Intralesional PV-10 for the treatment of in-transit melanoma metastases-Results of a prospective, non-randomized, single center study

Read, Tavis A., Smith, Aaron, Thomas, Janine, David, Michael, Foote, Matthew, Wagels, Michael, Barbour, Andrew and Smithers, B. Mark (2018) Intralesional PV-10 for the treatment of in-transit melanoma metastases-Results of a prospective, non-randomized, single center study. Journal of Surgical Oncology, 117 4: 579-587. doi:10.1002/jso.24921


Author Read, Tavis A.
Smith, Aaron
Thomas, Janine
David, Michael
Foote, Matthew
Wagels, Michael
Barbour, Andrew
Smithers, B. Mark
Title Intralesional PV-10 for the treatment of in-transit melanoma metastases-Results of a prospective, non-randomized, single center study
Journal name Journal of Surgical Oncology   Check publisher's open access policy
ISSN 1096-9098
0022-4790
Publication date 2018-03-12
Year available 2018
Sub-type Article (original research)
DOI 10.1002/jso.24921
Open Access Status Not yet assessed
Volume 117
Issue 4
Start page 579
End page 587
Total pages 9
Place of publication Hoboken, NJ, United States
Publisher John Wiley & Sons
Language eng
Subject 2746 Surgery
2730 Oncology
Abstract Background: Patients with in-transit melanoma metastases frequently experience high rates of recurrence, limited overall survival and reduced quality of life. After promising results within a Phase II, multi-center study, PV-10 treatment was continued at our institution for patients with in-transit disease. Methodology: An open-label, non-randomized, prospective study was performed at the Princess Alexandra Hospital, Queensland, Australia. Patients were treated with PV-10 in accordance with the treatment protocol established during a previous Phase II study. The primary outcome was the complete response of treated lesions. Results: Forty-five patients were enrolled over a total of 82 treatment episodes from July 2008 to December 2015. With sequential PV-10 treatments the complete response rate was 42% and overall response rate 87% on an intention to treat analysis. The median follow-up duration was 22 months and the median overall survival was 25 months from first PV-10 treatment. Having fewer than 15 metastases at the time of treatment was associated with a complete response (P = 0.03). Conclusions: Intralesional PV-10 provided rapid lesion-specific ablation of melanoma metastases with well-tolerated local effects and minimal systemic adverse events. This therapy should be considered for patients with multiple accessible deposits within the spectrum of low to moderate disease volume.
Formatted abstract
Background: Patients with in‐transit melanoma metastases frequently experience high rates of recurrence, limited overall survival and reduced quality of life. After promising results within a Phase II, multi‐center study, PV‐10 treatment was continued at our institution for patients with in‐transit disease.

Methodology: An open‐label, non‐randomized, prospective study was performed at the Princess Alexandra Hospital, Queensland, Australia. Patients were treated with PV‐10 in accordance with the treatment protocol established during a previous Phase II study. The primary outcome was the complete response of treated lesions.

Results: Forty‐five patients were enrolled over a total of 82 treatment episodes from July 2008 to December 2015. With sequential PV‐10 treatments the complete response rate was 42% and overall response rate 87% on an intention to treat analysis. The median follow‐up duration was 22 months and the median overall survival was 25 months from first PV‐10 treatment. Having fewer than 15 metastases at the time of treatment was associated with a complete response (P = 0.03).

Conclusions: Intralesional PV‐10 provided rapid lesion‐specific ablation of melanoma metastases with well‐tolerated local effects and minimal systemic adverse events. This therapy should be considered for patients with multiple accessible deposits within the spectrum of low to moderate disease volume.
Keyword PV-10
Rose Bengal
In-transit
Intralesional
Melanoma
Metastases
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: HERDC Pre-Audit
School of Health and Rehabilitation Sciences Publications
School of Medicine Publications
 
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Created: Wed, 14 Mar 2018, 10:00:44 EST