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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.

journal of surgical oncology

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