User login
Cardiothoracic Surgery Resident Poster Competition
Represent your institution with a scientific poster of your clinical/investigative research at the 2016 AATS Annual Meeting in Baltimore, Maryland, May 14-18, 2016. The Competition is open to senior cardiothoracic surgery residents and/or congenital heart surgery fellows worldwide
North American residents must (1) Be in their last year of either an ACGME-accredited or RCPSC-accredited US or Canadian cardiothoracic surgery residency program or congenital heart surgery fellowship, and (2) Upload a support letter from their Program Director as part of their application.
International residents must (1) Be in their last year of a cardiothoracic training program at an AATS Member’s institution, and (2) Upload a sponsor letter from an AATS member at their institution as part of their application.
Application — Residents/fellows must provide a brief abstract of the research on their posters. Research may include information previously presented and/or published.
Benefits — Participant/institutions will (1) Receive a $500 stipend to offset travel and hotel accommodation to the Annual Meeting, (2) Receive a complimentary Annual Meeting registration, and (3) Have access to a Skills Course (Saturday, May 14) and Postgraduate Course (Sunday, May 15).
The participant’s training program will be responsible for the cost of any additional resident/fellow travel and accommodations.
Deadline: January 22, 2016
Represent your institution with a scientific poster of your clinical/investigative research at the 2016 AATS Annual Meeting in Baltimore, Maryland, May 14-18, 2016. The Competition is open to senior cardiothoracic surgery residents and/or congenital heart surgery fellows worldwide
North American residents must (1) Be in their last year of either an ACGME-accredited or RCPSC-accredited US or Canadian cardiothoracic surgery residency program or congenital heart surgery fellowship, and (2) Upload a support letter from their Program Director as part of their application.
International residents must (1) Be in their last year of a cardiothoracic training program at an AATS Member’s institution, and (2) Upload a sponsor letter from an AATS member at their institution as part of their application.
Application — Residents/fellows must provide a brief abstract of the research on their posters. Research may include information previously presented and/or published.
Benefits — Participant/institutions will (1) Receive a $500 stipend to offset travel and hotel accommodation to the Annual Meeting, (2) Receive a complimentary Annual Meeting registration, and (3) Have access to a Skills Course (Saturday, May 14) and Postgraduate Course (Sunday, May 15).
The participant’s training program will be responsible for the cost of any additional resident/fellow travel and accommodations.
Deadline: January 22, 2016
Represent your institution with a scientific poster of your clinical/investigative research at the 2016 AATS Annual Meeting in Baltimore, Maryland, May 14-18, 2016. The Competition is open to senior cardiothoracic surgery residents and/or congenital heart surgery fellows worldwide
North American residents must (1) Be in their last year of either an ACGME-accredited or RCPSC-accredited US or Canadian cardiothoracic surgery residency program or congenital heart surgery fellowship, and (2) Upload a support letter from their Program Director as part of their application.
International residents must (1) Be in their last year of a cardiothoracic training program at an AATS Member’s institution, and (2) Upload a sponsor letter from an AATS member at their institution as part of their application.
Application — Residents/fellows must provide a brief abstract of the research on their posters. Research may include information previously presented and/or published.
Benefits — Participant/institutions will (1) Receive a $500 stipend to offset travel and hotel accommodation to the Annual Meeting, (2) Receive a complimentary Annual Meeting registration, and (3) Have access to a Skills Course (Saturday, May 14) and Postgraduate Course (Sunday, May 15).
The participant’s training program will be responsible for the cost of any additional resident/fellow travel and accommodations.
Deadline: January 22, 2016
Apply to the AATS Summer Internship Scholarship
Medical students: Submissions are open for the AATS Summer Internship Scholarship giving up to 40 successful candidates the opportunity to spend eight weeks during the summer working in the cardiothoracic surgery department of a North American AATS member.
Program Goal — The program aims to broaden medical students’ educational experiences and to provide insight into cardiothoracic surgery.
Eligibility — (1) Candidates must be a North American first- or second-year medical student (as of January 2, 2016), (2) Host sponsor (an AATS member) must provide a letter of support/approval, and (3) Internships must take place at the institution of the host sponsor.
Application — The application must include no more than a one-page outline that includes what the candidate hopes to accomplish during his/her eight-week scholarship and specifies the proposed intern’s exposure to CT surgery, including both laboratory and clinical experience
Selection — (1) No more than two students from a single institution may receive a scholarship, (2) If two students from the same institution are selected, each must have a different host sponsor, and (3) Award recipients must agree to submit a summary report and evaluation of their experience to AATS within 60 days of internship completion.
Deadline: Friday, January 15, 2016
Medical students: Submissions are open for the AATS Summer Internship Scholarship giving up to 40 successful candidates the opportunity to spend eight weeks during the summer working in the cardiothoracic surgery department of a North American AATS member.
Program Goal — The program aims to broaden medical students’ educational experiences and to provide insight into cardiothoracic surgery.
Eligibility — (1) Candidates must be a North American first- or second-year medical student (as of January 2, 2016), (2) Host sponsor (an AATS member) must provide a letter of support/approval, and (3) Internships must take place at the institution of the host sponsor.
Application — The application must include no more than a one-page outline that includes what the candidate hopes to accomplish during his/her eight-week scholarship and specifies the proposed intern’s exposure to CT surgery, including both laboratory and clinical experience
Selection — (1) No more than two students from a single institution may receive a scholarship, (2) If two students from the same institution are selected, each must have a different host sponsor, and (3) Award recipients must agree to submit a summary report and evaluation of their experience to AATS within 60 days of internship completion.
Deadline: Friday, January 15, 2016
Medical students: Submissions are open for the AATS Summer Internship Scholarship giving up to 40 successful candidates the opportunity to spend eight weeks during the summer working in the cardiothoracic surgery department of a North American AATS member.
Program Goal — The program aims to broaden medical students’ educational experiences and to provide insight into cardiothoracic surgery.
Eligibility — (1) Candidates must be a North American first- or second-year medical student (as of January 2, 2016), (2) Host sponsor (an AATS member) must provide a letter of support/approval, and (3) Internships must take place at the institution of the host sponsor.
Application — The application must include no more than a one-page outline that includes what the candidate hopes to accomplish during his/her eight-week scholarship and specifies the proposed intern’s exposure to CT surgery, including both laboratory and clinical experience
Selection — (1) No more than two students from a single institution may receive a scholarship, (2) If two students from the same institution are selected, each must have a different host sponsor, and (3) Award recipients must agree to submit a summary report and evaluation of their experience to AATS within 60 days of internship completion.
Deadline: Friday, January 15, 2016
Be an AATS Member for a Day
Medical Students, General Surgery Residents and I-6 CT Surgical Residents — Submissions are open for the AATS Member for a Day program. Up to 30 successful candidates will have the opportunity to accompany an AATS Member Mentor for portions of the 2016 AATS Annual Meeting.
Dates/Location: May 14-18, 2016, Baltimore, MD
Eligibility — Applicants must be North American medical students, general surgery residents or I-6 cardiothoracic residents (within their first three years).
Program Goals — Are to (1) offer insight into cardiothoracic surgery, and (2) provide an opportunity to network and build relationships within the cardiothoracic surgical community.
Benefits — (1) Complimentary hotel accommodation for a minimum of three and maximum of four nights at an AATS Annual Meeting hotel, (2) a $500 stipend to help offset travel costs, and (3) an additional $250 stipend to offset the cost of meals.
Deadline: Friday, January 15, 2016
Medical Students, General Surgery Residents and I-6 CT Surgical Residents — Submissions are open for the AATS Member for a Day program. Up to 30 successful candidates will have the opportunity to accompany an AATS Member Mentor for portions of the 2016 AATS Annual Meeting.
Dates/Location: May 14-18, 2016, Baltimore, MD
Eligibility — Applicants must be North American medical students, general surgery residents or I-6 cardiothoracic residents (within their first three years).
Program Goals — Are to (1) offer insight into cardiothoracic surgery, and (2) provide an opportunity to network and build relationships within the cardiothoracic surgical community.
Benefits — (1) Complimentary hotel accommodation for a minimum of three and maximum of four nights at an AATS Annual Meeting hotel, (2) a $500 stipend to help offset travel costs, and (3) an additional $250 stipend to offset the cost of meals.
Deadline: Friday, January 15, 2016
Medical Students, General Surgery Residents and I-6 CT Surgical Residents — Submissions are open for the AATS Member for a Day program. Up to 30 successful candidates will have the opportunity to accompany an AATS Member Mentor for portions of the 2016 AATS Annual Meeting.
Dates/Location: May 14-18, 2016, Baltimore, MD
Eligibility — Applicants must be North American medical students, general surgery residents or I-6 cardiothoracic residents (within their first three years).
Program Goals — Are to (1) offer insight into cardiothoracic surgery, and (2) provide an opportunity to network and build relationships within the cardiothoracic surgical community.
Benefits — (1) Complimentary hotel accommodation for a minimum of three and maximum of four nights at an AATS Annual Meeting hotel, (2) a $500 stipend to help offset travel costs, and (3) an additional $250 stipend to offset the cost of meals.
Deadline: Friday, January 15, 2016
ACR: Years of TNF blockers did not increase risk of lymphoma in RA
SAN FRANCISCO – Rheumatoid arthritis conferred a doubling of the risk of lymphoma when compared against the general population in a large Swedish registry study, regardless of the patients’ experience with biological disease-modifying antirheumatic drugs.
But patients who took biological disease-modifying antirheumatic drugs (bDMARDs) had a sixfold greater risk of natural killer or T-cell lymphoma than did the general population, and that association was about four times stronger than for patients who had never taken biologics, reported Dr. Karin Hellgren, who led the study at the Karolinska Institute in Stockholm. That finding in particular shows the need to keep studying the links between bDMARDs and specific lymphoma subtypes, he said.
Severe rheumatoid arthritis seems to strongly increase the risk of lymphoma (Arthritis Rheum. 2006;54[3]:692-701), but researchers have debated whether the reason relates to bDMARDs or RA itself. Clinical trials have produced conflicting results; observational studies have reported no overall link between bDMARDs and lymphoma, but have raised questions about long-term exposure, the effects of individual agents, and lymphoma subtypes, Dr. Hellgren said at the annual meeting of the American College of Rheumatology.
To delve deeper into these issues, he and his associates compared 15 years of data for 13,240 RA patients on bDMARDs from the Swedish Biologics (ARTIS), Patient, and Cancer Registers and a national cohort of 46,568 bDMARD-naive patients. The researchers also compared both groups with 458,846 age- and gender-matched adults from the Swedish Population Register, following individuals until the end of 2012 or until lymphoma diagnosis, death, emigration, or bDMARD initiation, in the case of the naive patients.
Overall, patients with RA averaged one diagnosis of lymphoma per 1,000 population, compared with 0.5 cases per 1,000 for the overall population of Sweden, Dr. Hellgren said. In terms of absolute numbers, there were 241 cases of lymphoma among bDMARD-naive patients, 1,413 cases in the general population, and 69 cases among patients on bDMARDs, including 68 who were taking TNF inhibitors. The average age of the latter group of patients was 57 years. They had been diagnosed with RA at about age 50, had a mean 28-joint Disease Activity Score score of 5.3, and averaged 5.9 years of exposure to TNF inhibitors. Their risk of any type of malignant lymphoma was about 20% higher than for bDMARD-naive patients, but the difference was insignificant overall and in subgroups stratified by gender, age, and year starting treatment. Likewise, although patients were at greater risk of lymphoma if they had been on bDMARDs for 5-15 years (hazard ratio, 1.9) than for less time (HRs, about 1.0), there was no significant difference in risk compared with bDMARD-naive patients.
“There also were no statistically significant differences between drugs,” including infliximab (Remicade), etanercept (Enbrel), and adalimumab (Humira), Dr. Hellgren said. “In terms of the newer TNF inhibitors and other biologics, data are still too scarce to evaluate,” he added. Both exposed and bDMARD-naive patients were at especially high risk of Hodgkin lymphoma and diffuse large B-cell lymphoma, compared with the general population, but the strongest association of all was between bDMARD exposure and natural killer or T-cell lymphoma (HR, 6.0; 95% CI, 2.7-13.3). “The distribution of lymphoma subtypes warrants further assessment,” Dr. Hellgren concluded.
The ARTIS registry is funded by AbbVie, Bristol-Myers Squibb, Roche, Merck, Pfizer, Sobi, Lilly, and UCB. Dr. Hellgren had no disclosures. One coauthor reported financial relationships with AstraZeneca, Pfizer, UCB, Roche, Merck, Bristol-Myers Squibb, and AbbVie.
SAN FRANCISCO – Rheumatoid arthritis conferred a doubling of the risk of lymphoma when compared against the general population in a large Swedish registry study, regardless of the patients’ experience with biological disease-modifying antirheumatic drugs.
But patients who took biological disease-modifying antirheumatic drugs (bDMARDs) had a sixfold greater risk of natural killer or T-cell lymphoma than did the general population, and that association was about four times stronger than for patients who had never taken biologics, reported Dr. Karin Hellgren, who led the study at the Karolinska Institute in Stockholm. That finding in particular shows the need to keep studying the links between bDMARDs and specific lymphoma subtypes, he said.
Severe rheumatoid arthritis seems to strongly increase the risk of lymphoma (Arthritis Rheum. 2006;54[3]:692-701), but researchers have debated whether the reason relates to bDMARDs or RA itself. Clinical trials have produced conflicting results; observational studies have reported no overall link between bDMARDs and lymphoma, but have raised questions about long-term exposure, the effects of individual agents, and lymphoma subtypes, Dr. Hellgren said at the annual meeting of the American College of Rheumatology.
To delve deeper into these issues, he and his associates compared 15 years of data for 13,240 RA patients on bDMARDs from the Swedish Biologics (ARTIS), Patient, and Cancer Registers and a national cohort of 46,568 bDMARD-naive patients. The researchers also compared both groups with 458,846 age- and gender-matched adults from the Swedish Population Register, following individuals until the end of 2012 or until lymphoma diagnosis, death, emigration, or bDMARD initiation, in the case of the naive patients.
Overall, patients with RA averaged one diagnosis of lymphoma per 1,000 population, compared with 0.5 cases per 1,000 for the overall population of Sweden, Dr. Hellgren said. In terms of absolute numbers, there were 241 cases of lymphoma among bDMARD-naive patients, 1,413 cases in the general population, and 69 cases among patients on bDMARDs, including 68 who were taking TNF inhibitors. The average age of the latter group of patients was 57 years. They had been diagnosed with RA at about age 50, had a mean 28-joint Disease Activity Score score of 5.3, and averaged 5.9 years of exposure to TNF inhibitors. Their risk of any type of malignant lymphoma was about 20% higher than for bDMARD-naive patients, but the difference was insignificant overall and in subgroups stratified by gender, age, and year starting treatment. Likewise, although patients were at greater risk of lymphoma if they had been on bDMARDs for 5-15 years (hazard ratio, 1.9) than for less time (HRs, about 1.0), there was no significant difference in risk compared with bDMARD-naive patients.
“There also were no statistically significant differences between drugs,” including infliximab (Remicade), etanercept (Enbrel), and adalimumab (Humira), Dr. Hellgren said. “In terms of the newer TNF inhibitors and other biologics, data are still too scarce to evaluate,” he added. Both exposed and bDMARD-naive patients were at especially high risk of Hodgkin lymphoma and diffuse large B-cell lymphoma, compared with the general population, but the strongest association of all was between bDMARD exposure and natural killer or T-cell lymphoma (HR, 6.0; 95% CI, 2.7-13.3). “The distribution of lymphoma subtypes warrants further assessment,” Dr. Hellgren concluded.
The ARTIS registry is funded by AbbVie, Bristol-Myers Squibb, Roche, Merck, Pfizer, Sobi, Lilly, and UCB. Dr. Hellgren had no disclosures. One coauthor reported financial relationships with AstraZeneca, Pfizer, UCB, Roche, Merck, Bristol-Myers Squibb, and AbbVie.
SAN FRANCISCO – Rheumatoid arthritis conferred a doubling of the risk of lymphoma when compared against the general population in a large Swedish registry study, regardless of the patients’ experience with biological disease-modifying antirheumatic drugs.
But patients who took biological disease-modifying antirheumatic drugs (bDMARDs) had a sixfold greater risk of natural killer or T-cell lymphoma than did the general population, and that association was about four times stronger than for patients who had never taken biologics, reported Dr. Karin Hellgren, who led the study at the Karolinska Institute in Stockholm. That finding in particular shows the need to keep studying the links between bDMARDs and specific lymphoma subtypes, he said.
Severe rheumatoid arthritis seems to strongly increase the risk of lymphoma (Arthritis Rheum. 2006;54[3]:692-701), but researchers have debated whether the reason relates to bDMARDs or RA itself. Clinical trials have produced conflicting results; observational studies have reported no overall link between bDMARDs and lymphoma, but have raised questions about long-term exposure, the effects of individual agents, and lymphoma subtypes, Dr. Hellgren said at the annual meeting of the American College of Rheumatology.
To delve deeper into these issues, he and his associates compared 15 years of data for 13,240 RA patients on bDMARDs from the Swedish Biologics (ARTIS), Patient, and Cancer Registers and a national cohort of 46,568 bDMARD-naive patients. The researchers also compared both groups with 458,846 age- and gender-matched adults from the Swedish Population Register, following individuals until the end of 2012 or until lymphoma diagnosis, death, emigration, or bDMARD initiation, in the case of the naive patients.
Overall, patients with RA averaged one diagnosis of lymphoma per 1,000 population, compared with 0.5 cases per 1,000 for the overall population of Sweden, Dr. Hellgren said. In terms of absolute numbers, there were 241 cases of lymphoma among bDMARD-naive patients, 1,413 cases in the general population, and 69 cases among patients on bDMARDs, including 68 who were taking TNF inhibitors. The average age of the latter group of patients was 57 years. They had been diagnosed with RA at about age 50, had a mean 28-joint Disease Activity Score score of 5.3, and averaged 5.9 years of exposure to TNF inhibitors. Their risk of any type of malignant lymphoma was about 20% higher than for bDMARD-naive patients, but the difference was insignificant overall and in subgroups stratified by gender, age, and year starting treatment. Likewise, although patients were at greater risk of lymphoma if they had been on bDMARDs for 5-15 years (hazard ratio, 1.9) than for less time (HRs, about 1.0), there was no significant difference in risk compared with bDMARD-naive patients.
“There also were no statistically significant differences between drugs,” including infliximab (Remicade), etanercept (Enbrel), and adalimumab (Humira), Dr. Hellgren said. “In terms of the newer TNF inhibitors and other biologics, data are still too scarce to evaluate,” he added. Both exposed and bDMARD-naive patients were at especially high risk of Hodgkin lymphoma and diffuse large B-cell lymphoma, compared with the general population, but the strongest association of all was between bDMARD exposure and natural killer or T-cell lymphoma (HR, 6.0; 95% CI, 2.7-13.3). “The distribution of lymphoma subtypes warrants further assessment,” Dr. Hellgren concluded.
The ARTIS registry is funded by AbbVie, Bristol-Myers Squibb, Roche, Merck, Pfizer, Sobi, Lilly, and UCB. Dr. Hellgren had no disclosures. One coauthor reported financial relationships with AstraZeneca, Pfizer, UCB, Roche, Merck, Bristol-Myers Squibb, and AbbVie.
AT THE ACR ANNUAL MEETING
Key clinical point: Exposure to biological disease-modifying antirheumatic drugs did not increase the overall risk of lymphoma among patients with rheumatoid arthritis.
Major finding: Patients were at greater risk of lymphoma if they had been on bDMARDs for 5-15 years (hazard ratio, 1.9) than for less time (HRs, about 1.0), but there was no significant difference in risk compared with bDMARD-naive patients. However, patients on bDMARDs had about a fourfold greater risk of NK/T-cell lymphoma compared with bDMARD-naive patients.
Data source: A matched registry analysis of 13,240 patients from the Swedish Biologics (ARTIS), Patient, and Cancer Registers; 46,568 bio-naive patients; and 458,846 members of the general population.
Disclosures: The ARTIS registry is funded by AbbVie, Bristol-Myers Squibb, Roche, Merck, Pfizer, Sobi, Lilly, and UCB. Dr. Hellgren had no disclosures. One coauthor reported financial relationships with AstraZeneca, Pfizer, UCB, Roche, Merck, Bristol-Myers Squibb, and AbbVie.
MDA may help prevent malaria resurgence
Plasmodium vivax
Image by Mae Melvin
Mass drug administration (MDA) may have helped prevent a resurgence of malaria in Greece, according to research published in PLOS Neglected Tropical Diseases.
Greece was declared malaria-free in 1974 and remained that way until 2011, when there was an outbreak of Plasmodium vivax malaria in Southern Greece.
The outbreak was linked to the presence of agricultural workers from malaria-endemic regions in malaria-receptive areas.
There were 21 P vivax cases from arriving immigrants reported in the Southern agricultural area of Evrotas, along with 36 local cases.
So Greece implemented an integrated control program, with house visits established to screen immigrants from malaria-endemic countries.
Screening included a rapid diagnostic test for those reporting symptoms associated with malaria, along with blood sampling for smear and molecular testing for malaria. Directly observed treatment was provided for all patients who tested positive.
A vector control program was also implemented, with indoor residual spraying and long-lasting insecticide nets provided in areas close to mosquito breeding sites.
Despite these interventions, 20 more cases of malaria were reported in 2012.
Due to fears that the malaria parasite may be re-establishing itself in the area, Greece implemented an MDA program. It consisted of a single course of chloroquine and primaquine, which are the first-line recommended antimalarials for P vivax.
The program was implemented prior to the onset of peak adult mosquito activity, and field teams remained in situ continuing the active case detection until the end of the mosquito season. They recorded and managed adverse events daily.
The researchers identified an immigrant population of 1270 individuals, mostly from Pakistan and Afghanistan. The MDA covered 87% of this population.
No malaria cases were reported for 2013 and 2014, when the MDA was ongoing.
Of the treated individuals, 13% reported gastrointestinal symptoms from primaquine, while 36% reported non-severe side effects from chloroquine, including headaches, dizziness, and gastrointestinal complaints.
One potentially serious adverse event was recorded. It was a case of primaquine-induced hemolysis due to a false-normal G6PD level obtained prior to enrollment. The patient was hospitalized and recovered fully.
The researchers said that, in this case, the MDA program was a suitable and effective response for a small and geographically confined population over a short seasonal transition period. And the combination of 2 drugs minimized the risk of drug resistance.
The team added that, although an observational study of this nature cannot assess the extent to which the MDA program was responsible for eliminating malaria, it indicates that MDA should be considered and can be effective in local settings alongside other malaria control measures. 
Plasmodium vivax
Image by Mae Melvin
Mass drug administration (MDA) may have helped prevent a resurgence of malaria in Greece, according to research published in PLOS Neglected Tropical Diseases.
Greece was declared malaria-free in 1974 and remained that way until 2011, when there was an outbreak of Plasmodium vivax malaria in Southern Greece.
The outbreak was linked to the presence of agricultural workers from malaria-endemic regions in malaria-receptive areas.
There were 21 P vivax cases from arriving immigrants reported in the Southern agricultural area of Evrotas, along with 36 local cases.
So Greece implemented an integrated control program, with house visits established to screen immigrants from malaria-endemic countries.
Screening included a rapid diagnostic test for those reporting symptoms associated with malaria, along with blood sampling for smear and molecular testing for malaria. Directly observed treatment was provided for all patients who tested positive.
A vector control program was also implemented, with indoor residual spraying and long-lasting insecticide nets provided in areas close to mosquito breeding sites.
Despite these interventions, 20 more cases of malaria were reported in 2012.
Due to fears that the malaria parasite may be re-establishing itself in the area, Greece implemented an MDA program. It consisted of a single course of chloroquine and primaquine, which are the first-line recommended antimalarials for P vivax.
The program was implemented prior to the onset of peak adult mosquito activity, and field teams remained in situ continuing the active case detection until the end of the mosquito season. They recorded and managed adverse events daily.
The researchers identified an immigrant population of 1270 individuals, mostly from Pakistan and Afghanistan. The MDA covered 87% of this population.
No malaria cases were reported for 2013 and 2014, when the MDA was ongoing.
Of the treated individuals, 13% reported gastrointestinal symptoms from primaquine, while 36% reported non-severe side effects from chloroquine, including headaches, dizziness, and gastrointestinal complaints.
One potentially serious adverse event was recorded. It was a case of primaquine-induced hemolysis due to a false-normal G6PD level obtained prior to enrollment. The patient was hospitalized and recovered fully.
The researchers said that, in this case, the MDA program was a suitable and effective response for a small and geographically confined population over a short seasonal transition period. And the combination of 2 drugs minimized the risk of drug resistance.
The team added that, although an observational study of this nature cannot assess the extent to which the MDA program was responsible for eliminating malaria, it indicates that MDA should be considered and can be effective in local settings alongside other malaria control measures.
Plasmodium vivax
Image by Mae Melvin
Mass drug administration (MDA) may have helped prevent a resurgence of malaria in Greece, according to research published in PLOS Neglected Tropical Diseases.
Greece was declared malaria-free in 1974 and remained that way until 2011, when there was an outbreak of Plasmodium vivax malaria in Southern Greece.
The outbreak was linked to the presence of agricultural workers from malaria-endemic regions in malaria-receptive areas.
There were 21 P vivax cases from arriving immigrants reported in the Southern agricultural area of Evrotas, along with 36 local cases.
So Greece implemented an integrated control program, with house visits established to screen immigrants from malaria-endemic countries.
Screening included a rapid diagnostic test for those reporting symptoms associated with malaria, along with blood sampling for smear and molecular testing for malaria. Directly observed treatment was provided for all patients who tested positive.
A vector control program was also implemented, with indoor residual spraying and long-lasting insecticide nets provided in areas close to mosquito breeding sites.
Despite these interventions, 20 more cases of malaria were reported in 2012.
Due to fears that the malaria parasite may be re-establishing itself in the area, Greece implemented an MDA program. It consisted of a single course of chloroquine and primaquine, which are the first-line recommended antimalarials for P vivax.
The program was implemented prior to the onset of peak adult mosquito activity, and field teams remained in situ continuing the active case detection until the end of the mosquito season. They recorded and managed adverse events daily.
The researchers identified an immigrant population of 1270 individuals, mostly from Pakistan and Afghanistan. The MDA covered 87% of this population.
No malaria cases were reported for 2013 and 2014, when the MDA was ongoing.
Of the treated individuals, 13% reported gastrointestinal symptoms from primaquine, while 36% reported non-severe side effects from chloroquine, including headaches, dizziness, and gastrointestinal complaints.
One potentially serious adverse event was recorded. It was a case of primaquine-induced hemolysis due to a false-normal G6PD level obtained prior to enrollment. The patient was hospitalized and recovered fully.
The researchers said that, in this case, the MDA program was a suitable and effective response for a small and geographically confined population over a short seasonal transition period. And the combination of 2 drugs minimized the risk of drug resistance.
The team added that, although an observational study of this nature cannot assess the extent to which the MDA program was responsible for eliminating malaria, it indicates that MDA should be considered and can be effective in local settings alongside other malaria control measures.
CHMP recommends pegaspargase for ALL
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for pegaspargase (Oncaspar) as part of combination antineoplastic therapy for pediatric and adult patients with acute lymphoblastic leukemia (ALL).
The CHMP’s opinion has been referred to the European Commission, which grants marketing authorization for drugs in the European Union.
If approved, pegaspargase will be marketed for the aforementioned indication in the 28 member countries of the European Union, as well as Iceland, Liechtenstein, and Norway.
Baxalta Incorporated, the company developing pegaspargase, expects a decision from the European Commission early next year.
First-line ALL
Researchers have evaluated the safety and effectiveness of pegaspargase in a study of 118 pediatric patients (ages 1 to 9) with newly diagnosed ALL. The patients were randomized 1:1 to pegaspargase or native E coli L-asparaginase, both as part of combination therapy.
Asparagine depletion (magnitude and duration) was similar between the 2 treatment arms. Event-free survival rates were also similar (about 80% in both arms), but the study was not designed to evaluate differences in event-free survival.
Grade 3/4 adverse events occurring in the pegaspargase and native E coli L-asparaginase arms, respectively, were abnormal liver tests (5% and 8%), elevated transaminases (3% and 7%), hyperbilirubinemia (2% and 2%), hyperglycemia (5% and 3%), central nervous system thrombosis (3% and 3%), coagulopathy (2% and 5%), pancreatitis (2% and 2%), and clinical allergic reactions to asparaginase (2% and 0%).
Previously treated ALL
Researchers have evaluated the effectiveness of pegaspargase in 4 open-label studies of patients with a history of prior clinical allergic reaction to asparaginase. The studies enrolled a total of 42 patients with multiply relapsed acute leukemia (39 with ALL).
Patients received pegaspargase as a single agent or in combination with multi-agent chemotherapy. The re-induction response rate was 50%—36% complete responses and 14% partial responses.
These results were similar to the overall response rates reported for patients with ALL receiving second-line, native E coli L-asparaginase-containing re-induction chemotherapy. However, antitumor activity was observed with single-agent pegaspargase as well (3 responses).
Adverse event information on pegaspargase in relapsed ALL has been compiled from 5 clinical trials. The studies enrolled a total of 174 patients with relapsed ALL who received pegaspargase as a single agent or in combination with multi-agent chemotherapy.
Sixty-two of the patients had prior hypersensitivity reactions to asparaginase, and 112 did not. Allergic reactions to pegaspargase occurred in 32% of previously hypersensitive patients and 10% of non-hypersensitive patients.
The most common adverse events observed in patients who received pegaspargase were clinical allergic reactions, elevated transaminases, hyperbilirubinemia, and coagulopathies. The most common serious adverse events due to pegaspargase were thrombosis (4%), hyperglycemia requiring insulin therapy (3%), and pancreatitis (1%).
For more details on these trials and pegaspargase, see the product information.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for pegaspargase (Oncaspar) as part of combination antineoplastic therapy for pediatric and adult patients with acute lymphoblastic leukemia (ALL).
The CHMP’s opinion has been referred to the European Commission, which grants marketing authorization for drugs in the European Union.
If approved, pegaspargase will be marketed for the aforementioned indication in the 28 member countries of the European Union, as well as Iceland, Liechtenstein, and Norway.
Baxalta Incorporated, the company developing pegaspargase, expects a decision from the European Commission early next year.
First-line ALL
Researchers have evaluated the safety and effectiveness of pegaspargase in a study of 118 pediatric patients (ages 1 to 9) with newly diagnosed ALL. The patients were randomized 1:1 to pegaspargase or native E coli L-asparaginase, both as part of combination therapy.
Asparagine depletion (magnitude and duration) was similar between the 2 treatment arms. Event-free survival rates were also similar (about 80% in both arms), but the study was not designed to evaluate differences in event-free survival.
Grade 3/4 adverse events occurring in the pegaspargase and native E coli L-asparaginase arms, respectively, were abnormal liver tests (5% and 8%), elevated transaminases (3% and 7%), hyperbilirubinemia (2% and 2%), hyperglycemia (5% and 3%), central nervous system thrombosis (3% and 3%), coagulopathy (2% and 5%), pancreatitis (2% and 2%), and clinical allergic reactions to asparaginase (2% and 0%).
Previously treated ALL
Researchers have evaluated the effectiveness of pegaspargase in 4 open-label studies of patients with a history of prior clinical allergic reaction to asparaginase. The studies enrolled a total of 42 patients with multiply relapsed acute leukemia (39 with ALL).
Patients received pegaspargase as a single agent or in combination with multi-agent chemotherapy. The re-induction response rate was 50%—36% complete responses and 14% partial responses.
These results were similar to the overall response rates reported for patients with ALL receiving second-line, native E coli L-asparaginase-containing re-induction chemotherapy. However, antitumor activity was observed with single-agent pegaspargase as well (3 responses).
Adverse event information on pegaspargase in relapsed ALL has been compiled from 5 clinical trials. The studies enrolled a total of 174 patients with relapsed ALL who received pegaspargase as a single agent or in combination with multi-agent chemotherapy.
Sixty-two of the patients had prior hypersensitivity reactions to asparaginase, and 112 did not. Allergic reactions to pegaspargase occurred in 32% of previously hypersensitive patients and 10% of non-hypersensitive patients.
The most common adverse events observed in patients who received pegaspargase were clinical allergic reactions, elevated transaminases, hyperbilirubinemia, and coagulopathies. The most common serious adverse events due to pegaspargase were thrombosis (4%), hyperglycemia requiring insulin therapy (3%), and pancreatitis (1%).
For more details on these trials and pegaspargase, see the product information.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for pegaspargase (Oncaspar) as part of combination antineoplastic therapy for pediatric and adult patients with acute lymphoblastic leukemia (ALL).
The CHMP’s opinion has been referred to the European Commission, which grants marketing authorization for drugs in the European Union.
If approved, pegaspargase will be marketed for the aforementioned indication in the 28 member countries of the European Union, as well as Iceland, Liechtenstein, and Norway.
Baxalta Incorporated, the company developing pegaspargase, expects a decision from the European Commission early next year.
First-line ALL
Researchers have evaluated the safety and effectiveness of pegaspargase in a study of 118 pediatric patients (ages 1 to 9) with newly diagnosed ALL. The patients were randomized 1:1 to pegaspargase or native E coli L-asparaginase, both as part of combination therapy.
Asparagine depletion (magnitude and duration) was similar between the 2 treatment arms. Event-free survival rates were also similar (about 80% in both arms), but the study was not designed to evaluate differences in event-free survival.
Grade 3/4 adverse events occurring in the pegaspargase and native E coli L-asparaginase arms, respectively, were abnormal liver tests (5% and 8%), elevated transaminases (3% and 7%), hyperbilirubinemia (2% and 2%), hyperglycemia (5% and 3%), central nervous system thrombosis (3% and 3%), coagulopathy (2% and 5%), pancreatitis (2% and 2%), and clinical allergic reactions to asparaginase (2% and 0%).
Previously treated ALL
Researchers have evaluated the effectiveness of pegaspargase in 4 open-label studies of patients with a history of prior clinical allergic reaction to asparaginase. The studies enrolled a total of 42 patients with multiply relapsed acute leukemia (39 with ALL).
Patients received pegaspargase as a single agent or in combination with multi-agent chemotherapy. The re-induction response rate was 50%—36% complete responses and 14% partial responses.
These results were similar to the overall response rates reported for patients with ALL receiving second-line, native E coli L-asparaginase-containing re-induction chemotherapy. However, antitumor activity was observed with single-agent pegaspargase as well (3 responses).
Adverse event information on pegaspargase in relapsed ALL has been compiled from 5 clinical trials. The studies enrolled a total of 174 patients with relapsed ALL who received pegaspargase as a single agent or in combination with multi-agent chemotherapy.
Sixty-two of the patients had prior hypersensitivity reactions to asparaginase, and 112 did not. Allergic reactions to pegaspargase occurred in 32% of previously hypersensitive patients and 10% of non-hypersensitive patients.
The most common adverse events observed in patients who received pegaspargase were clinical allergic reactions, elevated transaminases, hyperbilirubinemia, and coagulopathies. The most common serious adverse events due to pegaspargase were thrombosis (4%), hyperglycemia requiring insulin therapy (3%), and pancreatitis (1%).
For more details on these trials and pegaspargase, see the product information.
FDA approves new indication for dabigatran
Photo by ec-jpr
The US Food and Drug Administration (FDA) has approved the direct thrombin inhibitor dabigatran etexilate mesylate (Pradaxa) for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have undergone hip replacement surgery.
Dabigatran was initially approved by the FDA in 2010 to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
In 2014, dabigatran was approved to treat DVT and PE in patients who have been treated with a parenteral anticoagulant for 5 to 10 days and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.
A reversal agent for dabigatran, known as idarucizumab (Praxbind), was approved by the FDA last month.
Trial data
The latest approval of dabigatran is based on results of 2 randomized, double-blind, phase 3 trials in patients undergoing total hip replacement, RE-NOVATE™ and RE-NOVATE II™.
In the RE-NOVATE trial, 3494 patients were randomized to 3 groups receiving prophylactic treatment with 1 of 2 doses of dabigatran (220 mg or 150 mg) once daily or enoxaparin at 40 mg once daily for 28 to 35 days.
The first dabigatran group was given a dose of 110 mg on the day of surgery and 220 mg daily thereafter. The second dabigatran group received a dose of 75 mg on the day of surgery and 150 mg daily thereafter.
Patients taking dabigatran at 220 mg had a lower composite total of venous thromboembolism (VTE) and all-cause death (6.0%) than patients on enoxaparin (6.7%). However, the rate of major bleeding was higher with dabigatran at 220 mg (2.0%) than with enoxaparin (1.6%).
In the RE-NOVATE II trial, 2055 patients were randomized to prophylactic treatment for 28 to 35 days with dabigatran at 220 mg once daily or enoxaparin at 40 mg once daily. Patients receiving dabigatran were treated with a dose of 110 mg on the day of surgery and 220 mg daily thereafter.
The composite total of VTE and all-cause death occurred in 7.7% of patients in the dabigatran group and 8.8% of patients in the enoxaparin group. Again, the rate of major bleeding was higher with dabigatran at 220 mg (1.4%) than with enoxaparin (0.9%).
In both studies, the rate of major gastrointestinal bleeds in patients receiving dabigatran and enoxaparin was the same (0.1%). The rate of any gastrointestinal bleeds was 1.4% for dabigatran and 0.9% for enoxaparin.
The most common adverse events in both studies were gastrointestinal disorders. The incidence was the same across the dabigatran and enoxaparin treatment groups (39.5%).
Dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) occurred more frequently in patients receiving dabigatran (4.1%) than enoxaparin (3.8%).
Gastritis-like symptoms (including gastritis, GERD, esophagitis, erosive gastritis, and gastric hemorrhage) were less common in patients receiving dabigatran (0.6%) than enoxaparin (1.0%). Clinical myocardial infarction was reported in 2 (0.1%) dabigatran patients and 6 (0.3%) enoxaparin patients.
Dabigatran is marketed as Pradaxa by Boehringer Ingelheim. For more details on the drug, see the prescribing information.
Photo by ec-jpr
The US Food and Drug Administration (FDA) has approved the direct thrombin inhibitor dabigatran etexilate mesylate (Pradaxa) for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have undergone hip replacement surgery.
Dabigatran was initially approved by the FDA in 2010 to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
In 2014, dabigatran was approved to treat DVT and PE in patients who have been treated with a parenteral anticoagulant for 5 to 10 days and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.
A reversal agent for dabigatran, known as idarucizumab (Praxbind), was approved by the FDA last month.
Trial data
The latest approval of dabigatran is based on results of 2 randomized, double-blind, phase 3 trials in patients undergoing total hip replacement, RE-NOVATE™ and RE-NOVATE II™.
In the RE-NOVATE trial, 3494 patients were randomized to 3 groups receiving prophylactic treatment with 1 of 2 doses of dabigatran (220 mg or 150 mg) once daily or enoxaparin at 40 mg once daily for 28 to 35 days.
The first dabigatran group was given a dose of 110 mg on the day of surgery and 220 mg daily thereafter. The second dabigatran group received a dose of 75 mg on the day of surgery and 150 mg daily thereafter.
Patients taking dabigatran at 220 mg had a lower composite total of venous thromboembolism (VTE) and all-cause death (6.0%) than patients on enoxaparin (6.7%). However, the rate of major bleeding was higher with dabigatran at 220 mg (2.0%) than with enoxaparin (1.6%).
In the RE-NOVATE II trial, 2055 patients were randomized to prophylactic treatment for 28 to 35 days with dabigatran at 220 mg once daily or enoxaparin at 40 mg once daily. Patients receiving dabigatran were treated with a dose of 110 mg on the day of surgery and 220 mg daily thereafter.
The composite total of VTE and all-cause death occurred in 7.7% of patients in the dabigatran group and 8.8% of patients in the enoxaparin group. Again, the rate of major bleeding was higher with dabigatran at 220 mg (1.4%) than with enoxaparin (0.9%).
In both studies, the rate of major gastrointestinal bleeds in patients receiving dabigatran and enoxaparin was the same (0.1%). The rate of any gastrointestinal bleeds was 1.4% for dabigatran and 0.9% for enoxaparin.
The most common adverse events in both studies were gastrointestinal disorders. The incidence was the same across the dabigatran and enoxaparin treatment groups (39.5%).
Dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) occurred more frequently in patients receiving dabigatran (4.1%) than enoxaparin (3.8%).
Gastritis-like symptoms (including gastritis, GERD, esophagitis, erosive gastritis, and gastric hemorrhage) were less common in patients receiving dabigatran (0.6%) than enoxaparin (1.0%). Clinical myocardial infarction was reported in 2 (0.1%) dabigatran patients and 6 (0.3%) enoxaparin patients.
Dabigatran is marketed as Pradaxa by Boehringer Ingelheim. For more details on the drug, see the prescribing information.
Photo by ec-jpr
The US Food and Drug Administration (FDA) has approved the direct thrombin inhibitor dabigatran etexilate mesylate (Pradaxa) for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have undergone hip replacement surgery.
Dabigatran was initially approved by the FDA in 2010 to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
In 2014, dabigatran was approved to treat DVT and PE in patients who have been treated with a parenteral anticoagulant for 5 to 10 days and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.
A reversal agent for dabigatran, known as idarucizumab (Praxbind), was approved by the FDA last month.
Trial data
The latest approval of dabigatran is based on results of 2 randomized, double-blind, phase 3 trials in patients undergoing total hip replacement, RE-NOVATE™ and RE-NOVATE II™.
In the RE-NOVATE trial, 3494 patients were randomized to 3 groups receiving prophylactic treatment with 1 of 2 doses of dabigatran (220 mg or 150 mg) once daily or enoxaparin at 40 mg once daily for 28 to 35 days.
The first dabigatran group was given a dose of 110 mg on the day of surgery and 220 mg daily thereafter. The second dabigatran group received a dose of 75 mg on the day of surgery and 150 mg daily thereafter.
Patients taking dabigatran at 220 mg had a lower composite total of venous thromboembolism (VTE) and all-cause death (6.0%) than patients on enoxaparin (6.7%). However, the rate of major bleeding was higher with dabigatran at 220 mg (2.0%) than with enoxaparin (1.6%).
In the RE-NOVATE II trial, 2055 patients were randomized to prophylactic treatment for 28 to 35 days with dabigatran at 220 mg once daily or enoxaparin at 40 mg once daily. Patients receiving dabigatran were treated with a dose of 110 mg on the day of surgery and 220 mg daily thereafter.
The composite total of VTE and all-cause death occurred in 7.7% of patients in the dabigatran group and 8.8% of patients in the enoxaparin group. Again, the rate of major bleeding was higher with dabigatran at 220 mg (1.4%) than with enoxaparin (0.9%).
In both studies, the rate of major gastrointestinal bleeds in patients receiving dabigatran and enoxaparin was the same (0.1%). The rate of any gastrointestinal bleeds was 1.4% for dabigatran and 0.9% for enoxaparin.
The most common adverse events in both studies were gastrointestinal disorders. The incidence was the same across the dabigatran and enoxaparin treatment groups (39.5%).
Dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) occurred more frequently in patients receiving dabigatran (4.1%) than enoxaparin (3.8%).
Gastritis-like symptoms (including gastritis, GERD, esophagitis, erosive gastritis, and gastric hemorrhage) were less common in patients receiving dabigatran (0.6%) than enoxaparin (1.0%). Clinical myocardial infarction was reported in 2 (0.1%) dabigatran patients and 6 (0.3%) enoxaparin patients.
Dabigatran is marketed as Pradaxa by Boehringer Ingelheim. For more details on the drug, see the prescribing information.
Template can help guide care for cancer survivors
for radiation therapy
Photo by Rhoda Baer
A new template can help standardize plans for long-term care of cancer survivors who have undergone radiation therapy (RT), according to the American Society for Radiation Oncology (ASTRO).
An ASTRO advisory committee created the template to coordinate post-treatment care for cancer survivors among primary care providers (PCPs) and oncology
specialists (radiation, medical, and surgical), as well as patients themselves.
Details on the template appear in Practical Radiation Oncology.
“Factors such as earlier detection of cancer, increasingly effective treatment options, and an aging population lead to a growing number of cancer survivors and, ultimately, a need to educate and empower these individuals for their ongoing care,” said ASTRO chair Bruce D. Minsky, MD.
“The ASTRO template is designed to foster better coordination of post-treatment care for cancer survivors, including greater clarity in the dialogue between radiation oncologists and PCPs for issues such as less common side effects that may appear well after treatment is complete.”
Many radiation oncologists may already provide their patients with post-treatment materials such as diagnosis and treatment summaries, contacts for ancillary services such as financial or nutritional counselling, and information on potential late treatment effects.
But the ASTRO template coordinates these components in a central, plain-language document.
It also enables practices to meet new accreditation requirements set by the American College of Surgeons Commission on Cancer (CoC).
In response to a 2006 recommendation from the Institutes of Medicine that cancer patients be provided with a survivorship care plan (SCP) following treatment, CoC issued a mandate that cancer programs provide SCPs for all curative cancer patients by 2019 to maintain accreditation.
ASTRO’s template includes both elements required by the CoC in SCPs—namely, a summary of past treatment and directions for future care.
The treatment summary outlines the survivor’s diagnosis and stage information; treatment details such as the site, dosage, and schedule of RT; and contact information for providers who delivered the treatment.
The plan for follow-up care covers anticipated toxicities from RT, expected course of recovery from treatment-related toxicities, possible functional and/or social limitations, recommendations for preventative measures and behaviors, cancer information resources, and referrals to supportive care providers.
“This 2-page template facilitates consistency in SCPs across the discipline and also reduces the time and effort required by providers to complete each individual plan,” said Ronald Chen, MD, of the University of North Carolina at Chapel Hill.
“The field of radiation oncology has a long tradition of creating treatment summaries for each patient, even before the Institute of Medicine recommended survivorship care plans in 2006. This radiation-oncology-specific template will serve a dual purpose as both a traditional radiation oncology treatment summary and a plan for survivorship care that meets CoC requirements, thus reducing the burden on radiation oncologists from having to create 2 documents for each patient.”
for radiation therapy
Photo by Rhoda Baer
A new template can help standardize plans for long-term care of cancer survivors who have undergone radiation therapy (RT), according to the American Society for Radiation Oncology (ASTRO).
An ASTRO advisory committee created the template to coordinate post-treatment care for cancer survivors among primary care providers (PCPs) and oncology
specialists (radiation, medical, and surgical), as well as patients themselves.
Details on the template appear in Practical Radiation Oncology.
“Factors such as earlier detection of cancer, increasingly effective treatment options, and an aging population lead to a growing number of cancer survivors and, ultimately, a need to educate and empower these individuals for their ongoing care,” said ASTRO chair Bruce D. Minsky, MD.
“The ASTRO template is designed to foster better coordination of post-treatment care for cancer survivors, including greater clarity in the dialogue between radiation oncologists and PCPs for issues such as less common side effects that may appear well after treatment is complete.”
Many radiation oncologists may already provide their patients with post-treatment materials such as diagnosis and treatment summaries, contacts for ancillary services such as financial or nutritional counselling, and information on potential late treatment effects.
But the ASTRO template coordinates these components in a central, plain-language document.
It also enables practices to meet new accreditation requirements set by the American College of Surgeons Commission on Cancer (CoC).
In response to a 2006 recommendation from the Institutes of Medicine that cancer patients be provided with a survivorship care plan (SCP) following treatment, CoC issued a mandate that cancer programs provide SCPs for all curative cancer patients by 2019 to maintain accreditation.
ASTRO’s template includes both elements required by the CoC in SCPs—namely, a summary of past treatment and directions for future care.
The treatment summary outlines the survivor’s diagnosis and stage information; treatment details such as the site, dosage, and schedule of RT; and contact information for providers who delivered the treatment.
The plan for follow-up care covers anticipated toxicities from RT, expected course of recovery from treatment-related toxicities, possible functional and/or social limitations, recommendations for preventative measures and behaviors, cancer information resources, and referrals to supportive care providers.
“This 2-page template facilitates consistency in SCPs across the discipline and also reduces the time and effort required by providers to complete each individual plan,” said Ronald Chen, MD, of the University of North Carolina at Chapel Hill.
“The field of radiation oncology has a long tradition of creating treatment summaries for each patient, even before the Institute of Medicine recommended survivorship care plans in 2006. This radiation-oncology-specific template will serve a dual purpose as both a traditional radiation oncology treatment summary and a plan for survivorship care that meets CoC requirements, thus reducing the burden on radiation oncologists from having to create 2 documents for each patient.”
for radiation therapy
Photo by Rhoda Baer
A new template can help standardize plans for long-term care of cancer survivors who have undergone radiation therapy (RT), according to the American Society for Radiation Oncology (ASTRO).
An ASTRO advisory committee created the template to coordinate post-treatment care for cancer survivors among primary care providers (PCPs) and oncology
specialists (radiation, medical, and surgical), as well as patients themselves.
Details on the template appear in Practical Radiation Oncology.
“Factors such as earlier detection of cancer, increasingly effective treatment options, and an aging population lead to a growing number of cancer survivors and, ultimately, a need to educate and empower these individuals for their ongoing care,” said ASTRO chair Bruce D. Minsky, MD.
“The ASTRO template is designed to foster better coordination of post-treatment care for cancer survivors, including greater clarity in the dialogue between radiation oncologists and PCPs for issues such as less common side effects that may appear well after treatment is complete.”
Many radiation oncologists may already provide their patients with post-treatment materials such as diagnosis and treatment summaries, contacts for ancillary services such as financial or nutritional counselling, and information on potential late treatment effects.
But the ASTRO template coordinates these components in a central, plain-language document.
It also enables practices to meet new accreditation requirements set by the American College of Surgeons Commission on Cancer (CoC).
In response to a 2006 recommendation from the Institutes of Medicine that cancer patients be provided with a survivorship care plan (SCP) following treatment, CoC issued a mandate that cancer programs provide SCPs for all curative cancer patients by 2019 to maintain accreditation.
ASTRO’s template includes both elements required by the CoC in SCPs—namely, a summary of past treatment and directions for future care.
The treatment summary outlines the survivor’s diagnosis and stage information; treatment details such as the site, dosage, and schedule of RT; and contact information for providers who delivered the treatment.
The plan for follow-up care covers anticipated toxicities from RT, expected course of recovery from treatment-related toxicities, possible functional and/or social limitations, recommendations for preventative measures and behaviors, cancer information resources, and referrals to supportive care providers.
“This 2-page template facilitates consistency in SCPs across the discipline and also reduces the time and effort required by providers to complete each individual plan,” said Ronald Chen, MD, of the University of North Carolina at Chapel Hill.
“The field of radiation oncology has a long tradition of creating treatment summaries for each patient, even before the Institute of Medicine recommended survivorship care plans in 2006. This radiation-oncology-specific template will serve a dual purpose as both a traditional radiation oncology treatment summary and a plan for survivorship care that meets CoC requirements, thus reducing the burden on radiation oncologists from having to create 2 documents for each patient.”
Hope for Hidradenitis Suppurativa
In September 2015, the US Food and Drug Administration approved adalimumab, the well-known injectable tumor necrosis factor (TNF)–α inhibitor indicated for psoriasis and other inflammatory conditions, for treatment of moderate to severe hidradenitis suppurativa (HS), classifying it as the first and only US Food and Drug Administration–approved therapy for adults with HS.
Pivotal studies (PIONEER/HS-I and -II, phase 3, double-blind) evaluated 633 patients (307 in HS-I and 326 in HS-II) with moderate to severe HS who were randomized to adalimumab versus placebo for 12 weeks. There was significant clinical response (at least 50% reduction in abscess and inflammatory nodule count, defined as hidradenitis suppurativa clinical response, HiSCR) in the adalimumab group (42% vs 26% in HS-I, 59% vs. 28% in HS-II, P<.001), reduction in pain (significant in the HS-II trial, 45.7% vs 20.7%, P<.001; HS-I 27.9% vs 24.8%, P>.05), and no new safety concerns when compared to other adalimumab dosages and indications. Some HS-II study patients (19.3%) were permitted to use oral antibiotics during the study.
For the indication of adult HS (moderate to severe disease), adalimumab should be administered subcutaneously at a dosing regimen of 160 mg/4 syringes on day 1 (or 80 mg/2 syringes on days 1 and 2), followed by 80 mg/2 syringes on day 15, then 40 mg/1 syringe on day 29, and every 7 days thereafter for an indefinite treatment period.
What’s the Issue?
It sits well with dermatologists when the indications for a medication with which we have great familiarity are broadened to include new disease entities; it is even better when the new entity is a condition for which every dermatologist pines for efficacious treatment options. Despite the disease burden of HS, which can include pain, scarring, disfigurement, social exclusion, and/or embarrassment, as well as the wasteful and burdensome effect that HS has on health care resources, such as injudicious use of antibiotics and unnecessary emergency department visits and inpatient hospital stays,1 there is nonetheless a wide-open and inviting playing field for effective therapies.
Although a much higher dosage of adalimumab is required in the treatment of HS compared to what is indicated for psoriasis patients, its safety concerns and side effect profile were unchanged in HS, and therefore its monitoring guidelines remain the same. Not all patients in these studies showed a notable reduction in lesion count, but given that HS classically is unresponsive to most medication regimens, will you embrace this therapy option for your patients with HS?
Reference
1. Khalsa A, Liu G, Kirby JS. Increased utilization of emergency department and inpatient care by patients with hidradenitis suppurativa. J Am Acad Dermatol. 2015;73:609-614.
In September 2015, the US Food and Drug Administration approved adalimumab, the well-known injectable tumor necrosis factor (TNF)–α inhibitor indicated for psoriasis and other inflammatory conditions, for treatment of moderate to severe hidradenitis suppurativa (HS), classifying it as the first and only US Food and Drug Administration–approved therapy for adults with HS.
Pivotal studies (PIONEER/HS-I and -II, phase 3, double-blind) evaluated 633 patients (307 in HS-I and 326 in HS-II) with moderate to severe HS who were randomized to adalimumab versus placebo for 12 weeks. There was significant clinical response (at least 50% reduction in abscess and inflammatory nodule count, defined as hidradenitis suppurativa clinical response, HiSCR) in the adalimumab group (42% vs 26% in HS-I, 59% vs. 28% in HS-II, P<.001), reduction in pain (significant in the HS-II trial, 45.7% vs 20.7%, P<.001; HS-I 27.9% vs 24.8%, P>.05), and no new safety concerns when compared to other adalimumab dosages and indications. Some HS-II study patients (19.3%) were permitted to use oral antibiotics during the study.
For the indication of adult HS (moderate to severe disease), adalimumab should be administered subcutaneously at a dosing regimen of 160 mg/4 syringes on day 1 (or 80 mg/2 syringes on days 1 and 2), followed by 80 mg/2 syringes on day 15, then 40 mg/1 syringe on day 29, and every 7 days thereafter for an indefinite treatment period.
What’s the Issue?
It sits well with dermatologists when the indications for a medication with which we have great familiarity are broadened to include new disease entities; it is even better when the new entity is a condition for which every dermatologist pines for efficacious treatment options. Despite the disease burden of HS, which can include pain, scarring, disfigurement, social exclusion, and/or embarrassment, as well as the wasteful and burdensome effect that HS has on health care resources, such as injudicious use of antibiotics and unnecessary emergency department visits and inpatient hospital stays,1 there is nonetheless a wide-open and inviting playing field for effective therapies.
Although a much higher dosage of adalimumab is required in the treatment of HS compared to what is indicated for psoriasis patients, its safety concerns and side effect profile were unchanged in HS, and therefore its monitoring guidelines remain the same. Not all patients in these studies showed a notable reduction in lesion count, but given that HS classically is unresponsive to most medication regimens, will you embrace this therapy option for your patients with HS?
In September 2015, the US Food and Drug Administration approved adalimumab, the well-known injectable tumor necrosis factor (TNF)–α inhibitor indicated for psoriasis and other inflammatory conditions, for treatment of moderate to severe hidradenitis suppurativa (HS), classifying it as the first and only US Food and Drug Administration–approved therapy for adults with HS.
Pivotal studies (PIONEER/HS-I and -II, phase 3, double-blind) evaluated 633 patients (307 in HS-I and 326 in HS-II) with moderate to severe HS who were randomized to adalimumab versus placebo for 12 weeks. There was significant clinical response (at least 50% reduction in abscess and inflammatory nodule count, defined as hidradenitis suppurativa clinical response, HiSCR) in the adalimumab group (42% vs 26% in HS-I, 59% vs. 28% in HS-II, P<.001), reduction in pain (significant in the HS-II trial, 45.7% vs 20.7%, P<.001; HS-I 27.9% vs 24.8%, P>.05), and no new safety concerns when compared to other adalimumab dosages and indications. Some HS-II study patients (19.3%) were permitted to use oral antibiotics during the study.
For the indication of adult HS (moderate to severe disease), adalimumab should be administered subcutaneously at a dosing regimen of 160 mg/4 syringes on day 1 (or 80 mg/2 syringes on days 1 and 2), followed by 80 mg/2 syringes on day 15, then 40 mg/1 syringe on day 29, and every 7 days thereafter for an indefinite treatment period.
What’s the Issue?
It sits well with dermatologists when the indications for a medication with which we have great familiarity are broadened to include new disease entities; it is even better when the new entity is a condition for which every dermatologist pines for efficacious treatment options. Despite the disease burden of HS, which can include pain, scarring, disfigurement, social exclusion, and/or embarrassment, as well as the wasteful and burdensome effect that HS has on health care resources, such as injudicious use of antibiotics and unnecessary emergency department visits and inpatient hospital stays,1 there is nonetheless a wide-open and inviting playing field for effective therapies.
Although a much higher dosage of adalimumab is required in the treatment of HS compared to what is indicated for psoriasis patients, its safety concerns and side effect profile were unchanged in HS, and therefore its monitoring guidelines remain the same. Not all patients in these studies showed a notable reduction in lesion count, but given that HS classically is unresponsive to most medication regimens, will you embrace this therapy option for your patients with HS?
Reference
1. Khalsa A, Liu G, Kirby JS. Increased utilization of emergency department and inpatient care by patients with hidradenitis suppurativa. J Am Acad Dermatol. 2015;73:609-614.
Reference
1. Khalsa A, Liu G, Kirby JS. Increased utilization of emergency department and inpatient care by patients with hidradenitis suppurativa. J Am Acad Dermatol. 2015;73:609-614.
FDA okays prophylactic Pradaxa for VTE in hip replacement
The Food and Drug Administration has approved dabigatran for the prevention of deep venous thrombosis and pulmonary embolism for patients after hip replacement surgery.
The FDA’s approval was based on the results of two randomized, double-blind, phase III trials in patients undergoing total hip replacement, Boehringer Ingelheim, the manufacturer of the direct thrombin inhibitor, announced.
In RE-NOVATE I, the first trial, 3,494 patients were randomly assigned to three groups receiving prophylactic treatment with one of two doses of dabigatran (220 mg or 150 mg) once daily, or to the low-molecular-weight heparin enoxaparin at 40 mg once daily for 28-35 days. The first study drug arm was given 110 mg on the day of surgery and 220 mg daily thereafter; the second study drug arm received a dose of 75 mg on the day of surgery and 150 mg daily thereafter. Patients taking the dabigatran (Pradaxa) at 220 mg had a lower composite total of venous thromboembolism (VTE) and all-cause mortality (6.0%) than did those on enoxaparin 40 mg (6.7%), meeting the noninferiority mark (Lancet. 2007 Sep 15;370[9591]:949-56).
In RE-NOVATE II, 2,055 patients were randomly assigned prophylactic treatment for 28-35 days with the study drug dosed at 220 mg once daily, or enoxaparin 40 mg once daily. Patients receiving the study drug were treated with a dose of 110 mg on the day of surgery and 220 mg daily thereafter. The composite total of VTE and all-cause death occurred in 7.7% of patients in the study group vs. 8.8% of patients in the enoxaparin group, which was within the margin for noninferiority (Thromb Haemost. 2011 Apr;105[4]:721-9).
However, there were higher rates of major bleeding in RE-NOVATE I (2.0%, 1.6%) and II (1.4%, 0.9%) with 220 mg vs. enoxaparin. In both studies, the rate of major gastrointestinal bleeds in patients was the same (0.1%) for both the study and control drugs. The rate of any GI bleeds was 1.4% for the study drug and 0.9% for enoxaparin. The most common adverse events in both studies were GI disorders. The incidence rate was the same across all treatment groups (39.5%). Dyspepsia occurred more frequently in patients receiving the study drug (4.1%), compared with those taking enoxaparin (3.8%). Gastritislike symptoms were less common in patients receiving the study drug (0.6%), compared with enoxaparin (1.0%). Clinical myocardial infarction was reported in two (0.1%) study patients and six (0.3%) enoxaparin patients.
Pradaxa was initially indicated by the FDA in 2010 to reduce stroke and systemic embolism risk in patients with nonvalvular atrial fibrillation. In 2014, the FDA approved two additional indications for the drug for the treatment of VTE in patients treated with a parenteral anticoagulant for 5-10 day and to reduce the risk of recurrent VTE in patients who have been previously treated.
On Twitter @whitneymcknight
The Food and Drug Administration has approved dabigatran for the prevention of deep venous thrombosis and pulmonary embolism for patients after hip replacement surgery.
The FDA’s approval was based on the results of two randomized, double-blind, phase III trials in patients undergoing total hip replacement, Boehringer Ingelheim, the manufacturer of the direct thrombin inhibitor, announced.
In RE-NOVATE I, the first trial, 3,494 patients were randomly assigned to three groups receiving prophylactic treatment with one of two doses of dabigatran (220 mg or 150 mg) once daily, or to the low-molecular-weight heparin enoxaparin at 40 mg once daily for 28-35 days. The first study drug arm was given 110 mg on the day of surgery and 220 mg daily thereafter; the second study drug arm received a dose of 75 mg on the day of surgery and 150 mg daily thereafter. Patients taking the dabigatran (Pradaxa) at 220 mg had a lower composite total of venous thromboembolism (VTE) and all-cause mortality (6.0%) than did those on enoxaparin 40 mg (6.7%), meeting the noninferiority mark (Lancet. 2007 Sep 15;370[9591]:949-56).
In RE-NOVATE II, 2,055 patients were randomly assigned prophylactic treatment for 28-35 days with the study drug dosed at 220 mg once daily, or enoxaparin 40 mg once daily. Patients receiving the study drug were treated with a dose of 110 mg on the day of surgery and 220 mg daily thereafter. The composite total of VTE and all-cause death occurred in 7.7% of patients in the study group vs. 8.8% of patients in the enoxaparin group, which was within the margin for noninferiority (Thromb Haemost. 2011 Apr;105[4]:721-9).
However, there were higher rates of major bleeding in RE-NOVATE I (2.0%, 1.6%) and II (1.4%, 0.9%) with 220 mg vs. enoxaparin. In both studies, the rate of major gastrointestinal bleeds in patients was the same (0.1%) for both the study and control drugs. The rate of any GI bleeds was 1.4% for the study drug and 0.9% for enoxaparin. The most common adverse events in both studies were GI disorders. The incidence rate was the same across all treatment groups (39.5%). Dyspepsia occurred more frequently in patients receiving the study drug (4.1%), compared with those taking enoxaparin (3.8%). Gastritislike symptoms were less common in patients receiving the study drug (0.6%), compared with enoxaparin (1.0%). Clinical myocardial infarction was reported in two (0.1%) study patients and six (0.3%) enoxaparin patients.
Pradaxa was initially indicated by the FDA in 2010 to reduce stroke and systemic embolism risk in patients with nonvalvular atrial fibrillation. In 2014, the FDA approved two additional indications for the drug for the treatment of VTE in patients treated with a parenteral anticoagulant for 5-10 day and to reduce the risk of recurrent VTE in patients who have been previously treated.
On Twitter @whitneymcknight
The Food and Drug Administration has approved dabigatran for the prevention of deep venous thrombosis and pulmonary embolism for patients after hip replacement surgery.
The FDA’s approval was based on the results of two randomized, double-blind, phase III trials in patients undergoing total hip replacement, Boehringer Ingelheim, the manufacturer of the direct thrombin inhibitor, announced.
In RE-NOVATE I, the first trial, 3,494 patients were randomly assigned to three groups receiving prophylactic treatment with one of two doses of dabigatran (220 mg or 150 mg) once daily, or to the low-molecular-weight heparin enoxaparin at 40 mg once daily for 28-35 days. The first study drug arm was given 110 mg on the day of surgery and 220 mg daily thereafter; the second study drug arm received a dose of 75 mg on the day of surgery and 150 mg daily thereafter. Patients taking the dabigatran (Pradaxa) at 220 mg had a lower composite total of venous thromboembolism (VTE) and all-cause mortality (6.0%) than did those on enoxaparin 40 mg (6.7%), meeting the noninferiority mark (Lancet. 2007 Sep 15;370[9591]:949-56).
In RE-NOVATE II, 2,055 patients were randomly assigned prophylactic treatment for 28-35 days with the study drug dosed at 220 mg once daily, or enoxaparin 40 mg once daily. Patients receiving the study drug were treated with a dose of 110 mg on the day of surgery and 220 mg daily thereafter. The composite total of VTE and all-cause death occurred in 7.7% of patients in the study group vs. 8.8% of patients in the enoxaparin group, which was within the margin for noninferiority (Thromb Haemost. 2011 Apr;105[4]:721-9).
However, there were higher rates of major bleeding in RE-NOVATE I (2.0%, 1.6%) and II (1.4%, 0.9%) with 220 mg vs. enoxaparin. In both studies, the rate of major gastrointestinal bleeds in patients was the same (0.1%) for both the study and control drugs. The rate of any GI bleeds was 1.4% for the study drug and 0.9% for enoxaparin. The most common adverse events in both studies were GI disorders. The incidence rate was the same across all treatment groups (39.5%). Dyspepsia occurred more frequently in patients receiving the study drug (4.1%), compared with those taking enoxaparin (3.8%). Gastritislike symptoms were less common in patients receiving the study drug (0.6%), compared with enoxaparin (1.0%). Clinical myocardial infarction was reported in two (0.1%) study patients and six (0.3%) enoxaparin patients.
Pradaxa was initially indicated by the FDA in 2010 to reduce stroke and systemic embolism risk in patients with nonvalvular atrial fibrillation. In 2014, the FDA approved two additional indications for the drug for the treatment of VTE in patients treated with a parenteral anticoagulant for 5-10 day and to reduce the risk of recurrent VTE in patients who have been previously treated.
On Twitter @whitneymcknight
