Prerandomization factors and utilization of neoadjuvant chemotherapy in a clinical trial of extended versus standard pelvic lymphadenectomy at the time of radical cystectomy for bladder cancer.

Abstract

295 Background: Despite level I evidence supporting the use of cisplatin-based NAC, this practice has not been widely adopted. We assessed contemporary utilization of NAC within the context of an ongoing prospective clinical trial (SWOG S-1011; NCT01224665) in order to identify clinical and/or demographic factors that are associated with receipt of NAC. Methods: S1011 tests the hypothesis that an extended pelvic lymphadenectomy (PLND) is associated with a 10-12% improvement in recurrence-free survival compared to a standard PLND among patients with clinical stage T2-4aN0-2M0 urothelial cell carcinoma of the bladder. Patients are registered prior to RC and are randomized intra-operatively to extended vs. standard PLND. Receipt of NAC, including type and duration are is a stratification factor and prospectively recorded at registration. We evaluated the association of pre-randomization factors, including age, gender, clinical stage, performance status, and institution with the receipt of NAC. Results: 243 patients have been registered as of 9/18/2013 and 229 randomized. Among randomized patients, 119 (52%) received NAC, including 97 (82%) treated with cisplatin-based NAC. The most common NAC regimens, Gem-Cis (gemcitabine-cisplatin) and MVAC (methotrexate, vinblastine, adriamycin, and cisplatin), were administered to 58 and 35 patients, respectively. 63% (40/64) of patients with cT3-4a disease received NAC vs. 48% (79/165) with cT2. There was no association of age, gender, race, ethnicity or PS with receipt of NAC. Among 8 institutions with at least 10 patients registered, the range of utilization of neoadjuvant chemotherapy received was 7% to 83%. Reason for not giving NAC is recorded at time of registration and a detailed analysis will be presented. Conclusions: Interim analysis of S1011, a prospective surgical trial, reveals the highest rate of integration of NAC with RC to date and reflects a considerable change in evidence based practice patterns. The institutional variation in utilization of NAC warrants further exploration of factors influencing delivery of care. Clinical trial information: NCT01224665.