Evidence map›Paper›PMID 39017806›Full record

Trial reportInternational journal of clinical oncology2024

Phase 3 THOR Japanese subgroup analysis: erdafitinib in advanced or metastatic urothelial cancer and fibroblast growth factor receptor alterations.

Nobuaki Matsubara, Yuji Miura, Hiroyuki Nishiyama, Rikiya Taoka, Takahiro Kojima, Nobuaki Shimizu, Jason Hwang, Tatsuya Ote, Ryo Oyama, Kiichiro Toyoizumi and 4 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03390504 (A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

NCT03390504 phase3active not recruitingnot on this map

A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

TypeinterventionalSponsorJanssen Research & Development, LLCRan2018 to 2026Enrolled629ConditionsUrothelial CancerArmsErdafitinib, Vinflunine, Docetaxel, Pembrolizumab, Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Review
  6. Review
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

14 authors.

Nobuaki MatsubaraDepartment of Medical Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. nmatsuba@east.ncc.go.jp.
Yuji MiuraDepartment of Medical Oncology, Toranomon Hospital, 2-2-2 Toranomon, Minato-ku, Tokyo, 105-8470, Japan.
Hiroyuki NishiyamaDepartment of Urology, Institute of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan.
Rikiya TaokaDepartment of Urology, Faculty of Medicine, Kagawa University, 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, 761-0793, Japan.
Takahiro KojimaDepartment of Urology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.
Nobuaki ShimizuDepartment of Urology, Gunma Prefectural Cancer Center, 3-39-22 Showa-machi, Maebashi, Gunma, 371-8511, Japan.
Jason HwangDepartment of Medical Affairs, Janssen Pharmaceutical K.K, 5-2-3 Nishikanda, Chiyoda-ku, Tokyo, 101-0065, Japan.
Tatsuya OteOncology Clinical Development Department, Clinical Science Division, Research and Development, Janssen Pharmaceutical K.K, 5-2-3 Nishikanda, Chiyoda-ku, Tokyo, 101-0065, Japan.
Ryo OyamaResearch and Development, Janssen Pharmaceutical K.K, 5-2-3 Nishikanda, Chiyoda-ku, Tokyo, 101-0065, Japan.
Kiichiro ToyoizumiStatistics and Decision Sciences, Research and Development, Janssen Pharmaceutical K. K, 5-2-3 Nishikanda, Chiyoda-ku, Tokyo, 101-0065, Japan.
Sutapa MukhopadhyayJanssen Research and Development, 920 US Highway 202 S, Raritan, NJ, 08807, USA.
Spyros TriantosJanssen Research and Development, 1400 McKean Road, Spring House, PA, 19477, USA.
Kris DeprinceJanssen Research and Development, Turnhoutseweg 30, 2340, Beerse Anterwerpen, Belgium.
Yohann LoriotDepartment of Cancer Medicine, INSERM U981, Gustave Roussy, Universite Paris-Saclay, 94800, Villejuif, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the THOR trial (NCT03390504) Cohort 1, erdafitinib demonstrated significantly prolonged overall survival (OS) (median 12.1 versus 7.8 months) and reduced risk of death by 36% (hazard ratio 0.64, P = 0.005) compared with chemotherapy in metastatic urothelial carcinoma (mUC) patients with FGFR alterations who progressed after ≥ 1 prior treatments, including anti-PD-(L)1. There have been no reports of the Japanese subgroup results yet.

methodsTHOR Cohort 1 randomized patients to erdafitinib once daily or docetaxel/vinflunine once every 3 weeks. Primary endpoint was OS. Secondary endpoints included progression-free survival (PFS) and objective response rate (ORR). No specific statistical power was set for this Japanese subgroup analysis.

resultsOf 266 patients randomized, 27 (14 erdafitinib; 13 chemotherapy) were Japanese. Baseline characteristics were generally similar between treatments and to the overall population, except for more males, lower body weight, and more upper tract primary tumors among Japanese patients. Compared with chemotherapy, erdafitinib showed improved OS (median 25.4 versus 12.4 months), PFS (median 8.4 versus 2.9 months) and ORR (57.1% versus 15.4%). Any grade treatment-related adverse events (AEs) occurred in all patients from both arms but Grade 3/4 AEs and AEs leading to discontinuation were lower in the erdafitinib arm. No new safety signals were observed in the Japanese subgroup.

conclusionIn the Japanese subgroup, erdafitinib showed improved survival and response compared to chemotherapy, with no new safety concerns. These results support erdafitinib as a treatment option for Japanese mUC patients with FGFR alterations, and early FGFR testing after diagnosis of mUC should be considered.

Indexed as

QuinoxalinesAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Transitional CellEast Asian PeopleFemaleHumansJapanMaleMiddle AgedMutationProgression-Free SurvivalPyrazolesReceptors, Fibroblast Growth FactorerdafitinibPyrazolesQuinoxalinesReceptors, Fibroblast Growth FactorErdafitinibFibroblast growth factor receptorJapanese subgroupMetastatic urothelial carcinomaOral tyrosine kinase inhibitor

Identifiers

PMID39017806
PMCPMC11420312

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.