Evidence map›Paper›PMID 40622010›Full record

Trial reportThe oncologist2025

Immune-mediated adverse events in the randomized phase 3 TOPAZ-1 study of durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer.

Lorenzo Antonuzzo, Hidenori Takahashi, Joon Oh Park, Aumkhae Sookprasert, Roopinder Gillmore, Sheng-Shun Yang, Juan Cundom, Mila Petrova, Gina Vaccaro, Marielle Holmblad and 4 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03875235 (A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT03875235 phase3active not recruitingnot on this map

A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers

TypeinterventionalSponsorAstraZenecaRan2019 to 2027Enrolled810ConditionsBiliary Tract NeoplasmsArmsDurvalumab, Placebo
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
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

14 authors.

Lorenzo AntonuzzoClinical Oncology Unit, Careggi University Hospital, and Department of Experimental and Clinical Medicine, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.ORCID 0000-0003-3349-5604
Hidenori TakahashiDepartment of Gastroenterological Surgery, Osaka International Cancer Institute, 3-1-69, Otemae, Chuo-Ku, Osaka, 541-8567, Japan.
Joon Oh ParkDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, South Korea.ORCID 0000-0001-6502-2612
Aumkhae SookprasertMedical Oncology Unit, Department of Medicine, Faculty of Medicine, Khon Kaen University, 123 Mittraparp Road, Muang, Khon Kaen 40002, Thailand.
Roopinder GillmoreDepartment of Medical Oncology, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.
Sheng-Shun YangDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital, 1650 Taiwan Boulevard, Section 4, Taichung, 40705, Taiwan.ORCID 0000-0001-5800-1901
Juan CundomInstituto de Investigaciones Metabólicas, Libertad 836, C1012AAR Cdad, Buenos Aires, Argentina.
Mila PetrovaDepartment of Medical Oncology, MHAT Nadezhda, Blaga Vest Str, 1330 Sofia, Bulgaria.
Gina VaccaroProvidence Cancer Institute, 4805 Northeast Glisan Street, Portland, OR 97213, USA.
Marielle HolmbladOncology R&D, Late-Stage Development, AstraZeneca, 1 Medimmune Way, Gaithersburg, MD 20878-2204, USA.
Magdalena ŻotkiewiczOncology Biometrics, Late Oncology Statistics, AstraZeneca, Postępu 14, 02-676 Warsaw, Poland.
Julie WangOncology R&D, Late-Stage Development, AstraZeneca, 430 East 29 Street, New York, NY 10016, USA.
Nana RokutandaOncology R&D, Late-Stage Development, AstraZeneca, 1 Medimmune Way, Gaithersburg, MD 20878-2204, USA.
Do-Youn OhDivision of Medical Oncology, Department of Internal Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, and Cancer Research Institute, Seoul National University College of Medicine, 103, Daehak-ro, Jongno-gu, Seoul 110-744, South Korea.

Funding

AstraZeneca
6 · The paper itself

Abstract

introductionWe assessed immune-mediated adverse events (imAEs) in the TOPAZ-1 (NCT03875235) study of durvalumab plus gemcitabine and cisplatin (GemCis) in advanced biliary tract cancer (aBTC).

methodsParticipants were randomized 1:1 to durvalumab (1500 mg) or placebo, plus GemCis (gemcitabine [1000 mg/m2] and cisplatin [25 mg/m2]) intravenously, followed by durvalumab (1500 mg) or placebo Q4W. We assessed imAE incidence, time to onset (TTO), and association with overall survival (OS).

resultsIn durvalumab (n = 338) versus placebo (n = 342), imAEs were reported in 13.9% versus 4.7% of participants, with median TTO of 127.0 versus 86.5 days, respectively. OS HR for durvalumab versus placebo in participants with imAEs was 0.59 (95% CI, 0.30-1.23) and was 0.83 (95% CI, 0.70-1.00) in participants without imAEs.

conclusionsDurvalumab demonstrated an OS benefit versus placebo in aBTC, irrespective of imAEs, which were mostly low grade and manageable. The results in these subgroups were consistent with the overall primary analysis.

trial registrationClinicalTrials.gov NCT03875235.

Indexed as

Antibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsBiliary Tract NeoplasmsDeoxycytidineAdultAgedCisplatinFemaleGemcitabineHumansMaleMiddle AgedAntibodies, MonoclonalCisplatinDeoxycytidinedurvalumabGemcitabineBiliary tract neoplasmscholangiocarcinomagallbladder neoplasmsimmune checkpoint inhibitorimmunotherapy

Identifiers

PMID40622010
PMCPMC12230790

What OpenQuestion holds

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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.