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최종편집 2024-05-19 04:23 (일)
[The Liver Week] Tecentriq + Avastin confirmed the effect for patients with hepatocellular carcinoma
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[The Liver Week] Tecentriq + Avastin confirmed the effect for patients with hepatocellular carcinoma
  • Hyeokgi Lee, Newsmp
  • 승인 2021.05.19 16:59
  • 댓글 0
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   Yonsei University College of MedicineㆍCHA UniversityㆍUniversity of Ulsan College of Medicine announced the RWD… Similar to IMBRAVE150

In the first-line treatment of hepatocellular carcinoma (HCC), the real-world data (RWD) in South Korea was released, reaffirming the effectiveness and safety of the combination of Tecentriq (Ingredient: Atezolizumab) + Avastin (Ingredient: Bevacizumab).

It was shown that the effect of extending the survival time confirmed in IMBRAVE150, which was the basis for the approval of the relevant indication. 

IMBRAVE150 is a global phase 3 clinical study that compares the efficacy and safety of the combination of Tecentriq and Avastin therapy in the first-line treatment of HCC with the standard treatment Nexavar (Ingredient: Sorafenib). 

In this study, Tecentriq in combination with Avastin was found to have extended the overall survival (OS), and progressive-free survival (PFS) compared to Sorafenib.

On 19th May, the joint research team of Yonsei University College of Medicine, CHA University, and University of Ulsan College of Medicine released the RWD at The Liver Week 2021, a virtual conference of the Korean Association for the Study of the Liver.

The study retrospectively analyzed 86 unresectable HCC patients treated with Tecentriq + Avastin therapy at Yonsei University Severance Hospital, CHA University Bundang Medical Center, and Ulsan University Hospital from June 2020 to February 2021.

The average age of patients was 62 years, the average tumor size was 4.9cm, and the ECOG PS was 0 for 40% and 1/2 for 60%. In the BLCL stage, 80% were C and 20% were B, and in the Child-pugh class, about 95% were A and 5% were B.

The study found that no patients had a complete response (CR), but the partial response (PR) was 32.6%, the objective response rate (ORR) 32.6%, and the disease control rate (DCR) was 75.6%, with stable disease (SD) of 43%.

According to the OS analysis, the median OS was not reached at 6-month follow-up, and the overall survival rate at 6-month was 80.8%.

The median PFS was 9.6 months, with a progressive-survival rate of 53.2% at 6-month.

This is similar to the overall survival of 84.8% and 54.5% of the progressive-survival rate at 6-month of Tecentriq in combination with Avastin, which was identified in the IMBRAVE150 study analyzed at 9-months of median follow-up.

The median PFS was 6.8 months at IMBRAVE, shorter than the 9.6 months in this RWD.

Hypertension was the most common in adverse effects with 41.9%, AST level increase 37.2%, thrombocytopenia 36.0%, and fatigue 36.0%.

Grade 3 and 4 adverse events included 8.1% of AST level increase, 5.8% hypertension, 4.7% bilirubin in the blood increase, and 3.5% of thrombocytopenia, gastrointestinal bleeding, and gastrointestinal perforation.

The research team explained that the overall adverse events are manageable, including the most common hypertension.

Meanwhile, the combination of Tecentriq + Avastin therapy showed that the number of tumors (more than four) and size (more than 4.9cm) were adversely affected by predictive factors affecting the OS.

Moreover, the multivariate analysis suggested only statistical differences in tumor size and that the risk of death was more than five times higher than that of 4.9cm or less.

In the PFS, ECOG PS, Child-pugh class, AFP levels, and PIVKA were shown as predictive factors. Only PIVKA showed statistically significant differences, and the risk of disease progression or death was more than twice higher when above 223mAU/mL.
 


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