246P - Impact of renal impairment on first-line treatment in metastatic urothelial cancer

Background

First-line (1L) platinum-based chemotherapy (CT) improves survival in metastatic urothelial cancer (mUC). Cisplatin eligibility for pivotal clinical trials excludes renal impairment (eGFR≤60mL/min). Impact of renal impairment on prescribing in the real world is unknown.

Methods

A cohort of mUC patients (pts) having 1L CT was extracted from BLADDA, Australia’s multisite, urothelial cancer registry. Clinicodemographic and outcome data were analysed using descriptive statistics. Statistical significance was defined by p≤0.05. Progression-free (PFS) and overall (OS) survival was defined as time to progression or death from 1L CT.

Results

Our cohort included 132 pts, median age 70 (range 29-86), predominantly male (76%), ECOG 0-1 (88%) and de novo metastatic (58%). Renal function was known in 104 pts; 47% had eGFR≤60 (eGFR 40-60: 34%; eGFR≤40: 13%). Most pts received 1L platinum-based CT (76%). In pts without renal impairment (eGFR>60), carboplatin/gemcitabine was more common than cisplatin/gemcitabine (GC) (40% vs 31%, p=0.3). In pts with renal impairment (eGFR ≤60), carboplatin/gemcitabine remained the most common (33%), followed by GC (18%) and split dose GC (18%). Renal function did not predict cisplatin use (>60: 38% vs ≤60: 37%; OR 1.1, p=0.9), nor impact trial enrolment (>60: 6% vs ≤60: 12%; OR 0.4, p=0.2). Dose reductions were numerically more common in renal impairment (>60: 35% vs ≤60: 49%; OR 2, p=0.2). Renal impairment did not impact response rate (>60: 65% vs ≤60: 68%; p=0.8) but resulted in shorter PFS (14 months, 95% CI 9-19 vs 7, 95% CI 6-8) and OS (37 months, 95% CI 29-NE vs 27, 95% CI 22-33). Table: 246P

Conclusions

In this real-world analysis, pts receiving 1L CT with impaired renal function had inferior PFS and shortened OS, which was not explained by differences in cisplatin use. Our study is limited by few pts with eGFR<40 and did not evaluate those unfit for CT. Further research to determine optimal 1L therapy in this cohort is needed.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

AstraZeneca, BMS, Pfizer, Merck.

Disclosure

A.J. Weickhardt: Financial Interests, Personal, Advisory Board: Merck, Ipsen, Pfizer; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Coordinating PI, PCR MIB funding: Merck. P. Gibbs: Financial Interests, Personal, Advisory Board: Merck, Bayer, Amgen, Servier, Haystack Oncology; Financial Interests, Personal, Invited Speaker: MSD. B. Tran: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Astellas, Bayer, BMS, Ipsen, IQVIA, Janssen, Merck, MSD, Novartis, Pfizer, Roche, Sanofi, Tolmar, Sanofi Ammunix; Financial Interests, Personal, Invited Speaker: Amgen, Astellas, AstraZeneca, Bayer, BMS, Merck, Pfizer; Financial Interests, Institutional, Research Grant: Amgen, Astellas, AstraZeneca, Bayer, BMS, Genentech, Ipsen, Janssen, Pfizer, MSD; Financial Interests, Personal, Steering Committee Member: CG Oncology, Janssen, MSD. All other authors have declared no conflicts of interest.