PROs From the HIMALAYA Trial in Unresectable Hepatocellular Carcinoma

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As reported in the Journal of Clinical Oncology by Sangro et al, patient-reported outcome (PRO) analysis in the phase III HIMALAYA trial showed that tremelimumab/durvalumab and durvalumab produced better outcomes than sorafenib in patients with unresectable hepatocellular carcinoma (HCC).

The trial supported the October 2022 approval of tremelimumab plus durvalumab in this setting.

Study Details

In the multinational open-label trial, 1,171 patients were randomly assigned 1:1:1 to receive tremelimumab at 300 mg for one dose plus durvalumab at 1,500 mg every 4 weeks (STRIDE regimen; n = 393); durvalumab at 1,500 mg every 4 weeks (n = 389); or sorafenib at 400 mg twice daily (n = 389). Patients were evaluable for PRO assessments; PROs were assessed using the European Organization for Research and Treatment of Cancer 30-item Quality of Life Questionnaire and 18-item hepatocellular cancer module.

Key Findings

Across treatment groups, compliance rates for PROs were > 77% at baseline and > 70% overall. Baseline scores were comparable across treatment groups.

In both the STRIDE group and the durvalumab group, median times to deterioration in global health status/quality of life (7.5 and 7.4 vs 5.7 months), physical functioning (12.9 and 14.1 vs 7.4 months), fatigue (7.4 and 6.9 vs 5.4 months), appetite loss (12.6 and 11.1 vs 6.9 months), and abdominal pain (16.8 and 14.1 vs 8.9 months) were numerically longer vs the sorafenib group.

Clinically meaningful deterioration in PROs was not observed in any treatment group. The STRIDE group and durvalumab group had increased likelihood (odds ratio > 1) of reporting clinically meaningful improvements in global health status/quality of life; physical, role, and emotional functioning; and most disease-related symptoms.

Overall, PROs were generally similar in the STRIDE group and the durvalumab group.

The investigators concluded, “Compared with sorafenib, STRIDE and durvalumab were associated with clinically meaningful, patient-centered global health status/quality of life, functioning, and symptom benefits in people with unresectable hepatocellular carcinoma. These findings support the benefits of the STRIDE regimen compared with sorafenib for a diverse population reflective of the global unresectable hepatocellular carcinoma population.”

Bruno Sangro, MD, PhD, of the Liver Unit and HPB Oncology Area, Clínica Universidad de Navarra and CIBEREHD, Pamplona, Spain, is the corresponding author for the Journal of Clinical Oncology article.

Disclosure: The study was supported by AstraZeneca. For full disclosures of the study authors, visit

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