User login
Register for ACS Comprehensive General Surgery Review Course
The 2018 American College of Surgeons (ACS) Comprehensive General Surgery Review Course, July 26–29 in Chicago, IL, is an intensive three-and-a-half-day review course that will cover essential content areas in general surgery, including alimentary tract, endocrine and soft tissue, oncology, skin and breast, surgical critical care, trauma, and vascular operations, as well as perioperative care.
Course Chair John A. Weigelt, MD, DVM, MMA, FACS, and a distinguished faculty will use didactic and case-based formats to present a comprehensive and practical review. Dr. Weigelt recently retired from the Medical College of Wisconsin, where he was the Milt & Lidy Lunda/Charles Aprahamian Professor of Trauma Surgery, as well as professor and chief, division of trauma and critical care. He is joining the University of South Dakota and the Sanford Health System, Sioux Falls, this summer as professor of surgery. Dr. Weigelt is Medical Director of the ACS Surgical Education and Self-Assessment Program (SESAP®).
The course is a pragmatic review designed to focus on practice issues and will offer several special features, including self-assessment materials, such as pre- and posttests. It may be helpful in preparing for examinations. Self-assessment credit will be available.
The ACS is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide Continuing Medical Education for physicians.
The ACS designates this liv
Register today at bit.ly/2s19VtX, and read more about the course at www.facs.org/gsreviewcourse. Space is limited and registration will be accepted on a first-come, first-served basis. For more information and registration, visit the ACS website or e-mail [email protected] or [email protected].
The 2018 American College of Surgeons (ACS) Comprehensive General Surgery Review Course, July 26–29 in Chicago, IL, is an intensive three-and-a-half-day review course that will cover essential content areas in general surgery, including alimentary tract, endocrine and soft tissue, oncology, skin and breast, surgical critical care, trauma, and vascular operations, as well as perioperative care.
Course Chair John A. Weigelt, MD, DVM, MMA, FACS, and a distinguished faculty will use didactic and case-based formats to present a comprehensive and practical review. Dr. Weigelt recently retired from the Medical College of Wisconsin, where he was the Milt & Lidy Lunda/Charles Aprahamian Professor of Trauma Surgery, as well as professor and chief, division of trauma and critical care. He is joining the University of South Dakota and the Sanford Health System, Sioux Falls, this summer as professor of surgery. Dr. Weigelt is Medical Director of the ACS Surgical Education and Self-Assessment Program (SESAP®).
The course is a pragmatic review designed to focus on practice issues and will offer several special features, including self-assessment materials, such as pre- and posttests. It may be helpful in preparing for examinations. Self-assessment credit will be available.
The ACS is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide Continuing Medical Education for physicians.
The ACS designates this liv
Register today at bit.ly/2s19VtX, and read more about the course at www.facs.org/gsreviewcourse. Space is limited and registration will be accepted on a first-come, first-served basis. For more information and registration, visit the ACS website or e-mail [email protected] or [email protected].
The 2018 American College of Surgeons (ACS) Comprehensive General Surgery Review Course, July 26–29 in Chicago, IL, is an intensive three-and-a-half-day review course that will cover essential content areas in general surgery, including alimentary tract, endocrine and soft tissue, oncology, skin and breast, surgical critical care, trauma, and vascular operations, as well as perioperative care.
Course Chair John A. Weigelt, MD, DVM, MMA, FACS, and a distinguished faculty will use didactic and case-based formats to present a comprehensive and practical review. Dr. Weigelt recently retired from the Medical College of Wisconsin, where he was the Milt & Lidy Lunda/Charles Aprahamian Professor of Trauma Surgery, as well as professor and chief, division of trauma and critical care. He is joining the University of South Dakota and the Sanford Health System, Sioux Falls, this summer as professor of surgery. Dr. Weigelt is Medical Director of the ACS Surgical Education and Self-Assessment Program (SESAP®).
The course is a pragmatic review designed to focus on practice issues and will offer several special features, including self-assessment materials, such as pre- and posttests. It may be helpful in preparing for examinations. Self-assessment credit will be available.
The ACS is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide Continuing Medical Education for physicians.
The ACS designates this liv
Register today at bit.ly/2s19VtX, and read more about the course at www.facs.org/gsreviewcourse. Space is limited and registration will be accepted on a first-come, first-served basis. For more information and registration, visit the ACS website or e-mail [email protected] or [email protected].
ACS, other organizations concerned with patient safety offer recommendations on OR attire
The American College of Surgeons (ACS), the American Society of Anesthesiologists, the Association of periOperative Registered Nurses, the Association for Professionals in Infection Control and Epidemiology, the Association of Surgical Technologists, the Council on Surgical and Perioperative Safety, and The Joint Commission recently developed consensus recommendations on operating room (OR) attire. The recommendations focus specifically on ear and hair covering.
The group has reached the following conclusions:
Evidence-based recommendations on surgical attire developed for perioperative policies and procedures are best created collaboratively, with a multidisciplinary team representing surgery, anesthesia, nursing, and infection prevention.
The requirement for ear coverage is not supported by sufficient evidence.
At present, available scientific evidence does not demonstrate any association between the type of hat or extent of hair coverage and surgical site infection rates. In fact, a recent report in the
Other issues regarding areas of surgical attire need further evaluation.
For details, read the consensus statement on the ACS website at facs.org/about-acs/consensus-statements/or-attire.
In addition, the ACS recently received notification from The Joint Commission indicating that the accrediting body will incorporate the specifications outlined in the consensus statement into its survey procedures for hospitals and other relevant health care facilities.
The American College of Surgeons (ACS), the American Society of Anesthesiologists, the Association of periOperative Registered Nurses, the Association for Professionals in Infection Control and Epidemiology, the Association of Surgical Technologists, the Council on Surgical and Perioperative Safety, and The Joint Commission recently developed consensus recommendations on operating room (OR) attire. The recommendations focus specifically on ear and hair covering.
The group has reached the following conclusions:
Evidence-based recommendations on surgical attire developed for perioperative policies and procedures are best created collaboratively, with a multidisciplinary team representing surgery, anesthesia, nursing, and infection prevention.
The requirement for ear coverage is not supported by sufficient evidence.
At present, available scientific evidence does not demonstrate any association between the type of hat or extent of hair coverage and surgical site infection rates. In fact, a recent report in the
Other issues regarding areas of surgical attire need further evaluation.
For details, read the consensus statement on the ACS website at facs.org/about-acs/consensus-statements/or-attire.
In addition, the ACS recently received notification from The Joint Commission indicating that the accrediting body will incorporate the specifications outlined in the consensus statement into its survey procedures for hospitals and other relevant health care facilities.
The American College of Surgeons (ACS), the American Society of Anesthesiologists, the Association of periOperative Registered Nurses, the Association for Professionals in Infection Control and Epidemiology, the Association of Surgical Technologists, the Council on Surgical and Perioperative Safety, and The Joint Commission recently developed consensus recommendations on operating room (OR) attire. The recommendations focus specifically on ear and hair covering.
The group has reached the following conclusions:
Evidence-based recommendations on surgical attire developed for perioperative policies and procedures are best created collaboratively, with a multidisciplinary team representing surgery, anesthesia, nursing, and infection prevention.
The requirement for ear coverage is not supported by sufficient evidence.
At present, available scientific evidence does not demonstrate any association between the type of hat or extent of hair coverage and surgical site infection rates. In fact, a recent report in the
Other issues regarding areas of surgical attire need further evaluation.
For details, read the consensus statement on the ACS website at facs.org/about-acs/consensus-statements/or-attire.
In addition, the ACS recently received notification from The Joint Commission indicating that the accrediting body will incorporate the specifications outlined in the consensus statement into its survey procedures for hospitals and other relevant health care facilities.
ACS Clinical Scholars in Residence Program Application Deadline Extended
The American College of Surgeons (ACS) is offering a two-year, onsite fellowship in surgical outcomes research, health services research, and health care policy through the Clinical Scholars in Residence program. The application deadline for positions starting in 2019 has been extended to June 29, 2018.
Applicants must have completed two years of clinical training, be U.S. citizens, and obtained two years of program funding from their home institution or other granting agency. The applicant also must be a member of the ACS and in good standing with the College.
The Clinical Scholar will have the opportunity to work in multiple areas within the ACS Division of Research and Optimal Patient Care at the ACS headquarters in Chicago, IL, to advance the quality improvement initiatives of the ACS and to perform research relevant to ongoing projects within the ACS. Participants also will earn a masters degree after the two years program. The Clinical Scholar will receive strong mentorship in clinical, statistical, and health services research. Previous ACS Clinical Scholars in Residence since 2005 have had excellent, productive experiences that have launched careers in the field.
Important dates for Clinical Scholars in Residence program follow:
Application deadline extended: June 29, 2018
Interview notification: July 13, 2018
Interview Process: July 16–31, 2018
Notification of appointment: August 1, 2018
Starting date: July 1, 2019
For more information, go to facs.org/quality-programs/about/clinical-scholars-program. Contact the ACS Clinical Scholars in Residence Program at [email protected] with additional questions.
The American College of Surgeons (ACS) is offering a two-year, onsite fellowship in surgical outcomes research, health services research, and health care policy through the Clinical Scholars in Residence program. The application deadline for positions starting in 2019 has been extended to June 29, 2018.
Applicants must have completed two years of clinical training, be U.S. citizens, and obtained two years of program funding from their home institution or other granting agency. The applicant also must be a member of the ACS and in good standing with the College.
The Clinical Scholar will have the opportunity to work in multiple areas within the ACS Division of Research and Optimal Patient Care at the ACS headquarters in Chicago, IL, to advance the quality improvement initiatives of the ACS and to perform research relevant to ongoing projects within the ACS. Participants also will earn a masters degree after the two years program. The Clinical Scholar will receive strong mentorship in clinical, statistical, and health services research. Previous ACS Clinical Scholars in Residence since 2005 have had excellent, productive experiences that have launched careers in the field.
Important dates for Clinical Scholars in Residence program follow:
Application deadline extended: June 29, 2018
Interview notification: July 13, 2018
Interview Process: July 16–31, 2018
Notification of appointment: August 1, 2018
Starting date: July 1, 2019
For more information, go to facs.org/quality-programs/about/clinical-scholars-program. Contact the ACS Clinical Scholars in Residence Program at [email protected] with additional questions.
The American College of Surgeons (ACS) is offering a two-year, onsite fellowship in surgical outcomes research, health services research, and health care policy through the Clinical Scholars in Residence program. The application deadline for positions starting in 2019 has been extended to June 29, 2018.
Applicants must have completed two years of clinical training, be U.S. citizens, and obtained two years of program funding from their home institution or other granting agency. The applicant also must be a member of the ACS and in good standing with the College.
The Clinical Scholar will have the opportunity to work in multiple areas within the ACS Division of Research and Optimal Patient Care at the ACS headquarters in Chicago, IL, to advance the quality improvement initiatives of the ACS and to perform research relevant to ongoing projects within the ACS. Participants also will earn a masters degree after the two years program. The Clinical Scholar will receive strong mentorship in clinical, statistical, and health services research. Previous ACS Clinical Scholars in Residence since 2005 have had excellent, productive experiences that have launched careers in the field.
Important dates for Clinical Scholars in Residence program follow:
Application deadline extended: June 29, 2018
Interview notification: July 13, 2018
Interview Process: July 16–31, 2018
Notification of appointment: August 1, 2018
Starting date: July 1, 2019
For more information, go to facs.org/quality-programs/about/clinical-scholars-program. Contact the ACS Clinical Scholars in Residence Program at [email protected] with additional questions.
Veterans Can Now Access Medical Images and Reports Online
Veterans with a premium account on My HealtheVet no longer need to make an in-person visit to get their medical images and associated study reports—now they can do it online. VA Medical Images and Reports allows users to view, download, and share copies of their radiology studies, including x-rays, mammograms, MRIs, and CTs, from the VA Electronic Health Record.
Radiology studies are available in My HealtheVet 3 calendar days after the study report has been verified. When a request for a specific study is completed, veterans can view a lower resolution thumbnail copy of the images and the radiology report online or download a zip file with the information. For studies with large files, the user can opt to receive an e-mail notification when the download request is complete.
To view diagnostic-quality images, veterans may install a free medical image viewer on their computer. The images and reports can be copied to a CD, DVD, USB flash drive, or any portable drive to share with providers, across VA settings and outside the VA.
Veterans with a premium account on My HealtheVet no longer need to make an in-person visit to get their medical images and associated study reports—now they can do it online. VA Medical Images and Reports allows users to view, download, and share copies of their radiology studies, including x-rays, mammograms, MRIs, and CTs, from the VA Electronic Health Record.
Radiology studies are available in My HealtheVet 3 calendar days after the study report has been verified. When a request for a specific study is completed, veterans can view a lower resolution thumbnail copy of the images and the radiology report online or download a zip file with the information. For studies with large files, the user can opt to receive an e-mail notification when the download request is complete.
To view diagnostic-quality images, veterans may install a free medical image viewer on their computer. The images and reports can be copied to a CD, DVD, USB flash drive, or any portable drive to share with providers, across VA settings and outside the VA.
Veterans with a premium account on My HealtheVet no longer need to make an in-person visit to get their medical images and associated study reports—now they can do it online. VA Medical Images and Reports allows users to view, download, and share copies of their radiology studies, including x-rays, mammograms, MRIs, and CTs, from the VA Electronic Health Record.
Radiology studies are available in My HealtheVet 3 calendar days after the study report has been verified. When a request for a specific study is completed, veterans can view a lower resolution thumbnail copy of the images and the radiology report online or download a zip file with the information. For studies with large files, the user can opt to receive an e-mail notification when the download request is complete.
To view diagnostic-quality images, veterans may install a free medical image viewer on their computer. The images and reports can be copied to a CD, DVD, USB flash drive, or any portable drive to share with providers, across VA settings and outside the VA.
Quizartinib can prolong OS in rel/ref, FLT3-ITD AML
STOCKHOLM—Phase 3 results suggest the FLT3 inhibitor quizartinib can prolong overall survival (OS) in patients with relapsed/refractory, FLT3-ITD acute myeloid leukemia (AML).
In the QuANTUM-R study, patients who received single-agent quizartinib had a significantly longer median OS than patients who received salvage chemotherapy.
There was a trend toward improved event-free survival (EFS) with quizartinib as well.
“QuANTUM-R represents the first study that shows a significant improvement in overall survival for a single agent—a FLT3 inhibitor or any other targeted agent—in this population of FLT3-mutated AML patients with refractory or relapsed disease . . .,” said study investigator Jorge Cortes, MD, of MD Anderson Cancer Center in Houston, Texas.
Dr Cortes presented results from QuANTUM-R at the 23rd Congress of the European Hematology Association (EHA). The research was selected as the best late-breaking abstract (LB2600).
The study was funded by Daiichi Sankyo, Inc., and Dr Cortes is a consultant for the company.
Patients and treatment
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. They had received at least 1 cycle of an induction regimen containing standard-dose anthracycline or mitoxantrone.
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.
Baseline characteristics were similar between the treatment arms. The median age was 55 (range, 19-81) for patients receiving quizartinib and 58 (range, 18-78) for those receiving chemotherapy.
Thirty-three percent of the quizartinib arm had refractory disease, and 67% had relapsed disease. Thirty-four percent of the chemotherapy arm had refractory disease, and 66% had relapsed disease.
The percentage of patients with a prior allogeneic HSCT was 25% in the quizartinib arm and 23% in the chemotherapy arm. Most patients in both arms had intermediate-risk cytogenetics—78% of the quizartinib arm and 66% of the chemotherapy arm.
In all, 241 patients received quizartinib, and 94 received salvage chemotherapy—LoDAC (n=22), MEC (n=25), and FLAG-IDA (n=47). Of the 28 patients in the chemotherapy group who were not treated, most withdrew consent.
The median treatment duration was 4 cycles (range, 1-3) in the quizartinib arm and 1 cycle (range, 1-2) for patients who received LoDAC, MEC, and FLAG-IDA.
The most common reason for discontinuation of chemotherapy was lack of response/progression (n=49), followed by death (n=6). Twenty-four patients completed salvage chemotherapy.
In the quizarinib arm, the most common reasons for treatment discontinuation were HSCT (n=79), relapse (n=60), or lack of response/progression (n=47).
Thirty-two percent of quizartinib-treated patients and 12% of the chemotherapy group went on to HSCT.
Results
The median follow-up was 23.5 months. The efficacy results include all randomized patients, and the safety results include only those who received their assigned treatment.
The study’s primary endpoint was OS. The median OS 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 OS rate was 27% and 20%, respectively.
The median EFS was 6.0 weeks in the quizartinib arm and 3.7 weeks in the chemotherapy arm (hazard ratio=0.90, P=0.1071). Dr Cortes noted that patients who did not receive treatment were censored on day 1, and partial responses were counted as failures in the EFS analysis.
The overall response rate was 69% in the quizartinib arm and 30% in the chemotherapy arm.
The composite complete response (CR) rate was 48% in the quizartinib arm and 27% in the chemotherapy arm. This includes the CR rate (4% and 1%, respectively), the rate of CR with incomplete platelet recovery (4% and 0%, respectively), and the rate of CR with incomplete hematologic recovery (40% and 26%, respectively). The rate of partial response was 21% and 3%, respectively.
Dr Cortes said rates of treatment-emergent adverse events (TEAEs) were similar between the treatment arms.
Grade 3 or higher hematologic TEAEs 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 TEAEs 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, but there were no grade 4 cases. Two patients discontinued quizartinib due to QTcF prolongation.
“The safety of this drug has remained constant across over 1600 patients that have been treated with quizartinib across a variety of studies,” Dr Cortes said.
He added that QuANTUM-R results open up the possibility that quizartinib could be used in other settings. Researchers are already testing standard chemotherapy with and without quizartinib in a phase 3 trial of patients with newly diagnosed, FLT-ITD AML (QuANTUM-First).
STOCKHOLM—Phase 3 results suggest the FLT3 inhibitor quizartinib can prolong overall survival (OS) in patients with relapsed/refractory, FLT3-ITD acute myeloid leukemia (AML).
In the QuANTUM-R study, patients who received single-agent quizartinib had a significantly longer median OS than patients who received salvage chemotherapy.
There was a trend toward improved event-free survival (EFS) with quizartinib as well.
“QuANTUM-R represents the first study that shows a significant improvement in overall survival for a single agent—a FLT3 inhibitor or any other targeted agent—in this population of FLT3-mutated AML patients with refractory or relapsed disease . . .,” said study investigator Jorge Cortes, MD, of MD Anderson Cancer Center in Houston, Texas.
Dr Cortes presented results from QuANTUM-R at the 23rd Congress of the European Hematology Association (EHA). The research was selected as the best late-breaking abstract (LB2600).
The study was funded by Daiichi Sankyo, Inc., and Dr Cortes is a consultant for the company.
Patients and treatment
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. They had received at least 1 cycle of an induction regimen containing standard-dose anthracycline or mitoxantrone.
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.
Baseline characteristics were similar between the treatment arms. The median age was 55 (range, 19-81) for patients receiving quizartinib and 58 (range, 18-78) for those receiving chemotherapy.
Thirty-three percent of the quizartinib arm had refractory disease, and 67% had relapsed disease. Thirty-four percent of the chemotherapy arm had refractory disease, and 66% had relapsed disease.
The percentage of patients with a prior allogeneic HSCT was 25% in the quizartinib arm and 23% in the chemotherapy arm. Most patients in both arms had intermediate-risk cytogenetics—78% of the quizartinib arm and 66% of the chemotherapy arm.
In all, 241 patients received quizartinib, and 94 received salvage chemotherapy—LoDAC (n=22), MEC (n=25), and FLAG-IDA (n=47). Of the 28 patients in the chemotherapy group who were not treated, most withdrew consent.
The median treatment duration was 4 cycles (range, 1-3) in the quizartinib arm and 1 cycle (range, 1-2) for patients who received LoDAC, MEC, and FLAG-IDA.
The most common reason for discontinuation of chemotherapy was lack of response/progression (n=49), followed by death (n=6). Twenty-four patients completed salvage chemotherapy.
In the quizarinib arm, the most common reasons for treatment discontinuation were HSCT (n=79), relapse (n=60), or lack of response/progression (n=47).
Thirty-two percent of quizartinib-treated patients and 12% of the chemotherapy group went on to HSCT.
Results
The median follow-up was 23.5 months. The efficacy results include all randomized patients, and the safety results include only those who received their assigned treatment.
The study’s primary endpoint was OS. The median OS 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 OS rate was 27% and 20%, respectively.
The median EFS was 6.0 weeks in the quizartinib arm and 3.7 weeks in the chemotherapy arm (hazard ratio=0.90, P=0.1071). Dr Cortes noted that patients who did not receive treatment were censored on day 1, and partial responses were counted as failures in the EFS analysis.
The overall response rate was 69% in the quizartinib arm and 30% in the chemotherapy arm.
The composite complete response (CR) rate was 48% in the quizartinib arm and 27% in the chemotherapy arm. This includes the CR rate (4% and 1%, respectively), the rate of CR with incomplete platelet recovery (4% and 0%, respectively), and the rate of CR with incomplete hematologic recovery (40% and 26%, respectively). The rate of partial response was 21% and 3%, respectively.
Dr Cortes said rates of treatment-emergent adverse events (TEAEs) were similar between the treatment arms.
Grade 3 or higher hematologic TEAEs 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 TEAEs 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, but there were no grade 4 cases. Two patients discontinued quizartinib due to QTcF prolongation.
“The safety of this drug has remained constant across over 1600 patients that have been treated with quizartinib across a variety of studies,” Dr Cortes said.
He added that QuANTUM-R results open up the possibility that quizartinib could be used in other settings. Researchers are already testing standard chemotherapy with and without quizartinib in a phase 3 trial of patients with newly diagnosed, FLT-ITD AML (QuANTUM-First).
STOCKHOLM—Phase 3 results suggest the FLT3 inhibitor quizartinib can prolong overall survival (OS) in patients with relapsed/refractory, FLT3-ITD acute myeloid leukemia (AML).
In the QuANTUM-R study, patients who received single-agent quizartinib had a significantly longer median OS than patients who received salvage chemotherapy.
There was a trend toward improved event-free survival (EFS) with quizartinib as well.
“QuANTUM-R represents the first study that shows a significant improvement in overall survival for a single agent—a FLT3 inhibitor or any other targeted agent—in this population of FLT3-mutated AML patients with refractory or relapsed disease . . .,” said study investigator Jorge Cortes, MD, of MD Anderson Cancer Center in Houston, Texas.
Dr Cortes presented results from QuANTUM-R at the 23rd Congress of the European Hematology Association (EHA). The research was selected as the best late-breaking abstract (LB2600).
The study was funded by Daiichi Sankyo, Inc., and Dr Cortes is a consultant for the company.
Patients and treatment
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. They had received at least 1 cycle of an induction regimen containing standard-dose anthracycline or mitoxantrone.
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.
Baseline characteristics were similar between the treatment arms. The median age was 55 (range, 19-81) for patients receiving quizartinib and 58 (range, 18-78) for those receiving chemotherapy.
Thirty-three percent of the quizartinib arm had refractory disease, and 67% had relapsed disease. Thirty-four percent of the chemotherapy arm had refractory disease, and 66% had relapsed disease.
The percentage of patients with a prior allogeneic HSCT was 25% in the quizartinib arm and 23% in the chemotherapy arm. Most patients in both arms had intermediate-risk cytogenetics—78% of the quizartinib arm and 66% of the chemotherapy arm.
In all, 241 patients received quizartinib, and 94 received salvage chemotherapy—LoDAC (n=22), MEC (n=25), and FLAG-IDA (n=47). Of the 28 patients in the chemotherapy group who were not treated, most withdrew consent.
The median treatment duration was 4 cycles (range, 1-3) in the quizartinib arm and 1 cycle (range, 1-2) for patients who received LoDAC, MEC, and FLAG-IDA.
The most common reason for discontinuation of chemotherapy was lack of response/progression (n=49), followed by death (n=6). Twenty-four patients completed salvage chemotherapy.
In the quizarinib arm, the most common reasons for treatment discontinuation were HSCT (n=79), relapse (n=60), or lack of response/progression (n=47).
Thirty-two percent of quizartinib-treated patients and 12% of the chemotherapy group went on to HSCT.
Results
The median follow-up was 23.5 months. The efficacy results include all randomized patients, and the safety results include only those who received their assigned treatment.
The study’s primary endpoint was OS. The median OS 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 OS rate was 27% and 20%, respectively.
The median EFS was 6.0 weeks in the quizartinib arm and 3.7 weeks in the chemotherapy arm (hazard ratio=0.90, P=0.1071). Dr Cortes noted that patients who did not receive treatment were censored on day 1, and partial responses were counted as failures in the EFS analysis.
The overall response rate was 69% in the quizartinib arm and 30% in the chemotherapy arm.
The composite complete response (CR) rate was 48% in the quizartinib arm and 27% in the chemotherapy arm. This includes the CR rate (4% and 1%, respectively), the rate of CR with incomplete platelet recovery (4% and 0%, respectively), and the rate of CR with incomplete hematologic recovery (40% and 26%, respectively). The rate of partial response was 21% and 3%, respectively.
Dr Cortes said rates of treatment-emergent adverse events (TEAEs) were similar between the treatment arms.
Grade 3 or higher hematologic TEAEs 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 TEAEs 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, but there were no grade 4 cases. Two patients discontinued quizartinib due to QTcF prolongation.
“The safety of this drug has remained constant across over 1600 patients that have been treated with quizartinib across a variety of studies,” Dr Cortes said.
He added that QuANTUM-R results open up the possibility that quizartinib could be used in other settings. Researchers are already testing standard chemotherapy with and without quizartinib in a phase 3 trial of patients with newly diagnosed, FLT-ITD AML (QuANTUM-First).
Peripheral blood MRD correlates with treatment benefit in CLL
CHICAGO—Minimal residual disease (MRD) kinetics confirms the high, durable MRD-negativity with venetoclax plus rituximab in relapsed/refractory chronic lymphocytic leukemia (CLL), according to a further examination of the phase 3 MURANO study.
Undetectable MRD-negativity is associated with extended progression-free survival (PFS) and overall survival in patients receiving chemoimmunotherapy for CLL.
“Attainment of MRD-negativity in relapsed/refractory CLL is also a desired trial endpoint due to the subjectivity of complete response definition regarding pathologic lymph node size,” said Peter Hillmen, MD, of St James’s University Hospital, Leeds, United Kingdom, at the 2018 ASCO Annual Meeting.
Dr Hillmen reported new data on MRD response in cytogenetic and molecular risk groups, MRD sustainability and kinetics, and MRD conversion in the MURANO trial (abstract 7508).
MURANO trial (NCT02005471)
In the trial, venetoclax-rituximab showed superior PFS and peripheral blood and bone marrow MRD-negativity as compared to bendamustine plus rituximab (BR) in relapsed/refractory CLL patients.
Patients were randomized to venetoclax-rituximab for 6 months, followed by single-agent venetoclax for up to 1.5 years, or BR for 6 months. Peripheral blood samples were serially collected and bone marrow was collected at the end of combination treatment or at best response.
MRD findings
The new results show higher concordance in MRD-negativity between bone marrow and peripheral blood in venetoclax-rituximab (45 of 50 patients, 90%) vs BR (3 of 10 patients, 30%) in paired samples.
Focusing on peripheral blood MRD, Dr Hillmen said the best MRD-negativity rates were higher with venetoclax-rituximab (84%) than BR (23%). These results were independent of high-risk factors—such as del 17p, IGVH unmutated, and mutated TP53—only for venetoclax-rituximab treated patients.
“The superior peripheral blood MRD response with venetoclax-rituximab was consistent across subgroups at the end of completion of treatment,” Dr Hillmen said. “Most patients who achieved peripheral blood MRD-negativity on venetoclax-rituximab remained MRD-negative and were progression-free.”
Among 121 of 194 (62%) patients on venetoclax-rituximab who achieved MRD-negativity at the end of combination therapy, 100 (83%) patients maintained MRD-negativity and were progression-free at a median follow-up of 13.8 months. Two patients developed progressive disease and 2 patients died (unrelated to CLL).
Two patients developed Richter’s disease (with one MRD-positive directly before therapy) and 15 (12%) patients converted to confirmed MRD-positive at a median MRD-positive follow-up of 5.6 months.
“High peripheral blood MRD-negativity at the end of combination treatment and concordance with bone marrow MRD with venetoclax-rituximab,” Dr Hillmen said, “confirms the value of peripheral blood MRD for evaluation of treatment benefit in relapsed/refractory CLL patients. The high rate of peripheral blood MRD-negativity at end of combination treatment with venetoclax-rituximab was attained regardless of risk features.”
Some conversion to MRD-positivity occurred only in a small proportion of patients. Most cases were of intermediate level and remained progression-free, he said.
“MRD kinetics indicate that peripheral blood MRD-negativity with venetoclax-rituximab occurs early and is maintained over time with current follow-up,” Dr Hillmen added. The MRD data now provide a framework for designing response adaptive therapy.
The US Food and Drug Administration recently approved venetoclax-rituximab for CLL or small lymphocytic lymphoma for patients with or without del 17p.
Venetoclax is being developed by Genentech and Abbvie.
CHICAGO—Minimal residual disease (MRD) kinetics confirms the high, durable MRD-negativity with venetoclax plus rituximab in relapsed/refractory chronic lymphocytic leukemia (CLL), according to a further examination of the phase 3 MURANO study.
Undetectable MRD-negativity is associated with extended progression-free survival (PFS) and overall survival in patients receiving chemoimmunotherapy for CLL.
“Attainment of MRD-negativity in relapsed/refractory CLL is also a desired trial endpoint due to the subjectivity of complete response definition regarding pathologic lymph node size,” said Peter Hillmen, MD, of St James’s University Hospital, Leeds, United Kingdom, at the 2018 ASCO Annual Meeting.
Dr Hillmen reported new data on MRD response in cytogenetic and molecular risk groups, MRD sustainability and kinetics, and MRD conversion in the MURANO trial (abstract 7508).
MURANO trial (NCT02005471)
In the trial, venetoclax-rituximab showed superior PFS and peripheral blood and bone marrow MRD-negativity as compared to bendamustine plus rituximab (BR) in relapsed/refractory CLL patients.
Patients were randomized to venetoclax-rituximab for 6 months, followed by single-agent venetoclax for up to 1.5 years, or BR for 6 months. Peripheral blood samples were serially collected and bone marrow was collected at the end of combination treatment or at best response.
MRD findings
The new results show higher concordance in MRD-negativity between bone marrow and peripheral blood in venetoclax-rituximab (45 of 50 patients, 90%) vs BR (3 of 10 patients, 30%) in paired samples.
Focusing on peripheral blood MRD, Dr Hillmen said the best MRD-negativity rates were higher with venetoclax-rituximab (84%) than BR (23%). These results were independent of high-risk factors—such as del 17p, IGVH unmutated, and mutated TP53—only for venetoclax-rituximab treated patients.
“The superior peripheral blood MRD response with venetoclax-rituximab was consistent across subgroups at the end of completion of treatment,” Dr Hillmen said. “Most patients who achieved peripheral blood MRD-negativity on venetoclax-rituximab remained MRD-negative and were progression-free.”
Among 121 of 194 (62%) patients on venetoclax-rituximab who achieved MRD-negativity at the end of combination therapy, 100 (83%) patients maintained MRD-negativity and were progression-free at a median follow-up of 13.8 months. Two patients developed progressive disease and 2 patients died (unrelated to CLL).
Two patients developed Richter’s disease (with one MRD-positive directly before therapy) and 15 (12%) patients converted to confirmed MRD-positive at a median MRD-positive follow-up of 5.6 months.
“High peripheral blood MRD-negativity at the end of combination treatment and concordance with bone marrow MRD with venetoclax-rituximab,” Dr Hillmen said, “confirms the value of peripheral blood MRD for evaluation of treatment benefit in relapsed/refractory CLL patients. The high rate of peripheral blood MRD-negativity at end of combination treatment with venetoclax-rituximab was attained regardless of risk features.”
Some conversion to MRD-positivity occurred only in a small proportion of patients. Most cases were of intermediate level and remained progression-free, he said.
“MRD kinetics indicate that peripheral blood MRD-negativity with venetoclax-rituximab occurs early and is maintained over time with current follow-up,” Dr Hillmen added. The MRD data now provide a framework for designing response adaptive therapy.
The US Food and Drug Administration recently approved venetoclax-rituximab for CLL or small lymphocytic lymphoma for patients with or without del 17p.
Venetoclax is being developed by Genentech and Abbvie.
CHICAGO—Minimal residual disease (MRD) kinetics confirms the high, durable MRD-negativity with venetoclax plus rituximab in relapsed/refractory chronic lymphocytic leukemia (CLL), according to a further examination of the phase 3 MURANO study.
Undetectable MRD-negativity is associated with extended progression-free survival (PFS) and overall survival in patients receiving chemoimmunotherapy for CLL.
“Attainment of MRD-negativity in relapsed/refractory CLL is also a desired trial endpoint due to the subjectivity of complete response definition regarding pathologic lymph node size,” said Peter Hillmen, MD, of St James’s University Hospital, Leeds, United Kingdom, at the 2018 ASCO Annual Meeting.
Dr Hillmen reported new data on MRD response in cytogenetic and molecular risk groups, MRD sustainability and kinetics, and MRD conversion in the MURANO trial (abstract 7508).
MURANO trial (NCT02005471)
In the trial, venetoclax-rituximab showed superior PFS and peripheral blood and bone marrow MRD-negativity as compared to bendamustine plus rituximab (BR) in relapsed/refractory CLL patients.
Patients were randomized to venetoclax-rituximab for 6 months, followed by single-agent venetoclax for up to 1.5 years, or BR for 6 months. Peripheral blood samples were serially collected and bone marrow was collected at the end of combination treatment or at best response.
MRD findings
The new results show higher concordance in MRD-negativity between bone marrow and peripheral blood in venetoclax-rituximab (45 of 50 patients, 90%) vs BR (3 of 10 patients, 30%) in paired samples.
Focusing on peripheral blood MRD, Dr Hillmen said the best MRD-negativity rates were higher with venetoclax-rituximab (84%) than BR (23%). These results were independent of high-risk factors—such as del 17p, IGVH unmutated, and mutated TP53—only for venetoclax-rituximab treated patients.
“The superior peripheral blood MRD response with venetoclax-rituximab was consistent across subgroups at the end of completion of treatment,” Dr Hillmen said. “Most patients who achieved peripheral blood MRD-negativity on venetoclax-rituximab remained MRD-negative and were progression-free.”
Among 121 of 194 (62%) patients on venetoclax-rituximab who achieved MRD-negativity at the end of combination therapy, 100 (83%) patients maintained MRD-negativity and were progression-free at a median follow-up of 13.8 months. Two patients developed progressive disease and 2 patients died (unrelated to CLL).
Two patients developed Richter’s disease (with one MRD-positive directly before therapy) and 15 (12%) patients converted to confirmed MRD-positive at a median MRD-positive follow-up of 5.6 months.
“High peripheral blood MRD-negativity at the end of combination treatment and concordance with bone marrow MRD with venetoclax-rituximab,” Dr Hillmen said, “confirms the value of peripheral blood MRD for evaluation of treatment benefit in relapsed/refractory CLL patients. The high rate of peripheral blood MRD-negativity at end of combination treatment with venetoclax-rituximab was attained regardless of risk features.”
Some conversion to MRD-positivity occurred only in a small proportion of patients. Most cases were of intermediate level and remained progression-free, he said.
“MRD kinetics indicate that peripheral blood MRD-negativity with venetoclax-rituximab occurs early and is maintained over time with current follow-up,” Dr Hillmen added. The MRD data now provide a framework for designing response adaptive therapy.
The US Food and Drug Administration recently approved venetoclax-rituximab for CLL or small lymphocytic lymphoma for patients with or without del 17p.
Venetoclax is being developed by Genentech and Abbvie.
Sharpen your ax
Recently, I had a trauma call at my scenic little hospital in Maine. “Bleeding leg wound, Dr, Crosslin. We’ve got pressure on it. Come soon.” During my jog across the parking lot to the ER, I drifted into my residency mantra and started reciting the ABCs of trauma care:
Airway, Breathing, CT scan.
Airway, Breathing, C-spine collar.
Airway, Breathing, Consult with ortho.
Okay, so it’s been a while. Four years doesn’t seem like a long time, but that little span serves up a lot of change. You settle into a routine in your isolated, bucolic New England coastal town, where most trauma is related to hauling up lobster crates and having Massachusetts drivers scare the moxie out of locals in the crosswalks, and you forget about the hundreds of Level 1 traumas you managed over 5 years in Boston. The drilled-down, rapid sequence of the primary and secondary surveys gets lost, if just for a moment. Your confident swagger is replaced with a measured, humble shuffle into Trauma Bay 1. Do I scan the leg now? Did I feel for pulses in the foot? Wait, where do the major vessels branch again?
After addressing the issue at hand (or in this case, at foot), I kept thinking about the woodsman’s statement. I reflected on how I felt when I entered the trauma bay. Had I been doing enough to keep my own mental tools sharp? Well, actually, no. When did things slip just enough to allow hesitation and a bit of doubt to creep in? Probably sooner than I would care to admit. I certainly don’t think it took all of these 4 years for it to happen.
There has been some discussion of late surrounding the changes to maintenance of certification requirements from the American Board of Surgery. As with anything in surgery, we all need a chance to grumble about how things were better in the good old days. But then we grudgingly have to acknowledge that maybe – just maybe – the new approach makes some sense.
Did anyone really enjoy reporting on a 3-year cycle and taking a high-stakes, nausea-inducing exam every 10 years? I certainly wasn’t looking forward to reporting in this year about my “progress,” especially given how dull I seem to have become in so many subcategories just 4 years after graduation. But reporting every 5 years? That appeals to my inner slacker. Having a more-frequent-but-way-less-stressful examination that can be tailored to my practice? Yes, I’ll give that a shot.
It’s no secret we all are driven to care more about the things we enjoy doing, and educational science has established, quite firmly, the increased likelihood of concrete learning in higher numbers of loosely related fields when the primary subject is of particular interest to the learner. Elementary school teachers implemented that particular tidbit a long time ago. For me, the drive to excel leads me to the oncology, endocrine, and complex hernia reconstruction arenas. I do not pretend to be the world’s authority on trauma surgery, or anorectal surgery, or vascular surgery. I leave that expertise to others I secretly have judged to be far more pathological than myself. But I would be willing to glean more from reviewing those particular subjects if the overall focus is geared toward improving my knowledge and skill in cancer surgery.
In this ultramodern era, when the compendium of medical and surgical knowledge infinitely outpaces our ability to provide “one-stop shopping” services, perhaps it is time we accept the limitations of our interests and our abilities as part of the natural, beneficial evolution of good medical practice. The College’s willingness to work with the ABS to address the hot-button issue of continuing education in an interactive, relevant, timely manner should be a major point of pride. Rather than clinging to the dull ways of the past, I think we all are going to benefit from carrying a collectively sharper ax.
Dr. Crosslin is a general surgeon practicing in Rockport, Maine.
Recently, I had a trauma call at my scenic little hospital in Maine. “Bleeding leg wound, Dr, Crosslin. We’ve got pressure on it. Come soon.” During my jog across the parking lot to the ER, I drifted into my residency mantra and started reciting the ABCs of trauma care:
Airway, Breathing, CT scan.
Airway, Breathing, C-spine collar.
Airway, Breathing, Consult with ortho.
Okay, so it’s been a while. Four years doesn’t seem like a long time, but that little span serves up a lot of change. You settle into a routine in your isolated, bucolic New England coastal town, where most trauma is related to hauling up lobster crates and having Massachusetts drivers scare the moxie out of locals in the crosswalks, and you forget about the hundreds of Level 1 traumas you managed over 5 years in Boston. The drilled-down, rapid sequence of the primary and secondary surveys gets lost, if just for a moment. Your confident swagger is replaced with a measured, humble shuffle into Trauma Bay 1. Do I scan the leg now? Did I feel for pulses in the foot? Wait, where do the major vessels branch again?
After addressing the issue at hand (or in this case, at foot), I kept thinking about the woodsman’s statement. I reflected on how I felt when I entered the trauma bay. Had I been doing enough to keep my own mental tools sharp? Well, actually, no. When did things slip just enough to allow hesitation and a bit of doubt to creep in? Probably sooner than I would care to admit. I certainly don’t think it took all of these 4 years for it to happen.
There has been some discussion of late surrounding the changes to maintenance of certification requirements from the American Board of Surgery. As with anything in surgery, we all need a chance to grumble about how things were better in the good old days. But then we grudgingly have to acknowledge that maybe – just maybe – the new approach makes some sense.
Did anyone really enjoy reporting on a 3-year cycle and taking a high-stakes, nausea-inducing exam every 10 years? I certainly wasn’t looking forward to reporting in this year about my “progress,” especially given how dull I seem to have become in so many subcategories just 4 years after graduation. But reporting every 5 years? That appeals to my inner slacker. Having a more-frequent-but-way-less-stressful examination that can be tailored to my practice? Yes, I’ll give that a shot.
It’s no secret we all are driven to care more about the things we enjoy doing, and educational science has established, quite firmly, the increased likelihood of concrete learning in higher numbers of loosely related fields when the primary subject is of particular interest to the learner. Elementary school teachers implemented that particular tidbit a long time ago. For me, the drive to excel leads me to the oncology, endocrine, and complex hernia reconstruction arenas. I do not pretend to be the world’s authority on trauma surgery, or anorectal surgery, or vascular surgery. I leave that expertise to others I secretly have judged to be far more pathological than myself. But I would be willing to glean more from reviewing those particular subjects if the overall focus is geared toward improving my knowledge and skill in cancer surgery.
In this ultramodern era, when the compendium of medical and surgical knowledge infinitely outpaces our ability to provide “one-stop shopping” services, perhaps it is time we accept the limitations of our interests and our abilities as part of the natural, beneficial evolution of good medical practice. The College’s willingness to work with the ABS to address the hot-button issue of continuing education in an interactive, relevant, timely manner should be a major point of pride. Rather than clinging to the dull ways of the past, I think we all are going to benefit from carrying a collectively sharper ax.
Dr. Crosslin is a general surgeon practicing in Rockport, Maine.
Recently, I had a trauma call at my scenic little hospital in Maine. “Bleeding leg wound, Dr, Crosslin. We’ve got pressure on it. Come soon.” During my jog across the parking lot to the ER, I drifted into my residency mantra and started reciting the ABCs of trauma care:
Airway, Breathing, CT scan.
Airway, Breathing, C-spine collar.
Airway, Breathing, Consult with ortho.
Okay, so it’s been a while. Four years doesn’t seem like a long time, but that little span serves up a lot of change. You settle into a routine in your isolated, bucolic New England coastal town, where most trauma is related to hauling up lobster crates and having Massachusetts drivers scare the moxie out of locals in the crosswalks, and you forget about the hundreds of Level 1 traumas you managed over 5 years in Boston. The drilled-down, rapid sequence of the primary and secondary surveys gets lost, if just for a moment. Your confident swagger is replaced with a measured, humble shuffle into Trauma Bay 1. Do I scan the leg now? Did I feel for pulses in the foot? Wait, where do the major vessels branch again?
After addressing the issue at hand (or in this case, at foot), I kept thinking about the woodsman’s statement. I reflected on how I felt when I entered the trauma bay. Had I been doing enough to keep my own mental tools sharp? Well, actually, no. When did things slip just enough to allow hesitation and a bit of doubt to creep in? Probably sooner than I would care to admit. I certainly don’t think it took all of these 4 years for it to happen.
There has been some discussion of late surrounding the changes to maintenance of certification requirements from the American Board of Surgery. As with anything in surgery, we all need a chance to grumble about how things were better in the good old days. But then we grudgingly have to acknowledge that maybe – just maybe – the new approach makes some sense.
Did anyone really enjoy reporting on a 3-year cycle and taking a high-stakes, nausea-inducing exam every 10 years? I certainly wasn’t looking forward to reporting in this year about my “progress,” especially given how dull I seem to have become in so many subcategories just 4 years after graduation. But reporting every 5 years? That appeals to my inner slacker. Having a more-frequent-but-way-less-stressful examination that can be tailored to my practice? Yes, I’ll give that a shot.
It’s no secret we all are driven to care more about the things we enjoy doing, and educational science has established, quite firmly, the increased likelihood of concrete learning in higher numbers of loosely related fields when the primary subject is of particular interest to the learner. Elementary school teachers implemented that particular tidbit a long time ago. For me, the drive to excel leads me to the oncology, endocrine, and complex hernia reconstruction arenas. I do not pretend to be the world’s authority on trauma surgery, or anorectal surgery, or vascular surgery. I leave that expertise to others I secretly have judged to be far more pathological than myself. But I would be willing to glean more from reviewing those particular subjects if the overall focus is geared toward improving my knowledge and skill in cancer surgery.
In this ultramodern era, when the compendium of medical and surgical knowledge infinitely outpaces our ability to provide “one-stop shopping” services, perhaps it is time we accept the limitations of our interests and our abilities as part of the natural, beneficial evolution of good medical practice. The College’s willingness to work with the ABS to address the hot-button issue of continuing education in an interactive, relevant, timely manner should be a major point of pride. Rather than clinging to the dull ways of the past, I think we all are going to benefit from carrying a collectively sharper ax.
Dr. Crosslin is a general surgeon practicing in Rockport, Maine.
Study pinpoints skin cancer risk factors after hematopoietic cell transplant
CHICAGO – The 10-year incidence rates for both squamous cell carcinoma and basal cell carcinoma arising after hematopoietic cell transplantation are impressively high at 17%-plus for each, but the malignancies occur on two very different timelines, according to Jeffrey F. Scott, MD, a fellow in micrographic surgery and dermatologic oncology at Case Western Reserve University in Cleveland.
Most of the squamous cell carcinomas (SCCs) in a large multicenter retrospective study developed within the first 5 years following hematopoietic cell transplantation (HCT), while the majority of the basal cell carcinomas (BCCs) occurred after that point, Dr. Scott reported at the annual meeting of the American College of Mohs Surgery.
He presented the results of the study, which included 876 HCT recipients followed for a mean of 6.1 years. The study objective was to pin down the risk factors for skin cancer after HCT, especially the patient-specific ones. This has become a pressing issue because the use of HCT is steadily growing, and the 5-year survival rate now exceeds 50%.
The transplant-specific risk factors have previously been fairly well described by others. They include the donor source, type of disease, the conditioning regimen, whether whole body irradiation was used, immunosuppression, graft versus host disease (GVHD), and others.
The patient-centric risk factors, in contrast, have not been well characterized. And it’s critical to thoroughly understand these risk factors in order to develop targeted prevention and surveillance strategies, Dr. Scott said.
“There remains a significant knowledge gap within our field. I would venture that the majority of this audience has treated a patient with skin cancer who has had a transplant,” he said. “Yet when a patient asks us, ‘Doc, what is my risk for skin cancer after my HCT?’ we’re really unable to give them an accurate and complete assessment of that risk. That’s because we’re missing the second major category of risk factors: the patient-specific risk factors.”
The reason for that, he added, is that the major population-based studies and national HCT registries are run by hematologists and oncologists, and they haven’t adequately captured the patient-specific skin cancer risk factors. But these are variables very familiar to dermatologists. They include skin phenotype, history of UV radiation exposure, and history of pre-HCT skin cancer.
Dr. Scott said the multicenter study he presented has two major advantages over prior studies: its large size and thorough followup. Nearly all 876 patients were followed by both an oncologist and a dermatologist at the same institution.
During followup, the HCT recipients collectively developed 63 SCCs, 55 BCCs, and 16 malignant melanomas. The 5- and 10-year incidence rates for SCC were 10.6% and 17.2%. For BCC, the 5- and 10-year rates were 5.7% and 17.6%. All 16 cases of melanoma occurred within 5 years after HCT.
In multivariate Cox proportional hazard analyses, photodamage documented on examination was independently associated with a 3.2-fold increased risk of post-HCT SCC and a 3.5-fold increased risk of BCC.
A pre-transplant history of BCC was associated with a 3.9-fold increased likelihood of developing a BCC afterwards. Similarly, a pre-HCT history of SCC conferred a 4.2-fold increased risk of post-transplant SCC and was also independently associated with a 6.6-fold increased risk of developing melanoma post-HCT.
Fitzpatrick skin types I and II were respectively associated with 9.3- and 7.2-fold increased risks of post-HCT nonmelanoma skin cancer, compared with skin types III-VI.
Acute GVHD wasn’t associated with an increased risk of nonmelanoma skin cancer after HCT. However, in an observation that hasn’t previously been reported by others, chronic GVHD with skin involvement was associated with a 2.7-fold increased likelihood of SCC post-HCT, Dr. Scott noted.
What’s next for Dr. Scott and his coinvestigators? “Our ultimate goal with this project is to develop an interactive risk assessment tool like the National Cancer Institute’s Breast Cancer Risk Assessment Tool that can be online and used by patients and providers to estimate their individualized risk of basal cell carcinoma, squamous cell carcinoma, and melanoma after HCT,” he said.
Dr. Scott reported having no financial conflicts related to the study.
CHICAGO – The 10-year incidence rates for both squamous cell carcinoma and basal cell carcinoma arising after hematopoietic cell transplantation are impressively high at 17%-plus for each, but the malignancies occur on two very different timelines, according to Jeffrey F. Scott, MD, a fellow in micrographic surgery and dermatologic oncology at Case Western Reserve University in Cleveland.
Most of the squamous cell carcinomas (SCCs) in a large multicenter retrospective study developed within the first 5 years following hematopoietic cell transplantation (HCT), while the majority of the basal cell carcinomas (BCCs) occurred after that point, Dr. Scott reported at the annual meeting of the American College of Mohs Surgery.
He presented the results of the study, which included 876 HCT recipients followed for a mean of 6.1 years. The study objective was to pin down the risk factors for skin cancer after HCT, especially the patient-specific ones. This has become a pressing issue because the use of HCT is steadily growing, and the 5-year survival rate now exceeds 50%.
The transplant-specific risk factors have previously been fairly well described by others. They include the donor source, type of disease, the conditioning regimen, whether whole body irradiation was used, immunosuppression, graft versus host disease (GVHD), and others.
The patient-centric risk factors, in contrast, have not been well characterized. And it’s critical to thoroughly understand these risk factors in order to develop targeted prevention and surveillance strategies, Dr. Scott said.
“There remains a significant knowledge gap within our field. I would venture that the majority of this audience has treated a patient with skin cancer who has had a transplant,” he said. “Yet when a patient asks us, ‘Doc, what is my risk for skin cancer after my HCT?’ we’re really unable to give them an accurate and complete assessment of that risk. That’s because we’re missing the second major category of risk factors: the patient-specific risk factors.”
The reason for that, he added, is that the major population-based studies and national HCT registries are run by hematologists and oncologists, and they haven’t adequately captured the patient-specific skin cancer risk factors. But these are variables very familiar to dermatologists. They include skin phenotype, history of UV radiation exposure, and history of pre-HCT skin cancer.
Dr. Scott said the multicenter study he presented has two major advantages over prior studies: its large size and thorough followup. Nearly all 876 patients were followed by both an oncologist and a dermatologist at the same institution.
During followup, the HCT recipients collectively developed 63 SCCs, 55 BCCs, and 16 malignant melanomas. The 5- and 10-year incidence rates for SCC were 10.6% and 17.2%. For BCC, the 5- and 10-year rates were 5.7% and 17.6%. All 16 cases of melanoma occurred within 5 years after HCT.
In multivariate Cox proportional hazard analyses, photodamage documented on examination was independently associated with a 3.2-fold increased risk of post-HCT SCC and a 3.5-fold increased risk of BCC.
A pre-transplant history of BCC was associated with a 3.9-fold increased likelihood of developing a BCC afterwards. Similarly, a pre-HCT history of SCC conferred a 4.2-fold increased risk of post-transplant SCC and was also independently associated with a 6.6-fold increased risk of developing melanoma post-HCT.
Fitzpatrick skin types I and II were respectively associated with 9.3- and 7.2-fold increased risks of post-HCT nonmelanoma skin cancer, compared with skin types III-VI.
Acute GVHD wasn’t associated with an increased risk of nonmelanoma skin cancer after HCT. However, in an observation that hasn’t previously been reported by others, chronic GVHD with skin involvement was associated with a 2.7-fold increased likelihood of SCC post-HCT, Dr. Scott noted.
What’s next for Dr. Scott and his coinvestigators? “Our ultimate goal with this project is to develop an interactive risk assessment tool like the National Cancer Institute’s Breast Cancer Risk Assessment Tool that can be online and used by patients and providers to estimate their individualized risk of basal cell carcinoma, squamous cell carcinoma, and melanoma after HCT,” he said.
Dr. Scott reported having no financial conflicts related to the study.
CHICAGO – The 10-year incidence rates for both squamous cell carcinoma and basal cell carcinoma arising after hematopoietic cell transplantation are impressively high at 17%-plus for each, but the malignancies occur on two very different timelines, according to Jeffrey F. Scott, MD, a fellow in micrographic surgery and dermatologic oncology at Case Western Reserve University in Cleveland.
Most of the squamous cell carcinomas (SCCs) in a large multicenter retrospective study developed within the first 5 years following hematopoietic cell transplantation (HCT), while the majority of the basal cell carcinomas (BCCs) occurred after that point, Dr. Scott reported at the annual meeting of the American College of Mohs Surgery.
He presented the results of the study, which included 876 HCT recipients followed for a mean of 6.1 years. The study objective was to pin down the risk factors for skin cancer after HCT, especially the patient-specific ones. This has become a pressing issue because the use of HCT is steadily growing, and the 5-year survival rate now exceeds 50%.
The transplant-specific risk factors have previously been fairly well described by others. They include the donor source, type of disease, the conditioning regimen, whether whole body irradiation was used, immunosuppression, graft versus host disease (GVHD), and others.
The patient-centric risk factors, in contrast, have not been well characterized. And it’s critical to thoroughly understand these risk factors in order to develop targeted prevention and surveillance strategies, Dr. Scott said.
“There remains a significant knowledge gap within our field. I would venture that the majority of this audience has treated a patient with skin cancer who has had a transplant,” he said. “Yet when a patient asks us, ‘Doc, what is my risk for skin cancer after my HCT?’ we’re really unable to give them an accurate and complete assessment of that risk. That’s because we’re missing the second major category of risk factors: the patient-specific risk factors.”
The reason for that, he added, is that the major population-based studies and national HCT registries are run by hematologists and oncologists, and they haven’t adequately captured the patient-specific skin cancer risk factors. But these are variables very familiar to dermatologists. They include skin phenotype, history of UV radiation exposure, and history of pre-HCT skin cancer.
Dr. Scott said the multicenter study he presented has two major advantages over prior studies: its large size and thorough followup. Nearly all 876 patients were followed by both an oncologist and a dermatologist at the same institution.
During followup, the HCT recipients collectively developed 63 SCCs, 55 BCCs, and 16 malignant melanomas. The 5- and 10-year incidence rates for SCC were 10.6% and 17.2%. For BCC, the 5- and 10-year rates were 5.7% and 17.6%. All 16 cases of melanoma occurred within 5 years after HCT.
In multivariate Cox proportional hazard analyses, photodamage documented on examination was independently associated with a 3.2-fold increased risk of post-HCT SCC and a 3.5-fold increased risk of BCC.
A pre-transplant history of BCC was associated with a 3.9-fold increased likelihood of developing a BCC afterwards. Similarly, a pre-HCT history of SCC conferred a 4.2-fold increased risk of post-transplant SCC and was also independently associated with a 6.6-fold increased risk of developing melanoma post-HCT.
Fitzpatrick skin types I and II were respectively associated with 9.3- and 7.2-fold increased risks of post-HCT nonmelanoma skin cancer, compared with skin types III-VI.
Acute GVHD wasn’t associated with an increased risk of nonmelanoma skin cancer after HCT. However, in an observation that hasn’t previously been reported by others, chronic GVHD with skin involvement was associated with a 2.7-fold increased likelihood of SCC post-HCT, Dr. Scott noted.
What’s next for Dr. Scott and his coinvestigators? “Our ultimate goal with this project is to develop an interactive risk assessment tool like the National Cancer Institute’s Breast Cancer Risk Assessment Tool that can be online and used by patients and providers to estimate their individualized risk of basal cell carcinoma, squamous cell carcinoma, and melanoma after HCT,” he said.
Dr. Scott reported having no financial conflicts related to the study.
REPORTING FROM THE ACMS ANNUAL MEETING
Key clinical point:
Major finding: Photodamage documented on examination more than triples the risk of developing nonmelanoma skin cancer after hematopoietic cell transplantation.
Study details: A multicenter retrospective study of 876 hematopoietic cell recipients followed for a mean of 6.1 years.
Disclosures: The presenter reported having no financial conflicts related to the study, which was conducted without commercial support.
FDA already balances safety, access to investigational drugs
The Food and Drug Administration is generally achieving the balance between ensuring safety and providing access to investigational drugs through compassionate use programs, according to results from a new analysis that found that most of these drugs are available within 6 months of an application to the FDA.
But that balance may be threatened by the recently enacted Right to Try Act, Jeremy Puthumana, of Yale University, New Haven, Conn., and his colleagues reported in an article published on JAMA Network Open. They said the new law encourages sponsors to make investigational drugs available earlier in the clinical development period, potentially jeopardizing safety.
“These findings suggest the FDA and the pharmaceutical industry have established a balance between investigational new drug access and protection of patients from therapies without established safety, which may be compromised by policy makers seeking to speed access to investigational medicines through the Right to Try Act by removing the requirements for FDA oversight and approval of expanded access requests,” the researchers wrote.
The cross-sectional study examined all expanded access programs registered with ClinicalTrials.gov through Aug. 1, 2017. Of 92 expanded access programs for investigational drugs, 69.6% were initiated within 6 months following (43.5%) or preceding (26.1%) submission of a new drug application. Ninety of the 92 drugs ultimately went on to receive FDA approval.
Of the most common uses of the 92 drugs registered in expanded access programs between September 1996 and June 2017, half were used for the treatment of cancer; 16 drugs were used to treat metabolic, endocrine, and genetic diseases; and 14 drugs were used for the treatment of infectious diseases. But there were no significant differences in the timing of program initiation by therapeutic characteristics, the researchers found.
President Donald Trump signed the Right To Try Act of 2017 (S. 204) into law on May 30, 2018, despite opposition from physician and patient groups who expressed concerns that the law will remove FDA safeguards.
The study was funded by a grant from the National Institutes of Health. The researchers reported research support from the Laura and John Arnold Foundation, Johnson and Johnson, Medtronic, the Blue Cross-Blue Shield Association, the FDA, and other federal agencies.
SOURCE: Puthumana J et al. JAMA Network Open. 2018 Jun 15. doi:10.1001/jamanetworkopen.2018.0283.
The Food and Drug Administration is generally achieving the balance between ensuring safety and providing access to investigational drugs through compassionate use programs, according to results from a new analysis that found that most of these drugs are available within 6 months of an application to the FDA.
But that balance may be threatened by the recently enacted Right to Try Act, Jeremy Puthumana, of Yale University, New Haven, Conn., and his colleagues reported in an article published on JAMA Network Open. They said the new law encourages sponsors to make investigational drugs available earlier in the clinical development period, potentially jeopardizing safety.
“These findings suggest the FDA and the pharmaceutical industry have established a balance between investigational new drug access and protection of patients from therapies without established safety, which may be compromised by policy makers seeking to speed access to investigational medicines through the Right to Try Act by removing the requirements for FDA oversight and approval of expanded access requests,” the researchers wrote.
The cross-sectional study examined all expanded access programs registered with ClinicalTrials.gov through Aug. 1, 2017. Of 92 expanded access programs for investigational drugs, 69.6% were initiated within 6 months following (43.5%) or preceding (26.1%) submission of a new drug application. Ninety of the 92 drugs ultimately went on to receive FDA approval.
Of the most common uses of the 92 drugs registered in expanded access programs between September 1996 and June 2017, half were used for the treatment of cancer; 16 drugs were used to treat metabolic, endocrine, and genetic diseases; and 14 drugs were used for the treatment of infectious diseases. But there were no significant differences in the timing of program initiation by therapeutic characteristics, the researchers found.
President Donald Trump signed the Right To Try Act of 2017 (S. 204) into law on May 30, 2018, despite opposition from physician and patient groups who expressed concerns that the law will remove FDA safeguards.
The study was funded by a grant from the National Institutes of Health. The researchers reported research support from the Laura and John Arnold Foundation, Johnson and Johnson, Medtronic, the Blue Cross-Blue Shield Association, the FDA, and other federal agencies.
SOURCE: Puthumana J et al. JAMA Network Open. 2018 Jun 15. doi:10.1001/jamanetworkopen.2018.0283.
The Food and Drug Administration is generally achieving the balance between ensuring safety and providing access to investigational drugs through compassionate use programs, according to results from a new analysis that found that most of these drugs are available within 6 months of an application to the FDA.
But that balance may be threatened by the recently enacted Right to Try Act, Jeremy Puthumana, of Yale University, New Haven, Conn., and his colleagues reported in an article published on JAMA Network Open. They said the new law encourages sponsors to make investigational drugs available earlier in the clinical development period, potentially jeopardizing safety.
“These findings suggest the FDA and the pharmaceutical industry have established a balance between investigational new drug access and protection of patients from therapies without established safety, which may be compromised by policy makers seeking to speed access to investigational medicines through the Right to Try Act by removing the requirements for FDA oversight and approval of expanded access requests,” the researchers wrote.
The cross-sectional study examined all expanded access programs registered with ClinicalTrials.gov through Aug. 1, 2017. Of 92 expanded access programs for investigational drugs, 69.6% were initiated within 6 months following (43.5%) or preceding (26.1%) submission of a new drug application. Ninety of the 92 drugs ultimately went on to receive FDA approval.
Of the most common uses of the 92 drugs registered in expanded access programs between September 1996 and June 2017, half were used for the treatment of cancer; 16 drugs were used to treat metabolic, endocrine, and genetic diseases; and 14 drugs were used for the treatment of infectious diseases. But there were no significant differences in the timing of program initiation by therapeutic characteristics, the researchers found.
President Donald Trump signed the Right To Try Act of 2017 (S. 204) into law on May 30, 2018, despite opposition from physician and patient groups who expressed concerns that the law will remove FDA safeguards.
The study was funded by a grant from the National Institutes of Health. The researchers reported research support from the Laura and John Arnold Foundation, Johnson and Johnson, Medtronic, the Blue Cross-Blue Shield Association, the FDA, and other federal agencies.
SOURCE: Puthumana J et al. JAMA Network Open. 2018 Jun 15. doi:10.1001/jamanetworkopen.2018.0283.
FROM JAMA NETWORK OPEN
Key clinical point: Major finding: Nearly 70% of investigational drugs registered in expanded access programs were made available outside of clinical trials within 6 months of submission of a new drug application.
Study details: A cross-sectional study examining expanded access and compassionate use programs registered through Aug. 1, 2017.
Disclosures: The study was funded by grant from the National Institutes of Health. The researchers reported research support from the Laura and John Arnold Foundation, Johnson and Johnson, Medtronic, the Blue Cross-Blue Shield Association, the FDA and other federal agencies.
Source: Puthumana J et al., JAMA Network Open. 2018 Jun 15. doi:10.1001/jamanetworkopen.2018.0283.
Low vitamin D linked with DVT in lupus patients
AMSTERDAM – Low blood levels of vitamin D were linked with a roughly doubled risk for deep vein thrombosis in a review of nearly 1,400 patients with systemic lupus erythematosus at one U.S. center.
Based on these findings, patients with systemic lupus erythematosus (SLE) should have their blood vitamin D monitored regularly, and if it’s less than 40 ng/mL – the level that was linked with this thrombotic risk – they should receive a vitamin D supplement, Michelle A. Petri, MD, said while presenting a poster at the European Congress of Rheumatology.
She recommended supplementation that provides 50,000 IU of vitamin D weekly, a treatment that appears safe to add to two other routine treatments she recommends for SLE patients – aspirin and hydroxychloroquine.
SLE patients should also have their vitamin D level rechecked on a regular basis, perhaps annually, to confirm that their level remains above 40 ng/mL, said Dr. Petri, professor of medicine and director of the Lupus Center at Johns Hopkins Medicine in Baltimore. She acknowledged that this level is above the target level often applied to the general population, but remains safe.
“It looks like vitamin D may be a useful treatment to add to aspirin and hydroxychloroquine in patients with SLE. It looks very simple and important, but this finding should be repeated and validated by other groups,” commented John D. Isaacs, MD, professor of clinical rheumatology at Newcastle University in Newcastle upon Tyne, England.
Dr. Petri and her associates reviewed records for 1,392 SLE patients enrolled in a Johns Hopkins registry. The patients averaged about 43 years old, 92% were women, and 27% had a history of a thrombotic event, either prior to or after their enrollment. The most common thrombotic event was deep vein thrombosis (DVT), in 14%, and also included stroke in 7%, myocardial infarction in 4%, and a smaller number with other types of arterial or venous thromboses. All these patients also had their blood vitamin D level checked at least once, at the time of enrollment, and 77% had a level below 40 ng/mL.
The first analysis looked at the link between any thrombotic event and vitamin D levels, and included adjustment for age, race, sex, and level of lupus anticoagulant. This showed a statistically significant 2.3-fold increased risk for DVT among patients with a vitamin D level of less than 40 ng/mL, compared with those with a higher level. The researchers did not find a significant association between low vitamin D levels and the rates of total thrombotic events or any arterial thrombotic event.
A second analysis censored out thrombotic events that occurred prior to enrollment and focused on incident thromboses after enrollment into the registry. This analysis showed a statistically significant 75% increased rate of new onset DVT episodes among patients with low vitamin D at entry after adjustment for age, race, and sex. The researchers found no significant associations between low vitamin D and the incidence of any other type of incident thrombosis.
Dr. Petri and Dr. Isaacs reported having no relevant financial disclosures.
SOURCE: Petri MA et al. Ann Rheum Dis. 2018;77(Suppl 2):388, Abstract THU0341.
AMSTERDAM – Low blood levels of vitamin D were linked with a roughly doubled risk for deep vein thrombosis in a review of nearly 1,400 patients with systemic lupus erythematosus at one U.S. center.
Based on these findings, patients with systemic lupus erythematosus (SLE) should have their blood vitamin D monitored regularly, and if it’s less than 40 ng/mL – the level that was linked with this thrombotic risk – they should receive a vitamin D supplement, Michelle A. Petri, MD, said while presenting a poster at the European Congress of Rheumatology.
She recommended supplementation that provides 50,000 IU of vitamin D weekly, a treatment that appears safe to add to two other routine treatments she recommends for SLE patients – aspirin and hydroxychloroquine.
SLE patients should also have their vitamin D level rechecked on a regular basis, perhaps annually, to confirm that their level remains above 40 ng/mL, said Dr. Petri, professor of medicine and director of the Lupus Center at Johns Hopkins Medicine in Baltimore. She acknowledged that this level is above the target level often applied to the general population, but remains safe.
“It looks like vitamin D may be a useful treatment to add to aspirin and hydroxychloroquine in patients with SLE. It looks very simple and important, but this finding should be repeated and validated by other groups,” commented John D. Isaacs, MD, professor of clinical rheumatology at Newcastle University in Newcastle upon Tyne, England.
Dr. Petri and her associates reviewed records for 1,392 SLE patients enrolled in a Johns Hopkins registry. The patients averaged about 43 years old, 92% were women, and 27% had a history of a thrombotic event, either prior to or after their enrollment. The most common thrombotic event was deep vein thrombosis (DVT), in 14%, and also included stroke in 7%, myocardial infarction in 4%, and a smaller number with other types of arterial or venous thromboses. All these patients also had their blood vitamin D level checked at least once, at the time of enrollment, and 77% had a level below 40 ng/mL.
The first analysis looked at the link between any thrombotic event and vitamin D levels, and included adjustment for age, race, sex, and level of lupus anticoagulant. This showed a statistically significant 2.3-fold increased risk for DVT among patients with a vitamin D level of less than 40 ng/mL, compared with those with a higher level. The researchers did not find a significant association between low vitamin D levels and the rates of total thrombotic events or any arterial thrombotic event.
A second analysis censored out thrombotic events that occurred prior to enrollment and focused on incident thromboses after enrollment into the registry. This analysis showed a statistically significant 75% increased rate of new onset DVT episodes among patients with low vitamin D at entry after adjustment for age, race, and sex. The researchers found no significant associations between low vitamin D and the incidence of any other type of incident thrombosis.
Dr. Petri and Dr. Isaacs reported having no relevant financial disclosures.
SOURCE: Petri MA et al. Ann Rheum Dis. 2018;77(Suppl 2):388, Abstract THU0341.
AMSTERDAM – Low blood levels of vitamin D were linked with a roughly doubled risk for deep vein thrombosis in a review of nearly 1,400 patients with systemic lupus erythematosus at one U.S. center.
Based on these findings, patients with systemic lupus erythematosus (SLE) should have their blood vitamin D monitored regularly, and if it’s less than 40 ng/mL – the level that was linked with this thrombotic risk – they should receive a vitamin D supplement, Michelle A. Petri, MD, said while presenting a poster at the European Congress of Rheumatology.
She recommended supplementation that provides 50,000 IU of vitamin D weekly, a treatment that appears safe to add to two other routine treatments she recommends for SLE patients – aspirin and hydroxychloroquine.
SLE patients should also have their vitamin D level rechecked on a regular basis, perhaps annually, to confirm that their level remains above 40 ng/mL, said Dr. Petri, professor of medicine and director of the Lupus Center at Johns Hopkins Medicine in Baltimore. She acknowledged that this level is above the target level often applied to the general population, but remains safe.
“It looks like vitamin D may be a useful treatment to add to aspirin and hydroxychloroquine in patients with SLE. It looks very simple and important, but this finding should be repeated and validated by other groups,” commented John D. Isaacs, MD, professor of clinical rheumatology at Newcastle University in Newcastle upon Tyne, England.
Dr. Petri and her associates reviewed records for 1,392 SLE patients enrolled in a Johns Hopkins registry. The patients averaged about 43 years old, 92% were women, and 27% had a history of a thrombotic event, either prior to or after their enrollment. The most common thrombotic event was deep vein thrombosis (DVT), in 14%, and also included stroke in 7%, myocardial infarction in 4%, and a smaller number with other types of arterial or venous thromboses. All these patients also had their blood vitamin D level checked at least once, at the time of enrollment, and 77% had a level below 40 ng/mL.
The first analysis looked at the link between any thrombotic event and vitamin D levels, and included adjustment for age, race, sex, and level of lupus anticoagulant. This showed a statistically significant 2.3-fold increased risk for DVT among patients with a vitamin D level of less than 40 ng/mL, compared with those with a higher level. The researchers did not find a significant association between low vitamin D levels and the rates of total thrombotic events or any arterial thrombotic event.
A second analysis censored out thrombotic events that occurred prior to enrollment and focused on incident thromboses after enrollment into the registry. This analysis showed a statistically significant 75% increased rate of new onset DVT episodes among patients with low vitamin D at entry after adjustment for age, race, and sex. The researchers found no significant associations between low vitamin D and the incidence of any other type of incident thrombosis.
Dr. Petri and Dr. Isaacs reported having no relevant financial disclosures.
SOURCE: Petri MA et al. Ann Rheum Dis. 2018;77(Suppl 2):388, Abstract THU0341.
REPORTING FROM THE EULAR 2018 CONGRESS
Key clinical point:
Major finding: Lupus patients with a vitamin D level below 40 ng/mL had 2.3-fold more DVT events, compared with those with higher levels.
Study details: A review of 1,392 lupus patients at one U.S. center.
Disclosures: Dr. Petri and Dr. Isaacs reported having no relevant financial disclosures.
Source: Petri MA et al. Ann Rheum Dis. 2018;77(Suppl 2):388. Abstract THU0341.