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J Surg Oncol. 2017 Jun;115(7):891-897. doi: 10.1002/jso.24580. Epub 2017 Feb 23.

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.

Author information

1
Department of Radiation Oncology, Princess Alexandra Hospital, Queensland Health, Brisbane, Australia.
2
School of Medicine, The University of Queensland, Princess Alexandra Hospital, Brisbane, Australia.
3
Queensland Melanoma Project, Princess Alexandra Hospital, Queensland Health, Brisbane, Australia.
4
Departmentof Plastic and Reconstructive Surgery, Princess Alexandra Hospital, Queensland Health, Brisbane, Australia.

Abstract

BACKGROUND:

In-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.

METHODS:

An 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.

RESULTS:

Fifteen 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.

CONCLUSIONS:

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

KEYWORDS:

PV-10; in-transit; melanoma; metastases; radiotherapy; trial

PMID:
28230241
PMCID:
PMC6221132
DOI:
10.1002/jso.24580
[Indexed for MEDLINE]
Free PMC Article

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