Reproducible safety and efficacy of durvalumab with or without tremelimumab for hepatocellular carcinoma in clinical practice: Results of the DT-real study - PubMed
3 months ago
- #Real-world evidence
- #Immunotherapy
- #Hepatocellular carcinoma
- Durvalumab plus tremelimumab (STRIDE) is a first-line treatment for unresectable hepatocellular carcinoma (HCC).
- The DT-real study evaluated STRIDE and durvalumab monotherapy in 233 patients across 35 centers, comparing outcomes between those meeting (HIMALAYA-IN) and not meeting (HIMALAYA-OUT) trial criteria.
- Median overall survival (OS) was 20.4 months overall, with HIMALAYA-IN patients achieving significantly longer OS (23.0 months) than HIMALAYA-OUT patients (12.2 months).
- Macrovascular invasion and hepatic decompensation were independent negative prognostic factors, with hepatic decompensation occurring in 10.5% of patients within 12 months.
- Objective response rates were 23.7% for HIMALAYA-IN and 17.8% for HIMALAYA-OUT patients, with disease control linked to improved 24-month OS (58.2% vs. 44.8%).
- Grade 3-4 treatment-related adverse events occurred in 16.3% of patients, showing an acceptable safety profile.
- The study validates STRIDE's efficacy and safety in real-world practice, with hepatic decompensation and disease control as key survival determinants.