With a median overall survival of only 11 months, intrahepatic cholangiocarcinoma (IHC) warrants more effective therapies. Researchers recently discovered that a regimen of hepatic arterial infusion of floxuridine plus systemic gemcitabine and oxaliplatin produces promising outcomes in patients with unresectable IHC.
In this phase 2 clinical trial, 38 patients with histologically confirmed, unresectable IHC were enrolled and treated. Participants with resectable metastatic disease to regional lymph nodes and those who received prior systemic therapy were allowed; however, those with distant metastatic disease were excluded. Over half of patients in the study were women, and patients had a median age of 64 years. Patients were administered hepatic arterial infusion of floxuridine in combination with systemic gemcitabine and oxaliplatin.
After a median follow-up of 30.5 months, 58% of patients achieved a partial radiographic response, while 84% achieved disease control at six months. Among those treated, 4 patients had a sufficient enough response to undergo resection, and 1 patient achieved a complete pathologic response. Median progression-free survival was 11.8 months. Six-month progression-free survival was found to be at a rate of 84.1%. Median overall survival was 25 months, with a one-year overall survival rate of 89.5%. Those with node-negative disease showed no difference in overall survival compared with patients with resectable regional lymph nodes. Grade 4 toxic events occurred in 4 patients and included hypertension, gastroduodenal artery aneurysms, and an infection in the pump pocket.
The study authors, led by Andrea Cercek, MD, medical oncologist at Memorial Sloan Kettering Cancer Center, conclude, "Hepatic arterial infusion plus systemic chemotherapy appears to be highly active and tolerable in patients with unresectable IHC; further evaluation is warranted."
For More Information
Cercek A, Boerner T, Tan BR, et al (2019). Assessment of hepatic arterial infusion of floxuridine in combination with systemic gemcitabine and oxaliplatin in patients with unresectable intrahepatic cholangiocarcinoma. JAMA Oncol. [Epub ahead of print] DOI:10.1001/jamaoncol.2019.3718
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