Cisplatin-Ineligible and Chemotherapy-Ineligible Patients Should Be the Focus of New Drug Development in Patients With Advanced Bladder Cancer

Abstract

Figure 1 Therapeutic Regimens Administered in Patients Presenting With Unresectable Locally Advanced or Metastatic Urothelial Carcinoma in the SEER-Medicare Database (N [ 1031) Cisplatin-based combination chemotherapy is standard first-line treatment for patients with advanced bladder cancer (ABC) based on randomized trials. The median survival with these regimens is 13 to 15 months, and 5% to 15% of patients attain long-term survival. However, cisplatin ineligibility is common because of renal dysfunction (creatinine clearance 70 years (45 of 148 [30.4%]) (P 1⁄4 .05). Moreover, in patients with locally advanced bladder cancer undergoing radical cystectomy, the proportion of patients ineligible for cisplatin because of renal dysfunction ranged from 28% by the CockroftGault formula and 52% by the Jelliffe formula, and an agedependent increase in incidence of renal dysfunction was observed. To better capture the use of cisplatin administration in patients presenting with ABC (unresectable or metastatic disease) in a population database that captures chemotherapy administration more completely through medical claims, we examined the Surveillance, Epidemiology and End Results (SEER)-Medicare linked fee-for-service database. We identified incident ABC patients aged 66 years presenting with the following stages of bladder cancer between 2004 and 2007: T4bN0M0, anyTN1-3M0, and anyTanyNM1. These patients were followed up to December 31, 2009. Outpatient and inpatient Medicare claims data were queried for receipt and type of chemotherapy used, which was classified as cisplatin based, carboplatin based, no platinum treatment, or no chemotherapy. Descriptive analyses were performed to examine associations between receiving chemotherapy and patient demographics, tumor characteristics, and survival. A total of 1031 patients with ABC met inclusion criteria. The median age was 74 years—69.8% were men and 88.75% were white Americans. When examining by presenting stage, 4.6% were T4bN0M0, 55.3% were anyTN1-3M0, and 40.1% were anyTanyNM1 according to the American Joint Committee on Cancer,