Abstract 1758P
Background
Radical cystectomy (RC) is the standard of care for MIBC and MIBC-HR in France. No French data is published for MIBC and MIBC-HR pts, particularly in the adjuvant setting. The objectives of this study were to describe the characteristics and the management of MIBC-HR pts who had RC in France and to estimate their disease-free survival (DFS) and overall survival (OS).
Methods
Pts aged 18+ years with MIBC who had RC from October 2012 to June 2018 were selected from the French multicenter (n=14) prospective cohort on bladder cancer (COBLAnCE cohort). Pts with metastatic disease at RC were excluded. Pts were classified as MIBC-HR if they were staged pT3-pT4a; or ypT2-ypT4a; or (y)pN+. DFS was defined as the time between RC and the first disease recurrence or death from any cause; OS was defined as the time between RC and death from any cause, both calculated using Kaplan-Meier method.
Results
Among the 431 MIBC pts selected, 59.4% were MIBC-HR (n=256). Of these, 204 pts were men (79.7%); median age at diagnosis was 68 years (yrs). Most MIBC-HR pts were a current or former smoker (n=201, 78.5%). For staging, 226 pts were (y)pT3a or higher (88.3%) and 132 were N- (51.6%). The distribution of treatment strategies was 54.7% RC alone (n=140), 27.0% RC + adjuvant chemotherapy (AC) (n=69), 16.0% neoadjuvant chemotherapy (NAC) + RC (n=41), 2.0% both NAC and AC (n=5), and 0.3% NAC + radiotherapy (n=1). The use of AC was steady over the study period. Among pts with AC only, 86.8% received cisplatin-based therapy (n=59). In total, 175 pts (68.3%) had experienced an event up to the end of follow-up. With a median follow-up of 5.0 yrs, outcomes for patients with MIBC-HR and MIBC-HR without AC were as follows (all respectively): median DFS = 1.3 yrs [95% confidence interval (CI), 1.0-1.6] and 1.2 yrs [95% CI, 0.7-1.5], 2-year DFS = 39.9% [95% CI, 33.9-46.1] and 37.9% [95% CI, 31.0-45.4], median OS = 2.3 yrs [95% CI, 1.8-3.1] and 2.1 yrs [95% CI, 1.6-2.7], 5 yr OS = 33.2% [95% CI, 27.1-40.0] and 29.6% [95% CI, 22.7-37.7].
Conclusions
This study provides new information regarding the use of AC in France and the substantial burden of MIBC-HR pts with poor DFS and OS after RC with curative intent, whatever the AC status.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Bristol Myers Squibb.
Disclosure
F.P. Colrat: Financial Interests, Personal, Full or part-time Employment, HEOR Manager: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Theradiag, Valbiotis, Ose Immuno, Mediantechnologies. J. Bonastre: Financial Interests, Personal, Advisory Board, Health economic board in bladder cancer: BMS; Financial Interests, Institutional, Funding, Funding of the MICADO study: BMS. S. Teitsson, A. Prudent: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. S. Branchoux: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. S. Benhamou: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Sponsor/Funding: BMS. Y. Allory: Financial Interests, Personal, Invited Speaker: BMS, MSD. T. Lebret: Financial Interests, Personal, Other, Congress: BMS, Ferring. All other authors have declared no conflicts of interest.