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. 2025;103(8):742-747.
doi: 10.1159/000542517. Epub 2024 Nov 11.

First-Line Durvalumab plus Tremelimumab Treatment for Unresectable Hepatocellular Carcinoma in Real-World Clinical Practice

Yasutoshi Fujii  1   2 , Tomokazu Kawaoka  3 , Yuki Shirane  3 , Ryoichi Miura  3 , Hikaru Nakahara  4 , Kenji Yamaoka  3 , Shinsuke Uchikawa  3 , Hatsue Fujino  3 , Atsushi Ono  3 , Eisuke Murakami  3 , Daiki Miki  3 , Nelson Clair Hayes  3 , Masataka Tsuge  3 , Yuko Nakamura  5 , Kazuo Awai  5 , Shiro Oka  3
Affiliations

First-Line Durvalumab plus Tremelimumab Treatment for Unresectable Hepatocellular Carcinoma in Real-World Clinical Practice

Yasutoshi Fujii et al. Oncology. 2025.

Abstract

Introduction: Durvalumab plus tremelimumab combination therapy (STRIDE regimen) is a new first-line option for unresectable hepatocellular carcinoma (uHCC), but little real-world data are available to determine which patients are most likely to respond.

Methods: This study retrospectively evaluated patients with uHCC who were treated with the STRIDE regimen as the 1st line at our hospital. The primary endpoint of the study was the objective response rate (ORR). We focused on identifying factors associated with cases that had a favorable response.

Results: Twenty-one patients were included. In best response, there were 11 partial response cases, with an ORR of 52.4%. Median progression-free survival was 6.8 months, and overall survival did not reach the median time. A high tumor-to-liver ratio of the maximum value of the standardized uptake value (TLR) on baseline fluorodeoxyglucose positron emission tomography (FDG-PET) was associated with response, while TLRs were significantly higher in poorly differentiated uHCC.

Conclusion: The STRIDE regimen may be beneficial for systemic therapy-naive uHCC patients. High TLR on baseline FDG-PET could be a potentially useful biomarker for response.

Keywords: Durvalumab; Hepatocellular carcinoma; Immune checkpoint inhibitors; Positron emission tomography; Tremelimumab.

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Conflict of interest statement

Tomokazu Kawaoka received an honorarium from AstraZeneca K.K. and Chugai Pharmaceutical Co., Ltd.

Figures

Fig. 1.
Fig. 1.
Overall therapeutic outcomes of the STRIDE regimen. a Best response evaluated with RECIST 1.1 and mRECIST is shown. b Kaplan-Meier curve estimates of PFS. PR, partial response; SD, stable disease; PD, progressive disease; NE, not evaluable; ORR, overall response rate; DCR, disease control rate; PFS, progression-free survival.
Fig. 2.
Fig. 2.
Association between TLRs and response and tumor differentiation. a Association between the TLRs on baseline FDG-PET and response. b Association between the TLRs and tumor differentiation. TLR, the tumor-to-liver ratio of the maximum value of the standardized uptake value. *Mann-Whitney U test. †Tukey’s honestly significant difference test.
Fig. 3.
Fig. 3.
The change in target lesion from baseline. A spider plot defined the change in target lesion from baseline according to RECIST 1.1. The line is shown in a blue-to-red gradient corresponding to the degree of TLR. PR, partial response; SD, stable disease; PD, progressive disease.
See this image and copyright information in PMC

References

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