Evidence map›Paper›PMID 34053782›Full record

Trial reportEuropean urology2021

Is There a Detrimental Effect of Antibiotic Therapy in Patients with Muscle-invasive Bladder Cancer Treated with Neoadjuvant Pembrolizumab?

Filippo Pederzoli, Marco Bandini, Daniele Raggi, Laura Marandino, Giuseppe Basile, Massimo Alfano, Renzo Colombo, Andrea Salonia, Alberto Briganti, Andrea Gallina and 2 more

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in European urology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 2 pooled it
7.1field-weighted citation impact, top 2% 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

39 citing papers in PubMed, 2 syntheses or guidelines pooled it, 52 citations in OpenAlex.

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  16. Effects of antibiotics on the anti-tumor efficacy of immune checkpoint inhibitor therapy.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 3 institutions in 1 country.

Filippo PederzoliUnit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Vita-Salute San Raffaele University, Milan, Italy.
Marco BandiniUnit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Vita-Salute San Raffaele University, Milan, Italy.
Daniele RaggiFondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Laura MarandinoFondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Giuseppe BasileUnit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Vita-Salute San Raffaele University, Milan, Italy.
Massimo AlfanoUnit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Vita-Salute San Raffaele University, Milan, Italy.
Renzo ColomboUnit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Vita-Salute San Raffaele University, Milan, Italy.
Andrea SaloniaUnit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Vita-Salute San Raffaele University, Milan, Italy.
Alberto BrigantiUnit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Vita-Salute San Raffaele University, Milan, Italy.
Andrea GallinaUnit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Vita-Salute San Raffaele University, Milan, Italy.
Francesco MontorsiUnit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Vita-Salute San Raffaele University, Milan, Italy.
Andrea NecchiUnit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Vita-Salute San Raffaele University, Milan, Italy; Department of Medical Oncology, IRCCS Ospedale San Raffaele, Milan, Italy. Electronic address: necchi.andrea@hsr.it.
Vita-Salute San Raffaele University · ITFondazione IRCCS Istituto Nazionale dei Tumori · ITIRCCS Ospedale San Raffaele · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In locally advanced and metastatic malignancies, antibiotic (ATB) therapy has a negative effect on immunotherapy efficacy. Therefore, we aimed to evaluate whether ATB therapy and use of specific ATB classes with concomitant neoadjuvant pembrolizumab affected pathologic complete response (ypT0N0) and relapse-free survival (RFS) for patients with clinical T2-4N0M0 bladder cancer enrolled in the PURE-01 study. Of the 149 patients evaluated, 48 (32%) received any concomitant ATB therapy. The ATB class most commonly administered was fluoroquinolones (16 patients; 33%). In the ATB cohort, seven patients (15%) achieved ypT0N0 status, compared to 50 (50%; p < 0.001) in the untreated group. Moreover, ATB use was negatively associated with ypT0N0 status (odds ratio 0.18, 95% confidence interval [CI] 0.05-0.48; p = 0.001). The 24-mo RFS rate was 63% (95% CI 48-83%) in the ATB group versus 90% (95% CI 83-97) in the untreated group. We found that ATB use was associated with a higher recurrence rate (hazard ratio [HR] 2.64, 95% CI 1.08-6.50; p = 0.03). Exploratory analyses showed that fluoroquinolone use was associated with a higher recurrence rate (HR 3.28, 95% CI 1.12-9.60; p = 0.03). Our study revealed an association between ATB use and neoadjuvant immunotherapy efficacy in an intention-to-cure population, highlighting the need for future studies to better investigate this relationship. PATIENT SUMMARY: The efficacy of immunotherapy for cancer is influenced by several patient and tumor factors, including the use of antibiotics. We found that antibiotics taken at the same time as immunotherapy drugs were associated with lower rates of complete response and of recurrence-free survival among patients with muscle-invasive bladder cancer. These findings need to be confirmed in future studies.

Indexed as

Anti-Bacterial AgentsAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalDrug InteractionsUrinary Bladder NeoplasmsCystectomyHumansImmune Checkpoint InhibitorsNeoadjuvant TherapyNeoplasm InvasivenessAnti-Bacterial AgentsAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalImmune Checkpoint InhibitorspembrolizumabAntibioticImmunotherapyMicrobiotaMuscle-invasive bladder cancerPembrolizumab

Identifiers

PMID34053782
OpenAlexW3164285162

What OpenQuestion holds

Textmetadata
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.