Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial

PROOF 302 is an ongoing randomized, double-blind, placebo-controlled, adjuvant phase III trial (NCT04197986) in approximately 218 patients from 120 centers worldwide. Eligibility criteria include post-surgical high-risk muscle-invasive upper tract urothelial cancer (85% of patients) or urothelial bl...

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Detalles Bibliográficos
Autores: Pal, Sumanta, Somford, Diederik M., Grivas, Petros, Sridhar, Srikala S., Gupta, Shilpa, Bellmunt Molins, Joaquim, 1959-, Sonpavde, Guru, Fleming, Mark T., Lerner, Seth Paul, Loriot, Yohann, Hoffman-Censits, Jean, Valderrama, Begoña P., Andresen, Corina, Schnabel, Marco J., Cole, Suzanne, Daneshmand, Siamak
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:10230/55778
Acceso en línea:http://hdl.handle.net/10230/55778
http://dx.doi.org/10.2217/fon-2021-1629
Access Level:acceso abierto
Palabra clave:FGFR inhibitor
FGFR3
PROOF 302
Adjuvant cisplatin-based chemotherapy
Adjuvant therapy
Cisplatin-therapy refusal
Fusions or rearrangements
Infigratinib
Muscle-invasive urothelial carcinoma
Mutations
Neoadjuvant cisplatin-based chemotherapy
Phase III
Upper tract urothelial carcinoma
Urothelial bladder carcinoma
Urothelial carcinoma
Descripción
Sumario:PROOF 302 is an ongoing randomized, double-blind, placebo-controlled, adjuvant phase III trial (NCT04197986) in approximately 218 patients from 120 centers worldwide. Eligibility criteria include post-surgical high-risk muscle-invasive upper tract urothelial cancer (85% of patients) or urothelial bladder cancer (15%), susceptible FGFR3 alterations (activating mutations, gene fusions or rearrangements), ≤120 days following radical surgery and ineligible for/or refusing cisplatin-based (neo)adjuvant chemotherapy. Patients receive either oral infigratinib 125 mg or placebo daily on days 1-21 of a 28-day cycle for up to 52 weeks or until recurrence, unacceptable toxicity or death. Primary end point: centrally determined disease-free survival (DFS); secondary end points: investigator-assessed DFS, metastasis-free survival, overall survival and safety/tolerability; exploratory end points: correlative biomarker analysis, quality-of-life and infigratinib pharmacokinetics.

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