Hepatic arterial infusion chemotherapy plus sintilimab shows promise for advanced liver cancer
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Treatment with hepatic arterial infusion chemotherapy in combination with sintilimab allowed for surgical resection and produced survival rates similar to lesser advanced hepatocellular carcinoma, according to a presenter at The International Liver Congress.
“FOLFOX-HAIC in combination with sintilimab is a safe and successful conversion therapy providing outstanding PFS to advanced HCC,” Li Xu, MD, PhD, of the Sun Yat-sen University Cancer Center in China, said during a press conference. “Although our results are almost all in HBV-related HCC, we highly recommend investigators in other countries to do some trials about this new strategy and maybe more and more patients with advanced HCC could be cured.”
Xu and colleagues enrolled 30 patients with locally advanced, potentially resectable hepatocellular carcinoma treated with hepatic arterial infusion chemotherapy with modified FOLFOX (FOLFOX-HAIC) in combination with sintilimab (Tyvyt; Eli Lilly, Innovent Biologics), a PD-1 inhibitor.
Patients were mostly men (93.3%) and had HBV (96.7%). Median treatment cycle was 2 years with tumor evaluation performed every 6 to 8 weeks, with referral for surgical treatment when eligible. The median tumor size was 9.7 cm, and about half had multiple tumors. All patients presented with vascular invasion, 26 of the portal vein and 15 of the hepatic vein. All 30 had safety data; 29 included for efficacy.
“The primary endpoint of PFS was 15.7 months and 12 months PFS rate of 57.9%. That’s almost equal to outcomes of patients with early- and middle-stage HCC,” Xu said.
At 12 months, progression-free survival was 57.9% (95% CI, 42.3-79.4) and overall survival was 82.3% (95% CI, 69.4-97.1). Objective response rate was 44.8% (95% CI, 27-64) while disease control rate was 82.7% (95% CI, 63.5-93.5).
“Of the 30 patients who received combination therapy, 21 of them were successfully converted for surgery, 19 for surgical resection and two for [radiofrequency ablation],” Xu said.
Nineteen of the patients moved on to receive hepatectomy — most after just two sessions of treatment — with three showing pathologic complete response. Additionally, two patients showed deep response and received radical ablation, with one confirmed to have pathologic complete response. Fourteen patients remain tumor-free.
Most treatment-related adverse events were grades 1 and 2 with the most common being pyrexia (10%), rash (10%) and pruritus (10%). One treatment related serious adverse event was grade 4 postoperative liver dysfunction. The patient permanently discontinued the study drug and remains tumor free, Xu said.