Management of fibroblast growth factor receptor inhibitor (FGFRi) treatment-emergent adverse events (TEAEs) of interest in patients (Pts) with locally advanced or metastatic urothelial carcinoma (mUC)
| العنوان: | Management of fibroblast growth factor receptor inhibitor (FGFRi) treatment-emergent adverse events (TEAEs) of interest in patients (Pts) with locally advanced or metastatic urothelial carcinoma (mUC) |
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| المؤلفون: | Keqin Qi, Yousef Zakharia, Robert Huddart, Se Hoon Park, Scott T. Tagawa, Yohann Loriot, Andrea Necchi, Monika Joshi, Jesús García-Donas, Manish Monga, Earle F. Burgess, Anne OHagan, Begoña Mellado, Arash Rezazadeh, Arlene O. Siefker-Radtke, Manu Sondhi, Ignacio Duran, Mark D. Fleming, Sergei Varlamov |
| المصدر: | Journal of Clinical Oncology. 39:426-426 |
| بيانات النشر: | American Society of Clinical Oncology (ASCO), 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Cancer Research, Metastatic Urothelial Carcinoma, Oncology, Erdafitinib, Fibroblast growth factor receptor, Kinase, business.industry, Locally advanced, Cancer research, Medicine, In patient, Adverse effect, business |
| الوصف: | 426 Background: Erdafitinib (ERDA), a pan-FGFR kinase inhibitor, was US FDA approved for adults with mUC with susceptible FGFR3/2 alterations ( FGFRa) who progressed on ≥ 1 line of prior platinum-based chemotherapy based on primary results of the BLC2001 trial (NCT02365597). At final analysis (median 2-y follow-up), ERDA showed median OS of 11.3 mo and a manageable safety profile. Some FGFRi toxicities are distinct from those of other small-molecule TKIs. Proactive AE management can avoid treatment discontinuation, ensuring maximum benefit. We report the frequency and management of TEAEs of interest (central serous retinopathy [CSR], hyperphosphatemia [“on-target” FGFRi class effect], stomatitis, and skin and nail toxicities) for the optimal schedule of ERDA from the final analysis of BLC2001. Methods: The open-label, phase II BLC2001 study enrolled pts with measurable mUC, prespecified FGFRa, and progression during/after ≥ 1 line of prior chemotherapy or ≤ 12 mos of (neo)adjuvant chemotherapy or who were cisplatin ineligible, chemo naive. Optimal dose schedule in the study was 8 mg/d continuous ERDA in 28-d cycles with uptitration to 9 mg/d (ERDA 8 mg/d UpT) if prespecified serum phosphate level was not reached and no significant TEAEs occurred. ERDA 8 mg/d UpT safety results as of Aug 9, 2019 (final analysis) are summarized here. AEs were graded using NCI CTCAE v4.0. Results: Median follow-up for 101 pts treated with ERDA 8 mg/d UpT was 24.0 mos; median treatment duration was 5.4 mos. All pts had ≥ 1 TEAE. Hyperphosphatemia, stomatitis, nail disorders, skin disorders, and CSR TEAEs occurred in 78%, 59%, 59%, 55%, and 27% of pts, respectively (few were grade [gr] 3; none were gr ≥ 4; Table). TEAEs were mostly managed with concomitant treatment and dose modifications. As of data cutoff, hyperphosphatemia had resolved in 74/79 (94%) pts; stomatitis in 44/60 (73%); nail and skin TEAEs in 26/60 (43%) and 25/55 (45%), respectively; and CSR in 17/27 (63%). Most unresolved TEAEs were gr 1–2. No treatment-related deaths occurred. Conclusions: ERDA had measurable benefit in pts with advanced UC with FGFRa. As with other targeted therapies, exposure to ERDA is associated with a pattern of AEs. The most common and FGFRi class effect TEAEs were generally reversible and managed by supportive care and dose modification. Clinical trial information: NCT02365597 . Research Sponsor: Janssen Research & Development, LLC[Table: see text] |
| تدمد: | 1527-7755 0732-183X |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::f324f90f013ea7f85fa8977552d22ad3 https://doi.org/10.1200/jco.2021.39.6_suppl.426 |
| رقم الأكسشن: | edsair.doi...........f324f90f013ea7f85fa8977552d22ad3 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15277755 0732183X |
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