Key clinical point: Among women with breast cancer and high clinical risk, a subgroup of patients with low genomic risk identified by the 70-gene signature showed excellent distant metastasis-free survival (DMFS) even without chemotherapy. No benefits of chemotherapy were observed in women older than 50 years.

Major finding: Eight-year DMFS in patients with high clinical but low genomic risk with vs. without chemotherapy was 92.0% vs. 89.4%, with the benefit of adding chemotherapy to endocrine therapy remaining small (absolute difference, 2·6 percentage points). Chemotherapy showed no benefits in older women aged more than 50 years (absolute difference, 0.2 percentage points).

Study details: Findings are from the 8-year analysis of phase 3 MINDACT trial, including women with primary nonmetastatic invasive breast cancer with up to 3 positive lymph nodes. The 70-gene signature (MammaPrint) identified women with high clinical but low genomic risk who were randomly assigned to chemotherapy (n=749) vs. no chemotherapy (n=748).

Disclosures: This study was funded by European Commission Sixth Framework Programme (ECSFP). Some investigators including the lead author reported ties with various pharmaceutical companies and funding agencies including the ECSFP.

Source: Piccart M et al. Lancet Oncol. 2021 Mar 12. doi: 10.1016/S1470-2045(21)00007-3.

Key clinical point: Among women with breast cancer and high clinical risk, a subgroup of patients with low genomic risk identified by the 70-gene signature showed excellent distant metastasis-free survival (DMFS) even without chemotherapy. No benefits of chemotherapy were observed in women older than 50 years.

Major finding: Eight-year DMFS in patients with high clinical but low genomic risk with vs. without chemotherapy was 92.0% vs. 89.4%, with the benefit of adding chemotherapy to endocrine therapy remaining small (absolute difference, 2·6 percentage points). Chemotherapy showed no benefits in older women aged more than 50 years (absolute difference, 0.2 percentage points).

Study details: Findings are from the 8-year analysis of phase 3 MINDACT trial, including women with primary nonmetastatic invasive breast cancer with up to 3 positive lymph nodes. The 70-gene signature (MammaPrint) identified women with high clinical but low genomic risk who were randomly assigned to chemotherapy (n=749) vs. no chemotherapy (n=748).

Disclosures: This study was funded by European Commission Sixth Framework Programme (ECSFP). Some investigators including the lead author reported ties with various pharmaceutical companies and funding agencies including the ECSFP.

Source: Piccart M et al. Lancet Oncol. 2021 Mar 12. doi: 10.1016/S1470-2045(21)00007-3.

Key clinical point: Among women with breast cancer and high clinical risk, a subgroup of patients with low genomic risk identified by the 70-gene signature showed excellent distant metastasis-free survival (DMFS) even without chemotherapy. No benefits of chemotherapy were observed in women older than 50 years.

Major finding: Eight-year DMFS in patients with high clinical but low genomic risk with vs. without chemotherapy was 92.0% vs. 89.4%, with the benefit of adding chemotherapy to endocrine therapy remaining small (absolute difference, 2·6 percentage points). Chemotherapy showed no benefits in older women aged more than 50 years (absolute difference, 0.2 percentage points).

Study details: Findings are from the 8-year analysis of phase 3 MINDACT trial, including women with primary nonmetastatic invasive breast cancer with up to 3 positive lymph nodes. The 70-gene signature (MammaPrint) identified women with high clinical but low genomic risk who were randomly assigned to chemotherapy (n=749) vs. no chemotherapy (n=748).

Disclosures: This study was funded by European Commission Sixth Framework Programme (ECSFP). Some investigators including the lead author reported ties with various pharmaceutical companies and funding agencies including the ECSFP.

Source: Piccart M et al. Lancet Oncol. 2021 Mar 12. doi: 10.1016/S1470-2045(21)00007-3.

Key clinical point: Among women with breast cancer and high clinical risk, a subgroup of patients with low genomic risk identified by the 70-gene signature showed excellent distant metastasis-free survival (DMFS) even without chemotherapy. No benefits of chemotherapy were observed in women older than 50 years.

Major finding: Eight-year DMFS in patients with high clinical but low genomic risk with vs. without chemotherapy was 92.0% vs. 89.4%, with the benefit of adding chemotherapy to endocrine therapy remaining small (absolute difference, 2·6 percentage points). Chemotherapy showed no benefits in older women aged more than 50 years (absolute difference, 0.2 percentage points).

Study details: Findings are from the 8-year analysis of phase 3 MINDACT trial, including women with primary nonmetastatic invasive breast cancer with up to 3 positive lymph nodes. The 70-gene signature (MammaPrint) identified women with high clinical but low genomic risk who were randomly assigned to chemotherapy (n=749) vs. no chemotherapy (n=748).

Disclosures: This study was funded by European Commission Sixth Framework Programme (ECSFP). Some investigators including the lead author reported ties with various pharmaceutical companies and funding agencies including the ECSFP.

Source: Piccart M et al. Lancet Oncol. 2021 Mar 12. doi: 10.1016/S1470-2045(21)00007-3.

Key clinical point: Among women with breast cancer and high clinical risk, a subgroup of patients with low genomic risk identified by the 70-gene signature showed excellent distant metastasis-free survival (DMFS) even without chemotherapy. No benefits of chemotherapy were observed in women older than 50 years.

Major finding: Eight-year DMFS in patients with high clinical but low genomic risk with vs. without chemotherapy was 92.0% vs. 89.4%, with the benefit of adding chemotherapy to endocrine therapy remaining small (absolute difference, 2·6 percentage points). Chemotherapy showed no benefits in older women aged more than 50 years (absolute difference, 0.2 percentage points).

Study details: Findings are from the 8-year analysis of phase 3 MINDACT trial, including women with primary nonmetastatic invasive breast cancer with up to 3 positive lymph nodes. The 70-gene signature (MammaPrint) identified women with high clinical but low genomic risk who were randomly assigned to chemotherapy (n=749) vs. no chemotherapy (n=748).

Disclosures: This study was funded by European Commission Sixth Framework Programme (ECSFP). Some investigators including the lead author reported ties with various pharmaceutical companies and funding agencies including the ECSFP.

Source: Piccart M et al. Lancet Oncol. 2021 Mar 12. doi: 10.1016/S1470-2045(21)00007-3.

Key clinical point: Among women with breast cancer and high clinical risk, a subgroup of patients with low genomic risk identified by the 70-gene signature showed excellent distant metastasis-free survival (DMFS) even without chemotherapy. No benefits of chemotherapy were observed in women older than 50 years.

Major finding: Eight-year DMFS in patients with high clinical but low genomic risk with vs. without chemotherapy was 92.0% vs. 89.4%, with the benefit of adding chemotherapy to endocrine therapy remaining small (absolute difference, 2·6 percentage points). Chemotherapy showed no benefits in older women aged more than 50 years (absolute difference, 0.2 percentage points).

Study details: Findings are from the 8-year analysis of phase 3 MINDACT trial, including women with primary nonmetastatic invasive breast cancer with up to 3 positive lymph nodes. The 70-gene signature (MammaPrint) identified women with high clinical but low genomic risk who were randomly assigned to chemotherapy (n=749) vs. no chemotherapy (n=748).

Disclosures: This study was funded by European Commission Sixth Framework Programme (ECSFP). Some investigators including the lead author reported ties with various pharmaceutical companies and funding agencies including the ECSFP.

Source: Piccart M et al. Lancet Oncol. 2021 Mar 12. doi: 10.1016/S1470-2045(21)00007-3.

In a new randomized trial that investigated the question of whether thrombolysis can be omitted for patients with stroke who are undergoing endovascular thrombectomy for a large-vessel occlusion, results were similar for both approaches.

The MR CLEAN NO IV trial failed to show superiority or noninferiority of direct endovascular treatment over intravenous alteplase (tissue plasminogen activator, tPA) followed by endovascular treatment, and functional outcomes were not significantly different. In addition, hemorrhage rates with or without intravenous alteplase administration before endovascular treatment were similar.

“From the MR CLEAN NO IV results, we cannot change standard practice, as we failed to show superiority of the direct endovascular approach, and we also didn’t meet the noninferiority criteria. So, the standard practice of giving tPA to those eligible still holds,” said co–lead investigator Yvo Roos, MD.

“But I think we can say that these results suggest that there may also not be such a need for tPA in patients who can go straight for endovascular therapy,” said Dr. Roos, who is professor of neurology at Amsterdam Medical Center.

“If we are not sure whether a patient is suitable for tPA because they have a higher bleeding risk, I think we can be reassured about missing the tPA out and going straight to endovascular treatment. So, if in doubt, leave it out,” he added.

Results of the MR CLEAN NO IV trial were presented at the International Stroke Conference sponsored by the American Heart Association.
 

“If in doubt, leave it out”

Dr. Roos noted that three trials have investigated the question regarding dropping thrombolysis for patients who can receive thrombectomy quickly. These are the DIRECT MT, SKIP, and DEVT studies. All of these trials were conducted in Asian countries, and none found differences in functional outcomes between the two approaches.

The largest of these studies – the DIRECT-MT trial, from China, which was a sister study to MR CLEAN NO IV – did show noninferiority of the direct endovascular approach to tPA plus endovascular treatment.

But because of differences in health care logistics and trial populations, the benefits and risks of dropping thrombolysis in Western countries are not known, explained Charles Majoie, MD, who is co–lead investigator of the current trial and is chair of neuroradiology at Amsterdam Medical Center.

The MR CLEAN NO IV trial was designed to show superiority of the direct endovascular approach with noninferiority for hemorrhage. It enrolled 540 European patients who were eligible for both thrombolysis and thrombectomy and who presented to a thrombectomy-capable center. They were randomly assigned to receive thrombolysis plus endovascular therapy or direct endovascular therapy alone.

The mean time from stroke onset to groin puncture (the start of endovascular therapy) was very fast in both groups – 130 minutes in the direct group, and 135 minutes in the tPA group.

The primary outcome was a shift analysis of the Modified Rankin Scale (mRS). On that outcome, the trial failed to show significant superiority of the direct approach (odds ratio, 0.88; 95% confidence interval, 0.65-1.19).

A good functional outcome (mRS, 0-2) was achieved in 49% of the direct thrombectomy group and in 51% of the tPA group (OR, 0.95; 95% CI, 0.65-1.40).

Safety results showed no difference in any of the hemorrhage endpoints between the two groups. The rate of symptomatic intracranial hemorrhage was actually numerically higher in the direct thrombectomy group (5.9% vs. 5.3%).

“One of the most intriguing results of this study is that there was no increase in hemorrhage in the tPA group,” Dr. Roos commented. “This is very surprising, as we have always thought thrombolysis causes an increased bleeding risk. But after these results, we may have to rethink that idea – perhaps it is not the tPA itself that causes bleeding risk but rather the opening up of the vessel.”

On the failure to show noninferiority of the direct approach, Dr. Roos suggested that the trial may have been underpowered in this respect.

“Our sister trial, DIRECT-MT, was a noninferiority study. They had 650 patients, and they just reached noninferiority,” he said. “In MR CLEAN NO IV, we were aiming for superiority, and we had fewer patients – 540. We didn’t show superiority, and we didn’t have quite enough patients to show noninferiority.”

He added that, considering all the four studies together, the results look very similar and suggest no difference between the two approaches.
 

Individualized approach probable

Dr. Majoie suggested that different patients may be suitable for the different approaches.

“I think we are heading for individualized treatment. If we have a young patient and the angiography suite is ready, we could probably skip tPA, but it would be for the neurologist/neuroradiologist to make individualized decisions on this,” he said. “We need to look at subgroups for more information.”

Another large trial that investigated this issue, SWIFT-DIRECT, is expected to be presented later this year. An Australian trial, DIRECT-SAFE, is ongoing and is at an early stage of recruitment.

Dr. Roos said that the data from all the trials will be combined for a more comprehensive analysis of the benefits and risks of the two approaches in various subgroups.

Commenting on the study was cochair of the ISC session at which it was presented, Tudor Jovin, MD, chair of neurology at Cooper University Hospital, Cherry Hill, N.J.

“Putting these results together with the previous Asian studies, I think we can say that direct thrombectomy without tPA is clearly not superior to the combined approach of tPA plus thrombectomy,” he said.

Dr. Jovin explained that, in theory, direct thrombectomy could be faster than the combined approach and that the risk for symptomatic intracerebral hemorrhage could be lower. But neither of these two possible benefits were seen in this study.

He agreed with Dr. Roos that MR CLEAN NO IV could have failed to show noninferiority of the direct strategy because the sample was not large enough.

“The results of the two approaches are very similar in this study and in the Asian studies, so it doesn’t appear that tPA adds very much, and it is associated with a significant increase in costs,” he said.

“The answer will probably be that there is not a ‘one-size-fits-all’ strategy, and we may end up using different approaches for different patient groups,” Dr. Jovin added. “Information on this will come from subgroups analyses from these trials.”

MR CLEAN NO-IV trial was part of the CONTRAST consortium, which is supported by the Netherlands Cardiovascular Research Initiative (an initiative of the Dutch Heart Foundation), the Brain Foundation Netherlands, Medtronic, Health-Holland, and Top Sector Life Sciences. The study received additional unrestricted funding from Stryker European Operations. Dr. Roos and Dr. Majoie are shareholders of Nico Lab.

A version of this article first appeared on Medscape.com.

In a new randomized trial that investigated the question of whether thrombolysis can be omitted for patients with stroke who are undergoing endovascular thrombectomy for a large-vessel occlusion, results were similar for both approaches.

The MR CLEAN NO IV trial failed to show superiority or noninferiority of direct endovascular treatment over intravenous alteplase (tissue plasminogen activator, tPA) followed by endovascular treatment, and functional outcomes were not significantly different. In addition, hemorrhage rates with or without intravenous alteplase administration before endovascular treatment were similar.

“From the MR CLEAN NO IV results, we cannot change standard practice, as we failed to show superiority of the direct endovascular approach, and we also didn’t meet the noninferiority criteria. So, the standard practice of giving tPA to those eligible still holds,” said co–lead investigator Yvo Roos, MD.

“But I think we can say that these results suggest that there may also not be such a need for tPA in patients who can go straight for endovascular therapy,” said Dr. Roos, who is professor of neurology at Amsterdam Medical Center.

“If we are not sure whether a patient is suitable for tPA because they have a higher bleeding risk, I think we can be reassured about missing the tPA out and going straight to endovascular treatment. So, if in doubt, leave it out,” he added.

Results of the MR CLEAN NO IV trial were presented at the International Stroke Conference sponsored by the American Heart Association.
 

“If in doubt, leave it out”

Dr. Roos noted that three trials have investigated the question regarding dropping thrombolysis for patients who can receive thrombectomy quickly. These are the DIRECT MT, SKIP, and DEVT studies. All of these trials were conducted in Asian countries, and none found differences in functional outcomes between the two approaches.

The largest of these studies – the DIRECT-MT trial, from China, which was a sister study to MR CLEAN NO IV – did show noninferiority of the direct endovascular approach to tPA plus endovascular treatment.

But because of differences in health care logistics and trial populations, the benefits and risks of dropping thrombolysis in Western countries are not known, explained Charles Majoie, MD, who is co–lead investigator of the current trial and is chair of neuroradiology at Amsterdam Medical Center.

The MR CLEAN NO IV trial was designed to show superiority of the direct endovascular approach with noninferiority for hemorrhage. It enrolled 540 European patients who were eligible for both thrombolysis and thrombectomy and who presented to a thrombectomy-capable center. They were randomly assigned to receive thrombolysis plus endovascular therapy or direct endovascular therapy alone.

The mean time from stroke onset to groin puncture (the start of endovascular therapy) was very fast in both groups – 130 minutes in the direct group, and 135 minutes in the tPA group.

The primary outcome was a shift analysis of the Modified Rankin Scale (mRS). On that outcome, the trial failed to show significant superiority of the direct approach (odds ratio, 0.88; 95% confidence interval, 0.65-1.19).

A good functional outcome (mRS, 0-2) was achieved in 49% of the direct thrombectomy group and in 51% of the tPA group (OR, 0.95; 95% CI, 0.65-1.40).

Safety results showed no difference in any of the hemorrhage endpoints between the two groups. The rate of symptomatic intracranial hemorrhage was actually numerically higher in the direct thrombectomy group (5.9% vs. 5.3%).

“One of the most intriguing results of this study is that there was no increase in hemorrhage in the tPA group,” Dr. Roos commented. “This is very surprising, as we have always thought thrombolysis causes an increased bleeding risk. But after these results, we may have to rethink that idea – perhaps it is not the tPA itself that causes bleeding risk but rather the opening up of the vessel.”

On the failure to show noninferiority of the direct approach, Dr. Roos suggested that the trial may have been underpowered in this respect.

“Our sister trial, DIRECT-MT, was a noninferiority study. They had 650 patients, and they just reached noninferiority,” he said. “In MR CLEAN NO IV, we were aiming for superiority, and we had fewer patients – 540. We didn’t show superiority, and we didn’t have quite enough patients to show noninferiority.”

He added that, considering all the four studies together, the results look very similar and suggest no difference between the two approaches.
 

Individualized approach probable

Dr. Majoie suggested that different patients may be suitable for the different approaches.

“I think we are heading for individualized treatment. If we have a young patient and the angiography suite is ready, we could probably skip tPA, but it would be for the neurologist/neuroradiologist to make individualized decisions on this,” he said. “We need to look at subgroups for more information.”

Another large trial that investigated this issue, SWIFT-DIRECT, is expected to be presented later this year. An Australian trial, DIRECT-SAFE, is ongoing and is at an early stage of recruitment.

Dr. Roos said that the data from all the trials will be combined for a more comprehensive analysis of the benefits and risks of the two approaches in various subgroups.

Commenting on the study was cochair of the ISC session at which it was presented, Tudor Jovin, MD, chair of neurology at Cooper University Hospital, Cherry Hill, N.J.

“Putting these results together with the previous Asian studies, I think we can say that direct thrombectomy without tPA is clearly not superior to the combined approach of tPA plus thrombectomy,” he said.

Dr. Jovin explained that, in theory, direct thrombectomy could be faster than the combined approach and that the risk for symptomatic intracerebral hemorrhage could be lower. But neither of these two possible benefits were seen in this study.

He agreed with Dr. Roos that MR CLEAN NO IV could have failed to show noninferiority of the direct strategy because the sample was not large enough.

“The results of the two approaches are very similar in this study and in the Asian studies, so it doesn’t appear that tPA adds very much, and it is associated with a significant increase in costs,” he said.

“The answer will probably be that there is not a ‘one-size-fits-all’ strategy, and we may end up using different approaches for different patient groups,” Dr. Jovin added. “Information on this will come from subgroups analyses from these trials.”

MR CLEAN NO-IV trial was part of the CONTRAST consortium, which is supported by the Netherlands Cardiovascular Research Initiative (an initiative of the Dutch Heart Foundation), the Brain Foundation Netherlands, Medtronic, Health-Holland, and Top Sector Life Sciences. The study received additional unrestricted funding from Stryker European Operations. Dr. Roos and Dr. Majoie are shareholders of Nico Lab.

A version of this article first appeared on Medscape.com.

In a new randomized trial that investigated the question of whether thrombolysis can be omitted for patients with stroke who are undergoing endovascular thrombectomy for a large-vessel occlusion, results were similar for both approaches.

The MR CLEAN NO IV trial failed to show superiority or noninferiority of direct endovascular treatment over intravenous alteplase (tissue plasminogen activator, tPA) followed by endovascular treatment, and functional outcomes were not significantly different. In addition, hemorrhage rates with or without intravenous alteplase administration before endovascular treatment were similar.

“From the MR CLEAN NO IV results, we cannot change standard practice, as we failed to show superiority of the direct endovascular approach, and we also didn’t meet the noninferiority criteria. So, the standard practice of giving tPA to those eligible still holds,” said co–lead investigator Yvo Roos, MD.

“But I think we can say that these results suggest that there may also not be such a need for tPA in patients who can go straight for endovascular therapy,” said Dr. Roos, who is professor of neurology at Amsterdam Medical Center.

“If we are not sure whether a patient is suitable for tPA because they have a higher bleeding risk, I think we can be reassured about missing the tPA out and going straight to endovascular treatment. So, if in doubt, leave it out,” he added.

Results of the MR CLEAN NO IV trial were presented at the International Stroke Conference sponsored by the American Heart Association.
 

“If in doubt, leave it out”

Dr. Roos noted that three trials have investigated the question regarding dropping thrombolysis for patients who can receive thrombectomy quickly. These are the DIRECT MT, SKIP, and DEVT studies. All of these trials were conducted in Asian countries, and none found differences in functional outcomes between the two approaches.

The largest of these studies – the DIRECT-MT trial, from China, which was a sister study to MR CLEAN NO IV – did show noninferiority of the direct endovascular approach to tPA plus endovascular treatment.

But because of differences in health care logistics and trial populations, the benefits and risks of dropping thrombolysis in Western countries are not known, explained Charles Majoie, MD, who is co–lead investigator of the current trial and is chair of neuroradiology at Amsterdam Medical Center.

The MR CLEAN NO IV trial was designed to show superiority of the direct endovascular approach with noninferiority for hemorrhage. It enrolled 540 European patients who were eligible for both thrombolysis and thrombectomy and who presented to a thrombectomy-capable center. They were randomly assigned to receive thrombolysis plus endovascular therapy or direct endovascular therapy alone.

The mean time from stroke onset to groin puncture (the start of endovascular therapy) was very fast in both groups – 130 minutes in the direct group, and 135 minutes in the tPA group.

The primary outcome was a shift analysis of the Modified Rankin Scale (mRS). On that outcome, the trial failed to show significant superiority of the direct approach (odds ratio, 0.88; 95% confidence interval, 0.65-1.19).

A good functional outcome (mRS, 0-2) was achieved in 49% of the direct thrombectomy group and in 51% of the tPA group (OR, 0.95; 95% CI, 0.65-1.40).

Safety results showed no difference in any of the hemorrhage endpoints between the two groups. The rate of symptomatic intracranial hemorrhage was actually numerically higher in the direct thrombectomy group (5.9% vs. 5.3%).

“One of the most intriguing results of this study is that there was no increase in hemorrhage in the tPA group,” Dr. Roos commented. “This is very surprising, as we have always thought thrombolysis causes an increased bleeding risk. But after these results, we may have to rethink that idea – perhaps it is not the tPA itself that causes bleeding risk but rather the opening up of the vessel.”

On the failure to show noninferiority of the direct approach, Dr. Roos suggested that the trial may have been underpowered in this respect.

“Our sister trial, DIRECT-MT, was a noninferiority study. They had 650 patients, and they just reached noninferiority,” he said. “In MR CLEAN NO IV, we were aiming for superiority, and we had fewer patients – 540. We didn’t show superiority, and we didn’t have quite enough patients to show noninferiority.”

He added that, considering all the four studies together, the results look very similar and suggest no difference between the two approaches.
 

Individualized approach probable

Dr. Majoie suggested that different patients may be suitable for the different approaches.

“I think we are heading for individualized treatment. If we have a young patient and the angiography suite is ready, we could probably skip tPA, but it would be for the neurologist/neuroradiologist to make individualized decisions on this,” he said. “We need to look at subgroups for more information.”

Another large trial that investigated this issue, SWIFT-DIRECT, is expected to be presented later this year. An Australian trial, DIRECT-SAFE, is ongoing and is at an early stage of recruitment.

Dr. Roos said that the data from all the trials will be combined for a more comprehensive analysis of the benefits and risks of the two approaches in various subgroups.

Commenting on the study was cochair of the ISC session at which it was presented, Tudor Jovin, MD, chair of neurology at Cooper University Hospital, Cherry Hill, N.J.

“Putting these results together with the previous Asian studies, I think we can say that direct thrombectomy without tPA is clearly not superior to the combined approach of tPA plus thrombectomy,” he said.

Dr. Jovin explained that, in theory, direct thrombectomy could be faster than the combined approach and that the risk for symptomatic intracerebral hemorrhage could be lower. But neither of these two possible benefits were seen in this study.

He agreed with Dr. Roos that MR CLEAN NO IV could have failed to show noninferiority of the direct strategy because the sample was not large enough.

“The results of the two approaches are very similar in this study and in the Asian studies, so it doesn’t appear that tPA adds very much, and it is associated with a significant increase in costs,” he said.

“The answer will probably be that there is not a ‘one-size-fits-all’ strategy, and we may end up using different approaches for different patient groups,” Dr. Jovin added. “Information on this will come from subgroups analyses from these trials.”

MR CLEAN NO-IV trial was part of the CONTRAST consortium, which is supported by the Netherlands Cardiovascular Research Initiative (an initiative of the Dutch Heart Foundation), the Brain Foundation Netherlands, Medtronic, Health-Holland, and Top Sector Life Sciences. The study received additional unrestricted funding from Stryker European Operations. Dr. Roos and Dr. Majoie are shareholders of Nico Lab.

A version of this article first appeared on Medscape.com.

Key clinical point: Women vs. men with migraine had a higher frequency of self-reported neck pain and higher prevalence and severity of cutaneous allodynia (CA).

Major finding: Women vs. men showed higher prevalence of self-reported neck pain (73.33% vs. 43.33%; P = .04), CA (P = .001), and 4 times higher risk of having severe CA (P = .007).

Study details: Findings are from a cross-sectional study of 30 men and 30 women with migraine.

Disclosures: The study was supported by a grant from the Fundação de Amparo à Pesquisa do Estado de São Paulo to NDS Xavier. No other conflicts of interest were reported.

Source: Xavier NDS et al. Pain Med. 2021 Mar 19. doi: 10.1093/pm/pnab106.

Key clinical point: Women vs. men with migraine had a higher frequency of self-reported neck pain and higher prevalence and severity of cutaneous allodynia (CA).

Major finding: Women vs. men showed higher prevalence of self-reported neck pain (73.33% vs. 43.33%; P = .04), CA (P = .001), and 4 times higher risk of having severe CA (P = .007).

Study details: Findings are from a cross-sectional study of 30 men and 30 women with migraine.

Disclosures: The study was supported by a grant from the Fundação de Amparo à Pesquisa do Estado de São Paulo to NDS Xavier. No other conflicts of interest were reported.

Source: Xavier NDS et al. Pain Med. 2021 Mar 19. doi: 10.1093/pm/pnab106.

Key clinical point: Women vs. men with migraine had a higher frequency of self-reported neck pain and higher prevalence and severity of cutaneous allodynia (CA).

Major finding: Women vs. men showed higher prevalence of self-reported neck pain (73.33% vs. 43.33%; P = .04), CA (P = .001), and 4 times higher risk of having severe CA (P = .007).

Study details: Findings are from a cross-sectional study of 30 men and 30 women with migraine.

Disclosures: The study was supported by a grant from the Fundação de Amparo à Pesquisa do Estado de São Paulo to NDS Xavier. No other conflicts of interest were reported.

Source: Xavier NDS et al. Pain Med. 2021 Mar 19. doi: 10.1093/pm/pnab106.

Key clinical point: People with migraine may experience a wide range of comorbidities and co-occurring conditions, which should be managed effectively.

Major finding: Patients with vs. without migraine were 3 times more likely to experience insomnia (adjusted odds ratio [aOR], 3.79; 95% confidence interval, [95% CI], 3.6-4.0), depression (aOR, 3.18; 95% CI, 3.0-3.3), anxiety (aOR, 3.18; 95% CI, 3.0-3.3), and gastric ulcer/gastrointestinal bleeding (aOR, 3.11; 95% CI, 2.8-3.5).

Study details: Data come from the prospective, web-based Migraine in America Symptoms and Treatment survey involving adults with (n=15,133) and without migraine (n=77,453).

Disclosures: The study was funded and sponsored by Dr. Reddy’s Laboratories group of companies, Princeton, USA. The lead author along with others declared receiving grant support and/or honoraria from various sources. S Munjal and P Singh declared being employees while RB Lipton, DC Buse, ML Reed, TJ Schwedt, and DW Dodick reported being consultants at Dr. Reddy’s Laboratories.

Source: Buse DC et al. J Headache Pain. 2020 Mar 2. doi: 10.1186/s10194-020-1084-y.

Key clinical point: People with migraine may experience a wide range of comorbidities and co-occurring conditions, which should be managed effectively.

Major finding: Patients with vs. without migraine were 3 times more likely to experience insomnia (adjusted odds ratio [aOR], 3.79; 95% confidence interval, [95% CI], 3.6-4.0), depression (aOR, 3.18; 95% CI, 3.0-3.3), anxiety (aOR, 3.18; 95% CI, 3.0-3.3), and gastric ulcer/gastrointestinal bleeding (aOR, 3.11; 95% CI, 2.8-3.5).

Study details: Data come from the prospective, web-based Migraine in America Symptoms and Treatment survey involving adults with (n=15,133) and without migraine (n=77,453).

Disclosures: The study was funded and sponsored by Dr. Reddy’s Laboratories group of companies, Princeton, USA. The lead author along with others declared receiving grant support and/or honoraria from various sources. S Munjal and P Singh declared being employees while RB Lipton, DC Buse, ML Reed, TJ Schwedt, and DW Dodick reported being consultants at Dr. Reddy’s Laboratories.

Source: Buse DC et al. J Headache Pain. 2020 Mar 2. doi: 10.1186/s10194-020-1084-y.

Key clinical point: People with migraine may experience a wide range of comorbidities and co-occurring conditions, which should be managed effectively.

Major finding: Patients with vs. without migraine were 3 times more likely to experience insomnia (adjusted odds ratio [aOR], 3.79; 95% confidence interval, [95% CI], 3.6-4.0), depression (aOR, 3.18; 95% CI, 3.0-3.3), anxiety (aOR, 3.18; 95% CI, 3.0-3.3), and gastric ulcer/gastrointestinal bleeding (aOR, 3.11; 95% CI, 2.8-3.5).

Study details: Data come from the prospective, web-based Migraine in America Symptoms and Treatment survey involving adults with (n=15,133) and without migraine (n=77,453).

Disclosures: The study was funded and sponsored by Dr. Reddy’s Laboratories group of companies, Princeton, USA. The lead author along with others declared receiving grant support and/or honoraria from various sources. S Munjal and P Singh declared being employees while RB Lipton, DC Buse, ML Reed, TJ Schwedt, and DW Dodick reported being consultants at Dr. Reddy’s Laboratories.

Source: Buse DC et al. J Headache Pain. 2020 Mar 2. doi: 10.1186/s10194-020-1084-y.

Key clinical point: Addition of a calcitonin gene-related peptide (CGRP)-targeted monoclonal antibodies (mAbs) in patients with chronic migraine (CM) receiving onabotulinumtoxinA (onabot) resulted in further reductions in monthly headache days (MHDs) without major tolerability issues.

Major finding: Patients reported an average decrease of 10.9 MHDs (P less than .001) after onabot treatment and a further decrease of 5.7 MHDs (P less than .001) after addition of CGRP-targeted mAbs resulting in a total decrease of 16.6 MHDs (P less than .001) with combined therapy. No serious adverse events were reported.

Study details: The data come from a retrospective review of 153 patients with CM receiving onabot and subsequently prescribed CGRP-targeted mAbs.

Disclosures: The study did not receive any funding. The lead author F Cohen reported no conflicts of interest. The other authors declared receiving honoraria and research support from various sources and serving as consultant and/or advisory board member for various pharmaceutical companies.

Source: Cohen F et al. Pain Med. 2021 Mar 8. doi: 10.1093/pm/pnab093.

Key clinical point: Addition of a calcitonin gene-related peptide (CGRP)-targeted monoclonal antibodies (mAbs) in patients with chronic migraine (CM) receiving onabotulinumtoxinA (onabot) resulted in further reductions in monthly headache days (MHDs) without major tolerability issues.

Major finding: Patients reported an average decrease of 10.9 MHDs (P less than .001) after onabot treatment and a further decrease of 5.7 MHDs (P less than .001) after addition of CGRP-targeted mAbs resulting in a total decrease of 16.6 MHDs (P less than .001) with combined therapy. No serious adverse events were reported.

Study details: The data come from a retrospective review of 153 patients with CM receiving onabot and subsequently prescribed CGRP-targeted mAbs.

Disclosures: The study did not receive any funding. The lead author F Cohen reported no conflicts of interest. The other authors declared receiving honoraria and research support from various sources and serving as consultant and/or advisory board member for various pharmaceutical companies.

Source: Cohen F et al. Pain Med. 2021 Mar 8. doi: 10.1093/pm/pnab093.

Key clinical point: Addition of a calcitonin gene-related peptide (CGRP)-targeted monoclonal antibodies (mAbs) in patients with chronic migraine (CM) receiving onabotulinumtoxinA (onabot) resulted in further reductions in monthly headache days (MHDs) without major tolerability issues.

Major finding: Patients reported an average decrease of 10.9 MHDs (P less than .001) after onabot treatment and a further decrease of 5.7 MHDs (P less than .001) after addition of CGRP-targeted mAbs resulting in a total decrease of 16.6 MHDs (P less than .001) with combined therapy. No serious adverse events were reported.

Study details: The data come from a retrospective review of 153 patients with CM receiving onabot and subsequently prescribed CGRP-targeted mAbs.

Disclosures: The study did not receive any funding. The lead author F Cohen reported no conflicts of interest. The other authors declared receiving honoraria and research support from various sources and serving as consultant and/or advisory board member for various pharmaceutical companies.

Source: Cohen F et al. Pain Med. 2021 Mar 8. doi: 10.1093/pm/pnab093.

Key clinical point: Intravenous eptinezumab demonstrated a favorable safety profile in patients with chronic migraine (CM).

Major finding: Overall, 71.1% of patients experienced 1 or more treatment-emergent adverse events (TEAEs) during the entire 2 years of study duration with majority (95.6%) being mild or moderate. TEAEs leading to drug discontinuation or withdrawal were observed in only 7.8% and 6.3% of patients, respectively. Incidence of serious TEAEs and drug-related AEs was low.

Study details: PREVAIL, an open-label phase 3 trial, included 128 adults with CM who received at least 1 dose of eptinezumab (300 mg) every 12 weeks for up to 8 doses.

Disclosures: This study was funded by H. Lundbeck A/S, Copenhagen, Denmark. D Kudrow reported receiving grant support from, being on advisory board, and/or being speaker for multiple sources. Some of the authors reported being current/former full-time employees at Lundbeck Seattle BioPharmaceuticals or Alder Biopharmaceuticals (CKA Lundbeck Seattle Biopharmaceuticals, Inc).

Source: Kudrow D et al. BMC Neurol. 2021 Mar 19. doi: 10.1186/s12883-021-02123-w.

Key clinical point: Intravenous eptinezumab demonstrated a favorable safety profile in patients with chronic migraine (CM).

Major finding: Overall, 71.1% of patients experienced 1 or more treatment-emergent adverse events (TEAEs) during the entire 2 years of study duration with majority (95.6%) being mild or moderate. TEAEs leading to drug discontinuation or withdrawal were observed in only 7.8% and 6.3% of patients, respectively. Incidence of serious TEAEs and drug-related AEs was low.

Study details: PREVAIL, an open-label phase 3 trial, included 128 adults with CM who received at least 1 dose of eptinezumab (300 mg) every 12 weeks for up to 8 doses.

Disclosures: This study was funded by H. Lundbeck A/S, Copenhagen, Denmark. D Kudrow reported receiving grant support from, being on advisory board, and/or being speaker for multiple sources. Some of the authors reported being current/former full-time employees at Lundbeck Seattle BioPharmaceuticals or Alder Biopharmaceuticals (CKA Lundbeck Seattle Biopharmaceuticals, Inc).

Source: Kudrow D et al. BMC Neurol. 2021 Mar 19. doi: 10.1186/s12883-021-02123-w.

Key clinical point: Intravenous eptinezumab demonstrated a favorable safety profile in patients with chronic migraine (CM).

Major finding: Overall, 71.1% of patients experienced 1 or more treatment-emergent adverse events (TEAEs) during the entire 2 years of study duration with majority (95.6%) being mild or moderate. TEAEs leading to drug discontinuation or withdrawal were observed in only 7.8% and 6.3% of patients, respectively. Incidence of serious TEAEs and drug-related AEs was low.

Study details: PREVAIL, an open-label phase 3 trial, included 128 adults with CM who received at least 1 dose of eptinezumab (300 mg) every 12 weeks for up to 8 doses.

Disclosures: This study was funded by H. Lundbeck A/S, Copenhagen, Denmark. D Kudrow reported receiving grant support from, being on advisory board, and/or being speaker for multiple sources. Some of the authors reported being current/former full-time employees at Lundbeck Seattle BioPharmaceuticals or Alder Biopharmaceuticals (CKA Lundbeck Seattle Biopharmaceuticals, Inc).

Source: Kudrow D et al. BMC Neurol. 2021 Mar 19. doi: 10.1186/s12883-021-02123-w.

Sandy was placed in memory care recently.

In my world, as a 23-year veteran of the neurology frontline trenches, this is a pretty common occurrence for my patients.

But Sandy isn’t my patient.

She’s a longtime friend.

My parents met Sandy and her husband on New Year’s Eve, 1968. I was 2. Phoenix wasn’t a particularly big city back then.

Growing up we had summer pool parties and get-togethers with them and other families. My mom and Sandy have close birthdays, and when they both turned 50 their husbands threw them a combined 100-year surprise party. As couples they made occasional trips to Las Vegas.

In adolescence, when my voice changed, I sounded a lot like my dad, and Sandy could never tell us apart. So when I answered the phone and she thought it was him, I’d just fly with the conversation, becoming increasingly preposterous until she said: “Okay, now I know who this is. Let me talk to your mom.” Maybe she was just humoring me the whole time. But it was good for a laugh.

Ten years ago my mom mentioned Sandy had been diagnosed with Alzheimer’s disease by another neurologist in town. For a long time her deterioration was slow.

I last saw her 8 years ago, at my dad’s services. At that time we had a nice conversation. I didn’t go into my trained “neurology mode” – I’ve never been her doctor – but enjoyed talking to her as a family friend I hadn’t seen in years. There were a few gaps in her memory, but she was still the person I’d always been fond of.

Eight years is a long time in Alzheimer’s disease, and she finally reached the point where placement was no longer an option. My mom had spoken to her the week before, but told me Sandy couldn’t really carry a conversation now.

Sandy isn’t dead, but by the same token she is. Placement in memory care is often the realization that the person we knew and loved isn’t there anymore. In a world where we can often keep people physically up and around, our ability to do the same with their minds and souls is still desperately in need of a truly effective treatment. Such treatment isn’t even on the horizon ... yet.

As a neurologist, I know this reality. I explain it to families every day.

But when it comes to someone I know outside of my profession, that doesn’t make it any easier.

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

Sandy was placed in memory care recently.

In my world, as a 23-year veteran of the neurology frontline trenches, this is a pretty common occurrence for my patients.

But Sandy isn’t my patient.

She’s a longtime friend.

My parents met Sandy and her husband on New Year’s Eve, 1968. I was 2. Phoenix wasn’t a particularly big city back then.

Growing up we had summer pool parties and get-togethers with them and other families. My mom and Sandy have close birthdays, and when they both turned 50 their husbands threw them a combined 100-year surprise party. As couples they made occasional trips to Las Vegas.

In adolescence, when my voice changed, I sounded a lot like my dad, and Sandy could never tell us apart. So when I answered the phone and she thought it was him, I’d just fly with the conversation, becoming increasingly preposterous until she said: “Okay, now I know who this is. Let me talk to your mom.” Maybe she was just humoring me the whole time. But it was good for a laugh.

Ten years ago my mom mentioned Sandy had been diagnosed with Alzheimer’s disease by another neurologist in town. For a long time her deterioration was slow.

I last saw her 8 years ago, at my dad’s services. At that time we had a nice conversation. I didn’t go into my trained “neurology mode” – I’ve never been her doctor – but enjoyed talking to her as a family friend I hadn’t seen in years. There were a few gaps in her memory, but she was still the person I’d always been fond of.

Eight years is a long time in Alzheimer’s disease, and she finally reached the point where placement was no longer an option. My mom had spoken to her the week before, but told me Sandy couldn’t really carry a conversation now.

Sandy isn’t dead, but by the same token she is. Placement in memory care is often the realization that the person we knew and loved isn’t there anymore. In a world where we can often keep people physically up and around, our ability to do the same with their minds and souls is still desperately in need of a truly effective treatment. Such treatment isn’t even on the horizon ... yet.

As a neurologist, I know this reality. I explain it to families every day.

But when it comes to someone I know outside of my profession, that doesn’t make it any easier.

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

Sandy was placed in memory care recently.

In my world, as a 23-year veteran of the neurology frontline trenches, this is a pretty common occurrence for my patients.

But Sandy isn’t my patient.

She’s a longtime friend.

My parents met Sandy and her husband on New Year’s Eve, 1968. I was 2. Phoenix wasn’t a particularly big city back then.

Growing up we had summer pool parties and get-togethers with them and other families. My mom and Sandy have close birthdays, and when they both turned 50 their husbands threw them a combined 100-year surprise party. As couples they made occasional trips to Las Vegas.

In adolescence, when my voice changed, I sounded a lot like my dad, and Sandy could never tell us apart. So when I answered the phone and she thought it was him, I’d just fly with the conversation, becoming increasingly preposterous until she said: “Okay, now I know who this is. Let me talk to your mom.” Maybe she was just humoring me the whole time. But it was good for a laugh.

Ten years ago my mom mentioned Sandy had been diagnosed with Alzheimer’s disease by another neurologist in town. For a long time her deterioration was slow.

I last saw her 8 years ago, at my dad’s services. At that time we had a nice conversation. I didn’t go into my trained “neurology mode” – I’ve never been her doctor – but enjoyed talking to her as a family friend I hadn’t seen in years. There were a few gaps in her memory, but she was still the person I’d always been fond of.

Eight years is a long time in Alzheimer’s disease, and she finally reached the point where placement was no longer an option. My mom had spoken to her the week before, but told me Sandy couldn’t really carry a conversation now.

Sandy isn’t dead, but by the same token she is. Placement in memory care is often the realization that the person we knew and loved isn’t there anymore. In a world where we can often keep people physically up and around, our ability to do the same with their minds and souls is still desperately in need of a truly effective treatment. Such treatment isn’t even on the horizon ... yet.

As a neurologist, I know this reality. I explain it to families every day.

But when it comes to someone I know outside of my profession, that doesn’t make it any easier.

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

A novel technique for pulmonary nodule ablation is feasible and safe for the treatment of early-stage lung cancers, lung metastases, and highly suspicious lung nodules, according to investigators.

The technique – bronchoscopic transbronchial microwave ablation – had a 100% technical success rate and produced low rates of complications in a single-center study.

“We combined the best of both worlds [for this] technique,” said investigator Joyce Chan, MBBS, of Prince of Wales Hospital in Hong Kong, when describing the method at the European Lung Cancer Virtual Congress 2021 (Abstract 64MO).

Dr. Chan explained that microwave ablation of lung nodules is faster and produces larger ablation zones, compared with radiofrequency ablation, and bronchoscopic ablation is thought to produce fewer pleural-based complications than percutaneous ablation.

Bronchoscopic transbronchial microwave ablation is performed in a hybrid operating room. First, the patient is intubated and anesthetized. Then, electromagnetic navigation bronchoscopy is used to zero in on the lung nodule, which is punctured by a microwave catheter. Cone-beam CT is used to confirm the location of the catheter.

“Next, we connect the system externally to a console, and then we just press the button to microwave it, just like what you do to food,” Dr. Chan explained.

Ablation takes about 10 minutes, and another CT is done to assess success. Ground-glass opacities are seen in the ablated area.
 

Study results

Dr. Chan and colleagues performed a retrospective analysis of 36 patients who underwent bronchoscopic transbronchial microwave ablation between March 2019 and December 2020.

The patients were unfit for or unwilling to undergo surgical resection. They had to have stage 1a lung cancers, isolated lung oligometastases, or radiologically suspicious lesions. The nodules had to be less than 3 cm in size, preferably with a bronchus leading directly to the lesion.

The patients had a mean age of 68 years. Their lesions had a mean maximal diameter of 15.2 mm, and 68% were in the peripheral one-third of the lung.

In all, 44 nodules were treated with bronchoscopic transbronchial microwave ablation. The technical success rate was 100%, although eight nodules required double ablation.

The majority of patients (95%) were discharged within 3 days, with 77% discharged on day 1. Complications included mild pain (15.9%), pneumothorax (9.1%), fever/ablation reaction (4.5%), self-limiting hemoptysis (2.3%), and bronchopleural fistula (2.3%).

The ablation zone volume decreased “rapidly” in the first 6-9 months, then leveled off, Dr. Chan noted.

In the 16 nodules with 1 year of follow-up, there were 2 complete responses, 13 partial responses, and no progressions.

It’s too soon to know if the recurrence rate will be lower than the up to 30% recurrence rate with percutaneous microwave ablation, and it’s too soon to know if, without transpleural puncture, the risk of tumor seeding is lower, Dr. Chan said.

“This presentation ... is extremely important,” said invited discussant John Edwards, MBChB, PhD, of Sheffield (England) Teaching Hospitals National Health Service Foundation Trust. “There is a great novelty value in the combination. The complications and the radiologic response rates were quite acceptable.”

The research was funded by the University Grants Committee in Hong Kong. Dr. Chan reported having no disclosures. Her colleagues disclosed relationships with Medtronic, Siemens Healthineers, and Johnson & Johnson. Dr. Edwards disclosed relationships with AstraZeneca, Zimmer Biomet, Stryker Leibinger, Pacific Biosciences, BioNano Genomics, Argenx, and Moderna.

[email protected]

A novel technique for pulmonary nodule ablation is feasible and safe for the treatment of early-stage lung cancers, lung metastases, and highly suspicious lung nodules, according to investigators.

The technique – bronchoscopic transbronchial microwave ablation – had a 100% technical success rate and produced low rates of complications in a single-center study.

“We combined the best of both worlds [for this] technique,” said investigator Joyce Chan, MBBS, of Prince of Wales Hospital in Hong Kong, when describing the method at the European Lung Cancer Virtual Congress 2021 (Abstract 64MO).

Dr. Chan explained that microwave ablation of lung nodules is faster and produces larger ablation zones, compared with radiofrequency ablation, and bronchoscopic ablation is thought to produce fewer pleural-based complications than percutaneous ablation.

Bronchoscopic transbronchial microwave ablation is performed in a hybrid operating room. First, the patient is intubated and anesthetized. Then, electromagnetic navigation bronchoscopy is used to zero in on the lung nodule, which is punctured by a microwave catheter. Cone-beam CT is used to confirm the location of the catheter.

“Next, we connect the system externally to a console, and then we just press the button to microwave it, just like what you do to food,” Dr. Chan explained.

Ablation takes about 10 minutes, and another CT is done to assess success. Ground-glass opacities are seen in the ablated area.
 

Study results

Dr. Chan and colleagues performed a retrospective analysis of 36 patients who underwent bronchoscopic transbronchial microwave ablation between March 2019 and December 2020.

The patients were unfit for or unwilling to undergo surgical resection. They had to have stage 1a lung cancers, isolated lung oligometastases, or radiologically suspicious lesions. The nodules had to be less than 3 cm in size, preferably with a bronchus leading directly to the lesion.

The patients had a mean age of 68 years. Their lesions had a mean maximal diameter of 15.2 mm, and 68% were in the peripheral one-third of the lung.

In all, 44 nodules were treated with bronchoscopic transbronchial microwave ablation. The technical success rate was 100%, although eight nodules required double ablation.

The majority of patients (95%) were discharged within 3 days, with 77% discharged on day 1. Complications included mild pain (15.9%), pneumothorax (9.1%), fever/ablation reaction (4.5%), self-limiting hemoptysis (2.3%), and bronchopleural fistula (2.3%).

The ablation zone volume decreased “rapidly” in the first 6-9 months, then leveled off, Dr. Chan noted.

In the 16 nodules with 1 year of follow-up, there were 2 complete responses, 13 partial responses, and no progressions.

It’s too soon to know if the recurrence rate will be lower than the up to 30% recurrence rate with percutaneous microwave ablation, and it’s too soon to know if, without transpleural puncture, the risk of tumor seeding is lower, Dr. Chan said.

“This presentation ... is extremely important,” said invited discussant John Edwards, MBChB, PhD, of Sheffield (England) Teaching Hospitals National Health Service Foundation Trust. “There is a great novelty value in the combination. The complications and the radiologic response rates were quite acceptable.”

The research was funded by the University Grants Committee in Hong Kong. Dr. Chan reported having no disclosures. Her colleagues disclosed relationships with Medtronic, Siemens Healthineers, and Johnson & Johnson. Dr. Edwards disclosed relationships with AstraZeneca, Zimmer Biomet, Stryker Leibinger, Pacific Biosciences, BioNano Genomics, Argenx, and Moderna.

[email protected]

A novel technique for pulmonary nodule ablation is feasible and safe for the treatment of early-stage lung cancers, lung metastases, and highly suspicious lung nodules, according to investigators.

The technique – bronchoscopic transbronchial microwave ablation – had a 100% technical success rate and produced low rates of complications in a single-center study.

“We combined the best of both worlds [for this] technique,” said investigator Joyce Chan, MBBS, of Prince of Wales Hospital in Hong Kong, when describing the method at the European Lung Cancer Virtual Congress 2021 (Abstract 64MO).

Dr. Chan explained that microwave ablation of lung nodules is faster and produces larger ablation zones, compared with radiofrequency ablation, and bronchoscopic ablation is thought to produce fewer pleural-based complications than percutaneous ablation.

Bronchoscopic transbronchial microwave ablation is performed in a hybrid operating room. First, the patient is intubated and anesthetized. Then, electromagnetic navigation bronchoscopy is used to zero in on the lung nodule, which is punctured by a microwave catheter. Cone-beam CT is used to confirm the location of the catheter.

“Next, we connect the system externally to a console, and then we just press the button to microwave it, just like what you do to food,” Dr. Chan explained.

Ablation takes about 10 minutes, and another CT is done to assess success. Ground-glass opacities are seen in the ablated area.
 

Study results

Dr. Chan and colleagues performed a retrospective analysis of 36 patients who underwent bronchoscopic transbronchial microwave ablation between March 2019 and December 2020.

The patients were unfit for or unwilling to undergo surgical resection. They had to have stage 1a lung cancers, isolated lung oligometastases, or radiologically suspicious lesions. The nodules had to be less than 3 cm in size, preferably with a bronchus leading directly to the lesion.

The patients had a mean age of 68 years. Their lesions had a mean maximal diameter of 15.2 mm, and 68% were in the peripheral one-third of the lung.

In all, 44 nodules were treated with bronchoscopic transbronchial microwave ablation. The technical success rate was 100%, although eight nodules required double ablation.

The majority of patients (95%) were discharged within 3 days, with 77% discharged on day 1. Complications included mild pain (15.9%), pneumothorax (9.1%), fever/ablation reaction (4.5%), self-limiting hemoptysis (2.3%), and bronchopleural fistula (2.3%).

The ablation zone volume decreased “rapidly” in the first 6-9 months, then leveled off, Dr. Chan noted.

In the 16 nodules with 1 year of follow-up, there were 2 complete responses, 13 partial responses, and no progressions.

It’s too soon to know if the recurrence rate will be lower than the up to 30% recurrence rate with percutaneous microwave ablation, and it’s too soon to know if, without transpleural puncture, the risk of tumor seeding is lower, Dr. Chan said.

“This presentation ... is extremely important,” said invited discussant John Edwards, MBChB, PhD, of Sheffield (England) Teaching Hospitals National Health Service Foundation Trust. “There is a great novelty value in the combination. The complications and the radiologic response rates were quite acceptable.”

The research was funded by the University Grants Committee in Hong Kong. Dr. Chan reported having no disclosures. Her colleagues disclosed relationships with Medtronic, Siemens Healthineers, and Johnson & Johnson. Dr. Edwards disclosed relationships with AstraZeneca, Zimmer Biomet, Stryker Leibinger, Pacific Biosciences, BioNano Genomics, Argenx, and Moderna.

[email protected]

Psoriatic arthritis may be associated with excess mortality risk but the current evidence to support excess mortality in psoriatic arthritis is inconclusive. Nevertheless, identifying risk factors for mortality in patients with psoriatic arthritis is important so that modifiable factors could be addressed. Vela et al investigated whether the cumulative pain experienced by psoriatic arthritis patients was associated with increased mortality. Using data from the Danish nationwide registry of biological therapies (DANBIO), the authors showed that although there was a significant association between pain intensity and mortality (odds ratio 1.06 (95%CI 1.02 to 1.10) per 5 VAS unit increase), no association was found when the analyses was adjusted for confounders including age, CRP, joint counts, HAQ score, treatment, and comorbidities. As expected, recent glucocorticoid use, chronic obstructive pulmonary disease, diabetes mellitus, cancer and cardiovascular disease were associated with excess mortality. The results indicate that mortality in psoriatic arthritis is primarily driven by associated comorbidities; holistic management of psoriatic disease should include management of associated comorbidities.

Comorbidities have a major impact on patients with psoriatic arthritis and influence a patient’s quality of life and function as well as treatment response. Neuropsychiatric comorbidities have been less studied in psoriatic arthritis. An intriguing study by Garcia et al indicate that cognitive impairment may be associated with psoriatic arthritis. In a small cross-sectional study, they demonstrated that patients with psoriatic arthritis score worse on the Montreal Cognitive Assessment (MoCA) tool compared to controls, with executive skills, naming, language, and abstraction being most affected. Further research is required to explore whether other comorbidities such as cerebrovascular disease, depression or sleep disturbances explain the cognitive impairment. Depression and anxiety are also associated with reduced likelihood of achieving remission or low disease activity state in psoriatic arthritis. In a study of 743 patients, Wong et al demonstrated that patients with depression or anxiety are less likely to achieve a state of sustained minimal disease activity. These studies once again highlight the management of comorbidities to achieve improved outcomes in patients with psoriatic arthritis.

New data also indicate efficacy of targeted therapy in psoriatic arthritis. In two phase 3 trials funded by LEO pharma, Mease et al report that brodalumab, an interleukin 17 receptor inhibitor that is already available for the treatment for psoriasis, is efficacious in the treatment of psoriatic arthritis. Although the trial was terminated early, pooled data from the two trials showed that higher proportions of patients on 140 mg and 210 mg of brodalumab achieved American College of Rheumatology (ACR)20 response at week 16 compared to placebo group (45.8% and 47.9%, respectively vs. 20.9%; P less than .0001).

There are limited data on treatment withdrawal in patients with psoriatic arthritis. Coates et al investigated whether continued treatment with ixekizumab, an interleukin 17A inhibitor was superior to withdrawing ixekizumab in maintaining minimal disease activity state in patents with psoriatic arthritis. They showed that more patients relapsed rapidly after ixekizumab was withdrawn compared to those continuing ixekizumab treatment. Importantly, >95% of patients who relapsed with treatment withdrawal re-achieved MDA on retreatment with ixekizumab within a median duration of 4.1 weeks. Thus, ixekizumab treatment is best maintained after a patient achieves a state of minimal disease activity. If the treatment needs to be interrupted (e.g., infection, surgery), most patients will re-achieve the state of minimal disease activity on retreatment.

Finally, research continues to demonstrate delayed diagnosis of psoriatic arthritis. Karmacharya et al showed that only 45% of patients receive a diagnosis of psoriatic arthritis by 2 years after symptom onset. This study from the population-based Rochester Epidemiology Project indicates that earlier age of onset of symptoms, the presence of higher body mass index and enthesitis are associated with diagnostic delay. Further education of health care providers and patients with psoriasis about psoriatic arthritis may help reduce diagnostic delay; delayed diagnosis leads to poorer long-term outcomes.

Psoriatic arthritis may be associated with excess mortality risk but the current evidence to support excess mortality in psoriatic arthritis is inconclusive. Nevertheless, identifying risk factors for mortality in patients with psoriatic arthritis is important so that modifiable factors could be addressed. Vela et al investigated whether the cumulative pain experienced by psoriatic arthritis patients was associated with increased mortality. Using data from the Danish nationwide registry of biological therapies (DANBIO), the authors showed that although there was a significant association between pain intensity and mortality (odds ratio 1.06 (95%CI 1.02 to 1.10) per 5 VAS unit increase), no association was found when the analyses was adjusted for confounders including age, CRP, joint counts, HAQ score, treatment, and comorbidities. As expected, recent glucocorticoid use, chronic obstructive pulmonary disease, diabetes mellitus, cancer and cardiovascular disease were associated with excess mortality. The results indicate that mortality in psoriatic arthritis is primarily driven by associated comorbidities; holistic management of psoriatic disease should include management of associated comorbidities.

Comorbidities have a major impact on patients with psoriatic arthritis and influence a patient’s quality of life and function as well as treatment response. Neuropsychiatric comorbidities have been less studied in psoriatic arthritis. An intriguing study by Garcia et al indicate that cognitive impairment may be associated with psoriatic arthritis. In a small cross-sectional study, they demonstrated that patients with psoriatic arthritis score worse on the Montreal Cognitive Assessment (MoCA) tool compared to controls, with executive skills, naming, language, and abstraction being most affected. Further research is required to explore whether other comorbidities such as cerebrovascular disease, depression or sleep disturbances explain the cognitive impairment. Depression and anxiety are also associated with reduced likelihood of achieving remission or low disease activity state in psoriatic arthritis. In a study of 743 patients, Wong et al demonstrated that patients with depression or anxiety are less likely to achieve a state of sustained minimal disease activity. These studies once again highlight the management of comorbidities to achieve improved outcomes in patients with psoriatic arthritis.

New data also indicate efficacy of targeted therapy in psoriatic arthritis. In two phase 3 trials funded by LEO pharma, Mease et al report that brodalumab, an interleukin 17 receptor inhibitor that is already available for the treatment for psoriasis, is efficacious in the treatment of psoriatic arthritis. Although the trial was terminated early, pooled data from the two trials showed that higher proportions of patients on 140 mg and 210 mg of brodalumab achieved American College of Rheumatology (ACR)20 response at week 16 compared to placebo group (45.8% and 47.9%, respectively vs. 20.9%; P less than .0001).

There are limited data on treatment withdrawal in patients with psoriatic arthritis. Coates et al investigated whether continued treatment with ixekizumab, an interleukin 17A inhibitor was superior to withdrawing ixekizumab in maintaining minimal disease activity state in patents with psoriatic arthritis. They showed that more patients relapsed rapidly after ixekizumab was withdrawn compared to those continuing ixekizumab treatment. Importantly, >95% of patients who relapsed with treatment withdrawal re-achieved MDA on retreatment with ixekizumab within a median duration of 4.1 weeks. Thus, ixekizumab treatment is best maintained after a patient achieves a state of minimal disease activity. If the treatment needs to be interrupted (e.g., infection, surgery), most patients will re-achieve the state of minimal disease activity on retreatment.

Finally, research continues to demonstrate delayed diagnosis of psoriatic arthritis. Karmacharya et al showed that only 45% of patients receive a diagnosis of psoriatic arthritis by 2 years after symptom onset. This study from the population-based Rochester Epidemiology Project indicates that earlier age of onset of symptoms, the presence of higher body mass index and enthesitis are associated with diagnostic delay. Further education of health care providers and patients with psoriasis about psoriatic arthritis may help reduce diagnostic delay; delayed diagnosis leads to poorer long-term outcomes.

Psoriatic arthritis may be associated with excess mortality risk but the current evidence to support excess mortality in psoriatic arthritis is inconclusive. Nevertheless, identifying risk factors for mortality in patients with psoriatic arthritis is important so that modifiable factors could be addressed. Vela et al investigated whether the cumulative pain experienced by psoriatic arthritis patients was associated with increased mortality. Using data from the Danish nationwide registry of biological therapies (DANBIO), the authors showed that although there was a significant association between pain intensity and mortality (odds ratio 1.06 (95%CI 1.02 to 1.10) per 5 VAS unit increase), no association was found when the analyses was adjusted for confounders including age, CRP, joint counts, HAQ score, treatment, and comorbidities. As expected, recent glucocorticoid use, chronic obstructive pulmonary disease, diabetes mellitus, cancer and cardiovascular disease were associated with excess mortality. The results indicate that mortality in psoriatic arthritis is primarily driven by associated comorbidities; holistic management of psoriatic disease should include management of associated comorbidities.

Comorbidities have a major impact on patients with psoriatic arthritis and influence a patient’s quality of life and function as well as treatment response. Neuropsychiatric comorbidities have been less studied in psoriatic arthritis. An intriguing study by Garcia et al indicate that cognitive impairment may be associated with psoriatic arthritis. In a small cross-sectional study, they demonstrated that patients with psoriatic arthritis score worse on the Montreal Cognitive Assessment (MoCA) tool compared to controls, with executive skills, naming, language, and abstraction being most affected. Further research is required to explore whether other comorbidities such as cerebrovascular disease, depression or sleep disturbances explain the cognitive impairment. Depression and anxiety are also associated with reduced likelihood of achieving remission or low disease activity state in psoriatic arthritis. In a study of 743 patients, Wong et al demonstrated that patients with depression or anxiety are less likely to achieve a state of sustained minimal disease activity. These studies once again highlight the management of comorbidities to achieve improved outcomes in patients with psoriatic arthritis.

New data also indicate efficacy of targeted therapy in psoriatic arthritis. In two phase 3 trials funded by LEO pharma, Mease et al report that brodalumab, an interleukin 17 receptor inhibitor that is already available for the treatment for psoriasis, is efficacious in the treatment of psoriatic arthritis. Although the trial was terminated early, pooled data from the two trials showed that higher proportions of patients on 140 mg and 210 mg of brodalumab achieved American College of Rheumatology (ACR)20 response at week 16 compared to placebo group (45.8% and 47.9%, respectively vs. 20.9%; P less than .0001).

There are limited data on treatment withdrawal in patients with psoriatic arthritis. Coates et al investigated whether continued treatment with ixekizumab, an interleukin 17A inhibitor was superior to withdrawing ixekizumab in maintaining minimal disease activity state in patents with psoriatic arthritis. They showed that more patients relapsed rapidly after ixekizumab was withdrawn compared to those continuing ixekizumab treatment. Importantly, >95% of patients who relapsed with treatment withdrawal re-achieved MDA on retreatment with ixekizumab within a median duration of 4.1 weeks. Thus, ixekizumab treatment is best maintained after a patient achieves a state of minimal disease activity. If the treatment needs to be interrupted (e.g., infection, surgery), most patients will re-achieve the state of minimal disease activity on retreatment.

Finally, research continues to demonstrate delayed diagnosis of psoriatic arthritis. Karmacharya et al showed that only 45% of patients receive a diagnosis of psoriatic arthritis by 2 years after symptom onset. This study from the population-based Rochester Epidemiology Project indicates that earlier age of onset of symptoms, the presence of higher body mass index and enthesitis are associated with diagnostic delay. Further education of health care providers and patients with psoriasis about psoriatic arthritis may help reduce diagnostic delay; delayed diagnosis leads to poorer long-term outcomes.