Evidence map›Paper›PMID 35474942›Full record

ArticleBJUI compass2020

Intravesical gemcitabine as bladder-preserving treatment for BCG unresponsive non-muscle-invasive bladder cancer. Results from a single-arm, open-label study.

Rodolfo Hurle, Paolo Casale, Emanuela Morenghi, Alberto Saita, Nicolòmaria Buffi, Giovanni Lughezzani, Piergiuseppe Colombo, Roberto Contieri, Nicola Frego, Giorgio Guazzoni and 1 more

Open access · goldAbstract read
In one paragraph

Article in BJUI compass, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.6field-weighted citation impact, top 16% 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

14 citing papers in PubMed, 17 citations in OpenAlex.

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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

11 authors at 1 institution in 1 country.

Rodolfo HurleDepartment of Urology Humanitas Clinical and Research Center - IRCCS Rozzano Italy.
Paolo CasaleDepartment of Urology Humanitas Clinical and Research Center - IRCCS Rozzano Italy.
Emanuela MorenghiDepartment of Medical Statistic Humanitas Clinical and Research Center - IRCCS Rozzano Italy.
Alberto SaitaDepartment of Urology Humanitas Clinical and Research Center - IRCCS Rozzano Italy.
Nicolòmaria BuffiDepartment of Urology Humanitas Clinical and Research Center - IRCCS Rozzano Italy.
Giovanni LughezzaniDepartment of Urology Humanitas Clinical and Research Center - IRCCS Rozzano Italy.
Piergiuseppe ColomboDepartment of Pathology Humanitas Clinical and Research Center - IRCCS Rozzano Italy.
Roberto ContieriDepartment of Urology Humanitas Clinical and Research Center - IRCCS Rozzano Italy.
Nicola FregoDepartment of Urology Humanitas Clinical and Research Center - IRCCS Rozzano Italy.
Giorgio GuazzoniDepartment of Urology Humanitas Clinical and Research Center - IRCCS Rozzano Italy.
Massimo LazzeriDepartment of Urology Humanitas Clinical and Research Center - IRCCS Rozzano Italy.ORCID https://orcid.org/0000-0002-4411-3715
Humanitas University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: There is an unmet alternative medical therapy for BCG unresponsive patients. Objective: To report efficacy of intravesical gemcitabine in NMIBC patients, who failed a previous course of BCG, or intolerant, and unwilling to undergo radical cystectomy (RC). Material and methods: This is an open-label, single-arm study, which enrolled patients showing a failure or were intolerant to BCG and unwilling to undergo the RC. Intravesical gemcitabine was administered once a week for six consecutive weeks and once a month for 12 months. The primary outcome was DFS defined as the lack of a tumor on cystoscopy and negative urine cytology. Secondary endpoint was safety defined according a grading of side effects. OS, PFS, and DFS were described with Kaplan-Meier method at 12 and 24 months. Results and limitations: Overall 36 patients were enrolled. The median follow-up was 27 months. The DFS was 68.75% at the end of induction phase and 44.44% and 31.66% at 12 and 24 months of, respectively. The PFS was 43.75%. The OS and CSS were 77.9% (95% CI 58.78%-88.92%) and 80.68% (95% CI 61.49%-90.96%), respectively. There was no life threatening event or treatment-related death (grade 4 or 5). The most common mild and moderate adverse events reported were urinary symptoms (LUTS) and fatigue (G1-G2). Conclusion: Patients who presented an unresponsive-BCG recurrent NMIBC and unwilling to receive a RC, could benefit from intravesical gemcitabine as salvage organ-sparing treatment.

Indexed as

BCGbladder cancergemcitabineintravesical therapy

Identifiers

PMID35474942
PMCPMC8988784
OpenAlexW3038858354

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.