Riccardo Lencioni, MD, FSIR, EBIR, discusses unmet needs in unresectable hepatocellular carcinoma.

Dr Lencioni on Unmet Needs in Unresectable HCC

Riccardo Lencioni, MD, FSIR, EBIR, professor, director, Diagnostic Imaging and Intervention, Pisa University School of Medicine, discusses unmet needs in patients with unresectable hepatocellular carcinoma (HCC).

Although the HCC treatment armamentarium has substantially expanded in recent years, this disease remains challenging to manage, as patients continue to have a poor prognosis, Lencioni begins. A multidisciplinary approach is crucial to improving patient outcomes, he states. This involves a comprehensive assessment of all available therapies, including surgery, transplantation, ablation, embolization therapies, and the emerging field of immunotherapy-based systemic treatments, he details.

Lencioni states that it is essential to recognize that patients with HCC often face 2 concurrent challenges: managing the tumor itself and addressing underlying chronic liver disease. Therefore, patient selection is paramount, with careful consideration given to liver function and the risk of bleeding. Each patient's unique characteristics must be thoroughly evaluated to determine the most appropriate treatment approach for their specific situation, Lencioni emphasizes.

By adopting a multidisciplinary approach and conducting individualized assessments, healthcare providers can optimize treatment decisions and improve outcomes for patients with HCC, Lencioni reiterates. This comprehensive strategy ensures that patients receive tailored care that addresses both the tumor and the underlying liver disease, ultimately leading to better management of this complex condition, he states.

The phase 3 EMERALD-1 trial (NCT03778957) may usher in a new era in the treatment of patients with unresectable HCC by demonstrating, for the first time, the significant benefits of combining locoregional, liver-directed therapy with a systemically active drug, Lencioni elucidates. Findings from the final progression-free survival (PFS) analysis of the trial showed that patients treated with transarterial chemoembolization (TACE), durvalumab (Imfinzi), and bevacizumab (Avastin) achieved a median PFS of 15.0 months (95% CI, 11.1-18.9) vs 8.2 months (95% CI, 6.9-11.1) with TACE plus placebos (n = 205). These data were 

These data have the potential to redefine the standard of care for this patient population, offering a new treatment option that could address unique challenges and unmet needs in HCC, he concludes.

Videos

The EMERALD-1 trial of TACE/durvalumab/bevacizumab in patients with unresectable hepatocellular carcinoma

Dr Lencioni on the Results of the EMERALD-1 Trial in Unresectable HCC

Riccardo Lencioni, MD, FSIR, EBIR, professor, director, Diagnostic Imaging and Intervention, Pisa University School of Medicine, discusses outcomes from the phase 3 EMERALD-1 trial (NCT03778957) investigating transarterial chemoembolization (TACE) combined with durvalumab (Imfinzi) with or without bevacizumab (Avastin) in patients with unresectable hepatocellular carcinoma (HCC). 

The double-blind, global investigation evaluated patients with embolization-eligible unresectable HCC. To be eligible for the investigation, patients must have had Child-Pugh A to B7 liver function, an ECOG performance status 0 or 1, and no evidence ofextrahepatic disease. Outcomes from the study were reported during 

The primary end point of the study was successfully met, Lencioni begins. Theincorporation of durvalumab with bevacizumab and TACE demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with TACE plus placebo, he emphasizes. The hazard ratio for PFS was 0.77 (95% CI, 0.61-0.98; stratified log-rank 

 = .032), and the median treatment duration was 8.67 months (95% CI, 0.9-45.5) in the control arm, representing one of the most noteworthy results reported with TACE in a global trial. Treatment duration persisted for a median of 13.75 months (95% CI, 1.6-40.6) in patients who received the combination of durvalumab, bevacizumab, and TACE, Lencioni elucidates.

The PFS advantage observed with durvalumab plus bevacizumab and TACE appears consistent across various patient subgroups and is notably evident in patients with limited tumor burden within the up to 7 criteria and those with more extensive dissemination beyond the episodic criteria, Lencioni continues. Although the study is still in progress for the secondary end point of overall survival, which was immature at the interim analysis and did not reach statistical significance, this trialhas ushered in a new treatment era for patients with HCC, he states. It is the first to demonstrate that combining local-regional liver-directed therapy with a systemically active drug can yield a statistically significant and clinically meaningful PFS benefit for patients, Lencioni concludes.

Riccardo Lencioni, MD, FSIR, EB, discusses the EMERALD-1 trial of TACE/durvalumab/bevacizumab in patients with unresectable hepatocellular carcinoma.

Riccardo Lencioni, MD, professor in the Department of Radiology at the University of Pisa School of Medicine in Pisa, Italy, discusses how response to hepatocellular carcinoma (HCC) treatment can be best assessed in patients.

For patients who receive locoregional therapies, there is a general consensus that using modified Response Evaluation Criteria in Solid Tumors (mRECIST) provides useful and reliable predictors of patient survival. However, there are emerging data that mRECIST criteria may also be an independent predictor of survival for patients with advanced HCC who are receiving systemic therapies.

Applying these criteria in assessing patient response to treatment will be increasingly important as the treatment landscape for HCC expands with the addition of new agents. Understanding which patients benefit most from particular therapies will be of particular value in tailoring patient care.

View more from the 2018 International Liver Cancer Association Annual Conference 

Riccardo Lencioni, MD, professor in the department of radiology at the University of Pisa School of Medicine in Pisa, Italy, discusses how response to hepatocellular carcinoma (HCC) treatment can be best assessed in patients.

Riccardo Lencioni, MD

Articles

Dr Lencioni on Unmet Needs in Unresectable HCC

Dr Lencioni on the Results of the EMERALD-1 Trial in Unresectable HCC

Dr. Lencioni on Assessing Response to HCC Therapy