Key clinical point: The presence of nonalcoholic fatty liver disease (NAFLD) or metabolic syndrome (MS) did not affect the long-term oncological outcomes in patients with hepatocellular carcinoma (HCC) treated with multibipolar percutaneous radiofrequency ablation (RFA).

Major finding: Neither NAFLD-HCC nor MS was associated with overall tumor recurrence (hazard ratio [HR], 1.12; P = .536 and HR, 0.99; P = .965, respectively) or overall survival (HR, 1.19; P = .45 and HR, 0.99; P = .980, respectively).

Study details: This multicenter retrospective study included 520 adult patients with HCC who underwent first-line multibipolar percutaneous RFA treatment.

Disclosures: The study did not receive any specific funding. T Dao, N Ganne-Carrié, and JC Nault reported receiving grants, speaker’s fees, personal fees, or invitations for medical meetings from various pharmaceutical companies.

Source: Nguyen N et al. Liver Int. 2021 Dec 11. doi: 10.1111/liv.15129.

Key clinical point: The presence of nonalcoholic fatty liver disease (NAFLD) or metabolic syndrome (MS) did not affect the long-term oncological outcomes in patients with hepatocellular carcinoma (HCC) treated with multibipolar percutaneous radiofrequency ablation (RFA).

Major finding: Neither NAFLD-HCC nor MS was associated with overall tumor recurrence (hazard ratio [HR], 1.12; P = .536 and HR, 0.99; P = .965, respectively) or overall survival (HR, 1.19; P = .45 and HR, 0.99; P = .980, respectively).

Study details: This multicenter retrospective study included 520 adult patients with HCC who underwent first-line multibipolar percutaneous RFA treatment.

Disclosures: The study did not receive any specific funding. T Dao, N Ganne-Carrié, and JC Nault reported receiving grants, speaker’s fees, personal fees, or invitations for medical meetings from various pharmaceutical companies.

Source: Nguyen N et al. Liver Int. 2021 Dec 11. doi: 10.1111/liv.15129.

Key clinical point: The presence of nonalcoholic fatty liver disease (NAFLD) or metabolic syndrome (MS) did not affect the long-term oncological outcomes in patients with hepatocellular carcinoma (HCC) treated with multibipolar percutaneous radiofrequency ablation (RFA).

Major finding: Neither NAFLD-HCC nor MS was associated with overall tumor recurrence (hazard ratio [HR], 1.12; P = .536 and HR, 0.99; P = .965, respectively) or overall survival (HR, 1.19; P = .45 and HR, 0.99; P = .980, respectively).

Study details: This multicenter retrospective study included 520 adult patients with HCC who underwent first-line multibipolar percutaneous RFA treatment.

Disclosures: The study did not receive any specific funding. T Dao, N Ganne-Carrié, and JC Nault reported receiving grants, speaker’s fees, personal fees, or invitations for medical meetings from various pharmaceutical companies.

Source: Nguyen N et al. Liver Int. 2021 Dec 11. doi: 10.1111/liv.15129.

Key clinical point: Treatment with immune checkpoint inhibitors (ICIs) was associated with prolonged survival and better safety compared with standard care in patients with unresectable hepatocellular carcinoma (HCC).

Major finding: ICIs vs standard care were associated with superior overall survival (hazard ratio [HR], 0.75; P = .006), progression-free survival (HR, 0.74; P = .03), and overall response rate (odds ratio [OR], 2.82; P < .001) and lower odds of grade 3 or 4 treatment-related adverse events (OR, 0.44; P = .04).

Study details: Findings are from a meta-analysis of 3 randomized controlled trials (KEYNOTE-240, CheckMate-459, and IMbrave150), including 1,657 patients with unresectable HCC treated with either ICIs (n=985) or standard care (n=672).

Disclosures: No source of funding was identified. The lead author and JPS Vasconcelos received grants and/or personal fees from various pharmaceutical companies.

Source: Jácome AA et al. JAMA Netw Open. 2021 Dec 6. doi: 10.1001/jamanetworkopen.2021.36128.

Key clinical point: Treatment with immune checkpoint inhibitors (ICIs) was associated with prolonged survival and better safety compared with standard care in patients with unresectable hepatocellular carcinoma (HCC).

Major finding: ICIs vs standard care were associated with superior overall survival (hazard ratio [HR], 0.75; P = .006), progression-free survival (HR, 0.74; P = .03), and overall response rate (odds ratio [OR], 2.82; P < .001) and lower odds of grade 3 or 4 treatment-related adverse events (OR, 0.44; P = .04).

Study details: Findings are from a meta-analysis of 3 randomized controlled trials (KEYNOTE-240, CheckMate-459, and IMbrave150), including 1,657 patients with unresectable HCC treated with either ICIs (n=985) or standard care (n=672).

Disclosures: No source of funding was identified. The lead author and JPS Vasconcelos received grants and/or personal fees from various pharmaceutical companies.

Source: Jácome AA et al. JAMA Netw Open. 2021 Dec 6. doi: 10.1001/jamanetworkopen.2021.36128.

Key clinical point: Treatment with immune checkpoint inhibitors (ICIs) was associated with prolonged survival and better safety compared with standard care in patients with unresectable hepatocellular carcinoma (HCC).

Major finding: ICIs vs standard care were associated with superior overall survival (hazard ratio [HR], 0.75; P = .006), progression-free survival (HR, 0.74; P = .03), and overall response rate (odds ratio [OR], 2.82; P < .001) and lower odds of grade 3 or 4 treatment-related adverse events (OR, 0.44; P = .04).

Study details: Findings are from a meta-analysis of 3 randomized controlled trials (KEYNOTE-240, CheckMate-459, and IMbrave150), including 1,657 patients with unresectable HCC treated with either ICIs (n=985) or standard care (n=672).

Disclosures: No source of funding was identified. The lead author and JPS Vasconcelos received grants and/or personal fees from various pharmaceutical companies.

Source: Jácome AA et al. JAMA Netw Open. 2021 Dec 6. doi: 10.1001/jamanetworkopen.2021.36128.

Key clinical point: The better safety profile of transarterial radioembolization (TARE) together with comparable efficacy makes it a potential therapeutic alternative to surgical resection for large single nodular hepatocellular carcinoma (HCC).

Main finding: After inverse probability weighting, TARE vs surgical resection achieved similar overall survival (hazard ratio [HR], 0.98; P = .97), time to progression (HR, 1.10; P = .80), and time to intrahepatic progression (HR, 1.45; P = .30), along with a shorter hospital stay (3 days vs 12 days; P < .001) and lower patient proportion experiencing adverse events requiring intervention (0.0% vs 3.2%; P = .39).

Study details: Findings are from a retrospective cohort study including 557 adult patients with single nodular HCC measuring ≥5 cm who underwent either surgical resection (n=500) or TARE (n=57) shortly after diagnosis.

Disclosures: The authors reported no source of funding. Some of the authors received lecture fees or research grants from various sources.

Source: Kim J et al. J Nucl Med. 2021 Dec 9. doi: 10.2967/jnumed.121.263147.

Key clinical point: The better safety profile of transarterial radioembolization (TARE) together with comparable efficacy makes it a potential therapeutic alternative to surgical resection for large single nodular hepatocellular carcinoma (HCC).

Main finding: After inverse probability weighting, TARE vs surgical resection achieved similar overall survival (hazard ratio [HR], 0.98; P = .97), time to progression (HR, 1.10; P = .80), and time to intrahepatic progression (HR, 1.45; P = .30), along with a shorter hospital stay (3 days vs 12 days; P < .001) and lower patient proportion experiencing adverse events requiring intervention (0.0% vs 3.2%; P = .39).

Study details: Findings are from a retrospective cohort study including 557 adult patients with single nodular HCC measuring ≥5 cm who underwent either surgical resection (n=500) or TARE (n=57) shortly after diagnosis.

Disclosures: The authors reported no source of funding. Some of the authors received lecture fees or research grants from various sources.

Source: Kim J et al. J Nucl Med. 2021 Dec 9. doi: 10.2967/jnumed.121.263147.

Key clinical point: The better safety profile of transarterial radioembolization (TARE) together with comparable efficacy makes it a potential therapeutic alternative to surgical resection for large single nodular hepatocellular carcinoma (HCC).

Main finding: After inverse probability weighting, TARE vs surgical resection achieved similar overall survival (hazard ratio [HR], 0.98; P = .97), time to progression (HR, 1.10; P = .80), and time to intrahepatic progression (HR, 1.45; P = .30), along with a shorter hospital stay (3 days vs 12 days; P < .001) and lower patient proportion experiencing adverse events requiring intervention (0.0% vs 3.2%; P = .39).

Study details: Findings are from a retrospective cohort study including 557 adult patients with single nodular HCC measuring ≥5 cm who underwent either surgical resection (n=500) or TARE (n=57) shortly after diagnosis.

Disclosures: The authors reported no source of funding. Some of the authors received lecture fees or research grants from various sources.

Source: Kim J et al. J Nucl Med. 2021 Dec 9. doi: 10.2967/jnumed.121.263147.

Key clinical point: Alpha-fetoprotein (AFP) levels during liver transplantation (LT) and their modulation while on the waitlist are predictors of hepatocellular carcinoma (HCC) recurrence after LT in patients meeting the Milan criteria.

Main finding: An AFP value >25.5 ng/mL (area under the receiver operating characteristic curve, 0.69) could strongly predict HCC recurrence after LT (subdistribution hazard ratio, 2.5; P = .01), which also showed a significant association with an increase in AFP levels by >20.8% while on the waitlist (P = .034).

Study details: The data are derived from a retrospective single-center study that analyzed 207 patients with HCC fulfilling the Milan criteria who were put on the waitlist for LT and had AFP levels >400 ng/mL at transplant.

Disclosures: Financial support for the study was provided by the association Friends of transplantation. The authors reported no conflict of interests.

Source: Magro B et al. Cancers. 2021 Nov 27. doi: 10.3390/cancers13235976.

Key clinical point: Alpha-fetoprotein (AFP) levels during liver transplantation (LT) and their modulation while on the waitlist are predictors of hepatocellular carcinoma (HCC) recurrence after LT in patients meeting the Milan criteria.

Main finding: An AFP value >25.5 ng/mL (area under the receiver operating characteristic curve, 0.69) could strongly predict HCC recurrence after LT (subdistribution hazard ratio, 2.5; P = .01), which also showed a significant association with an increase in AFP levels by >20.8% while on the waitlist (P = .034).

Study details: The data are derived from a retrospective single-center study that analyzed 207 patients with HCC fulfilling the Milan criteria who were put on the waitlist for LT and had AFP levels >400 ng/mL at transplant.

Disclosures: Financial support for the study was provided by the association Friends of transplantation. The authors reported no conflict of interests.

Source: Magro B et al. Cancers. 2021 Nov 27. doi: 10.3390/cancers13235976.

Key clinical point: Alpha-fetoprotein (AFP) levels during liver transplantation (LT) and their modulation while on the waitlist are predictors of hepatocellular carcinoma (HCC) recurrence after LT in patients meeting the Milan criteria.

Main finding: An AFP value >25.5 ng/mL (area under the receiver operating characteristic curve, 0.69) could strongly predict HCC recurrence after LT (subdistribution hazard ratio, 2.5; P = .01), which also showed a significant association with an increase in AFP levels by >20.8% while on the waitlist (P = .034).

Study details: The data are derived from a retrospective single-center study that analyzed 207 patients with HCC fulfilling the Milan criteria who were put on the waitlist for LT and had AFP levels >400 ng/mL at transplant.

Disclosures: Financial support for the study was provided by the association Friends of transplantation. The authors reported no conflict of interests.

Source: Magro B et al. Cancers. 2021 Nov 27. doi: 10.3390/cancers13235976.

Key clinical point: High diastolic whole blood viscosity (WBV) may serve as a new independent factor associated with extrahepatic metastasis and poor survival in patients with hepatocellular carcinoma (HCC).

Main finding: After adjusting for confounding variables, high diastolic WBV was independently associated with extrahepatic metastasis (adjusted odds ratio, 23.41; P < .001) and poor survival (adjusted hazard ratio, 3.81; P < .001) and significantly predicted extrahepatic metastasis at an optimal cutoff of 16 cP (area under the receiver operating characteristic curve, 0.768; P < .001).

Study details: Findings are from a pilot retrospective study including 181 patients with HCC, of which 148 were treatment-naïve having preserved liver function and 33 received nivolumab.

Disclosures: The study was sponsored by Young Medical Scientist Research Grant through the Daewoong Foundation and the Research Fund of Seoul St. Mary’s Hospital, The Catholic University of Korea. The authors did not declare any conflict of interests.

Source: Han JW et al. PLoS ONE. 2021 Dec 2. doi: 10.1371/journal.pone.0260311.

Key clinical point: High diastolic whole blood viscosity (WBV) may serve as a new independent factor associated with extrahepatic metastasis and poor survival in patients with hepatocellular carcinoma (HCC).

Main finding: After adjusting for confounding variables, high diastolic WBV was independently associated with extrahepatic metastasis (adjusted odds ratio, 23.41; P < .001) and poor survival (adjusted hazard ratio, 3.81; P < .001) and significantly predicted extrahepatic metastasis at an optimal cutoff of 16 cP (area under the receiver operating characteristic curve, 0.768; P < .001).

Study details: Findings are from a pilot retrospective study including 181 patients with HCC, of which 148 were treatment-naïve having preserved liver function and 33 received nivolumab.

Disclosures: The study was sponsored by Young Medical Scientist Research Grant through the Daewoong Foundation and the Research Fund of Seoul St. Mary’s Hospital, The Catholic University of Korea. The authors did not declare any conflict of interests.

Source: Han JW et al. PLoS ONE. 2021 Dec 2. doi: 10.1371/journal.pone.0260311.

Key clinical point: High diastolic whole blood viscosity (WBV) may serve as a new independent factor associated with extrahepatic metastasis and poor survival in patients with hepatocellular carcinoma (HCC).

Main finding: After adjusting for confounding variables, high diastolic WBV was independently associated with extrahepatic metastasis (adjusted odds ratio, 23.41; P < .001) and poor survival (adjusted hazard ratio, 3.81; P < .001) and significantly predicted extrahepatic metastasis at an optimal cutoff of 16 cP (area under the receiver operating characteristic curve, 0.768; P < .001).

Study details: Findings are from a pilot retrospective study including 181 patients with HCC, of which 148 were treatment-naïve having preserved liver function and 33 received nivolumab.

Disclosures: The study was sponsored by Young Medical Scientist Research Grant through the Daewoong Foundation and the Research Fund of Seoul St. Mary’s Hospital, The Catholic University of Korea. The authors did not declare any conflict of interests.

Source: Han JW et al. PLoS ONE. 2021 Dec 2. doi: 10.1371/journal.pone.0260311.

Key clinical point: The modified Response Evaluation Criteria in Solid Tumors (mRECIST)-determined radiologic response rate of transarterial chemoembolization (TACE) plus radiotherapy (RT) among patients with advanced hepatocellular carcinoma (HCC) showing macroscopic vascular invasion (MVI) is an independent prognosticator for overall survival (OS).

Main finding: Responders vs nonresponders had significantly longer median OS at 2 months (23.1 months vs 8.0 months; adjusted hazard ratio [aHR], 3.194; P < .001) and 4 months (responders vs nonresponders: 26.5 months vs 9.3 months; aHR, 4.534; P < .001).

Study details: This was a retrospective review study including 427 patients with advanced HCC and MVI who received first-line treatment with TACE plus respiratory-gated 3-dimensional conformal RT in the 2-month analysis, whereas the patient number reduced to 355 in the 4-month analysis.

Disclosures: The study was supported by the Asan Institute for Life Sciences of Asan Medical Center, Seoul, Republic of Korea. The authors declared no conflict of interests.

Source: Jung J et al. Liver Cancer. 2021 Dec 7. doi: 10.1159/000521227.

Key clinical point: The modified Response Evaluation Criteria in Solid Tumors (mRECIST)-determined radiologic response rate of transarterial chemoembolization (TACE) plus radiotherapy (RT) among patients with advanced hepatocellular carcinoma (HCC) showing macroscopic vascular invasion (MVI) is an independent prognosticator for overall survival (OS).

Main finding: Responders vs nonresponders had significantly longer median OS at 2 months (23.1 months vs 8.0 months; adjusted hazard ratio [aHR], 3.194; P < .001) and 4 months (responders vs nonresponders: 26.5 months vs 9.3 months; aHR, 4.534; P < .001).

Study details: This was a retrospective review study including 427 patients with advanced HCC and MVI who received first-line treatment with TACE plus respiratory-gated 3-dimensional conformal RT in the 2-month analysis, whereas the patient number reduced to 355 in the 4-month analysis.

Disclosures: The study was supported by the Asan Institute for Life Sciences of Asan Medical Center, Seoul, Republic of Korea. The authors declared no conflict of interests.

Source: Jung J et al. Liver Cancer. 2021 Dec 7. doi: 10.1159/000521227.

Key clinical point: The modified Response Evaluation Criteria in Solid Tumors (mRECIST)-determined radiologic response rate of transarterial chemoembolization (TACE) plus radiotherapy (RT) among patients with advanced hepatocellular carcinoma (HCC) showing macroscopic vascular invasion (MVI) is an independent prognosticator for overall survival (OS).

Main finding: Responders vs nonresponders had significantly longer median OS at 2 months (23.1 months vs 8.0 months; adjusted hazard ratio [aHR], 3.194; P < .001) and 4 months (responders vs nonresponders: 26.5 months vs 9.3 months; aHR, 4.534; P < .001).

Study details: This was a retrospective review study including 427 patients with advanced HCC and MVI who received first-line treatment with TACE plus respiratory-gated 3-dimensional conformal RT in the 2-month analysis, whereas the patient number reduced to 355 in the 4-month analysis.

Disclosures: The study was supported by the Asan Institute for Life Sciences of Asan Medical Center, Seoul, Republic of Korea. The authors declared no conflict of interests.

Source: Jung J et al. Liver Cancer. 2021 Dec 7. doi: 10.1159/000521227.

Key clinical point: Hepatic arterial infusion chemotherapy of infusional fluorouracil, leucovorin, and oxaliplatin (HAIC-FO) is better than sorafenib at improving survival in patients with locally advanced hepatocellular carcinoma (HCC).

Main finding: At a median follow-up of 17.1 and 19.8 months, HAIC-FO- and sorafenib-treated patients showed a median overall survival (OS) of 13.9 months (95% CI, 10.6-17.2) and 8.2 months (95% CI, 7.5-9.0), respectively (hazard ratio [HR], 0.408; P = .001), with OS improvements favoring HAIC-FO vs sorafenib in even high-risk patients (10.8 months vs 5.7 months; HR, 0.343; P < .001). Grade 3/4 adverse events were more frequent with sorafenib vs HAIC-FO (48.1% vs20.3%).

Study details: The data come from the open-label, phase 3 FOHAIC-1 trial, which included 262 systemic therapy-naive patients with locally advanced or unresectable HCC who were randomly assigned to receive either HAIC-FO (n=130) or sorafenib (n=132).

Disclosures: The National Natural Science Foundation of China sponsored the study. The authors did not report any potential conflict of interests.

Source: Lyu N et al. J Clin Oncol. 2021 Dec 14. doi: 10.1200/JCO.21.01963.

Key clinical point: Hepatic arterial infusion chemotherapy of infusional fluorouracil, leucovorin, and oxaliplatin (HAIC-FO) is better than sorafenib at improving survival in patients with locally advanced hepatocellular carcinoma (HCC).

Main finding: At a median follow-up of 17.1 and 19.8 months, HAIC-FO- and sorafenib-treated patients showed a median overall survival (OS) of 13.9 months (95% CI, 10.6-17.2) and 8.2 months (95% CI, 7.5-9.0), respectively (hazard ratio [HR], 0.408; P = .001), with OS improvements favoring HAIC-FO vs sorafenib in even high-risk patients (10.8 months vs 5.7 months; HR, 0.343; P < .001). Grade 3/4 adverse events were more frequent with sorafenib vs HAIC-FO (48.1% vs20.3%).

Study details: The data come from the open-label, phase 3 FOHAIC-1 trial, which included 262 systemic therapy-naive patients with locally advanced or unresectable HCC who were randomly assigned to receive either HAIC-FO (n=130) or sorafenib (n=132).

Disclosures: The National Natural Science Foundation of China sponsored the study. The authors did not report any potential conflict of interests.

Source: Lyu N et al. J Clin Oncol. 2021 Dec 14. doi: 10.1200/JCO.21.01963.

Key clinical point: Hepatic arterial infusion chemotherapy of infusional fluorouracil, leucovorin, and oxaliplatin (HAIC-FO) is better than sorafenib at improving survival in patients with locally advanced hepatocellular carcinoma (HCC).

Main finding: At a median follow-up of 17.1 and 19.8 months, HAIC-FO- and sorafenib-treated patients showed a median overall survival (OS) of 13.9 months (95% CI, 10.6-17.2) and 8.2 months (95% CI, 7.5-9.0), respectively (hazard ratio [HR], 0.408; P = .001), with OS improvements favoring HAIC-FO vs sorafenib in even high-risk patients (10.8 months vs 5.7 months; HR, 0.343; P < .001). Grade 3/4 adverse events were more frequent with sorafenib vs HAIC-FO (48.1% vs20.3%).

Study details: The data come from the open-label, phase 3 FOHAIC-1 trial, which included 262 systemic therapy-naive patients with locally advanced or unresectable HCC who were randomly assigned to receive either HAIC-FO (n=130) or sorafenib (n=132).

Disclosures: The National Natural Science Foundation of China sponsored the study. The authors did not report any potential conflict of interests.

Source: Lyu N et al. J Clin Oncol. 2021 Dec 14. doi: 10.1200/JCO.21.01963.

Key clinical point: Longer follow-up results confirm the survival benefits and consistent safety of first-line atezolizumab + bevacizumab vs sorafenib in patients with locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC).

Major finding: After a 15.6-month median follow-up, the median overall survival (19.2 months vs 13.4 months; stratified hazard ratio [HR] for death, 0.66; P < .001) and progression-free survival (6.9 months vs 4.3 months; HR for death/progression, 0.65; P < .001) were higher with atezolizumab + bevacizumab vs sorafenib. Treatment-related grade 3/4 adverse events occurred in 43% vs 46% of patients receiving atezolizumab + bevacizumab vs sorafenib.

Study details: Findings are from a post hoc analysis of the phase 3 IMbrave150 trial including 501 treatment-naïve patients with locally advanced or metastatic and/or unresectable HCC. Patients were randomly assigned to atezolizumab + bevacizumab or sorafenib.

Disclosures: This study was funded by F. Hoffman-La Roche (FHLR)/Genentech. All investigators reported receiving financial or nonfinancial support, providing expert testimony, being an employee of, or holding shares/stocks in various pharmaceutical companies including FHLR/Genentech.

Source: Cheng AL et al. J Hepatol. 2021 Dec 10. doi: 10.1016/j.jhep.2021.11.030.

Key clinical point: Longer follow-up results confirm the survival benefits and consistent safety of first-line atezolizumab + bevacizumab vs sorafenib in patients with locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC).

Major finding: After a 15.6-month median follow-up, the median overall survival (19.2 months vs 13.4 months; stratified hazard ratio [HR] for death, 0.66; P < .001) and progression-free survival (6.9 months vs 4.3 months; HR for death/progression, 0.65; P < .001) were higher with atezolizumab + bevacizumab vs sorafenib. Treatment-related grade 3/4 adverse events occurred in 43% vs 46% of patients receiving atezolizumab + bevacizumab vs sorafenib.

Study details: Findings are from a post hoc analysis of the phase 3 IMbrave150 trial including 501 treatment-naïve patients with locally advanced or metastatic and/or unresectable HCC. Patients were randomly assigned to atezolizumab + bevacizumab or sorafenib.

Disclosures: This study was funded by F. Hoffman-La Roche (FHLR)/Genentech. All investigators reported receiving financial or nonfinancial support, providing expert testimony, being an employee of, or holding shares/stocks in various pharmaceutical companies including FHLR/Genentech.

Source: Cheng AL et al. J Hepatol. 2021 Dec 10. doi: 10.1016/j.jhep.2021.11.030.

Key clinical point: Longer follow-up results confirm the survival benefits and consistent safety of first-line atezolizumab + bevacizumab vs sorafenib in patients with locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC).

Major finding: After a 15.6-month median follow-up, the median overall survival (19.2 months vs 13.4 months; stratified hazard ratio [HR] for death, 0.66; P < .001) and progression-free survival (6.9 months vs 4.3 months; HR for death/progression, 0.65; P < .001) were higher with atezolizumab + bevacizumab vs sorafenib. Treatment-related grade 3/4 adverse events occurred in 43% vs 46% of patients receiving atezolizumab + bevacizumab vs sorafenib.

Study details: Findings are from a post hoc analysis of the phase 3 IMbrave150 trial including 501 treatment-naïve patients with locally advanced or metastatic and/or unresectable HCC. Patients were randomly assigned to atezolizumab + bevacizumab or sorafenib.

Disclosures: This study was funded by F. Hoffman-La Roche (FHLR)/Genentech. All investigators reported receiving financial or nonfinancial support, providing expert testimony, being an employee of, or holding shares/stocks in various pharmaceutical companies including FHLR/Genentech.

Source: Cheng AL et al. J Hepatol. 2021 Dec 10. doi: 10.1016/j.jhep.2021.11.030.

Key clinical point: First-line nivolumab treatment did not improve overall survival in patients with advanced hepatocellular carcinoma (HCC) compared with sorafenib.

Major finding: At a minimum follow-up of 22.8 months, nivolumab vs sorafenib did not meet the prespecified significance boundary for superior overall survival (16.4 months vs 14.7 months; hazard ratio, 0.85; P = .075).

Study details: Findings are from the phase 3 CheckMate 459 trial including 743 adult patients with advanced HCC randomly assigned to receive either nivolumab (n=371) or sorafenib (n=372).

Disclosures: This study was supported by Bristol Myers Squibb (BMS) and Ono Pharmaceutical. Some investigators including the lead author reported receiving grants and fees from, participation on data safety monitoring board or advisory boards for, owning stocks in, and being an employee of various pharmaceutical companies, including BMS and Ono Pharmaceutical.

Source: Yau T et al. Lancet Oncol. 2021 Dec 13. doi: 10.1016/S1470-2045(21)00604-5.

Key clinical point: First-line nivolumab treatment did not improve overall survival in patients with advanced hepatocellular carcinoma (HCC) compared with sorafenib.

Major finding: At a minimum follow-up of 22.8 months, nivolumab vs sorafenib did not meet the prespecified significance boundary for superior overall survival (16.4 months vs 14.7 months; hazard ratio, 0.85; P = .075).

Study details: Findings are from the phase 3 CheckMate 459 trial including 743 adult patients with advanced HCC randomly assigned to receive either nivolumab (n=371) or sorafenib (n=372).

Disclosures: This study was supported by Bristol Myers Squibb (BMS) and Ono Pharmaceutical. Some investigators including the lead author reported receiving grants and fees from, participation on data safety monitoring board or advisory boards for, owning stocks in, and being an employee of various pharmaceutical companies, including BMS and Ono Pharmaceutical.

Source: Yau T et al. Lancet Oncol. 2021 Dec 13. doi: 10.1016/S1470-2045(21)00604-5.

Key clinical point: First-line nivolumab treatment did not improve overall survival in patients with advanced hepatocellular carcinoma (HCC) compared with sorafenib.

Major finding: At a minimum follow-up of 22.8 months, nivolumab vs sorafenib did not meet the prespecified significance boundary for superior overall survival (16.4 months vs 14.7 months; hazard ratio, 0.85; P = .075).

Study details: Findings are from the phase 3 CheckMate 459 trial including 743 adult patients with advanced HCC randomly assigned to receive either nivolumab (n=371) or sorafenib (n=372).

Disclosures: This study was supported by Bristol Myers Squibb (BMS) and Ono Pharmaceutical. Some investigators including the lead author reported receiving grants and fees from, participation on data safety monitoring board or advisory boards for, owning stocks in, and being an employee of various pharmaceutical companies, including BMS and Ono Pharmaceutical.

Source: Yau T et al. Lancet Oncol. 2021 Dec 13. doi: 10.1016/S1470-2045(21)00604-5.

A steroid-free clinical response had no impact on multiple components of Crohn’s disease progression, based on data from 95 adults.

The therapeutic goals of Crohn’s disease have evolved from controlling symptoms to blocking disease progression and reducing complications, wrote David Laharie, MD, of Hôpital Haut-Lévêque, Pessac, France, and colleagues. The goal of steroid-free remission has been used as an endpoint of treatment, but data on the impact of such remission on long-term disease are limited, the researchers noted in a retrospective study published in Clinical Gastroenterology and Hepatology.

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In the study, the researchers reviewed data from 95 adults with early Crohn’s disease (CD) who participated in the TAILORIX trial involving treatment with infliximab and immunosuppressants. The primary endpoint of the TAILORIX trial was sustained corticosteroid-free remission from week 22 to 54. In the current study, the primary endpoint was progression-free survival at 1, 3, and 5 years in patients who did or did not meet the TAILORIX primary endpoint. The median disease duration was 4.5 months, and the median follow-up was 64.2 months.

Progression-free survival was defined as a composite of luminal surgery, anal surgery, hospitalization, and the need for a new CD treatment during the follow-up period.

In the study population, 45 patients achieved corticosteroid-free remission and 50 did not. At 54 weeks, 17 patients with corticosteroid-free remission (38%) and 28 patients without remission (56%) achieved complete mucosal healing, and progression-free survival rates were similar between these groups.

Overall, the rates of progression-free survival at 1, 3, and 5 years were not significantly different between the remission and nonremission groups: 86% versus 91%, respectively, at 1 year; 70% for both groups at 3 years; and 64% and 61%, respectively, at 5 years.

The researchers also compared individual components of the primary endpoint (luminal surgery, anal surgery, hospitalization, and the need for a new CD treatment), and found no significant differences in survival rates in patients who had and had not achieved steroid-free remission.

Survival rates without luminal surgery at 1, 3, and 5 years were 97% versus 96%, 93% versus 90%, and 87% versus 82%, respectively, for remission and nonremission groups. Similarly, survival rates without anal surgery were 93%, 86%, and 86% versus 96%, 88%, and 85%, respectively, for the two groups. Rates of hospitalization-free survival at 1, 3, and 5 years were 90% versus 92%, 81% versus 81%, and 78% versus 69%, respectively, in the remission and nonremission groups. Survival rates without a new systemic CD treatment also were similar at 1, 3, and 5 years: 93% versus 95%, 71% versus 93%, and 60% versus 51%, respectively, for the remission and nonremission groups.

CD progression was not associated with not achieving corticosteroid-free remission (hazard ratio, 0.861). Other factors that were not associated with disease progression in this study included CRP greater than 5 mg/L, age older than 30 years, active smoking, and B1 phenotype.

The researchers noted that, although endoscopic and clinical remission is currently recommended for CD, “there is no validated or standardized definition of this endoscopic goal.” The high rates of survival without major abdominal surgery, regardless of remission status, suggest a significant impact of early combination therapy for CD patients who were biologic naive. Other studies have shown similar improved outcomes for CD patients with early treatment.

The study findings were limited by several factors including the retrospective design and lack of power to compare long-term progression-free survival, the researchers noted. However, the results were strengthened by the robust data on hospitalizations and surgeries from the TAILORIX trial.

The results support a more flexible strategy for CD, “recommending endoscopic and clinical remission in early diagnosed patients and less stringent objectives in those with more refractory or advanced disease,” they concluded.
 

Findings may guide patient management

The current study is important to help clinicians know whether CD patients who achieve a short-term, steroid-free clinical and endoscopic remission go on to experience better long-term disease outcomes than those who do not achieve this short-term remission, Atsushi Sakuraba, MD, of the University of Chicago said in an interview.

Dr. Sakuraba said that he was surprised by the study findings. “Achieving a clinical remission off steroids with complete endoscopic remission, i.e., deep remission, is considered a treatment goal, but the fact that it did not result in less disease progression was surprising.”

The take-home message for clinicians from the study is that CD patients may still experience disease progression after achieving a single time of clinical and endoscopic remission “mainly due to loss of response to infliximab, so continued long-term disease monitoring and control are required,” Dr. Sakuraba said.

The current study was a post hoc follow-up analysis of a previous trial, Dr. Sakuraba noted. Therefore, studies primarily focused on changing the disease progression and natural course of CD are warranted.

Dr. Laharie disclosed counseling, boards, transportation, or fees from AbbVie, Biogaran, Biogen, Ferring, HAC-pharma, Janssen, MSD, Novartis, Pfizer, Prometheus, Roche, Takeda, Theradiag, and Tillots. Dr. Sakuraba had no relevant financial conflicts to disclose.

A steroid-free clinical response had no impact on multiple components of Crohn’s disease progression, based on data from 95 adults.

The therapeutic goals of Crohn’s disease have evolved from controlling symptoms to blocking disease progression and reducing complications, wrote David Laharie, MD, of Hôpital Haut-Lévêque, Pessac, France, and colleagues. The goal of steroid-free remission has been used as an endpoint of treatment, but data on the impact of such remission on long-term disease are limited, the researchers noted in a retrospective study published in Clinical Gastroenterology and Hepatology.

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In the study, the researchers reviewed data from 95 adults with early Crohn’s disease (CD) who participated in the TAILORIX trial involving treatment with infliximab and immunosuppressants. The primary endpoint of the TAILORIX trial was sustained corticosteroid-free remission from week 22 to 54. In the current study, the primary endpoint was progression-free survival at 1, 3, and 5 years in patients who did or did not meet the TAILORIX primary endpoint. The median disease duration was 4.5 months, and the median follow-up was 64.2 months.

Progression-free survival was defined as a composite of luminal surgery, anal surgery, hospitalization, and the need for a new CD treatment during the follow-up period.

In the study population, 45 patients achieved corticosteroid-free remission and 50 did not. At 54 weeks, 17 patients with corticosteroid-free remission (38%) and 28 patients without remission (56%) achieved complete mucosal healing, and progression-free survival rates were similar between these groups.

Overall, the rates of progression-free survival at 1, 3, and 5 years were not significantly different between the remission and nonremission groups: 86% versus 91%, respectively, at 1 year; 70% for both groups at 3 years; and 64% and 61%, respectively, at 5 years.

The researchers also compared individual components of the primary endpoint (luminal surgery, anal surgery, hospitalization, and the need for a new CD treatment), and found no significant differences in survival rates in patients who had and had not achieved steroid-free remission.

Survival rates without luminal surgery at 1, 3, and 5 years were 97% versus 96%, 93% versus 90%, and 87% versus 82%, respectively, for remission and nonremission groups. Similarly, survival rates without anal surgery were 93%, 86%, and 86% versus 96%, 88%, and 85%, respectively, for the two groups. Rates of hospitalization-free survival at 1, 3, and 5 years were 90% versus 92%, 81% versus 81%, and 78% versus 69%, respectively, in the remission and nonremission groups. Survival rates without a new systemic CD treatment also were similar at 1, 3, and 5 years: 93% versus 95%, 71% versus 93%, and 60% versus 51%, respectively, for the remission and nonremission groups.

CD progression was not associated with not achieving corticosteroid-free remission (hazard ratio, 0.861). Other factors that were not associated with disease progression in this study included CRP greater than 5 mg/L, age older than 30 years, active smoking, and B1 phenotype.

The researchers noted that, although endoscopic and clinical remission is currently recommended for CD, “there is no validated or standardized definition of this endoscopic goal.” The high rates of survival without major abdominal surgery, regardless of remission status, suggest a significant impact of early combination therapy for CD patients who were biologic naive. Other studies have shown similar improved outcomes for CD patients with early treatment.

The study findings were limited by several factors including the retrospective design and lack of power to compare long-term progression-free survival, the researchers noted. However, the results were strengthened by the robust data on hospitalizations and surgeries from the TAILORIX trial.

The results support a more flexible strategy for CD, “recommending endoscopic and clinical remission in early diagnosed patients and less stringent objectives in those with more refractory or advanced disease,” they concluded.
 

Findings may guide patient management

The current study is important to help clinicians know whether CD patients who achieve a short-term, steroid-free clinical and endoscopic remission go on to experience better long-term disease outcomes than those who do not achieve this short-term remission, Atsushi Sakuraba, MD, of the University of Chicago said in an interview.

Dr. Sakuraba said that he was surprised by the study findings. “Achieving a clinical remission off steroids with complete endoscopic remission, i.e., deep remission, is considered a treatment goal, but the fact that it did not result in less disease progression was surprising.”

The take-home message for clinicians from the study is that CD patients may still experience disease progression after achieving a single time of clinical and endoscopic remission “mainly due to loss of response to infliximab, so continued long-term disease monitoring and control are required,” Dr. Sakuraba said.

The current study was a post hoc follow-up analysis of a previous trial, Dr. Sakuraba noted. Therefore, studies primarily focused on changing the disease progression and natural course of CD are warranted.

Dr. Laharie disclosed counseling, boards, transportation, or fees from AbbVie, Biogaran, Biogen, Ferring, HAC-pharma, Janssen, MSD, Novartis, Pfizer, Prometheus, Roche, Takeda, Theradiag, and Tillots. Dr. Sakuraba had no relevant financial conflicts to disclose.

A steroid-free clinical response had no impact on multiple components of Crohn’s disease progression, based on data from 95 adults.

The therapeutic goals of Crohn’s disease have evolved from controlling symptoms to blocking disease progression and reducing complications, wrote David Laharie, MD, of Hôpital Haut-Lévêque, Pessac, France, and colleagues. The goal of steroid-free remission has been used as an endpoint of treatment, but data on the impact of such remission on long-term disease are limited, the researchers noted in a retrospective study published in Clinical Gastroenterology and Hepatology.

undefined undefined/iStock/Getty Images

In the study, the researchers reviewed data from 95 adults with early Crohn’s disease (CD) who participated in the TAILORIX trial involving treatment with infliximab and immunosuppressants. The primary endpoint of the TAILORIX trial was sustained corticosteroid-free remission from week 22 to 54. In the current study, the primary endpoint was progression-free survival at 1, 3, and 5 years in patients who did or did not meet the TAILORIX primary endpoint. The median disease duration was 4.5 months, and the median follow-up was 64.2 months.

Progression-free survival was defined as a composite of luminal surgery, anal surgery, hospitalization, and the need for a new CD treatment during the follow-up period.

In the study population, 45 patients achieved corticosteroid-free remission and 50 did not. At 54 weeks, 17 patients with corticosteroid-free remission (38%) and 28 patients without remission (56%) achieved complete mucosal healing, and progression-free survival rates were similar between these groups.

Overall, the rates of progression-free survival at 1, 3, and 5 years were not significantly different between the remission and nonremission groups: 86% versus 91%, respectively, at 1 year; 70% for both groups at 3 years; and 64% and 61%, respectively, at 5 years.

The researchers also compared individual components of the primary endpoint (luminal surgery, anal surgery, hospitalization, and the need for a new CD treatment), and found no significant differences in survival rates in patients who had and had not achieved steroid-free remission.

Survival rates without luminal surgery at 1, 3, and 5 years were 97% versus 96%, 93% versus 90%, and 87% versus 82%, respectively, for remission and nonremission groups. Similarly, survival rates without anal surgery were 93%, 86%, and 86% versus 96%, 88%, and 85%, respectively, for the two groups. Rates of hospitalization-free survival at 1, 3, and 5 years were 90% versus 92%, 81% versus 81%, and 78% versus 69%, respectively, in the remission and nonremission groups. Survival rates without a new systemic CD treatment also were similar at 1, 3, and 5 years: 93% versus 95%, 71% versus 93%, and 60% versus 51%, respectively, for the remission and nonremission groups.

CD progression was not associated with not achieving corticosteroid-free remission (hazard ratio, 0.861). Other factors that were not associated with disease progression in this study included CRP greater than 5 mg/L, age older than 30 years, active smoking, and B1 phenotype.

The researchers noted that, although endoscopic and clinical remission is currently recommended for CD, “there is no validated or standardized definition of this endoscopic goal.” The high rates of survival without major abdominal surgery, regardless of remission status, suggest a significant impact of early combination therapy for CD patients who were biologic naive. Other studies have shown similar improved outcomes for CD patients with early treatment.

The study findings were limited by several factors including the retrospective design and lack of power to compare long-term progression-free survival, the researchers noted. However, the results were strengthened by the robust data on hospitalizations and surgeries from the TAILORIX trial.

The results support a more flexible strategy for CD, “recommending endoscopic and clinical remission in early diagnosed patients and less stringent objectives in those with more refractory or advanced disease,” they concluded.
 

Findings may guide patient management

The current study is important to help clinicians know whether CD patients who achieve a short-term, steroid-free clinical and endoscopic remission go on to experience better long-term disease outcomes than those who do not achieve this short-term remission, Atsushi Sakuraba, MD, of the University of Chicago said in an interview.

Dr. Sakuraba said that he was surprised by the study findings. “Achieving a clinical remission off steroids with complete endoscopic remission, i.e., deep remission, is considered a treatment goal, but the fact that it did not result in less disease progression was surprising.”

The take-home message for clinicians from the study is that CD patients may still experience disease progression after achieving a single time of clinical and endoscopic remission “mainly due to loss of response to infliximab, so continued long-term disease monitoring and control are required,” Dr. Sakuraba said.

The current study was a post hoc follow-up analysis of a previous trial, Dr. Sakuraba noted. Therefore, studies primarily focused on changing the disease progression and natural course of CD are warranted.

Dr. Laharie disclosed counseling, boards, transportation, or fees from AbbVie, Biogaran, Biogen, Ferring, HAC-pharma, Janssen, MSD, Novartis, Pfizer, Prometheus, Roche, Takeda, Theradiag, and Tillots. Dr. Sakuraba had no relevant financial conflicts to disclose.