Evidence map›Paper›PMID 39680823›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2025

Phase II Trial of Risk-Enabled Therapy After Neoadjuvant Chemotherapy for Muscle-Invasive Bladder Cancer (RETAIN 1).

Daniel M Geynisman, Philip H Abbosh, Eric Ross, Matthew R Zibelman, Pooja Ghatalia, Fern Anari, James R Mark, Lambros Stamatakis, Jean H Hoffman-Censits, Rosalia Viterbo and 9 more

Abstract readClinical Trial, Phase IIEquivalence Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 2 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

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

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  7. Neoadjuvant Atezolizumab With Gemcitabine and Cisplatin in Patients With Muscle-Invasive Bladder Cancer: A Multicenter, Single-Arm, Phase II Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
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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

19 authors.

Daniel M GeynismanFox Chase Cancer Center, Philadelphia, PA.ORCID 0000-0002-1423-5295
Philip H AbboshFox Chase Cancer Center, Philadelphia, PA.ORCID 0000-0003-3611-9532
Eric RossFox Chase Cancer Center, Philadelphia, PA.ORCID 0000-0002-0890-2418
Matthew R ZibelmanFox Chase Cancer Center, Philadelphia, PA.ORCID 0000-0003-1475-6477
Pooja GhataliaFox Chase Cancer Center, Philadelphia, PA.
Fern AnariFox Chase Cancer Center, Philadelphia, PA.
James R MarkThomas Jefferson University Hospital, Philadelphia, PA.ORCID 0000-0001-7675-3437
Lambros StamatakisMedStar Washington Hospital Center, Washington D.C.
Jean H Hoffman-CensitsSidney Kimmel Comprehensive Cancer Center (Johns Hopkins).ORCID 0000-0002-6970-6509
Rosalia ViterboFox Chase Cancer Center, Philadelphia, PA.
Richard E GreenbergFox Chase Cancer Center, Philadelphia, PA.ORCID 0000-0002-8609-1307
Thomas M ChurillaFox Chase Cancer Center, Philadelphia, PA.
Eric M HorwitzFox Chase Cancer Center, Philadelphia, PA.ORCID 0000-0003-2187-317X
Mark A HallmanFox Chase Cancer Center, Philadelphia, PA.ORCID 0000-0002-2825-0656
Marc C SmaldoneFox Chase Cancer Center, Philadelphia, PA.
Robert UzzoFox Chase Cancer Center, Philadelphia, PA.
David Y T ChenFox Chase Cancer Center, Philadelphia, PA.ORCID 0000-0003-4574-2027
Alexander KutikovFox Chase Cancer Center, Philadelphia, PA.
Elizabeth R PlimackFox Chase Cancer Center, Philadelphia, PA.ORCID 0000-0002-7618-0744

Funding

WORD PROCESSING CENTER--COREP30CA006927 · NCI · RESEARCH INST OF FOX CHASE CAN CTR · PI Dietmar J Kappes · 1985 to 2026
$138.8M
NCI NIH HHS P30 CA006927
6 · The paper itself

Abstract

purposeCisplatin-based neoadjuvant chemotherapy (NAC) followed by cystectomy is the standard of care for patients with muscle-invasive bladder cancer (MIBC). Mutations in DNA damage repair genes are associated with pathologic downstaging after NAC. We hypothesized that a combination of biomarker selection and clinical staging would identify patients for cystectomy-sparing active surveillance (AS). PATIENTS AND

methodsWe conducted a single-arm, phase II, noninferiority trial to evaluate a risk-adapted approach for MIBC. Patients with cT2-T3N0M0 MIBC underwent NAC with accelerated methotrexate, vinblastine, doxorubicin, and cisplatin (AMVAC). Pre-NAC transurethral bladder tumor specimens were sequenced for mutations in

resultsSeventy patients were enrolled, 33 (47%) had a mutation, and 25 (36%) began per-protocol AS. With a median follow-up of 40 months, the 2-year MFS for all patients was 72.9% (lower bound exact one-sided 95% CI, 62.8). The 2-year MFS was 76.0% in the AS group (95% CI, 54.2 to 88.4) and 71.1% (95% CI, 55.5 to 82.1) in the remaining patients. In the AS group, 17 patients (68%) had some recurrence and 12 (48%) were metastasis-free with an intact bladder. The 2-year overall survival (OS) was 84.3% (95% CI, 73.4 to 91.0); OS was 88.0% (95% CI, 67.3 to 96.0) and 82.2% (95% CI, 67.6 to 90.7) in the AS and not-AS groups, respectively.

conclusionPatients with MIBC treated with AMVAC followed by a risk-adapted approach to local consolidation achieved a 2-year MFS rate of 73%. The primary end point was not met, but 17% of all enrolled patients and 48% of the AS group avoided cystectomy without metastatic disease.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsNeoadjuvant TherapyUrinary Bladder NeoplasmsAdultAgedChemotherapy, AdjuvantCisplatinCystectomyDoxorubicinFemaleHumansMaleMethotrexateMiddle AgedMutationNeoplasm InvasivenessCisplatinDoxorubicinMethotrexateVinblastine

Identifiers

PMID39680823
PMCPMC11908952

What OpenQuestion holds

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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.