Radioembolization can be considered as first-line treatment for unresectable intrahepatic cholangiocarcinoma (ICH), according to data from “Radioembolization with yttrium-90 glass microspheres as first-line treatment for unresectable intrahepatic cholangiocarcinoma – a prospective phase 2 clinical trial.”
The study, which is one of the SIR 2022 Abstracts of the Year, sought to evaluate the safety and efficacy of Y-90 glass microsphere embolization as first-line treatment without chemotherapy for unresectable IHC.
“The prognosis of this disease is very dismal,” said lead author Bela Kis, MD, PhD, FSIR. “Median overall survival (OS) is 3–6 months with supportive care and only approximately 12 months with standard of care chemotherapy with cisplatin and gemcitabine. Unfortunately, 70% of patients have major adverse events while on chemotherapy, which have a major impact on their quality of life.”
In a prior retrospective study, Dr. Kis and fellow researchers demonstrated similar 12-month survival in a diverse group of patients where most received radioembolization in the salvage settings after having failed chemotherapy. “Only 6% developed major adverse events,” Dr. Kis said.
According to Dr. Kis, in a recent prospective phase 2 clinical trial (MISPHEC), the combination of Y-90 radioembolization with chemotherapy as a first line treatment in IHC showed a median OS of 22 months—though 71% of patients had severe, grade 3 and 4 adverse events. “Since the side effect profile of radioembolization is very favorable, we decided to investigate the role of radioembolization without chemotherapy for first-line treatment for IHC,” he said.
Dr. Kis and fellow researchers enrolled 25 eligible patients into their IRB-approved phase II study. Patients were included if they had no evidence of extrahepatic metastasis, Childs-Pugh A, without main portal vein thrombus, bilirubin < 2 mg/dL, ECOG performance status of 0-2, and no prior chemotherapy, liver embolization or radiation therapy for IHC. Two patients were excluded from the analysis due to unrecognized lung metastasis during treatment and right hepatectomy after treatment, respectively. The remainder of patients did not receive chemotherapy following the Y-90 therapy.
According to Dr. Kis, the results of the study may change the current treatment paradigm of IHC. “We found 27.2 months median OS from diagnosis and 19.4 months from the radioembolization treatment and only 2 patients (9%) developed major adverse events,” he said. “Therefore, the OS appears significantly better compared to standard of care chemotherapy with much less adverse events.”
The data is a promising addition to the Y-90 literature, though Dr. Kis says further investigation is required. “Our study had only 23 patients, and this was a single-arm, single-institution study,” he said. “A larger, multi-institutional randomized trial is needed comparing radioembolization to chemotherapy as first-line treatment to obtain convincing evidence for the utility of radioembolization as first-line treatment for IHC.”
