Evidence map›Paper›PMID 41461960›Full record

Trial reportJournal of cancer research and clinical oncology2025

Subgroup analyses of the phase 3 FOCUS study of melphalan/hepatic delivery system 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, Erika Richtig, Sebastian Ochsenreither, Sunil A Reddy and 11 more

Abstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Journal of cancer research and clinical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed.

  1. 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

21 authors.

Jonathan S ZagerDepartments of Cutaneous Oncology and Sarcoma, Moffitt Cancer Center, Tampa, FL, USA. Jonathan.Zager@moffitt.org.
Marlana OrloffThomas Jefferson University, Philadelphia, PA, USA.
Pier Francesco FerrucciMultiMedica Group, Milan, Italy.
Junsung ChoiDepartments of Cutaneous Oncology and Sarcoma, Moffitt Cancer Center, Tampa, FL, USA.
David J EschelmanThomas Jefferson University, Philadelphia, PA, USA.
Evan S GlazerThe University of Tennessee Health Science Center, Memphis, TN, USA.
Aslam EjazUniversity of Illinois Chicago, Chicago, IL, USA.
Erika RichtigMedical University of Graz, Graz, Austria.
Sebastian OchsenreitherCharité Hospital Berlin, 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.
Martin GschnellUniversity Hospital Marburg, Marburg, Germany.
Reinhard DummerUniversity Hospital Zürich, Zurich, Switzerland.
Ana AranceHospital Clínic Barcelona, Barcelona, Spain.
Stephen William FenwickLiverpool University Hospitals, Liverpool, UK.
Joseph J SaccoThe Clatterbridge Cancer Center, University of Liverpool, Liverpool, UK.
Johnny JohnDelcath Systems, Queensbury, NY, USA.
Matthew WheaterUniversity Hospital Southampton, Southampton, UK.
Christian H OttensmeierLiverpool University Hospitals, Liverpool, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo assess efficacy and safety in subgroups of patients treated with Melphalan/Hepatic Delivery System (melphalan/HDS), a drug/device combination for liver-directed treatment of metastatic UM (mUM) patients. Previously reported FOCUS study results indicated melphalan/HDS treatment provides a clinically meaningful response rate and favorable benefit-risk ratio in patients with unresectable mUM.

methodsPatients with mUM received treatment with melphalan (3.0 mg/kg ideal body weight) every 6-8 weeks for up to 6 cycles. Post hoc analyses of efficacy and safety were conducted for patient subgroups based on demographic and baseline disease characteristics.

results102 patients with mUM were enrolled; treatment was attempted in 95 patients; 91 patients received treatment. Subgroup analyses showed consistent tumor response regardless of age, sex, geographic region, presence/absence of extrahepatic lesions, and prior therapy. Patients with lower tumor burden had better objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) than those with higher tumor burden (ORR: 51.1 vs. 22.2%, p = 0.008; mPFS: 11.3 vs. 5.8 months, p = 0.007; mOS: 26.7 vs. 15.4 months, p = 0.008). Patients with 1-25% liver involvement had higher mOS than those with 26-50% liver involvement (22.4 vs. 16.9 months; p = 0.030); patients with low or normal lactate dehydrogenase (LDH) had higher mOS than those with elevated LDH (23.5 vs. 15.3 months; p = 0.019). The overall safety profile was similar across subgroups without evidence of cumulative toxicity with successive treatment cycles.

conclusionResults demonstrate a favorable benefit-risk profile for melphalan/HDS across clinically relevant subgroups. However, early treatment in patients with low tumor burden may offer best results.

Indexed as

Antineoplastic Agents, AlkylatingLiver NeoplasmsMelanomaMelphalanUveal NeoplasmsAdultAgedAged, 80 and overDrug Delivery SystemsFemaleHumansMaleMiddle AgedUveal MelanomaAntineoplastic Agents, AlkylatingMelphalanLiver-directed therapyMelphalan/HDSMelphalan/Hepatic Delivery SystemMetastatic uveal melanomaOcular melanomaPercutaneous Hepatic Perfusion (PHP)

Identifiers

PMID41461960
PMCPMC12748326

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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.