Evidence map›Paper›PMID 36603175›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

Multicenter Phase II Clinical Trial of Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy for Patients With High-Grade Upper Tract Urothelial Carcinoma.

Jonathan A Coleman, Wesley Yip, Nathan C Wong, Daniel D Sjoberg, Bernard H Bochner, Guido Dalbagni, S Machele Donat, Harry W Herr, Eugene K Cha, Timothy F Donahue and 23 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 63 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 5 pooled it
30.5field-weighted citation impact, top 1% 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

63 citing papers in PubMed, 5 syntheses or guidelines pooled it, 96 citations in OpenAlex.

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3 more citing papers are in PubMed but not listed here.

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

33 authors at 6 institutions in 1 country.

Jonathan A ColemanMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-6428-7835
Wesley YipMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-2389-3046
Nathan C WongMemorial Sloan Kettering Cancer Center, New York, NY.
Daniel D SjobergMemorial Sloan Kettering Cancer Center, New York, NY.
Bernard H BochnerMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0003-0846-0848
Guido DalbagniMemorial Sloan Kettering Cancer Center, New York, NY.
S Machele DonatMemorial Sloan Kettering Cancer Center, New York, NY.
Harry W HerrMemorial Sloan Kettering Cancer Center, New York, NY.
Eugene K ChaMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-8807-2353
Timothy F DonahueMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0003-1855-1794
Eugene J PietzakMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-5121-5701
A Ari HakimiMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-0930-8824
Kwanghee KimMemorial Sloan Kettering Cancer Center, New York, NY.
Hikmat A Al-AhmadieMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-2938-6627
H Alberto VargasMemorial Sloan Kettering Cancer Center, New York, NY.
Ricardo G AlvimMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-9774-1723
Soleen GhafoorMemorial Sloan Kettering Cancer Center, New York, NY.
Nicole E BenfanteMemorial Sloan Kettering Cancer Center, New York, NY.
Anoop M MeraneyHartford Hospital, Hartford, CT.
Steven J ShichmanHartford Hospital, Hartford, CT.
Jeffrey M KamradtHartford Hospital, Hartford, CT.
Suresh G NairLehigh Valley Health Network, Allentown, PA.ORCID 0000-0001-7763-9732
Angelo A BaccalaLehigh Valley Health Network, Allentown, PA.
Paul PalycaLehigh Valley Health Network, Allentown, PA.
Bradley W LashLehigh Valley Health Network, Allentown, PA.
Muhammad A RizviLehigh Valley Health Network, Allentown, PA.
Scott K SwansonMayo Clinic Cancer Center, Scottsdale, AZ.
Antonio F MuinaMiami Cancer Institute, Miami, FL.
Andrea B ApoloNational Cancer Institute, Bethesda, MD.ORCID 0000-0001-9409-1836
Gopa IyerMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-5093-6099
Jonathan E RosenbergMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0003-2637-4249
Min Y TeoMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0003-2511-6731
Dean F BajorinMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0003-4001-7088
Memorial Sloan Kettering Cancer Center · USLehigh Valley Hospital-Pocono · USHartford Hospital · USMayo Clinic in Arizona · USMiami Heart Research Institute · USNational Cancer Institute · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
SPORE in Bladder CancerP50CA221745 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI BAJORIN, DEAN F. · 2018 to 2024
$11.8M
Bladder Cancer ProgramZIABC011351 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI APOLO, ANDREA · 2010 to 2025
$9.4M
UROLOGY ONCOLOGY RESEARCH TRAINING GRANTT32CA082088 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Brett Stewart Carver · 1999 to 2026
$7.1M
NCI NIH HHS P30 CA008748NCI NIH HHS P50 CA221745NCI NIH HHS T32 CA082088
6 · The paper itself

Abstract

purposeNeoadjuvant chemotherapy (NAC) has proven survival benefits for patients with invasive urothelial carcinoma of the bladder, yet its role for upper tract urothelial carcinoma (UTUC) remains undefined. We conducted a multicenter, single-arm, phase II trial of NAC with gemcitabine and split-dose cisplatin (GC) for patients with high-risk UTUC before extirpative surgery to evaluate response, survival, and tolerability.

methodsEligible patients with defined criteria for high-risk localized UTUC received four cycles of split-dose GC before surgical resection and lymph node dissection. The primary study end point was rate of pathologic response (defined as < ypT2N0). Secondary end points included progression-free survival (PFS), overall survival (OS), and safety and tolerability.

resultsAmong 57 patients evaluated, 36 (63%) demonstrated pathologic response (95% CI, 49 to 76). A complete pathologic response (ypT0N0) was noted in 11 patients (19%). Fifty-one patients (89%) tolerated at least three complete cycles of split-dose GC, 27 patients (47%) tolerated four complete cycles, and all patients proceeded to surgery. With a median follow up of 3.1 years, 2- and 5-year PFS rates were 89% (95% CI, 81 to 98) and 72% (95% CI, 59 to 87), while 2- and 5-year OS rates were 93% (95% CI, 86 to 100) and 79% (95% CI, 67 to 94), respectively. Pathologic complete and partial responses were associated with improved PFS and OS compared with nonresponders (≥ ypT2N any; 2-year PFS 100% and 95%

conclusionNAC with split-dose GC for high-risk UTUC is a well-tolerated, effective therapy demonstrating evidence of pathologic response that is associated with favorable survival outcomes. Given that these survival outcomes are superior to historical series, these data support the use of NAC as a standard of care for high-risk UTUC, and split-dose GC is a viable option for NAC.

Indexed as

Carcinoma, Transitional CellUrinary Bladder NeoplasmsCisplatinGemcitabineHumansNeoadjuvant TherapyCisplatinGemcitabine

Identifiers

PMID36603175
PMCPMC10043554
OpenAlexW4313549663

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.