RT Journal Article
T1 Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial.
A1 Pal, Sumanta K
A1 Somford, Diederik M
A1 Grivas, Petros
A1 Sridhar, Srikala S
A1 Gupta, Shilpa
A1 Bellmunt, Joaquim
A1 Sonpavde, Guru
A1 Fleming, Mark T
A1 Lerner, Seth P
A1 Loriot, Yohann
A1 Hoffman-Censits, Jean
A1 Valderrama, Begoña P
A1 Andresen, Corina
A1 Schnabel, Marco J
A1 Cole, Suzanne
A1 Daneshmand, Siamak
K1 FGFR inhibitor
K1 FGFR3
K1 PROOF 302
K1 adjuvant cisplatin-based chemotherapy
K1 adjuvant therapy
K1 cisplatin-therapy refusal
K1 fusions or rearrangements
K1 infigratinib
K1 muscle-invasive urothelial carcinoma
K1 mutations
K1 neoadjuvant cisplatin-based chemotherapy
K1 phase III
K1 upper tract urothelial carcinoma
K1 urothelial bladder carcinoma
K1 urothelial carcinoma
AB 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.
YR 2022
FD 2022-05-24
LK http://hdl.handle.net/10668/20492
UL http://hdl.handle.net/10668/20492
LA en
DS RISalud
RD Apr 4, 2025