Patient-Reported Outcomes Following Tremelimumab Plus Durvalumab in Unresectable HCC

Previous data from the phase 3 HIMALAYA trial demonstrated that treatment with the Single Tremelimumab Regular Interval Durvalumab (STRIDE) regimen resulted in increased overall survival compared with sorafenib for patients with unresectable hepatocellular carcinoma (uHCC).

Research from Bruno Sangro, MD, PhD, and colleagues published in the Journal of Clinical Oncology evaluated patient-reported outcomes (PROs) from the HIMALAYA trial.

In the study, participants randomly received STRIDE, durvalumab, or sorafenib. Researchers evaluated PROs using the European Organization for Research and Treatment of Cancer 30-item Quality of Life Questionnaire and the 18-item HCC module. They also analyzed time to deterioration (TTD), change from baseline, and improvement rate in global health status/quality of life (GHS/QOL), functioning, and disease-related symptoms.

Of the 1171 participants, 393 received STRIDE, 389 received durvalumab, and 389 underwent treatment with sorafenib. Dr. Sangro and colleagues noted that the compliance rates for PROs were less than 77% at baseline and less than 70% overall, with baseline scores remaining comparable overall.

In the STRIDE and durvalumab cohorts, TTD in GHS/QOL, physical functioning, fatigue, appetite loss, and abdominal pain was numerically longer when compared with the sorafenib cohort. Investigators did not observe any clinically meaningful deterioration in PROs across any of the treatment groups.

Dr. Sangro and colleagues noted that in the STRIDE arm, TTD in nausea and abdominal swelling was numerically longer compared with sorafenib. Additionally, the chance of a clinically significant improvement in GHS/QOL, role, emotional and social functioning, and disease-related symptoms was increased in the STRIDE and durvalumab cohorts compared with the sorafenib group.

“Compared with sorafenib, STRIDE and durvalumab were associated with clinically meaningful, patient-centered GHS/QOL, functioning, and symptom benefits in [patients] with uHCC,” the researchers wrote. “These findings support the benefits of the STRIDE regimen compared with sorafenib for a diverse population reflective of the global uHCC population.”