PMID- 27902496
OWN - NLM
STAT- MEDLINE
DCOM- 20171106
LR  - 20180227
IS  - 1473-5741 (Electronic)
IS  - 0959-4973 (Linking)
VI  - 28
IP  - 3
DP  - 2017 Mar
TI  - Final results of the phase III URO-BCG 4 multicenter study: efficacy and 
      tolerance of one-third dose BCG maintenance in nonmuscle invasive bladder cancer.
PG  - 335-340
LID - 10.1097/CAD.0000000000000456 [doi]
AB  - The objective of this study was to assess at 3 years bacillus Calmette-Guerin 
      (BCG) maintenance treatment for NMIBC using one-third dose schedule and fewer 
      instillations every 3 or 6 months. This was a phase III randomized study 
      including patients with intermediate-risk or high-risk NMIBC, who received, after 
      a full-dose induction schedule, three-weekly instillations of one-third dose BCG 
      every 6 months (group I) and two-weekly instillations every 3 months (group II) 
      during 3 years. We assessed oncological efficacy, BCG side effects, leukocyturia, 
      and prostate-specific antigen. No tumor recurrence was reported at 36 months for 
      55 (82.09%) patients in group I versus 64 (90.14%) patients in group II 
      (P=0.241). Muscle invasion was observed in six patients at 36 months (P=0.942). 
      In terms of BCG toxicity, grade II and III local or systemic side effects were, 
      respectively, reported in 8.7 and 23.9% of patients during the first year. 
      Nevertheless, the adverse events (AEs) score at 36 months underlined a lower 
      median value of 0.8 in group I versus 1.1 in group II (P=0.037). Furthermore, 
      9.9% major AEs occurred in group II versus 3% in group I (P=0.031). Leukocyturia 
      and prostate-specific antigen level were not associated significantly with either 
      tumor recurrence or muscle progression. We observed a significant difference in 
      the AEs score at 36 months, suggesting less toxicity in patients who were treated 
      with one-third dose of BCG for 3 consecutive weeks every 6 months.
FAU - Nouhaud, Francois X
AU  - Nouhaud FX
AD  - aUrology Department, Charles Nicolle University Hospital bInserm 1404, 
      Onco-Urology Group, Clinical Investigation Center, Rouen cUrology Department, 
      Nantes University Hospital, Nantes dUrology Department, Amiens University 
      Hospital, Amiens eUrology Department, Lyon University Hospital, Lyon fUrology 
      Department, Kremlin Bicetre University Hospital, Paris gUrology Department, 
      Toulouse University Hospital, Toulouse, France.
FAU - Rigaud, Jerome
AU  - Rigaud J
FAU - Saint, Fabien
AU  - Saint F
FAU - Colombel, Marc
AU  - Colombel M
FAU - Irani, Jacques
AU  - Irani J
FAU - Soulie, Michel
AU  - Soulie M
FAU - Pfister, Christian
AU  - Pfister C
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - England
TA  - Anticancer Drugs
JT  - Anti-cancer drugs
JID - 9100823
RN  - 0 (BCG Vaccine)
SB  - IM
MH  - Administration, Intravesical
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - BCG Vaccine/*administration & dosage/adverse effects
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Invasiveness
MH  - Urinary Bladder Neoplasms/*drug therapy/pathology
EDAT- 2016/12/03 06:00
MHDA- 2017/11/07 06:00
CRDT- 2016/12/01 06:00
PHST- 2016/12/03 06:00 [pubmed]
PHST- 2017/11/07 06:00 [medline]
PHST- 2016/12/01 06:00 [entrez]
AID - 10.1097/CAD.0000000000000456 [doi]
PST - ppublish
SO  - Anticancer Drugs. 2017 Mar;28(3):335-340. doi: 10.1097/CAD.0000000000000456.