PMID- 36212980
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221011
IS  - 2666-1683 (Electronic)
IS  - 2666-1691 (Print)
IS  - 2666-1683 (Linking)
VI  - 45
DP  - 2022 Nov
TI  - Intravesical Ty21a Treatment of Non-muscle-invasive Bladder Cancer Shows a Good 
      Safety Profile.
PG  - 55-58
LID - 10.1016/j.euros.2022.09.004 [doi]
AB  - Standard-of-care immunotherapy for non-muscle-invasive bladder cancer (NMIBC) 
      with intravesical Bacillus Calmettte-Guerin (BCG) is associated with adverse 
      events (AEs), disease recurrence/progression, and supply shortages. Preclinical 
      data have shown that intravesical instillation of Ty21a/Vivotif, the oral vaccine 
      against typhoid fever, may be an effective and safer alternative to BCG. We 
      assessed the safety of intravesical Ty21a in NMIBC. For ethical reasons, patients 
      with low- or intermediate-risk NMIBC not requiring BCG immunotherapy were 
      enrolled. To determine the maximum tolerated dose, escalating doses of 
      Ty21a/Vivotif were intravesically instilled in three patients once a week for 4 
      wk in phase 1a. In phase 1b, ten patients received the selected dose (1 x 10(8) 
      CFU) once a week for 6 wk, as for standard BCG therapy. At this dose, all 
      patients completed their treatment. Most patients experienced minor systemic AEs, 
      while half reported mild local bladder AEs. AEs only occurred after one or two 
      instillations for 40% of the patients. Ty21a bacteria were only recovered in 
      three out of 72 urinary samples at 1 wk after instillation. Intravesical Ty21a 
      might be well tolerated with no cumulative side effects, no fever >39  degrees C, and 
      lower risk of bacterial persistence than with BCG. Ty21a treatment thus warrants 
      clinical trials to explore its safety and antitumor efficacy in high-risk NMIBC. 
      This trial is registered on ClinicalTrials.gov as NCT03421236. PATIENT SUMMARY: 
      We examined the safety of a new intra-bladder immunotherapy for 
      non-muscle-invasive bladder cancer as an alternative to the standard BCG 
      treatment. Our data show that the Ty21a vaccine might be well tolerated. Further 
      studies are needed to determine the safety and antitumor efficacy of this 
      treatment.
CI  - (c) 2022 The Authors.
FAU - Lucca, Ilaria
AU  - Lucca I
AD  - Department of Urology, Centre Hospitalier Universitaire Vaudois, University of 
      Lausanne, Lausanne, Switzerland.
FAU - Derre, Laurent
AU  - Derre L
AD  - Department of Urology, Centre Hospitalier Universitaire Vaudois, University of 
      Lausanne, Lausanne, Switzerland.
FAU - Cesson, Valerie
AU  - Cesson V
AD  - Department of Urology, Centre Hospitalier Universitaire Vaudois, University of 
      Lausanne, Lausanne, Switzerland.
FAU - Bohner, Perrine
AU  - Bohner P
AD  - Department of Urology, Centre Hospitalier Universitaire Vaudois, University of 
      Lausanne, Lausanne, Switzerland.
FAU - Crettenand, Francois
AU  - Crettenand F
AD  - Department of Urology, Centre Hospitalier Universitaire Vaudois, University of 
      Lausanne, Lausanne, Switzerland.
FAU - Rodrigues-Dias, Sonia
AU  - Rodrigues-Dias S
AD  - Department of Urology, Centre Hospitalier Universitaire Vaudois, University of 
      Lausanne, Lausanne, Switzerland.
FAU - Dartiguenave, Florence
AU  - Dartiguenave F
AD  - Department of Urology, Centre Hospitalier Universitaire Vaudois, University of 
      Lausanne, Lausanne, Switzerland.
FAU - Masnada, Audrey
AU  - Masnada A
AD  - Department of Urology, Centre Hospitalier Universitaire Vaudois, University of 
      Lausanne, Lausanne, Switzerland.
FAU - Texeira-Pereira, Carla
AU  - Texeira-Pereira C
AD  - Department of Urology, Centre Hospitalier Universitaire Vaudois, University of 
      Lausanne, Lausanne, Switzerland.
FAU - Benmerzoug, Sulayman
AU  - Benmerzoug S
AD  - Department of Urology, Centre Hospitalier Universitaire Vaudois, University of 
      Lausanne, Lausanne, Switzerland.
FAU - Chevalier, Mathieu
AU  - Chevalier M
AD  - Department of Urology, Centre Hospitalier Universitaire Vaudois, University of 
      Lausanne, Lausanne, Switzerland.
FAU - Domingos-Pereira, Sonia
AU  - Domingos-Pereira S
AD  - Department of Urology, Centre Hospitalier Universitaire Vaudois, University of 
      Lausanne, Lausanne, Switzerland.
FAU - Nguyen, Sylvain
AU  - Nguyen S
AD  - Department of Urology, Centre Hospitalier Universitaire Vaudois, University of 
      Lausanne, Lausanne, Switzerland.
FAU - Polak, Lenka
AU  - Polak L
AD  - Department of Urology, Centre Hospitalier Universitaire Vaudois, University of 
      Lausanne, Lausanne, Switzerland.
FAU - Schneider, Anna
AU  - Schneider A
AD  - Department of Urology, Centre Hospitalier Universitaire Vaudois, University of 
      Lausanne, Lausanne, Switzerland.
FAU - Roth, Beat
AU  - Roth B
AD  - Department of Urology, Centre Hospitalier Universitaire Vaudois, University of 
      Lausanne, Lausanne, Switzerland.
FAU - Jichlinski, Patrice
AU  - Jichlinski P
AD  - Department of Urology, Centre Hospitalier Universitaire Vaudois, University of 
      Lausanne, Lausanne, Switzerland.
FAU - Nardelli-Haefliger, Denise
AU  - Nardelli-Haefliger D
AD  - Department of Urology, Centre Hospitalier Universitaire Vaudois, University of 
      Lausanne, Lausanne, Switzerland.
LA  - eng
SI  - ClinicalTrials.gov/NCT03421236
PT  - Journal Article
DEP - 20221003
PL  - Netherlands
TA  - Eur Urol Open Sci
JT  - European urology open science
JID - 101771568
PMC - PMC9539774
OTO - NOTNLM
OT  - Intravesical microbial immunotherapy
OT  - Non-muscle-invasive bladder cancer
OT  - Phase 1 trial
OT  - Salmonella Ty21a
EDAT- 2022/10/11 06:00
MHDA- 2022/10/11 06:01
PMCR- 2022/10/03
CRDT- 2022/10/10 04:22
PHST- 2022/09/12 00:00 [accepted]
PHST- 2022/10/10 04:22 [entrez]
PHST- 2022/10/11 06:00 [pubmed]
PHST- 2022/10/11 06:01 [medline]
PHST- 2022/10/03 00:00 [pmc-release]
AID - S2666-1683(22)01904-8 [pii]
AID - 10.1016/j.euros.2022.09.004 [doi]
PST - epublish
SO  - Eur Urol Open Sci. 2022 Oct 3;45:55-58. doi: 10.1016/j.euros.2022.09.004. 
      eCollection 2022 Nov.