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Mature Survival (Os) Data of a Randomised International Phase Ii Trial (Jasint1): Vinflunine (Vfl)-Gemcitabine (Gem) Vs. Vfl-Cbdca in Cddp-Unfit Patients (Pts) with Advanced Urothelial Carcinoma (Uc)

2014; Elsevier BV; Volume: 25; Linguagem: Inglês

10.1093/annonc/mdu337.5

1569-8041

Maria De Santis, Paweł Wiechno, C. Lucas, Chia‐Chi Lin, Wu‐Chou Su, Joaquim Bellmunt, K. Legrand, Ronan Fougeray, Stéphane Culine,

Bladder and Urothelial Cancer Treatments

ABSTRACT Aim: There is no standard 1st line chemotherapy (CT) for advanced or metastatic UC in pts unfit for a CDDP-based regimen. VFL, an EMA approved agent in the post-platinum setting has shown to be safe in pts with renal impairment. The study aimed to assess the benefit/risk ratio of 2 VFL-based CT regimens in UC. Methods: Pts with a creatinine clearance (CrCl) Results: 69 pts (34 arm A, 35 arm B) were enrolled over 18 months: at the median (med) follow-up of 25.9 mo 74% pts had died. Pts characteristics were similar in both groups: med age 70 yrs; PS 0 / 1 in 42% / 58%; primary sites: 52% bladder and 46% upper tract; visceral mets 49%, med CrCl 46mL/min. Med number of cycles was 5 (A) and 4 (B). More haematological G3/4 adverse events (AE) were reported in arm B: neutropenia in 68% (vs 38%) and febrile neutropenia in 14% (vs 3%) of pts. Main non-haematological G3/4 AE were fatigue (21.7%), infection (7.2%), and constipation (4.3%) without major difference between arms. DCR was 77% in both groups; ORR was 44.1% vs 28.6%, med PFS 5.9 vs 6.1 mo and med OS 14.0 vs 12.8 mo in arms A and B, respectively. Cause of death: progression in 90%, 1 drug-related AE (B), other reasons in 8%. Further anticancer drugs: 59% (A) and 51% (B); CBDCA, GEM and paclitaxel in 23%, 29% and 30%, respectively, with more taxanes in arm A (35%) and more GEM in arm B (37%). Conclusions: Both VFL doublets are feasible with a similar DCR. However, a higher ORR and OS, while showing less haematological toxicity, favour VFL-GEM which warrants further clinical study. Disclosure: M. De Santis: Advisory board: Laboratoire Pierre Fabre Corporate-sponsored research: Laboratoire Pierre Fabre Consultancy: Laboratoire Pierre Fabre; C. Lucas: Pierre Fabre employee; J. Bellmunt: Advisory board member of Laboratoires Pierre Fabre; K. Legrand and R. Fougeray: Laboratoires Pierre Fabre employee; S. Culine: Advisory board member and consultancies for Laboratoires Pierre Fabre. All other authors have declared no conflicts of interest.