TACE with drug-eluting microspheres as “safe and effective” as conventional TACE, pooled analysis shows

4707
TACE
Filipe Veloso Gomes presenting at SIO 2021

The sustained release of anthracyclines and durable embolization from LifePearl microspheres (Terumo Europe) makes transarterial chemoembolization (TACE) with these embolic agents a safe and effective treatment option for patients with early and intermediate stage hepatocellular carcinoma (HCC). This was the conclusion presented by Filipe Veloso Gomes (Hepato-biliary-pancreatic and Transplant Center, Hospital Curry Cabral, Centro Hospitalar Universitario de Lisboa Central, Lisbon, Portugal) at the 2021 meeting of the Society of Interventional Oncology (SIO; 3–5 February, online).

Today, TACE is indicated for the treatment of unresectable HCC, according to the latest European Society for Medical Oncology (ESMO) clinical practice guidelines, with level IA evidence for Barcelona Clinic Liver Cancer (BCLC) stage B tumours (intermediate stage tumours), and level IB evidence for tumours categorised as BCLC 0–A (early) stage. TACE is recommended for patients awaiting liver transplants.

Veloso Gomes and his colleagues set out to assess contemporary interventional oncology practice in HCC, and conducted a pooled analysis of patient-level data from more than 550 patients with this liver cancer, enrolled across five different single arm studies and treated with anthracyclines-loaded LifePearl.

Safety was assessed by close monitoring of adverse events, according to the Common Terminology Criteria for Adverse Events (CTCAE). Tumour response was evaluated following hospital practice, according to mRECIST (modified Response Evaluation Criteria In Solid Tumours; used in four studies) and RECIST1.1 (in one study) and analysed as best overall response. Kaplan-Meier analysis was used to estimate event rates for time to event outcomes: progression-free survival, time to un-TACE-able progression, and overall survival.

Of the 586 patients included in the study, 57% were in BCLC 0/A stage, which the presenter said “clearly demonstrates the indication for TACE in a wide spectrum of patients”.

Adverse events were reported in 197 (33.6%) patients; the majority of these (23.3% of all patients) were grade 3. A further 2.3% were grade 4, and 1.5% were grade 5. The most frequent adverse events were related to post-embolization syndrome. Hepatobiliary toxicities were detected in 6.9% of all patients. Veloso Gomes therefore told SIO delegates that there was “a good tolerability and acceptable toxicity” of TACE with LifePearl.

In addition, he commented: “Hepatobiliary toxicities as [assessed by] imaging findings were lower than with other drug-eluting microsphere TACE [procedures] and similar to conventional TACE studies.” He specifically mentioned the recently published, prospective PARIS registry in his talk, which reported a higher hepatobiliary toxicity of 12.9% (in 30 of 233 procedures). Veloso Gomes noted that this 12.9% toxicity rate was still lower than that published in the literature from previous studies of drug-eluting microsphere TACE, and was more comparable to the rate seen in conventional TACE (cTACE) procedures.

He continued: “There was a high tumour response rate [in the pooled analysis that was the key focus of his presentation] that translated into promising progression-free survival, time to un-TACE-able progression, and overall survival. The overall survival observed in this analysis is among the best overall survival observed in recent TACE trials and meta-analyses.”

The presenter also cited some limitations to their methodology, which boil down to the fact that this pooled analysis was not planned prior to conducting the individual studies. Therefore, he said that there was heterogeneity in the populations enrolled, as well as differences in the recording of variables, including frequency, timing, type of imaging, and follow-up duration.


LEAVE A REPLY

Please enter your comment!
Please enter your name here