Evidence map›Paper›PMID 38734774›Full record

ArticleWorld journal of urology2024

Induction and maintenance of sequential intravesical gemcitabine/docetaxel for intermediate and high-risk non-muscle invasive bladder cancer with different dosage protocols.

Reuben Ben-David, Neeraja Tillu, Parissa Alerasool, Christine Bieber, Daniel Ranti, Serena Tolani, Justin Eisenhauer, Rainjade Chung, Etienne Lavallée, Nikhil Waingankar and 5 more

Registry-linked trialAbstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in World journal of urology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07322263 (Intravesical Gemcitabine and Docetaxel for High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT07322263 phase2recruitingnot on this mapstarted 2026, after this paper: background citation

Intravesical Gemcitabine and Docetaxel for High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer: A Prospective Cohort Study (GEMDOCE-BU)

TypeinterventionalSponsorMichael A. O'DonnellRan2026 to 2033Enrolled174ConditionsBladder Cancer, Non-Muscle Invasive Bladder Cancer (NMIBC), Urothelial Carcinoma, Carcinoma in Situ (CIS)ArmsIntravesical Gemcitabine and Docetaxel
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Review
  3. 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

15 authors.

Reuben Ben-David *Department of Urology, Icahn School of Medicine at Mount Sinai, The Milton and Carroll Petrie, New York, NY, USA. reuben.bendavid@mountsinai.org.ORCID http://orcid.org/0000-0001-7946-7145
Neeraja Tillu *Department of Urology, Icahn School of Medicine at Mount Sinai, The Milton and Carroll Petrie, New York, NY, USA.
Parissa AlerasoolDepartment of Urology, Ichan School of Medicine at Mount Sinai, Tisch Cancer Institute, 1425 Madison Avenue, New York, NY, USA.
Christine BieberDepartment of Urology, Icahn School of Medicine at Mount Sinai, The Milton and Carroll Petrie, New York, NY, USA.
Daniel RantiDepartment of Urology, Icahn School of Medicine at Mount Sinai, The Milton and Carroll Petrie, New York, NY, USA.
Serena TolaniDepartment of Urology, Icahn School of Medicine at Mount Sinai, The Milton and Carroll Petrie, New York, NY, USA.
Justin EisenhauerDepartment of Urology, Icahn School of Medicine at Mount Sinai, The Milton and Carroll Petrie, New York, NY, USA.
Rainjade ChungDepartment of Urology, Columbia University Irving Medical Center, New York, NY, USA.
Etienne LavalléeDepartment of Urology, Icahn School of Medicine at Mount Sinai, The Milton and Carroll Petrie, New York, NY, USA.
Nikhil WaingankarDepartment of Urology, Icahn School of Medicine at Mount Sinai, The Milton and Carroll Petrie, New York, NY, USA.
Kyrollis AttallaDepartment of Urology, Icahn School of Medicine at Mount Sinai, The Milton and Carroll Petrie, New York, NY, USA.
Peter WiklundDepartment of Urology, Icahn School of Medicine at Mount Sinai, The Milton and Carroll Petrie, New York, NY, USA.
Reza MehrazinDepartment of Urology, Icahn School of Medicine at Mount Sinai, The Milton and Carroll Petrie, New York, NY, USA.
Christopher B AndersonDepartment of Urology, Columbia University Irving Medical Center, New York, NY, USA.
John P SfakianosDepartment of Urology, Icahn School of Medicine at Mount Sinai, The Milton and Carroll Petrie, New York, NY, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe combination of sequential intravesical gemcitabine and docetaxel (Gem/Doce) chemotherapy has been considered a feasible option for BCG (Bacillus Calmette-Guérin) treatment in non-muscle invasive bladder cancer (NMIBC), gaining popularity during BCG shortage period. We seek to determine the efficacy of the treatment by comparing Gem/Doce induction alone vs induction with maintenance, and to evaluate the treatment outcomes of two different dosage protocols.

methodsA bi-center retrospective analysis of consecutive patients treated with Gem/Doce for NMIBC between 2018 and 2023 was performed. Baseline characteristics, risk group stratification (AUA 2020 guidelines), pathological, and surveillance reports were collected. Kaplan-Meier survival analysis was performed to detect Recurrence-free survival (RFS).

resultsOverall, 83 patients (68 males, 15 females) with a median age of 73 (IQR 66-79), and a median follow-up time of 18 months (IQR 9-25), were included. Forty-one had an intermediate-risk disease (49%) and 42 had a high-risk disease (51%). Thirty-seven patients (45%) had a recurrence; 19 (23%) had a high-grade recurrence. RFS of Gem/Doce induction-only vs induction + maintenance was at 6 months 88% vs 100%, at 12 months 71% vs 97%, at 18 months 57% vs 91%, and at 24 months 31% vs 87%, respectively (log-rank, p < 0.0001). Patients who received 2 g Gemcitabine with Docetaxel had better RFS for all-grade recurrences (log-rank, p = 0.017). However, no difference was found for high-grade recurrences.

conclusionGem/Doce induction with maintenance resulted in significantly better RFS than induction-only. Combining 2 g gemcitabine with docetaxel resulted in better RFS for all-grade but not for high-grade recurrences. Further prospective trials are necessary to validate our results.

Indexed as

DeoxycytidineDocetaxelGemcitabineNeoplasm InvasivenessNon-Muscle Invasive Bladder NeoplasmsAdministration, IntravesicalAgedAntineoplastic Combined Chemotherapy ProtocolsDose-Response Relationship, DrugFemaleHumansInduction ChemotherapyMaintenance ChemotherapyMaleRetrospective StudiesRisk AssessmentDeoxycytidineDocetaxelGemcitabineIntravesical drug administrationNon-muscle invasive bladder neoplasmsUrinary bladder neoplasms

Identifiers

PMID38734774

What OpenQuestion holds

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Registered trials

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.