Evidence map›Paper›PMID 25348780›Full record

Trial reportAnnals of surgical oncology2015

Phase 2 Study of Intralesional PV-10 in Refractory Metastatic Melanoma.

John F Thompson, Sanjiv S Agarwala, B Mark Smithers, Merrick I Ross, Charles R Scoggins, Brendon J Coventry, Susan J Neuhaus, David R Minor, Jamie M Singer, Eric A Wachter

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Annals of surgical oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 63 papers.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed
4.0field-weighted citation impact, top 5% 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

63 citing papers in PubMed, 148 citations in OpenAlex.

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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

10 authors at 8 institutions in 2 countries.

John F ThompsonMelanoma Institute Australia and the University of Sydney, Sydney, NSW, Australia.
Sanjiv S Agarwala
B Mark Smithers
Merrick I Ross
Charles R Scoggins
Brendon J Coventry
Susan J Neuhaus
David R Minor
Jamie M Singer
Eric A Wachter
California Pacific Medical Center · USPrincess Alexandra Hospital · AURoyal Adelaide Hospital · AUSt. Luke's-Roosevelt Hospital Center · USThe University of Adelaide · AUThe University of Sydney · AUThe University of Texas MD Anderson Cancer Center · USUniversity of Louisville · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
6 · The paper itself

Abstract

purposeThis international, multicenter, single-arm trial assessed efficacy and safety of intralesional rose bengal (PV-10) in 80 patients with refractory cutaneous or subcutaneous metastatic melanoma.

methodsSixty-two stage III and 18 stage IV melanoma patients with disease refractory to a median of six prior interventions received intralesional PV-10 into up to 20 cutaneous and subcutaneous lesions up to four times over a 16-week period and were followed for 52 weeks. Objectives were to determine best overall response rate in injected target lesions and uninjected bystander lesions, assess durability of response, and characterize adverse events.

resultsFor target lesions, the best overall response rate was 51 %, and the complete response rate was 26 %. Median time to response was 1.9 months, and median duration of response was 4.0 months, with 8 % of patients having no evidence of disease after 52 weeks. Response was dependent on untreated disease burden, with complete response achieved in 50 % of patients receiving PV-10 to all of their disease. Response of target lesions correlated with bystander lesion regression and the occurrence of locoregional blistering. Adverse events were predominantly mild to moderate and locoregional to the treatment site, with no treatment-associated grade 4 or 5 adverse events.

conclusionsIntralesional PV-10 yielded durable local control with high rates of complete response. Toxicity was confined predominantly to the injection site. Cutaneous bystander tumor regression is consistent with an immunologic response secondary to ablation. This intralesional approach for local disease control could be complementary to current and investigational treatments for melanoma.

Indexed as

AdultAgedAged, 80 and overFemaleFluorescent DyesFollow-Up StudiesHumansInjections, IntralesionalLymphatic MetastasisMaleMelanomaMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPrognosisRose BengalFluorescent DyesRose Bengal

Identifiers

PMID25348780
PMCPMC4458269
OpenAlexW2069438330

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.