Evidence map›Paper›PMID 36250938›Full record

Trial reportThe Journal of urology2023

Clinical Efficacy of Neoadjuvant Intravesical Mitomycin-C Therapy Immediately Before Transurethral Resection of Bladder Tumor in Patients With Nonmuscle-invasive Bladder Cancer: Preliminary Results of a Prospective, Randomized Phase II Study.

Hye Won Lee, Hyung Ho Lee, Eun Young Park, Weon Seo Park, Sung Han Kim, Jae Young Joung, Jinsoo Chung, Ho Kyung Seo

Open access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in The Journal of urology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
3.3field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
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  3. Observational
  4. Article
  5. Review
  6. Review
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  8. Article
  9. Round up.Indian journal of urology : IJU : journal of the Urological Society of India
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 4 countries.

Hye Won LeeDepartment of Urology, Center for Urologic Cancer, National Cancer Center, Goyang, Korea.
Hyung Ho LeeDepartment of Urology, Center for Urologic Cancer, National Cancer Center, Goyang, Korea.
Eun Young ParkBiostatistics Collaboration Team, Research Core Center, National Cancer Center, Goyang, Korea.
Weon Seo ParkDepartment of Pathology, Center for Urologic Cancer, National Cancer Center, Goyang, Korea.
Sung Han KimDepartment of Urology, Center for Urologic Cancer, National Cancer Center, Goyang, Korea.
Jae Young JoungDepartment of Urology, Center for Urologic Cancer, National Cancer Center, Goyang, Korea.
Jinsoo ChungDepartment of Urology, Center for Urologic Cancer, National Cancer Center, Goyang, Korea.
Ho Kyung SeoDepartment of Urology, Center for Urologic Cancer, National Cancer Center, Goyang, Korea.
Center for Cancer Research · USNational Cancer Center · KRCore Laboratories (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIntravesical mitomycin-C is recommended immediately after transurethral resection of bladder tumor for nonmuscle-invasive bladder cancer. However, a lack of compliance occurs due to the associated complications. Here, we aimed to assess the efficacy and safety of intravesical mitomycin-C before transurethral resection of bladder tumor in patients with nonmuscle-invasive bladder cancer. MATERIALS AND

methodsThis was a single-center, open-label, parallel-arm, randomized phase II clinical trial in patients with suspected nonmuscle-invasive bladder cancer before transurethral resection of bladder tumor. Participants were randomly assigned (1:1) to receive 2 doses of intravesical mitomycin-C (40 mg/20 mL) 1 day and 4 hours before transurethral resection of bladder tumor (n = 49) or no treatment (n = 50) with block randomization (size 2 and 4), stratified by bacillus Calmette-Guérin/intravesical mitomycin-C. The primary endpoint was recurrence-free survival and secondary endpoints were progression-free survival and adverse events in the per-protocol analysis.

resultsSeventy-one patients (33, intervention; 38, control) were well matched for baseline characteristics. Sixty-one had been followed without recurrence for at least 10.4 months; 3 and 8 patients showed recurrence in the intervention and control groups, respectively. The 1-year recurrence-free survival rate was 97% and 89% for the intervention and control groups, respectively. Neoadjuvant intravesical mitomycin-C resulted in a reduction (63%) in the relative recurrence risk (hazard ratio, 0.37; 80% 1-sided confidence interval, -∞-0.65,

conclusionsTwo doses of neoadjuvant intravesical mitomycin-C are safe and effective in reducing nonmuscle-invasive bladder cancer recurrence and progression after transurethral resection of bladder tumor.

Indexed as

MitomycinUrinary Bladder NeoplasmsHumansProspective StudiesTransurethral Resection of BladderTreatment OutcomeMitomycinmitomycinneoadjuvant therapyurinary bladder neoplasms

Identifiers

PMID36250938
PMCPMC12721670
OpenAlexW4304687655

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.