PMID- 28230241
OWN - NLM
STAT- MEDLINE
DCOM- 20170823
LR  - 20181207
IS  - 1096-9098 (Electronic)
IS  - 0022-4790 (Linking)
VI  - 115
IP  - 7
DP  - 2017 Jun
TI  - 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.
PG  - 891-897
LID - 10.1002/jso.24580 [doi]
AB  - 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.
CI  - (c) 2017 Wiley Periodicals, Inc.
FAU - Foote, Matthew
AU  - Foote M
AD  - Department of Radiation Oncology, Princess Alexandra Hospital, Queensland Health,
      Brisbane, Australia.
AD  - School of Medicine, The University of Queensland, Princess Alexandra Hospital,
      Brisbane, Australia.
AD  - Queensland Melanoma Project, Princess Alexandra Hospital, Queensland Health,
      Brisbane, Australia.
FAU - Read, Tavis
AU  - Read T
AD  - School of Medicine, The University of Queensland, Princess Alexandra Hospital,
      Brisbane, Australia.
AD  - Departmentof Plastic and Reconstructive Surgery, Princess Alexandra Hospital,
      Queensland Health, Brisbane, Australia.
AD  - Queensland Melanoma Project, Princess Alexandra Hospital, Queensland Health,
      Brisbane, Australia.
FAU - Thomas, Janine
AU  - Thomas J
AD  - Queensland Melanoma Project, Princess Alexandra Hospital, Queensland Health,
      Brisbane, Australia.
FAU - Wagels, Michael
AU  - Wagels M
AD  - School of Medicine, The University of Queensland, Princess Alexandra Hospital,
      Brisbane, Australia.
AD  - Departmentof Plastic and Reconstructive Surgery, Princess Alexandra Hospital,
      Queensland Health, Brisbane, Australia.
AD  - Queensland Melanoma Project, Princess Alexandra Hospital, Queensland Health,
      Brisbane, Australia.
FAU - Burmeister, Bryan
AU  - Burmeister B
AD  - Department of Radiation Oncology, Princess Alexandra Hospital, Queensland Health,
      Brisbane, Australia.
AD  - Queensland Melanoma Project, Princess Alexandra Hospital, Queensland Health,
      Brisbane, Australia.
FAU - Smithers, B Mark
AU  - Smithers BM
AD  - School of Medicine, The University of Queensland, Princess Alexandra Hospital,
      Brisbane, Australia.
AD  - Queensland Melanoma Project, Princess Alexandra Hospital, Queensland Health,
      Brisbane, Australia.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20170223
PL  - United States
TA  - J Surg Oncol
JT  - Journal of surgical oncology
JID - 0222643
RN  - 0 (Fluorescent Dyes)
RN  - 1ZPG1ELY14 (Rose Bengal)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Female
MH  - Fluorescent Dyes/*therapeutic use
MH  - Humans
MH  - Injections, Intralesional
MH  - Male
MH  - Melanoma/mortality/secondary/*therapy
MH  - Middle Aged
MH  - Neoplasm Recurrence, Local
MH  - Radiation Dose Hypofractionation
MH  - *Radiotherapy, Adjuvant
MH  - Rose Bengal/*therapeutic use
MH  - Skin Neoplasms/mortality/secondary/*therapy
PMC - PMC6221132
OTO - NOTNLM
OT  - PV-10
OT  - in-transit
OT  - melanoma
OT  - metastases
OT  - radiotherapy
OT  - trial
EDAT- 2017/02/24 06:00
MHDA- 2017/08/24 06:00
CRDT- 2017/02/24 06:00
PHST- 2016/10/11 00:00 [received]
PHST- 2016/12/28 00:00 [revised]
PHST- 2017/01/20 00:00 [accepted]
PHST- 2017/02/24 06:00 [pubmed]
PHST- 2017/08/24 06:00 [medline]
PHST- 2017/02/24 06:00 [entrez]
AID - 10.1002/jso.24580 [doi]
PST - ppublish
SO  - J Surg Oncol. 2017 Jun;115(7):891-897. doi: 10.1002/jso.24580. Epub 2017 Feb 23.