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Kaseb et al report the results of a Phase 2 study where 27 patients with resectable HCC were randomized to receive either nivolumab alone or the combination of nivolumab and ipilimumab for 6 weeks before surgery, and then for up to 2 years after resection. Estimated median progression-free survival (PFS) was 9.4 months with nivolumab and 19.53 months with nivolumab plus ipilimumab (hazard ratio [HR] 0.99, 95% CI 0.31–2.54); median time to progression was 9.4 months in the nivolumab group and 19.53 months in the nivolumab plus ipilimumab group (HR 0.89, 95% CI 0.31–2.54). Three (23%) of 13 patients had an overall response with nivolumab monotherapy, versus none with nivolumab plus ipilimumab. Three (33%) of nine patients had a major pathological response (ie, ≥70% necrosis in the resected tumor area) with nivolumab monotherapy compared with three (27%) of 11 with nivolumab plus ipilimumab. Grade 3–4 adverse events were higher with nivolumab plus ipilimumab (six [43%] of 14 patients) than with nivolumab alone (three [23%] of 13). The authors concluded that immunotherapy is safe and feasible in patients with resectable hepatocellular carcinoma.
Marron et al. evaluated the clinical activity of cemiplimab (an anti-PD-1) in 21 patients with resectable hepatocellular carcinoma. Cemiplimab was administered twice every 3 weeks before and 8 times after surgery. Of the 20 patients with resected tumors, four (20%) had significant (>70%) tumor necrosis with 15% showing complete (100%) tumor necrosis. Three (15%) of 20 patients had a radiologic partial response, and all other patients maintained stable disease. Seven (33%) patients had grade 3 adverse events. No grade 4 or 5 events were observed. The investigators concluded that perioperative cemiplimab should be studied further in patients with resectable HCC.
Finally, Guan et al. compared outcomes of 498 patients with resected HCC who also had hepatitis B virus infection (defined as HBsAg-positivity for >90 days). Of those, 367 patients (73.69%) received at least 3 months of postoperative anti-viral treatment (AVT), while 131 (27.31%) did not (non-AVT group). Propensity score matching (PSM) analysis was performed on 206 patients. AVT was associated with better recurrence-free survival (RFS) and overall survival (OS) either before or after PSM. After PSM, the 1-, 3-, and 5-year RFS rates were 85.3%, 65.7%, and 19.1% vs. 76.7%, 46.6%, and 5.8% in the AVT and non-AVT groups, respectively (P = .001). The corresponding 1-, 3-, and 5-year OS rates were 99.0%, 89.8%, and 64.0% vs. 96.1%, 70.5%, and 43.2% in the AVT and non-AVT groups (P < .001). Risk factors that were independently associated with a poor RFS included HBV DNA positivity (P = .002), preoperative alpha fetoprotein (AFP) level of ≥20 ng/mL (P < .001), poor differentiation (P = .022), multiple tumors (P = .037), and microvascular invasion (P < .001). The conclusion was that AVT improves outcomes in patients with HBV and resectable HCC.
Kaseb et al report the results of a Phase 2 study where 27 patients with resectable HCC were randomized to receive either nivolumab alone or the combination of nivolumab and ipilimumab for 6 weeks before surgery, and then for up to 2 years after resection. Estimated median progression-free survival (PFS) was 9.4 months with nivolumab and 19.53 months with nivolumab plus ipilimumab (hazard ratio [HR] 0.99, 95% CI 0.31–2.54); median time to progression was 9.4 months in the nivolumab group and 19.53 months in the nivolumab plus ipilimumab group (HR 0.89, 95% CI 0.31–2.54). Three (23%) of 13 patients had an overall response with nivolumab monotherapy, versus none with nivolumab plus ipilimumab. Three (33%) of nine patients had a major pathological response (ie, ≥70% necrosis in the resected tumor area) with nivolumab monotherapy compared with three (27%) of 11 with nivolumab plus ipilimumab. Grade 3–4 adverse events were higher with nivolumab plus ipilimumab (six [43%] of 14 patients) than with nivolumab alone (three [23%] of 13). The authors concluded that immunotherapy is safe and feasible in patients with resectable hepatocellular carcinoma.
Marron et al. evaluated the clinical activity of cemiplimab (an anti-PD-1) in 21 patients with resectable hepatocellular carcinoma. Cemiplimab was administered twice every 3 weeks before and 8 times after surgery. Of the 20 patients with resected tumors, four (20%) had significant (>70%) tumor necrosis with 15% showing complete (100%) tumor necrosis. Three (15%) of 20 patients had a radiologic partial response, and all other patients maintained stable disease. Seven (33%) patients had grade 3 adverse events. No grade 4 or 5 events were observed. The investigators concluded that perioperative cemiplimab should be studied further in patients with resectable HCC.
Finally, Guan et al. compared outcomes of 498 patients with resected HCC who also had hepatitis B virus infection (defined as HBsAg-positivity for >90 days). Of those, 367 patients (73.69%) received at least 3 months of postoperative anti-viral treatment (AVT), while 131 (27.31%) did not (non-AVT group). Propensity score matching (PSM) analysis was performed on 206 patients. AVT was associated with better recurrence-free survival (RFS) and overall survival (OS) either before or after PSM. After PSM, the 1-, 3-, and 5-year RFS rates were 85.3%, 65.7%, and 19.1% vs. 76.7%, 46.6%, and 5.8% in the AVT and non-AVT groups, respectively (P = .001). The corresponding 1-, 3-, and 5-year OS rates were 99.0%, 89.8%, and 64.0% vs. 96.1%, 70.5%, and 43.2% in the AVT and non-AVT groups (P < .001). Risk factors that were independently associated with a poor RFS included HBV DNA positivity (P = .002), preoperative alpha fetoprotein (AFP) level of ≥20 ng/mL (P < .001), poor differentiation (P = .022), multiple tumors (P = .037), and microvascular invasion (P < .001). The conclusion was that AVT improves outcomes in patients with HBV and resectable HCC.
Kaseb et al report the results of a Phase 2 study where 27 patients with resectable HCC were randomized to receive either nivolumab alone or the combination of nivolumab and ipilimumab for 6 weeks before surgery, and then for up to 2 years after resection. Estimated median progression-free survival (PFS) was 9.4 months with nivolumab and 19.53 months with nivolumab plus ipilimumab (hazard ratio [HR] 0.99, 95% CI 0.31–2.54); median time to progression was 9.4 months in the nivolumab group and 19.53 months in the nivolumab plus ipilimumab group (HR 0.89, 95% CI 0.31–2.54). Three (23%) of 13 patients had an overall response with nivolumab monotherapy, versus none with nivolumab plus ipilimumab. Three (33%) of nine patients had a major pathological response (ie, ≥70% necrosis in the resected tumor area) with nivolumab monotherapy compared with three (27%) of 11 with nivolumab plus ipilimumab. Grade 3–4 adverse events were higher with nivolumab plus ipilimumab (six [43%] of 14 patients) than with nivolumab alone (three [23%] of 13). The authors concluded that immunotherapy is safe and feasible in patients with resectable hepatocellular carcinoma.
Marron et al. evaluated the clinical activity of cemiplimab (an anti-PD-1) in 21 patients with resectable hepatocellular carcinoma. Cemiplimab was administered twice every 3 weeks before and 8 times after surgery. Of the 20 patients with resected tumors, four (20%) had significant (>70%) tumor necrosis with 15% showing complete (100%) tumor necrosis. Three (15%) of 20 patients had a radiologic partial response, and all other patients maintained stable disease. Seven (33%) patients had grade 3 adverse events. No grade 4 or 5 events were observed. The investigators concluded that perioperative cemiplimab should be studied further in patients with resectable HCC.
Finally, Guan et al. compared outcomes of 498 patients with resected HCC who also had hepatitis B virus infection (defined as HBsAg-positivity for >90 days). Of those, 367 patients (73.69%) received at least 3 months of postoperative anti-viral treatment (AVT), while 131 (27.31%) did not (non-AVT group). Propensity score matching (PSM) analysis was performed on 206 patients. AVT was associated with better recurrence-free survival (RFS) and overall survival (OS) either before or after PSM. After PSM, the 1-, 3-, and 5-year RFS rates were 85.3%, 65.7%, and 19.1% vs. 76.7%, 46.6%, and 5.8% in the AVT and non-AVT groups, respectively (P = .001). The corresponding 1-, 3-, and 5-year OS rates were 99.0%, 89.8%, and 64.0% vs. 96.1%, 70.5%, and 43.2% in the AVT and non-AVT groups (P < .001). Risk factors that were independently associated with a poor RFS included HBV DNA positivity (P = .002), preoperative alpha fetoprotein (AFP) level of ≥20 ng/mL (P < .001), poor differentiation (P = .022), multiple tumors (P = .037), and microvascular invasion (P < .001). The conclusion was that AVT improves outcomes in patients with HBV and resectable HCC.