Clinical Edge Journal Scan

Key Clinical Point: Maintenance therapy with subcutaneous risankizumab showed superior efficacy than withdrawal from risankizumab to receive subcutaneous placebo in patients with moderate-to-severe Crohn’s disease (CD). It also had a tolerable safety profile.

Major finding: At week 52, patients receiving maintenance 360 mg risankizumab vs. placebo showed higher rates of Crohn’s Disease Activity Index clinical remission (adjusted difference [Δ] 15%; 95% CI 4%-25%) and endoscopic response (Δ 28%; 95% CI 19%-37%), with findings being similar for 180 mg risankizumab. The incidence of adverse events was similar across treatment groups.

Study details: Findings are from the phase 3 FORTIFY trial including 542 patients with moderate-to-severe CD who showed a clinical response to risankizumab in the ADVANCE and MOTIVATE induction trials and were randomly assigned to receive subcutaneous risankizumab (180 or 360 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speakers’ fees, consulting fees, or serving as advisory board members for various sources, including AbbVie.

Source: Ferrante M et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: Results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022;399(10340):2031-2046 (May 28). Doi: 10.1016/S0140-6736(22)00466-4

Key Clinical Point: Maintenance therapy with subcutaneous risankizumab showed superior efficacy than withdrawal from risankizumab to receive subcutaneous placebo in patients with moderate-to-severe Crohn’s disease (CD). It also had a tolerable safety profile.

Major finding: At week 52, patients receiving maintenance 360 mg risankizumab vs. placebo showed higher rates of Crohn’s Disease Activity Index clinical remission (adjusted difference [Δ] 15%; 95% CI 4%-25%) and endoscopic response (Δ 28%; 95% CI 19%-37%), with findings being similar for 180 mg risankizumab. The incidence of adverse events was similar across treatment groups.

Study details: Findings are from the phase 3 FORTIFY trial including 542 patients with moderate-to-severe CD who showed a clinical response to risankizumab in the ADVANCE and MOTIVATE induction trials and were randomly assigned to receive subcutaneous risankizumab (180 or 360 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speakers’ fees, consulting fees, or serving as advisory board members for various sources, including AbbVie.

Source: Ferrante M et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: Results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022;399(10340):2031-2046 (May 28). Doi: 10.1016/S0140-6736(22)00466-4

Key Clinical Point: Maintenance therapy with subcutaneous risankizumab showed superior efficacy than withdrawal from risankizumab to receive subcutaneous placebo in patients with moderate-to-severe Crohn’s disease (CD). It also had a tolerable safety profile.

Major finding: At week 52, patients receiving maintenance 360 mg risankizumab vs. placebo showed higher rates of Crohn’s Disease Activity Index clinical remission (adjusted difference [Δ] 15%; 95% CI 4%-25%) and endoscopic response (Δ 28%; 95% CI 19%-37%), with findings being similar for 180 mg risankizumab. The incidence of adverse events was similar across treatment groups.

Study details: Findings are from the phase 3 FORTIFY trial including 542 patients with moderate-to-severe CD who showed a clinical response to risankizumab in the ADVANCE and MOTIVATE induction trials and were randomly assigned to receive subcutaneous risankizumab (180 or 360 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speakers’ fees, consulting fees, or serving as advisory board members for various sources, including AbbVie.

Source: Ferrante M et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: Results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022;399(10340):2031-2046 (May 28). Doi: 10.1016/S0140-6736(22)00466-4

Key clinical point: Tofacitinib showed higher efficacy and comparable safety to vedolizumab in patients with ulcerative colitis (UC) with prior treatment failure with anti-tumor necrosis factor (anti-TNF) therapy.

Major finding: Patients treated with tofacitinib vs. vedolizumab were more likely to achieve corticosteroid-free remission at weeks 12 (odds ratio [OR] 6.33; P < .01), 24 (OR 3.02; P < .01), and 52 (OR 1.86; P = .01). The overall risk for adverse events (AE) was higher in patients treated with vedolizumab (OR 1.83; P = .02), whereas the risk for serious AE was similar in both the groups.

Study details: This was a prospective cohort study of 148 patients with UC from the Initiative on Crohn and Colitis (ICC) registry who were treated with vedolizumab (n = 83) or tofacitinib (n = 65) after the failure of treatment with at least one anti-TNF agent.

Disclosures: The ICC fellowship was sponsored by AbbVie, Pfizer, and others. Some authors reported receiving grants, consulting fees, speakers’ fees, presentation fees from, or serving on advisory boards for various sources, including the sponsors of the ICC Fellowship.

Source: Straatmijer T et al. Superior effectiveness of tofacitinib compared to vedolizumab in anti-TNF experienced ulcerative colitis patients: A nationwide Dutch Registry study. Clin Gastroenterol Hepatol. 2022 (May 26). Doi: 10.1016/j.cgh.2022.04.038

Key clinical point: Tofacitinib showed higher efficacy and comparable safety to vedolizumab in patients with ulcerative colitis (UC) with prior treatment failure with anti-tumor necrosis factor (anti-TNF) therapy.

Major finding: Patients treated with tofacitinib vs. vedolizumab were more likely to achieve corticosteroid-free remission at weeks 12 (odds ratio [OR] 6.33; P < .01), 24 (OR 3.02; P < .01), and 52 (OR 1.86; P = .01). The overall risk for adverse events (AE) was higher in patients treated with vedolizumab (OR 1.83; P = .02), whereas the risk for serious AE was similar in both the groups.

Study details: This was a prospective cohort study of 148 patients with UC from the Initiative on Crohn and Colitis (ICC) registry who were treated with vedolizumab (n = 83) or tofacitinib (n = 65) after the failure of treatment with at least one anti-TNF agent.

Disclosures: The ICC fellowship was sponsored by AbbVie, Pfizer, and others. Some authors reported receiving grants, consulting fees, speakers’ fees, presentation fees from, or serving on advisory boards for various sources, including the sponsors of the ICC Fellowship.

Source: Straatmijer T et al. Superior effectiveness of tofacitinib compared to vedolizumab in anti-TNF experienced ulcerative colitis patients: A nationwide Dutch Registry study. Clin Gastroenterol Hepatol. 2022 (May 26). Doi: 10.1016/j.cgh.2022.04.038

Key clinical point: Tofacitinib showed higher efficacy and comparable safety to vedolizumab in patients with ulcerative colitis (UC) with prior treatment failure with anti-tumor necrosis factor (anti-TNF) therapy.

Major finding: Patients treated with tofacitinib vs. vedolizumab were more likely to achieve corticosteroid-free remission at weeks 12 (odds ratio [OR] 6.33; P < .01), 24 (OR 3.02; P < .01), and 52 (OR 1.86; P = .01). The overall risk for adverse events (AE) was higher in patients treated with vedolizumab (OR 1.83; P = .02), whereas the risk for serious AE was similar in both the groups.

Study details: This was a prospective cohort study of 148 patients with UC from the Initiative on Crohn and Colitis (ICC) registry who were treated with vedolizumab (n = 83) or tofacitinib (n = 65) after the failure of treatment with at least one anti-TNF agent.

Disclosures: The ICC fellowship was sponsored by AbbVie, Pfizer, and others. Some authors reported receiving grants, consulting fees, speakers’ fees, presentation fees from, or serving on advisory boards for various sources, including the sponsors of the ICC Fellowship.

Source: Straatmijer T et al. Superior effectiveness of tofacitinib compared to vedolizumab in anti-TNF experienced ulcerative colitis patients: A nationwide Dutch Registry study. Clin Gastroenterol Hepatol. 2022 (May 26). Doi: 10.1016/j.cgh.2022.04.038

Key Clinical Point: Intravenous risankizumab induction therapy is safe and effective in patients with moderate-to-severe Crohn’s disease (CD).

Major finding: In the ADVANCE trial, Crohn’s Disease Activity Index clinical remission at week 12 was higher with 600 mg risankizumab (adjusted difference [Δ] 21%) and 1200 mg (Δ 17%) vs. placebo, with the endoscopic response being higher with 600 mg risankizumab (Δ 28%) and 1200 mg (Δ 20%; all P < .0001) vs. placebo. The MOTIVATE trial reported similar findings. The incidence of adverse events was similar across all treatment groups.

Study details: This study included patients with moderate-to-severe CD and intolerance/inadequate response to biologics or conventional therapy from the phase 3 ADVANCE (n=931) and MOTIVATE  (n = 618) trials who were randomly assigned to receive risankizumab (600 or 1200 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speaker’s fees, or consulting fees or serving as advisory board members for various sources, including AbbVie.

Source: D’Haens G et al. Risankizumab as induction therapy for Crohn's disease: Results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022;399(10340):2015-2030 (May 28). Doi: 10.1016/S0140-6736(22)00467-6

Key Clinical Point: Intravenous risankizumab induction therapy is safe and effective in patients with moderate-to-severe Crohn’s disease (CD).

Major finding: In the ADVANCE trial, Crohn’s Disease Activity Index clinical remission at week 12 was higher with 600 mg risankizumab (adjusted difference [Δ] 21%) and 1200 mg (Δ 17%) vs. placebo, with the endoscopic response being higher with 600 mg risankizumab (Δ 28%) and 1200 mg (Δ 20%; all P < .0001) vs. placebo. The MOTIVATE trial reported similar findings. The incidence of adverse events was similar across all treatment groups.

Study details: This study included patients with moderate-to-severe CD and intolerance/inadequate response to biologics or conventional therapy from the phase 3 ADVANCE (n=931) and MOTIVATE  (n = 618) trials who were randomly assigned to receive risankizumab (600 or 1200 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speaker’s fees, or consulting fees or serving as advisory board members for various sources, including AbbVie.

Source: D’Haens G et al. Risankizumab as induction therapy for Crohn's disease: Results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022;399(10340):2015-2030 (May 28). Doi: 10.1016/S0140-6736(22)00467-6

Key Clinical Point: Intravenous risankizumab induction therapy is safe and effective in patients with moderate-to-severe Crohn’s disease (CD).

Major finding: In the ADVANCE trial, Crohn’s Disease Activity Index clinical remission at week 12 was higher with 600 mg risankizumab (adjusted difference [Δ] 21%) and 1200 mg (Δ 17%) vs. placebo, with the endoscopic response being higher with 600 mg risankizumab (Δ 28%) and 1200 mg (Δ 20%; all P < .0001) vs. placebo. The MOTIVATE trial reported similar findings. The incidence of adverse events was similar across all treatment groups.

Study details: This study included patients with moderate-to-severe CD and intolerance/inadequate response to biologics or conventional therapy from the phase 3 ADVANCE (n=931) and MOTIVATE  (n = 618) trials who were randomly assigned to receive risankizumab (600 or 1200 mg) or placebo.

Disclosures: This study was funded by AbbVie. Some authors declared being employees or holding stocks at AbbVie, and other authors reported receiving grants, speaker’s fees, or consulting fees or serving as advisory board members for various sources, including AbbVie.

Source: D’Haens G et al. Risankizumab as induction therapy for Crohn's disease: Results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022;399(10340):2015-2030 (May 28). Doi: 10.1016/S0140-6736(22)00467-6

Liver transplantation cures both HCC and the underlying cirrhosis; however, tumor progression while the patient is on the waiting list is an ongoing concern. Couillard and colleagues reported a retrospective study of 88 patients with HCC who underwent percutaneous microwave ablation for 141 tumors while on the liver transplant list. The median follow-up was 61 months. Seventy-one patients (80.7%) underwent liver transplantation after a median wait time of 8.5 months. No tumor seeding was identified. Seventeen patients (19.3%) were removed from the waitlist, four (4.5%) of whom because of tumor progression outside of the Milan criteria. A total of five of 71 (7.0%) patients had posttransplant recurrence of HCC and all died during this time. The 5-year overall survival (OS) following liver transplantation was 76.7% and the disease-specific survival after transplantation was 89.6%. The authors concluded that microwave ablation is a safe and effective treatment that bridges patients to successful transplantation.

Radiation segmentectomy is performed by the administration of radioactive yttrium (⁹⁰Y)-bound microspheres transarterially to the segment of liver containing an unresected tumor. Kim and colleagues described the results of a prospective trial that evaluated the efficacy of radiation segmentectomy with curative intent in patients with Child-Pugh score A–B7 and small (< 3 cm), unresectable HCC, where the tumors were in a location unsuitable for ablation. Of the 44 individuals assessed for eligibility, 29 patients were included in the study. A complete response was observed in 24 (83%) patients, and a partial response was observed in 5 (17%) patients. All patients had an initial objective tumor response, and 26 (90%) had a sustained complete response during 24 months of clinical follow-up. The treatment was well tolerated, with four (14%) patients having grade 3 leukopenia and two (7%) having grade 3 thrombocytopenia. The authors concluded that radiation segmentectomy should be investigated further as a potentially curative option for patients with HCC.

Portal vein thrombosis (PVT) has been considered a contraindication to transarterial chemoembolization (TACE) due to the concern for inadvertent liver ischemia if the hepatic artery becomes obstructed. Several studies have demonstrated that this risk is low. Stereotactic body radiation therapy (SBRT) is used to effectively target HCC (especially when there is a portal vein tumor) while minimizing collateral damage to the liver. Zhang and colleagues performed a meta-analysis of nine studies totaling 938 patients who had HCC with tumor PVT. Of those, 483 received either SBRT or TACE, and 455 were treated with both TACE and SBRT. There were 255 events reported in the monotherapy groups and 174 events in the combination groups. Following statistical analyses of all available data, the authors concluded that SBRT plus TACE yielded significantly higher 1-year OS (RR [relative risk] 1.52; 95% CI 1.33-1.74), 2-year OS (RR 2.00; 95% CI 1.48-2.70), and a lower progressive disease rate (RR 0.45; 95% CI 0.26-0.79) than monotherapy. The combination treatment was both safe and effective.

Liver transplantation cures both HCC and the underlying cirrhosis; however, tumor progression while the patient is on the waiting list is an ongoing concern. Couillard and colleagues reported a retrospective study of 88 patients with HCC who underwent percutaneous microwave ablation for 141 tumors while on the liver transplant list. The median follow-up was 61 months. Seventy-one patients (80.7%) underwent liver transplantation after a median wait time of 8.5 months. No tumor seeding was identified. Seventeen patients (19.3%) were removed from the waitlist, four (4.5%) of whom because of tumor progression outside of the Milan criteria. A total of five of 71 (7.0%) patients had posttransplant recurrence of HCC and all died during this time. The 5-year overall survival (OS) following liver transplantation was 76.7% and the disease-specific survival after transplantation was 89.6%. The authors concluded that microwave ablation is a safe and effective treatment that bridges patients to successful transplantation.

Radiation segmentectomy is performed by the administration of radioactive yttrium (⁹⁰Y)-bound microspheres transarterially to the segment of liver containing an unresected tumor. Kim and colleagues described the results of a prospective trial that evaluated the efficacy of radiation segmentectomy with curative intent in patients with Child-Pugh score A–B7 and small (< 3 cm), unresectable HCC, where the tumors were in a location unsuitable for ablation. Of the 44 individuals assessed for eligibility, 29 patients were included in the study. A complete response was observed in 24 (83%) patients, and a partial response was observed in 5 (17%) patients. All patients had an initial objective tumor response, and 26 (90%) had a sustained complete response during 24 months of clinical follow-up. The treatment was well tolerated, with four (14%) patients having grade 3 leukopenia and two (7%) having grade 3 thrombocytopenia. The authors concluded that radiation segmentectomy should be investigated further as a potentially curative option for patients with HCC.

Portal vein thrombosis (PVT) has been considered a contraindication to transarterial chemoembolization (TACE) due to the concern for inadvertent liver ischemia if the hepatic artery becomes obstructed. Several studies have demonstrated that this risk is low. Stereotactic body radiation therapy (SBRT) is used to effectively target HCC (especially when there is a portal vein tumor) while minimizing collateral damage to the liver. Zhang and colleagues performed a meta-analysis of nine studies totaling 938 patients who had HCC with tumor PVT. Of those, 483 received either SBRT or TACE, and 455 were treated with both TACE and SBRT. There were 255 events reported in the monotherapy groups and 174 events in the combination groups. Following statistical analyses of all available data, the authors concluded that SBRT plus TACE yielded significantly higher 1-year OS (RR [relative risk] 1.52; 95% CI 1.33-1.74), 2-year OS (RR 2.00; 95% CI 1.48-2.70), and a lower progressive disease rate (RR 0.45; 95% CI 0.26-0.79) than monotherapy. The combination treatment was both safe and effective.

Liver transplantation cures both HCC and the underlying cirrhosis; however, tumor progression while the patient is on the waiting list is an ongoing concern. Couillard and colleagues reported a retrospective study of 88 patients with HCC who underwent percutaneous microwave ablation for 141 tumors while on the liver transplant list. The median follow-up was 61 months. Seventy-one patients (80.7%) underwent liver transplantation after a median wait time of 8.5 months. No tumor seeding was identified. Seventeen patients (19.3%) were removed from the waitlist, four (4.5%) of whom because of tumor progression outside of the Milan criteria. A total of five of 71 (7.0%) patients had posttransplant recurrence of HCC and all died during this time. The 5-year overall survival (OS) following liver transplantation was 76.7% and the disease-specific survival after transplantation was 89.6%. The authors concluded that microwave ablation is a safe and effective treatment that bridges patients to successful transplantation.

Radiation segmentectomy is performed by the administration of radioactive yttrium (⁹⁰Y)-bound microspheres transarterially to the segment of liver containing an unresected tumor. Kim and colleagues described the results of a prospective trial that evaluated the efficacy of radiation segmentectomy with curative intent in patients with Child-Pugh score A–B7 and small (< 3 cm), unresectable HCC, where the tumors were in a location unsuitable for ablation. Of the 44 individuals assessed for eligibility, 29 patients were included in the study. A complete response was observed in 24 (83%) patients, and a partial response was observed in 5 (17%) patients. All patients had an initial objective tumor response, and 26 (90%) had a sustained complete response during 24 months of clinical follow-up. The treatment was well tolerated, with four (14%) patients having grade 3 leukopenia and two (7%) having grade 3 thrombocytopenia. The authors concluded that radiation segmentectomy should be investigated further as a potentially curative option for patients with HCC.

Portal vein thrombosis (PVT) has been considered a contraindication to transarterial chemoembolization (TACE) due to the concern for inadvertent liver ischemia if the hepatic artery becomes obstructed. Several studies have demonstrated that this risk is low. Stereotactic body radiation therapy (SBRT) is used to effectively target HCC (especially when there is a portal vein tumor) while minimizing collateral damage to the liver. Zhang and colleagues performed a meta-analysis of nine studies totaling 938 patients who had HCC with tumor PVT. Of those, 483 received either SBRT or TACE, and 455 were treated with both TACE and SBRT. There were 255 events reported in the monotherapy groups and 174 events in the combination groups. Following statistical analyses of all available data, the authors concluded that SBRT plus TACE yielded significantly higher 1-year OS (RR [relative risk] 1.52; 95% CI 1.33-1.74), 2-year OS (RR 2.00; 95% CI 1.48-2.70), and a lower progressive disease rate (RR 0.45; 95% CI 0.26-0.79) than monotherapy. The combination treatment was both safe and effective.

Liver transplantation cures both HCC and the underlying cirrhosis; however, tumor progression while the patient is on the waiting list is an ongoing concern. Couillard and colleagues reported a retrospective study of 88 patients with HCC who underwent percutaneous microwave ablation for 141 tumors while on the liver transplant list. The median follow-up was 61 months. Seventy-one patients (80.7%) underwent liver transplantation after a median wait time of 8.5 months. No tumor seeding was identified. Seventeen patients (19.3%) were removed from the waitlist, four (4.5%) of whom because of tumor progression outside of the Milan criteria. A total of five of 71 (7.0%) patients had posttransplant recurrence of HCC and all died during this time. The 5-year overall survival (OS) following liver transplantation was 76.7% and the disease-specific survival after transplantation was 89.6%. The authors concluded that microwave ablation is a safe and effective treatment that bridges patients to successful transplantation.

Radiation segmentectomy is performed by the administration of radioactive yttrium (⁹⁰Y)-bound microspheres transarterially to the segment of liver containing an unresected tumor. Kim and colleagues described the results of a prospective trial that evaluated the efficacy of radiation segmentectomy with curative intent in patients with Child-Pugh score A–B7 and small (< 3 cm), unresectable HCC, where the tumors were in a location unsuitable for ablation. Of the 44 individuals assessed for eligibility, 29 patients were included in the study. A complete response was observed in 24 (83%) patients, and a partial response was observed in 5 (17%) patients. All patients had an initial objective tumor response, and 26 (90%) had a sustained complete response during 24 months of clinical follow-up. The treatment was well tolerated, with four (14%) patients having grade 3 leukopenia and two (7%) having grade 3 thrombocytopenia. The authors concluded that radiation segmentectomy should be investigated further as a potentially curative option for patients with HCC.

Portal vein thrombosis (PVT) has been considered a contraindication to transarterial chemoembolization (TACE) due to the concern for inadvertent liver ischemia if the hepatic artery becomes obstructed. Several studies have demonstrated that this risk is low. Stereotactic body radiation therapy (SBRT) is used to effectively target HCC (especially when there is a portal vein tumor) while minimizing collateral damage to the liver. Zhang and colleagues performed a meta-analysis of nine studies totaling 938 patients who had HCC with tumor PVT. Of those, 483 received either SBRT or TACE, and 455 were treated with both TACE and SBRT. There were 255 events reported in the monotherapy groups and 174 events in the combination groups. Following statistical analyses of all available data, the authors concluded that SBRT plus TACE yielded significantly higher 1-year OS (RR [relative risk] 1.52; 95% CI 1.33-1.74), 2-year OS (RR 2.00; 95% CI 1.48-2.70), and a lower progressive disease rate (RR 0.45; 95% CI 0.26-0.79) than monotherapy. The combination treatment was both safe and effective.

Liver transplantation cures both HCC and the underlying cirrhosis; however, tumor progression while the patient is on the waiting list is an ongoing concern. Couillard and colleagues reported a retrospective study of 88 patients with HCC who underwent percutaneous microwave ablation for 141 tumors while on the liver transplant list. The median follow-up was 61 months. Seventy-one patients (80.7%) underwent liver transplantation after a median wait time of 8.5 months. No tumor seeding was identified. Seventeen patients (19.3%) were removed from the waitlist, four (4.5%) of whom because of tumor progression outside of the Milan criteria. A total of five of 71 (7.0%) patients had posttransplant recurrence of HCC and all died during this time. The 5-year overall survival (OS) following liver transplantation was 76.7% and the disease-specific survival after transplantation was 89.6%. The authors concluded that microwave ablation is a safe and effective treatment that bridges patients to successful transplantation.

Radiation segmentectomy is performed by the administration of radioactive yttrium (⁹⁰Y)-bound microspheres transarterially to the segment of liver containing an unresected tumor. Kim and colleagues described the results of a prospective trial that evaluated the efficacy of radiation segmentectomy with curative intent in patients with Child-Pugh score A–B7 and small (< 3 cm), unresectable HCC, where the tumors were in a location unsuitable for ablation. Of the 44 individuals assessed for eligibility, 29 patients were included in the study. A complete response was observed in 24 (83%) patients, and a partial response was observed in 5 (17%) patients. All patients had an initial objective tumor response, and 26 (90%) had a sustained complete response during 24 months of clinical follow-up. The treatment was well tolerated, with four (14%) patients having grade 3 leukopenia and two (7%) having grade 3 thrombocytopenia. The authors concluded that radiation segmentectomy should be investigated further as a potentially curative option for patients with HCC.

Portal vein thrombosis (PVT) has been considered a contraindication to transarterial chemoembolization (TACE) due to the concern for inadvertent liver ischemia if the hepatic artery becomes obstructed. Several studies have demonstrated that this risk is low. Stereotactic body radiation therapy (SBRT) is used to effectively target HCC (especially when there is a portal vein tumor) while minimizing collateral damage to the liver. Zhang and colleagues performed a meta-analysis of nine studies totaling 938 patients who had HCC with tumor PVT. Of those, 483 received either SBRT or TACE, and 455 were treated with both TACE and SBRT. There were 255 events reported in the monotherapy groups and 174 events in the combination groups. Following statistical analyses of all available data, the authors concluded that SBRT plus TACE yielded significantly higher 1-year OS (RR [relative risk] 1.52; 95% CI 1.33-1.74), 2-year OS (RR 2.00; 95% CI 1.48-2.70), and a lower progressive disease rate (RR 0.45; 95% CI 0.26-0.79) than monotherapy. The combination treatment was both safe and effective.

Liver transplantation cures both HCC and the underlying cirrhosis; however, tumor progression while the patient is on the waiting list is an ongoing concern. Couillard and colleagues reported a retrospective study of 88 patients with HCC who underwent percutaneous microwave ablation for 141 tumors while on the liver transplant list. The median follow-up was 61 months. Seventy-one patients (80.7%) underwent liver transplantation after a median wait time of 8.5 months. No tumor seeding was identified. Seventeen patients (19.3%) were removed from the waitlist, four (4.5%) of whom because of tumor progression outside of the Milan criteria. A total of five of 71 (7.0%) patients had posttransplant recurrence of HCC and all died during this time. The 5-year overall survival (OS) following liver transplantation was 76.7% and the disease-specific survival after transplantation was 89.6%. The authors concluded that microwave ablation is a safe and effective treatment that bridges patients to successful transplantation.

Radiation segmentectomy is performed by the administration of radioactive yttrium (⁹⁰Y)-bound microspheres transarterially to the segment of liver containing an unresected tumor. Kim and colleagues described the results of a prospective trial that evaluated the efficacy of radiation segmentectomy with curative intent in patients with Child-Pugh score A–B7 and small (< 3 cm), unresectable HCC, where the tumors were in a location unsuitable for ablation. Of the 44 individuals assessed for eligibility, 29 patients were included in the study. A complete response was observed in 24 (83%) patients, and a partial response was observed in 5 (17%) patients. All patients had an initial objective tumor response, and 26 (90%) had a sustained complete response during 24 months of clinical follow-up. The treatment was well tolerated, with four (14%) patients having grade 3 leukopenia and two (7%) having grade 3 thrombocytopenia. The authors concluded that radiation segmentectomy should be investigated further as a potentially curative option for patients with HCC.

Portal vein thrombosis (PVT) has been considered a contraindication to transarterial chemoembolization (TACE) due to the concern for inadvertent liver ischemia if the hepatic artery becomes obstructed. Several studies have demonstrated that this risk is low. Stereotactic body radiation therapy (SBRT) is used to effectively target HCC (especially when there is a portal vein tumor) while minimizing collateral damage to the liver. Zhang and colleagues performed a meta-analysis of nine studies totaling 938 patients who had HCC with tumor PVT. Of those, 483 received either SBRT or TACE, and 455 were treated with both TACE and SBRT. There were 255 events reported in the monotherapy groups and 174 events in the combination groups. Following statistical analyses of all available data, the authors concluded that SBRT plus TACE yielded significantly higher 1-year OS (RR [relative risk] 1.52; 95% CI 1.33-1.74), 2-year OS (RR 2.00; 95% CI 1.48-2.70), and a lower progressive disease rate (RR 0.45; 95% CI 0.26-0.79) than monotherapy. The combination treatment was both safe and effective.

First, Blauvelt and colleagues presented findings from the ongoing LIBERTY AD PED-OLE open-label extension study, including 294 adolescents with moderate to severe AD who participated in previous dupilumab trials. Patients received a maintenance dose of 300 mg dupilumab every 4 weeks, which was increased to a weight-based every-other-week regimen if there was inadequate clinical response to every-4-week dosing. They found that 81.2% of patients achieved an Eczema Area and Severity Index (EASI-75) response at week 52 with every-4-week dosing, and 51.9% of patients at week 48 after switching to every-2-week doing. These results indicate that some adolescents may be able to maintain clinical efficacy with monthly dosing, while others may require every-2-week dosing. Of note, no new safety signals emerged during the study and most adverse events were mild to moderate.

Two more studies were published showing real-world effectiveness and safety of dupilumab. Eichenfield and colleagues performed a retrospective, observational study of the effectiveness of dupilumab after 4 months of treatment using data from national electronic medical records in adults with moderate-to-severe AD. They found that most patients achieved at least a one-grade (81.8%) or two-grade (62.8%) improvement of their Investigator's Global Assessment (IGA) scores, with 42.8% achieving IGA scores of 0/1 (clear/minimal). There were also significant improvements in itch and lesional extent. The results were remarkably similar to those observed in the phase 3 clinical trial program of dupilumab in adults with moderate-to-severe AD.

Bagel and colleagues published baseline characteristics of patients enrolled in the ongoing PROSE longitudinal real-world registry of dupilumab use in adults with moderate-to-severe AD. Almost half of the patients (49.5%) previously received systemic medications, including 41.0% with systemic corticosteroids, 16.8% with nonsteroidal systemic therapies, such as cyclosporine and methotrexate, and 10.2% with phototherapy. This result indicates that many medical professionals are not using dupilumab as a first-line systemic therapy, despite its established record on safety and efficacy. It appears that many clinicians prefer a short-term treatment regimen, such as systemic corticosteroids, prior to initiating long-term treatment with dupilumab. However, short-term treatment approaches are not ideal for this chronic and often lifelong disease. It is important that clinicians develop appropriate long-term treatment approaches for atopic dermatitis in general, regardless of any specific therapy.

On a different research note, my research group just published the results of a longitudinal dermatology practice–based study of depressive symptoms in 695 adults with AD over time.¹ We found that approximately half of the patients experienced fluctuating severity of depressive symptoms, and 45.65% experienced persistent severity of depression. Severity of AD lesions and itch were the strongest predictors of more severe symptoms of depression. Perhaps most fascinating about this research was that symptoms of depression improved dramatically in a very large subset of patients who experienced reduced AD severity with standard-of-care treatment. These results highlight the broader impacts of AD on mental health, which were recently recognized by the American Academy of Dermatology's guideline update on AD comorbidities.² Moreover, our study demonstrated that many of these mental health impacts were modifiable with optimized AD therapy.

Additional References

1.         Chatrath S, Lei D, Yousaf M, et al. vc Longitudinal course and predictors of depressive symptoms in atopic dermatitis. J Am Acad Dermatol. 2022 (May 9). Doi: 10.1016/j.jaad.2022.04.061

2.         Davis DMR, Drucker AM, Alikhan A, et al. American Academy of Dermatology Guidelines: Awareness of comorbidities associated with atopic dermatitis in adults. J Am Acad Dermatol. 2022;86:1335-1336.e18. Doi: 10.1016/j.jaad.2022.01.009

First, Blauvelt and colleagues presented findings from the ongoing LIBERTY AD PED-OLE open-label extension study, including 294 adolescents with moderate to severe AD who participated in previous dupilumab trials. Patients received a maintenance dose of 300 mg dupilumab every 4 weeks, which was increased to a weight-based every-other-week regimen if there was inadequate clinical response to every-4-week dosing. They found that 81.2% of patients achieved an Eczema Area and Severity Index (EASI-75) response at week 52 with every-4-week dosing, and 51.9% of patients at week 48 after switching to every-2-week doing. These results indicate that some adolescents may be able to maintain clinical efficacy with monthly dosing, while others may require every-2-week dosing. Of note, no new safety signals emerged during the study and most adverse events were mild to moderate.

Two more studies were published showing real-world effectiveness and safety of dupilumab. Eichenfield and colleagues performed a retrospective, observational study of the effectiveness of dupilumab after 4 months of treatment using data from national electronic medical records in adults with moderate-to-severe AD. They found that most patients achieved at least a one-grade (81.8%) or two-grade (62.8%) improvement of their Investigator's Global Assessment (IGA) scores, with 42.8% achieving IGA scores of 0/1 (clear/minimal). There were also significant improvements in itch and lesional extent. The results were remarkably similar to those observed in the phase 3 clinical trial program of dupilumab in adults with moderate-to-severe AD.

Bagel and colleagues published baseline characteristics of patients enrolled in the ongoing PROSE longitudinal real-world registry of dupilumab use in adults with moderate-to-severe AD. Almost half of the patients (49.5%) previously received systemic medications, including 41.0% with systemic corticosteroids, 16.8% with nonsteroidal systemic therapies, such as cyclosporine and methotrexate, and 10.2% with phototherapy. This result indicates that many medical professionals are not using dupilumab as a first-line systemic therapy, despite its established record on safety and efficacy. It appears that many clinicians prefer a short-term treatment regimen, such as systemic corticosteroids, prior to initiating long-term treatment with dupilumab. However, short-term treatment approaches are not ideal for this chronic and often lifelong disease. It is important that clinicians develop appropriate long-term treatment approaches for atopic dermatitis in general, regardless of any specific therapy.

On a different research note, my research group just published the results of a longitudinal dermatology practice–based study of depressive symptoms in 695 adults with AD over time.¹ We found that approximately half of the patients experienced fluctuating severity of depressive symptoms, and 45.65% experienced persistent severity of depression. Severity of AD lesions and itch were the strongest predictors of more severe symptoms of depression. Perhaps most fascinating about this research was that symptoms of depression improved dramatically in a very large subset of patients who experienced reduced AD severity with standard-of-care treatment. These results highlight the broader impacts of AD on mental health, which were recently recognized by the American Academy of Dermatology's guideline update on AD comorbidities.² Moreover, our study demonstrated that many of these mental health impacts were modifiable with optimized AD therapy.

Additional References

1.         Chatrath S, Lei D, Yousaf M, et al. vc Longitudinal course and predictors of depressive symptoms in atopic dermatitis. J Am Acad Dermatol. 2022 (May 9). Doi: 10.1016/j.jaad.2022.04.061

2.         Davis DMR, Drucker AM, Alikhan A, et al. American Academy of Dermatology Guidelines: Awareness of comorbidities associated with atopic dermatitis in adults. J Am Acad Dermatol. 2022;86:1335-1336.e18. Doi: 10.1016/j.jaad.2022.01.009

First, Blauvelt and colleagues presented findings from the ongoing LIBERTY AD PED-OLE open-label extension study, including 294 adolescents with moderate to severe AD who participated in previous dupilumab trials. Patients received a maintenance dose of 300 mg dupilumab every 4 weeks, which was increased to a weight-based every-other-week regimen if there was inadequate clinical response to every-4-week dosing. They found that 81.2% of patients achieved an Eczema Area and Severity Index (EASI-75) response at week 52 with every-4-week dosing, and 51.9% of patients at week 48 after switching to every-2-week doing. These results indicate that some adolescents may be able to maintain clinical efficacy with monthly dosing, while others may require every-2-week dosing. Of note, no new safety signals emerged during the study and most adverse events were mild to moderate.

Two more studies were published showing real-world effectiveness and safety of dupilumab. Eichenfield and colleagues performed a retrospective, observational study of the effectiveness of dupilumab after 4 months of treatment using data from national electronic medical records in adults with moderate-to-severe AD. They found that most patients achieved at least a one-grade (81.8%) or two-grade (62.8%) improvement of their Investigator's Global Assessment (IGA) scores, with 42.8% achieving IGA scores of 0/1 (clear/minimal). There were also significant improvements in itch and lesional extent. The results were remarkably similar to those observed in the phase 3 clinical trial program of dupilumab in adults with moderate-to-severe AD.

Bagel and colleagues published baseline characteristics of patients enrolled in the ongoing PROSE longitudinal real-world registry of dupilumab use in adults with moderate-to-severe AD. Almost half of the patients (49.5%) previously received systemic medications, including 41.0% with systemic corticosteroids, 16.8% with nonsteroidal systemic therapies, such as cyclosporine and methotrexate, and 10.2% with phototherapy. This result indicates that many medical professionals are not using dupilumab as a first-line systemic therapy, despite its established record on safety and efficacy. It appears that many clinicians prefer a short-term treatment regimen, such as systemic corticosteroids, prior to initiating long-term treatment with dupilumab. However, short-term treatment approaches are not ideal for this chronic and often lifelong disease. It is important that clinicians develop appropriate long-term treatment approaches for atopic dermatitis in general, regardless of any specific therapy.

On a different research note, my research group just published the results of a longitudinal dermatology practice–based study of depressive symptoms in 695 adults with AD over time.¹ We found that approximately half of the patients experienced fluctuating severity of depressive symptoms, and 45.65% experienced persistent severity of depression. Severity of AD lesions and itch were the strongest predictors of more severe symptoms of depression. Perhaps most fascinating about this research was that symptoms of depression improved dramatically in a very large subset of patients who experienced reduced AD severity with standard-of-care treatment. These results highlight the broader impacts of AD on mental health, which were recently recognized by the American Academy of Dermatology's guideline update on AD comorbidities.² Moreover, our study demonstrated that many of these mental health impacts were modifiable with optimized AD therapy.

Additional References

1.         Chatrath S, Lei D, Yousaf M, et al. vc Longitudinal course and predictors of depressive symptoms in atopic dermatitis. J Am Acad Dermatol. 2022 (May 9). Doi: 10.1016/j.jaad.2022.04.061

2.         Davis DMR, Drucker AM, Alikhan A, et al. American Academy of Dermatology Guidelines: Awareness of comorbidities associated with atopic dermatitis in adults. J Am Acad Dermatol. 2022;86:1335-1336.e18. Doi: 10.1016/j.jaad.2022.01.009

Key clinical point: Stereotactic body radiotherapy (SBRT) plus transcatheter arterial chemoembolization (TACE) may be safe and more effective than either of the procedures alone (monotherapy) for treating inoperable hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).

Major finding: SBRT plus TACE vs. monotherapy led to significantly higher overall survival (1-year: risk ratio [RR] 1.52; 95% CI 1.33-1.74; 2-year: RR 2.00; 95% CI 1.48-2.70) and objective response (RR 1.22; 95% CI 1.08-1.37) rates, a significantly lower disease progression rate (RR 0.45; 95% CI 0.26-0.79), and a similar adverse event incidence (RR 1.03; 95% CI 0.82-1.31).

Study details: This was a meta-analysis of nine studies involving 938 patients with inoperable HCC and PVTT who received SBRT plus TACE (n = 455) or monotherapy (n = 483).

Disclosures: The study was sponsored by Chinese Medical Hand in Hand Project Committee & Beijing Medical Award Foundation, among others. The authors declared no conflicts of interest.

Source: Zhang X-F et al. Stereotactic body radiotherapy plus transcatheter arterial chemoembolization for inoperable hepatocellular carcinoma patients with portal vein tumour thrombus: A meta-analysis. PLoS One. 2022;17(5): e0268779 (May 20). Doi: 10.1371/journal.pone.0268779

Key clinical point: Stereotactic body radiotherapy (SBRT) plus transcatheter arterial chemoembolization (TACE) may be safe and more effective than either of the procedures alone (monotherapy) for treating inoperable hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).

Major finding: SBRT plus TACE vs. monotherapy led to significantly higher overall survival (1-year: risk ratio [RR] 1.52; 95% CI 1.33-1.74; 2-year: RR 2.00; 95% CI 1.48-2.70) and objective response (RR 1.22; 95% CI 1.08-1.37) rates, a significantly lower disease progression rate (RR 0.45; 95% CI 0.26-0.79), and a similar adverse event incidence (RR 1.03; 95% CI 0.82-1.31).

Study details: This was a meta-analysis of nine studies involving 938 patients with inoperable HCC and PVTT who received SBRT plus TACE (n = 455) or monotherapy (n = 483).

Disclosures: The study was sponsored by Chinese Medical Hand in Hand Project Committee & Beijing Medical Award Foundation, among others. The authors declared no conflicts of interest.

Source: Zhang X-F et al. Stereotactic body radiotherapy plus transcatheter arterial chemoembolization for inoperable hepatocellular carcinoma patients with portal vein tumour thrombus: A meta-analysis. PLoS One. 2022;17(5): e0268779 (May 20). Doi: 10.1371/journal.pone.0268779

Key clinical point: Stereotactic body radiotherapy (SBRT) plus transcatheter arterial chemoembolization (TACE) may be safe and more effective than either of the procedures alone (monotherapy) for treating inoperable hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).

Major finding: SBRT plus TACE vs. monotherapy led to significantly higher overall survival (1-year: risk ratio [RR] 1.52; 95% CI 1.33-1.74; 2-year: RR 2.00; 95% CI 1.48-2.70) and objective response (RR 1.22; 95% CI 1.08-1.37) rates, a significantly lower disease progression rate (RR 0.45; 95% CI 0.26-0.79), and a similar adverse event incidence (RR 1.03; 95% CI 0.82-1.31).

Study details: This was a meta-analysis of nine studies involving 938 patients with inoperable HCC and PVTT who received SBRT plus TACE (n = 455) or monotherapy (n = 483).

Disclosures: The study was sponsored by Chinese Medical Hand in Hand Project Committee & Beijing Medical Award Foundation, among others. The authors declared no conflicts of interest.

Source: Zhang X-F et al. Stereotactic body radiotherapy plus transcatheter arterial chemoembolization for inoperable hepatocellular carcinoma patients with portal vein tumour thrombus: A meta-analysis. PLoS One. 2022;17(5): e0268779 (May 20). Doi: 10.1371/journal.pone.0268779

Key clinical point: Atezolizumab plus bevacizumab (Atez/Bev) shows potent therapeutic efficacy against unresectable hepatocellular carcinoma (uHCC) in patients with a good hepatic function, classified as Child-Pugh A (CP-A), but has decreased efficacy in those with CP-B.

Major finding: Patients with CP-A vs. CP-B showed better 6-, 12-, and 18-month progression-free (58.2%, 36.1%, and 27.8% vs. 49.6%, 8.7%, and non-estimable, respectively; P < .001) and overall (89.9%, 71.7%, and 51.4% vs. 63.6%, 18.4%, and non-estimable, respectively; P < .001) survival rates.

Study details: This retrospective study included 457 patients with uHCC and CP-A (n = 427) or CP-B (n = 30) who received Atez/Bev.

Disclosures: This study received no financial support. Some authors declared serving as advisors for and receiving lecture fees or research funds from various sources. Two authors declared serving as editors/editorial board members of Liver Cancer.

Source: Tanaka T et al. Therapeutic efficacy of atezolizumab plus bevacizumab treatment for unresectable hepatocellular carcinoma in patients with Child-Pugh class A or B liver function in real-world clinical practice. Hepatol Res. 2022 (May 28). Doi: 10.1111/hepr.13797

Key clinical point: Atezolizumab plus bevacizumab (Atez/Bev) shows potent therapeutic efficacy against unresectable hepatocellular carcinoma (uHCC) in patients with a good hepatic function, classified as Child-Pugh A (CP-A), but has decreased efficacy in those with CP-B.

Major finding: Patients with CP-A vs. CP-B showed better 6-, 12-, and 18-month progression-free (58.2%, 36.1%, and 27.8% vs. 49.6%, 8.7%, and non-estimable, respectively; P < .001) and overall (89.9%, 71.7%, and 51.4% vs. 63.6%, 18.4%, and non-estimable, respectively; P < .001) survival rates.

Study details: This retrospective study included 457 patients with uHCC and CP-A (n = 427) or CP-B (n = 30) who received Atez/Bev.

Disclosures: This study received no financial support. Some authors declared serving as advisors for and receiving lecture fees or research funds from various sources. Two authors declared serving as editors/editorial board members of Liver Cancer.

Source: Tanaka T et al. Therapeutic efficacy of atezolizumab plus bevacizumab treatment for unresectable hepatocellular carcinoma in patients with Child-Pugh class A or B liver function in real-world clinical practice. Hepatol Res. 2022 (May 28). Doi: 10.1111/hepr.13797

Key clinical point: Atezolizumab plus bevacizumab (Atez/Bev) shows potent therapeutic efficacy against unresectable hepatocellular carcinoma (uHCC) in patients with a good hepatic function, classified as Child-Pugh A (CP-A), but has decreased efficacy in those with CP-B.

Major finding: Patients with CP-A vs. CP-B showed better 6-, 12-, and 18-month progression-free (58.2%, 36.1%, and 27.8% vs. 49.6%, 8.7%, and non-estimable, respectively; P < .001) and overall (89.9%, 71.7%, and 51.4% vs. 63.6%, 18.4%, and non-estimable, respectively; P < .001) survival rates.

Study details: This retrospective study included 457 patients with uHCC and CP-A (n = 427) or CP-B (n = 30) who received Atez/Bev.

Disclosures: This study received no financial support. Some authors declared serving as advisors for and receiving lecture fees or research funds from various sources. Two authors declared serving as editors/editorial board members of Liver Cancer.

Source: Tanaka T et al. Therapeutic efficacy of atezolizumab plus bevacizumab treatment for unresectable hepatocellular carcinoma in patients with Child-Pugh class A or B liver function in real-world clinical practice. Hepatol Res. 2022 (May 28). Doi: 10.1111/hepr.13797

Key clinical point: Therapy with atezolizumab plus bevacizumab (Atez/Bev) vs. lenvatinib in the first-line setting may confer a survival benefit in patients with unresectable hepatocellular carcinoma (uHCC).

Major finding: Patients receiving Atez/Bev vs. lenvatinib showed better overall survival (1 year: 67.2% vs. 66.2%; 1.5 years: 58.1% vs. 52.7%; P = .002) and progression-free survival (1 year: 31.6% vs. 20.4%; 1.5 years: non-estimable vs. 11.2%; P < .0001) rates.

Study details: This retrospective study included 251 systemic treatment-naive patients with uHCC who received standard-dose Atez/Bev (n = 194) or lenvatinib (n = 57).

Disclosures: The study did not receive any funding. Some authors declared serving as advisors or receiving lecture fees or research funding from various sources.

Source: Hiraoka A et al. Does first-line treatment have prognostic impact for unresectable HCC?—Atezolizumab plus bevacizumab versus lenvatinib .Cancer Med. 2022 (Jun 3). Doi: 10.1002/cam4.4854

Key clinical point: Therapy with atezolizumab plus bevacizumab (Atez/Bev) vs. lenvatinib in the first-line setting may confer a survival benefit in patients with unresectable hepatocellular carcinoma (uHCC).

Major finding: Patients receiving Atez/Bev vs. lenvatinib showed better overall survival (1 year: 67.2% vs. 66.2%; 1.5 years: 58.1% vs. 52.7%; P = .002) and progression-free survival (1 year: 31.6% vs. 20.4%; 1.5 years: non-estimable vs. 11.2%; P < .0001) rates.

Study details: This retrospective study included 251 systemic treatment-naive patients with uHCC who received standard-dose Atez/Bev (n = 194) or lenvatinib (n = 57).

Disclosures: The study did not receive any funding. Some authors declared serving as advisors or receiving lecture fees or research funding from various sources.

Source: Hiraoka A et al. Does first-line treatment have prognostic impact for unresectable HCC?—Atezolizumab plus bevacizumab versus lenvatinib .Cancer Med. 2022 (Jun 3). Doi: 10.1002/cam4.4854

Key clinical point: Therapy with atezolizumab plus bevacizumab (Atez/Bev) vs. lenvatinib in the first-line setting may confer a survival benefit in patients with unresectable hepatocellular carcinoma (uHCC).

Major finding: Patients receiving Atez/Bev vs. lenvatinib showed better overall survival (1 year: 67.2% vs. 66.2%; 1.5 years: 58.1% vs. 52.7%; P = .002) and progression-free survival (1 year: 31.6% vs. 20.4%; 1.5 years: non-estimable vs. 11.2%; P < .0001) rates.

Study details: This retrospective study included 251 systemic treatment-naive patients with uHCC who received standard-dose Atez/Bev (n = 194) or lenvatinib (n = 57).

Disclosures: The study did not receive any funding. Some authors declared serving as advisors or receiving lecture fees or research funding from various sources.

Source: Hiraoka A et al. Does first-line treatment have prognostic impact for unresectable HCC?—Atezolizumab plus bevacizumab versus lenvatinib .Cancer Med. 2022 (Jun 3). Doi: 10.1002/cam4.4854

Key clinical point: Nivolumab may serve as a first-line systemic treatment option in patients with hepatocellular carcinoma (HCC) and Child-Pugh B (CP-B) cirrhosis.

Major finding: Patients receiving nivolumab vs. sorafenib had a 31% reduced hazard of death (adjusted hazard ratio 0.69; P = .008) and were less likely to discontinue treatment due to toxicity (12% vs. 36%; P = .001).

Study details: The data come from a retrospective real-world cohort study that included patients with HCC and CP-B cirrhosis who received nivolumab (n = 79) or sorafenib (n = 431) as the first-line systemic treatment.

Disclosures: The study was funded by the US National Institutes of Health. Some authors declared serving on the advisory boards of or receiving honoraria or research grants from various sources.

Source: Chapin WJ et al. Comparison of nivolumab and sorafenib for first systemic therapy in patients with hepatocellular carcinoma and Child-Pugh B cirrhosis. Cancer Med. 2022 (Jun 2). Doi:   10.1002/cam4.4906

Key clinical point: Nivolumab may serve as a first-line systemic treatment option in patients with hepatocellular carcinoma (HCC) and Child-Pugh B (CP-B) cirrhosis.

Major finding: Patients receiving nivolumab vs. sorafenib had a 31% reduced hazard of death (adjusted hazard ratio 0.69; P = .008) and were less likely to discontinue treatment due to toxicity (12% vs. 36%; P = .001).

Study details: The data come from a retrospective real-world cohort study that included patients with HCC and CP-B cirrhosis who received nivolumab (n = 79) or sorafenib (n = 431) as the first-line systemic treatment.

Disclosures: The study was funded by the US National Institutes of Health. Some authors declared serving on the advisory boards of or receiving honoraria or research grants from various sources.

Source: Chapin WJ et al. Comparison of nivolumab and sorafenib for first systemic therapy in patients with hepatocellular carcinoma and Child-Pugh B cirrhosis. Cancer Med. 2022 (Jun 2). Doi:   10.1002/cam4.4906

Key clinical point: Nivolumab may serve as a first-line systemic treatment option in patients with hepatocellular carcinoma (HCC) and Child-Pugh B (CP-B) cirrhosis.

Major finding: Patients receiving nivolumab vs. sorafenib had a 31% reduced hazard of death (adjusted hazard ratio 0.69; P = .008) and were less likely to discontinue treatment due to toxicity (12% vs. 36%; P = .001).

Study details: The data come from a retrospective real-world cohort study that included patients with HCC and CP-B cirrhosis who received nivolumab (n = 79) or sorafenib (n = 431) as the first-line systemic treatment.

Disclosures: The study was funded by the US National Institutes of Health. Some authors declared serving on the advisory boards of or receiving honoraria or research grants from various sources.

Source: Chapin WJ et al. Comparison of nivolumab and sorafenib for first systemic therapy in patients with hepatocellular carcinoma and Child-Pugh B cirrhosis. Cancer Med. 2022 (Jun 2). Doi:   10.1002/cam4.4906