Early data from the world’s largest prospective registry study on transarterial radioembolization (TARE) with yttrium-90 (Y-90) glass microspheres in the treatment of primary and metastatic liver tumors demonstrate prolonged survival and a low adverse event rate, and therefore a positive benefit for patients.
“The PROACTIF French Registry Study of Y-90 Glass Microspheres for the Treatment of Liver Malignancies: Interim Analysis of 670 Hepatocellular Carcinoma (HCC) Patients” provides interim data from PROACTIF, a prospective, open-label, noninterventional French postapproval study that began in January 2019.
“We should collect data from more than 1,000 HCC patients in the registry and the final results are expected mid-2025,” said lead author Etienne Garin, MD, PhD. The registry study reflects the outcomes of patients who are treated per standard of care with guidance to perform pre-treatment dosimetry according to treatment goals (complete response, disease control, bridge to surgery) and to perform posttreatment dosimetry. Most patients received personalized dosimetry, which Dr. Garin said has been used successfully in France for years.
The DOSISPHERE-01 trial, which was the focus of one of SIR 2023’s Abstracts of the Year, showed that increasing the tumor dose while controlling normal tissue dose—rather than a standardized dose to perfused volume—improves survival outcomes for patients with HCC.
“The use of personalized dosimetry has been validated by DOSISPHERE-01, but that was a relatively smaller study,” Dr. Garin said. “The next step is to document the use of personalized dosimetry in wider use, not just at a few centers of excellence in France, but across the country and eventually worldwide.”
The PROACTIF registry study has 32 investigating sites, all of which are using personalized dosimetry to treat HCC patients while evaluating the effectiveness, quality of life and safety of this approach in a real-world setting.
The abstract includes data from 670 HCC patients, 80.3% of whom were Child-Pugh A and 55.5% of whom were ECOG 0. Almost 40% had solitary tumor, with a mean lesion size of 68.7 mm. Approximately half of the patients received selective administration, and half received lobar administration; 73% of patients had pre-treatment multicompartment dosimetry assessments.
Over 87% of patients survived to 6 months, and almost 45% survived to 24 months, with a mean survival rate of 20.8 months. Patients with unilobar disease had higher overall survival than those with bilobar disease (21.7 months versus 18 months), as did those who received selective administration over nonselective (29.6 months versus 16.4 months).
Of the 670 patients, 42 experienced treatment-emergent adverse events (38 of which were device or procedure related) and 37 patients experienced serious adverse events.
“This is the third interim analysis,” said Dr. Garin, who added that the registry closed enrollment on Dec. 31, 2023, “with over 1,300 patients treated either for HCC, intrahepatic cholangiocarcinoma or metastatic colorectal cancer.”
While the future data will shed light on the overall survival and quality of life for patients with various disease states who receive personalized dosimetry, Dr. Garin said the early data from the PROACTIF registry study show that it is possible to adopt a personalized dosage approach in a widespread, real-world application.
This abstract will be presented on Tuesday, March 26 at 3:18 p.m. MT during the Liver Locoregional 2 session at SIR 2024.
