دورية أكاديمية
أعرض في EDS

Management of Fibroblast Growth Factor Inhibitor Treatment-emergent Adverse Events of Interest in Patients with Locally Advanced or Metastatic Urothelial Carcinoma.

التفاصيل البيبلوغرافية
العنوان: Management of Fibroblast Growth Factor Inhibitor Treatment-emergent Adverse Events of Interest in Patients with Locally Advanced or Metastatic Urothelial Carcinoma.
المؤلفون: Siefker-Radtke, AO, Necchi, A, Park, SH, García-Donas, J, Huddart, RA, Burgess, EF, Fleming, MT, Rezazadeh Kalebasty, A, Mellado, B, Varlamov, S, Joshi, M, Duran, I, Tagawa, ST, Zakharia, Y, Qi, K, Akapame, S, Triantos, S, O'Hagan, A, Loriot, Y
المساهمون: Huddart, Robert
بيانات النشر: ELSEVIER
سنة النشر: 2023
المجموعة: The Institute of Cancer Research (ICR): Publications Repository
مصطلحات موضوعية: Erdafitinib, Fibroblast growth factor inhibitor, Toxicity, Urothelial carcinoma
جغرافية الموضوع: Netherlands
الوصف: 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 ...
نوع الوثيقة: article in journal/newspaper
وصف الملف: 9; application/pdf
اللغة: English
تدمد: 2666-1683
العلاقة: S2666-1683(23)00013-7; European Urology Open Science, 2023, 50 pp. 1 - 9; https://repository.icr.ac.uk/handle/internal/5769Test
الإتاحة: https://repository.icr.ac.uk/handle/internal/5769Test
حقوق: https://creativecommons.org/licenses/by-nc-nd/4.0Test/
رقم الانضمام: edsbas.11EFC798
قاعدة البيانات: BASE
الوصف
تدمد:26661683