Key clinical point: Lenvatinib (LEN)-transcatheter arterial chemoembolization (LEN-TACE) sequential therapy may be more clinically beneficial than LEN monotherapy in patients with unresectable hepatocellular carcinoma (HCC) responsive to initial LEN treatment without exerting any additional adverse effects.

Major finding: The LEN-TACE vs. LEN monotherapy group showed a significantly higher median overall survival (31.2 months vs. 13.9 months; P = .002) and progression-free survival (12.2 months vs. 7.1 months; P = .037). The LEN-TACE group had an acceptable safety profile, with only liver dysfunction being significantly higher (P = .04).

Study details: Findings are from a retrospective, multicenter cohort study on patients with intermediate- or advanced-stage unresectable HCC who responded to initial LEN treatment. Among these, 63 patients receiving LEN-TACE sequential therapy were propensity-score matched to those receiving LEN monotherapy.

Disclosures: The authors declared no source of funding or conflict of interests.

Source: Kuroda H et al. Objective response by mRECIST to initial lenvatinib therapy is an independent factor contributing to deep response in hepatocellular carcinoma treated with lenvatinib-transcatheter arterial chemoembolization sequential therapy. Liver Cancer. 2022 (Feb 15). Doi: 10.1159/000522424

Key clinical point: Lenvatinib (LEN)-transcatheter arterial chemoembolization (LEN-TACE) sequential therapy may be more clinically beneficial than LEN monotherapy in patients with unresectable hepatocellular carcinoma (HCC) responsive to initial LEN treatment without exerting any additional adverse effects.

Major finding: The LEN-TACE vs. LEN monotherapy group showed a significantly higher median overall survival (31.2 months vs. 13.9 months; P = .002) and progression-free survival (12.2 months vs. 7.1 months; P = .037). The LEN-TACE group had an acceptable safety profile, with only liver dysfunction being significantly higher (P = .04).

Study details: Findings are from a retrospective, multicenter cohort study on patients with intermediate- or advanced-stage unresectable HCC who responded to initial LEN treatment. Among these, 63 patients receiving LEN-TACE sequential therapy were propensity-score matched to those receiving LEN monotherapy.

Disclosures: The authors declared no source of funding or conflict of interests.

Source: Kuroda H et al. Objective response by mRECIST to initial lenvatinib therapy is an independent factor contributing to deep response in hepatocellular carcinoma treated with lenvatinib-transcatheter arterial chemoembolization sequential therapy. Liver Cancer. 2022 (Feb 15). Doi: 10.1159/000522424

Key clinical point: Lenvatinib (LEN)-transcatheter arterial chemoembolization (LEN-TACE) sequential therapy may be more clinically beneficial than LEN monotherapy in patients with unresectable hepatocellular carcinoma (HCC) responsive to initial LEN treatment without exerting any additional adverse effects.

Major finding: The LEN-TACE vs. LEN monotherapy group showed a significantly higher median overall survival (31.2 months vs. 13.9 months; P = .002) and progression-free survival (12.2 months vs. 7.1 months; P = .037). The LEN-TACE group had an acceptable safety profile, with only liver dysfunction being significantly higher (P = .04).

Study details: Findings are from a retrospective, multicenter cohort study on patients with intermediate- or advanced-stage unresectable HCC who responded to initial LEN treatment. Among these, 63 patients receiving LEN-TACE sequential therapy were propensity-score matched to those receiving LEN monotherapy.

Disclosures: The authors declared no source of funding or conflict of interests.

Source: Kuroda H et al. Objective response by mRECIST to initial lenvatinib therapy is an independent factor contributing to deep response in hepatocellular carcinoma treated with lenvatinib-transcatheter arterial chemoembolization sequential therapy. Liver Cancer. 2022 (Feb 15). Doi: 10.1159/000522424

Key clinical point: Although treatment with transarterial chemoembolization (TACE) plus sorafenib does not significantly increase overall survival (OS) in patients with unresectable hepatocellular carcinoma (HCC) relative to TACE alone, it does offer a clinically meaningful OS prolongation.

Major finding: Patients receiving TACE plus sorafenib vs. TACE monotherapy showed a median OS of 36.2 months vs. 30.8 months (hazard ratio 0.861; P = .40). Despite being nonsignificant, the benefit (ΔOS 5.4 months) was clinically meaningful.

Study details: The data represent the final results of the multicenter, prospective phase 2 TACTICS trial including 156 patients aged >20 years with unresectable HCC having a life expectancy of ≥12 weeks who were randomly assigned to TACE plus sorafenib (n = 80) or TACE alone (n = 76).

Disclosures: The study was sponsored by Bayer Yakuhin Ltd., Japan. Some authors reported serving as speakers/advisory consultants for and receiving grants, personal fees, and consulting/advisory fees from various sources including Bayer. M Kudo is the Editor-in-Chief of Liver Cancer, and some others are its editorial board members.

Source: Kudo M et al. Final results of TACTICS: A randomized, prospective trial comparing transarterial chemoembolization plus sorafenib to transarterial chemoembolization alone in patients with unresectable hepatocellular carcinoma. Liver Cancer. 2022 (Feb 10). Doi: 10.1159/000522547

Key clinical point: Although treatment with transarterial chemoembolization (TACE) plus sorafenib does not significantly increase overall survival (OS) in patients with unresectable hepatocellular carcinoma (HCC) relative to TACE alone, it does offer a clinically meaningful OS prolongation.

Major finding: Patients receiving TACE plus sorafenib vs. TACE monotherapy showed a median OS of 36.2 months vs. 30.8 months (hazard ratio 0.861; P = .40). Despite being nonsignificant, the benefit (ΔOS 5.4 months) was clinically meaningful.

Study details: The data represent the final results of the multicenter, prospective phase 2 TACTICS trial including 156 patients aged >20 years with unresectable HCC having a life expectancy of ≥12 weeks who were randomly assigned to TACE plus sorafenib (n = 80) or TACE alone (n = 76).

Disclosures: The study was sponsored by Bayer Yakuhin Ltd., Japan. Some authors reported serving as speakers/advisory consultants for and receiving grants, personal fees, and consulting/advisory fees from various sources including Bayer. M Kudo is the Editor-in-Chief of Liver Cancer, and some others are its editorial board members.

Source: Kudo M et al. Final results of TACTICS: A randomized, prospective trial comparing transarterial chemoembolization plus sorafenib to transarterial chemoembolization alone in patients with unresectable hepatocellular carcinoma. Liver Cancer. 2022 (Feb 10). Doi: 10.1159/000522547

Key clinical point: Although treatment with transarterial chemoembolization (TACE) plus sorafenib does not significantly increase overall survival (OS) in patients with unresectable hepatocellular carcinoma (HCC) relative to TACE alone, it does offer a clinically meaningful OS prolongation.

Major finding: Patients receiving TACE plus sorafenib vs. TACE monotherapy showed a median OS of 36.2 months vs. 30.8 months (hazard ratio 0.861; P = .40). Despite being nonsignificant, the benefit (ΔOS 5.4 months) was clinically meaningful.

Study details: The data represent the final results of the multicenter, prospective phase 2 TACTICS trial including 156 patients aged >20 years with unresectable HCC having a life expectancy of ≥12 weeks who were randomly assigned to TACE plus sorafenib (n = 80) or TACE alone (n = 76).

Disclosures: The study was sponsored by Bayer Yakuhin Ltd., Japan. Some authors reported serving as speakers/advisory consultants for and receiving grants, personal fees, and consulting/advisory fees from various sources including Bayer. M Kudo is the Editor-in-Chief of Liver Cancer, and some others are its editorial board members.

Source: Kudo M et al. Final results of TACTICS: A randomized, prospective trial comparing transarterial chemoembolization plus sorafenib to transarterial chemoembolization alone in patients with unresectable hepatocellular carcinoma. Liver Cancer. 2022 (Feb 10). Doi: 10.1159/000522547

Key clinical point: Patients receiving tenofovir disoproxil fumarate (TDF) vs. entecavir (ETV) after curative liver resection for hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) showed significantly better overall survival and protection of liver function but no significant difference in the cumulative incidences of HCC recurrence.

Major finding: Although patients receiving TDF vs. ETV showed no significant difference in recurrence-free survival after propensity-score matching (hazard ratio [HR] 0.91; P = .45), they had significantly better overall survival (HR 0.37; P = .002) and liver function (P = .001).

Study details: This retrospective, single-center study reviewed data on 1,173 adult patients with HBV-related HCC who had undergone liver resection and were initially treated with either TDF or ETV for chronic HBV infection.

Disclosures: The study was funded by Sun Yat-sen University Cancer Center physician-scientist funding and National Science and Technology Major Project of China. The authors reported having no conflict of interests.

Source: Wang XH et al. Tenofovir vs. entecavir on prognosis of hepatitis B virus-related hepatocellular carcinoma after curative resection. J Gastroenterol. 2022;57:185-198 (Feb 13). Doi: 10.1007/s00535-022-01855-x

Key clinical point: Patients receiving tenofovir disoproxil fumarate (TDF) vs. entecavir (ETV) after curative liver resection for hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) showed significantly better overall survival and protection of liver function but no significant difference in the cumulative incidences of HCC recurrence.

Major finding: Although patients receiving TDF vs. ETV showed no significant difference in recurrence-free survival after propensity-score matching (hazard ratio [HR] 0.91; P = .45), they had significantly better overall survival (HR 0.37; P = .002) and liver function (P = .001).

Study details: This retrospective, single-center study reviewed data on 1,173 adult patients with HBV-related HCC who had undergone liver resection and were initially treated with either TDF or ETV for chronic HBV infection.

Disclosures: The study was funded by Sun Yat-sen University Cancer Center physician-scientist funding and National Science and Technology Major Project of China. The authors reported having no conflict of interests.

Source: Wang XH et al. Tenofovir vs. entecavir on prognosis of hepatitis B virus-related hepatocellular carcinoma after curative resection. J Gastroenterol. 2022;57:185-198 (Feb 13). Doi: 10.1007/s00535-022-01855-x

Key clinical point: Patients receiving tenofovir disoproxil fumarate (TDF) vs. entecavir (ETV) after curative liver resection for hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) showed significantly better overall survival and protection of liver function but no significant difference in the cumulative incidences of HCC recurrence.

Major finding: Although patients receiving TDF vs. ETV showed no significant difference in recurrence-free survival after propensity-score matching (hazard ratio [HR] 0.91; P = .45), they had significantly better overall survival (HR 0.37; P = .002) and liver function (P = .001).

Study details: This retrospective, single-center study reviewed data on 1,173 adult patients with HBV-related HCC who had undergone liver resection and were initially treated with either TDF or ETV for chronic HBV infection.

Disclosures: The study was funded by Sun Yat-sen University Cancer Center physician-scientist funding and National Science and Technology Major Project of China. The authors reported having no conflict of interests.

Source: Wang XH et al. Tenofovir vs. entecavir on prognosis of hepatitis B virus-related hepatocellular carcinoma after curative resection. J Gastroenterol. 2022;57:185-198 (Feb 13). Doi: 10.1007/s00535-022-01855-x

A new study has drawn attention to inaccurate measurement of LDL-cholesterol levels in some patients with current assays, which could lead to incorrect therapeutic approaches.

The patient groups most affected are those with high levels of the lipoprotein Lp(a), in whom LDL-cholesterol levels are being overestimated in current laboratory tests, the authors say.

“Current laboratory assays all have the limitation that they cannot measure or report LDL cholesterol accurately. They are actually measuring the combination of LDL and Lp(a),” senior study author Sotirios Tsimikas, MD, University of California, San Diego, explained to this news organization.

“Lp(a) can be lowered a little with niacin and PCSK9 inhibitors, but both have a quite a weak effect, and statins increase Lp(a). However, there are now multiple RNA-based therapeutics specifically targeting Lp(a) in clinical development,” he said.

At present, Lp(a) cholesterol has to be mathematically estimated, most commonly with the Dahlén formula, because of the lack of a validated, quantitative method to measure Lp(a) cholesterol, Dr. Tsimikas says.  

For the current study, the researchers used a novel, quantitative, sensitive method to directly measure Lp(a) cholesterol, then applied this method to data from a recent study with the one of the new Lp(a)-lowering drugs in development – pelacarsen – which was conducted in patients with elevated Lp(a) levels.

Results showed that direct Lp(a)-cholesterol assessment, and subtracting this value from the laboratory LDL-cholesterol value, provides a more accurate reflection of the baseline and change in LDL cholesterol, the authors report. In the current study, corrected LDL cholesterol was 13 to 16 mg/dL lower than laboratory-reported LDL cholesterol.

Using the corrected LDL-cholesterol results, the study showed that pelacarsen significantly decreases Lp(a) cholesterol, with neutral to modest effects on LDL.

The study also suggests that the current method of calculating Lp(a) cholesterol, and then deriving a corrected LDL cholesterol – the Dahlén formula – is not accurate. 

“The Dahlén formula relies on the assumption that Lp(a) cholesterol is universally a fixed 30% of Lp(a) mass, but this usually isn’t the case. The Dahlén formula needs to be discontinued. It can be highly inaccurate,” Dr. Tsimikas said.  

Important implications

In an accompanying editorial, Guillaume Paré, MD, Michael Chong, PhD student, and Pedrum Mohammadi-Shemirani, BSc, all of McMaster University, Hamilton, Ont., say the current findings have three important clinical implications.

“First, they provide further proof that in individuals with elevated Lp(a), the contribution of Lp(a)-cholesterol to LDL-cholesterol is non-negligible using standard assays, with 13-16 mg/dL lower LDL-cholesterol post-correction.”

Secondly, the editorialists point out that these new findings confirm that the effect of Lp(a) inhibitors is likely to be mostly confined to Lp(a), “as would be expected.”

Finally, “and perhaps more importantly, the authors highlight the need to improve clinical reporting of lipid fractions to properly treat LDL-cholesterol and Lp(a) in high-risk patients,” they note.

“The report paves the way for future studies investigating the clinical utility of these additional measurements to initiate and monitor lipid-lowering therapy,” they conclude.

The clinical trial was funded by Ionis Pharmaceuticals, and the direct Lp(a)-cholesterol measurements were funded by Novartis through a research grant to the University of California, San Diego. Dr. Tsimikas is an employee of Ionis Pharmaceuticals and of the University of California, San Diego, and he is a cofounder of Covicept Therapeutics. He is also a coinventor and receives royalties from patents owned by UCSD on oxidation-specific antibodies and on biomarkers related to oxidized lipoproteins, as well as a cofounder and has equity interest in Oxitope and Kleanthi Diagnostics.

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

A new study has drawn attention to inaccurate measurement of LDL-cholesterol levels in some patients with current assays, which could lead to incorrect therapeutic approaches.

The patient groups most affected are those with high levels of the lipoprotein Lp(a), in whom LDL-cholesterol levels are being overestimated in current laboratory tests, the authors say.

“Current laboratory assays all have the limitation that they cannot measure or report LDL cholesterol accurately. They are actually measuring the combination of LDL and Lp(a),” senior study author Sotirios Tsimikas, MD, University of California, San Diego, explained to this news organization.

“Lp(a) can be lowered a little with niacin and PCSK9 inhibitors, but both have a quite a weak effect, and statins increase Lp(a). However, there are now multiple RNA-based therapeutics specifically targeting Lp(a) in clinical development,” he said.

At present, Lp(a) cholesterol has to be mathematically estimated, most commonly with the Dahlén formula, because of the lack of a validated, quantitative method to measure Lp(a) cholesterol, Dr. Tsimikas says.  

For the current study, the researchers used a novel, quantitative, sensitive method to directly measure Lp(a) cholesterol, then applied this method to data from a recent study with the one of the new Lp(a)-lowering drugs in development – pelacarsen – which was conducted in patients with elevated Lp(a) levels.

Results showed that direct Lp(a)-cholesterol assessment, and subtracting this value from the laboratory LDL-cholesterol value, provides a more accurate reflection of the baseline and change in LDL cholesterol, the authors report. In the current study, corrected LDL cholesterol was 13 to 16 mg/dL lower than laboratory-reported LDL cholesterol.

Using the corrected LDL-cholesterol results, the study showed that pelacarsen significantly decreases Lp(a) cholesterol, with neutral to modest effects on LDL.

The study also suggests that the current method of calculating Lp(a) cholesterol, and then deriving a corrected LDL cholesterol – the Dahlén formula – is not accurate. 

“The Dahlén formula relies on the assumption that Lp(a) cholesterol is universally a fixed 30% of Lp(a) mass, but this usually isn’t the case. The Dahlén formula needs to be discontinued. It can be highly inaccurate,” Dr. Tsimikas said.  

Important implications

In an accompanying editorial, Guillaume Paré, MD, Michael Chong, PhD student, and Pedrum Mohammadi-Shemirani, BSc, all of McMaster University, Hamilton, Ont., say the current findings have three important clinical implications.

“First, they provide further proof that in individuals with elevated Lp(a), the contribution of Lp(a)-cholesterol to LDL-cholesterol is non-negligible using standard assays, with 13-16 mg/dL lower LDL-cholesterol post-correction.”

Secondly, the editorialists point out that these new findings confirm that the effect of Lp(a) inhibitors is likely to be mostly confined to Lp(a), “as would be expected.”

Finally, “and perhaps more importantly, the authors highlight the need to improve clinical reporting of lipid fractions to properly treat LDL-cholesterol and Lp(a) in high-risk patients,” they note.

“The report paves the way for future studies investigating the clinical utility of these additional measurements to initiate and monitor lipid-lowering therapy,” they conclude.

The clinical trial was funded by Ionis Pharmaceuticals, and the direct Lp(a)-cholesterol measurements were funded by Novartis through a research grant to the University of California, San Diego. Dr. Tsimikas is an employee of Ionis Pharmaceuticals and of the University of California, San Diego, and he is a cofounder of Covicept Therapeutics. He is also a coinventor and receives royalties from patents owned by UCSD on oxidation-specific antibodies and on biomarkers related to oxidized lipoproteins, as well as a cofounder and has equity interest in Oxitope and Kleanthi Diagnostics.

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

A new study has drawn attention to inaccurate measurement of LDL-cholesterol levels in some patients with current assays, which could lead to incorrect therapeutic approaches.

The patient groups most affected are those with high levels of the lipoprotein Lp(a), in whom LDL-cholesterol levels are being overestimated in current laboratory tests, the authors say.

“Current laboratory assays all have the limitation that they cannot measure or report LDL cholesterol accurately. They are actually measuring the combination of LDL and Lp(a),” senior study author Sotirios Tsimikas, MD, University of California, San Diego, explained to this news organization.

“Lp(a) can be lowered a little with niacin and PCSK9 inhibitors, but both have a quite a weak effect, and statins increase Lp(a). However, there are now multiple RNA-based therapeutics specifically targeting Lp(a) in clinical development,” he said.

At present, Lp(a) cholesterol has to be mathematically estimated, most commonly with the Dahlén formula, because of the lack of a validated, quantitative method to measure Lp(a) cholesterol, Dr. Tsimikas says.  

For the current study, the researchers used a novel, quantitative, sensitive method to directly measure Lp(a) cholesterol, then applied this method to data from a recent study with the one of the new Lp(a)-lowering drugs in development – pelacarsen – which was conducted in patients with elevated Lp(a) levels.

Results showed that direct Lp(a)-cholesterol assessment, and subtracting this value from the laboratory LDL-cholesterol value, provides a more accurate reflection of the baseline and change in LDL cholesterol, the authors report. In the current study, corrected LDL cholesterol was 13 to 16 mg/dL lower than laboratory-reported LDL cholesterol.

Using the corrected LDL-cholesterol results, the study showed that pelacarsen significantly decreases Lp(a) cholesterol, with neutral to modest effects on LDL.

The study also suggests that the current method of calculating Lp(a) cholesterol, and then deriving a corrected LDL cholesterol – the Dahlén formula – is not accurate. 

“The Dahlén formula relies on the assumption that Lp(a) cholesterol is universally a fixed 30% of Lp(a) mass, but this usually isn’t the case. The Dahlén formula needs to be discontinued. It can be highly inaccurate,” Dr. Tsimikas said.  

Important implications

In an accompanying editorial, Guillaume Paré, MD, Michael Chong, PhD student, and Pedrum Mohammadi-Shemirani, BSc, all of McMaster University, Hamilton, Ont., say the current findings have three important clinical implications.

“First, they provide further proof that in individuals with elevated Lp(a), the contribution of Lp(a)-cholesterol to LDL-cholesterol is non-negligible using standard assays, with 13-16 mg/dL lower LDL-cholesterol post-correction.”

Secondly, the editorialists point out that these new findings confirm that the effect of Lp(a) inhibitors is likely to be mostly confined to Lp(a), “as would be expected.”

Finally, “and perhaps more importantly, the authors highlight the need to improve clinical reporting of lipid fractions to properly treat LDL-cholesterol and Lp(a) in high-risk patients,” they note.

“The report paves the way for future studies investigating the clinical utility of these additional measurements to initiate and monitor lipid-lowering therapy,” they conclude.

The clinical trial was funded by Ionis Pharmaceuticals, and the direct Lp(a)-cholesterol measurements were funded by Novartis through a research grant to the University of California, San Diego. Dr. Tsimikas is an employee of Ionis Pharmaceuticals and of the University of California, San Diego, and he is a cofounder of Covicept Therapeutics. He is also a coinventor and receives royalties from patents owned by UCSD on oxidation-specific antibodies and on biomarkers related to oxidized lipoproteins, as well as a cofounder and has equity interest in Oxitope and Kleanthi Diagnostics.

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

Key clinical point: The risk for hepatocellular carcinoma (HCC) varies with underlying etiologies, with active hepatitis C virus (HCV) cirrhosis posing the highest and alcoholic or nonalcoholic fatty liver disease (NAFLD) cirrhosis posing the lowest risk of developing HCC.

Major finding: Patients with active HCV (3.36%) showed the highest annual HCC incidence rate, followed by those with cured HCV (1.71%), alcoholic liver disease (1.32%), and NAFLD cirrhosis (1.24%). Patients with active HCV vs. NAFLD were at a 2.1-fold higher risk for HCC (adjusted hazard ratio 2.16; 95% CI, 1.16-4.04).

Study details: This multicenter, prospective cohort study analyzed data from two multiethnic cohorts enrolling a total of 2,733 patients with cirrhosis.

Disclosures: The study received financial support from the National Cancer Institute; Cancer Prevention & Research Institute of Texas grant; and Center for Gastrointestinal Development, Infection, and Injury. No conflicts of interest were reported.

Source: Kanwal F et al. Risk factors for hepatocellular cancer in contemporary cohorts of patients with cirrhosis. Hepatology. 2022 (Mar 1). Doi: 10.1002/hep.32434

Key clinical point: The risk for hepatocellular carcinoma (HCC) varies with underlying etiologies, with active hepatitis C virus (HCV) cirrhosis posing the highest and alcoholic or nonalcoholic fatty liver disease (NAFLD) cirrhosis posing the lowest risk of developing HCC.

Major finding: Patients with active HCV (3.36%) showed the highest annual HCC incidence rate, followed by those with cured HCV (1.71%), alcoholic liver disease (1.32%), and NAFLD cirrhosis (1.24%). Patients with active HCV vs. NAFLD were at a 2.1-fold higher risk for HCC (adjusted hazard ratio 2.16; 95% CI, 1.16-4.04).

Study details: This multicenter, prospective cohort study analyzed data from two multiethnic cohorts enrolling a total of 2,733 patients with cirrhosis.

Disclosures: The study received financial support from the National Cancer Institute; Cancer Prevention & Research Institute of Texas grant; and Center for Gastrointestinal Development, Infection, and Injury. No conflicts of interest were reported.

Source: Kanwal F et al. Risk factors for hepatocellular cancer in contemporary cohorts of patients with cirrhosis. Hepatology. 2022 (Mar 1). Doi: 10.1002/hep.32434

Key clinical point: The risk for hepatocellular carcinoma (HCC) varies with underlying etiologies, with active hepatitis C virus (HCV) cirrhosis posing the highest and alcoholic or nonalcoholic fatty liver disease (NAFLD) cirrhosis posing the lowest risk of developing HCC.

Major finding: Patients with active HCV (3.36%) showed the highest annual HCC incidence rate, followed by those with cured HCV (1.71%), alcoholic liver disease (1.32%), and NAFLD cirrhosis (1.24%). Patients with active HCV vs. NAFLD were at a 2.1-fold higher risk for HCC (adjusted hazard ratio 2.16; 95% CI, 1.16-4.04).

Study details: This multicenter, prospective cohort study analyzed data from two multiethnic cohorts enrolling a total of 2,733 patients with cirrhosis.

Disclosures: The study received financial support from the National Cancer Institute; Cancer Prevention & Research Institute of Texas grant; and Center for Gastrointestinal Development, Infection, and Injury. No conflicts of interest were reported.

Source: Kanwal F et al. Risk factors for hepatocellular cancer in contemporary cohorts of patients with cirrhosis. Hepatology. 2022 (Mar 1). Doi: 10.1002/hep.32434

Key clinical point: Active hepatitis C virus (HCV) infection negatively affects overall and recurrence-free survival in patients with very early-stage hepatocellular carcinoma (HCC) after curative radiofrequency ablation (RFA).

Major finding: Active HCV infection was a significant risk factor for shorter overall survival (adjusted hazard ratio [aHR] 2.17; P = .003) and early recurrence of HCC (aHR 1.47; P = .022). Patients with vs. without active HCV infection had a shorter median overall (66 months vs. 145 months) and recurrence-free (20 months vs. 31 months) survival (both P < .001).

Study details: Findings are from a single-center retrospective study including 302 patients with very early-stage HCC (Barcelona Clinic Liver Cancer stage 0) who underwent RFA and had follow-up of >6 months, of which 195 had HCV infection, including 132 active infection cases.

Disclosures: M Kurosaki and N Izumi declared funding support from the Japan Agency for Medical Research and Development and Japanese Ministry of Health, Welfare, and Labor, respectively, and along with K Tsuchiya, receiving lecture fees from several sources.

Source: Takaura K et al. The impact of background liver disease on the long-term prognosis of very-early-stage HCC after ablation therapy. PLoS One. 2022;17(2):e0264075 (Feb 23). Doi:  10.1371/journal.pone.0264075

Key clinical point: Active hepatitis C virus (HCV) infection negatively affects overall and recurrence-free survival in patients with very early-stage hepatocellular carcinoma (HCC) after curative radiofrequency ablation (RFA).

Major finding: Active HCV infection was a significant risk factor for shorter overall survival (adjusted hazard ratio [aHR] 2.17; P = .003) and early recurrence of HCC (aHR 1.47; P = .022). Patients with vs. without active HCV infection had a shorter median overall (66 months vs. 145 months) and recurrence-free (20 months vs. 31 months) survival (both P < .001).

Study details: Findings are from a single-center retrospective study including 302 patients with very early-stage HCC (Barcelona Clinic Liver Cancer stage 0) who underwent RFA and had follow-up of >6 months, of which 195 had HCV infection, including 132 active infection cases.

Disclosures: M Kurosaki and N Izumi declared funding support from the Japan Agency for Medical Research and Development and Japanese Ministry of Health, Welfare, and Labor, respectively, and along with K Tsuchiya, receiving lecture fees from several sources.

Source: Takaura K et al. The impact of background liver disease on the long-term prognosis of very-early-stage HCC after ablation therapy. PLoS One. 2022;17(2):e0264075 (Feb 23). Doi:  10.1371/journal.pone.0264075

Key clinical point: Active hepatitis C virus (HCV) infection negatively affects overall and recurrence-free survival in patients with very early-stage hepatocellular carcinoma (HCC) after curative radiofrequency ablation (RFA).

Major finding: Active HCV infection was a significant risk factor for shorter overall survival (adjusted hazard ratio [aHR] 2.17; P = .003) and early recurrence of HCC (aHR 1.47; P = .022). Patients with vs. without active HCV infection had a shorter median overall (66 months vs. 145 months) and recurrence-free (20 months vs. 31 months) survival (both P < .001).

Study details: Findings are from a single-center retrospective study including 302 patients with very early-stage HCC (Barcelona Clinic Liver Cancer stage 0) who underwent RFA and had follow-up of >6 months, of which 195 had HCV infection, including 132 active infection cases.

Disclosures: M Kurosaki and N Izumi declared funding support from the Japan Agency for Medical Research and Development and Japanese Ministry of Health, Welfare, and Labor, respectively, and along with K Tsuchiya, receiving lecture fees from several sources.

Source: Takaura K et al. The impact of background liver disease on the long-term prognosis of very-early-stage HCC after ablation therapy. PLoS One. 2022;17(2):e0264075 (Feb 23). Doi:  10.1371/journal.pone.0264075

Key clinical point: Independent risk factors for postoperative recurrence among patients undergoing curative hepatic resection for early-stage hepatocellular carcinoma (HCC) include preoperative alpha-fetoprotein (AFP) level >400 µg/L, tumor size >5 cm, satellite nodules, multiple tumors, and microvascular invasion.

Major finding: Cirrhosis (adjusted hazard ratio [aHR] 1.49; P < .001), preoperative AFP level >400 µg/L (aHR 1.28; P = .004), tumor size >5 cm (aHR 1.74; P < .001), satellite nodules (aHR 1.35; P = .040), multiple tumors (aHR 1.63; P = .015), microvascular invasion (aHR 1.51; P < .001), and intraoperative blood transfusion (aHR 1.50; P = .013) were identified as independent risk factors associated with postoperative recurrence.

Study details: The data come from a large-scale, multicenter retrospective study including 1,424 adult patients who underwent curative hepatic resection for early-stage HCC (Barcelona Clinic Liver Cancer stage 0/A).

Disclosures: The study was supported by the National Natural Science Foundation of China. The authors reported no conflict of interests.

Source: Yao L-Q et al. Clinical features of recurrence after hepatic resection for early-stage hepatocellular carcinoma and long-term survival outcomes of patients with recurrence: A multi-institutional analysis. Ann Surg Oncol. 2022 Feb 22. Doi: 10.1245/s10434-022-11454-y

Key clinical point: Independent risk factors for postoperative recurrence among patients undergoing curative hepatic resection for early-stage hepatocellular carcinoma (HCC) include preoperative alpha-fetoprotein (AFP) level >400 µg/L, tumor size >5 cm, satellite nodules, multiple tumors, and microvascular invasion.

Major finding: Cirrhosis (adjusted hazard ratio [aHR] 1.49; P < .001), preoperative AFP level >400 µg/L (aHR 1.28; P = .004), tumor size >5 cm (aHR 1.74; P < .001), satellite nodules (aHR 1.35; P = .040), multiple tumors (aHR 1.63; P = .015), microvascular invasion (aHR 1.51; P < .001), and intraoperative blood transfusion (aHR 1.50; P = .013) were identified as independent risk factors associated with postoperative recurrence.

Study details: The data come from a large-scale, multicenter retrospective study including 1,424 adult patients who underwent curative hepatic resection for early-stage HCC (Barcelona Clinic Liver Cancer stage 0/A).

Disclosures: The study was supported by the National Natural Science Foundation of China. The authors reported no conflict of interests.

Source: Yao L-Q et al. Clinical features of recurrence after hepatic resection for early-stage hepatocellular carcinoma and long-term survival outcomes of patients with recurrence: A multi-institutional analysis. Ann Surg Oncol. 2022 Feb 22. Doi: 10.1245/s10434-022-11454-y

Key clinical point: Independent risk factors for postoperative recurrence among patients undergoing curative hepatic resection for early-stage hepatocellular carcinoma (HCC) include preoperative alpha-fetoprotein (AFP) level >400 µg/L, tumor size >5 cm, satellite nodules, multiple tumors, and microvascular invasion.

Major finding: Cirrhosis (adjusted hazard ratio [aHR] 1.49; P < .001), preoperative AFP level >400 µg/L (aHR 1.28; P = .004), tumor size >5 cm (aHR 1.74; P < .001), satellite nodules (aHR 1.35; P = .040), multiple tumors (aHR 1.63; P = .015), microvascular invasion (aHR 1.51; P < .001), and intraoperative blood transfusion (aHR 1.50; P = .013) were identified as independent risk factors associated with postoperative recurrence.

Study details: The data come from a large-scale, multicenter retrospective study including 1,424 adult patients who underwent curative hepatic resection for early-stage HCC (Barcelona Clinic Liver Cancer stage 0/A).

Disclosures: The study was supported by the National Natural Science Foundation of China. The authors reported no conflict of interests.

Source: Yao L-Q et al. Clinical features of recurrence after hepatic resection for early-stage hepatocellular carcinoma and long-term survival outcomes of patients with recurrence: A multi-institutional analysis. Ann Surg Oncol. 2022 Feb 22. Doi: 10.1245/s10434-022-11454-y

Key clinical point: Hampered ultrasound visualization in patients with cirrhosis receiving hepatocellular carcinoma (HCC) surveillance is associated with worse test performance, negatively affecting both sensitivity and specificity of surveillance.

Major finding: Patients with cirrhosis and HCC having severely impaired ultrasound visualization before HCC diagnosis showed increased odds of false-negative results (adjusted odds ratio [aOR] 7.94; 95% CI 1.23-51.16), whereas those with only cirrhosis having moderately impaired visualization showed increased odds of false-positive results (aOR 1.60; 95% CI 1.13-2.27).

Study details: This was a retrospective cohort study involving 2,238 patients with cirrhosis, with (n = 186) or without (n = 2,052) HCC, who underwent at least one abdominal ultrasound examination.

Disclosures: The study was supported by the United States National Institute of Health. A Singal and D Fetzer declared serving as consultants or advisory board members of or having research agreements with various organizations.

Source: Chong N et al. Association between ultrasound quality and test performance for HCC surveillance in patients with cirrhosis: a retrospective cohort study. Aliment Pharmacol Ther. 2022;55(6):683-690 (Feb 15). Doi: 10.1111/apt.16779

Key clinical point: Hampered ultrasound visualization in patients with cirrhosis receiving hepatocellular carcinoma (HCC) surveillance is associated with worse test performance, negatively affecting both sensitivity and specificity of surveillance.

Major finding: Patients with cirrhosis and HCC having severely impaired ultrasound visualization before HCC diagnosis showed increased odds of false-negative results (adjusted odds ratio [aOR] 7.94; 95% CI 1.23-51.16), whereas those with only cirrhosis having moderately impaired visualization showed increased odds of false-positive results (aOR 1.60; 95% CI 1.13-2.27).

Study details: This was a retrospective cohort study involving 2,238 patients with cirrhosis, with (n = 186) or without (n = 2,052) HCC, who underwent at least one abdominal ultrasound examination.

Disclosures: The study was supported by the United States National Institute of Health. A Singal and D Fetzer declared serving as consultants or advisory board members of or having research agreements with various organizations.

Source: Chong N et al. Association between ultrasound quality and test performance for HCC surveillance in patients with cirrhosis: a retrospective cohort study. Aliment Pharmacol Ther. 2022;55(6):683-690 (Feb 15). Doi: 10.1111/apt.16779

Key clinical point: Hampered ultrasound visualization in patients with cirrhosis receiving hepatocellular carcinoma (HCC) surveillance is associated with worse test performance, negatively affecting both sensitivity and specificity of surveillance.

Major finding: Patients with cirrhosis and HCC having severely impaired ultrasound visualization before HCC diagnosis showed increased odds of false-negative results (adjusted odds ratio [aOR] 7.94; 95% CI 1.23-51.16), whereas those with only cirrhosis having moderately impaired visualization showed increased odds of false-positive results (aOR 1.60; 95% CI 1.13-2.27).

Study details: This was a retrospective cohort study involving 2,238 patients with cirrhosis, with (n = 186) or without (n = 2,052) HCC, who underwent at least one abdominal ultrasound examination.

Disclosures: The study was supported by the United States National Institute of Health. A Singal and D Fetzer declared serving as consultants or advisory board members of or having research agreements with various organizations.

Source: Chong N et al. Association between ultrasound quality and test performance for HCC surveillance in patients with cirrhosis: a retrospective cohort study. Aliment Pharmacol Ther. 2022;55(6):683-690 (Feb 15). Doi: 10.1111/apt.16779

Key clinical point: Magnetic resonance elastography (MRE)-based shear strain mapping may serve as a noninvasive biomarker enabling the characterization of the tumor-liver interface and preoperative prediction of microvascular invasion (MVI) in patients with hepatocellular carcinoma (HCC).

Major finding: The positive MVI vs. negative MVI group displayed a significantly higher octahedral shear strain (OSS) percentage of low-shear-strain length (pLSL) at three evaluation frequencies (60 Hz: 75% vs. 40%, 40 Hz: 85% vs. 40%, and 30 Hz: 70% vs. 20%; all P < .01). The peritumor OSS-pLSL area under the receiver operating characteristic curve (0.73-0.90) for MVI prediction was good/excellent at all frequencies.

Study details: The data are derived from a retrospective study of 59 patients with HCC, all of whom underwent the conventional 60 Hz MRE examination; of these, 29 patients also underwent 40 and 30 Hz MRE examinations.

Disclosures: The study was funded by the National Natural Science Foundation of China, among others. The authors declared no conflict of interests.

Source: Li M et al. MR elastography-based shear strain mapping for assessment of microvascular invasion in hepatocellular carcinoma. Eur Radiol. 2022 (Feb 11). Doi: 10.1007/s00330-022-08578-w

Key clinical point: Magnetic resonance elastography (MRE)-based shear strain mapping may serve as a noninvasive biomarker enabling the characterization of the tumor-liver interface and preoperative prediction of microvascular invasion (MVI) in patients with hepatocellular carcinoma (HCC).

Major finding: The positive MVI vs. negative MVI group displayed a significantly higher octahedral shear strain (OSS) percentage of low-shear-strain length (pLSL) at three evaluation frequencies (60 Hz: 75% vs. 40%, 40 Hz: 85% vs. 40%, and 30 Hz: 70% vs. 20%; all P < .01). The peritumor OSS-pLSL area under the receiver operating characteristic curve (0.73-0.90) for MVI prediction was good/excellent at all frequencies.

Study details: The data are derived from a retrospective study of 59 patients with HCC, all of whom underwent the conventional 60 Hz MRE examination; of these, 29 patients also underwent 40 and 30 Hz MRE examinations.

Disclosures: The study was funded by the National Natural Science Foundation of China, among others. The authors declared no conflict of interests.

Source: Li M et al. MR elastography-based shear strain mapping for assessment of microvascular invasion in hepatocellular carcinoma. Eur Radiol. 2022 (Feb 11). Doi: 10.1007/s00330-022-08578-w

Key clinical point: Magnetic resonance elastography (MRE)-based shear strain mapping may serve as a noninvasive biomarker enabling the characterization of the tumor-liver interface and preoperative prediction of microvascular invasion (MVI) in patients with hepatocellular carcinoma (HCC).

Major finding: The positive MVI vs. negative MVI group displayed a significantly higher octahedral shear strain (OSS) percentage of low-shear-strain length (pLSL) at three evaluation frequencies (60 Hz: 75% vs. 40%, 40 Hz: 85% vs. 40%, and 30 Hz: 70% vs. 20%; all P < .01). The peritumor OSS-pLSL area under the receiver operating characteristic curve (0.73-0.90) for MVI prediction was good/excellent at all frequencies.

Study details: The data are derived from a retrospective study of 59 patients with HCC, all of whom underwent the conventional 60 Hz MRE examination; of these, 29 patients also underwent 40 and 30 Hz MRE examinations.

Disclosures: The study was funded by the National Natural Science Foundation of China, among others. The authors declared no conflict of interests.

Source: Li M et al. MR elastography-based shear strain mapping for assessment of microvascular invasion in hepatocellular carcinoma. Eur Radiol. 2022 (Feb 11). Doi: 10.1007/s00330-022-08578-w

As we transition out of the Omicron surge, the lessons we’ve learned from the prior surges carry forward and add to our knowledge foundation. Medical journals have published numerous research and perspectives manuscripts on all aspects of COVID-19 over the past 2 years, adding much-needed knowledge to our clinical practice during the pandemic. However, the story does not stop there, as the pandemic has impacted the usual, non-COVID-19 clinical care we provide. The value-based health care delivery model accounts for both COVID-19 clinical care and the usual care we provide our patients every day. Clinicians, administrators, and health care workers will need to know how to balance both worlds in the years to come.

In this issue of JCOM, the work of balancing the demands of COVID-19 care with those of system improvement continues. Two original research articles address the former, with Liesching et al¹ reporting data on improving clinical outcomes of patients with COVID-19 through acute care oxygen therapies, and Ali et al² explaining the impact of COVID-19 on STEMI care delivery models. Liesching et al’s study showed that patients admitted for COVID-19 after the first surge were more likely to receive high-flow nasal cannula and had better outcomes, while Ali et al showed that patients with STEMI yet again experienced worse outcomes during the first wave.

On the system improvement front, Cusick et al³ report on a quality improvement (QI) project that addressed acute disease management of heparin-induced thrombocytopenia (HIT) during hospitalization, Sosa et al⁴ discuss efforts to improve comorbidity capture at their institution, and Uche et al⁵ present the results of a nonpharmacologic initiative to improve management of chronic pain among veterans. Cusick et al’s QI project showed that a HIT testing strategy could be safely implemented through an evidence-based process to nudge resource utilization using specific management pathways. While capturing and measuring the complexity of diseases and comorbidities can be challenging, accurate capture is essential, as patient acuity has implications for reimbursement and quality comparisons for hospitals and physicians; Sosa et al describe a series of initiatives implemented at their institution that improved comorbidity capture. Furthermore, Uche et al report on a 10-week complementary and integrative health program for veterans with noncancer chronic pain that reduced pain intensity and improved quality of life for its participants. These QI reports show that, though the health care landscape has changed over the past 2 years, the aim remains the same: to provide the best care for patients regardless of the diagnosis, location, or time.

Conducting QI projects during the COVID-19 pandemic has been difficult, especially in terms of implementing consistent processes and management pathways while contending with staff and supply shortages. The pandemic, however, has highlighted the importance of continuing QI efforts, specifically around infectious disease prevention and good clinical practices. Moreover, the recent continuous learning and implementation around COVID-19 patient care has been a significant achievement, as clinicians and administrators worked continuously to understand and improve processes, create a supporting culture, and redesign care delivery on the fly. The management of both COVID-19 care and our usual care QI efforts should incorporate the lessons learned from the pandemic and leverage system redesign for future steps. As we’ve seen, survival in COVID-19 improved dramatically since the beginning of the pandemic, as clinical trials became more adaptive and efficient and system upgrades like telemedicine and digital technologies in the public health response led to major advancements. The work to improve the care provided in the clinic and at the bedside will continue through one collective approach in the new normal.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine Brigham and Women’s Hospital, Boston, MA; [email protected]

As we transition out of the Omicron surge, the lessons we’ve learned from the prior surges carry forward and add to our knowledge foundation. Medical journals have published numerous research and perspectives manuscripts on all aspects of COVID-19 over the past 2 years, adding much-needed knowledge to our clinical practice during the pandemic. However, the story does not stop there, as the pandemic has impacted the usual, non-COVID-19 clinical care we provide. The value-based health care delivery model accounts for both COVID-19 clinical care and the usual care we provide our patients every day. Clinicians, administrators, and health care workers will need to know how to balance both worlds in the years to come.

In this issue of JCOM, the work of balancing the demands of COVID-19 care with those of system improvement continues. Two original research articles address the former, with Liesching et al¹ reporting data on improving clinical outcomes of patients with COVID-19 through acute care oxygen therapies, and Ali et al² explaining the impact of COVID-19 on STEMI care delivery models. Liesching et al’s study showed that patients admitted for COVID-19 after the first surge were more likely to receive high-flow nasal cannula and had better outcomes, while Ali et al showed that patients with STEMI yet again experienced worse outcomes during the first wave.

On the system improvement front, Cusick et al³ report on a quality improvement (QI) project that addressed acute disease management of heparin-induced thrombocytopenia (HIT) during hospitalization, Sosa et al⁴ discuss efforts to improve comorbidity capture at their institution, and Uche et al⁵ present the results of a nonpharmacologic initiative to improve management of chronic pain among veterans. Cusick et al’s QI project showed that a HIT testing strategy could be safely implemented through an evidence-based process to nudge resource utilization using specific management pathways. While capturing and measuring the complexity of diseases and comorbidities can be challenging, accurate capture is essential, as patient acuity has implications for reimbursement and quality comparisons for hospitals and physicians; Sosa et al describe a series of initiatives implemented at their institution that improved comorbidity capture. Furthermore, Uche et al report on a 10-week complementary and integrative health program for veterans with noncancer chronic pain that reduced pain intensity and improved quality of life for its participants. These QI reports show that, though the health care landscape has changed over the past 2 years, the aim remains the same: to provide the best care for patients regardless of the diagnosis, location, or time.

Conducting QI projects during the COVID-19 pandemic has been difficult, especially in terms of implementing consistent processes and management pathways while contending with staff and supply shortages. The pandemic, however, has highlighted the importance of continuing QI efforts, specifically around infectious disease prevention and good clinical practices. Moreover, the recent continuous learning and implementation around COVID-19 patient care has been a significant achievement, as clinicians and administrators worked continuously to understand and improve processes, create a supporting culture, and redesign care delivery on the fly. The management of both COVID-19 care and our usual care QI efforts should incorporate the lessons learned from the pandemic and leverage system redesign for future steps. As we’ve seen, survival in COVID-19 improved dramatically since the beginning of the pandemic, as clinical trials became more adaptive and efficient and system upgrades like telemedicine and digital technologies in the public health response led to major advancements. The work to improve the care provided in the clinic and at the bedside will continue through one collective approach in the new normal.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine Brigham and Women’s Hospital, Boston, MA; [email protected]

As we transition out of the Omicron surge, the lessons we’ve learned from the prior surges carry forward and add to our knowledge foundation. Medical journals have published numerous research and perspectives manuscripts on all aspects of COVID-19 over the past 2 years, adding much-needed knowledge to our clinical practice during the pandemic. However, the story does not stop there, as the pandemic has impacted the usual, non-COVID-19 clinical care we provide. The value-based health care delivery model accounts for both COVID-19 clinical care and the usual care we provide our patients every day. Clinicians, administrators, and health care workers will need to know how to balance both worlds in the years to come.

In this issue of JCOM, the work of balancing the demands of COVID-19 care with those of system improvement continues. Two original research articles address the former, with Liesching et al¹ reporting data on improving clinical outcomes of patients with COVID-19 through acute care oxygen therapies, and Ali et al² explaining the impact of COVID-19 on STEMI care delivery models. Liesching et al’s study showed that patients admitted for COVID-19 after the first surge were more likely to receive high-flow nasal cannula and had better outcomes, while Ali et al showed that patients with STEMI yet again experienced worse outcomes during the first wave.

On the system improvement front, Cusick et al³ report on a quality improvement (QI) project that addressed acute disease management of heparin-induced thrombocytopenia (HIT) during hospitalization, Sosa et al⁴ discuss efforts to improve comorbidity capture at their institution, and Uche et al⁵ present the results of a nonpharmacologic initiative to improve management of chronic pain among veterans. Cusick et al’s QI project showed that a HIT testing strategy could be safely implemented through an evidence-based process to nudge resource utilization using specific management pathways. While capturing and measuring the complexity of diseases and comorbidities can be challenging, accurate capture is essential, as patient acuity has implications for reimbursement and quality comparisons for hospitals and physicians; Sosa et al describe a series of initiatives implemented at their institution that improved comorbidity capture. Furthermore, Uche et al report on a 10-week complementary and integrative health program for veterans with noncancer chronic pain that reduced pain intensity and improved quality of life for its participants. These QI reports show that, though the health care landscape has changed over the past 2 years, the aim remains the same: to provide the best care for patients regardless of the diagnosis, location, or time.

Conducting QI projects during the COVID-19 pandemic has been difficult, especially in terms of implementing consistent processes and management pathways while contending with staff and supply shortages. The pandemic, however, has highlighted the importance of continuing QI efforts, specifically around infectious disease prevention and good clinical practices. Moreover, the recent continuous learning and implementation around COVID-19 patient care has been a significant achievement, as clinicians and administrators worked continuously to understand and improve processes, create a supporting culture, and redesign care delivery on the fly. The management of both COVID-19 care and our usual care QI efforts should incorporate the lessons learned from the pandemic and leverage system redesign for future steps. As we’ve seen, survival in COVID-19 improved dramatically since the beginning of the pandemic, as clinical trials became more adaptive and efficient and system upgrades like telemedicine and digital technologies in the public health response led to major advancements. The work to improve the care provided in the clinic and at the bedside will continue through one collective approach in the new normal.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine Brigham and Women’s Hospital, Boston, MA; [email protected]