Evidence map›Paper›PMID 28230241›Full record

Trial reportJournal of surgical oncology2017

Results of a phase II, open-label, non-comparative study of intralesional PV-10 followed by radiotherapy for the treatment of in-transit or metastatic melanoma.

Matthew Foote, Tavis Read, Janine Thomas, Michael Wagels, Bryan Burmeister, B Mark Smithers

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of surgical oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing 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

14 citing papers in PubMed.

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  10. The Abscopal Effect: A Review of Pre-Clinical and Clinical Advances.International journal of molecular sciences · 2021
    Review
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  12. Article
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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

6 authors.

Matthew FooteDepartment of Radiation Oncology, Princess Alexandra Hospital, Queensland Health, Brisbane, Australia.
Tavis ReadSchool of Medicine, The University of Queensland, Princess Alexandra Hospital, Brisbane, Australia.
Janine ThomasQueensland Melanoma Project, Princess Alexandra Hospital, Queensland Health, Brisbane, Australia.
Michael WagelsSchool of Medicine, The University of Queensland, Princess Alexandra Hospital, Brisbane, Australia.
Bryan BurmeisterDepartment of Radiation Oncology, Princess Alexandra Hospital, Queensland Health, Brisbane, Australia.
B Mark SmithersSchool of Medicine, The University of Queensland, Princess Alexandra Hospital, Brisbane, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn-transit and recurrent dermal or subcutaneous melanoma metastases represent a significant burden of advanced disease. Intralesional Rose Bengal can elicit tumor selective ablation and a T-cell mediated abscopal effect in untreated lesions. A subset of patients in a phase II trial setting received external beam radiotherapy to their recurrent lesions with complete or partial response and no significant acute radiation reaction.

methodsAn open-label, single-arm phase II study was performed to assess the efficacy and safety of PV-10 followed by hypofractionated radiotherapy. Patients had in-transit melanoma metastases suitable for IL therapy and radiotherapy.

resultsFifteen patients were enrolled and thirteen completed both treatment components. The overall response rate was 86.6% and the clinical benefit was 93.3% on an intention to treat analysis (CR 33.3%, PR 53.3%, SD 6.7%). The median follow up duration was 19.25 months. Size of metastases (<10 mm) predicted lesion complete response (74.6%). Treatment was well tolerated with no associated grade 4 or 5 adverse events.

conclusionsThe combination of PV-10 and radiotherapy resulted in lesion-specific, normal tissue-sparing, ablation of disease with minimal local or systemic adverse effects.

Indexed as

Radiotherapy, AdjuvantAdultAgedAged, 80 and overFemaleFluorescent DyesHumansInjections, IntralesionalMaleMelanomaMiddle AgedNeoplasm Recurrence, LocalRadiation Dose HypofractionationRose BengalSkin NeoplasmsFluorescent DyesRose Bengalin-transitmelanomametastasesPV-10radiotherapytrial

Identifiers

PMID28230241
PMCPMC6221132

What OpenQuestion holds

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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.