Dutch investigators reported a 3-year overall survival of 33% in patients with advanced, unresectable cholangiocarcinoma confined to the liver who received the infusion chemotherapy vs 3% in historical controls treated with standard systemic gemcitabine/cisplatin.
The response with the pump is “clearly superior” to systemic treatment, said investigator Bas Groot Koerkamp, MD, who presented the findings at the ASCO Gastrointestinal Cancers Symposium.
“I do share the enthusiasm of my colleagues about immunotherapy and targeted treatments for intrahepatic cholangiocarcinoma,” said Dr. Koerkamp, a hepato-pancreato-biliary surgeon at Erasmus University Medical Center, Rotterdam, the Netherlands. But “none of these treatments has shown a 3-year overall survival of one in three with advanced disease.”
The hepatic arterial infusion pump, a hockey puck-sized device that essentially bathes liver tumors in floxuridine for about 2 weeks, is not a new technology. The pump has been around since at least the 1990s, developed largely at Memorial Sloan Kettering Cancer Center, New York City, where Dr. Koerkamp trained.
Three previous small studies in cholangiocarcinoma reported outcomes similar to Dr. Koerkamp’s. Despite the strong survival outcomes, uptake of these pumps has lagged.
A key reason is likely the lack of phase 3 trials evaluating the technology, Laleh Melstrom, MD, chief of surgical oncology at City of Hope, outside of Los Angeles, Duarte, California, told this news organization.
Dr. Melstrom, who moderated Dr. Koerkamp’s presentation, also noted that using the pump requires special attention to bilirubin levels to prevent biliary toxicity and knowledge of pump placement.
The pump, placed subcutaneously on one side of the lower abdomen, is connected to a side branch of the hepatic artery and then filled with the chemotherapy agent floxuridine. Delivering floxuridine directly to the hepatic artery increases liver lesion exposure 200-fold over systemic delivery. The pump needs to be refilled after 2 weeks.
“It’s not difficult to place the pump, even doing it robotically,” which was how it was placed in over 40% of patients in the study, Dr. Koerkamp said.
As for biliary toxicity, only one patient in the current study developed biliary sclerosis, which was easily handled with a stent. “You just put in a stent and continue,” Dr. Koerkamp said.
The current single-arm phase 2 study included 50 patients implanted with the hepatic pump at three centers in the Netherlands. All patients had advanced, unresectable cholangiocarcinoma confined to the liver.
Ultimately, 48 of 50 patients received treatment after one patient died of unrelated causes and another had an arterial dissection.
Overall, 38 received gemcitabine/cisplatin concurrently, and the remaining had the pump treatment alone, having already received the systemic combination. Most (84%) received at least four cycles of chemotherapy infusion.
Almost half of patients (46%) had a partial response to treatment, and 88% exhibited disease control at 6 months. Four patients who responded underwent a liver resection, one of whom had a complete pathologic response.
Median overall survival was 22 months vs 12 months in historical controls. One-year median overall survival was 80% in the treatment group vs 47% in controls, and 3-year median overall survival was 33% in the pump group vs 3% in controls.
An audience member noted that similar results have been reported for transarterial Yttrium-90 radioembolization, another and newer option to treat intrahepatic cholangiocarcinoma.
“The Y90 results are quite impressive,” Dr. Koerkamp said, adding that he’d like to see a head-to-head comparison.
“The main advantage of the pump is that it treats the entire liver,” as opposed to one lesion at a time, “so if you have 10 lesions [the pump] makes a lot more sense,” he said.
There is “definitely a movement” to “reinvigorate” the hepatic artery infusion pump approach, Dr. Melstrom said.
The study was funded by the Dutch Cancer Society. Dr. Koerkamp disclosed research funding from Tricumed, a maker of implantable infusion pumps. Dr. Melstrom didn’t have any disclosures.
A version of this article first appeared on Medscape.com.