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.
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.
authors.affiliation: Department of Radiation Oncology, Princess Alexandra Hospital, Queensland Health, Brisbane, Australia.|School of Medicine, The University of Queensland, Princess Alexandra Hospital, Brisbane, Australia.|Queensland Melanoma Project, Princess Alexandra Hospital, Queensland Health, Brisbane, Australia.
authors.forename: Matthew
authors.initials: M
authors.lastname: Foote
authors.affiliation: School of Medicine, The University of Queensland, Princess Alexandra Hospital, Brisbane, Australia.|Departmentof Plastic and Reconstructive Surgery, Princess Alexandra Hospital, Queensland Health, Brisbane, Australia.|Queensland Melanoma Project, Princess Alexandra Hospital, Queensland Health, Brisbane, Australia.
authors.forename: Tavis
authors.initials: T
authors.lastname: Read
authors.affiliation: Queensland Melanoma Project, Princess Alexandra Hospital, Queensland Health, Brisbane, Australia.
authors.forename: Janine
authors.initials: J
authors.lastname: Thomas
authors.affiliation: School of Medicine, The University of Queensland, Princess Alexandra Hospital, Brisbane, Australia.|Departmentof Plastic and Reconstructive Surgery, Princess Alexandra Hospital, Queensland Health, Brisbane, Australia.|Queensland Melanoma Project, Princess Alexandra Hospital, Queensland Health, Brisbane, Australia.
authors.forename: Michael
authors.initials: M
authors.lastname: Wagels
authors.affiliation: Department of Radiation Oncology, Princess Alexandra Hospital, Queensland Health, Brisbane, Australia.|Queensland Melanoma Project, Princess Alexandra Hospital, Queensland Health, Brisbane, Australia.
authors.forename: Bryan
authors.initials: B
authors.lastname: Burmeister
authors.affiliation: School of Medicine, The University of Queensland, Princess Alexandra Hospital, Brisbane, Australia.|Queensland Melanoma Project, Princess Alexandra Hospital, Queensland Health, Brisbane, Australia.
authors.forename: B Mark
authors.initials: BM
authors.lastname: Smithers
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005456:Fluorescent Dyes / Q000627:therapeutic use*; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D008545:Melanoma / Q000401:mortality / Q000556:secondary / Q000628:therapy*; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D000069473:Radiation Dose Hypofractionation; D018714:Radiotherapy, Adjuvant; D012395:Rose Bengal / Q000627:therapeutic use*; D012878:Skin Neoplasms / Q000401:mortality / Q000556:secondary / Q000628:therapy*
chemical_list: D005456:Fluorescent Dyes; D012395:Rose Bengal
keywords: PV-10; in-transit; melanoma; metastases; radiotherapy; trial