Effectiveness of Neoadjuvant Chemotherapy for Muscle-invasive Bladder Cancer in the Current Real World Setting in the USA.

Background: The use of neoadjuvant chemotherapy (NAC) before radical cystectomy (RC) is supported by results from several randomized control trials, including SWOG-8710.
Objective: To look at the effectiveness of NAC before RC in current real world practice in the USA.
Design, Setting, and Participants: We used the National Cancer Data Base (NCDB) to identify patients with nonmetastatic muscle-invasive urothelial carcinoma of the bladder who underwent RC between 2004 and 2012.
Intervention: Receipt of NAC before RC.
Outcome Measurements and Statistical Analysis: The primary endpoint was overall survival (OS). Secondary endpoints were rates of complete pathologic response (pT0), positive pathologic lymph nodes (pN+), and margin status. Using a landmark analysis to adjust for an immortal-time bias, OS comparison was performed using Cox regression analysis. Furthermore, logistic regression models examining secondary outcomes were fitted. To adjust for potential selection bias, propensity score-weighted analyses were performed.
Results and Limitations: Of 8732 patients who underwent RC, 1619 (19%) received NAC. Following propensity score adjustment, receipt of NAC was not associated with an OS benefit (hazard ratio 0.97; p=0.591). On secondary outcome analysis, higher pT0 rates (odds ratio 5.03; p<0.001) were recorded among patients who received NAC, although rates of pT0 were lower than for patients treated with NAC within the SWOG-8710 trial (13% vs 38%). Limitations include the retrospective design and limited details available regarding type of chemotherapy.
Conclusions: Important baseline differences between patients from the SWOG-8710 trial and those in general urologic practice exist. After adjusting for immortal-time bias, we did not find a clear survival advantage of NAC before RC when compared to RC alone in current general urology practice in the USA.
Patient Summary: The benefit of chemotherapy before radical cystectomy is supported by few randomized control trials. In this study, using a large national data set from the USA we found that preoperative chemotherapy is not associated with a survival benefit in all patients in general urology practice. Hence, better selection criteria are needed to determine who will benefit the most from chemotherapy before radical cystectomy.
(Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.)