Goldsmith/CDC

The US Food and Drug Administration (FDA) has granted fast track designation to TAK-426, a candidate vaccine for Zika virus.

TAK-426 is a purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate being developed by Takeda Pharmaceutical Company Limited with the aid of federal funding.

TAK-426 is currently being studied in a phase 1 trial, ZIK-101 (NCT03343626).

This randomized, placebo-controlled, double-blind trial was designed to evaluate the safety and immunogenicity of TAK-426 in 240 male and female subjects between the ages of 18 and 49.

The trial is taking place in the continental US and US territories. It is being conducted under a US Investigational New Drug application.

Takeda says that, if initial data from ZIK-101 are supportive, the company will work to progress into phase 2 development as soon as possible.

Takeda’s Zika program is supported by federal funds from the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services (contract No. HHSO100201600015C).

“We recognize the public health threat posed by the Zika virus,” said Laurence De Moerlooze, PhD, lead of the global Zika program at Takeda.

“As soon as Takeda received funding from BARDA, we mobilized a team and prioritized development of this vaccine candidate, initiating a phase 1 trial within 15 months of contract signature. With fast track designation, the ongoing support of BARDA, and the abilities of our organization, we are confident that we will continue to make expedient progress.”

About fast track designation

The FDA’s fast track designation is a process designed to facilitate the development and expedite the review of drugs and vaccines with the potential to treat serious or life-threatening conditions and address unmet medical needs.

The fast track process allows for more frequent interactions with the FDA, rolling reviews of a product application, and eligibility for priority review if relevant criteria are met. The FDA’s goal is to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.

Goldsmith/CDC

The US Food and Drug Administration (FDA) has granted fast track designation to TAK-426, a candidate vaccine for Zika virus.

TAK-426 is a purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate being developed by Takeda Pharmaceutical Company Limited with the aid of federal funding.

TAK-426 is currently being studied in a phase 1 trial, ZIK-101 (NCT03343626).

This randomized, placebo-controlled, double-blind trial was designed to evaluate the safety and immunogenicity of TAK-426 in 240 male and female subjects between the ages of 18 and 49.

The trial is taking place in the continental US and US territories. It is being conducted under a US Investigational New Drug application.

Takeda says that, if initial data from ZIK-101 are supportive, the company will work to progress into phase 2 development as soon as possible.

Takeda’s Zika program is supported by federal funds from the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services (contract No. HHSO100201600015C).

“We recognize the public health threat posed by the Zika virus,” said Laurence De Moerlooze, PhD, lead of the global Zika program at Takeda.

“As soon as Takeda received funding from BARDA, we mobilized a team and prioritized development of this vaccine candidate, initiating a phase 1 trial within 15 months of contract signature. With fast track designation, the ongoing support of BARDA, and the abilities of our organization, we are confident that we will continue to make expedient progress.”

About fast track designation

The FDA’s fast track designation is a process designed to facilitate the development and expedite the review of drugs and vaccines with the potential to treat serious or life-threatening conditions and address unmet medical needs.

The fast track process allows for more frequent interactions with the FDA, rolling reviews of a product application, and eligibility for priority review if relevant criteria are met. The FDA’s goal is to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.

Goldsmith/CDC

The US Food and Drug Administration (FDA) has granted fast track designation to TAK-426, a candidate vaccine for Zika virus.

TAK-426 is a purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate being developed by Takeda Pharmaceutical Company Limited with the aid of federal funding.

TAK-426 is currently being studied in a phase 1 trial, ZIK-101 (NCT03343626).

This randomized, placebo-controlled, double-blind trial was designed to evaluate the safety and immunogenicity of TAK-426 in 240 male and female subjects between the ages of 18 and 49.

The trial is taking place in the continental US and US territories. It is being conducted under a US Investigational New Drug application.

Takeda says that, if initial data from ZIK-101 are supportive, the company will work to progress into phase 2 development as soon as possible.

Takeda’s Zika program is supported by federal funds from the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services (contract No. HHSO100201600015C).

“We recognize the public health threat posed by the Zika virus,” said Laurence De Moerlooze, PhD, lead of the global Zika program at Takeda.

“As soon as Takeda received funding from BARDA, we mobilized a team and prioritized development of this vaccine candidate, initiating a phase 1 trial within 15 months of contract signature. With fast track designation, the ongoing support of BARDA, and the abilities of our organization, we are confident that we will continue to make expedient progress.”

About fast track designation

The FDA’s fast track designation is a process designed to facilitate the development and expedite the review of drugs and vaccines with the potential to treat serious or life-threatening conditions and address unmet medical needs.

The fast track process allows for more frequent interactions with the FDA, rolling reviews of a product application, and eligibility for priority review if relevant criteria are met. The FDA’s goal is to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.

APOE4 may determine memory loss in Alzheimer’s, a recent flu vaccine flop may have a Cold War connection, treating women’s urinary incontinence could have a restful side effect, and why the 3 months after a heart attack are particularly perilous.
 
Listen to the MDedge Daily News podcast for all the details on today’s top news.

APOE4 may determine memory loss in Alzheimer’s, a recent flu vaccine flop may have a Cold War connection, treating women’s urinary incontinence could have a restful side effect, and why the 3 months after a heart attack are particularly perilous.
 
Listen to the MDedge Daily News podcast for all the details on today’s top news.

APOE4 may determine memory loss in Alzheimer’s, a recent flu vaccine flop may have a Cold War connection, treating women’s urinary incontinence could have a restful side effect, and why the 3 months after a heart attack are particularly perilous.
 
Listen to the MDedge Daily News podcast for all the details on today’s top news.

Maintenance therapy with an aromatase inhibitor may improve progression-free survival in women with estrogen receptor (ER)–positive, high-grade serous ovarian cancers, results of a non-randomized, single-center study suggest.

Patients who received letrozole after debulking surgery and platinum-based chemotherapy had a significantly prolonged recurrence-free interval, compared with patients who declined the treatment, investigators reported in Gynecologic Oncology.

The benefit of letrozole maintenance treatment was also apparent in women with residual disease who received bevacizumab maintenance treatment, wrote first author Viola Heinzelmann-Schwarz, MD, of the Gynecological Cancer Center, University of Basel, Switzerland, and her coauthors.

The results “strongly suggest that endocrine maintenance therapy has more advantage than disadvantage for use in ovarian cancer patients and seems clearly justified,” when considered alongside other data regarding the potential benefit of letrozole in other treatment settings, Dr. Heinzelmann-Schwarz and her colleagues said.

“In contrast to available expensive maintenance medications like antiangiogenic [drugs] and PARP inhibitors, antihormonal drugs have a favorable safety profile, low cost, easy intake regimen with one tablet daily and an established prognostic target,” they added.

While the role of aromatase inhibitor maintenance therapy in high-grade serous ovarian cancer is unclear, previous studies have shown that patients with low-grade serous ovarian cancer may benefit from endocrine therapy.

Those studies in low-grade serous ovarian cancer include several small case series, and one retrospective analysis showing improved progression-free survival among women treated with endocrine therapy versus women who received observation only (J Clin Oncol. 2017 Apr. doi: 10.1200/JCO.2016.71.0632).

The more recent report by Dr. Heinzelmann-Schwarz and her colleagues included 50 women with ER-positive, FIGO (Fédération Internationale de Gynécologie et d’Obstétrique) stage III/IV high-grade serous ovarian cancer who were offered off-label letrozole treatment after debulking surgery and platinum-based chemotherapy. Twenty-three received letrozole maintenance treatment, and 27 declined.

In the group of women who received letrozole maintenance treatment, 60% were recurrence free at 24 months, compared with 38.5% of patients in the observation group (P = .035).

“This positive effect could particularly be seen when the treatment was initiated within 3 months after the end of adjuvant chemotherapy,” Dr. Heinzelmann-Schwarz and her coauthors wrote.

Among women with residual disease who received maintenance bevacizumab in addition to letrozole, 87.5% were recurrence free at 12 months, compared with 20.8% of patients who received bevacizumab only, the investigators said.

Minor side effects such as hot flushes, fatigue, and bone pain led to discontinuation in two patients (6.4%), and no serious adverse effects were seen during treatment, according to investigators.

Almost half of all high-grade serous ovarian cancers express ER, according to results of separate retrospective analyses also described by Dr. Heinzelmann-Schwarz and her colleagues in Gynecologic Oncology. They found that ER expression was similar regardless of drug resistance status (platinum sensitive versus platinum resistant) or treatment setting (primary or recurrent).

Dr. Heinzelmann-Schwarz and colleagues declared no conflicts of interest.

SOURCE: Heinzelmann-Schwarz V et al. Gyn Oncol. 2018 Jan. doi: 10.1016/j.ygyno.2017.10.036.

Maintenance therapy with an aromatase inhibitor may improve progression-free survival in women with estrogen receptor (ER)–positive, high-grade serous ovarian cancers, results of a non-randomized, single-center study suggest.

Patients who received letrozole after debulking surgery and platinum-based chemotherapy had a significantly prolonged recurrence-free interval, compared with patients who declined the treatment, investigators reported in Gynecologic Oncology.

The benefit of letrozole maintenance treatment was also apparent in women with residual disease who received bevacizumab maintenance treatment, wrote first author Viola Heinzelmann-Schwarz, MD, of the Gynecological Cancer Center, University of Basel, Switzerland, and her coauthors.

The results “strongly suggest that endocrine maintenance therapy has more advantage than disadvantage for use in ovarian cancer patients and seems clearly justified,” when considered alongside other data regarding the potential benefit of letrozole in other treatment settings, Dr. Heinzelmann-Schwarz and her colleagues said.

“In contrast to available expensive maintenance medications like antiangiogenic [drugs] and PARP inhibitors, antihormonal drugs have a favorable safety profile, low cost, easy intake regimen with one tablet daily and an established prognostic target,” they added.

While the role of aromatase inhibitor maintenance therapy in high-grade serous ovarian cancer is unclear, previous studies have shown that patients with low-grade serous ovarian cancer may benefit from endocrine therapy.

Those studies in low-grade serous ovarian cancer include several small case series, and one retrospective analysis showing improved progression-free survival among women treated with endocrine therapy versus women who received observation only (J Clin Oncol. 2017 Apr. doi: 10.1200/JCO.2016.71.0632).

The more recent report by Dr. Heinzelmann-Schwarz and her colleagues included 50 women with ER-positive, FIGO (Fédération Internationale de Gynécologie et d’Obstétrique) stage III/IV high-grade serous ovarian cancer who were offered off-label letrozole treatment after debulking surgery and platinum-based chemotherapy. Twenty-three received letrozole maintenance treatment, and 27 declined.

In the group of women who received letrozole maintenance treatment, 60% were recurrence free at 24 months, compared with 38.5% of patients in the observation group (P = .035).

“This positive effect could particularly be seen when the treatment was initiated within 3 months after the end of adjuvant chemotherapy,” Dr. Heinzelmann-Schwarz and her coauthors wrote.

Among women with residual disease who received maintenance bevacizumab in addition to letrozole, 87.5% were recurrence free at 12 months, compared with 20.8% of patients who received bevacizumab only, the investigators said.

Minor side effects such as hot flushes, fatigue, and bone pain led to discontinuation in two patients (6.4%), and no serious adverse effects were seen during treatment, according to investigators.

Almost half of all high-grade serous ovarian cancers express ER, according to results of separate retrospective analyses also described by Dr. Heinzelmann-Schwarz and her colleagues in Gynecologic Oncology. They found that ER expression was similar regardless of drug resistance status (platinum sensitive versus platinum resistant) or treatment setting (primary or recurrent).

Dr. Heinzelmann-Schwarz and colleagues declared no conflicts of interest.

SOURCE: Heinzelmann-Schwarz V et al. Gyn Oncol. 2018 Jan. doi: 10.1016/j.ygyno.2017.10.036.

Maintenance therapy with an aromatase inhibitor may improve progression-free survival in women with estrogen receptor (ER)–positive, high-grade serous ovarian cancers, results of a non-randomized, single-center study suggest.

Patients who received letrozole after debulking surgery and platinum-based chemotherapy had a significantly prolonged recurrence-free interval, compared with patients who declined the treatment, investigators reported in Gynecologic Oncology.

The benefit of letrozole maintenance treatment was also apparent in women with residual disease who received bevacizumab maintenance treatment, wrote first author Viola Heinzelmann-Schwarz, MD, of the Gynecological Cancer Center, University of Basel, Switzerland, and her coauthors.

The results “strongly suggest that endocrine maintenance therapy has more advantage than disadvantage for use in ovarian cancer patients and seems clearly justified,” when considered alongside other data regarding the potential benefit of letrozole in other treatment settings, Dr. Heinzelmann-Schwarz and her colleagues said.

“In contrast to available expensive maintenance medications like antiangiogenic [drugs] and PARP inhibitors, antihormonal drugs have a favorable safety profile, low cost, easy intake regimen with one tablet daily and an established prognostic target,” they added.

While the role of aromatase inhibitor maintenance therapy in high-grade serous ovarian cancer is unclear, previous studies have shown that patients with low-grade serous ovarian cancer may benefit from endocrine therapy.

Those studies in low-grade serous ovarian cancer include several small case series, and one retrospective analysis showing improved progression-free survival among women treated with endocrine therapy versus women who received observation only (J Clin Oncol. 2017 Apr. doi: 10.1200/JCO.2016.71.0632).

The more recent report by Dr. Heinzelmann-Schwarz and her colleagues included 50 women with ER-positive, FIGO (Fédération Internationale de Gynécologie et d’Obstétrique) stage III/IV high-grade serous ovarian cancer who were offered off-label letrozole treatment after debulking surgery and platinum-based chemotherapy. Twenty-three received letrozole maintenance treatment, and 27 declined.

In the group of women who received letrozole maintenance treatment, 60% were recurrence free at 24 months, compared with 38.5% of patients in the observation group (P = .035).

“This positive effect could particularly be seen when the treatment was initiated within 3 months after the end of adjuvant chemotherapy,” Dr. Heinzelmann-Schwarz and her coauthors wrote.

Among women with residual disease who received maintenance bevacizumab in addition to letrozole, 87.5% were recurrence free at 12 months, compared with 20.8% of patients who received bevacizumab only, the investigators said.

Minor side effects such as hot flushes, fatigue, and bone pain led to discontinuation in two patients (6.4%), and no serious adverse effects were seen during treatment, according to investigators.

Almost half of all high-grade serous ovarian cancers express ER, according to results of separate retrospective analyses also described by Dr. Heinzelmann-Schwarz and her colleagues in Gynecologic Oncology. They found that ER expression was similar regardless of drug resistance status (platinum sensitive versus platinum resistant) or treatment setting (primary or recurrent).

Dr. Heinzelmann-Schwarz and colleagues declared no conflicts of interest.

SOURCE: Heinzelmann-Schwarz V et al. Gyn Oncol. 2018 Jan. doi: 10.1016/j.ygyno.2017.10.036.

Replacing bleomycin with brentuximab vedotin in the classic ABVD regimen improved a measure of progression-free survival and reduced pulmonary toxicity in patients with previously untreated Hodgkin lymphoma, findings from a randomized, phase 3 trial suggest.

Patients receiving brentuximab plus chemotherapy had a “statistically significant and clinically meaningful improvement” in the rate of modified progression-free survival, according to results published in the New England Journal of Medicine.

Pulmonary toxicity also occurred at a lower rate with the regimen containing brentuximab, an anti-CD30 antibody–drug conjugate, wrote Joseph M. Connors, MD, of the British Columbia Cancer Agency, Vancouver, and his coauthors.

Taken together, these findings suggest brentuximab vedotin and chemotherapy had “substantially less pulmonary toxicity and appears to be more effective for frontline treatment of advanced-stage classic Hodgkin lymphoma,” the researchers wrote.

Bleomycin is often omitted from later cycles of chemotherapy for patients with Hodgkin lymphoma due to pulmonary symptoms, and is sometimes associated with unpredictable or even fatal pulmonary toxicity, the researchers noted.

The brentuximab vedotin arm of the trial did have more neurotoxicity, which was largely reversible, and more myelotoxicity, though that “can be ameliorated with prophylactic granulocyte colony-stimulating factor (G-CSF),” the researchers wrote.

The study by Dr. Connors and colleagues, known as ECHELON-1, was an open-label, multicenter, randomized phase 3 trial including patients with previously untreated stage III or IV classic Hodgkin lymphoma. Among enrolled patients, 664 received brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine (AVD), and 670 received standard doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).

The study used a primary endpoint of progression-free survival augmented to include not only time to disease progression or death, but also “modified progression,” which the researchers defined as evidence of noncomplete response at the end of frontline chemotherapy.

It is accepted practice to give more chemotherapy or radiotherapy in Hodgkin lymphoma patients who have a positive PET scan at the end of frontline therapy, since metabolically detectable residual disease reliably predicts imminent progression, Dr. Connors and coauthors wrote.

“In this context, the conventional endpoint of progression-free survival does not accurately assess the curative intent of frontline chemotherapy,” they wrote.

With a median 24.9-month follow-up, modified 2-year progression-free survival in the trial was 82.1% for patients receiving brentuximab plus AVD, versus 77.2% for ABVD (P = .03), a 23% risk reduction.

Pulmonary toxicity of grade 3 or higher occurred in less than 1% of patients in the brentuximab vedotin plus AVD arm of the trial and in 3% of the ABVD arm.

Neutropenia was reported in 58% and 45% in the brentuximab vedotin plus AVD and ABVD arms, respectively, while febrile neutropenia was reported in 19% and 8%, respectively.

In the brentuximab plus AVD group, the rate of febrile neutropenia was 11% for those patients who received primary prophylaxis with G-CSF, and 21% for patients who did not, the researchers noted.

Peripheral neuropathy was seen in 67% and 43% of the brentuximab vedotin plus AVD and ABVD arms, respectively, and about two-thirds of the patients in the brentuximab vedotin plus AVD arm had improvement or resolution at the final follow-up visit.

The study was supported by Millennium Pharmaceuticals and Seattle Genetics. Researchers reported ties to Millennium Pharmaceuticals, Takeda Pharmaceuticals, Seattle Genetics, and other companies.

hematologynews@frontlinemedcom.com

SOURCE: Connors JM et al. N Engl J Med. 2018;378:331-44.

Replacing bleomycin with brentuximab vedotin in the classic ABVD regimen improved a measure of progression-free survival and reduced pulmonary toxicity in patients with previously untreated Hodgkin lymphoma, findings from a randomized, phase 3 trial suggest.

Patients receiving brentuximab plus chemotherapy had a “statistically significant and clinically meaningful improvement” in the rate of modified progression-free survival, according to results published in the New England Journal of Medicine.

Pulmonary toxicity also occurred at a lower rate with the regimen containing brentuximab, an anti-CD30 antibody–drug conjugate, wrote Joseph M. Connors, MD, of the British Columbia Cancer Agency, Vancouver, and his coauthors.

Taken together, these findings suggest brentuximab vedotin and chemotherapy had “substantially less pulmonary toxicity and appears to be more effective for frontline treatment of advanced-stage classic Hodgkin lymphoma,” the researchers wrote.

Bleomycin is often omitted from later cycles of chemotherapy for patients with Hodgkin lymphoma due to pulmonary symptoms, and is sometimes associated with unpredictable or even fatal pulmonary toxicity, the researchers noted.

The brentuximab vedotin arm of the trial did have more neurotoxicity, which was largely reversible, and more myelotoxicity, though that “can be ameliorated with prophylactic granulocyte colony-stimulating factor (G-CSF),” the researchers wrote.

The study by Dr. Connors and colleagues, known as ECHELON-1, was an open-label, multicenter, randomized phase 3 trial including patients with previously untreated stage III or IV classic Hodgkin lymphoma. Among enrolled patients, 664 received brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine (AVD), and 670 received standard doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).

The study used a primary endpoint of progression-free survival augmented to include not only time to disease progression or death, but also “modified progression,” which the researchers defined as evidence of noncomplete response at the end of frontline chemotherapy.

It is accepted practice to give more chemotherapy or radiotherapy in Hodgkin lymphoma patients who have a positive PET scan at the end of frontline therapy, since metabolically detectable residual disease reliably predicts imminent progression, Dr. Connors and coauthors wrote.

“In this context, the conventional endpoint of progression-free survival does not accurately assess the curative intent of frontline chemotherapy,” they wrote.

With a median 24.9-month follow-up, modified 2-year progression-free survival in the trial was 82.1% for patients receiving brentuximab plus AVD, versus 77.2% for ABVD (P = .03), a 23% risk reduction.

Pulmonary toxicity of grade 3 or higher occurred in less than 1% of patients in the brentuximab vedotin plus AVD arm of the trial and in 3% of the ABVD arm.

Neutropenia was reported in 58% and 45% in the brentuximab vedotin plus AVD and ABVD arms, respectively, while febrile neutropenia was reported in 19% and 8%, respectively.

In the brentuximab plus AVD group, the rate of febrile neutropenia was 11% for those patients who received primary prophylaxis with G-CSF, and 21% for patients who did not, the researchers noted.

Peripheral neuropathy was seen in 67% and 43% of the brentuximab vedotin plus AVD and ABVD arms, respectively, and about two-thirds of the patients in the brentuximab vedotin plus AVD arm had improvement or resolution at the final follow-up visit.

The study was supported by Millennium Pharmaceuticals and Seattle Genetics. Researchers reported ties to Millennium Pharmaceuticals, Takeda Pharmaceuticals, Seattle Genetics, and other companies.

hematologynews@frontlinemedcom.com

SOURCE: Connors JM et al. N Engl J Med. 2018;378:331-44.

Replacing bleomycin with brentuximab vedotin in the classic ABVD regimen improved a measure of progression-free survival and reduced pulmonary toxicity in patients with previously untreated Hodgkin lymphoma, findings from a randomized, phase 3 trial suggest.

Patients receiving brentuximab plus chemotherapy had a “statistically significant and clinically meaningful improvement” in the rate of modified progression-free survival, according to results published in the New England Journal of Medicine.

Pulmonary toxicity also occurred at a lower rate with the regimen containing brentuximab, an anti-CD30 antibody–drug conjugate, wrote Joseph M. Connors, MD, of the British Columbia Cancer Agency, Vancouver, and his coauthors.

Taken together, these findings suggest brentuximab vedotin and chemotherapy had “substantially less pulmonary toxicity and appears to be more effective for frontline treatment of advanced-stage classic Hodgkin lymphoma,” the researchers wrote.

Bleomycin is often omitted from later cycles of chemotherapy for patients with Hodgkin lymphoma due to pulmonary symptoms, and is sometimes associated with unpredictable or even fatal pulmonary toxicity, the researchers noted.

The brentuximab vedotin arm of the trial did have more neurotoxicity, which was largely reversible, and more myelotoxicity, though that “can be ameliorated with prophylactic granulocyte colony-stimulating factor (G-CSF),” the researchers wrote.

The study by Dr. Connors and colleagues, known as ECHELON-1, was an open-label, multicenter, randomized phase 3 trial including patients with previously untreated stage III or IV classic Hodgkin lymphoma. Among enrolled patients, 664 received brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine (AVD), and 670 received standard doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).

The study used a primary endpoint of progression-free survival augmented to include not only time to disease progression or death, but also “modified progression,” which the researchers defined as evidence of noncomplete response at the end of frontline chemotherapy.

It is accepted practice to give more chemotherapy or radiotherapy in Hodgkin lymphoma patients who have a positive PET scan at the end of frontline therapy, since metabolically detectable residual disease reliably predicts imminent progression, Dr. Connors and coauthors wrote.

“In this context, the conventional endpoint of progression-free survival does not accurately assess the curative intent of frontline chemotherapy,” they wrote.

With a median 24.9-month follow-up, modified 2-year progression-free survival in the trial was 82.1% for patients receiving brentuximab plus AVD, versus 77.2% for ABVD (P = .03), a 23% risk reduction.

Pulmonary toxicity of grade 3 or higher occurred in less than 1% of patients in the brentuximab vedotin plus AVD arm of the trial and in 3% of the ABVD arm.

Neutropenia was reported in 58% and 45% in the brentuximab vedotin plus AVD and ABVD arms, respectively, while febrile neutropenia was reported in 19% and 8%, respectively.

In the brentuximab plus AVD group, the rate of febrile neutropenia was 11% for those patients who received primary prophylaxis with G-CSF, and 21% for patients who did not, the researchers noted.

Peripheral neuropathy was seen in 67% and 43% of the brentuximab vedotin plus AVD and ABVD arms, respectively, and about two-thirds of the patients in the brentuximab vedotin plus AVD arm had improvement or resolution at the final follow-up visit.

The study was supported by Millennium Pharmaceuticals and Seattle Genetics. Researchers reported ties to Millennium Pharmaceuticals, Takeda Pharmaceuticals, Seattle Genetics, and other companies.

hematologynews@frontlinemedcom.com

SOURCE: Connors JM et al. N Engl J Med. 2018;378:331-44.

Patients who are treated with psychotropics may experience better recovery from their symptoms and improved quality of life when they receive targeted treatment with cognitive-behavioral therapy (CBT). Clinicians can use certain CBT techniques to “jump-start” recovery in patients before prescribed medications produce their intended therapeutic effects. When practitioners are familiar with their use, techniques such as behavioral activation and tools that enhance adherence can be employed during a brief medication management (“med check”) visit.

Take these steps to implement brief CBT interventions into your patient’s routine visits:

• develop a clear, formulation-driven treatment target
• design an intervention that can be explained during a brief visit
• have handouts and worksheets available for patients to use
• provide written explanations and reminders for patients to use in out-of-session practice.

We present a case report that illustrates incorporating brief CBT interventions in a patient with major depressive disorder (MDD).

CASE REPORT

Using CBT to help a patient with MDD

Mr. L, age 52, presents with moderate MDD, and is started on fluoxetine, 20 mg/d. Mr. L has significant anhedonia and poor energy, and has been avoiding going to work and seeing friends. The psychiatrist explains to him how individuals with depression often want to refrain from activity and “shut down,” but that doing so will not improve his quality of life, and his mood will worsen.

The psychiatrist asks Mr. L to identify a pleasurable or important activity to complete before his next appointment. Mr. L decides that he would like to call a friend, because he has been isolated and his friends have been calling him. The psychiatrist encourages him to call one of his golf buddies. She instructs Mr. L to set reminders, such as cell phone alarms and notes on the refrigerator, to prompt him to “Call Phil Saturday at 10 am.” She uses a prescription pad to write an “action prescription”¹ to remind Mr. L of the importance of engaging in this activity.

To increase the likelihood that Mr. L will make this call, he and his psychiatrist discuss anticipated obstacles and potential facilitators of this behavior. Mr. L says that he might not be able to reach his friend, or that his negative self-talk might prevent him from making the call. With his psychiatrist’s help, Mr. L selects a second friend to call if the first friend does not answer the phone. They create a coping card² with encouraging and factual statements (eg, “My friend will be happy to hear from me” and “This will make me feel good”) for Mr. L to refer to if his negative self-talk interferes with his desire to make the call.

The psychiatrist also encourages Mr. L to complete a Behavioral Activation Worksheet (for examples, see http://www.cci.health.wa.gov.au/docs/ACF3B92.pdf or https://www.therapistaid.com/worksheets/behavioral-activation.pdf) to track his depression, pleasure, and sense of achievement before and after completing this activity.

As illustrated by this case, collaborating with the patient is critical to developing a realistic treatment plan that incorporates CBT techniques. With your help and encouragement, patients can use these tools to reach their goals and target the symptoms of their illnesses.

Patients who are treated with psychotropics may experience better recovery from their symptoms and improved quality of life when they receive targeted treatment with cognitive-behavioral therapy (CBT). Clinicians can use certain CBT techniques to “jump-start” recovery in patients before prescribed medications produce their intended therapeutic effects. When practitioners are familiar with their use, techniques such as behavioral activation and tools that enhance adherence can be employed during a brief medication management (“med check”) visit.

Take these steps to implement brief CBT interventions into your patient’s routine visits:

• develop a clear, formulation-driven treatment target
• design an intervention that can be explained during a brief visit
• have handouts and worksheets available for patients to use
• provide written explanations and reminders for patients to use in out-of-session practice.

We present a case report that illustrates incorporating brief CBT interventions in a patient with major depressive disorder (MDD).

CASE REPORT

Using CBT to help a patient with MDD

Mr. L, age 52, presents with moderate MDD, and is started on fluoxetine, 20 mg/d. Mr. L has significant anhedonia and poor energy, and has been avoiding going to work and seeing friends. The psychiatrist explains to him how individuals with depression often want to refrain from activity and “shut down,” but that doing so will not improve his quality of life, and his mood will worsen.

The psychiatrist asks Mr. L to identify a pleasurable or important activity to complete before his next appointment. Mr. L decides that he would like to call a friend, because he has been isolated and his friends have been calling him. The psychiatrist encourages him to call one of his golf buddies. She instructs Mr. L to set reminders, such as cell phone alarms and notes on the refrigerator, to prompt him to “Call Phil Saturday at 10 am.” She uses a prescription pad to write an “action prescription”¹ to remind Mr. L of the importance of engaging in this activity.

To increase the likelihood that Mr. L will make this call, he and his psychiatrist discuss anticipated obstacles and potential facilitators of this behavior. Mr. L says that he might not be able to reach his friend, or that his negative self-talk might prevent him from making the call. With his psychiatrist’s help, Mr. L selects a second friend to call if the first friend does not answer the phone. They create a coping card² with encouraging and factual statements (eg, “My friend will be happy to hear from me” and “This will make me feel good”) for Mr. L to refer to if his negative self-talk interferes with his desire to make the call.

The psychiatrist also encourages Mr. L to complete a Behavioral Activation Worksheet (for examples, see http://www.cci.health.wa.gov.au/docs/ACF3B92.pdf or https://www.therapistaid.com/worksheets/behavioral-activation.pdf) to track his depression, pleasure, and sense of achievement before and after completing this activity.

As illustrated by this case, collaborating with the patient is critical to developing a realistic treatment plan that incorporates CBT techniques. With your help and encouragement, patients can use these tools to reach their goals and target the symptoms of their illnesses.

Patients who are treated with psychotropics may experience better recovery from their symptoms and improved quality of life when they receive targeted treatment with cognitive-behavioral therapy (CBT). Clinicians can use certain CBT techniques to “jump-start” recovery in patients before prescribed medications produce their intended therapeutic effects. When practitioners are familiar with their use, techniques such as behavioral activation and tools that enhance adherence can be employed during a brief medication management (“med check”) visit.

Take these steps to implement brief CBT interventions into your patient’s routine visits:

• develop a clear, formulation-driven treatment target
• design an intervention that can be explained during a brief visit
• have handouts and worksheets available for patients to use
• provide written explanations and reminders for patients to use in out-of-session practice.

We present a case report that illustrates incorporating brief CBT interventions in a patient with major depressive disorder (MDD).

CASE REPORT

Using CBT to help a patient with MDD

Mr. L, age 52, presents with moderate MDD, and is started on fluoxetine, 20 mg/d. Mr. L has significant anhedonia and poor energy, and has been avoiding going to work and seeing friends. The psychiatrist explains to him how individuals with depression often want to refrain from activity and “shut down,” but that doing so will not improve his quality of life, and his mood will worsen.

The psychiatrist asks Mr. L to identify a pleasurable or important activity to complete before his next appointment. Mr. L decides that he would like to call a friend, because he has been isolated and his friends have been calling him. The psychiatrist encourages him to call one of his golf buddies. She instructs Mr. L to set reminders, such as cell phone alarms and notes on the refrigerator, to prompt him to “Call Phil Saturday at 10 am.” She uses a prescription pad to write an “action prescription”¹ to remind Mr. L of the importance of engaging in this activity.

To increase the likelihood that Mr. L will make this call, he and his psychiatrist discuss anticipated obstacles and potential facilitators of this behavior. Mr. L says that he might not be able to reach his friend, or that his negative self-talk might prevent him from making the call. With his psychiatrist’s help, Mr. L selects a second friend to call if the first friend does not answer the phone. They create a coping card² with encouraging and factual statements (eg, “My friend will be happy to hear from me” and “This will make me feel good”) for Mr. L to refer to if his negative self-talk interferes with his desire to make the call.

The psychiatrist also encourages Mr. L to complete a Behavioral Activation Worksheet (for examples, see http://www.cci.health.wa.gov.au/docs/ACF3B92.pdf or https://www.therapistaid.com/worksheets/behavioral-activation.pdf) to track his depression, pleasure, and sense of achievement before and after completing this activity.

As illustrated by this case, collaborating with the patient is critical to developing a realistic treatment plan that incorporates CBT techniques. With your help and encouragement, patients can use these tools to reach their goals and target the symptoms of their illnesses.

Retroperitoneal lymphadenectomy (LND) did not improve overall or disease-free survival in fully resected, high-risk, nonmetastatic renal cell carcinoma, according to a secondary analysis of the ASSURE adjuvant trial.

Patients were randomized to adjuvant sorafenib, sunitinib, or placebo in the ASSURE (Adjuvant Sorafenib and Sunitinib for Unfavorable Renal Carcinoma) trial, and those at high risk – which was defined by cN+ disease or determined at their surgeon’s discretion – underwent LND. The primary objective was to assess the effect of LND on overall survival; secondary objectives included the effect of LND on disease-free survival and the benefit of adjuvant therapy vs. placebo in patients who underwent LND.

Overall, 1,943 patients were enrolled in the ASSURE trial, of which 36.1% (701 patients) underwent LND. A median of three lymph nodes (interquartile range, one to eight) was examined, and disease was pN+ in 23.4% patients. A majority of the patients were male (67.4%), with a median age of 56 years. Most (94.5%) patients underwent radical nephrectomy, and 57.2% patients had open surgery rather than laparoscopic. Tumors were clear cell in 81.7% of cases and Fuhrman grade 3-4 in 66.1%, investigators reported in the Journal Of Urology.

“There was no improvement in overall survival for lymphadenectomy relative to no lymphadenectomy (HR, 1.14; 95% CI, 0.93-1.39; P = .20). For patients who underwent lymphadenectomy with pN+ disease, no improvement in overall or disease-free survival was observed for adjuvant therapy relative to placebo. Lymphadenectomy was overall safe, and did not increase the risk of surgical complications (14.2% vs. 13.4%; P = .63),” wrote Benjamin Ristau, MD, of Fox Chase Cancer Center in Philadelphia and his colleagues. LND was independently associated with other markers of aggressive surgical resection, such as open surgery, radical nephrectomy, and adrenalectomy.

The role of lymphadenectomy in patients undergoing surgery for high-risk renal cell carcinoma remains elusive, the authors wrote. Future strategies include a prospective trial in which patients with high-risk renal cell carcinoma are randomized to specific lymphadenectomy templates.

This study was supported by the National Cancer Institute of National Institutes of Health and the Canadian Cancer Research Institute. Christopher G. Wood reported conflicts of interest with Pfizer, Novartis and Argos. Other authors reported no conflicts of interest.

op@frontlinemedcom.com

SOURCE: Ristau BT et al. J Urol. 2018 Jan. doi: 10.1016/j.juro.2017.07.042.

Retroperitoneal lymphadenectomy (LND) did not improve overall or disease-free survival in fully resected, high-risk, nonmetastatic renal cell carcinoma, according to a secondary analysis of the ASSURE adjuvant trial.

Patients were randomized to adjuvant sorafenib, sunitinib, or placebo in the ASSURE (Adjuvant Sorafenib and Sunitinib for Unfavorable Renal Carcinoma) trial, and those at high risk – which was defined by cN+ disease or determined at their surgeon’s discretion – underwent LND. The primary objective was to assess the effect of LND on overall survival; secondary objectives included the effect of LND on disease-free survival and the benefit of adjuvant therapy vs. placebo in patients who underwent LND.

Overall, 1,943 patients were enrolled in the ASSURE trial, of which 36.1% (701 patients) underwent LND. A median of three lymph nodes (interquartile range, one to eight) was examined, and disease was pN+ in 23.4% patients. A majority of the patients were male (67.4%), with a median age of 56 years. Most (94.5%) patients underwent radical nephrectomy, and 57.2% patients had open surgery rather than laparoscopic. Tumors were clear cell in 81.7% of cases and Fuhrman grade 3-4 in 66.1%, investigators reported in the Journal Of Urology.

“There was no improvement in overall survival for lymphadenectomy relative to no lymphadenectomy (HR, 1.14; 95% CI, 0.93-1.39; P = .20). For patients who underwent lymphadenectomy with pN+ disease, no improvement in overall or disease-free survival was observed for adjuvant therapy relative to placebo. Lymphadenectomy was overall safe, and did not increase the risk of surgical complications (14.2% vs. 13.4%; P = .63),” wrote Benjamin Ristau, MD, of Fox Chase Cancer Center in Philadelphia and his colleagues. LND was independently associated with other markers of aggressive surgical resection, such as open surgery, radical nephrectomy, and adrenalectomy.

The role of lymphadenectomy in patients undergoing surgery for high-risk renal cell carcinoma remains elusive, the authors wrote. Future strategies include a prospective trial in which patients with high-risk renal cell carcinoma are randomized to specific lymphadenectomy templates.

This study was supported by the National Cancer Institute of National Institutes of Health and the Canadian Cancer Research Institute. Christopher G. Wood reported conflicts of interest with Pfizer, Novartis and Argos. Other authors reported no conflicts of interest.

op@frontlinemedcom.com

SOURCE: Ristau BT et al. J Urol. 2018 Jan. doi: 10.1016/j.juro.2017.07.042.

Retroperitoneal lymphadenectomy (LND) did not improve overall or disease-free survival in fully resected, high-risk, nonmetastatic renal cell carcinoma, according to a secondary analysis of the ASSURE adjuvant trial.

Patients were randomized to adjuvant sorafenib, sunitinib, or placebo in the ASSURE (Adjuvant Sorafenib and Sunitinib for Unfavorable Renal Carcinoma) trial, and those at high risk – which was defined by cN+ disease or determined at their surgeon’s discretion – underwent LND. The primary objective was to assess the effect of LND on overall survival; secondary objectives included the effect of LND on disease-free survival and the benefit of adjuvant therapy vs. placebo in patients who underwent LND.

Overall, 1,943 patients were enrolled in the ASSURE trial, of which 36.1% (701 patients) underwent LND. A median of three lymph nodes (interquartile range, one to eight) was examined, and disease was pN+ in 23.4% patients. A majority of the patients were male (67.4%), with a median age of 56 years. Most (94.5%) patients underwent radical nephrectomy, and 57.2% patients had open surgery rather than laparoscopic. Tumors were clear cell in 81.7% of cases and Fuhrman grade 3-4 in 66.1%, investigators reported in the Journal Of Urology.

“There was no improvement in overall survival for lymphadenectomy relative to no lymphadenectomy (HR, 1.14; 95% CI, 0.93-1.39; P = .20). For patients who underwent lymphadenectomy with pN+ disease, no improvement in overall or disease-free survival was observed for adjuvant therapy relative to placebo. Lymphadenectomy was overall safe, and did not increase the risk of surgical complications (14.2% vs. 13.4%; P = .63),” wrote Benjamin Ristau, MD, of Fox Chase Cancer Center in Philadelphia and his colleagues. LND was independently associated with other markers of aggressive surgical resection, such as open surgery, radical nephrectomy, and adrenalectomy.

The role of lymphadenectomy in patients undergoing surgery for high-risk renal cell carcinoma remains elusive, the authors wrote. Future strategies include a prospective trial in which patients with high-risk renal cell carcinoma are randomized to specific lymphadenectomy templates.

This study was supported by the National Cancer Institute of National Institutes of Health and the Canadian Cancer Research Institute. Christopher G. Wood reported conflicts of interest with Pfizer, Novartis and Argos. Other authors reported no conflicts of interest.

op@frontlinemedcom.com

SOURCE: Ristau BT et al. J Urol. 2018 Jan. doi: 10.1016/j.juro.2017.07.042.

Las Vegas – Smoking is more prevalent in Crohn’s disease (CD) patients than in patients with ulcerative colitis (UC), results from a retrospective analysis of national data showed. In addition, smoking status was associated with favorable outcomes in mortality, routine discharges, length of stay, and cost of care, a so-called “smoker’s paradox.”

“This paradox seems to be real, because we know that it has been shown in some heart diseases, that the patients who were smokers had better outcomes,” Zubair Khan, MD, said in an interview at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. In fact, a recent analysis of a nationwide cohort of patients who underwent primary percutaneous coronary intervention for ST-segment elevation myocardial infarction found that smokers had significantly lower risk‐adjusted in‐hospital mortality, compared with nonsmokers (J Am Heart Assoc. 2016 Apr 22;5:e003370. doi: 10.1161/JAHA.116.003370).

ricky_68fr/fotolia

*This story was updated on 3/26.

dbrunk@frontlinemedcom.com

SOURCE: Khan et al. Crohn’s & Colitis Congress, Poster 213.

Las Vegas – Smoking is more prevalent in Crohn’s disease (CD) patients than in patients with ulcerative colitis (UC), results from a retrospective analysis of national data showed. In addition, smoking status was associated with favorable outcomes in mortality, routine discharges, length of stay, and cost of care, a so-called “smoker’s paradox.”

“This paradox seems to be real, because we know that it has been shown in some heart diseases, that the patients who were smokers had better outcomes,” Zubair Khan, MD, said in an interview at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. In fact, a recent analysis of a nationwide cohort of patients who underwent primary percutaneous coronary intervention for ST-segment elevation myocardial infarction found that smokers had significantly lower risk‐adjusted in‐hospital mortality, compared with nonsmokers (J Am Heart Assoc. 2016 Apr 22;5:e003370. doi: 10.1161/JAHA.116.003370).

ricky_68fr/fotolia

*This story was updated on 3/26.

dbrunk@frontlinemedcom.com

SOURCE: Khan et al. Crohn’s & Colitis Congress, Poster 213.

Las Vegas – Smoking is more prevalent in Crohn’s disease (CD) patients than in patients with ulcerative colitis (UC), results from a retrospective analysis of national data showed. In addition, smoking status was associated with favorable outcomes in mortality, routine discharges, length of stay, and cost of care, a so-called “smoker’s paradox.”

“This paradox seems to be real, because we know that it has been shown in some heart diseases, that the patients who were smokers had better outcomes,” Zubair Khan, MD, said in an interview at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. In fact, a recent analysis of a nationwide cohort of patients who underwent primary percutaneous coronary intervention for ST-segment elevation myocardial infarction found that smokers had significantly lower risk‐adjusted in‐hospital mortality, compared with nonsmokers (J Am Heart Assoc. 2016 Apr 22;5:e003370. doi: 10.1161/JAHA.116.003370).

ricky_68fr/fotolia

*This story was updated on 3/26.

dbrunk@frontlinemedcom.com

SOURCE: Khan et al. Crohn’s & Colitis Congress, Poster 213.

Minnesota and South Carolina are at the top of the class for access to smoking cessation services, but a new report card from the American Lung Association shows that the treatment coverage in most states earned barely passable or failing grades.

In fact, 31 states received either a D (11 states) or an F (20 states) on the grading system. There were also 11 C’s and 7 B’s to go along with the two A’s, the ALA said in “State of Tobacco Control 2018.”

rfranki@frontlinemedcom.com

Minnesota and South Carolina are at the top of the class for access to smoking cessation services, but a new report card from the American Lung Association shows that the treatment coverage in most states earned barely passable or failing grades.

In fact, 31 states received either a D (11 states) or an F (20 states) on the grading system. There were also 11 C’s and 7 B’s to go along with the two A’s, the ALA said in “State of Tobacco Control 2018.”

rfranki@frontlinemedcom.com

Minnesota and South Carolina are at the top of the class for access to smoking cessation services, but a new report card from the American Lung Association shows that the treatment coverage in most states earned barely passable or failing grades.

In fact, 31 states received either a D (11 states) or an F (20 states) on the grading system. There were also 11 C’s and 7 B’s to go along with the two A’s, the ALA said in “State of Tobacco Control 2018.”

rfranki@frontlinemedcom.com

The number of colorectal cancers diagnosed after a colonoscopy remained consistent at approximately 8% over a 15-year period despite the introduction of quality improvement measures, according to data from a population-based cohort study of more than 1 million individuals in Canada.

“It is believed that the majority of PCCRCs [postcolonoscopy colorectal cancers] arise due to cancers or near cancers that were either missed or incompletely treated during colonoscopy,” wrote Sanjay K. Murthy, MD, of the University of Ottawa, and colleagues.

Established quality improvement measures included adenoma detection rate, cecal intubation rate, colonoscopy withdrawal time, and endoscopy training standards, but how well the measures have been implemented remains uncertain, the researchers said. In a study published in Gastrointestinal Endoscopy (2018 Jan 6. doi: 10.1016/j.gie.2017.12.027), the researchers assessed data from 1,093,658 eligible adults aged 50-74 years over a 15-year period. The time period was divided into three sections: July 1, 1996, to June 30, 2001; July 1, 2001, to June 30, 2006; and July 1, 2006, to Dec. 31, 2010.

Overall, the number of colonoscopy procedures increased during the study period, from 305 per 10,000 people in 1996-1997 to 870 per 10,000 people in 2010-2011, and the percentage of individuals who underwent complete colonoscopies increased from 67% in the 1996-2001 period to 88% in the 2006-2010 period. “There was a considerable increase in the proportion of colonoscopies performed in younger age groups and community clinics in successive study periods,” the researchers noted.

Comparing the 2006-2010 and 1996-2001 time periods yielded adjusted odds of PCCRC, distal PCCRC, and proximal PCCRC of 1.14, 1.11, and 1.14, respectively; the trends were not affected by endoscopist specialty or institutional setting.

“Our findings are concerning for lack of improvement in colonoscopy practice quality in Ontario, particularly in the wake of greater emphasis having been placed on colonoscopy quality metrics during the study period,” the researchers said. The findings contrast with the decline in PCCRC rates in the United Kingdom reported in a previous study of a similar time period, they noted.

The study findings were limited by several factors, including possible patient and outcome misclassification, an unvalidated definition for PCCRC, and unmeasured confounders such as changes in practice or changes in the definition of PCCRC. Although more research is needed in other jurisdictions to confirm, the results “call for increased population-based practice audit as well as endoscopy educational programs and certification requirements.”

The study was supported by a research grant to Dr. Murthy from the University of Ottawa. The researchers had no financial conflicts to disclose.

SOURCE: Murthy S et al. Gastrointest Endosc. 2018 Jan 6. doi: 10.1016/j.gie.2017.12.027

The number of colorectal cancers diagnosed after a colonoscopy remained consistent at approximately 8% over a 15-year period despite the introduction of quality improvement measures, according to data from a population-based cohort study of more than 1 million individuals in Canada.

“It is believed that the majority of PCCRCs [postcolonoscopy colorectal cancers] arise due to cancers or near cancers that were either missed or incompletely treated during colonoscopy,” wrote Sanjay K. Murthy, MD, of the University of Ottawa, and colleagues.

Established quality improvement measures included adenoma detection rate, cecal intubation rate, colonoscopy withdrawal time, and endoscopy training standards, but how well the measures have been implemented remains uncertain, the researchers said. In a study published in Gastrointestinal Endoscopy (2018 Jan 6. doi: 10.1016/j.gie.2017.12.027), the researchers assessed data from 1,093,658 eligible adults aged 50-74 years over a 15-year period. The time period was divided into three sections: July 1, 1996, to June 30, 2001; July 1, 2001, to June 30, 2006; and July 1, 2006, to Dec. 31, 2010.

Overall, the number of colonoscopy procedures increased during the study period, from 305 per 10,000 people in 1996-1997 to 870 per 10,000 people in 2010-2011, and the percentage of individuals who underwent complete colonoscopies increased from 67% in the 1996-2001 period to 88% in the 2006-2010 period. “There was a considerable increase in the proportion of colonoscopies performed in younger age groups and community clinics in successive study periods,” the researchers noted.

Comparing the 2006-2010 and 1996-2001 time periods yielded adjusted odds of PCCRC, distal PCCRC, and proximal PCCRC of 1.14, 1.11, and 1.14, respectively; the trends were not affected by endoscopist specialty or institutional setting.

“Our findings are concerning for lack of improvement in colonoscopy practice quality in Ontario, particularly in the wake of greater emphasis having been placed on colonoscopy quality metrics during the study period,” the researchers said. The findings contrast with the decline in PCCRC rates in the United Kingdom reported in a previous study of a similar time period, they noted.

The study findings were limited by several factors, including possible patient and outcome misclassification, an unvalidated definition for PCCRC, and unmeasured confounders such as changes in practice or changes in the definition of PCCRC. Although more research is needed in other jurisdictions to confirm, the results “call for increased population-based practice audit as well as endoscopy educational programs and certification requirements.”

The study was supported by a research grant to Dr. Murthy from the University of Ottawa. The researchers had no financial conflicts to disclose.

SOURCE: Murthy S et al. Gastrointest Endosc. 2018 Jan 6. doi: 10.1016/j.gie.2017.12.027

The number of colorectal cancers diagnosed after a colonoscopy remained consistent at approximately 8% over a 15-year period despite the introduction of quality improvement measures, according to data from a population-based cohort study of more than 1 million individuals in Canada.

“It is believed that the majority of PCCRCs [postcolonoscopy colorectal cancers] arise due to cancers or near cancers that were either missed or incompletely treated during colonoscopy,” wrote Sanjay K. Murthy, MD, of the University of Ottawa, and colleagues.

Established quality improvement measures included adenoma detection rate, cecal intubation rate, colonoscopy withdrawal time, and endoscopy training standards, but how well the measures have been implemented remains uncertain, the researchers said. In a study published in Gastrointestinal Endoscopy (2018 Jan 6. doi: 10.1016/j.gie.2017.12.027), the researchers assessed data from 1,093,658 eligible adults aged 50-74 years over a 15-year period. The time period was divided into three sections: July 1, 1996, to June 30, 2001; July 1, 2001, to June 30, 2006; and July 1, 2006, to Dec. 31, 2010.

Overall, the number of colonoscopy procedures increased during the study period, from 305 per 10,000 people in 1996-1997 to 870 per 10,000 people in 2010-2011, and the percentage of individuals who underwent complete colonoscopies increased from 67% in the 1996-2001 period to 88% in the 2006-2010 period. “There was a considerable increase in the proportion of colonoscopies performed in younger age groups and community clinics in successive study periods,” the researchers noted.

Comparing the 2006-2010 and 1996-2001 time periods yielded adjusted odds of PCCRC, distal PCCRC, and proximal PCCRC of 1.14, 1.11, and 1.14, respectively; the trends were not affected by endoscopist specialty or institutional setting.

“Our findings are concerning for lack of improvement in colonoscopy practice quality in Ontario, particularly in the wake of greater emphasis having been placed on colonoscopy quality metrics during the study period,” the researchers said. The findings contrast with the decline in PCCRC rates in the United Kingdom reported in a previous study of a similar time period, they noted.

The study findings were limited by several factors, including possible patient and outcome misclassification, an unvalidated definition for PCCRC, and unmeasured confounders such as changes in practice or changes in the definition of PCCRC. Although more research is needed in other jurisdictions to confirm, the results “call for increased population-based practice audit as well as endoscopy educational programs and certification requirements.”

The study was supported by a research grant to Dr. Murthy from the University of Ottawa. The researchers had no financial conflicts to disclose.

SOURCE: Murthy S et al. Gastrointest Endosc. 2018 Jan 6. doi: 10.1016/j.gie.2017.12.027

A lot has changed in acute myocardial infarction management in the 36 years since investigators for the Beta-Blocker Heart Attack Trial (BHAT) reported that the treatment of AMI in patients with propranolol, the beta-blocker of the day, reduced mortality by over 25% over 3 years (JAMA. 1981 Nov 6;246[18]:2073-4), and a European trial of timolol confirmed those findings.

New medications have been developed, including ACE inhibitors, statins, and a variety of drugs that modify the thrombotic process that occurs with the event. In addition, endovascular procedures have modified the obstructive coronary vascular anatomy that precipitated the event. At the same time, the definition of an AMI has changed dramatically, now depending in many instances on transitory elevation of the highly sensitive troponins. The BHAT definition depended largely on electrocardiographic changes associated with the event, which were ST-segment elevations in 79% of the occurrences, or significant ST-segment changes associated often with elevation of the insensitive enzyme, serum glutamic transaminase, and significant symptoms. The characteristics of the BHAT patient only faintly resemble the patients who we now classify with AMIs, and its definition expanded well beyond the BHAT patients. And yet beta-blocker therapy is still part of the class I or II recommendations for the treatment of an AMI.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

A lot has changed in acute myocardial infarction management in the 36 years since investigators for the Beta-Blocker Heart Attack Trial (BHAT) reported that the treatment of AMI in patients with propranolol, the beta-blocker of the day, reduced mortality by over 25% over 3 years (JAMA. 1981 Nov 6;246[18]:2073-4), and a European trial of timolol confirmed those findings.

New medications have been developed, including ACE inhibitors, statins, and a variety of drugs that modify the thrombotic process that occurs with the event. In addition, endovascular procedures have modified the obstructive coronary vascular anatomy that precipitated the event. At the same time, the definition of an AMI has changed dramatically, now depending in many instances on transitory elevation of the highly sensitive troponins. The BHAT definition depended largely on electrocardiographic changes associated with the event, which were ST-segment elevations in 79% of the occurrences, or significant ST-segment changes associated often with elevation of the insensitive enzyme, serum glutamic transaminase, and significant symptoms. The characteristics of the BHAT patient only faintly resemble the patients who we now classify with AMIs, and its definition expanded well beyond the BHAT patients. And yet beta-blocker therapy is still part of the class I or II recommendations for the treatment of an AMI.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

A lot has changed in acute myocardial infarction management in the 36 years since investigators for the Beta-Blocker Heart Attack Trial (BHAT) reported that the treatment of AMI in patients with propranolol, the beta-blocker of the day, reduced mortality by over 25% over 3 years (JAMA. 1981 Nov 6;246[18]:2073-4), and a European trial of timolol confirmed those findings.

New medications have been developed, including ACE inhibitors, statins, and a variety of drugs that modify the thrombotic process that occurs with the event. In addition, endovascular procedures have modified the obstructive coronary vascular anatomy that precipitated the event. At the same time, the definition of an AMI has changed dramatically, now depending in many instances on transitory elevation of the highly sensitive troponins. The BHAT definition depended largely on electrocardiographic changes associated with the event, which were ST-segment elevations in 79% of the occurrences, or significant ST-segment changes associated often with elevation of the insensitive enzyme, serum glutamic transaminase, and significant symptoms. The characteristics of the BHAT patient only faintly resemble the patients who we now classify with AMIs, and its definition expanded well beyond the BHAT patients. And yet beta-blocker therapy is still part of the class I or II recommendations for the treatment of an AMI.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.