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Effect of Intravesical Instillation of Gemcitabine vs Saline Immediately Following Resection of Suspected Low-Grade Non-Muscle-Invasive Bladder Cancer on Tumor Recurrence: SWOG S0337 Randomized Clinical Trial.

Abstract Low-grade non-muscle-invasive urothelial cancer frequently recurs after excision by transurethral resection of bladder tumor (TURBT).
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title jama
Publication Year Start




PMID- 29801011
OWN - NLM
STAT- MEDLINE
DCOM- 20180607
LR  - 20180607
IS  - 1538-3598 (Electronic)
IS  - 0098-7484 (Linking)
VI  - 319
IP  - 18
DP  - 2018 May 8
TI  - Effect of Intravesical Instillation of Gemcitabine vs Saline Immediately
      Following Resection of Suspected Low-Grade Non-Muscle-Invasive Bladder Cancer on 
      Tumor Recurrence: SWOG S0337 Randomized Clinical Trial.
PG  - 1880-1888
LID - 10.1001/jama.2018.4657 [doi]
AB  - Importance: Low-grade non-muscle-invasive urothelial cancer frequently recurs
      after excision by transurethral resection of bladder tumor (TURBT). Objective: To
      determine whether immediate post-TURBT intravesical instillation of gemcitabine
      reduces recurrence of suspected low-grade non-muscle-invasive urothelial cancer
      compared with saline. Design, Setting, and Participants: Randomized double-blind 
      clinical trial conducted at 23 US centers. Patients with suspected low-grade
      non-muscle-invasive urothelial cancer based on cystoscopic appearance without any
      high-grade or without more than 2 low-grade urothelial cancer episodes within 18 
      months before index TURBT were enrolled between January 23, 2008, and August 14, 
      2012, and followed up every 3 months with cystoscopy and cytology for 2 years and
      then semiannually for 2 years. Patients were monitored for tumor recurrence,
      progression to muscle invasion, survival, and toxic effects. The final date of
      follow-up was August 14, 2016. Interventions: Participants were randomly assigned
      to receive intravesical instillation of gemcitabine (2 g in 100 mL of saline) (n 
      = 201) or saline (100 mL) (n = 205) for 1 hour immediately following TURBT. Main 
      Outcomes and Measures: The primary outcome was time to recurrence of cancer.
      Secondary end points were time to muscle invasion and death due to any cause.
      Results: Among 406 randomized eligible patients (median age, 66 years; 84.7%
      men), 383 completed the trial. In the intention-to-treat analysis, 67 of 201
      patients (4-year estimate, 35%) in the gemcitabine group and 91 of 205 patients
      (4-year estimate, 47%) in the saline group had cancer recurrence within 4.0 years
      (hazard ratio, 0.66; 95% CI, 0.48-0.90; P<.001 by 1-sided log-rank test for time 
      to recurrence). Among the 215 patients with low-grade non-muscle-invasive
      urothelial cancer who underwent TURBT and drug instillation, 34 of 102 patients
      (4-year estimate, 34%) in the gemcitabine group and 59 of 113 patients (4-year
      estimate, 54%) in the saline group had cancer recurrence (hazard ratio, 0.53; 95%
      CI, 0.35-0.81; P = .001 by 1-sided log-rank test for time to recurrence). Fifteen
      patients had tumors that progressed to muscle invasion (5 in the gemcitabine
      group and 10 in the saline group; P = .22 by 1-sided log-rank test) and 42 died
      of any cause (17 in the gemcitabine group and 25 in the saline group; P = .12 by 
      1-sided log-rank test). There were no grade 4 or 5 adverse events and no
      significant differences in adverse events of grade 3 or lower. Conclusions and
      Relevance: Among patients with suspected low-grade non-muscle-invasive urothelial
      cancer, immediate postresection intravesical instillation of gemcitabine,
      compared with instillation of saline, significantly reduced the risk of
      recurrence over a median of 4.0 years. These findings support using this therapy,
      but further research is needed to compare gemcitabine with other intravesical
      agents. Trial Registration: clinicaltrials.gov Identifier: NCT00445601.
FAU - Messing, Edward M
AU  - Messing EM
AD  - University of Rochester, Rochester, New York.
FAU - Tangen, Catherine M
AU  - Tangen CM
AD  - SWOG Statistical Center, Seattle, Washington.
AD  - Fred Hutchinson Cancer Research Center, Seattle, Washington.
FAU - Lerner, Seth P
AU  - Lerner SP
AD  - Baylor College of Medicine, Houston, Texas.
FAU - Sahasrabudhe, Deepak M
AU  - Sahasrabudhe DM
AD  - University of Rochester, Rochester, New York.
FAU - Koppie, Theresa M
AU  - Koppie TM
AD  - Oregon Health & Science University, Portland.
FAU - Wood, David P Jr
AU  - Wood DP Jr
AD  - Beaumont Health, Royal Oak, Michigan.
FAU - Mack, Philip C
AU  - Mack PC
AD  - University of California Davis, Sacramento.
FAU - Svatek, Robert S
AU  - Svatek RS
AD  - University of Texas-San Antonio, San Antonio.
FAU - Evans, Christopher P
AU  - Evans CP
AD  - University of California Davis, Sacramento.
FAU - Hafez, Khaled S
AU  - Hafez KS
AD  - University of Michigan, Ann Arbor.
FAU - Culkin, Daniel J
AU  - Culkin DJ
AD  - University of Oklahoma, Oklahoma City.
FAU - Brand, Timothy C
AU  - Brand TC
AD  - Madigan Army Medical Center, Tacoma, Washington.
FAU - Karsh, Lawrence I
AU  - Karsh LI
AD  - Urology Center of Colorado, Denver.
FAU - Holzbeierlein, Jeffrey M
AU  - Holzbeierlein JM
AD  - University of Kansas Cancer Center, Kansas City.
FAU - Wilson, Shandra S
AU  - Wilson SS
AD  - University of Colorado, Aurora.
FAU - Wu, Guan
AU  - Wu G
AD  - University of Rochester, Rochester, New York.
FAU - Plets, Melissa
AU  - Plets M
AD  - SWOG Statistical Center, Seattle, Washington.
AD  - Fred Hutchinson Cancer Research Center, Seattle, Washington.
FAU - Vogelzang, Nicholas J
AU  - Vogelzang NJ
AD  - Comprehensive Cancer Centers of Nevada, Las Vegas.
FAU - Thompson, Ian M Jr
AU  - Thompson IM Jr
AD  - CHRISTUS Santa Rosa Medical Center, San Antonio, Texas.
LA  - eng
SI  - ClinicalTrials.gov/NCT00445601
GR  - U10 CA180888/CA/NCI NIH HHS/United States
GR  - U10 CA180819/CA/NCI NIH HHS/United States
GR  - U10 CA180846/CA/NCI NIH HHS/United States
GR  - U10 CA180834/CA/NCI NIH HHS/United States
GR  - U10 CA180858/CA/NCI NIH HHS/United States
GR  - U10 CA128567/CA/NCI NIH HHS/United States
GR  - U10 CA180801/CA/NCI NIH HHS/United States
GR  - UG1 CA189953/CA/NCI NIH HHS/United States
GR  - UG1 CA189854/CA/NCI NIH HHS/United States
GR  - U10 CA180830/CA/NCI NIH HHS/United States
GR  - U10 CA180818/CA/NCI NIH HHS/United States
GR  - U10 CA022433/CA/NCI NIH HHS/United States
GR  - U10 CA068183/CA/NCI NIH HHS/United States
GR  - U10 CA046282/CA/NCI NIH HHS/United States
GR  - U10 CA058416/CA/NCI NIH HHS/United States
GR  - U10 CA046113/CA/NCI NIH HHS/United States
GR  - U10 CA037981/CA/NCI NIH HHS/United States
GR  - N01 CA004919/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PL  - United States
TA  - JAMA
JT  - JAMA
JID - 7501160
RN  - 0 (Antimetabolites, Antineoplastic)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 451W47IQ8X (Sodium Chloride)
RN  - B76N6SBZ8R (gemcitabine)
SB  - AIM
SB  - IM
CIN - JAMA. 2018 May 8;319(18):1864-1865. PMID: 29800998
MH  - Administration, Intravesical
MH  - Aged
MH  - Antimetabolites, Antineoplastic/*administration & dosage/adverse effects
MH  - Carcinoma, Papillary/*drug therapy/pathology
MH  - Deoxycytidine/administration & dosage/adverse effects/*analogs & derivatives
MH  - Double-Blind Method
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Invasiveness
MH  - Neoplasm Recurrence, Local/epidemiology/*prevention & control
MH  - Sodium Chloride/*administration & dosage
MH  - Urinary Bladder Neoplasms/*drug therapy/pathology
MH  - Urothelium
EDAT- 2018/05/26 06:00
MHDA- 2018/06/08 06:00
CRDT- 2018/05/26 06:00
PHST- 2018/05/26 06:00 [entrez]
PHST- 2018/05/26 06:00 [pubmed]
PHST- 2018/06/08 06:00 [medline]
AID - 2680547 [pii]
AID - 10.1001/jama.2018.4657 [doi]
PST - ppublish
SO  - JAMA. 2018 May 8;319(18):1880-1888. doi: 10.1001/jama.2018.4657.