Overall survival was better with hepatic arterial infusion chemotherapy compared with transarterial chemoembolization, according to phase 3 study findings.
Patients with hepatocellular carcinoma (HCC) whose tumors couldn’t be surgically removed lived longer after being treated with hepatic arterial infusion chemotherapy (HAIC) compared with those who received transarterial chemoembolization (TACE), according to phase 3 study findings presented at the 2020 European Society for Medical Oncology Virtual Congress.
The trial, which was conducted in China, included 315 patients who were chosen randomly to receive either HAIC with oxaliplatin, fluorouracil and leucovorin, or TACE. Patients were mostly men, at least 18 years old and had a primary HCC tumor measuring more than seven centimeters. In addition, 90% of the patients had hepatitis B infection, 60% had liver cirrhosis and about half had more than three lesions.
TACE is the current standard of care for patients with unresectable intermediate-stage HCC. “Intermediate or BCLC B stage HCC is a largely heterogenous group that includes patients who do not benefit from TACE — the standard of care — with a median overall survival of only nine to 13 months,” Dr. Lorenza Rimassa, associate professor of medical oncology, Humanitas University and Humanitas Research Hospital-IRCCS in Milan, Italy, said in a discussion following the presentation. “This represents an important unmet clinical need and new data are strongly needed.”
Patients who were treated with HAIC received up to six cycles, whereas TACE was given on demand. Treatment continued until tumor progression or if the patient could no longer tolerate it.
“There was no significant difference in the number of patients receiving either subsequent treatment between the two (groups),” study author Dr. Ming Shi, department of Hepatobiliary Oncology, Cancer Center, Sun Yat-sen University, in Guangzhou, China, said during the virtual meeting.
The researchers found that overall survival, the study’s primary endpoint, was 23.1 months with HAIC compared with 16.07 months with TACE. HAIC patients also had a higher overall response rate compared with TACE patients, 45.9% versus 17.9%, respectively. Median progression-free survival, or the time a patient lives without disease worsening, was 9.63 months in the HAIC group versus 5.4 months in the TACE group.
“We can appreciate that overall survival is longer than expected in the TACE (group), overall survival curves seem to separate after six months, (and) progression-free survival curves seem to separate from the beginning,” Ramissa said. “(But) we have further questions.”
Although both groups experienced serious side effects, HAIC had a better safety profile compared with TACE, Shi said. Serious side effects occurred in the TACE group (30%) versus the HAIC group (19%). These included abdominal swelling caused by accumulation of fluid, hyperbilirubinemia (too much bilirubin in the blood), upper gastrointestinal bleeding, inflammation of the bile duct system and infection. However, the HAIC group experienced more occurrences of thrombocytopenia, neutropenia and diarrhea. Two treatment-related grade 5 events were seen in each group.
The cut-off for the present analysis was April 2020 and patient follow-up is on-going.
“HAIC is not a globally accepted treatment for HCC,” Rimassa said regarding trial design. “It is mainly used in China where this trial has been conducted and more clinical trials are needed to define it’s true.”