PMID- 30334959
OWN - NLM
STAT- MEDLINE
DCOM- 20181031
LR  - 20231004
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 97
IP  - 42
DP  - 2018 Oct
TI  - Randomized study of intravesical pirarubicin chemotherapy with low and 
      intermediate-risk nonmuscle-invasive bladder cancer in Japan: Comparison of a 
      single immediate postoperative intravesical instillation with short-term adjuvant 
      intravesical instillations after transurethral resection.
PG  - e12740
LID - 10.1097/MD.0000000000012740 [doi]
LID - e12740
AB  - PURPOSE: The objective of this study was to evaluate the efficacy, defined by the 
      3-year tumor recurrence-free survival rate, of intravesical chemotherapy using 
      pirarubicin (THP) in patients with low or intermediate-risk nonmuscle-invasive 
      bladder cancer (NMIBC). PATIENTS AND METHODS: Between October 2010 and January 
      2015, 206 patients were enrolled, and finally 113 were randomized to receive 
      either a single immediate postoperative intravesical instillation of THP (30 mg) 
      (Group A), or 8 additional weekly intravesical instillations of THP (30 mg) after 
      a single postoperative instillation (Group B). The patients were examined by 
      performing cystoscopy and urine cytology every 3 months after transurethral 
      resection to determine bladder tumor recurrence. The primary endpoint was 
      3-year-recurrence-free survival rate. RESULTS: All 113 patients were bacillus 
      Calmette-Guerin (BCG)-naive. The 3-year recurrence free survival rate was 63.7% 
      for Group A and 85.3% for Group B (log-rank test, P = .0070). In patients with 
      intermediate recurrence risk, the 3-year recurrence-free survival rate was 63.4% 
      in Group A and 86.1% in Group B (log-rank test, P = .0036). Cox regression 
      analysis revealed that only additional instillation of THP was a significant 
      independent factor for recurrence-free rate in patients with intermediate risk. 
      No patient with progression was noted during this period. Frequent adverse 
      effects (AEs) were frequent urination and micturition pain, and no severe AEs 
      (Grade 3 or more) occurred. CONCLUSION: Additional instillation of THP (30 mg) 
      weekly for 8 weeks reduced the risk of tumor recurrence without severe AEs in 
      BCG-naive NMIBC patients with intermediate risk.
FAU - Naya, Yoshio
AU  - Naya Y
AD  - Department of Urology, Meiji University of Integrative Medicine, Nantan.
AD  - Department Urology, Nagahama City Kohoku Hospital, Nagahama.
FAU - Mikami, Kazuya
AU  - Mikami K
AD  - Department of Urology, Kyoto First Red-Cross Hospital.
FAU - Takaha, Natsuki
AU  - Takaha N
AD  - Department of Urology, Meiji University of Integrative Medicine, Nantan.
FAU - Inoue, Yuuta
AU  - Inoue Y
AD  - Department of Urology, Kyoto Prefectural University of Medicine, Kyoto.
FAU - Fujihara, Atsuko
AU  - Fujihara A
AD  - Department of Urology, Kyoto Prefectural University of Medicine, Kyoto.
FAU - Kanazawa, Motohiro
AU  - Kanazawa M
AD  - Department of Urology, Kyoto Prefectural University of Medicine, Kyoto.
FAU - Nakanishi, Hiroyuki
AU  - Nakanishi H
AD  - Department of Urology, Kyoto Chubu Medical Center, Nantan.
FAU - Miyashita, Hiroaki
AU  - Miyashita H
AD  - Department of Urology, Omihachiman Community Medical Center, Omihachiman, Japan.
FAU - Ukimura, Osamu
AU  - Ukimura O
AD  - Department of Urology, Kyoto Prefectural University of Medicine, Kyoto.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Antineoplastic Agents)
RN  - 80168379AG (Doxorubicin)
RN  - D58G680W0G (pirarubicin)
SB  - IM
MH  - Administration, Intravesical
MH  - Aged
MH  - Antineoplastic Agents/*administration & dosage
MH  - Chemotherapy, Adjuvant/methods
MH  - Disease-Free Survival
MH  - Doxorubicin/administration & dosage/*analogs & derivatives
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Japan
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Recurrence, Local/epidemiology/etiology
MH  - Postoperative Period
MH  - Prospective Studies
MH  - Regression Analysis
MH  - Risk Factors
MH  - Time Factors
MH  - Treatment Outcome
MH  - Urinary Bladder/surgery
MH  - Urinary Bladder Neoplasms/*therapy
MH  - Urologic Surgical Procedures/*methods
PMC - PMC6211924
COIS- The authors have no conflicts of interest to disclose.
EDAT- 2018/10/20 06:00
MHDA- 2018/11/01 06:00
PMCR- 2018/10/19
CRDT- 2018/10/19 06:00
PHST- 2018/10/19 06:00 [entrez]
PHST- 2018/10/20 06:00 [pubmed]
PHST- 2018/11/01 06:00 [medline]
PHST- 2018/10/19 00:00 [pmc-release]
AID - 00005792-201810190-00022 [pii]
AID - MD-D-18-03143 [pii]
AID - 10.1097/MD.0000000000012740 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2018 Oct;97(42):e12740. doi: 10.1097/MD.0000000000012740.