Hepatocellular Carcinoma

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.

Key clinical point: Advanced age and liver stiffness measurement (LSM) on transient elastography, both pretreatment and at 24-week sustained virological response (SVR24), may aid in predicting the risk of hepatocellular carcinoma (HCC) in patients with hepatitis C virus (HCV) who achieved SVR to interferon (IFN)-free direct-acting antivirals (DAA).

Main finding: Multivariate analysis revealed age ≥71 years (adjusted hazard ratio [aHR] 3.402; P = .005) and LSM ≥9.2 kPa (aHR 6.328; P < .001) to be the significant predictive factors at pretreatment and age ≥71 years (aHR 2.689; P = .014) and LSM ≥8.4 kPa (aHR 6.642; P < .001) at SVR24.

Study details: This was a multicenter retrospective study including 567 patients with no history of HCC but with HCV infection treated with DAAs and who achieved SVR24.

Disclosures: The study was sponsored by the Ministry of Education, Culture, Sports, Science, and Technology of Japan; Japan Society for the Promotion of Science; Japan Agency for Medical Research and Development; and Ministry of Health, Labor, and Welfare of Japan. Some authors declared receiving speaker fees/research grants from various pharmaceutical companies.

Source: Nakai M et al. Sci Rep. 2022;12:1449 (Jan 27). Doi: 10.1038/s41598-022-05492-5.

Key clinical point: Advanced age and liver stiffness measurement (LSM) on transient elastography, both pretreatment and at 24-week sustained virological response (SVR24), may aid in predicting the risk of hepatocellular carcinoma (HCC) in patients with hepatitis C virus (HCV) who achieved SVR to interferon (IFN)-free direct-acting antivirals (DAA).

Main finding: Multivariate analysis revealed age ≥71 years (adjusted hazard ratio [aHR] 3.402; P = .005) and LSM ≥9.2 kPa (aHR 6.328; P < .001) to be the significant predictive factors at pretreatment and age ≥71 years (aHR 2.689; P = .014) and LSM ≥8.4 kPa (aHR 6.642; P < .001) at SVR24.

Study details: This was a multicenter retrospective study including 567 patients with no history of HCC but with HCV infection treated with DAAs and who achieved SVR24.

Disclosures: The study was sponsored by the Ministry of Education, Culture, Sports, Science, and Technology of Japan; Japan Society for the Promotion of Science; Japan Agency for Medical Research and Development; and Ministry of Health, Labor, and Welfare of Japan. Some authors declared receiving speaker fees/research grants from various pharmaceutical companies.

Source: Nakai M et al. Sci Rep. 2022;12:1449 (Jan 27). Doi: 10.1038/s41598-022-05492-5.

Key clinical point: Advanced age and liver stiffness measurement (LSM) on transient elastography, both pretreatment and at 24-week sustained virological response (SVR24), may aid in predicting the risk of hepatocellular carcinoma (HCC) in patients with hepatitis C virus (HCV) who achieved SVR to interferon (IFN)-free direct-acting antivirals (DAA).

Main finding: Multivariate analysis revealed age ≥71 years (adjusted hazard ratio [aHR] 3.402; P = .005) and LSM ≥9.2 kPa (aHR 6.328; P < .001) to be the significant predictive factors at pretreatment and age ≥71 years (aHR 2.689; P = .014) and LSM ≥8.4 kPa (aHR 6.642; P < .001) at SVR24.

Study details: This was a multicenter retrospective study including 567 patients with no history of HCC but with HCV infection treated with DAAs and who achieved SVR24.

Disclosures: The study was sponsored by the Ministry of Education, Culture, Sports, Science, and Technology of Japan; Japan Society for the Promotion of Science; Japan Agency for Medical Research and Development; and Ministry of Health, Labor, and Welfare of Japan. Some authors declared receiving speaker fees/research grants from various pharmaceutical companies.

Source: Nakai M et al. Sci Rep. 2022;12:1449 (Jan 27). Doi: 10.1038/s41598-022-05492-5.

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.

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.

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.

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.

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.

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.

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.

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.