Evidence map›Paper›PMID 39480527›Full record

Trial reportWorld journal of urology2024

A 3-arm randomized control trial to compare the efficacy of re-circulant hyperthermic intravesical chemotherapy versus conventional intravesical mitomycin C and BCG therapy for intermediate-risk non-muscle invasive bladder cancer.

Ankit Sachan, Rishi Nayyar, Sahil Pethe, Prashant Singh, Amlesh Seth

Abstract readRandomized Controlled TrialComparative Study
PubMed Publisher
In one paragraph

Trial report in World journal of urology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Neoadjuvant chemotherapy for bladder cancer: Two decades on.Indian journal of urology : IJU : journal of the Urological Society of India
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Ankit SachanDepartment of Urology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.
Rishi NayyarDepartment of Urology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India. nayyarrishi2020@gmail.com.
Sahil PetheDepartment of Urology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.
Prashant SinghDepartment of Urology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.
Amlesh SethDepartment of Urology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTo evaluate the efficacy and side effects of re-circulant hyperthermic intravesical chemotherapy versus conventional treatments for intermediate risk non-muscle invasive bladder cancer (NMIBC).

methodsA randomized 3-arm, parallel group trial was conducted at a single tertiary care centre. 135 patients with low-grade intermediate-risk cancer, having undergone complete resection of bladder tumor were included. Patients were assigned 1:1:1, to receive intra-vesical chemo-hyperthermia (C-HT), mitomycin-C (MMC) or BCG therapy. There was no treatment crossover. Patients were followed up with check cystoscopy every 3 months for histopathological recurrence.

resultsThe three arms were comparable in terms of age, gender, tumor size, number of tumors and clinical stage or grade of tumors. Mean tumor size was 2.58 (± 0.88) cm and the mean number of tumors resected was 2.04 (± 1.02) (Range 1-5). There was no significant difference between the various groups for tumor recurrence (χ2 = 1.96, p = 0.375) or time to recurrence (13.6 vs. 10.8 vs. 9.8 months, p = 0.844) though incidence of non-healing necrotic area was higher with C-HT (22.2% vs. 11.1% and 4.8%, χ2 = 6.093, p = 0.048). Median (IQR) follow up period was 26 (12-52) months. Treatment discontinuation or drug intolerance was significantly higher in BCG arm (p = 0.03).

conclusionsIntravesical C-HT with MMC, conventional MMC and BCG are equally effective and comparable alternatives for intravesical therapy in low-grade intermediate-risk NMIBC. Higher incidence of non-healing resection site with C-HT and higher local symptoms with BCG are a concern.

Indexed as

Antibiotics, AntineoplasticBCG VaccineHyperthermia, InducedMitomycinNeoplasm InvasivenessUrinary Bladder NeoplasmsAdjuvants, ImmunologicAdministration, IntravesicalAgedCombined Modality TherapyFemaleHumansMaleMiddle AgedNon-Muscle Invasive Bladder NeoplasmsTreatment OutcomeAdjuvants, ImmunologicAntibiotics, AntineoplasticBCG VaccineMitomycinBCGBladder cancerChemohyperthermiaHIVECIntermediate riskIntravesical therapyLow-gradeMitomycin CNMIBC

Identifiers

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Registered trials

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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.