dc.contributor.author | Siefker-Radtke, AO | |
dc.contributor.author | Necchi, A | |
dc.contributor.author | Park, SH | |
dc.contributor.author | García-Donas, J | |
dc.contributor.author | Huddart, RA | |
dc.contributor.author | Burgess, EF | |
dc.contributor.author | Fleming, MT | |
dc.contributor.author | Rezazadeh Kalebasty, A | |
dc.contributor.author | Mellado, B | |
dc.contributor.author | Varlamov, S | |
dc.contributor.author | Joshi, M | |
dc.contributor.author | Duran, I | |
dc.contributor.author | Tagawa, ST | |
dc.contributor.author | Zakharia, Y | |
dc.contributor.author | Qi, K | |
dc.contributor.author | Akapame, S | |
dc.contributor.author | Triantos, S | |
dc.contributor.author | O'Hagan, A | |
dc.contributor.author | Loriot, Y | |
dc.coverage.spatial | Netherlands | |
dc.date.accessioned | 2023-05-02T08:59:02Z | |
dc.date.available | 2023-05-02T08:59:02Z | |
dc.date.issued | 2023-04-01 | |
dc.identifier | S2666-1683(23)00013-7 | |
dc.identifier.citation | European Urology Open Science, 2023, 50 pp. 1 - 9 | |
dc.identifier.issn | 2666-1683 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5769 | |
dc.identifier.eissn | 2666-1683 | |
dc.identifier.eissn | 2666-1683 | |
dc.description.abstract | BACKGROUND: Erdafitinib is indicated for the treatment of adults with locally advanced/metastatic urothelial carcinoma and susceptible FGFR3/2 alterations progressing on/after one or more lines of prior platinum-based chemotherapy. OBJECTIVE: To better understand the frequency and management of select treatment-emergent adverse events (TEAEs) to enable optimal fibroblast growth factor receptor inhibitor (FGFRi) treatment. DESIGN SETTING AND PARTICIPANTS: Longer-term efficacy and safety results of the BLC2001 (NCT02365597) trial in patients with locally advanced and unresectable or metastatic urothelial carcinoma were studied. INTERVENTION: Erdafitinib schedule of 8 mg/d continuous in 28-d cycles, with uptitration to 9 mg/d if serum phosphate level was <5.5 mg/dl and no significant TEAEs occurred. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Adverse events were graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. The Kaplan-Meier methodology was used for the cumulative incidence of the first onset of TEAEs by grade. Time to resolution of TEAEs was summarized descriptively. RESULTS AND LIMITATIONS: At data cutoff, the median treatment duration was 5.4 mo among 101 patients receiving erdafitinib. Select TEAEs (total; grade 3) were hyperphosphatemia (78%; 2.0%), stomatitis (59%; 14%), nail events (59%; 15%), non-central serous retinopathy (non-CSR) eye disorders (56%; 5.0%), skin events (55%; 7.9%), diarrhea (55%; 4.0%), and CSR (27%; 4.0%). Select TEAEs were mostly of grade 1 or 2, and were managed effectively with dose modifications, including dose reductions or interruptions, and/or supportive concomitant therapies, resulting in few events leading to treatment discontinuation. Further work is needed to determine whether management is generalizable to the nonprotocol/general population. CONCLUSIONS: Identification of select TEAEs and appropriate management with dose modification and/or concomitant therapies resulted in improvement or resolution of most TEAEs in patients, allowing for continuation of FGFRi treatment to ensure maximum benefit. PATIENT SUMMARY: Early identification and proactive management are warranted to mitigate or possibly prevent erdafitinib side effects to allow for maximum drug benefit in patients with locally advanced or metastatic bladder cancer. | |
dc.format.extent | 1 - 9 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | ELSEVIER | |
dc.relation.ispartof | European Urology Open Science | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | |
dc.subject | Erdafitinib | |
dc.subject | Fibroblast growth factor inhibitor | |
dc.subject | Toxicity | |
dc.subject | Urothelial carcinoma | |
dc.title | Management of Fibroblast Growth Factor Inhibitor Treatment-emergent Adverse Events of Interest in Patients with Locally Advanced or Metastatic Urothelial Carcinoma. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2022-12-22 | |
dc.date.updated | 2023-05-02T08:54:39Z | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1016/j.euros.2022.12.019 | |
rioxxterms.licenseref.startdate | 2023-04-01 | |
rioxxterms.type | Journal Article/Review | |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/37101768 | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Clinical Academic Radiotherapy (Huddart) | |
pubs.publication-status | Published online | |
pubs.publisher-url | http://dx.doi.org/10.1016/j.euros.2022.12.019 | |
pubs.volume | 50 | |
icr.researchteam | Clinic Acad RT Huddart | |
dc.contributor.icrauthor | Huddart, Robert | |
icr.provenance | Deposited by Prof Robert Huddart on 2023-05-02. Deposit type is initial. No. of files: 1. Files: Siefker-Radtke_BLC2001_ToxMS_revision_09NOV2022_TRACKED[46].docx | |
icr.provenance | Deposited by Mr Arek Surman (impersonating Prof Robert Huddart) on 2023-05-02. Deposit type is subsequent. No. of files: 1. Files: 1-s2.0-S2666168323000137-main.pdf | |