Erdafitinib in BCG-treated high-risk non-muscle-invasive bladder cancer
Por:
Catto, JWF, Tran, B, Rouprêt, M, Gschwend, JE, Loriot, Y, Nishiyama, H, Redorta, JP, Daneshmand, S, Hussain, SA, Cutuli, HJ, Procopio, G, Guadalupi, V, Vasdev, N, Naini, V, Crow, L, Triantos, S, Baig, M, Steinberg, G
Publicada:
1 ene 2024
Ahead of Print:
1 ene 2024
Resumen:
Background: Treatment options are limited for patients with high-risk non-muscle-invasive bladder cancer (NMIBC) with disease recurrence after bacillus Calmette-Guerin (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, highrisk NMIBC harboring FGFR alterations who had disease recurrence after BCG therapy and refused or were ineligible for radical cystectomy.
Filiaciones:
Catto, JWF:
Univ Sheffield, Dept Oncol & Metab, Sheffield, England
Sheffield Teaching Hosp NHS Trust, Sheffield, England
Univ Sheffield, Med Sch, Dept Oncol & Metab, G Floor, Sheffield GU19, England
Tran, B:
Peter MacCallum Canc Ctr, Dept Med Oncol, Melbourne, Australia
Rouprêt, M:
Sorbonne Univ, Hop Pitie Salpetriere, Dept Urol, GRC Predict Oncouro 5, Paris, France
Gschwend, JE:
Tech Univ Munich, Sch Med & Hlth, Dept Urol, Munich, Germany
Loriot, Y:
Univ Paris Saclay, Dept Canc Med, INSERM, Gustave Roussy,U981, Villejuif, France
Nishiyama, H:
Univ Tsukuba, Inst Med, Dept Urol, Tsukuba, Japan
Redorta, JP:
Univ Autonoma Barcelona, Dept Urol, Fundacio Puigvert, Barcelona, Spain
Daneshmand, S:
Univ Southern Calif, Norris Comprehens Canc Ctr, Dept Urol, Los Angeles, CA USA
Hussain, SA:
Univ Sheffield, Dept Oncol & Metab, Sheffield, England
Sheffield Teaching Hosp NHS Trust, Sheffield, England
Cutuli, HJ:
Sirio Libanes Hosp, Urooncol & Res Unit, Buenos Aires, Argentina
Procopio, G:
Fdn IRCCS Ist Nazl Tumori Milano, Oncol Med Genitourinaria, Milan, Italy
Guadalupi, V:
Fdn IRCCS Ist Nazl Tumori Milano, Oncol Med Genitourinaria, Milan, Italy
Vasdev, N:
Lister Hosp, Hertfordshire & Bedfordshire Urol Canc Ctr, East & North Herts NHS Trust, Stevenage, England
Univ Hertfordshire, Sch Life & Med Sci, Hatfield, England
Naini, V:
Janssen Res & Dev, San Diego, CA USA
Crow, L:
Janssen Res & Dev, Spring House, PA USA
Triantos, S:
Janssen Res & Dev, Spring House, PA USA
Baig, M:
Janssen Res & Dev, Spring House, PA USA
Steinberg, G:
Rush Univ, Med Ctr, Dept Urol, Chicago, IL USA
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