| Title: |
Erdafitinib in BCG-treated high-risk non-muscle-invasive bladder cancer |
| Authors: |
Catto, James; Tran, Ben; Rouprêt, Morgan; Gschwend, Jürgen; Loriot, Yohann; Nishiyama, Hiroyuki; Palou, Juan; Daneshmand, Sia; Hussain, S.A.; Cutuli, Hernán Javier; Procopio, Giuseppe; Guadalupi, Valentina; Vasdev, Nikhil; Naini, Vahid; Crow, Lauren; Triantos, Spyros; Baig, Mahadi; Steinberg, Gary; Bengió, Rubén; Salinas, Jorge; Ameye, Filip; Joniau, Steven; Rodrigues da Rosa, Diogo; Martins da Trindade, Karine; de Almeida Luz, Murilo; Bavaresco, Mario Henrique; de Paula, Adriano; Santiag, Jose; Wang, Shaogang; Ye, Dingwei; Boegemann, Martin; Roghmann, Florian; Heidrich, Albert; Hellmis, Eva; Rodríguez Faba, Óscar; Dominguez, Jose Luís; Mathieu, Romain; Colombel, Marc; Bladou, Franck; Artignan, Xavier; Shimpi, Rajendra; Tambaro, Rosa; Sirotova, Zuzana; Spada, Massimiliano; Necchi, Andrea; Nakatsu, Hiroomi; Kikuchi, Eiji; Shimizu, Nobuaki; Kanao, Kent; Sumitomo, Makoto; Naito, Yushi; Ham, Won Sik; Jung, Seung-Il; Ha, Hongkoo; Joo, Kwan Joong; Ku, Ja Hyeon; Seo, Ho Kyung; Yun, Seokjoong; Kolodziej, Anna; Lawinski, Janusz; Morris, David; Daneshmand, Siamak; Mian, Badar; Lee, Eugene |
| Publication Year: |
2024 |
| Collection: |
Universitat Autònoma de Barcelona: Dipòsit Digital de Documents de la UAB |
| Subject Terms: |
Erdafitinib; FGFR; Intravesical chemotherapy; Non-muscle-invasive bladder cancer; Recurrence-free survival; Safety |
| Description: |
Background: Treatment options are limited for patients with high-risk non-muscle-invasive bladder cancer (NMIBC) with disease recurrence after bacillus Calmette-Guérin (BCG) treatment and who are ineligible for/refuse radical cystectomy. FGFR alterations are commonly detected in NMIBC. We evaluated the activity of oral erdafitinib, a selective pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, versus intravesical chemotherapy in patients with high-risk NMIBC and select FGFR3/2 alterations following recurrence after BCG treatment. Patients and methods: Patients aged ≥18 years with recurrent, BCG-treated, papillary-only high-risk NMIBC (high-grade Ta/T1) and select FGFR alterations refusing or ineligible for radical cystectomy were randomized to 6 mg daily oral erdafitinib or investigator's choice of intravesical chemotherapy (mitomycin C or gemcitabine). The primary endpoint was recurrence-free survival (RFS). The key secondary endpoint was safety. Results: Study enrollment was discontinued due to slow accrual. Seventy-three patients were randomized 2 : 1 to erdafitinib (n = 49) and chemotherapy (n = 24). Median follow-up for RFS was 13.4 months for both groups. Median RFS was not reached for erdafitinib [95% confidence interval (CI) 16.9 months-not estimable] and was 11.6 months (95% CI 6.4-20.1 months) for chemotherapy, with an estimated hazard ratio of 0.28 (95% CI 0.1-0.6; nominal P value = 0.0008). In this population, safety results were generally consistent with known profiles for erdafitinib and chemotherapy. Conclusions: Erdafitinib prolonged RFS compared with intravesical chemotherapy in patients with papillary-only, high-risk NMIBC harboring FGFR alterations who had disease recurrence after BCG therapy and refused or were ineligible for radical cystectomy. |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| ISSN: |
15698041 |
| Relation: |
Annals of oncology; Vol. 35 Núm. 1 (january 2024), p. 98-106; https://ddd.uab.cat/record/304051; urn:10.1016/j.annonc.2023.09.3116; urn:oai:ddd.uab.cat:304051; urn:scopus_id:85175616619; urn:articleid:15698041v35n1p98; urn:pmid:37871701 |
| Availability: |
https://ddd.uab.cat/record/304051 |
| Rights: |
open access ; Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original. ; https://creativecommons.org/licenses/by/4.0/ |
| Accession Number: |
edsbas.8EFA59D8 |
| Database: |
BASE |