Evidence map›Paper›PMID 32761328›Full record

Trial reportAnnals of surgical oncology2021

Percutaneous Hepatic Perfusion with Melphalan in Patients with Unresectable Ocular Melanoma Metastases Confined to the Liver: A Prospective Phase II Study.

T Susanna Meijer, Mark C Burgmans, Eleonora M de Leede, Lioe-Fee de Geus-Oei, Bas Boekestijn, Henricus J M Handgraaf, Denise E Hilling, Jacob Lutjeboer, Jaap Vuijk, Christian H Martini and 6 more

Open access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Annals of surgical oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
2.9field-weighted citation impact, top 8% of its field
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

26 citing papers in PubMed, 34 citations in OpenAlex.

  1. Trial
  2. Trial
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  4. Article
  5. Review
  6. Article
  7. Review
  8. Article
  9. Management of liver metastases from uveal melanoma.The British journal of surgery · 2025
    Review
  10. Article
  11. The Current State of Systemic Therapy of Metastatic Uveal Melanoma.American journal of clinical dermatology · 2024
    Review
  12. Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Regional chemotherapy for uveal melanoma liver metastases.International journal of ophthalmology · 2023
    Review
  20. 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

16 authors at 1 institution in 1 country.

T Susanna MeijerDepartment of Radiology, Leiden University Medical Center, Leiden, The Netherlands. t.s.meijer@lumc.nl.ORCID http://orcid.org/0000-0003-2257-3232
Mark C BurgmansDepartment of Radiology, Leiden University Medical Center, Leiden, The Netherlands.
Eleonora M de LeedeDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
Lioe-Fee de Geus-OeiDepartment of Radiology, Leiden University Medical Center, Leiden, The Netherlands.
Bas BoekestijnDepartment of Radiology, Leiden University Medical Center, Leiden, The Netherlands.
Henricus J M HandgraafDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
Denise E HillingDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
Jacob LutjeboerDepartment of Radiology, Leiden University Medical Center, Leiden, The Netherlands.
Jaap VuijkDepartment of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands.
Christian H MartiniDepartment of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands.
Arian R van ErkelDepartment of Radiology, Leiden University Medical Center, Leiden, The Netherlands.
Rutger W van der MeerDepartment of Radiology, Leiden University Medical Center, Leiden, The Netherlands.
Fred G J TijlDepartment of Extra Corporal Circulation, Leiden University Medical Center, Leiden, The Netherlands.
Frank M SpeetjensDepartment of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.
Ellen KapiteijnDepartment of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.
Alexander L VahrmeijerDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
Leiden University Medical Center · NL

Funding

Delcath Systems Inc, New York, NY, USA No grant number applies
6 · The paper itself

Abstract

backgroundOcular melanoma is the most common primary intraocular malignancy and has a very poor prognosis once liver metastases occur. The aim of this study was to prospectively assess the efficacy and safety of percutaneous hepatic perfusion with melphalan (M-PHP) using the new second-generation (GEN 2) hemofiltration system in patients with ocular melanoma metastases confined to the liver.

methodsProspective, single-center, single-arm, phase II study including patients with unresectable ocular melanoma metastases confined to the liver. Treatment consisted of two M-PHP procedures at 6-8 weeks interval. Procedures were performed using the CHEMOSAT (GEN 2) system with 3 mg/kg melphalan. Primary endpoints were overall response rate (ORR) and best overall response (BOR). Secondary endpoints included overall survival (OS), progression-free survival (PFS), hepatic PFS (hPFS), and safety.

resultsSixty-four M-PHP procedures were performed in 35 patients between February 2014 and June 2017. The ORR was 72%. BOR was as follows: complete response in 3%, partial response in 69%, stable disease in 13%, and progressive disease in 16%. There was no treatment-related mortality. Fourteen serious adverse events occurred. At a median follow-up of 19.1 months (range 5.6-69.5), median OS was 19.1 months and was significantly longer in responders than in nonresponders (27.5 vs. 11.9 months, p < 0.001). The 1- and 2-year OS was 77% and 43%, respectively. PFS and hPFS were 7.6 and 11.2 months, respectively.

conclusionsM-PHP using the GEN 2 filter can achieve a high ORR and prolonged survival in patients with liver-only ocular melanoma metastases.

Indexed as

Liver NeoplasmsMelanomaAntineoplastic Agents, AlkylatingChemotherapy, Cancer, Regional PerfusionFemaleHumansLiverMaleMelphalanPerfusionProspective StudiesAntineoplastic Agents, AlkylatingMelphalan

Identifiers

PMID32761328
PMCPMC7801354
OpenAlexW3047450798

What OpenQuestion holds

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LicenceCC BY
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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.