PMID- 34883272
OWN - NLM
STAT- MEDLINE
DCOM- 20220308
LR  - 20220531
IS  - 1873-1597 (Electronic)
IS  - 1572-1000 (Linking)
VI  - 37
DP  - 2022 Mar
TI  - Efficacy and safety of HpD-PDT for Extramammary Paget's Disease refractory to 
      conventional therapy: A prospective, open-label and single arm pilot study.
PG  - 102670
LID - S1572-1000(21)00487-7 [pii]
LID - 10.1016/j.pdpdt.2021.102670 [doi]
AB  - BACKGROUND: Extramammary Paget's Disease (EMPD) is an intraepithelial cancer that 
      is prone to recurrence and sometimes refractory to therapy. A few EMPD cases have 
      been treated with Photodynamic therapy (PDT), which reported high complete 
      remission (CR) rates and low recurrence with hematoporphyrin derivatives (HpD) 
      The aim of this study was to further explore the efficacy and safety of HpD-PDT 
      for EMPD patients. METHODS: Open-label, single arm, pilot study was designed to 
      investigate the role of HpD-PDT in EMPD. The HpD sensitizer was given 
      intravenously at a dose of 3 or 5 mg/kg 48 h before light irradiation with a 
      laser 630 nm red light at a dose level of 150-200 J/cm(2). Clinical parameters 
      involving gender, age, disease course, previous treatment, tumor thickness, long 
      diameter of lesion, TNM staging, EMPD staging, HpD dosage, Visual Analogue Scale 
      (VAS) score, 1st month visit result, subsequent treatment, follow up period and 
      endpoint outcomes were collected to evaluate efficacy and safety of the 
      intervention. RESULTS: Eleven patients with pathologic confirmed EMPD were 
      treated with HpD-PDT. The thickness of skin lesions which were located in vulva, 
      penis, scrotum, and perianal area is 0.8 approximately 6.7 mm (mean thickness 2.9 mm). All 
      patients were followed up for an average of 17.4 months (12 approximately 27 months). Complete 
      remission (CR) rate and partial remission (PR) rate at the 1st month were 90.1% 
      (10/11) and 9.1% (1/11) respectively. At the end of follow-up, 72.7% of the 
      subjects (8/11) showed CR. Pain, infection, photosensitivity and uroschesis are 
      recorded as adverse events (AEs) in this population, and no event of hepatic 
      impairment was reported. After treatment, all the eleven patients showed 
      different degrees of scar in the treatment site, but none of them had any 
      structural or functional abnormalities. CONCLUSIONS: According to our study, 
      HpD-PDT in EMPD is able to offer acceptable disease outcomes including relatively 
      high CR rate, with good cosmetic and functional outcomes, and could be considered 
      a potential recommended therapy for patients with EMPD. TRIAL REGISTRATION: 
      Chinese Clinical Trial Register (ChiCTR-1900024965).
CI  - Copyright (c) 2021. Published by Elsevier B.V.
FAU - Wang, Dixin
AU  - Wang D
AD  - Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University 
      School of Medicine, Shanghai, China.
FAU - Wang, Peiru
AU  - Wang P
AD  - Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University 
      School of Medicine, Shanghai, China.
FAU - Li, Chunxiao
AU  - Li C
AD  - Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University 
      School of Medicine, Shanghai, China.
FAU - Zhou, Zhongxia
AU  - Zhou Z
AD  - Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University 
      School of Medicine, Shanghai, China.
FAU - Zhang, Linglin
AU  - Zhang L
AD  - Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University 
      School of Medicine, Shanghai, China.
FAU - Zhang, Guolong
AU  - Zhang G
AD  - Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University 
      School of Medicine, Shanghai, China.
FAU - Wang, Xiuli
AU  - Wang X
AD  - Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University 
      School of Medicine, Shanghai, China. Electronic address: 
      wangxiuli_1400023@tongji.edu.cn.
LA  - eng
PT  - Clinical Study
PT  - Journal Article
DEP - 20211207
PL  - Netherlands
TA  - Photodiagnosis Photodyn Ther
JT  - Photodiagnosis and photodynamic therapy
JID - 101226123
SB  - IM
MH  - Female
MH  - *Hematoporphyrin Photoradiation/adverse effects
MH  - Humans
MH  - Male
MH  - *Paget Disease, Extramammary/drug therapy
MH  - Pilot Projects
MH  - Prospective Studies
OTO - NOTNLM
OT  - Extramammary Paget's disease
OT  - Hematoporphyrin derivative
OT  - HpD-PDT
OT  - Photodynamic therapy
OT  - prospective study
EDAT- 2021/12/10 06:00
MHDA- 2022/03/09 06:00
CRDT- 2021/12/09 20:16
PHST- 2021/09/12 00:00 [received]
PHST- 2021/11/28 00:00 [revised]
PHST- 2021/11/29 00:00 [accepted]
PHST- 2021/12/10 06:00 [pubmed]
PHST- 2022/03/09 06:00 [medline]
PHST- 2021/12/09 20:16 [entrez]
AID - S1572-1000(21)00487-7 [pii]
AID - 10.1016/j.pdpdt.2021.102670 [doi]
PST - ppublish
SO  - Photodiagnosis Photodyn Ther. 2022 Mar;37:102670. doi: 
      10.1016/j.pdpdt.2021.102670. Epub 2021 Dec 7.