Evidence map›Paper›PMID 26597368›Full record

Trial reportAnnals of surgical oncology2016

Results of a Randomized Controlled Multicenter Phase III Trial of Percutaneous Hepatic Perfusion Compared with Best Available Care for Patients with Melanoma Liver Metastases.

Marybeth S Hughes, Jonathan Zager, Mark Faries, H Richard Alexander, Richard E Royal, Bradford Wood, Junsung Choi, Kevin McCluskey, Eric Whitman, Sanjiv Agarwala and 6 more

Open access · greenAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Annals of surgical oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 74 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 5 pooled it
8.0field-weighted citation impact, top 2% 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

74 citing papers in PubMed, 5 syntheses or guidelines pooled it, 146 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Cryotherapy for liver metastases.The Cochrane database of systematic reviews · 2019
    Pooled it
  4. Systemic treatments for metastatic cutaneous melanoma.The Cochrane database of systematic reviews · 2018
    Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. The Current State of Systemic Therapy of Metastatic Uveal Melanoma.American journal of clinical dermatology · 2024
    Review

14 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 13 institutions in 1 country.

Marybeth S HughesCenter for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Jonathan ZagerH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Mark FariesJohn Wayne Cancer Institute, Providence St. John's Health Center, Santa Monica, CA, USA.
H Richard AlexanderMarlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, MD, USA.
Richard E RoyalM.D. Anderson Cancer Center, University of Texas, Houston, TX, USA.
Bradford WoodCenter for Interventional Oncology, National Institutes of Health, Bethesda, MD, USA.
Junsung ChoiH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Kevin McCluskeyUniversity of Pittsburgh Schools of the Health Sciences, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Eric WhitmanCarol G. Simon Cancer Center, Atlantic Health System, Morristown, NJ, USA.
Sanjiv AgarwalaSt. Luke's Cancer Center, Bethlehem, PA, USA.
Gary SiskinAlbany Medical Neurosciences Institute, Albany, NY, USA.
Charles NuttingRIA Endovascular, Greenwood Village, CO, USA.
Mary Ann ToomeyCenter for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Carole WebbCenter for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
Tatiana BeresnevCenter for Cancer Research, National Cancer Institute, Bethesda, MD, USA.
James F PingpankUniversity of Pittsburgh Schools of the Health Sciences, University of Pittsburgh Medical Center, Pittsburgh, PA, USA. pingpankjf@upmc.edu.
Center for Cancer Research · USMoffitt Cancer Center · USNational Cancer Institute · USAlbany Medical Center Hospital · USAtlantic Health System · USNational Institutes of Health Clinical Center · USSaint John's Health Center · USSensory Processing Disorder Foundation · USSt. Luke's University Health Network · USThe University of Texas MD Anderson Cancer Center · USUniversity of Maryland, Baltimore · USUniversity of Pittsburgh Medical Center · USUPMC Hillman Cancer Center · US

Funding

Center for Interventional OncologyZIDBC011242 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI WOOD, BRADFORD J · 2009 to 2025
$18.7M
Interventional OncologyZIACL040015 · CLC · CLINICAL CENTER · PI WOOD, BRADFORD · 2009 to 2025
$0k
Intramural NIH HHS ZID BC011242
6 · The paper itself

Abstract

purposeThere is no consensus for the treatment of melanoma metastatic to the liver. Percutaneous hepatic perfusion with melphalan (PHP-Mel) is a method of delivering regional chemotherapy selectively to the liver. In this study, we report the results of a multicenter, randomized controlled trial comparing PHP-Mel with best alternative care (BAC) for patients with ocular or cutaneous melanoma metastatic to the liver. PATIENTS AND

methodsA total of 93 patients were randomized to PHP-Mel (n = 44) or BAC (n = 49). On the PHP-Mel arm, melphalan was delivered via the hepatic artery, and the hepatic effluent captured and filtered extracorporeally prior to return to the systemic circulation via a venovenous bypass circuit. PHP-Mel was repeatable every 4-8 weeks. The primary endpoint was hepatic progression-free survival (hPFS), and secondary endpoints included overall PFS (oPFS), overall survival (OS), hepatic objective response (hOR), and safety.

resultshPFS was 7.0 months for PHP-Mel and 1.6 months for BAC (p < 0.0001), while oPFS was 5.4 months for PHP-Mel and 1.6 months for BAC (p < 0.0001). Median OS was not significantly different (PHP-Mel 10.6 months vs. BAC 10.0 months), likely due to crossover to PHP-Mel treatment (57.1 %) from the BAC arm, and the hOR was 36.4 % for PHP-Mel and 2.0 % for BAC (p < 0.001). The majority of adverse events were related to bone marrow suppression. Four deaths were attributed to PHP-Mel, three in the primary PHP-Mel group, and one post-crossover to PHP-Mel from BAC.

conclusionThis randomized, phase III study demonstrated the efficacy of the PHP-Mel procedure. hPFS, oPFS, and hOR were significantly improved with PHP-Mel. PHP with melphalan should provide a new treatment option for unresectable metastatic melanoma in the liver.

Indexed as

Hepatic ArteryAdultAgedAntineoplastic Combined Chemotherapy ProtocolsChemotherapy, Cancer, Regional PerfusionEmbolization, TherapeuticEye NeoplasmsFemaleFollow-Up StudiesHumansInfusions, Intra-ArterialLiver NeoplasmsMaleMelanomaMiddle AgedNeoplasm Staging

Identifiers

PMID26597368
PMCPMC8185532
OpenAlexW2175338710

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.