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Liver resection in HCC: Robot-assisted and laparoscopic vs. open
Key clinical point: Robot-assisted liver resection (RALR) and laparoscopic liver resection (LLR) show similar long-term oncological outcomes to open liver resection (OLR) in the treatment of Barcelona Clinic Liver Cancer (BCLC) stage 0-A hepatocellular carcinoma (HCC) along with allowing faster patient recovery.
Main finding: OLR, LLR, and RALR achieved 5-year overall survival rates of 78.6%, 76.8%, and 74.4% (P = .90) and 5-year disease-free survival rates of 57.9%, 51.3%, and 51.8% (P = .64), respectively. Patients undergoing LLR (6 days) or RALR (8 days) vs. OLR (12 days) recovered faster (both P < .001).
Study details: The data come from a single-center prospective study that compared 3 propensity score-matched cohorts of 56 patients each who were aged 14-75 years and received no previous treatment before undergoing either ALR, LLR, or OLR due to BCLC stage 0-A HCC.
Disclosures: The study was supported by the Key Project of Science and Technology in Hubei Province, General Project of Natural Science Foundation of Hubei Province, and General Project of Health Commission of Hubei Province. No conflicts of interest were disclosed.
Source: Zhu P et al. Ann Surg. 2022 (Jan 25). Doi: 10.1097/SLA.0000000000005380.
Key clinical point: Robot-assisted liver resection (RALR) and laparoscopic liver resection (LLR) show similar long-term oncological outcomes to open liver resection (OLR) in the treatment of Barcelona Clinic Liver Cancer (BCLC) stage 0-A hepatocellular carcinoma (HCC) along with allowing faster patient recovery.
Main finding: OLR, LLR, and RALR achieved 5-year overall survival rates of 78.6%, 76.8%, and 74.4% (P = .90) and 5-year disease-free survival rates of 57.9%, 51.3%, and 51.8% (P = .64), respectively. Patients undergoing LLR (6 days) or RALR (8 days) vs. OLR (12 days) recovered faster (both P < .001).
Study details: The data come from a single-center prospective study that compared 3 propensity score-matched cohorts of 56 patients each who were aged 14-75 years and received no previous treatment before undergoing either ALR, LLR, or OLR due to BCLC stage 0-A HCC.
Disclosures: The study was supported by the Key Project of Science and Technology in Hubei Province, General Project of Natural Science Foundation of Hubei Province, and General Project of Health Commission of Hubei Province. No conflicts of interest were disclosed.
Source: Zhu P et al. Ann Surg. 2022 (Jan 25). Doi: 10.1097/SLA.0000000000005380.
Key clinical point: Robot-assisted liver resection (RALR) and laparoscopic liver resection (LLR) show similar long-term oncological outcomes to open liver resection (OLR) in the treatment of Barcelona Clinic Liver Cancer (BCLC) stage 0-A hepatocellular carcinoma (HCC) along with allowing faster patient recovery.
Main finding: OLR, LLR, and RALR achieved 5-year overall survival rates of 78.6%, 76.8%, and 74.4% (P = .90) and 5-year disease-free survival rates of 57.9%, 51.3%, and 51.8% (P = .64), respectively. Patients undergoing LLR (6 days) or RALR (8 days) vs. OLR (12 days) recovered faster (both P < .001).
Study details: The data come from a single-center prospective study that compared 3 propensity score-matched cohorts of 56 patients each who were aged 14-75 years and received no previous treatment before undergoing either ALR, LLR, or OLR due to BCLC stage 0-A HCC.
Disclosures: The study was supported by the Key Project of Science and Technology in Hubei Province, General Project of Natural Science Foundation of Hubei Province, and General Project of Health Commission of Hubei Province. No conflicts of interest were disclosed.
Source: Zhu P et al. Ann Surg. 2022 (Jan 25). Doi: 10.1097/SLA.0000000000005380.
Tenofovir disoproxil fumarate vs. entecavir: Curtailing the risk of chronic hepatitis B-induced HCC
Key clinical point: In treatment-naive patients with chronic hepatitis B, therapy with tenofovir disoproxil fumarate (TDF) vs. entecavir (ETV) is associated with a lower risk of developing hepatocellular carcinoma (HCC) in the future.
Main finding: During the follow-up, patients receiving TDF showed a lower crude HCC incidence rate than those receiving ETV (0.30 vs. 0.62 per 100 person-years). TDF vs. ETV was associated with a significantly reduced risk of HCC occurrence (adjusted subdistribution hazard ratio 0.58; P = .01).
Study details: The data come from a retrospective cohort study including 10,061 adult treatment-naive patients with chronic hepatitis B but no evidence of HCC and who initiated therapy with ETV (n = 3,934) or TDF (n = 6,127).
Disclosures: The study was sponsored by Gilead Sciences. WR Kim, M Lu, and S Gordon declared serving as an advisory board member and consultant for or receiving research funding from Gilead Sciences. The rest of the authors are current or former employees and stockholders of Gilead Sciences.
Source: Kim WR et al. Aliment Pharmacol Ther. 2022 (Feb 8). Doi: 10.1111/apt.16786.
Key clinical point: In treatment-naive patients with chronic hepatitis B, therapy with tenofovir disoproxil fumarate (TDF) vs. entecavir (ETV) is associated with a lower risk of developing hepatocellular carcinoma (HCC) in the future.
Main finding: During the follow-up, patients receiving TDF showed a lower crude HCC incidence rate than those receiving ETV (0.30 vs. 0.62 per 100 person-years). TDF vs. ETV was associated with a significantly reduced risk of HCC occurrence (adjusted subdistribution hazard ratio 0.58; P = .01).
Study details: The data come from a retrospective cohort study including 10,061 adult treatment-naive patients with chronic hepatitis B but no evidence of HCC and who initiated therapy with ETV (n = 3,934) or TDF (n = 6,127).
Disclosures: The study was sponsored by Gilead Sciences. WR Kim, M Lu, and S Gordon declared serving as an advisory board member and consultant for or receiving research funding from Gilead Sciences. The rest of the authors are current or former employees and stockholders of Gilead Sciences.
Source: Kim WR et al. Aliment Pharmacol Ther. 2022 (Feb 8). Doi: 10.1111/apt.16786.
Key clinical point: In treatment-naive patients with chronic hepatitis B, therapy with tenofovir disoproxil fumarate (TDF) vs. entecavir (ETV) is associated with a lower risk of developing hepatocellular carcinoma (HCC) in the future.
Main finding: During the follow-up, patients receiving TDF showed a lower crude HCC incidence rate than those receiving ETV (0.30 vs. 0.62 per 100 person-years). TDF vs. ETV was associated with a significantly reduced risk of HCC occurrence (adjusted subdistribution hazard ratio 0.58; P = .01).
Study details: The data come from a retrospective cohort study including 10,061 adult treatment-naive patients with chronic hepatitis B but no evidence of HCC and who initiated therapy with ETV (n = 3,934) or TDF (n = 6,127).
Disclosures: The study was sponsored by Gilead Sciences. WR Kim, M Lu, and S Gordon declared serving as an advisory board member and consultant for or receiving research funding from Gilead Sciences. The rest of the authors are current or former employees and stockholders of Gilead Sciences.
Source: Kim WR et al. Aliment Pharmacol Ther. 2022 (Feb 8). Doi: 10.1111/apt.16786.
Sorafenib plus HAIC a favorable therapeutic option for HCC with major portal vein tumor thrombosis
Key clinical point: Compared with sorafenib alone, its combination with 3cir-OFF hepatic arterial infusion chemotherapy (HAIC) offers significantly prolonged survival and an acceptable safety profile in patients with advanced hepatocellular carcinoma (HCC) and major portal vein tumor thrombosis (PVTT).
Main finding: Sorafenib plus HAIC vs. sorafenib alone led to a longer median overall survival (16.3 months vs. 6.5 months; hazard ratio [HR] 0.28; P < .001) and progression-free survival (9.0 months vs. 2.5 months; HR 0.26; P < .001) but more frequent grade 3/4 adverse events.
Study details: This was a phase 2 study involving adult, systemic treatment-naive patients with inoperable advanced primary HCC and major PVTT who were randomly assigned to receive either sorafenib plus HAIC (n = 32) or sorafenib alone (n = 32).
Disclosures: The study was sponsored by the Beijing Hospitals Authority Clinical Medicine Development of Special Funding Support, Beijing Natural Science Foundation, and National Natural Science Foundation of China. None of the authors reported any conflicts of interest.
Source: Zheng K et al. Radiology. 2022 (Feb 1). Doi: 10.1148/radiol.211545.
Key clinical point: Compared with sorafenib alone, its combination with 3cir-OFF hepatic arterial infusion chemotherapy (HAIC) offers significantly prolonged survival and an acceptable safety profile in patients with advanced hepatocellular carcinoma (HCC) and major portal vein tumor thrombosis (PVTT).
Main finding: Sorafenib plus HAIC vs. sorafenib alone led to a longer median overall survival (16.3 months vs. 6.5 months; hazard ratio [HR] 0.28; P < .001) and progression-free survival (9.0 months vs. 2.5 months; HR 0.26; P < .001) but more frequent grade 3/4 adverse events.
Study details: This was a phase 2 study involving adult, systemic treatment-naive patients with inoperable advanced primary HCC and major PVTT who were randomly assigned to receive either sorafenib plus HAIC (n = 32) or sorafenib alone (n = 32).
Disclosures: The study was sponsored by the Beijing Hospitals Authority Clinical Medicine Development of Special Funding Support, Beijing Natural Science Foundation, and National Natural Science Foundation of China. None of the authors reported any conflicts of interest.
Source: Zheng K et al. Radiology. 2022 (Feb 1). Doi: 10.1148/radiol.211545.
Key clinical point: Compared with sorafenib alone, its combination with 3cir-OFF hepatic arterial infusion chemotherapy (HAIC) offers significantly prolonged survival and an acceptable safety profile in patients with advanced hepatocellular carcinoma (HCC) and major portal vein tumor thrombosis (PVTT).
Main finding: Sorafenib plus HAIC vs. sorafenib alone led to a longer median overall survival (16.3 months vs. 6.5 months; hazard ratio [HR] 0.28; P < .001) and progression-free survival (9.0 months vs. 2.5 months; HR 0.26; P < .001) but more frequent grade 3/4 adverse events.
Study details: This was a phase 2 study involving adult, systemic treatment-naive patients with inoperable advanced primary HCC and major PVTT who were randomly assigned to receive either sorafenib plus HAIC (n = 32) or sorafenib alone (n = 32).
Disclosures: The study was sponsored by the Beijing Hospitals Authority Clinical Medicine Development of Special Funding Support, Beijing Natural Science Foundation, and National Natural Science Foundation of China. None of the authors reported any conflicts of interest.
Source: Zheng K et al. Radiology. 2022 (Feb 1). Doi: 10.1148/radiol.211545.
Posthepatectomy antiviral therapy boosts survival outcomes in HBV-related HCC
Key clinical point: Antiviral therapy (AVT)-mediated reduction in liver inflammation and fibrosis is associated with improvement in the long-term outcomes of patients who have undergone hepatectomy for hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC).
Main finding: AVT vs. non-AVT patients exhibited significantly higher 5-year recurrence-free survival (RFS) rates (19.1% vs. 5.8%; P = .001) and overall survival (OS) rates (64.0% vs. 43.2%; P < .001). Improvements in liver inflammation and fibrosis were independently associated with better RFS (both P < .001) and OS (P = .013 and P < .001, respectively).
Study details: The study matched 103 adult patients who received AVT after having undergone hepatectomy for HBV-related HCC to an equal number of those who did not receive posthepatectomy AVT.
Disclosures: The study was sponsored by the National Natural Science Foundation of China and Foundation of Zhongshan Hospital. The authors did not declare any conflicts of interest.
Source: Guan R-Y et al. Am J Surg. 2022 (Jan 25). Doi: 10.1016/j.amjsurg.2022.01.008.
Key clinical point: Antiviral therapy (AVT)-mediated reduction in liver inflammation and fibrosis is associated with improvement in the long-term outcomes of patients who have undergone hepatectomy for hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC).
Main finding: AVT vs. non-AVT patients exhibited significantly higher 5-year recurrence-free survival (RFS) rates (19.1% vs. 5.8%; P = .001) and overall survival (OS) rates (64.0% vs. 43.2%; P < .001). Improvements in liver inflammation and fibrosis were independently associated with better RFS (both P < .001) and OS (P = .013 and P < .001, respectively).
Study details: The study matched 103 adult patients who received AVT after having undergone hepatectomy for HBV-related HCC to an equal number of those who did not receive posthepatectomy AVT.
Disclosures: The study was sponsored by the National Natural Science Foundation of China and Foundation of Zhongshan Hospital. The authors did not declare any conflicts of interest.
Source: Guan R-Y et al. Am J Surg. 2022 (Jan 25). Doi: 10.1016/j.amjsurg.2022.01.008.
Key clinical point: Antiviral therapy (AVT)-mediated reduction in liver inflammation and fibrosis is associated with improvement in the long-term outcomes of patients who have undergone hepatectomy for hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC).
Main finding: AVT vs. non-AVT patients exhibited significantly higher 5-year recurrence-free survival (RFS) rates (19.1% vs. 5.8%; P = .001) and overall survival (OS) rates (64.0% vs. 43.2%; P < .001). Improvements in liver inflammation and fibrosis were independently associated with better RFS (both P < .001) and OS (P = .013 and P < .001, respectively).
Study details: The study matched 103 adult patients who received AVT after having undergone hepatectomy for HBV-related HCC to an equal number of those who did not receive posthepatectomy AVT.
Disclosures: The study was sponsored by the National Natural Science Foundation of China and Foundation of Zhongshan Hospital. The authors did not declare any conflicts of interest.
Source: Guan R-Y et al. Am J Surg. 2022 (Jan 25). Doi: 10.1016/j.amjsurg.2022.01.008.
H1-antihistamines may ward off HCC from patients with HBV, HCV, or dual infections
Key clinical point: H1-antihistamines (AH) may serve as potential adjuvants in preventing hepatocellular carcinoma (HCC) occurrence in patients with hepatitis B virus (HBV), hepatitis C virus (HCV), or dual HBV-HCV infection.
Main finding: AH use vs. nonuse led to a significantly reduced risk of HCC occurrence in patients infected with HBV (adjusted hazard ratio [aHR] 0.489; 95% CI 0.455-0.524), HCV (aHR 0.484; 95% CI 0.450-0.522), and dual HBV-HCV (aHR 0.469; 95% CI 0.416-0.529).
Study details: This was a retrospective cohort study involving adult patients with either HBV (n = 521,071), HCV (n = 169,159), or dual HBV-HCV (n = 39,016) infection, with each of the 3 cohorts including AH users (HBV, n = 127,398; HCV, n = 40,428; dual HBV-HCV, n = 8,661) and an equal number of non-AH users (<28 cumulative defined daily doses) after 1:1 individual matching.
Disclosures: The study was conducted with financial support from the Ministry of Science and Technology of the Republic of China and Taipei Medical University Hospital. The authors did not report any conflicts of interest.
Source: Shen YC et al. J Clin Oncol. 2022 (Jan 19). Doi: 10.1200/JCO.21.01802.
Key clinical point: H1-antihistamines (AH) may serve as potential adjuvants in preventing hepatocellular carcinoma (HCC) occurrence in patients with hepatitis B virus (HBV), hepatitis C virus (HCV), or dual HBV-HCV infection.
Main finding: AH use vs. nonuse led to a significantly reduced risk of HCC occurrence in patients infected with HBV (adjusted hazard ratio [aHR] 0.489; 95% CI 0.455-0.524), HCV (aHR 0.484; 95% CI 0.450-0.522), and dual HBV-HCV (aHR 0.469; 95% CI 0.416-0.529).
Study details: This was a retrospective cohort study involving adult patients with either HBV (n = 521,071), HCV (n = 169,159), or dual HBV-HCV (n = 39,016) infection, with each of the 3 cohorts including AH users (HBV, n = 127,398; HCV, n = 40,428; dual HBV-HCV, n = 8,661) and an equal number of non-AH users (<28 cumulative defined daily doses) after 1:1 individual matching.
Disclosures: The study was conducted with financial support from the Ministry of Science and Technology of the Republic of China and Taipei Medical University Hospital. The authors did not report any conflicts of interest.
Source: Shen YC et al. J Clin Oncol. 2022 (Jan 19). Doi: 10.1200/JCO.21.01802.
Key clinical point: H1-antihistamines (AH) may serve as potential adjuvants in preventing hepatocellular carcinoma (HCC) occurrence in patients with hepatitis B virus (HBV), hepatitis C virus (HCV), or dual HBV-HCV infection.
Main finding: AH use vs. nonuse led to a significantly reduced risk of HCC occurrence in patients infected with HBV (adjusted hazard ratio [aHR] 0.489; 95% CI 0.455-0.524), HCV (aHR 0.484; 95% CI 0.450-0.522), and dual HBV-HCV (aHR 0.469; 95% CI 0.416-0.529).
Study details: This was a retrospective cohort study involving adult patients with either HBV (n = 521,071), HCV (n = 169,159), or dual HBV-HCV (n = 39,016) infection, with each of the 3 cohorts including AH users (HBV, n = 127,398; HCV, n = 40,428; dual HBV-HCV, n = 8,661) and an equal number of non-AH users (<28 cumulative defined daily doses) after 1:1 individual matching.
Disclosures: The study was conducted with financial support from the Ministry of Science and Technology of the Republic of China and Taipei Medical University Hospital. The authors did not report any conflicts of interest.
Source: Shen YC et al. J Clin Oncol. 2022 (Jan 19). Doi: 10.1200/JCO.21.01802.
Lenvatinib proves its worth against HCC in the real-world setting
Key clinical point: Given its efficacy and safety as first-line therapy for advanced hepatocellular carcinoma (HCC), lenvatinib may serve as an alternative for patients with advanced
HCC and contraindications to immunotherapies.
Main finding: The median overall survival (12.8 months; 95% CI, 10.9-14.7 months) and progression-free survival (6.4 months; 95% CI, 5.1-7.7 months) achieved by lenvatinib in the real world were comparable with those reported by the phase 3 REFLECT trial (13.6 months and 7.4 months, respectively). Similarly, the percentage of patients showing grade 3 or higher adverse events (47.3%) was equivalent to that in REFLECT (56.7%).
Study details: The findings are derived from a real-world retrospective multicenter study, termed ELEVATOR, which included 205 patients with advanced HCC and no history of prior systemic therapy and who received first-line therapy with lenvatinib.
Disclosures: The study was sponsored by Eisai. Some of the authors declared receiving speaker/advisor/consultant honoraria from various pharmaceutical companies including Eisai.
Source: Welland S et al. Liver Cancer. 2022 (Jan 14). Doi: 10.1159/000521746.
Key clinical point: Given its efficacy and safety as first-line therapy for advanced hepatocellular carcinoma (HCC), lenvatinib may serve as an alternative for patients with advanced
HCC and contraindications to immunotherapies.
Main finding: The median overall survival (12.8 months; 95% CI, 10.9-14.7 months) and progression-free survival (6.4 months; 95% CI, 5.1-7.7 months) achieved by lenvatinib in the real world were comparable with those reported by the phase 3 REFLECT trial (13.6 months and 7.4 months, respectively). Similarly, the percentage of patients showing grade 3 or higher adverse events (47.3%) was equivalent to that in REFLECT (56.7%).
Study details: The findings are derived from a real-world retrospective multicenter study, termed ELEVATOR, which included 205 patients with advanced HCC and no history of prior systemic therapy and who received first-line therapy with lenvatinib.
Disclosures: The study was sponsored by Eisai. Some of the authors declared receiving speaker/advisor/consultant honoraria from various pharmaceutical companies including Eisai.
Source: Welland S et al. Liver Cancer. 2022 (Jan 14). Doi: 10.1159/000521746.
Key clinical point: Given its efficacy and safety as first-line therapy for advanced hepatocellular carcinoma (HCC), lenvatinib may serve as an alternative for patients with advanced
HCC and contraindications to immunotherapies.
Main finding: The median overall survival (12.8 months; 95% CI, 10.9-14.7 months) and progression-free survival (6.4 months; 95% CI, 5.1-7.7 months) achieved by lenvatinib in the real world were comparable with those reported by the phase 3 REFLECT trial (13.6 months and 7.4 months, respectively). Similarly, the percentage of patients showing grade 3 or higher adverse events (47.3%) was equivalent to that in REFLECT (56.7%).
Study details: The findings are derived from a real-world retrospective multicenter study, termed ELEVATOR, which included 205 patients with advanced HCC and no history of prior systemic therapy and who received first-line therapy with lenvatinib.
Disclosures: The study was sponsored by Eisai. Some of the authors declared receiving speaker/advisor/consultant honoraria from various pharmaceutical companies including Eisai.
Source: Welland S et al. Liver Cancer. 2022 (Jan 14). Doi: 10.1159/000521746.
GALAD performs modestly in detecting HCC in a phase 3 biomarker study
Key clinical point: Although using the triple biomarkers alpha-fetoprotein (AFP), Lens culinaris agglutinin-reactive fraction of AFP (AFP-L3), and des-gamma-carboxy prothrombin (DCP) in combination in the GALAD score is associated with increased sensitivity of hepatocellular carcinoma (HCC) diagnosis, the corresponding increase in false-positive results negates the advantage.
Main finding: Within 6, 12, and 24 months of HCC diagnosis, GALAD showed the highest true positive rate (TPR; 63.6%, 73.8%, and 71.4%, respectively) but a false positive rate (FPR) of 21.5%-22.9%; at a fixed 10% FPR, the TPR decreased (42.4%-46.9%), making the performance similar to that of AFP-L3 alone.
Study details: The findings are from a prospective cohort, phase 3 biomarker study including 534 patients with cirrhosis, but without present or past HCC, undergoing biannual HCC surveillance with liver imaging (ultrasound, computed tomography, or magnetic resonance imaging) and serum AFP. Of these patients, 50 progressed to develop HCC.
Disclosures: The study was sponsored by US National Institutes of
Health-National Cancer Institute, US National Institute of Diabetes and Digestive and Kidney Diseases, and Wako Inc. The authors declared having no conflicts of interest.
Source: Tayob N et al. Clin Gastroenterol Hepatol. 2022 (Feb 2). Doi: 10.1016/j.cgh.2022.01.047.
Key clinical point: Although using the triple biomarkers alpha-fetoprotein (AFP), Lens culinaris agglutinin-reactive fraction of AFP (AFP-L3), and des-gamma-carboxy prothrombin (DCP) in combination in the GALAD score is associated with increased sensitivity of hepatocellular carcinoma (HCC) diagnosis, the corresponding increase in false-positive results negates the advantage.
Main finding: Within 6, 12, and 24 months of HCC diagnosis, GALAD showed the highest true positive rate (TPR; 63.6%, 73.8%, and 71.4%, respectively) but a false positive rate (FPR) of 21.5%-22.9%; at a fixed 10% FPR, the TPR decreased (42.4%-46.9%), making the performance similar to that of AFP-L3 alone.
Study details: The findings are from a prospective cohort, phase 3 biomarker study including 534 patients with cirrhosis, but without present or past HCC, undergoing biannual HCC surveillance with liver imaging (ultrasound, computed tomography, or magnetic resonance imaging) and serum AFP. Of these patients, 50 progressed to develop HCC.
Disclosures: The study was sponsored by US National Institutes of
Health-National Cancer Institute, US National Institute of Diabetes and Digestive and Kidney Diseases, and Wako Inc. The authors declared having no conflicts of interest.
Source: Tayob N et al. Clin Gastroenterol Hepatol. 2022 (Feb 2). Doi: 10.1016/j.cgh.2022.01.047.
Key clinical point: Although using the triple biomarkers alpha-fetoprotein (AFP), Lens culinaris agglutinin-reactive fraction of AFP (AFP-L3), and des-gamma-carboxy prothrombin (DCP) in combination in the GALAD score is associated with increased sensitivity of hepatocellular carcinoma (HCC) diagnosis, the corresponding increase in false-positive results negates the advantage.
Main finding: Within 6, 12, and 24 months of HCC diagnosis, GALAD showed the highest true positive rate (TPR; 63.6%, 73.8%, and 71.4%, respectively) but a false positive rate (FPR) of 21.5%-22.9%; at a fixed 10% FPR, the TPR decreased (42.4%-46.9%), making the performance similar to that of AFP-L3 alone.
Study details: The findings are from a prospective cohort, phase 3 biomarker study including 534 patients with cirrhosis, but without present or past HCC, undergoing biannual HCC surveillance with liver imaging (ultrasound, computed tomography, or magnetic resonance imaging) and serum AFP. Of these patients, 50 progressed to develop HCC.
Disclosures: The study was sponsored by US National Institutes of
Health-National Cancer Institute, US National Institute of Diabetes and Digestive and Kidney Diseases, and Wako Inc. The authors declared having no conflicts of interest.
Source: Tayob N et al. Clin Gastroenterol Hepatol. 2022 (Feb 2). Doi: 10.1016/j.cgh.2022.01.047.
Resectable HCC: Neoadjuvant cemiplimab appears effective and safe in phase 2
Key clinical point: Perioperative programmed cell death protein 1 blockade via neoadjuvant cemiplimab monotherapy may offer survival benefit in patients with resectable hepatocellular carcinoma (HCC) without compromising on safety.
Main finding: Significant (>70%) tumor necrosis was observed in 20% of patients who underwent successful resection, of which 15% showed complete (100%) tumor necrosis. Grade 3 adverse events were observed in 33% of patients, whereas no grade 4/5 adverse events were noted.
Study details: The preliminary data are derived from a single-center phase 2 trial involving 21 adult patients with resectable HCC who received 2 doses of cemiplimab followed by surgical resection.
Disclosures: This study was sponsored by Regeneron Pharmaceuticals. Some of the authors, including the lead author, declared receiving research funds from or serving as an employee and shareholder, consultant, or advisor for various organizations including Regeneron Pharmaceuticals.
Source: Marron TU et al. Lancet Gastroenterol Hepatol. 2022;7(3):P219-29 (Jan 19). Doi: 10.1016/S2468-1253(21)00385-X.
Key clinical point: Perioperative programmed cell death protein 1 blockade via neoadjuvant cemiplimab monotherapy may offer survival benefit in patients with resectable hepatocellular carcinoma (HCC) without compromising on safety.
Main finding: Significant (>70%) tumor necrosis was observed in 20% of patients who underwent successful resection, of which 15% showed complete (100%) tumor necrosis. Grade 3 adverse events were observed in 33% of patients, whereas no grade 4/5 adverse events were noted.
Study details: The preliminary data are derived from a single-center phase 2 trial involving 21 adult patients with resectable HCC who received 2 doses of cemiplimab followed by surgical resection.
Disclosures: This study was sponsored by Regeneron Pharmaceuticals. Some of the authors, including the lead author, declared receiving research funds from or serving as an employee and shareholder, consultant, or advisor for various organizations including Regeneron Pharmaceuticals.
Source: Marron TU et al. Lancet Gastroenterol Hepatol. 2022;7(3):P219-29 (Jan 19). Doi: 10.1016/S2468-1253(21)00385-X.
Key clinical point: Perioperative programmed cell death protein 1 blockade via neoadjuvant cemiplimab monotherapy may offer survival benefit in patients with resectable hepatocellular carcinoma (HCC) without compromising on safety.
Main finding: Significant (>70%) tumor necrosis was observed in 20% of patients who underwent successful resection, of which 15% showed complete (100%) tumor necrosis. Grade 3 adverse events were observed in 33% of patients, whereas no grade 4/5 adverse events were noted.
Study details: The preliminary data are derived from a single-center phase 2 trial involving 21 adult patients with resectable HCC who received 2 doses of cemiplimab followed by surgical resection.
Disclosures: This study was sponsored by Regeneron Pharmaceuticals. Some of the authors, including the lead author, declared receiving research funds from or serving as an employee and shareholder, consultant, or advisor for various organizations including Regeneron Pharmaceuticals.
Source: Marron TU et al. Lancet Gastroenterol Hepatol. 2022;7(3):P219-29 (Jan 19). Doi: 10.1016/S2468-1253(21)00385-X.
Phase 2 validates the safety and efficacy of nivolumab with or without ipilimumab in resectable HCC
Key clinical point: In addition to being safe, perioperative administration of nivolumab with or without ipilimumab may elicit a major response with longer recurrence-free survival in patients with resectable hepatocellular carcinoma (HCC).
Main finding: Grade 3/4 treatment-related adverse events were observed in 43% and 23% of patients with nivolumab+ipilimumab and nivolumab alone, respectively (P = .69). Of the patients who underwent surgery, nivolumab alone and nivolumab+ipilimumab caused a major pathology-related response in 33% (95% CI 7.5%-70.1%) and 27% (95% CI 6%-61%), respectively, who showed improved recurrence-free survival vs. those with no pathological response (log-rank P = .049).
Study details: This was a single-center, phase 2 trial including 27 adult patients with resectable HCC who were randomly assigned to receive nivolumab alone (n = 13) or nivolumab plus ipilimumab (n = 14) before and after partial hepatectomy.
Disclosures: The study was sponsored by Bristol Myers Squibb (BMS) and the US National Institutes of Health. A few authors, including the lead author, served as a consultants/advisors or were stock owners of and received research funding/honoraria from numerous organizations including BMS.
Source: Kaseb AO et al. Lancet Gastroenterol Hepatol. 2022;7(3):P208-18 (Jan 19). Doi: 10.1016/S2468-1253(21)00427-1.
Key clinical point: In addition to being safe, perioperative administration of nivolumab with or without ipilimumab may elicit a major response with longer recurrence-free survival in patients with resectable hepatocellular carcinoma (HCC).
Main finding: Grade 3/4 treatment-related adverse events were observed in 43% and 23% of patients with nivolumab+ipilimumab and nivolumab alone, respectively (P = .69). Of the patients who underwent surgery, nivolumab alone and nivolumab+ipilimumab caused a major pathology-related response in 33% (95% CI 7.5%-70.1%) and 27% (95% CI 6%-61%), respectively, who showed improved recurrence-free survival vs. those with no pathological response (log-rank P = .049).
Study details: This was a single-center, phase 2 trial including 27 adult patients with resectable HCC who were randomly assigned to receive nivolumab alone (n = 13) or nivolumab plus ipilimumab (n = 14) before and after partial hepatectomy.
Disclosures: The study was sponsored by Bristol Myers Squibb (BMS) and the US National Institutes of Health. A few authors, including the lead author, served as a consultants/advisors or were stock owners of and received research funding/honoraria from numerous organizations including BMS.
Source: Kaseb AO et al. Lancet Gastroenterol Hepatol. 2022;7(3):P208-18 (Jan 19). Doi: 10.1016/S2468-1253(21)00427-1.
Key clinical point: In addition to being safe, perioperative administration of nivolumab with or without ipilimumab may elicit a major response with longer recurrence-free survival in patients with resectable hepatocellular carcinoma (HCC).
Main finding: Grade 3/4 treatment-related adverse events were observed in 43% and 23% of patients with nivolumab+ipilimumab and nivolumab alone, respectively (P = .69). Of the patients who underwent surgery, nivolumab alone and nivolumab+ipilimumab caused a major pathology-related response in 33% (95% CI 7.5%-70.1%) and 27% (95% CI 6%-61%), respectively, who showed improved recurrence-free survival vs. those with no pathological response (log-rank P = .049).
Study details: This was a single-center, phase 2 trial including 27 adult patients with resectable HCC who were randomly assigned to receive nivolumab alone (n = 13) or nivolumab plus ipilimumab (n = 14) before and after partial hepatectomy.
Disclosures: The study was sponsored by Bristol Myers Squibb (BMS) and the US National Institutes of Health. A few authors, including the lead author, served as a consultants/advisors or were stock owners of and received research funding/honoraria from numerous organizations including BMS.
Source: Kaseb AO et al. Lancet Gastroenterol Hepatol. 2022;7(3):P208-18 (Jan 19). Doi: 10.1016/S2468-1253(21)00427-1.
More evidence links MI to cognitive decline over time
new research suggests.
Although cognition in the acute phase after MI was not different than those without an MI in large observational cohorts, cognitive decline became significantly different over a median 6.5 years of follow-up.
The results reinforce the idea that heart health is closely tied to brain health, lead study author Michelle C. Johansen, MD, PhD, assistant professor of neurology cerebrovascular division, Johns Hopkins University, Baltimore, said in an interview. “From a clinical standpoint, heart health affects brain health and there may be effective interventions to prevent heart attack from happening that could reduce the rate of cognitive decline.”
The study was presented during the International Stroke Conference sponsored by the American Heart Association.
Researchers are increasingly recognizing the vascular contribution to cognitive impairment, said Dr. Johansen. This could involve “silent” or subclinical strokes that go unrecognized until seen on imaging.
The study included 31,377 adults free of MI and dementia from six large, well-known cohort studies: the Atherosclerosis Risk in Communities Study, the Coronary Artery Risk Development in Young Adults Study, the Cardiovascular Health Study, the Framingham Offspring Study, the Multi-Ethnic Study of Atherosclerosis, and the Northern Manhattan Study
About 56% of study participants were women, 23% were Black, 8% were Hispanic, and 69% were White.
They were followed from 1971 to 2017 with investigators repeatedly measuring vascular risk factors. The median study follow-up was 6.5 years, but some were followed for up to 20 years. During that time, there were 1,047 incident MIs.
The researchers performed a pooled analysis from these studies “using some fancy statistical techniques,” said Dr. Johansen. “The unique thing about this study was we were able to harmonize the cognitive measures.”
This allowed the researchers to determine if incident MI affected cognitive decline soon after the event and then long-term after the event. The primary outcome was change in global cognition. Additional outcomes were memory and executive function.
The median time between the first MI and the cognitive assessment was about 1.8 years but ranged from about 6 months to 4 years, said Dr. Johansen. Participants were a median age of 60 years at the time of the first cognitive assessment.
The researchers adjusted results for demographic factors, heart disease risk factors, and cognitive test results prior to the MI. Participants who had a stroke during the follow-up period were excluded from the analysis as stroke can affect cognition.
The study showed incident MI was associated with significant decline in global cognition (–0.71; 95% confidence interval, –1.02 to 0.42; P < .0001) and executive function (–0.68; 95% CI, –0.97 to 0.39; P < .004), but not memory, after the MI.
As cognition naturally declines with age, the researchers took that into consideration. “We anticipated cognition over time was going to go down, which it did, but the question we asked was: ‘How did the slope, which we knew was going to decline over time, compare in people who did not have a MI versus those that did?’ ” said Dr. Johansen.
After adjusting the model accordingly, the effect estimates indicating declines in global cognition and executive function were not significant.
However, another model that looked at the effect of incident MI on decline in cognitive function over the years following the event found significant differences.
Compared with participants without MI, those with incident MI had significantly faster declines in global cognition (–0.15 points/year faster, 95% CI, –0.21 to –0.10; P < .002), memory (–0.13 points/year faster, 95% CI, –0.23 to –0.04; P = .004), and executive function (–0.14 points/year faster, 95% CI, –0.20 to –0.08; P < .0001).
Dr. Johansen surmised that MI may result in subclinical infarcts or inflammation, or that MI and cognitive decline have shared vascular risk factors.
She said she can only speculate about why there was not more of a cognitive decline surrounding the MI. “It may be that right after the event, subjects are kind of sick from other things so it’s hard to see exactly what’s going on. Sometimes people can have other problems just from being in the hospital and having a heart attack may make cognition difficult to assess.”
The researchers also looked at those who had a second MI. “We asked whether the decline we saw after the first heart attack among those who had two heart attacks was explained by the fact they had more than one heart attack, and the answer to that question is no,” Dr. Johansen said.
The next research steps for Dr. Johansen and associates are to look at differences in race and sex.
Karen L. Furie, MD, chair, department of neurology, Brown University, and chief of neurology at Rhode Island Hospital, the Miriam Hospital, and the Bradley Hospital, all in Providence, provided a comment on the research.
MI and cognitive decline have a number of common risk factors, including hypertension, diabetes, high cholesterol, smoking, physical inactivity, and poor diet that can lead to obesity, said Dr. Furie.
“It’s critically important to identify these risk factors as early as possible,” she said. “People in early and middle life may not be receiving optimal medical management or engaging in ideal lifestyle choices and these contribute to the development and progression of atherosclerotic disease over the subsequent decades.”
In theory, she said, if these risk factors were eliminated or adequately treated earlier in life, “both the heart and brain could age naturally and in a healthy manner, enabling a higher functioning and better quality of life.”
The study was funded by the National Institute of Neurological Disorders and Stroke and the National Institute of Aging of the National Institutes of Health. Dr. Johansen receives research funding from NINDS.
A version of this article first appeared on Medscape.com.
new research suggests.
Although cognition in the acute phase after MI was not different than those without an MI in large observational cohorts, cognitive decline became significantly different over a median 6.5 years of follow-up.
The results reinforce the idea that heart health is closely tied to brain health, lead study author Michelle C. Johansen, MD, PhD, assistant professor of neurology cerebrovascular division, Johns Hopkins University, Baltimore, said in an interview. “From a clinical standpoint, heart health affects brain health and there may be effective interventions to prevent heart attack from happening that could reduce the rate of cognitive decline.”
The study was presented during the International Stroke Conference sponsored by the American Heart Association.
Researchers are increasingly recognizing the vascular contribution to cognitive impairment, said Dr. Johansen. This could involve “silent” or subclinical strokes that go unrecognized until seen on imaging.
The study included 31,377 adults free of MI and dementia from six large, well-known cohort studies: the Atherosclerosis Risk in Communities Study, the Coronary Artery Risk Development in Young Adults Study, the Cardiovascular Health Study, the Framingham Offspring Study, the Multi-Ethnic Study of Atherosclerosis, and the Northern Manhattan Study
About 56% of study participants were women, 23% were Black, 8% were Hispanic, and 69% were White.
They were followed from 1971 to 2017 with investigators repeatedly measuring vascular risk factors. The median study follow-up was 6.5 years, but some were followed for up to 20 years. During that time, there were 1,047 incident MIs.
The researchers performed a pooled analysis from these studies “using some fancy statistical techniques,” said Dr. Johansen. “The unique thing about this study was we were able to harmonize the cognitive measures.”
This allowed the researchers to determine if incident MI affected cognitive decline soon after the event and then long-term after the event. The primary outcome was change in global cognition. Additional outcomes were memory and executive function.
The median time between the first MI and the cognitive assessment was about 1.8 years but ranged from about 6 months to 4 years, said Dr. Johansen. Participants were a median age of 60 years at the time of the first cognitive assessment.
The researchers adjusted results for demographic factors, heart disease risk factors, and cognitive test results prior to the MI. Participants who had a stroke during the follow-up period were excluded from the analysis as stroke can affect cognition.
The study showed incident MI was associated with significant decline in global cognition (–0.71; 95% confidence interval, –1.02 to 0.42; P < .0001) and executive function (–0.68; 95% CI, –0.97 to 0.39; P < .004), but not memory, after the MI.
As cognition naturally declines with age, the researchers took that into consideration. “We anticipated cognition over time was going to go down, which it did, but the question we asked was: ‘How did the slope, which we knew was going to decline over time, compare in people who did not have a MI versus those that did?’ ” said Dr. Johansen.
After adjusting the model accordingly, the effect estimates indicating declines in global cognition and executive function were not significant.
However, another model that looked at the effect of incident MI on decline in cognitive function over the years following the event found significant differences.
Compared with participants without MI, those with incident MI had significantly faster declines in global cognition (–0.15 points/year faster, 95% CI, –0.21 to –0.10; P < .002), memory (–0.13 points/year faster, 95% CI, –0.23 to –0.04; P = .004), and executive function (–0.14 points/year faster, 95% CI, –0.20 to –0.08; P < .0001).
Dr. Johansen surmised that MI may result in subclinical infarcts or inflammation, or that MI and cognitive decline have shared vascular risk factors.
She said she can only speculate about why there was not more of a cognitive decline surrounding the MI. “It may be that right after the event, subjects are kind of sick from other things so it’s hard to see exactly what’s going on. Sometimes people can have other problems just from being in the hospital and having a heart attack may make cognition difficult to assess.”
The researchers also looked at those who had a second MI. “We asked whether the decline we saw after the first heart attack among those who had two heart attacks was explained by the fact they had more than one heart attack, and the answer to that question is no,” Dr. Johansen said.
The next research steps for Dr. Johansen and associates are to look at differences in race and sex.
Karen L. Furie, MD, chair, department of neurology, Brown University, and chief of neurology at Rhode Island Hospital, the Miriam Hospital, and the Bradley Hospital, all in Providence, provided a comment on the research.
MI and cognitive decline have a number of common risk factors, including hypertension, diabetes, high cholesterol, smoking, physical inactivity, and poor diet that can lead to obesity, said Dr. Furie.
“It’s critically important to identify these risk factors as early as possible,” she said. “People in early and middle life may not be receiving optimal medical management or engaging in ideal lifestyle choices and these contribute to the development and progression of atherosclerotic disease over the subsequent decades.”
In theory, she said, if these risk factors were eliminated or adequately treated earlier in life, “both the heart and brain could age naturally and in a healthy manner, enabling a higher functioning and better quality of life.”
The study was funded by the National Institute of Neurological Disorders and Stroke and the National Institute of Aging of the National Institutes of Health. Dr. Johansen receives research funding from NINDS.
A version of this article first appeared on Medscape.com.
new research suggests.
Although cognition in the acute phase after MI was not different than those without an MI in large observational cohorts, cognitive decline became significantly different over a median 6.5 years of follow-up.
The results reinforce the idea that heart health is closely tied to brain health, lead study author Michelle C. Johansen, MD, PhD, assistant professor of neurology cerebrovascular division, Johns Hopkins University, Baltimore, said in an interview. “From a clinical standpoint, heart health affects brain health and there may be effective interventions to prevent heart attack from happening that could reduce the rate of cognitive decline.”
The study was presented during the International Stroke Conference sponsored by the American Heart Association.
Researchers are increasingly recognizing the vascular contribution to cognitive impairment, said Dr. Johansen. This could involve “silent” or subclinical strokes that go unrecognized until seen on imaging.
The study included 31,377 adults free of MI and dementia from six large, well-known cohort studies: the Atherosclerosis Risk in Communities Study, the Coronary Artery Risk Development in Young Adults Study, the Cardiovascular Health Study, the Framingham Offspring Study, the Multi-Ethnic Study of Atherosclerosis, and the Northern Manhattan Study
About 56% of study participants were women, 23% were Black, 8% were Hispanic, and 69% were White.
They were followed from 1971 to 2017 with investigators repeatedly measuring vascular risk factors. The median study follow-up was 6.5 years, but some were followed for up to 20 years. During that time, there were 1,047 incident MIs.
The researchers performed a pooled analysis from these studies “using some fancy statistical techniques,” said Dr. Johansen. “The unique thing about this study was we were able to harmonize the cognitive measures.”
This allowed the researchers to determine if incident MI affected cognitive decline soon after the event and then long-term after the event. The primary outcome was change in global cognition. Additional outcomes were memory and executive function.
The median time between the first MI and the cognitive assessment was about 1.8 years but ranged from about 6 months to 4 years, said Dr. Johansen. Participants were a median age of 60 years at the time of the first cognitive assessment.
The researchers adjusted results for demographic factors, heart disease risk factors, and cognitive test results prior to the MI. Participants who had a stroke during the follow-up period were excluded from the analysis as stroke can affect cognition.
The study showed incident MI was associated with significant decline in global cognition (–0.71; 95% confidence interval, –1.02 to 0.42; P < .0001) and executive function (–0.68; 95% CI, –0.97 to 0.39; P < .004), but not memory, after the MI.
As cognition naturally declines with age, the researchers took that into consideration. “We anticipated cognition over time was going to go down, which it did, but the question we asked was: ‘How did the slope, which we knew was going to decline over time, compare in people who did not have a MI versus those that did?’ ” said Dr. Johansen.
After adjusting the model accordingly, the effect estimates indicating declines in global cognition and executive function were not significant.
However, another model that looked at the effect of incident MI on decline in cognitive function over the years following the event found significant differences.
Compared with participants without MI, those with incident MI had significantly faster declines in global cognition (–0.15 points/year faster, 95% CI, –0.21 to –0.10; P < .002), memory (–0.13 points/year faster, 95% CI, –0.23 to –0.04; P = .004), and executive function (–0.14 points/year faster, 95% CI, –0.20 to –0.08; P < .0001).
Dr. Johansen surmised that MI may result in subclinical infarcts or inflammation, or that MI and cognitive decline have shared vascular risk factors.
She said she can only speculate about why there was not more of a cognitive decline surrounding the MI. “It may be that right after the event, subjects are kind of sick from other things so it’s hard to see exactly what’s going on. Sometimes people can have other problems just from being in the hospital and having a heart attack may make cognition difficult to assess.”
The researchers also looked at those who had a second MI. “We asked whether the decline we saw after the first heart attack among those who had two heart attacks was explained by the fact they had more than one heart attack, and the answer to that question is no,” Dr. Johansen said.
The next research steps for Dr. Johansen and associates are to look at differences in race and sex.
Karen L. Furie, MD, chair, department of neurology, Brown University, and chief of neurology at Rhode Island Hospital, the Miriam Hospital, and the Bradley Hospital, all in Providence, provided a comment on the research.
MI and cognitive decline have a number of common risk factors, including hypertension, diabetes, high cholesterol, smoking, physical inactivity, and poor diet that can lead to obesity, said Dr. Furie.
“It’s critically important to identify these risk factors as early as possible,” she said. “People in early and middle life may not be receiving optimal medical management or engaging in ideal lifestyle choices and these contribute to the development and progression of atherosclerotic disease over the subsequent decades.”
In theory, she said, if these risk factors were eliminated or adequately treated earlier in life, “both the heart and brain could age naturally and in a healthy manner, enabling a higher functioning and better quality of life.”
The study was funded by the National Institute of Neurological Disorders and Stroke and the National Institute of Aging of the National Institutes of Health. Dr. Johansen receives research funding from NINDS.
A version of this article first appeared on Medscape.com.
FROM ISC 2022