Defining “cisplatin ineligible” patients with metastatic bladder cancer.

Abstract

238 Background: Cisplatin-based chemotherapy is standard first-line treatment for patients (pts) with metastatic urothelial carcinoma (UC). However, a large proportion of pts with UC are considered “unfit” for cisplatin, leading to clinical trials designed specifically for cisplatin-ineligible pts, with substantial variability in eligibility criteria. A clear and consistent definition of pts “unfit” for cisplatin-based therapy will aid in the development of standard eligibility criteria. Methods: We assembled a panel of GU medical oncologists and followed a three-fold approach. First, we surveyed 120 international GU medical oncologists. Subsequently, we reviewed the literature regarding ‘cisplatin ineligibility‘ in solid tumors. Finally, the panel reconciled the survey results and available literature and generated a consensus definition. Results: Responses were received from 65/120 (54%) of those surveyed. The survey results are shown in the Table . Reconciling the survey results with the available literature, the panel recommended the following be used to consistently define pts with metastatic UC “unfit” for cisplatin-based chemotherapy for clinical trial purposes: (1) ECOG performance status of 2 and/or (2) creatinine-clearance < 60 ml/min and/or (3) CTCAE Gr ≥ 2 hearing loss and/or (4) CTCAE Gr ≥ 2 neuropathy. Conclusions: Substantial variability exists in investigators' definitions of pts with metastatic UC “unfit” for cisplatin. A consensus definition is proposed for standardization of eligibility criteria. [Table: see text] No significant financial relationships to disclose.