Evidence map›Paper›PMID 34383381›Full record

Trial reportBJU international2022

Intravesical mitomycin C (MMC) and MMC + cytosine arabinoside for non-muscle-invasive bladder cancer: a randomised clinical trial.

Yasuyoshi Miyata, Toshifumi Tsurusaki, Yasushi Hayashida, Yushi Imasato, Kosuke Takehara, Daiyu Aoki, Masaharu Nishikido, Junichi Watanabe, Kensuke Mitsunari, Tomohiro Matsuo and 4 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BJU international, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.1field-weighted citation impact, top 13% 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

8 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. The emerging roles of exosomal long non-coding RNAs in bladder cancer.Journal of cellular and molecular medicine · 2022
    Review
  7. Review
  8. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 5 institutions in 1 country.

Yasuyoshi MiyataDepartment of Urology, Nagasaki University Graduate School of Biomedical Sciences, Japan.ORCID 0000-0001-6272-6657
Toshifumi TsurusakiDepartment of Urology, The Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan.
Yasushi HayashidaDepartment of Urology, National Hospital Organization Ureshino Medical Center, Ureshino, Japan.
Yushi ImasatoDepartment of Urology, The Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan.
Kosuke TakeharaDepartment of Urology, Nagasaki Harbor Medical Center, Nagasaki, Japan.
Daiyu AokiDepartment of Urology, Japan Community Health care Organization Isahaya General Hospital, Isahaya, Japan.
Masaharu NishikidoDepartment of Urology, National Hospital Organization Nagasaki Medical Center, Ohmura, Japan.
Junichi WatanabeDepartment of Urology, Nagasaki Harbor Medical Center, Nagasaki, Japan.
Kensuke MitsunariDepartment of Urology, Nagasaki University Graduate School of Biomedical Sciences, Japan.
Tomohiro MatsuoDepartment of Urology, Nagasaki University Graduate School of Biomedical Sciences, Japan.
Kojiro OhbaDepartment of Urology, Nagasaki University Graduate School of Biomedical Sciences, Japan.
Keisuke TaniguchiDepartment of Urology, National Hospital Organization Ureshino Medical Center, Ureshino, Japan.
Hideki SakaiDepartment of Urology, Nagasaki University Graduate School of Biomedical Sciences, Japan.
Nagasaki University Urological Oncology Research Group
Nagasaki University · JPNagasaki Medical Center · JPJapanese Red Cross Society, Japan · JPNational Hospital Organization · JPJapan Community Healthcare Organization · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo compare the urinary pH, recurrence-free survival (RFS), and safety of adjuvant intravesical therapy in patients with non-muscle-invasive bladder cancer (NMIBC) receiving mitomycin C (MMC) therapy and MMC + cytosine arabinoside (Ara-C) therapy. PATIENTS AND

methodsA total of 165 patients with NMIBC from six hospitals were randomly allocated to two groups: weekly instillation of MMC + Ara-C (30 mg/30 mL + 200 mg/10 mL) for 6 weeks and the same instillation schedule of MMC (30 mg/40 mL). The primary outcome was RFS, and secondary outcomes were urinary pH and toxicity in the two groups.

resultsA total of 81 and 87 patients were randomised into the MMC and MMC + Ara-C groups, respectively. Overall, the RFS in the MMC + Ara-C group was significantly longer (P = 0.018) than that in the MMC group. A similar significant difference was detected in patients with intermediate-risk NMIBC, but not in those with high-risk NMIBC. The mean (SD) urinary pH was significantly higher in the MMC + Ara-C group than in the MMC group, at 6.56 (0.61) vs 5.78 (0.64) (P < 0.001), and the frequency of a urinary pH of >7.0 in the MMC and MMC + Ara-C groups was 6.3% and 26.7%, respectively (P < 0.001). Multivariate analysis models including clinicopathological features and second transurethral resection demonstrated that increased urinary pH was associated with better outcomes (hazard ratio 0.18, 95% confidential interval 0.18-0.038; P < 0.001). In all, there were 14 and 10 adverse events in the MMC and MMC + Ara-C groups, respectively, without a significant difference (P = 0.113).

conclusionsOur randomised clinical trial suggested that intravesical therapy with MMC and Ara-C is useful and safe for patients with intermediate-risk NMIBC. Increase in urinary pH with Ara-C is speculated as a mechanism for increased anti-cancer effects.

Indexed as

MitomycinUrinary Bladder NeoplasmsAdministration, IntravesicalAntibiotics, AntineoplasticCytarabineFemaleHumansMaleAntibiotics, AntineoplasticCytarabineMitomycin#BladderCancer#blcsmcytosine arabinosideintravesical therapymitomycin Cnon-muscle-invasive bladder cancerrandomised trialurinary pH#uroonc

Identifiers

PMID34383381
PMCPMC9290455
OpenAlexW3188551730

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

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.