Evidence map›Paper›PMID 38805668›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

Patient-Reported Outcomes From the Phase III HIMALAYA Study of Tremelimumab Plus Durvalumab in Unresectable Hepatocellular Carcinoma.

Bruno Sangro, Peter R Galle, Robin Kate Kelley, Chaiyut Charoentum, Enrico N De Toni, Yurii Ostapenko, Jeong Heo, Ann-Lii Cheng, Andrea Wilson Woods, Charu Gupta and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03298451 (A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma), which is not on this map. Cited by 40 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03298451 phase3active not recruitingnot on this map

A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

TypeinterventionalSponsorAstraZenecaRan2017 to 2027Enrolled1,324ConditionsHepatocellular CarcinomaArmsDurvalumab, Tremelimumab (Regimen 1), Tremelimumab (Regimen 2), Sorafenib, Durvalumab (Regimen 1)
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  15. Immune biomarkers for head and neck cancer.Cancer immunology, immunotherapy : CII · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Bruno SangroLiver Unit and HPB Oncology Area, Clínica Universidad de Navarra and CIBEREHD, Pamplona, Spain.ORCID 0000-0002-4177-6417
Peter R GalleUniversity Medical Center, Mainz, Germany.
Robin Kate KelleyHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA.ORCID 0000-0002-1984-2430
Chaiyut CharoentumDepartment of Internal Medicine, Faculty of Medicine, Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University, Chiang Mai, Thailand.
Enrico N De ToniDepartment of Medicine II, University Hospital, LMU Munich, Munich, Germany.ORCID 0000-0002-8101-8207
Yurii OstapenkoDepartment of Minimally Invasive and Endoscopic Surgery, Intervention Radiology, National Cancer Institute, Kiev, Ukraine.
Jeong HeoDepartment of Internal Medicine, College of Medicine, Pusan National University and Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.ORCID 0000-0003-0961-7851
Ann-Lii ChengNational Taiwan University Cancer Center and National Taiwan University Hospital, Taipei, Taiwan.ORCID 0000-0002-9152-6512
Andrea Wilson WoodsBlue Faery: The Adrienne Wilson Liver Cancer Association, Birmingham, AL.ORCID 0000-0003-0680-4993
Charu GuptaAstraZeneca, Wilmington, DE.
Jayne AbrahamPatient-Centered Solutions, Scientific Services, IQVIA, New York, NY.
Carrie L McCoyAstraZeneca, Gaithersburg, MD.
Nikunj PatelAstraZeneca, Gaithersburg, MD.
Alejandra NegroAstraZeneca, Gaithersburg, MD.
Arndt VogelGastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.ORCID 0000-0003-0560-5538
Ghassan K Abou-AlfaDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-1522-8054

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeIn the phase III HIMALAYA study (ClinicalTrials.gov identifier: NCT03298451) in unresectable hepatocellular carcinoma (uHCC), the Single Tremelimumab Regular Interval Durvalumab (STRIDE) regimen significantly improved overall survival versus sorafenib, and durvalumab monotherapy was noninferior to sorafenib. Patient-reported outcomes (PROs), a secondary outcome from HIMALAYA, are reported here.

methodsParticipants were randomly assigned to receive STRIDE, durvalumab, or sorafenib. PROs were assessed (preplanned secondary outcome) using the European Organization for Research and Treatment of Cancer 30-item Quality of Life Questionnaire and the 18-item HCC module. Time to deterioration (TTD), change from baseline and improvement rate in global health status/quality of life (GHS/QoL), functioning, and disease-related symptoms were analyzed.

resultsIn total, 1,171 participants were randomly assigned to STRIDE (n = 393), durvalumab (n = 389), or sorafenib (n = 389) and were evaluable for PRO assessments. Across treatment arms, compliance rates for PROs were >77% at baseline and >70% overall. Baseline scores were comparable across treatment arms. TTD in GHS/QoL, physical functioning, fatigue, appetite loss, and abdominal pain was numerically longer for both STRIDE and durvalumab versus sorafenib. Clinically meaningful deterioration in PROs was not observed in any treatment arm. However, TTD in nausea and abdominal swelling was numerically longer for STRIDE versus sorafenib, and the likelihood of clinically meaningful improvement in GHS/QoL, role, emotional and social functioning, and disease-related symptoms was greater with STRIDE and durvalumab versus sorafenib. PROs with STRIDE and durvalumab were generally similar.

conclusionCompared with sorafenib, STRIDE and durvalumab were associated with clinically meaningful, patient-centered GHS/QoL, functioning, and symptom benefits in people with uHCC. These findings support the benefits of the STRIDE regimen compared with sorafenib for a diverse population reflective of the global uHCC population.

Indexed as

Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, HepatocellularLiver NeoplasmsPatient Reported Outcome MeasuresQuality of LifeAdultAgedFemaleHumansMaleMiddle AgedSorafenibAntibodies, MonoclonalAntibodies, Monoclonal, HumanizeddurvalumabSorafenibtremelimumab

Identifiers

PMID38805668
PMCPMC11315407

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.