Evidence map›Paper›PMID 38573872›Full record

ArticleThe Journal of urology2024

Phase 1b Trial Evaluating Tolerability and Activity of Targeted Fibroblast Growth Factor Receptor Inhibition in Localized Upper Tract Urothelial Carcinoma.

Surena F Matin, Mehrad Adibi, Amishi Y Shah, Omar Alhalabi, Paul Corn, Charles Guo, Rhenita Amirtharaj, Lianchun Xiao, Suzanne Lange, Dzifa Y Duose and 3 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in The 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 NCT04228042 (Tolerability and Activity of Neoadjuvant Infigratinib, an Inhibitor of FGFR, in Upper Tract Urothelial Carcinoma), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
4.0field-weighted citation impact, top 6% 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.

NCT04228042 phase1 / phase2terminatednot on this map

Tolerability and Activity of Neoadjuvant Infigratinib, an Inhibitor of FGFR, in Upper Tract Urothelial Carcinoma

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2020 to 2024Enrolled15ConditionsRenal Pelvis and Ureter Urothelial CarcinomaArmsInfigratinib, Quality-of-Life Assessment, Questionnaire Administration, Surgical Procedure
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
  2. Pathogenic Role of FGFR3 Autoantibodies in Small Fiber Neuropathy.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
    Article
  3. Review
  4. Review
  5. Review
  6. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 2 institutions in 1 country.

Surena F MatinDepartment of Urology, MD Anderson Cancer Center, Houston, Texas.
Mehrad AdibiDepartment of Urology, MD Anderson Cancer Center, Houston, Texas.
Amishi Y ShahDepartment of Genitourinary Medical Oncology, MD Anderson Cancer Center, Houston, Texas.
Omar AlhalabiDepartment of Genitourinary Medical Oncology, MD Anderson Cancer Center, Houston, Texas.
Paul CornDepartment of Genitourinary Medical Oncology, MD Anderson Cancer Center, Houston, Texas.
Charles GuoDepartment of Pathology, MD Anderson Cancer Center, Houston, Texas.
Rhenita AmirtharajDepartment of Urology, MD Anderson Cancer Center, Houston, Texas.
Lianchun XiaoDepartment of Biostatistics, MD Anderson Cancer Center, Houston, Texas.
Suzanne LangeDepartment of Urology, MD Anderson Cancer Center, Houston, Texas.
Dzifa Y DuoseDepartment of Translational Molecular Pathology, MD Anderson Cancer Center, Houston, Texas.
Shufang WangDepartment of Translational Molecular Pathology, MD Anderson Cancer Center, Houston, Texas.
Sumanta PalDepartment of Medical Oncology and Therapeutics Research, City of Hope, Duarte, California.
Matthew T CampbellDepartment of Genitourinary Medical Oncology, MD Anderson Cancer Center, Houston, Texas.
The University of Texas MD Anderson Cancer Center · USCity of Hope · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

purposeWe initiated a biomarker-informed preoperative study of infigratinib, a fibroblast growth factor receptor (FGFR) inhibitor, in patients with localized upper tract urothelial carcinoma (UTUC), a population with high unmet needs and tumor with a high frequency of FGFR3 alterations. MATERIALS AND

methodsPatients with localized UTUC undergoing ureteroscopy or nephroureterectomy/ureterectomy were enrolled on a phase 1b trial (NCT04228042). Once-daily infigratinib 125 mg by mouth × 21 days (28-day cycle) was given for 2 cycles. Tolerability was monitored by Bayesian design and predefined stopping boundaries. The primary endpoint was tolerability, and the secondary endpoint was objective response based on tumor mapping, done after endoscopic biopsy and post-trial surgery. Total planned enrollment: 20 patients. Targeted sequencing performed using a NovaSeq 6000 solid tumor panel.

resultsFrom May 2021 to November 2022, 14 patients were enrolled, at which point the trial was closed due to termination of all infigratinib oncology trials. Two patients (14.3%) had treatment-terminating toxicities, well below the stopping threshold. Responses occurred in 6 (66.7%) of 9 patients with FGFR3 alterations. Responders had median tumor size reduction of 67%, with 3 of 5 patients initially planned for nephroureterectomy/ureterectomy converted to ureteroscopy. Median follow-up in responders was 24.7 months (14.9-28.9).

conclusionsIn this first trial of targeted therapy for localized UTUC, FGFR inhibition was well tolerated and had significant activity in FGFR3 altered tumors. Renal preservation was enabled in a substantial proportion of participants. These data support the design of a biomarker-driven phase 2 trial of FGFR3 inhibition in this population with significant unmet clinical needs.

Indexed as

Carcinoma, Transitional CellUreteral NeoplasmsAgedAged, 80 and overFemaleHumansKidney NeoplasmsMaleMiddle AgedNephroureterectomyPhenylurea CompoundsPyrimidinesReceptor, Fibroblast Growth Factor, Type 3Treatment OutcomeUreteroscopyFGFR3 protein, humaninfigratinibPhenylurea CompoundsPyrimidinesReceptor, Fibroblast Growth Factor, Type 3clinical trialtargeted therapyureter cancerurothelial cancer

Identifiers

PMID38573872
PMCPMC11251863
OpenAlexW4393929912

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.