Durvalumab Monotherapy in Complex Advanced Hepatocellular Carcinoma: A Real-World Study of Patients Ineligible for Combination Immunotherapy

IF 2.9 2区医学 Q2 ONCOLOGY Cancer Medicine Pub Date : 2025-02-27 DOI:10.1002/cam4.70642

Chihiro Miwa, Sadahisa Ogasawara, Takuya Yonemoto, Sae Yumita, Tomomi Okubo, Miyuki Nakagawa, Keisuke Koroki, Masanori Inoue, Naoya Kanogawa, Masato Nakamura, Takayuki Kondo, Shingo Nakamoto, Norio Itokawa, Masanori Atsukawa, Ei Itobayashi, Naoya Kato

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Abstract

Aim

Combination immunotherapy is the standard of care for advanced hepatocellular carcinoma (HCC). However, some patients are unsuitable for such treatment. This study investigated the safety and effectiveness of durvalumab monotherapy in a real-world cohort with advanced HCC who were poor candidates for combination immunotherapy.

Methods

We retrospectively analyzed data from 35 patients with advanced HCC treated with durvalumab monotherapy across three Japanese institutions between January and December 2023. Patients were selected based on their ineligibility for combination immunotherapy or vascular endothelial growth factor inhibiting tyrosine kinase inhibitors (VEGF-TKIs). Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs) were assessed.

Results

The median age was 71 years, with 51.4% classified as Child–Pugh B or C. Notably, 91.4% of patients were ineligible for the IMbrave150 or HIMALAYA trials. Median PFS was 2.7 months (95% CI: 1.84–6.2) and the median OS was not reached. The ORR and DCR were 2.9% and 51.4%, respectively. Grade ≥ 3 treatment-related AEs (trAEs) occurred in 8.6% of patients, with a discontinuation rate of 11.4% due to AEs. The most common AEs were aspartate aminotransferase (AST) increased (34.3%), hypoalbuminemia (28.6%), and alanine aminotransferase (ALT) increased (25.7%). Immune-mediated AEs (imAEs) affected 14.3% of the patients. The albumin-bilirubin (ALBI) scores showed no significant deterioration in patients without progressive disease (PD) over 12 weeks after treatment initiation (p = 0.771).

Conclusions

Durvalumab monotherapy demonstrated a favorable safety profile and comparable effectiveness to VEGF-TKIs in patients with advanced HCC unsuitable for combination immunotherapy, especially for those with Child–Pugh B status.

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来源期刊

Cancer Medicine ONCOLOGY-

CiteScore

5.50

自引率

2.50%

发文量

907

审稿时长

19 weeks

期刊介绍： Cancer Medicine is a peer-reviewed, open access, interdisciplinary journal providing rapid publication of research from global biomedical researchers across the cancer sciences. The journal will consider submissions from all oncologic specialties, including, but not limited to, the following areas: Clinical Cancer Research Translational research ∙ clinical trials ∙ chemotherapy ∙ radiation therapy ∙ surgical therapy ∙ clinical observations ∙ clinical guidelines ∙ genetic consultation ∙ ethical considerations Cancer Biology: Molecular biology ∙ cellular biology ∙ molecular genetics ∙ genomics ∙ immunology ∙ epigenetics ∙ metabolic studies ∙ proteomics ∙ cytopathology ∙ carcinogenesis ∙ drug discovery and delivery. Cancer Prevention: Behavioral science ∙ psychosocial studies ∙ screening ∙ nutrition ∙ epidemiology and prevention ∙ community outreach. Bioinformatics: Gene expressions profiles ∙ gene regulation networks ∙ genome bioinformatics ∙ pathwayanalysis ∙ prognostic biomarkers. Cancer Medicine publishes original research articles, systematic reviews, meta-analyses, and research methods papers, along with invited editorials and commentaries. Original research papers must report well-conducted research with conclusions supported by the data presented in the paper.