Evidence map›Paper›PMID 24510314›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2014

Hepatic intra-arterial versus intravenous fotemustine in patients with liver metastases from uveal melanoma (EORTC 18021): a multicentric randomized trial.

S Leyvraz, S Piperno-Neumann, S Suciu, J F Baurain, M Zdzienicki, A Testori, E Marshall, M Scheulen, T Jouary, S Negrier and 6 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00110123 (Intravenous Versus Intra-Arterial Fotemustine Chemotherapy in Patients With Liver Metastases From Uveal Melanoma), which is not on this map. Cited by 63 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 4 pooled it
10.0field-weighted citation impact, top 1% 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.

NCT00110123 phase3terminatednot on this map

Intravenous Versus Intra-Arterial Fotemustine Chemotherapy in Patients With Liver Metastases From Uveal Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group

TypeinterventionalSponsorEuropean Organisation for Research and Treatment of Cancer - EORTCRan2005Enrolled171ConditionsIntraocular Melanoma, Metastatic CancerArmsfotemustine, isolated perfusion
3 · Its place in the literature

Who cites it

63 citing papers in PubMed, 4 syntheses or guidelines pooled it, 143 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Potential of Nanoparticle-Based Phototherapies for Future Treatment of Uveal Melanoma.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
    Review
  11. Uveal Melanoma: Changing Paradigms of Treatment.Ocular oncology and pathology · 2026
    Review
  12. Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Article
  18. Management of liver metastases from uveal melanoma.The British journal of surgery · 2025
    Review
  19. Review
  20. Article

3 more citing papers are in PubMed but not listed here.

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 15 institutions in 8 countries.

S LeyvrazOncology Department, University Hospital, Lausanne, Switzerland. Electronic address: serge.leyvraz@chuv.ch.
S Piperno-NeumannInstitut Curie, Paris, France.
S SuciuEORTC Headquarters, Brussels.
J F BaurainCentre du Cancer, Cliniques Universitaires Saint-Luc, Brussels, Belgium.
M ZdzienickiMaria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.
A TestoriEuropean Institute of Oncology, Milan, Italy.
E MarshallClatterbridge Centre for Oncology, Wirral, UK.
M ScheulenWest German Cancer Center, University of Essen Medical School, Essen, Germany.
T JouaryUniversity Hospital Bordeaux Saint André, Bordeaux.
S NegrierLéon-Bérard Cancer Centre, Lyon, France.
J B VermorkenAntwerp University Hospital, Edegem, Belgium.
E KaempgenUniversitätsklinik Erlangen, Erlangen, Germany.
X DurandoCentre Jean Perrin, Clermont-Ferrand, France.
D SchadendorfUniversity Hospital Essen, Essen.
R Karra GurunathEORTC Headquarters, Brussels.
U KeilholzDepartment of Hematology and Medical Oncology, Charité, CBF, Berlin, Germany.
European Organisation for Research and Treatment of Cancer · NLAntwerp University Hospital · BECentre de Recherche en Cancérologie de Lyon · FRCentre Jean Perrin · FRCharité - Universitätsmedizin Berlin · DEClatterbridge Cancer Centre NHS Foundation Trust · GBCliniques Universitaires Saint-Luc · BEEssen University Hospital · DEEuropean Institute of Oncology · ITHôpital Saint-André · FRInstitut Curie · FRThe Maria Sklodowska-Curie National Research Institute of Oncology · PLUniversitätsklinikum Erlangen · DEUniversity Hospital of Lausanne · CHWest German Heart and Vascular Center Essen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn uveal melanoma (UM) with metastatic disease limited to the liver, the effect of an intrahepatic treatment on survival is unknown. We investigated prospectively the efficacy and toxicity of hepatic intra-arterial (HIA) versus systemic (IV) fotemustine in patients with liver metastases from UM. PATIENTS AND

methodsPatients were randomly assigned to receive either IV or HIA fotemustine at 100 mg/m(2) on days 1, 8, 15 (and 22 in HIA arm only) as induction, and after a 5-week rest period every 3 weeks as maintenance. Primary end point was overall survival (OS). Response rate (RR), progression-free survival (PFS) and safety were secondary end points.

resultsAccrual was stopped after randomization of 171 patients based on the results of a futility OS analysis. A total of 155 patients died and 16 were still alive [median follow-up 1.6 years (range 0.25-6 years)]. HIA did not improve OS (median 14.6 months) when compared with the IV arm (median 13.8 months), hazard ratio (HR) 1.09; 95% confidence interval (CI) 0.79-1.50, log-rank P = 0.59. However, there was a significant benefit on PFS for HIA compared with IV with a median of 4.5 versus 3.5 months, respectively (HR 0.62; 95% CI 0.45-0.84, log-rank P = 0.002). The 1-year PFS rate was 24% in the HIA arm versus 8% in the IV arm. An improved RR was seen in the HIA (10.5%) compared with IV treatment (2.4%). In the IV arm, the most frequent grade ≥3 toxicity was thrombocytopenia (42.1%) and neutropenia (62.6%), compared with 21.2% and 28.7% in the HIA arm. The main grade ≥3 toxicity related to HIA was catheter complications (12%) and liver toxicity (4.5%) apart from two toxic deaths.

conclusionHIA treatment with fotemustine did not translate into an improved OS compared with IV treatment, despite better RR and PFS. Intrahepatic treatment should still be considered as experimental. EUDRACT NUMBER AND CLINICALTRIALSGOV IDENTIFIER: 2004-002245-12 and NCT00110123.

Indexed as

Administration, IntravenousAdultAgedAged, 80 and overAntineoplastic AgentsDisease-Free SurvivalFemaleHepatic ArteryHumansInfusions, Intra-ArterialLiverLiver NeoplasmsMaleMelanomaMiddle AgedNitrosourea CompoundsAntineoplastic AgentsfotemustineNitrosourea CompoundsOrganophosphorus Compoundschemotherapyintra-hepatic treatmentliver metastasesuveal melanoma

Identifiers

PMID24510314
PMCPMC4433517
OpenAlexW2109536183

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.