±R (hazard ratio [HR]=0.57; P=0.033). The estimated 10-year PFS rate was 41% in the IFRT arm and 59% in the CVP±R arm.

Patients randomized to receive CVP plus R (n=31) had significantly better PFS than patients randomized to receive IFRT alone (n=31) over the same time period (HR=0.26; P=0.045).

There were 10 deaths in the IRFT arm and 5 in the CVP±R arm, but there was no significant difference in OS between the arms (HR=0.62; P=0.40). The 10-year OS rate was 86% in the IFRT arm and 95% in the CVP±R arm.

There was no significant between-arm difference in transformation to aggressive lymphoma (P=0.1). Transformation occurred in 10 patients in the IFRT arm and 4 in the CVP±R arm.

Safety

There were 148 patients from both arms who ultimately received IFRT, and 69 patients who received CVP±R.

Grade 2 toxicities occurring in more than 10% of IFRT recipients included upper gastrointestinal (n=27; 18%), skin (n=21; 14%), and mucous membrane (n=19; 12%) toxicity. One IFRT recipient had grade 3 mucositis, and 1 had grade 4 esophageal/pharyngeal mucosal toxicity.

Grade 3 toxicities occurring in at least 2 patients in the CVP±R arm included neutropenia (n=10; 14%), infection (n=8; 12%), diarrhea (n=3; 4%), elevated gamma-glutamyl transferase (n=3; 4%), fatigue (n=3; 4%), and febrile neutropenia (n=3; 4%).

Three patients (4%) in the CVP±R arm had acute grade 3 neuropathy related to vincristine. Ten patients (14%) had grade 4 neutropenia.

The most common late toxicities for the entire patient cohort were salivary gland (n=8; 5%) and skin (n=4; 3%) toxicities.

Grade 3 lung and menopausal toxicities occurred in 1 patient each. Two patients had late grade 3 vincristine neuropathy. One patient who had grade 3 neuropathy during chemotherapy progressed to grade 4.

Hospital/Peter Barta

Health-related financial hardship is common among adult survivors of childhood cancer, according to a study published in the Journal of the National Cancer Institute.

Researchers analyzed more than 2800 long-term childhood cancer survivors (CCSs) and found that 65% had financial challenges related to their cancer diagnosis.

“These findings suggest primary care doctors and oncologists should routinely screen childhood cancer survivors for possible financial hardship,” said I-Chan Huang, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

Specifically, Dr Huang recommends that healthcare providers routinely ask CCSs if they are unable to purchase medications, ever skip appointments for economic reasons, or worry about how to pay their medical bills.

For this study, Dr Huang and his colleagues analyzed data from 2811 CCSs. The subjects had a mean age of 31.8 (range, 18 to 65) and were a mean of 23.6 years from cancer diagnosis. Most (57.8%) had been diagnosed with hematologic malignancies, 32.0% with solid tumors, and 10.1% with central nervous system malignancies.

All subjects had been treated at St. Jude and enrolled in the St. Jude LIFE study. Participants return to St. Jude periodically for several days of clinical and functional assessments. Data for this study were collected during the CCSs’ first St. Jude LIFE evaluations.

Assessing hardship

The researchers measured 3 types of financial hardship—material, psychological, and coping/behavioral.

About 1 in 5 CCSs (22.4%) reported material financial hardship. In other words, their cancer had an impact on their financial situation.

More than half of CCSs (51.1%) reported psychological hardship—concern about their ability to pay for medical expenses.

And 33% of CCSs reported coping/behavioral hardship—an inability to see a doctor or go to the hospital due to finances.

Roughly 65% of CCSs reported at least 1 type of financial hardship.

All 3 types of hardship were significantly associated with somatization (all P<0.001), anxiety (all P<0.001), depression (all P<0.001), suicidal thoughts (all P<0.05), and difficulty in retirement planning (all P<0.001).

Furthermore, CCSs who reported financial hardship had significantly lower health-related quality of life (P<0.001 for all 3 domains), sensation abnormality (all P<0.001), pulmonary symptoms (all P<0.05), and cardiac symptoms (all P<0.05).

Predicting hardship

Intensive cancer treatment, chronic health conditions, second cancers, age at the time of study evaluation, education level, and annual household income were all significantly associated with a greater risk of financial hardship.

CCSs age 40 and older had an increased risk of psychological and coping/behavioral hardship (P<0.001 for both domains).

CCSs with an annual household income of less than $40,000 had an increased risk of material, psychological, and coping/behavioral hardship, compared to CCSs with an income of $80,000 or more (P<0.001 for all domains).

CCSs who did not obtain a high school diploma had an increased risk of material (P<0.001), psychological (P<0.01), and coping/behavioral hardship (P<0.001) compared to college graduates.

CCSs who received cancer treatments associated with a high-risk disease burden (vs low-risk) had an increased risk of material (P=0.01) and psychological (P=0.004) hardship.

Health conditions associated with material financial hardship included grade 2-4 myocardial infarction (P<0.001), peripheral neuropathy (P<0.001), subsequent neoplasm (P<0.001), seizure (P=0.007), reproductive disorders (P=0.01), stroke (P=0.02), amputation (P=0.02), upper gastrointestinal disease (P=0.04), and hearing loss (P=0.05).

Grade 2-4 myocardial infarction and reproductive disorders were significantly associated with psychological financial hardship (P=0.02 for both).

“Severe late effects that emerge early in life and disrupt education and training opportunities are a double hit for survivors,” Dr Huang said. “These health problems decrease the survivors’ earning mobility and financial security later in life. The phenomenon leaves them at risk for poor health and psychological outcomes compared to healthier survivors.”

Hospital/Peter Barta

Health-related financial hardship is common among adult survivors of childhood cancer, according to a study published in the Journal of the National Cancer Institute.

Researchers analyzed more than 2800 long-term childhood cancer survivors (CCSs) and found that 65% had financial challenges related to their cancer diagnosis.

“These findings suggest primary care doctors and oncologists should routinely screen childhood cancer survivors for possible financial hardship,” said I-Chan Huang, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

Specifically, Dr Huang recommends that healthcare providers routinely ask CCSs if they are unable to purchase medications, ever skip appointments for economic reasons, or worry about how to pay their medical bills.

For this study, Dr Huang and his colleagues analyzed data from 2811 CCSs. The subjects had a mean age of 31.8 (range, 18 to 65) and were a mean of 23.6 years from cancer diagnosis. Most (57.8%) had been diagnosed with hematologic malignancies, 32.0% with solid tumors, and 10.1% with central nervous system malignancies.

All subjects had been treated at St. Jude and enrolled in the St. Jude LIFE study. Participants return to St. Jude periodically for several days of clinical and functional assessments. Data for this study were collected during the CCSs’ first St. Jude LIFE evaluations.

Assessing hardship

The researchers measured 3 types of financial hardship—material, psychological, and coping/behavioral.

About 1 in 5 CCSs (22.4%) reported material financial hardship. In other words, their cancer had an impact on their financial situation.

More than half of CCSs (51.1%) reported psychological hardship—concern about their ability to pay for medical expenses.

And 33% of CCSs reported coping/behavioral hardship—an inability to see a doctor or go to the hospital due to finances.

Roughly 65% of CCSs reported at least 1 type of financial hardship.

All 3 types of hardship were significantly associated with somatization (all P<0.001), anxiety (all P<0.001), depression (all P<0.001), suicidal thoughts (all P<0.05), and difficulty in retirement planning (all P<0.001).

Furthermore, CCSs who reported financial hardship had significantly lower health-related quality of life (P<0.001 for all 3 domains), sensation abnormality (all P<0.001), pulmonary symptoms (all P<0.05), and cardiac symptoms (all P<0.05).

Predicting hardship

Intensive cancer treatment, chronic health conditions, second cancers, age at the time of study evaluation, education level, and annual household income were all significantly associated with a greater risk of financial hardship.

CCSs age 40 and older had an increased risk of psychological and coping/behavioral hardship (P<0.001 for both domains).

CCSs with an annual household income of less than $40,000 had an increased risk of material, psychological, and coping/behavioral hardship, compared to CCSs with an income of $80,000 or more (P<0.001 for all domains).

CCSs who did not obtain a high school diploma had an increased risk of material (P<0.001), psychological (P<0.01), and coping/behavioral hardship (P<0.001) compared to college graduates.

CCSs who received cancer treatments associated with a high-risk disease burden (vs low-risk) had an increased risk of material (P=0.01) and psychological (P=0.004) hardship.

Health conditions associated with material financial hardship included grade 2-4 myocardial infarction (P<0.001), peripheral neuropathy (P<0.001), subsequent neoplasm (P<0.001), seizure (P=0.007), reproductive disorders (P=0.01), stroke (P=0.02), amputation (P=0.02), upper gastrointestinal disease (P=0.04), and hearing loss (P=0.05).

Grade 2-4 myocardial infarction and reproductive disorders were significantly associated with psychological financial hardship (P=0.02 for both).

“Severe late effects that emerge early in life and disrupt education and training opportunities are a double hit for survivors,” Dr Huang said. “These health problems decrease the survivors’ earning mobility and financial security later in life. The phenomenon leaves them at risk for poor health and psychological outcomes compared to healthier survivors.”

Hospital/Peter Barta

Health-related financial hardship is common among adult survivors of childhood cancer, according to a study published in the Journal of the National Cancer Institute.

Researchers analyzed more than 2800 long-term childhood cancer survivors (CCSs) and found that 65% had financial challenges related to their cancer diagnosis.

“These findings suggest primary care doctors and oncologists should routinely screen childhood cancer survivors for possible financial hardship,” said I-Chan Huang, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

Specifically, Dr Huang recommends that healthcare providers routinely ask CCSs if they are unable to purchase medications, ever skip appointments for economic reasons, or worry about how to pay their medical bills.

For this study, Dr Huang and his colleagues analyzed data from 2811 CCSs. The subjects had a mean age of 31.8 (range, 18 to 65) and were a mean of 23.6 years from cancer diagnosis. Most (57.8%) had been diagnosed with hematologic malignancies, 32.0% with solid tumors, and 10.1% with central nervous system malignancies.

All subjects had been treated at St. Jude and enrolled in the St. Jude LIFE study. Participants return to St. Jude periodically for several days of clinical and functional assessments. Data for this study were collected during the CCSs’ first St. Jude LIFE evaluations.

Assessing hardship

The researchers measured 3 types of financial hardship—material, psychological, and coping/behavioral.

About 1 in 5 CCSs (22.4%) reported material financial hardship. In other words, their cancer had an impact on their financial situation.

More than half of CCSs (51.1%) reported psychological hardship—concern about their ability to pay for medical expenses.

And 33% of CCSs reported coping/behavioral hardship—an inability to see a doctor or go to the hospital due to finances.

Roughly 65% of CCSs reported at least 1 type of financial hardship.

All 3 types of hardship were significantly associated with somatization (all P<0.001), anxiety (all P<0.001), depression (all P<0.001), suicidal thoughts (all P<0.05), and difficulty in retirement planning (all P<0.001).

Furthermore, CCSs who reported financial hardship had significantly lower health-related quality of life (P<0.001 for all 3 domains), sensation abnormality (all P<0.001), pulmonary symptoms (all P<0.05), and cardiac symptoms (all P<0.05).

Predicting hardship

Intensive cancer treatment, chronic health conditions, second cancers, age at the time of study evaluation, education level, and annual household income were all significantly associated with a greater risk of financial hardship.

CCSs age 40 and older had an increased risk of psychological and coping/behavioral hardship (P<0.001 for both domains).

CCSs with an annual household income of less than $40,000 had an increased risk of material, psychological, and coping/behavioral hardship, compared to CCSs with an income of $80,000 or more (P<0.001 for all domains).

CCSs who did not obtain a high school diploma had an increased risk of material (P<0.001), psychological (P<0.01), and coping/behavioral hardship (P<0.001) compared to college graduates.

CCSs who received cancer treatments associated with a high-risk disease burden (vs low-risk) had an increased risk of material (P=0.01) and psychological (P=0.004) hardship.

Health conditions associated with material financial hardship included grade 2-4 myocardial infarction (P<0.001), peripheral neuropathy (P<0.001), subsequent neoplasm (P<0.001), seizure (P=0.007), reproductive disorders (P=0.01), stroke (P=0.02), amputation (P=0.02), upper gastrointestinal disease (P=0.04), and hearing loss (P=0.05).

Grade 2-4 myocardial infarction and reproductive disorders were significantly associated with psychological financial hardship (P=0.02 for both).

“Severe late effects that emerge early in life and disrupt education and training opportunities are a double hit for survivors,” Dr Huang said. “These health problems decrease the survivors’ earning mobility and financial security later in life. The phenomenon leaves them at risk for poor health and psychological outcomes compared to healthier survivors.”

AML cells

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to quizartinib, an investigational FLT3 inhibitor, for the treatment of adults with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML).

The FDA granted quizartinib breakthrough designation based on results from the phase 3 QuANTUM-R study, which were presented at the 23rd Congress of the European Hematology Association in June.

QuANTUM-R enrolled adults with FLT3-ITD AML (at least 3% FLT3-ITD allelic ratio) who had refractory disease or had relapsed within 6 months of their first complete remission.

Patients were randomized to receive once-daily treatment with quizartinib (n=245) or a salvage chemotherapy regimen (n=122)—low-dose cytarabine (LoDAC, n=29); combination mitoxantrone, etoposide, and cytarabine (MEC, n=40); or combination fludarabine, cytarabine, and idarubicin (FLAG-IDA, n=53).

Responders could proceed to hematopoietic stem cell transplant (HSCT), and those in the quizartinib arm could resume quizartinib after HSCT. Thirty-two percent of quizartinib-treated patients and 12% of the chemotherapy group went on to HSCT.

The median follow-up was 23.5 months. The efficacy results include all randomized patients.

The overall response rate was 69% in the quizartinib arm and 30% in the chemotherapy arm. The complete response (CR) rate was 4% and 1%, respectively; the rate of CR with incomplete platelet recovery was 4% and 0%, respectively; and the rate of CR with incomplete hematologic recovery was 40% and 26%, respectively.

The median overall survival was 6.2 months in the quizartinib arm and 4.7 months in the chemotherapy arm (hazard ratio=0.76, P=0.0177). The 1-year overall survival rate was 27% and 20%, respectively.

The median event-free survival was 6.0 weeks in the quizartinib arm and 3.7 weeks in the chemotherapy arm (hazard ratio=0.90, P=0.1071).

The safety results include only patients who received their assigned treatment—241 patients who received quizartinib and 94 who received salvage chemotherapy (22 on LoDAC, 25 on MEC, and 47 on FLAG-IDA).

Grade 3 or higher hematologic treatment-emergent adverse events occurring in at least 5% of patients (in the quizartinib and chemotherapy groups, respectively) included thrombocytopenia (35% and 34%), anemia (30% and 29%), neutropenia (32% and 25%), febrile neutropenia (31% and 21%), and leukopenia (17% and 16%).

Grade 3 or higher nonhematologic treatment-emergent adverse events occurring in at least 5% of patients (in the quizartinib and chemotherapy groups, respectively) included fatigue (8% and 1%), hypokalemia (12% and 9%), sepsis/septic shock (16% and 18%), dyspnea (5% for both), hypophosphatemia (5% for both), and pneumonia (12% and 9%).

Three percent of patients in the quizartinib arm had grade 3 QTcF prolongation, and 2 patients discontinued quizartinib due to QTcF prolongation.

About breakthrough designation

Breakthrough designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions.

The designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as rolling submission and priority review.

To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.

Other designations for quizartinib

In addition to breakthrough therapy designation, quizartinib has fast track and orphan drug designations from the FDA.

The FDA’s fast track development program is designed to expedite clinical development and submission of applications for products with the potential to treat serious or life-threatening conditions and address unmet medical needs.

Fast track designation facilitates frequent interactions with the FDA review team, including meetings to discuss the product’s development plan and written communications about issues such as trial design and use of biomarkers.

Products that receive fast track designation may be eligible for accelerated approval and priority review if relevant criteria are met. Such products may also be eligible for rolling review, which allows a developer to submit individual sections of a product’s application for review as they are ready, rather than waiting until all sections are complete.

The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.

Orphan designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.

AML cells

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to quizartinib, an investigational FLT3 inhibitor, for the treatment of adults with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML).

The FDA granted quizartinib breakthrough designation based on results from the phase 3 QuANTUM-R study, which were presented at the 23rd Congress of the European Hematology Association in June.

QuANTUM-R enrolled adults with FLT3-ITD AML (at least 3% FLT3-ITD allelic ratio) who had refractory disease or had relapsed within 6 months of their first complete remission.

Patients were randomized to receive once-daily treatment with quizartinib (n=245) or a salvage chemotherapy regimen (n=122)—low-dose cytarabine (LoDAC, n=29); combination mitoxantrone, etoposide, and cytarabine (MEC, n=40); or combination fludarabine, cytarabine, and idarubicin (FLAG-IDA, n=53).

Responders could proceed to hematopoietic stem cell transplant (HSCT), and those in the quizartinib arm could resume quizartinib after HSCT. Thirty-two percent of quizartinib-treated patients and 12% of the chemotherapy group went on to HSCT.

The median follow-up was 23.5 months. The efficacy results include all randomized patients.

The overall response rate was 69% in the quizartinib arm and 30% in the chemotherapy arm. The complete response (CR) rate was 4% and 1%, respectively; the rate of CR with incomplete platelet recovery was 4% and 0%, respectively; and the rate of CR with incomplete hematologic recovery was 40% and 26%, respectively.

The median overall survival was 6.2 months in the quizartinib arm and 4.7 months in the chemotherapy arm (hazard ratio=0.76, P=0.0177). The 1-year overall survival rate was 27% and 20%, respectively.

The median event-free survival was 6.0 weeks in the quizartinib arm and 3.7 weeks in the chemotherapy arm (hazard ratio=0.90, P=0.1071).

The safety results include only patients who received their assigned treatment—241 patients who received quizartinib and 94 who received salvage chemotherapy (22 on LoDAC, 25 on MEC, and 47 on FLAG-IDA).

Grade 3 or higher hematologic treatment-emergent adverse events occurring in at least 5% of patients (in the quizartinib and chemotherapy groups, respectively) included thrombocytopenia (35% and 34%), anemia (30% and 29%), neutropenia (32% and 25%), febrile neutropenia (31% and 21%), and leukopenia (17% and 16%).

Grade 3 or higher nonhematologic treatment-emergent adverse events occurring in at least 5% of patients (in the quizartinib and chemotherapy groups, respectively) included fatigue (8% and 1%), hypokalemia (12% and 9%), sepsis/septic shock (16% and 18%), dyspnea (5% for both), hypophosphatemia (5% for both), and pneumonia (12% and 9%).

Three percent of patients in the quizartinib arm had grade 3 QTcF prolongation, and 2 patients discontinued quizartinib due to QTcF prolongation.

About breakthrough designation

Breakthrough designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions.

The designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as rolling submission and priority review.

To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.

Other designations for quizartinib

In addition to breakthrough therapy designation, quizartinib has fast track and orphan drug designations from the FDA.

The FDA’s fast track development program is designed to expedite clinical development and submission of applications for products with the potential to treat serious or life-threatening conditions and address unmet medical needs.

Fast track designation facilitates frequent interactions with the FDA review team, including meetings to discuss the product’s development plan and written communications about issues such as trial design and use of biomarkers.

Products that receive fast track designation may be eligible for accelerated approval and priority review if relevant criteria are met. Such products may also be eligible for rolling review, which allows a developer to submit individual sections of a product’s application for review as they are ready, rather than waiting until all sections are complete.

The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.

Orphan designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.

AML cells

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to quizartinib, an investigational FLT3 inhibitor, for the treatment of adults with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML).

The FDA granted quizartinib breakthrough designation based on results from the phase 3 QuANTUM-R study, which were presented at the 23rd Congress of the European Hematology Association in June.

QuANTUM-R enrolled adults with FLT3-ITD AML (at least 3% FLT3-ITD allelic ratio) who had refractory disease or had relapsed within 6 months of their first complete remission.

Patients were randomized to receive once-daily treatment with quizartinib (n=245) or a salvage chemotherapy regimen (n=122)—low-dose cytarabine (LoDAC, n=29); combination mitoxantrone, etoposide, and cytarabine (MEC, n=40); or combination fludarabine, cytarabine, and idarubicin (FLAG-IDA, n=53).

Responders could proceed to hematopoietic stem cell transplant (HSCT), and those in the quizartinib arm could resume quizartinib after HSCT. Thirty-two percent of quizartinib-treated patients and 12% of the chemotherapy group went on to HSCT.

The median follow-up was 23.5 months. The efficacy results include all randomized patients.

The overall response rate was 69% in the quizartinib arm and 30% in the chemotherapy arm. The complete response (CR) rate was 4% and 1%, respectively; the rate of CR with incomplete platelet recovery was 4% and 0%, respectively; and the rate of CR with incomplete hematologic recovery was 40% and 26%, respectively.

The median overall survival was 6.2 months in the quizartinib arm and 4.7 months in the chemotherapy arm (hazard ratio=0.76, P=0.0177). The 1-year overall survival rate was 27% and 20%, respectively.

The median event-free survival was 6.0 weeks in the quizartinib arm and 3.7 weeks in the chemotherapy arm (hazard ratio=0.90, P=0.1071).

The safety results include only patients who received their assigned treatment—241 patients who received quizartinib and 94 who received salvage chemotherapy (22 on LoDAC, 25 on MEC, and 47 on FLAG-IDA).

Grade 3 or higher hematologic treatment-emergent adverse events occurring in at least 5% of patients (in the quizartinib and chemotherapy groups, respectively) included thrombocytopenia (35% and 34%), anemia (30% and 29%), neutropenia (32% and 25%), febrile neutropenia (31% and 21%), and leukopenia (17% and 16%).

Grade 3 or higher nonhematologic treatment-emergent adverse events occurring in at least 5% of patients (in the quizartinib and chemotherapy groups, respectively) included fatigue (8% and 1%), hypokalemia (12% and 9%), sepsis/septic shock (16% and 18%), dyspnea (5% for both), hypophosphatemia (5% for both), and pneumonia (12% and 9%).

Three percent of patients in the quizartinib arm had grade 3 QTcF prolongation, and 2 patients discontinued quizartinib due to QTcF prolongation.

About breakthrough designation

Breakthrough designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions.

The designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as rolling submission and priority review.

To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.

Other designations for quizartinib

In addition to breakthrough therapy designation, quizartinib has fast track and orphan drug designations from the FDA.

The FDA’s fast track development program is designed to expedite clinical development and submission of applications for products with the potential to treat serious or life-threatening conditions and address unmet medical needs.

Fast track designation facilitates frequent interactions with the FDA review team, including meetings to discuss the product’s development plan and written communications about issues such as trial design and use of biomarkers.

Products that receive fast track designation may be eligible for accelerated approval and priority review if relevant criteria are met. Such products may also be eligible for rolling review, which allows a developer to submit individual sections of a product’s application for review as they are ready, rather than waiting until all sections are complete.

The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.

Orphan designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.