PMID- 36535955
OWN - NLM
STAT- MEDLINE
DCOM- 20221222
LR  - 20230207
IS  - 1464-5157 (Electronic)
IS  - 0265-6736 (Linking)
VI  - 40
IP  - 1
DP  - 2023
TI  - Development and investigation of a novel device with gemcitabine for hyperthermic 
      intravesical chemotherapy.
PG  - 2129103
LID - 10.1080/02656736.2022.2129103 [doi]
AB  - PURPOSE: To evaluate the safety and efficacy of a novel hyperthermic intravesical 
      chemotherapy (HIVEC) device in combination with gemcitabine. MATERIALS AND 
      METHODS: A pilot clinical trial was performed on patients with high-risk 
      non-muscle invasive bladder cancer (NMIBC), who received HIVEC via the novel 
      device (BR-PRG). Treatment regimen included eight weekly instillations of 
      intravesical GEM (3 g in 150 mL normal saline [NS]) at a temperature of 45  degrees C for 
      60 min. Assessment of adverse events (AEs) was the primary objective of the 
      trial. Disease recurrence and the thermal stability of GEM were also analyzed. 
      RESULTS: A total of 116 HIVEC treatments were delivered. Fifteen and eighteen 
      patients were included in the effectiveness and safety analysis, respectively. 
      Median follow-up was 12 months; five patients experienced a disease recurrence. 
      One-year cumulative incidence of recurrence was 23.8% in EORTC intermediate risk 
      group and 37.5% in high-risk group. Ten patients experienced at least one AE, 
      with the most common being acute urinary tract infection, followed by urinary 
      tract pain, and hematuria. Two patients experienced acute cystitis (grade 3 AE) 
      and instillations were postponed until full recovery. Other AEs were minor, and 
      no systemic toxicity was observed. The contents of GEM in solution of 0.9% NS or 
      NS mixed with artificial urine were stable at 25  degrees C, 37  degrees C, 43  degrees C, 45  degrees C, 47  degrees C 
      and 50  degrees C for 2 h. CONCLUSION: GEM can be an ideal drug for use in HIVEC due to 
      its good thermal stability. BR-PRG, combined with GEM was safe and effective in 
      administering HIVEC.
FAU - Jing, Li
AU  - Jing L
AUID- ORCID: 0000-0003-3145-0963
AD  - Department of Urology, Affiliated Cancer Hospital and Institute of Guangzhou 
      Medical University, Guangzhou, China.
FAU - Wenjian, Chen
AU  - Wenjian C
AD  - Department of Urology, Affiliated Cancer Hospital and Institute of Guangzhou 
      Medical University, Guangzhou, China.
FAU - Meimei, Zhang
AU  - Meimei Z
AD  - Department of Pharmacy, Affiliated Cancer Hospital and Institute of Guangzhou 
      Medical University, Guangzhou, China.
FAU - Yanfei, Chen
AU  - Yanfei C
AD  - Department of Urology, Affiliated Cancer Hospital and Institute of Guangzhou 
      Medical University, Guangzhou, China.
FAU - Xuejin, Zhu
AU  - Xuejin Z
AD  - Department of Urology, Affiliated Cancer Hospital and Institute of Guangzhou 
      Medical University, Guangzhou, China.
FAU - Bin, Wang
AU  - Bin W
AD  - Department of Urology, Affiliated Cancer Hospital and Institute of Guangzhou 
      Medical University, Guangzhou, China.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Int J Hyperthermia
JT  - International journal of hyperthermia : the official journal of European Society 
      for Hyperthermic Oncology, North American Hyperthermia Group
JID - 8508395
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Humans
MH  - Gemcitabine
MH  - *Hyperthermia, Induced/adverse effects
MH  - Incidence
MH  - Neoplasm Invasiveness
MH  - Neoplasm Recurrence, Local
MH  - *Urinary Bladder Neoplasms/drug therapy
MH  - Pilot Projects
OTO - NOTNLM
OT  - Bladder cancer
OT  - gemcitabine
OT  - hyperthermia
OT  - intravesical chemotherapy
OT  - recurrence
EDAT- 2022/12/20 06:00
MHDA- 2022/12/22 06:00
CRDT- 2022/12/19 23:19
PHST- 2022/12/19 23:19 [entrez]
PHST- 2022/12/20 06:00 [pubmed]
PHST- 2022/12/22 06:00 [medline]
AID - 10.1080/02656736.2022.2129103 [doi]
PST - ppublish
SO  - Int J Hyperthermia. 2023;40(1):2129103. doi: 10.1080/02656736.2022.2129103.