Sunday, March 19, 2017

PV-10 followed by radiation = ORR of 86% in in-transit, dermal and sub q melanoma

I have been yelling about intralesionals and Rose Bengal (PV-10) for YEARS!!!!!!!!!!!!!

Here's a review:
2016: Intralesional Therapy....and patterns of response from the T-VEC OPTiM trial
2016: Intralesional PV-10 (Rose Bengal, y'all!!!) positive treatment for in-transit melanoma
ASCO 2016: New studies! Rose Bengal and Pembro for Stage IV y'all!!! Enrolling! For Stage IIIb/c: PV-10 vs T-VEC.
2016: Study on Intralesional Rose Bengal out of Moffitt...we know a bit more about HOW it works!!!
2016: CAVATAK - intralesional therapy derived from the coxsackievirus
And finally, this one...with 3 links to additional reports from 2014, 2013, and 2012, and2014: More info from ASCO....PV-10...Rose Bengal for melanoma....

Now, there is this......

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, Read, Thomas, et al. J Surg Oncol. 2017 Feb 23.

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.
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.
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. The median follow up duration was 19.25 months. Size of metastases (less than10 mm) predicted lesion complete response (74.6%). Treatment was well tolerated with no associated grade 4 or 5 adverse events.  
The combination of PV-10 and radiotherapy resulted in lesion-specific, normal tissue-sparing, ablation of disease with minimal local or systemic adverse effects.

Small numbers of patients, but the results - "Not bad, not at all bad!!!" - c

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