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

Foote, Matthew, Read, Tavis, Thomas, Janine, Wagels, Michael, Burmeister, Bryan and Smithers, B. Mark (2017) 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. Journal of Surgical Oncology, . doi:10.1002/jso.24580


Author Foote, Matthew
Read, Tavis
Thomas, Janine
Wagels, Michael
Burmeister, Bryan
Smithers, B. Mark
Title 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
Journal name Journal of Surgical Oncology   Check publisher's open access policy
ISSN 1096-9098
0022-4790
Publication date 2017-02-23
Sub-type Article (original research)
DOI 10.1002/jso.24580
Open Access Status DOI
Total pages 7
Place of publication Hoboken, NJ, United States
Publisher John Wiley & Sons
Collection year 2018
Language eng
Formatted 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 (<10mm) 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.
Keyword In-transit
Melanoma
Metastases
PV-10
Radiotherapy
Trial
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 Medicine Publications
 
Versions
Version Filter Type
Citation counts: Scopus Citation Count Cited 0 times in Scopus Article
Google Scholar Search Google Scholar
Created: Tue, 14 Mar 2017, 00:24:17 EST by System User on behalf of Learning and Research Services (UQ Library)