Evidence map›Paper›PMID 40192993›Full record

Trial reportAnnals of surgical oncology2025

An Open-label, Randomized Study of Melphalan/Hepatic Delivery System Versus Best Alternative Care in Patients with Unresectable Metastatic Uveal Melanoma.

Jonathan S Zager, Marlana Orloff, Pier Francesco Ferrucci, Junsung Choi, David J Eschelman, Evan S Glazer, Aslam Ejaz, J Harrison Howard, Erika Richtig, Sebastian Ochsenreither and 16 more

Abstract readRandomized Controlled TrialComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of surgical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

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

  1. Guideline
  2. Uveal Melanoma: Changing Paradigms of Treatment.Ocular oncology and pathology · 2026
    Review
  3. Article
  4. Article
  5. 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

26 authors.

Jonathan S ZagerDepartment of Cutaneous Oncology, Moffitt Cancer Center, Tampa, FL, USA. Jonathan.Zager@moffitt.org.ORCID http://orcid.org/0000-0002-6886-4468
Marlana OrloffThomas Jefferson University, Philadelphia, PA, USA.
Pier Francesco FerrucciEuropean Institute of Oncology, IRCCS, Milan, Italy.
Junsung ChoiDepartment of Oncologic Sciences, University of South Florida, Morsani School of Medicine, Tampa, FL, USA.
David J EschelmanThomas Jefferson University, Philadelphia, PA, USA.
Evan S GlazerThe University of Tennessee Health Science Center, Memphis, TN, USA.
Aslam EjazThe Ohio State University, Columbus, OH, USA.
J Harrison HowardUniversity of South Alabama, Mobile, AL, USA.
Erika RichtigMedical University of Graz, Graz, Austria.
Sebastian OchsenreitherCharité Comprehensive Cancer Center, Berlin, Germany.
Sunil A ReddyStanford University, Stanford, CA, USA.
Michael C LoweEmory University, Atlanta, GA, USA.
Georgia M BeasleyDuke University, Durham, NC, USA.
Anja GesierichUniversity Hospital Würzburg, Würzburg, Germany.
Armin BenderUniversity Hospital Marburg, Marburg, Germany.
Martin GschnellUniversity Hospital Marburg, Marburg, Germany.
Reinhard DummerUniversity Hospital Zürich, Zürich, Switzerland.
Michel RivoireLéon Bérard Center, Lyon, France.
Ana AranceHospital Clínic Barcelona, Barcelona, Spain.
Stephen William FenwickLiverpool University Hospitals, NHS Foundation Trust, Liverpool, UK.
Joseph J SaccoThe Clatterbridge Cancer Center, University of Liverpool, Liverpool, UK.
Sebastian HaferkampUniversity Hospital Regensburg, Regensburg, Germany.
Carsten WeishauptUniversity Hospital Münster, Münster, Germany.
Johnny JohnDelcath Systems, Inc., Queensbury, NY, USA.
Matthew WheaterUniversity Hospital Southampton, NHS Foundation Trust, Southampton, UK.
Christian H OttensmeierLiverpool University Hospitals, NHS Foundation Trust, Liverpool, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMetastatic uveal melanoma (mUM) has a poor prognosis, with liver metastases typically presenting a therapeutic challenge. Melphalan/Hepatic Delivery System (Melphalan/HDS) is a drug/medical device combination used for liver-directed treatment of unresectable mUM patients. This study assessed efficacy and safety of Melphalan/HDS versus best alternative care (BAC).

methodsEligible patients with unresectable mUM were randomized (1:1) to receive Melphalan/HDS (3 mg/kg ideal body weight) once every 6 to 8 weeks for a maximum of 6 cycles or BAC. Due to slow enrollment and patient reluctance to receive BAC treatment, the study design was amended to a single-arm Melphalan/HDS study, and all efficacy analyses of the randomized study were treated as exploratory.

resultsThe study enrolled 85 patients. Eligible patients were randomized to receive Melphalan/HDS (n = 43) or BAC (n = 42), and 72 patients received study treatment (Melphalan/HDS [n = 40]; BAC [n = 32]). Exploratory analyses of efficacy endpoints showed numerical differences consistently favoring the Melphalan/HDS arm versus BAC (median overall survival: 18.5 vs. 14.5 months; median progression-free survival: 9.1 vs. 3.3 months; objective response rate: 27.5% vs. 9.4%; and disease control rate: 80.0% vs. 46.9%). Serious adverse events (SAEs) occurred in 51.2% of Melphalan/HDS and in 21.9% of BAC patients. The most common (>5%) SAEs included thrombocytopenia (19.5%), neutropenia (9.8%), leukopenia (9.8%) and febrile neutropenia (7.3%) in Melphalan/HDS patients and cholecystitis, nausea and vomiting (6.3% each) in BAC patients. No treatment-related deaths were observed.

conclusionTreatment with Melphalan/HDS shows clinically meaningful efficacy and demonstrates a favorable benefit-risk profile in patients with unresectable mUM as compared to BAC.

Indexed as

Antineoplastic Agents, AlkylatingDrug Delivery SystemsLiver NeoplasmsMelanomaMelphalanUveal NeoplasmsAdultAgedFemaleFollow-Up StudiesHumansMaleMiddle AgedPrognosisSurvival RateUveal MelanomaAntineoplastic Agents, AlkylatingMelphalanLiver-directed therapyMelphalan/Hepatic Delivery SystemMetastatic uveal melanomaOcular melanomaPercutaneous hepatic perfusion

Identifiers

PMID40192993
PMCPMC12130151

What OpenQuestion holds

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Registered trials

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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.