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Non-muscle invasive bladder cancer (NMIBC) is a common and burdensome malignancy. A substantial proportion of patients with intermediate- and high-risk disease will progress to invasive bladder cancer and are at a significant risk for metastasis and death. Bacillus Calmette-Guerin (BCG) therapy for selected cases has been the standard of care for nearly 40 years. Unfortunately, a world-wide shortage has made BCG challenging to obtain. Furthermore, recurrences and progressions do occur. With the US Food and Drug Administration creating a clear path to drug approval for novel treatments, many therapies have been tested, including intravesical cytotoxic chemotherapy, intravesical immunotherapy, systemic immunotherapy, and novel agents, such as gene therapy and targeted therapy. In this review, we highlight ongoing clinical trials.

Background: Targeted therapies (TTs) have revolutionized metastatic renal cell carcinoma (mRCC) treatment in the past decade, largely replacing immunotherapy including high-dose interleukin-2 (HD IL-2) therapy. We evaluated trends in HD IL-2 use for mRCC in the IT era. Methods: Our cohort comprised a weighted estimate of all patients undergoing HD IL-2 treatment for mRCC from 2004 to 2012 using the Premier Hospital Database. We assessed temporal trends in HD IL-2 use including patient. disease, and hospital characteristics stratified by era (pre-TT uptake: 2004-2006, uptake: 2007-2009, and post-TT uptake: 2010-2012) and fitted multivariable regression models to identify predictors of treatment toxicity and tolerability. Results: An estimated 2,351 patients received HD IL-2 therapy for mRCC in the United States from 2004 to 2012. The use decreased from 2004 to 2008. HD IL-2 therapy became increasingly centralized in teaching hospitals (24% of treatments in 2004 and 89.5% in 2012). Most patients who received HD IL-2 therapy were men, white, younger than 60 years, had lung metastases, and were otherwise healthy. Vasopressors, intensive care unit admission, and hemodialysis were necessary in 53.4%, 33.0%, and 7.1%, respectively. Factors associated with toxicities in multivariable analyses included being unmarried, male sex, and multiple metastatic sites. African Americans and patients with single-site metastases were less likely to receive multiple treatment cycles. Conclusions: HD IL-2 therapy is used infrequently for mRCC in the United States, and its application has diminished with the uptake of TT. Patients are being increasingly treated in teaching hospitals, suggesting a centralization of care and possible barriers to access. A recent slight increase in HD IL-2 therapy use likely reflects recognition of the inability of TT to effect a complete response. (C) 2015 Elsevier Inc. All rights reserved.