Federal Practitioner

CHICAGO – Another major study appears to back the use of intravenous iron repletion in patients with heart failure (HF) and iron deficiency, strengthening largely consistent evidence, researchers say, that the treatment may improve symptoms and prevent some HF-related hospital admissions.

To be sure, the IRONMAN trial, which compared intravenous iron versus usual care in such patients – most with reduced ejection fraction and not hospitalized – failed to show a benefit for its primary endpoint. The 18% reduction in risk for HF hospitalization or cardiovascular (CV) death seen in the trial, however encouraging, can only be called a trend (P = .07).

But the intervention showed signs of benefit for some secondary endpoints, including quality of life scores, and hinted at such an effect on HF hospitalization. Risk for the latter endpoint dropped 20% (P = .085) over a median follow-up of 2.7 years.

The findings “build upon the other data we have that correcting iron deficiency can help improve well-being, and particularly reduce the risk of hospitalization, in a broad range of [HF] patients,” said Paul Kalra, MD, of the University of Glasgow and Portsmouth (England) Hospitals University NHS Trust.

The tested regimen “was well tolerated with no safety concerns” and offers “reassurance about the long-term safety” of the intravenous iron it used, ferric derisomaltose (MonoFerric), in patients with HF, Dr. Kalra said at a media briefing on the trial.

The remarks preceded his formal presentation of IRONMAN at the American Heart Association scientific sessions. Dr. Kalra is also lead author on the trial’s publication in The Lancet.

IRONMAN strengthens the base of evidence supporting intravenous iron in HF with iron deficiency, especially chronic HF in outpatients, Dr. Kalra and others said. It also supports efficacy for a form of intravenous iron not previously tested in a major HF trial.

Still, “the totality of data are now supporting intravenous iron per se,” regardless of the iron agent used, said Dr. Kalra. But ferric derisomaltose may have dosing advantages, he observed, “and we’ve now got these long-term safety data.”

The strongest prior support for intravenous iron in HF came from hospitalized patients who received it as ferric carboxymaltose (Ferinject) and were followed only 12 months. That was in the AFFIRM-AHF trial, published 2 years ago, which also missed its primary endpoint – the same one used in IRONMAN. Some outcomes in the two trials were similar.

The risk for HF hospitalization or CV death for intravenous iron therapy, compared with usual care, in AFFIRM-AHF fell 21% (P = .059), missing significance but apparently driven by a 26% drop in risk for HF readmissions (P = .013). But neither that trial nor IRONMAN suggested a benefit for CV mortality on its own.
 

The COVID effect

In IRONMAN, Dr. Kalra said, usual care could include oral iron supplementation, which 17% of patients in the control group received. That could potentially have kept the intravenous iron group from making a better showing for the primary endpoint, he proposed.

And some iron doses and other treatments were missed by a substantial number of patients in both groups who entered the trial after the United Kingdom’s national lockdown in response to the COVID-19 pandemic, he observed. “Patients were not able to come into hospitals for research visits, or in fact when they were able, may not have wanted to.”

So, the group conducted a “prespecified” sensitivity analysis that excluded the 9% of patients enrolled by the end of March 2020, about the time of the first lockdown, and followed the remainder for another 6 months.

In that analysis, risk for HF hospitalization or CV death declined 24% in the intravenous iron group, a marginal but significant result (P = .047) that was dominated by an improvement in HF hospitalizations.
 

Effects on guidelines

The intravenous iron recommendations in the European HF guidelines refer only to ferric carboxymaltose without mentioning other forms, such as ferric derisomaltose, “but this is now a class effect given the similarities between AFFIRM-AHF and IRONMAN,” said Gregory D. Lewis, MD, Mass General Brigham, Boston, invited discussant for Dr. Kalra’s presentation at the AHA session.

“In the United States, we relegate IV iron to improvement in functional capacity as a comorbidity of heart failure. Perhaps this role will expand,” added Dr. Lewis, who is medical director of his center’s heart transplant program.

He also wondered aloud whether the purported clinical benefits of intravenous iron in HF patients with iron deficiency, not as yet supported by a significant primary-endpoint showing in one of the major trials, currently justify expansion of its use in practice.

“With the benefits of IV iron on exercise capacity and quality of life, and the safety of administering high doses of IV iron,” potentially reducing HF polypharmacy, he noted, “should we be considering IV iron more commonly for utilization in our patients even if we find that heart failure hospitalizations and mortality are only modestly improved?”

IRONMAN “asked whether there’s benefit to IV iron in the longer term,” Kiran Musunuru, MD, PhD, MPH, University of Pennsylvania,Philadelphia, observed at the media briefing. As the trial was reported, “that does in fact, seem to be the case,” said Dr. Musunuru, who was not involved in IRONMAN.

Therefore, he said, “this study reinforces the message that we should be routinely monitoring our heart failure patients for iron deficiency and supplementing them as needed.”

A commentary linked to the IRONMAN publication agreed. The trial “increases the evidence base for the treatment of iron deficiency with intravenous iron supplementation,” wrote the editorialists, led by Theresa A. McDonagh, MD, King’s College Hospital and School of Cardiovascular Sciences, London.

Patients with acute or chronic HF, iron deficiency, and reduced or mildly reduced ejection fractions “should be offered treatment with intravenous iron to reduce their risk of hospital admission for heart failure,” they concluded.
 

Mostly reduced-EF outpatients

The open-label, blinded-endpoint IRONMAN trial, conducted at 70 centers in the United Kingdom, entered adults with HF, ejection fractions 45% or lower within the previous 2 years, and iron deficiency defined as transferrin saturation less than 20% or serum ferritin levels below 100 mcg/L, the report states. They were either hospitalized for HF, had such a hospitalization within the past 6 months, or were outpatients with elevated natriuretic peptide levels; the third category accounted for two thirds of the trial population.

Of the 1,137 randomized patients, 569 were assigned to receive intravenous ferric derisomaltose at weight- and hemoglobin-adjusted dosages; 568 went to the usual-care group.

• HF hospitalization or CV death: RR, 0.76 (95% confidence interval, 0.58-1.00; P = .047)
• HF hospitalization: RR 0.76 (95% CI, 0.56-1.03; P = .077)

Fewer patients in the intravenous iron group experienced serious cardiac adverse events, 36% compared with 43% in for those on usual care, P = .016.

The recently updated European Society of Cardiology guidelines for HF made it a class 1 recommendation to assess iron status in every patient, Kalra observed. “It doesn›t specify how frequently, but I think we should be thinking about every 4-6 months.”

Dr. Kalra disclosed receiving research grants from Pharmacosmos; and consulting or lecturing for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Novartis, Pfizer, Pharmacosmos, Servier, and Vifor Pharma. Dr. Musunuru disclosed significant ownership interest in Verve Therapeutics and Variant Bio. Dr. Lewis disclosed relationships with NXT, American Regent, and RIVUS; and receiving research grants from Cytokinetics and Amgen.

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

CHICAGO – Another major study appears to back the use of intravenous iron repletion in patients with heart failure (HF) and iron deficiency, strengthening largely consistent evidence, researchers say, that the treatment may improve symptoms and prevent some HF-related hospital admissions.

To be sure, the IRONMAN trial, which compared intravenous iron versus usual care in such patients – most with reduced ejection fraction and not hospitalized – failed to show a benefit for its primary endpoint. The 18% reduction in risk for HF hospitalization or cardiovascular (CV) death seen in the trial, however encouraging, can only be called a trend (P = .07).

But the intervention showed signs of benefit for some secondary endpoints, including quality of life scores, and hinted at such an effect on HF hospitalization. Risk for the latter endpoint dropped 20% (P = .085) over a median follow-up of 2.7 years.

The findings “build upon the other data we have that correcting iron deficiency can help improve well-being, and particularly reduce the risk of hospitalization, in a broad range of [HF] patients,” said Paul Kalra, MD, of the University of Glasgow and Portsmouth (England) Hospitals University NHS Trust.

The tested regimen “was well tolerated with no safety concerns” and offers “reassurance about the long-term safety” of the intravenous iron it used, ferric derisomaltose (MonoFerric), in patients with HF, Dr. Kalra said at a media briefing on the trial.

The remarks preceded his formal presentation of IRONMAN at the American Heart Association scientific sessions. Dr. Kalra is also lead author on the trial’s publication in The Lancet.

IRONMAN strengthens the base of evidence supporting intravenous iron in HF with iron deficiency, especially chronic HF in outpatients, Dr. Kalra and others said. It also supports efficacy for a form of intravenous iron not previously tested in a major HF trial.

Still, “the totality of data are now supporting intravenous iron per se,” regardless of the iron agent used, said Dr. Kalra. But ferric derisomaltose may have dosing advantages, he observed, “and we’ve now got these long-term safety data.”

The strongest prior support for intravenous iron in HF came from hospitalized patients who received it as ferric carboxymaltose (Ferinject) and were followed only 12 months. That was in the AFFIRM-AHF trial, published 2 years ago, which also missed its primary endpoint – the same one used in IRONMAN. Some outcomes in the two trials were similar.

The risk for HF hospitalization or CV death for intravenous iron therapy, compared with usual care, in AFFIRM-AHF fell 21% (P = .059), missing significance but apparently driven by a 26% drop in risk for HF readmissions (P = .013). But neither that trial nor IRONMAN suggested a benefit for CV mortality on its own.
 

The COVID effect

In IRONMAN, Dr. Kalra said, usual care could include oral iron supplementation, which 17% of patients in the control group received. That could potentially have kept the intravenous iron group from making a better showing for the primary endpoint, he proposed.

And some iron doses and other treatments were missed by a substantial number of patients in both groups who entered the trial after the United Kingdom’s national lockdown in response to the COVID-19 pandemic, he observed. “Patients were not able to come into hospitals for research visits, or in fact when they were able, may not have wanted to.”

So, the group conducted a “prespecified” sensitivity analysis that excluded the 9% of patients enrolled by the end of March 2020, about the time of the first lockdown, and followed the remainder for another 6 months.

In that analysis, risk for HF hospitalization or CV death declined 24% in the intravenous iron group, a marginal but significant result (P = .047) that was dominated by an improvement in HF hospitalizations.
 

Effects on guidelines

The intravenous iron recommendations in the European HF guidelines refer only to ferric carboxymaltose without mentioning other forms, such as ferric derisomaltose, “but this is now a class effect given the similarities between AFFIRM-AHF and IRONMAN,” said Gregory D. Lewis, MD, Mass General Brigham, Boston, invited discussant for Dr. Kalra’s presentation at the AHA session.

“In the United States, we relegate IV iron to improvement in functional capacity as a comorbidity of heart failure. Perhaps this role will expand,” added Dr. Lewis, who is medical director of his center’s heart transplant program.

He also wondered aloud whether the purported clinical benefits of intravenous iron in HF patients with iron deficiency, not as yet supported by a significant primary-endpoint showing in one of the major trials, currently justify expansion of its use in practice.

“With the benefits of IV iron on exercise capacity and quality of life, and the safety of administering high doses of IV iron,” potentially reducing HF polypharmacy, he noted, “should we be considering IV iron more commonly for utilization in our patients even if we find that heart failure hospitalizations and mortality are only modestly improved?”

IRONMAN “asked whether there’s benefit to IV iron in the longer term,” Kiran Musunuru, MD, PhD, MPH, University of Pennsylvania,Philadelphia, observed at the media briefing. As the trial was reported, “that does in fact, seem to be the case,” said Dr. Musunuru, who was not involved in IRONMAN.

Therefore, he said, “this study reinforces the message that we should be routinely monitoring our heart failure patients for iron deficiency and supplementing them as needed.”

A commentary linked to the IRONMAN publication agreed. The trial “increases the evidence base for the treatment of iron deficiency with intravenous iron supplementation,” wrote the editorialists, led by Theresa A. McDonagh, MD, King’s College Hospital and School of Cardiovascular Sciences, London.

Patients with acute or chronic HF, iron deficiency, and reduced or mildly reduced ejection fractions “should be offered treatment with intravenous iron to reduce their risk of hospital admission for heart failure,” they concluded.
 

Mostly reduced-EF outpatients

The open-label, blinded-endpoint IRONMAN trial, conducted at 70 centers in the United Kingdom, entered adults with HF, ejection fractions 45% or lower within the previous 2 years, and iron deficiency defined as transferrin saturation less than 20% or serum ferritin levels below 100 mcg/L, the report states. They were either hospitalized for HF, had such a hospitalization within the past 6 months, or were outpatients with elevated natriuretic peptide levels; the third category accounted for two thirds of the trial population.

Of the 1,137 randomized patients, 569 were assigned to receive intravenous ferric derisomaltose at weight- and hemoglobin-adjusted dosages; 568 went to the usual-care group.

• HF hospitalization or CV death: RR, 0.76 (95% confidence interval, 0.58-1.00; P = .047)
• HF hospitalization: RR 0.76 (95% CI, 0.56-1.03; P = .077)

Fewer patients in the intravenous iron group experienced serious cardiac adverse events, 36% compared with 43% in for those on usual care, P = .016.

The recently updated European Society of Cardiology guidelines for HF made it a class 1 recommendation to assess iron status in every patient, Kalra observed. “It doesn›t specify how frequently, but I think we should be thinking about every 4-6 months.”

Dr. Kalra disclosed receiving research grants from Pharmacosmos; and consulting or lecturing for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Novartis, Pfizer, Pharmacosmos, Servier, and Vifor Pharma. Dr. Musunuru disclosed significant ownership interest in Verve Therapeutics and Variant Bio. Dr. Lewis disclosed relationships with NXT, American Regent, and RIVUS; and receiving research grants from Cytokinetics and Amgen.

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

CHICAGO – Another major study appears to back the use of intravenous iron repletion in patients with heart failure (HF) and iron deficiency, strengthening largely consistent evidence, researchers say, that the treatment may improve symptoms and prevent some HF-related hospital admissions.

To be sure, the IRONMAN trial, which compared intravenous iron versus usual care in such patients – most with reduced ejection fraction and not hospitalized – failed to show a benefit for its primary endpoint. The 18% reduction in risk for HF hospitalization or cardiovascular (CV) death seen in the trial, however encouraging, can only be called a trend (P = .07).

But the intervention showed signs of benefit for some secondary endpoints, including quality of life scores, and hinted at such an effect on HF hospitalization. Risk for the latter endpoint dropped 20% (P = .085) over a median follow-up of 2.7 years.

The findings “build upon the other data we have that correcting iron deficiency can help improve well-being, and particularly reduce the risk of hospitalization, in a broad range of [HF] patients,” said Paul Kalra, MD, of the University of Glasgow and Portsmouth (England) Hospitals University NHS Trust.

The tested regimen “was well tolerated with no safety concerns” and offers “reassurance about the long-term safety” of the intravenous iron it used, ferric derisomaltose (MonoFerric), in patients with HF, Dr. Kalra said at a media briefing on the trial.

The remarks preceded his formal presentation of IRONMAN at the American Heart Association scientific sessions. Dr. Kalra is also lead author on the trial’s publication in The Lancet.

IRONMAN strengthens the base of evidence supporting intravenous iron in HF with iron deficiency, especially chronic HF in outpatients, Dr. Kalra and others said. It also supports efficacy for a form of intravenous iron not previously tested in a major HF trial.

Still, “the totality of data are now supporting intravenous iron per se,” regardless of the iron agent used, said Dr. Kalra. But ferric derisomaltose may have dosing advantages, he observed, “and we’ve now got these long-term safety data.”

The strongest prior support for intravenous iron in HF came from hospitalized patients who received it as ferric carboxymaltose (Ferinject) and were followed only 12 months. That was in the AFFIRM-AHF trial, published 2 years ago, which also missed its primary endpoint – the same one used in IRONMAN. Some outcomes in the two trials were similar.

The risk for HF hospitalization or CV death for intravenous iron therapy, compared with usual care, in AFFIRM-AHF fell 21% (P = .059), missing significance but apparently driven by a 26% drop in risk for HF readmissions (P = .013). But neither that trial nor IRONMAN suggested a benefit for CV mortality on its own.
 

The COVID effect

In IRONMAN, Dr. Kalra said, usual care could include oral iron supplementation, which 17% of patients in the control group received. That could potentially have kept the intravenous iron group from making a better showing for the primary endpoint, he proposed.

And some iron doses and other treatments were missed by a substantial number of patients in both groups who entered the trial after the United Kingdom’s national lockdown in response to the COVID-19 pandemic, he observed. “Patients were not able to come into hospitals for research visits, or in fact when they were able, may not have wanted to.”

So, the group conducted a “prespecified” sensitivity analysis that excluded the 9% of patients enrolled by the end of March 2020, about the time of the first lockdown, and followed the remainder for another 6 months.

In that analysis, risk for HF hospitalization or CV death declined 24% in the intravenous iron group, a marginal but significant result (P = .047) that was dominated by an improvement in HF hospitalizations.
 

Effects on guidelines

The intravenous iron recommendations in the European HF guidelines refer only to ferric carboxymaltose without mentioning other forms, such as ferric derisomaltose, “but this is now a class effect given the similarities between AFFIRM-AHF and IRONMAN,” said Gregory D. Lewis, MD, Mass General Brigham, Boston, invited discussant for Dr. Kalra’s presentation at the AHA session.

“In the United States, we relegate IV iron to improvement in functional capacity as a comorbidity of heart failure. Perhaps this role will expand,” added Dr. Lewis, who is medical director of his center’s heart transplant program.

He also wondered aloud whether the purported clinical benefits of intravenous iron in HF patients with iron deficiency, not as yet supported by a significant primary-endpoint showing in one of the major trials, currently justify expansion of its use in practice.

“With the benefits of IV iron on exercise capacity and quality of life, and the safety of administering high doses of IV iron,” potentially reducing HF polypharmacy, he noted, “should we be considering IV iron more commonly for utilization in our patients even if we find that heart failure hospitalizations and mortality are only modestly improved?”

IRONMAN “asked whether there’s benefit to IV iron in the longer term,” Kiran Musunuru, MD, PhD, MPH, University of Pennsylvania,Philadelphia, observed at the media briefing. As the trial was reported, “that does in fact, seem to be the case,” said Dr. Musunuru, who was not involved in IRONMAN.

Therefore, he said, “this study reinforces the message that we should be routinely monitoring our heart failure patients for iron deficiency and supplementing them as needed.”

A commentary linked to the IRONMAN publication agreed. The trial “increases the evidence base for the treatment of iron deficiency with intravenous iron supplementation,” wrote the editorialists, led by Theresa A. McDonagh, MD, King’s College Hospital and School of Cardiovascular Sciences, London.

Patients with acute or chronic HF, iron deficiency, and reduced or mildly reduced ejection fractions “should be offered treatment with intravenous iron to reduce their risk of hospital admission for heart failure,” they concluded.
 

Mostly reduced-EF outpatients

The open-label, blinded-endpoint IRONMAN trial, conducted at 70 centers in the United Kingdom, entered adults with HF, ejection fractions 45% or lower within the previous 2 years, and iron deficiency defined as transferrin saturation less than 20% or serum ferritin levels below 100 mcg/L, the report states. They were either hospitalized for HF, had such a hospitalization within the past 6 months, or were outpatients with elevated natriuretic peptide levels; the third category accounted for two thirds of the trial population.

Of the 1,137 randomized patients, 569 were assigned to receive intravenous ferric derisomaltose at weight- and hemoglobin-adjusted dosages; 568 went to the usual-care group.

• HF hospitalization or CV death: RR, 0.76 (95% confidence interval, 0.58-1.00; P = .047)
• HF hospitalization: RR 0.76 (95% CI, 0.56-1.03; P = .077)

Fewer patients in the intravenous iron group experienced serious cardiac adverse events, 36% compared with 43% in for those on usual care, P = .016.

The recently updated European Society of Cardiology guidelines for HF made it a class 1 recommendation to assess iron status in every patient, Kalra observed. “It doesn›t specify how frequently, but I think we should be thinking about every 4-6 months.”

Dr. Kalra disclosed receiving research grants from Pharmacosmos; and consulting or lecturing for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Novartis, Pfizer, Pharmacosmos, Servier, and Vifor Pharma. Dr. Musunuru disclosed significant ownership interest in Verve Therapeutics and Variant Bio. Dr. Lewis disclosed relationships with NXT, American Regent, and RIVUS; and receiving research grants from Cytokinetics and Amgen.

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

Key clinical point: The use of aspirin is independently associated with a reduced risk for hepatocellular carcinoma (HCC) incidence, recurrence, and mortality, but an increased risk for bleeding.

Major finding: Aspirin use was associated with a reduced incidence of HCC (hazard ratio [HR] 0.75; 95% CI 0.71-0.80), recurrence of HCC (HR 0.79; 95% CI 0.65-0.96), and HCC-related mortality (HR 0.64; 95% CI 0.44-0.94), but an increased risk for bleeding (HR 1.10; 95% CI 1.02-1.20).

Study details: This study meta-analyzed the data of 3,273,524 individuals from 30 studies on HCC incidence, HCC recurrence, or mortality.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Ma S, Qu G et al. Does aspirin reduce the incidence, recurrence, and mortality of hepatocellular carcinoma? A GRADE-assessed systematic review and dose-response meta-analysis. Eur J Clin Pharmacol. 2022 (Nov 5). Doi: 10.1007/s00228-022-03414-y

Key clinical point: The use of aspirin is independently associated with a reduced risk for hepatocellular carcinoma (HCC) incidence, recurrence, and mortality, but an increased risk for bleeding.

Major finding: Aspirin use was associated with a reduced incidence of HCC (hazard ratio [HR] 0.75; 95% CI 0.71-0.80), recurrence of HCC (HR 0.79; 95% CI 0.65-0.96), and HCC-related mortality (HR 0.64; 95% CI 0.44-0.94), but an increased risk for bleeding (HR 1.10; 95% CI 1.02-1.20).

Study details: This study meta-analyzed the data of 3,273,524 individuals from 30 studies on HCC incidence, HCC recurrence, or mortality.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Ma S, Qu G et al. Does aspirin reduce the incidence, recurrence, and mortality of hepatocellular carcinoma? A GRADE-assessed systematic review and dose-response meta-analysis. Eur J Clin Pharmacol. 2022 (Nov 5). Doi: 10.1007/s00228-022-03414-y

Key clinical point: The use of aspirin is independently associated with a reduced risk for hepatocellular carcinoma (HCC) incidence, recurrence, and mortality, but an increased risk for bleeding.

Major finding: Aspirin use was associated with a reduced incidence of HCC (hazard ratio [HR] 0.75; 95% CI 0.71-0.80), recurrence of HCC (HR 0.79; 95% CI 0.65-0.96), and HCC-related mortality (HR 0.64; 95% CI 0.44-0.94), but an increased risk for bleeding (HR 1.10; 95% CI 1.02-1.20).

Study details: This study meta-analyzed the data of 3,273,524 individuals from 30 studies on HCC incidence, HCC recurrence, or mortality.

Disclosures: This study did not report the source of funding. The authors declared no conflicts of interest.

Source: Ma S, Qu G et al. Does aspirin reduce the incidence, recurrence, and mortality of hepatocellular carcinoma? A GRADE-assessed systematic review and dose-response meta-analysis. Eur J Clin Pharmacol. 2022 (Nov 5). Doi: 10.1007/s00228-022-03414-y

Key clinical point: Among patients with hepatocellular carcinoma (HCC), an “ideal candidate for ablation” per the Barcelona Clinic Liver Cancer (BCLC) staging system may not be ideal for microwave ablation (MWA); however, patients with BCLC-0 disease may comprise the optimal population for MWA.

Major finding: Liver resection (LRE) vs MWA led to a significantly longer recurrence-free survival in the overall population (P = .025) and patients with BCLC-A disease (P = .003) but not in those with BCLC-0 disease (P = .270), in addition to similar overall survival (P = .976) and post-procedure-related complication rates (P = 1.00) in BCLC-0 patients.

Study details: This retrospective study included patients with HCC who met the criteria of “ideal candidates for ablation” per the BCLC staging system and propensity score-matched those receiving MWA and LRE (overall population 140 pairs; BCLC-0 disease 35 pairs; BCLC-A disease 99 pairs).

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Tong Y, Cai R  et al. Liver resection versus microwave ablation for hepatocellular carcinoma in ideal candidates for ablation per Barcelona Clinic Liver Cancer staging: A propensity score matching and inverse probability of treatment weighting analysis. Aliment Pharmacol Ther. 2022;56(11-12):1602-1614 (Oct 26). Doi: 10.1111/apt.17263

Key clinical point: Among patients with hepatocellular carcinoma (HCC), an “ideal candidate for ablation” per the Barcelona Clinic Liver Cancer (BCLC) staging system may not be ideal for microwave ablation (MWA); however, patients with BCLC-0 disease may comprise the optimal population for MWA.

Major finding: Liver resection (LRE) vs MWA led to a significantly longer recurrence-free survival in the overall population (P = .025) and patients with BCLC-A disease (P = .003) but not in those with BCLC-0 disease (P = .270), in addition to similar overall survival (P = .976) and post-procedure-related complication rates (P = 1.00) in BCLC-0 patients.

Study details: This retrospective study included patients with HCC who met the criteria of “ideal candidates for ablation” per the BCLC staging system and propensity score-matched those receiving MWA and LRE (overall population 140 pairs; BCLC-0 disease 35 pairs; BCLC-A disease 99 pairs).

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Tong Y, Cai R  et al. Liver resection versus microwave ablation for hepatocellular carcinoma in ideal candidates for ablation per Barcelona Clinic Liver Cancer staging: A propensity score matching and inverse probability of treatment weighting analysis. Aliment Pharmacol Ther. 2022;56(11-12):1602-1614 (Oct 26). Doi: 10.1111/apt.17263

Key clinical point: Among patients with hepatocellular carcinoma (HCC), an “ideal candidate for ablation” per the Barcelona Clinic Liver Cancer (BCLC) staging system may not be ideal for microwave ablation (MWA); however, patients with BCLC-0 disease may comprise the optimal population for MWA.

Major finding: Liver resection (LRE) vs MWA led to a significantly longer recurrence-free survival in the overall population (P = .025) and patients with BCLC-A disease (P = .003) but not in those with BCLC-0 disease (P = .270), in addition to similar overall survival (P = .976) and post-procedure-related complication rates (P = 1.00) in BCLC-0 patients.

Study details: This retrospective study included patients with HCC who met the criteria of “ideal candidates for ablation” per the BCLC staging system and propensity score-matched those receiving MWA and LRE (overall population 140 pairs; BCLC-0 disease 35 pairs; BCLC-A disease 99 pairs).

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Tong Y, Cai R  et al. Liver resection versus microwave ablation for hepatocellular carcinoma in ideal candidates for ablation per Barcelona Clinic Liver Cancer staging: A propensity score matching and inverse probability of treatment weighting analysis. Aliment Pharmacol Ther. 2022;56(11-12):1602-1614 (Oct 26). Doi: 10.1111/apt.17263

Key clinical point: Compared with transcatheter arterial chemoembolization (TACE) followed by radiotherapy (RT), administering RT before TACE leads to better survival outcomes in patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombus (PVTT).

Major finding: Patients who received RT+TACE vs TACE+RT had significantly longer median progression-free survival (6.6 vs 4.2 months; hazard ratio [HR] 0.66; P = .030), with the prolongation of median overall survival being marginally significant (15.4 vs 11.5 months; HR 0.68; P = .054).

Study details: Findings are from a randomized controlled study including 120 patients with unresectable HCC and PVTT who were randomly assigned (1:1) to receive RT+TACE or TACE+RT.

Disclosures: This study was supported by the Clinical Research Plan of Shanghai Shenkang Hospital Development Center, China, among others. The authors declared no conflicts of interest.

Source: Guo L et al. Radiotherapy prior to or after transcatheter arterial chemoembolization for the treatment of hepatocellular carcinoma with portal vein tumor thrombus: A randomized controlled trial. Hepatol Int. 2022 (Oct 21). Doi: 10.1007/s12072-022-10423-7

Key clinical point: Compared with transcatheter arterial chemoembolization (TACE) followed by radiotherapy (RT), administering RT before TACE leads to better survival outcomes in patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombus (PVTT).

Major finding: Patients who received RT+TACE vs TACE+RT had significantly longer median progression-free survival (6.6 vs 4.2 months; hazard ratio [HR] 0.66; P = .030), with the prolongation of median overall survival being marginally significant (15.4 vs 11.5 months; HR 0.68; P = .054).

Study details: Findings are from a randomized controlled study including 120 patients with unresectable HCC and PVTT who were randomly assigned (1:1) to receive RT+TACE or TACE+RT.

Disclosures: This study was supported by the Clinical Research Plan of Shanghai Shenkang Hospital Development Center, China, among others. The authors declared no conflicts of interest.

Source: Guo L et al. Radiotherapy prior to or after transcatheter arterial chemoembolization for the treatment of hepatocellular carcinoma with portal vein tumor thrombus: A randomized controlled trial. Hepatol Int. 2022 (Oct 21). Doi: 10.1007/s12072-022-10423-7

Key clinical point: Compared with transcatheter arterial chemoembolization (TACE) followed by radiotherapy (RT), administering RT before TACE leads to better survival outcomes in patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombus (PVTT).

Major finding: Patients who received RT+TACE vs TACE+RT had significantly longer median progression-free survival (6.6 vs 4.2 months; hazard ratio [HR] 0.66; P = .030), with the prolongation of median overall survival being marginally significant (15.4 vs 11.5 months; HR 0.68; P = .054).

Study details: Findings are from a randomized controlled study including 120 patients with unresectable HCC and PVTT who were randomly assigned (1:1) to receive RT+TACE or TACE+RT.

Disclosures: This study was supported by the Clinical Research Plan of Shanghai Shenkang Hospital Development Center, China, among others. The authors declared no conflicts of interest.

Source: Guo L et al. Radiotherapy prior to or after transcatheter arterial chemoembolization for the treatment of hepatocellular carcinoma with portal vein tumor thrombus: A randomized controlled trial. Hepatol Int. 2022 (Oct 21). Doi: 10.1007/s12072-022-10423-7

Key clinical point: Atezolizumab plus bevacizumab (Atezo/Bev) is a more effective and safe first-line therapy than lenvatinib in patients with unresectable hepatocellular carcinoma (HCC).

Major finding: Patients who received Atezo/Bev vs lenvatinib had a significantly longer progression-free survival (8.3 vs 6.0 months; P = .005) and overall survival (median survival time not reached vs 20.2 months; P = .039) and lower prevalence of grade ≥3 adverse events, such as hypertension (P = .004) and proteinuria (P = .046).

Study details: This retrospective study propensity score-matched patients with unresectable HCC who received Atezo/Bev (n = 152) with those who received lenvatinib (n = 152) as first-line systemic therapies.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Niizeki T et al. Comparison of efficacy and safety of atezolizumab plus bevacizumab and lenvatinib as first-line therapy for unresectable hepatocellular carcinoma: A propensity score matching analysis. Target Oncol. 2022 (Oct 22). Doi: 10.1007/s11523-022-00921-x

Key clinical point: Atezolizumab plus bevacizumab (Atezo/Bev) is a more effective and safe first-line therapy than lenvatinib in patients with unresectable hepatocellular carcinoma (HCC).

Major finding: Patients who received Atezo/Bev vs lenvatinib had a significantly longer progression-free survival (8.3 vs 6.0 months; P = .005) and overall survival (median survival time not reached vs 20.2 months; P = .039) and lower prevalence of grade ≥3 adverse events, such as hypertension (P = .004) and proteinuria (P = .046).

Study details: This retrospective study propensity score-matched patients with unresectable HCC who received Atezo/Bev (n = 152) with those who received lenvatinib (n = 152) as first-line systemic therapies.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Niizeki T et al. Comparison of efficacy and safety of atezolizumab plus bevacizumab and lenvatinib as first-line therapy for unresectable hepatocellular carcinoma: A propensity score matching analysis. Target Oncol. 2022 (Oct 22). Doi: 10.1007/s11523-022-00921-x

Key clinical point: Atezolizumab plus bevacizumab (Atezo/Bev) is a more effective and safe first-line therapy than lenvatinib in patients with unresectable hepatocellular carcinoma (HCC).

Major finding: Patients who received Atezo/Bev vs lenvatinib had a significantly longer progression-free survival (8.3 vs 6.0 months; P = .005) and overall survival (median survival time not reached vs 20.2 months; P = .039) and lower prevalence of grade ≥3 adverse events, such as hypertension (P = .004) and proteinuria (P = .046).

Study details: This retrospective study propensity score-matched patients with unresectable HCC who received Atezo/Bev (n = 152) with those who received lenvatinib (n = 152) as first-line systemic therapies.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Niizeki T et al. Comparison of efficacy and safety of atezolizumab plus bevacizumab and lenvatinib as first-line therapy for unresectable hepatocellular carcinoma: A propensity score matching analysis. Target Oncol. 2022 (Oct 22). Doi: 10.1007/s11523-022-00921-x

Key clinical point: The combination of alpha-fetoprotein (AFP) and carbohydrate antigen 19-9 (CA19-9) may effectively predict the prognosis of patients with hepatocellular carcinoma (HCC) after radical hepatectomy.

Major finding: The 5-year overall and recurrence-free survival rates were significantly lower among patients with high preoperative serum AFP and CA19-9 levels than among those with high serum AFP or CA19-9 levels (P = .022 and P = .004, respectively) and those with low serum AFP and CA19-9 levels (both P < .001).

Study details: This retrospective study included 711 patients with HCC who were categorized as having low (≤400 ng/mL; n = 381) or high (>400 ng/mL; n = 330) preoperative serum AFP levels and as having low (≤37 U/mL; n = 552) or high (>37 U/mL; n = 159) preoperative serum CA19-9 levels.

Disclosures: This study was sponsored by the Youth Program of Scientific Research Foundation of Guangxi Medical University Cancer Hospital, China, among others. The authors declared no conflicts of interest.

Source: Zhang J et al. Prognostic significance of combined α-fetoprotein and CA19-9 for hepatocellular carcinoma after hepatectomy. World J Surg Oncol. 2022;20:346 (Oct 19). Doi: 10.1186/s12957-022-02806-9

Key clinical point: The combination of alpha-fetoprotein (AFP) and carbohydrate antigen 19-9 (CA19-9) may effectively predict the prognosis of patients with hepatocellular carcinoma (HCC) after radical hepatectomy.

Major finding: The 5-year overall and recurrence-free survival rates were significantly lower among patients with high preoperative serum AFP and CA19-9 levels than among those with high serum AFP or CA19-9 levels (P = .022 and P = .004, respectively) and those with low serum AFP and CA19-9 levels (both P < .001).

Study details: This retrospective study included 711 patients with HCC who were categorized as having low (≤400 ng/mL; n = 381) or high (>400 ng/mL; n = 330) preoperative serum AFP levels and as having low (≤37 U/mL; n = 552) or high (>37 U/mL; n = 159) preoperative serum CA19-9 levels.

Disclosures: This study was sponsored by the Youth Program of Scientific Research Foundation of Guangxi Medical University Cancer Hospital, China, among others. The authors declared no conflicts of interest.

Source: Zhang J et al. Prognostic significance of combined α-fetoprotein and CA19-9 for hepatocellular carcinoma after hepatectomy. World J Surg Oncol. 2022;20:346 (Oct 19). Doi: 10.1186/s12957-022-02806-9

Key clinical point: The combination of alpha-fetoprotein (AFP) and carbohydrate antigen 19-9 (CA19-9) may effectively predict the prognosis of patients with hepatocellular carcinoma (HCC) after radical hepatectomy.

Major finding: The 5-year overall and recurrence-free survival rates were significantly lower among patients with high preoperative serum AFP and CA19-9 levels than among those with high serum AFP or CA19-9 levels (P = .022 and P = .004, respectively) and those with low serum AFP and CA19-9 levels (both P < .001).

Study details: This retrospective study included 711 patients with HCC who were categorized as having low (≤400 ng/mL; n = 381) or high (>400 ng/mL; n = 330) preoperative serum AFP levels and as having low (≤37 U/mL; n = 552) or high (>37 U/mL; n = 159) preoperative serum CA19-9 levels.

Disclosures: This study was sponsored by the Youth Program of Scientific Research Foundation of Guangxi Medical University Cancer Hospital, China, among others. The authors declared no conflicts of interest.

Source: Zhang J et al. Prognostic significance of combined α-fetoprotein and CA19-9 for hepatocellular carcinoma after hepatectomy. World J Surg Oncol. 2022;20:346 (Oct 19). Doi: 10.1186/s12957-022-02806-9

Key clinical point: Compared with hepatic arterial infusion chemotherapy (HAIC)+lenvatinib, the triple therapeutic regimen HAIC+lenvatinib+sequential ablation significantly improved the survival of patients with advanced hepatocellular carcinoma (HCC) without compromising safety.

Major finding: Patients who received HAIC+lenvatinib+sequential ablation vs HAIC+lenvatinib had a significantly longer median overall survival (>30 vs 13.6 months; P = .010), progression-free survival (PFS; 12.8 vs 5.6 months; P = .001), and intrahepatic PFS (14.6 vs 6.4 months; P = .002) and similar incidence of grade 1-2 (P = .404) and 3-4 (P = .333) adverse events.

Study details: This multicenter retrospective study included 150 patients with advanced HCC who received HAIC+lenvatinib (n = 97) or HAIC+lenvatinib+sequential ablation (n = 53).

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Liu Y et al. Efficacy and safety of hepatic arterial infusion chemotherapy combined with lenvatinib and sequential ablation in the treatment of advanced hepatocellular carcinoma. Cancer Med. 2022 (Oct 17). Doi: 10.1002/cam4.5366

Key clinical point: Compared with hepatic arterial infusion chemotherapy (HAIC)+lenvatinib, the triple therapeutic regimen HAIC+lenvatinib+sequential ablation significantly improved the survival of patients with advanced hepatocellular carcinoma (HCC) without compromising safety.

Major finding: Patients who received HAIC+lenvatinib+sequential ablation vs HAIC+lenvatinib had a significantly longer median overall survival (>30 vs 13.6 months; P = .010), progression-free survival (PFS; 12.8 vs 5.6 months; P = .001), and intrahepatic PFS (14.6 vs 6.4 months; P = .002) and similar incidence of grade 1-2 (P = .404) and 3-4 (P = .333) adverse events.

Study details: This multicenter retrospective study included 150 patients with advanced HCC who received HAIC+lenvatinib (n = 97) or HAIC+lenvatinib+sequential ablation (n = 53).

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Liu Y et al. Efficacy and safety of hepatic arterial infusion chemotherapy combined with lenvatinib and sequential ablation in the treatment of advanced hepatocellular carcinoma. Cancer Med. 2022 (Oct 17). Doi: 10.1002/cam4.5366

Key clinical point: Compared with hepatic arterial infusion chemotherapy (HAIC)+lenvatinib, the triple therapeutic regimen HAIC+lenvatinib+sequential ablation significantly improved the survival of patients with advanced hepatocellular carcinoma (HCC) without compromising safety.

Major finding: Patients who received HAIC+lenvatinib+sequential ablation vs HAIC+lenvatinib had a significantly longer median overall survival (>30 vs 13.6 months; P = .010), progression-free survival (PFS; 12.8 vs 5.6 months; P = .001), and intrahepatic PFS (14.6 vs 6.4 months; P = .002) and similar incidence of grade 1-2 (P = .404) and 3-4 (P = .333) adverse events.

Study details: This multicenter retrospective study included 150 patients with advanced HCC who received HAIC+lenvatinib (n = 97) or HAIC+lenvatinib+sequential ablation (n = 53).

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Liu Y et al. Efficacy and safety of hepatic arterial infusion chemotherapy combined with lenvatinib and sequential ablation in the treatment of advanced hepatocellular carcinoma. Cancer Med. 2022 (Oct 17). Doi: 10.1002/cam4.5366

Key clinical point: Atezolizumab plus bevacizumab (Atez/Bev) is effective and safe against both virus-related and non-viral hepatocellular carcinoma (HCC).

Major finding: The objective response rate (20.6% and 24.6%, respectively; P = .55), median progression-free survival (7.0 and 6.2 months, respectively; hazard ratio 0.96; P = .33), and incidence and severity of adverse events, including diarrhea and liver injury, were comparable between patients with virus-related and non-viral HCC.

Study details: Findings are from a retrospective cohort study including 126 propensity score-matched pairs of patients with virus-related and non-viral HCC who had Child-Pugh class A, Barcelona Clinic Liver Cancer stage B or C, and performance status ≤1 and received Atez/Bev.

Disclosures: No source of funding was reported. Some authors declared receiving honoraria and research grants from various sources.

Source: Hatanaka T et al. Comparative efficacy and safety of atezolizumab and bevacizumab between hepatocellular carcinoma patients with viral and non-viral infection: A Japanese multicenter observational study. Cancer Med. 2022 (Oct 13). Doi: 10.1002/cam4.5337

Key clinical point: Atezolizumab plus bevacizumab (Atez/Bev) is effective and safe against both virus-related and non-viral hepatocellular carcinoma (HCC).

Major finding: The objective response rate (20.6% and 24.6%, respectively; P = .55), median progression-free survival (7.0 and 6.2 months, respectively; hazard ratio 0.96; P = .33), and incidence and severity of adverse events, including diarrhea and liver injury, were comparable between patients with virus-related and non-viral HCC.

Study details: Findings are from a retrospective cohort study including 126 propensity score-matched pairs of patients with virus-related and non-viral HCC who had Child-Pugh class A, Barcelona Clinic Liver Cancer stage B or C, and performance status ≤1 and received Atez/Bev.

Disclosures: No source of funding was reported. Some authors declared receiving honoraria and research grants from various sources.

Source: Hatanaka T et al. Comparative efficacy and safety of atezolizumab and bevacizumab between hepatocellular carcinoma patients with viral and non-viral infection: A Japanese multicenter observational study. Cancer Med. 2022 (Oct 13). Doi: 10.1002/cam4.5337

Key clinical point: Atezolizumab plus bevacizumab (Atez/Bev) is effective and safe against both virus-related and non-viral hepatocellular carcinoma (HCC).

Major finding: The objective response rate (20.6% and 24.6%, respectively; P = .55), median progression-free survival (7.0 and 6.2 months, respectively; hazard ratio 0.96; P = .33), and incidence and severity of adverse events, including diarrhea and liver injury, were comparable between patients with virus-related and non-viral HCC.

Study details: Findings are from a retrospective cohort study including 126 propensity score-matched pairs of patients with virus-related and non-viral HCC who had Child-Pugh class A, Barcelona Clinic Liver Cancer stage B or C, and performance status ≤1 and received Atez/Bev.

Disclosures: No source of funding was reported. Some authors declared receiving honoraria and research grants from various sources.

Source: Hatanaka T et al. Comparative efficacy and safety of atezolizumab and bevacizumab between hepatocellular carcinoma patients with viral and non-viral infection: A Japanese multicenter observational study. Cancer Med. 2022 (Oct 13). Doi: 10.1002/cam4.5337

CHICAGO – It’s been said that one can observe a lot just by watching. Turning such observation inward, new evidence suggests, might lead to blood pressure (BP) reductions that approach what’s possible from an antihypertensive agent.

Systolic BP fell over 6 months by almost 6 mm Hg, on average, in people with elevated BP who participated in an 8-week mindful awareness program as part of a randomized trial that included a usual-care control group.

The program taught established mindfulness-training techniques aimed at modifying behaviors regarding diet, exercise, and other controllable influences on the success of antihypertensive therapy.

Participants in the program, called Mindfulness-Based Blood Pressure Reduction (MB-BP), also the name of the single-center study, “showed potentially clinically relevant reductions in systolic blood pressure,” said principal investigator Eric B. Loucks, PhD, Brown University, Providence, R.I.

The phase 2 trial has some limitations, he observed, including on generalizability. For example, it entered about 200 mostly White, college-educated adults from one metropolitan area.

But if these findings are replicated in further studies, “preferably by other research groups, in a larger and broader population, and with longer follow-up,” Dr. Loucks said, the MB-BP intervention could become “an appealing approach to help control blood pressure.”

Dr. Loucks made the comments at a press conference prior to his formal presentation of MB-BP Nov. 6 at American Heart Association (AHA) Scientific Sessions 2022, held in Chicago and virtually.

Mindfulness-based interventions for elevated BP have not been widely studied, “so this is exactly what we need: a well-done trial with a control group to show that it actually works,” Amit Khera, MD, not connected with MB-BP, told this news organization.

The trial is “really important for proof of concept, but it had only 200 people. You need a larger one, and you need longer-term data,” agreed Dr. Khera, who directs the preventive cardiology program at the University of Texas Southwestern Medical Center, in Dallas. “Six months is good, but we want to see if it’s durable.”

Rhian M. Touyz, MBBCh, also not part of MB-BP, agreed that the nearly 6 mm Hg mean systolic BP reduction among program participants is clinically relevant. “I think in the context of global risk and reduction of target organ damage and cardiovascular events, it is significant in terms of events at a population level,” Dr. Touyz, McGill University Health Centre, Montreal, told this news organization.

Many patients on antihypertensive therapy that’s falling short resist the addition of another such agent, she observed, and instead might show further BP reduction from mindfulness training. The intervention probably also “would benefit health in general.” Mindfulness-based approaches could therefore be useful additions to treatment protocols for elevated BP, Dr. Touyz said.
 

How the training works

The MB-BP program used validated mindfulness-based stress-management techniques, adapted to address elevated BP, that included “personalized feedback and education about hypertension risk factors, mindful awareness training of participants’ relationships with hypertension risk factors, and support for behavior change,” Dr. Loucks and colleagues reported.

Participants were trained in mindfulness skills that included “self-awareness and emotion regulation,” Dr. Loucks said, which they then could apply to their “relationships with the things that we know influence blood pressure, like physical activity, diet, antihypertensive medication adherence, or alcohol consumption.”

One goal is to promote greater “attention control,” he said, “so that there’s some self-awareness that arises in terms of how we feel the next day, after a lot of alcohol consumption, for example, or lack of physical activity.” The process can provide insights that inspire patients to modify behaviors and risk factors that elevate BP, Dr. Loucks explained.
 

Effects on medication use

Systolic BP responses led some program participants to be managed on fewer or reduced dosages of antihypertensive meds, he told this news organization. Physicians seen outside of the trial could adjust their prescriptions, intensifying or pulling back on meds depending on their assessments of the patient. Any prescription changes would be documented by the researchers at the patient’s next class or trial-clinic visit.

The group that did the training, Dr. Loucks said, was 33% less likely to increase and 30% more likely to decrease their use of BP-lowering medications compared with the control group.

Elevated BP is so common and undertreated that “there is a need for every possible level of intervention, starting from the population level to the individual and everything else in between,” nephrologist Janani Rangaswami, MD, George Washington University, Washington, said at the press conference.

Therefore, “this mindfulness-based approach, in addition to standard of care with pharmacotherapy, is a really welcome addition to the hypertension literature,” said Dr. Rangaswami, who directs her center’s cardiorenal program. The systolic BP reduction seen in the intervention group, she agreed, was “clinically important and meaningful.”
 

Blinded assessments

The trial entered 201 patients with systolic and diastolic BP greater than 120 mm Hg and 80 mm Hg, respectively; 58.7% were women, 81% were White, and 73% were college-educated, Dr. Loucks reported.

The 100 assigned to the “enhanced usual care” control group received educational materials on controlling high BP. They and the 101 who followed the mindfulness-based program were given and trained on a home BP-monitoring device. They were then followed for the primary endpoint of change in systolic BP at 6 months.

Data management and outcomes assessments were conducted by trialists not involved in the training intervention who were blinded to randomization assignment.

In a prespecified unadjusted analysis by intention-to-treat, systolic BP in the intervention group dropped by a mean of 5.9 mm Hg (P < .001) compared with baseline and 4.5 mm Hg (P = .045), compared with the control group.

A post hoc analysis adjusted for sex and baseline BP showed an average 4.3 mm Hg reduction (P = .056) in those following the MB-BP program, compared with controls.

There were no observed significant effects on diastolic BP.

The study offered clues to how engagement in the MB-BP program might promote reductions in systolic BP, Dr. Loucks observed. For example, it may have led to increased activity levels, reduced sodium intake, and other dietary improvements.

Indeed, program participants averaged about 351 minutes less sedentary time (P = .02) and showed a 0.32-point improvement in Dietary Approaches to Stop Hypertension scores (P = .08), compared with the control group, Dr. Loucks reported. Other modifiable risk factors for elevated BP that could have responded to the mindfulness-based training, he proposed, include obesity, alcohol intake, and reaction to stress.

Dr. Loucks reports that he developed the MB-BP training and was a program instructor but did not receive related financial compensation; he had no other disclosures. Dr. Khera, Dr. Touyz, and Dr. Rangaswami had no relevant financial relationships.

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

CHICAGO – It’s been said that one can observe a lot just by watching. Turning such observation inward, new evidence suggests, might lead to blood pressure (BP) reductions that approach what’s possible from an antihypertensive agent.

Systolic BP fell over 6 months by almost 6 mm Hg, on average, in people with elevated BP who participated in an 8-week mindful awareness program as part of a randomized trial that included a usual-care control group.

The program taught established mindfulness-training techniques aimed at modifying behaviors regarding diet, exercise, and other controllable influences on the success of antihypertensive therapy.

Participants in the program, called Mindfulness-Based Blood Pressure Reduction (MB-BP), also the name of the single-center study, “showed potentially clinically relevant reductions in systolic blood pressure,” said principal investigator Eric B. Loucks, PhD, Brown University, Providence, R.I.

The phase 2 trial has some limitations, he observed, including on generalizability. For example, it entered about 200 mostly White, college-educated adults from one metropolitan area.

But if these findings are replicated in further studies, “preferably by other research groups, in a larger and broader population, and with longer follow-up,” Dr. Loucks said, the MB-BP intervention could become “an appealing approach to help control blood pressure.”

Dr. Loucks made the comments at a press conference prior to his formal presentation of MB-BP Nov. 6 at American Heart Association (AHA) Scientific Sessions 2022, held in Chicago and virtually.

Mindfulness-based interventions for elevated BP have not been widely studied, “so this is exactly what we need: a well-done trial with a control group to show that it actually works,” Amit Khera, MD, not connected with MB-BP, told this news organization.

The trial is “really important for proof of concept, but it had only 200 people. You need a larger one, and you need longer-term data,” agreed Dr. Khera, who directs the preventive cardiology program at the University of Texas Southwestern Medical Center, in Dallas. “Six months is good, but we want to see if it’s durable.”

Rhian M. Touyz, MBBCh, also not part of MB-BP, agreed that the nearly 6 mm Hg mean systolic BP reduction among program participants is clinically relevant. “I think in the context of global risk and reduction of target organ damage and cardiovascular events, it is significant in terms of events at a population level,” Dr. Touyz, McGill University Health Centre, Montreal, told this news organization.

Many patients on antihypertensive therapy that’s falling short resist the addition of another such agent, she observed, and instead might show further BP reduction from mindfulness training. The intervention probably also “would benefit health in general.” Mindfulness-based approaches could therefore be useful additions to treatment protocols for elevated BP, Dr. Touyz said.
 

How the training works

The MB-BP program used validated mindfulness-based stress-management techniques, adapted to address elevated BP, that included “personalized feedback and education about hypertension risk factors, mindful awareness training of participants’ relationships with hypertension risk factors, and support for behavior change,” Dr. Loucks and colleagues reported.

Participants were trained in mindfulness skills that included “self-awareness and emotion regulation,” Dr. Loucks said, which they then could apply to their “relationships with the things that we know influence blood pressure, like physical activity, diet, antihypertensive medication adherence, or alcohol consumption.”

One goal is to promote greater “attention control,” he said, “so that there’s some self-awareness that arises in terms of how we feel the next day, after a lot of alcohol consumption, for example, or lack of physical activity.” The process can provide insights that inspire patients to modify behaviors and risk factors that elevate BP, Dr. Loucks explained.
 

Effects on medication use

Systolic BP responses led some program participants to be managed on fewer or reduced dosages of antihypertensive meds, he told this news organization. Physicians seen outside of the trial could adjust their prescriptions, intensifying or pulling back on meds depending on their assessments of the patient. Any prescription changes would be documented by the researchers at the patient’s next class or trial-clinic visit.

The group that did the training, Dr. Loucks said, was 33% less likely to increase and 30% more likely to decrease their use of BP-lowering medications compared with the control group.

Elevated BP is so common and undertreated that “there is a need for every possible level of intervention, starting from the population level to the individual and everything else in between,” nephrologist Janani Rangaswami, MD, George Washington University, Washington, said at the press conference.

Therefore, “this mindfulness-based approach, in addition to standard of care with pharmacotherapy, is a really welcome addition to the hypertension literature,” said Dr. Rangaswami, who directs her center’s cardiorenal program. The systolic BP reduction seen in the intervention group, she agreed, was “clinically important and meaningful.”
 

Blinded assessments

The trial entered 201 patients with systolic and diastolic BP greater than 120 mm Hg and 80 mm Hg, respectively; 58.7% were women, 81% were White, and 73% were college-educated, Dr. Loucks reported.

The 100 assigned to the “enhanced usual care” control group received educational materials on controlling high BP. They and the 101 who followed the mindfulness-based program were given and trained on a home BP-monitoring device. They were then followed for the primary endpoint of change in systolic BP at 6 months.

Data management and outcomes assessments were conducted by trialists not involved in the training intervention who were blinded to randomization assignment.

In a prespecified unadjusted analysis by intention-to-treat, systolic BP in the intervention group dropped by a mean of 5.9 mm Hg (P < .001) compared with baseline and 4.5 mm Hg (P = .045), compared with the control group.

A post hoc analysis adjusted for sex and baseline BP showed an average 4.3 mm Hg reduction (P = .056) in those following the MB-BP program, compared with controls.

There were no observed significant effects on diastolic BP.

The study offered clues to how engagement in the MB-BP program might promote reductions in systolic BP, Dr. Loucks observed. For example, it may have led to increased activity levels, reduced sodium intake, and other dietary improvements.

Indeed, program participants averaged about 351 minutes less sedentary time (P = .02) and showed a 0.32-point improvement in Dietary Approaches to Stop Hypertension scores (P = .08), compared with the control group, Dr. Loucks reported. Other modifiable risk factors for elevated BP that could have responded to the mindfulness-based training, he proposed, include obesity, alcohol intake, and reaction to stress.

Dr. Loucks reports that he developed the MB-BP training and was a program instructor but did not receive related financial compensation; he had no other disclosures. Dr. Khera, Dr. Touyz, and Dr. Rangaswami had no relevant financial relationships.

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

CHICAGO – It’s been said that one can observe a lot just by watching. Turning such observation inward, new evidence suggests, might lead to blood pressure (BP) reductions that approach what’s possible from an antihypertensive agent.

Systolic BP fell over 6 months by almost 6 mm Hg, on average, in people with elevated BP who participated in an 8-week mindful awareness program as part of a randomized trial that included a usual-care control group.

The program taught established mindfulness-training techniques aimed at modifying behaviors regarding diet, exercise, and other controllable influences on the success of antihypertensive therapy.

Participants in the program, called Mindfulness-Based Blood Pressure Reduction (MB-BP), also the name of the single-center study, “showed potentially clinically relevant reductions in systolic blood pressure,” said principal investigator Eric B. Loucks, PhD, Brown University, Providence, R.I.

The phase 2 trial has some limitations, he observed, including on generalizability. For example, it entered about 200 mostly White, college-educated adults from one metropolitan area.

But if these findings are replicated in further studies, “preferably by other research groups, in a larger and broader population, and with longer follow-up,” Dr. Loucks said, the MB-BP intervention could become “an appealing approach to help control blood pressure.”

Dr. Loucks made the comments at a press conference prior to his formal presentation of MB-BP Nov. 6 at American Heart Association (AHA) Scientific Sessions 2022, held in Chicago and virtually.

Mindfulness-based interventions for elevated BP have not been widely studied, “so this is exactly what we need: a well-done trial with a control group to show that it actually works,” Amit Khera, MD, not connected with MB-BP, told this news organization.

The trial is “really important for proof of concept, but it had only 200 people. You need a larger one, and you need longer-term data,” agreed Dr. Khera, who directs the preventive cardiology program at the University of Texas Southwestern Medical Center, in Dallas. “Six months is good, but we want to see if it’s durable.”

Rhian M. Touyz, MBBCh, also not part of MB-BP, agreed that the nearly 6 mm Hg mean systolic BP reduction among program participants is clinically relevant. “I think in the context of global risk and reduction of target organ damage and cardiovascular events, it is significant in terms of events at a population level,” Dr. Touyz, McGill University Health Centre, Montreal, told this news organization.

Many patients on antihypertensive therapy that’s falling short resist the addition of another such agent, she observed, and instead might show further BP reduction from mindfulness training. The intervention probably also “would benefit health in general.” Mindfulness-based approaches could therefore be useful additions to treatment protocols for elevated BP, Dr. Touyz said.
 

How the training works

The MB-BP program used validated mindfulness-based stress-management techniques, adapted to address elevated BP, that included “personalized feedback and education about hypertension risk factors, mindful awareness training of participants’ relationships with hypertension risk factors, and support for behavior change,” Dr. Loucks and colleagues reported.

Participants were trained in mindfulness skills that included “self-awareness and emotion regulation,” Dr. Loucks said, which they then could apply to their “relationships with the things that we know influence blood pressure, like physical activity, diet, antihypertensive medication adherence, or alcohol consumption.”

One goal is to promote greater “attention control,” he said, “so that there’s some self-awareness that arises in terms of how we feel the next day, after a lot of alcohol consumption, for example, or lack of physical activity.” The process can provide insights that inspire patients to modify behaviors and risk factors that elevate BP, Dr. Loucks explained.
 

Effects on medication use

Systolic BP responses led some program participants to be managed on fewer or reduced dosages of antihypertensive meds, he told this news organization. Physicians seen outside of the trial could adjust their prescriptions, intensifying or pulling back on meds depending on their assessments of the patient. Any prescription changes would be documented by the researchers at the patient’s next class or trial-clinic visit.

The group that did the training, Dr. Loucks said, was 33% less likely to increase and 30% more likely to decrease their use of BP-lowering medications compared with the control group.

Elevated BP is so common and undertreated that “there is a need for every possible level of intervention, starting from the population level to the individual and everything else in between,” nephrologist Janani Rangaswami, MD, George Washington University, Washington, said at the press conference.

Therefore, “this mindfulness-based approach, in addition to standard of care with pharmacotherapy, is a really welcome addition to the hypertension literature,” said Dr. Rangaswami, who directs her center’s cardiorenal program. The systolic BP reduction seen in the intervention group, she agreed, was “clinically important and meaningful.”
 

Blinded assessments

The trial entered 201 patients with systolic and diastolic BP greater than 120 mm Hg and 80 mm Hg, respectively; 58.7% were women, 81% were White, and 73% were college-educated, Dr. Loucks reported.

The 100 assigned to the “enhanced usual care” control group received educational materials on controlling high BP. They and the 101 who followed the mindfulness-based program were given and trained on a home BP-monitoring device. They were then followed for the primary endpoint of change in systolic BP at 6 months.

Data management and outcomes assessments were conducted by trialists not involved in the training intervention who were blinded to randomization assignment.

In a prespecified unadjusted analysis by intention-to-treat, systolic BP in the intervention group dropped by a mean of 5.9 mm Hg (P < .001) compared with baseline and 4.5 mm Hg (P = .045), compared with the control group.

A post hoc analysis adjusted for sex and baseline BP showed an average 4.3 mm Hg reduction (P = .056) in those following the MB-BP program, compared with controls.

There were no observed significant effects on diastolic BP.

The study offered clues to how engagement in the MB-BP program might promote reductions in systolic BP, Dr. Loucks observed. For example, it may have led to increased activity levels, reduced sodium intake, and other dietary improvements.

Indeed, program participants averaged about 351 minutes less sedentary time (P = .02) and showed a 0.32-point improvement in Dietary Approaches to Stop Hypertension scores (P = .08), compared with the control group, Dr. Loucks reported. Other modifiable risk factors for elevated BP that could have responded to the mindfulness-based training, he proposed, include obesity, alcohol intake, and reaction to stress.

Dr. Loucks reports that he developed the MB-BP training and was a program instructor but did not receive related financial compensation; he had no other disclosures. Dr. Khera, Dr. Touyz, and Dr. Rangaswami had no relevant financial relationships.

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

Key clinical point: The use of immune checkpoint inhibitor (ICI)-based regimens after prior immunotherapy is safe and confers a treatment benefit in a clinically meaningful proportion of patients with hepatocellular carcinoma (HCC).

Major finding: The objective response and disease control rates were 22% and 59% with first-line ICI therapy (ICI-1) and 26% and 55% with second-line ICI therapy (ICI-2), respectively. The median times to progression with ICI-1 and ICI-2 were 5.4 (95% CI 3.0-7.7) months and 5.2 (95% CI 3.3-7.0) months, respectively. Grade 3-4 treatment-related adverse events with ICI-1 and ICI-2 occurred in 16% and 17% of patients, respectively.

Study details: This multicenter retrospective included 58 patients with HCC who received ≥2 lines of ICI-based therapies.

Disclosures: This study did not receive any specific funding. Some authors declared serving as investigators for or receiving advisory, consulting, or speaker fees or travel support from various sources.

Source: Scheiner B et al. Efficacy and safety of immune checkpoint inhibitor rechallenge in individuals with hepatocellular carcinoma. JHEP Rep. 2022;100620 (Oct 26). Doi: 10.1016/j.jhepr.2022.100620

Key clinical point: The use of immune checkpoint inhibitor (ICI)-based regimens after prior immunotherapy is safe and confers a treatment benefit in a clinically meaningful proportion of patients with hepatocellular carcinoma (HCC).

Major finding: The objective response and disease control rates were 22% and 59% with first-line ICI therapy (ICI-1) and 26% and 55% with second-line ICI therapy (ICI-2), respectively. The median times to progression with ICI-1 and ICI-2 were 5.4 (95% CI 3.0-7.7) months and 5.2 (95% CI 3.3-7.0) months, respectively. Grade 3-4 treatment-related adverse events with ICI-1 and ICI-2 occurred in 16% and 17% of patients, respectively.

Study details: This multicenter retrospective included 58 patients with HCC who received ≥2 lines of ICI-based therapies.

Disclosures: This study did not receive any specific funding. Some authors declared serving as investigators for or receiving advisory, consulting, or speaker fees or travel support from various sources.

Source: Scheiner B et al. Efficacy and safety of immune checkpoint inhibitor rechallenge in individuals with hepatocellular carcinoma. JHEP Rep. 2022;100620 (Oct 26). Doi: 10.1016/j.jhepr.2022.100620

Key clinical point: The use of immune checkpoint inhibitor (ICI)-based regimens after prior immunotherapy is safe and confers a treatment benefit in a clinically meaningful proportion of patients with hepatocellular carcinoma (HCC).

Major finding: The objective response and disease control rates were 22% and 59% with first-line ICI therapy (ICI-1) and 26% and 55% with second-line ICI therapy (ICI-2), respectively. The median times to progression with ICI-1 and ICI-2 were 5.4 (95% CI 3.0-7.7) months and 5.2 (95% CI 3.3-7.0) months, respectively. Grade 3-4 treatment-related adverse events with ICI-1 and ICI-2 occurred in 16% and 17% of patients, respectively.

Study details: This multicenter retrospective included 58 patients with HCC who received ≥2 lines of ICI-based therapies.

Disclosures: This study did not receive any specific funding. Some authors declared serving as investigators for or receiving advisory, consulting, or speaker fees or travel support from various sources.

Source: Scheiner B et al. Efficacy and safety of immune checkpoint inhibitor rechallenge in individuals with hepatocellular carcinoma. JHEP Rep. 2022;100620 (Oct 26). Doi: 10.1016/j.jhepr.2022.100620