Critical analysis of contemporary clinical research in muscle‐invasive and metastatic urothelial cancer

Abstract

BACKGROUND: There have been no improvements in the treatment of metastatic urothelial cancer in the past several decades. A census of contemporary clinical research in this disease was performed to identify potential barriers and opportunities. METHODS: These authors performed a search for clinical trials exploring interventions in muscle-invasive and metastatic urothelial cancer, using the ClinicalTrials.gov registry. Data extracted from the registry included title, recruitment status, interventions, sponsor, phase, enrollment, study design, and study sites. RESULTS: Among 120 eligible trials exploring interventions in muscle-invasive and metastatic urothelial cancer, 73% were phase 2 and 73% were nonrandomized. The majority (63%) involved treatment in the metastatic disease state. The median planned enrollment size per trial was 45 patients (interquartile range, 47 patients). The majority of trials (55%) involved 3 study sites. Trials most commonly explored interventions in the first-line metastatic (30%) or second-line metastatic (37%) settings. Targeted therapeutics were studied in 58% of the trials. Among 56 trials that completed enrollment, the median time to complete accrual was 50 months (range, 10-109 months), and these trials enrolled a median of 40 patients per trial (interquartile range, 44 patients). CONCLUSIONS: The majority of contemporary clinical trials in muscle-invasive and metastatic urothelial cancer are small, nonrandomized, phase 2 trials involving 1 to 3 study sites. Enhanced communication and collaboration among the urothelial cancer community, and other stakeholders, is needed to facilitate the design and conduct of trials capable of expediting progress in this disease.

Long non-coding RNA ARAP1-AS1 promotes the progression of bladder cancer by regulating miR-4735-3p/NOTCH2 axis

“…[1][2][3][4] In spite of the great progress has been made in the clinical treatment of BCa, the overall survival rate for BCa patients is still pessimistic. [5][6][7][8] The prognosis of BCa patients is closely related to the clinical stage of BCa, but the specific early-stage symptoms for BCa patients are unclear. [9][10][11][12] Thus, it is still urgent to differentiate novel biomarkers for the early diagnosis and efficient treatment for BCa patients.…”

Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of bladder carcinoma

“…Adjuvant cisplatin-based chemotherapy has never been definitively proven to improve overall survival, but it is frequently used. Systemic therapy for metastatic disease has historically consisted of platinum-based chemotherapy, and this is discussed in the consensus report [ 19 , 20 ]. The following objectives were deemed as priorities for the discussion of the panel meeting for muscle invasive and advanced disease: 1) to define the role of immune checkpoint inhibitors in the treatment of metastatic urothelial cancer, 2) to comment on the clinical utility of biomarkers predictive of benefit to treatment with these therapies, and 3) to discuss potential utility of immune-based therapy in the muscle invasive, non-metastatic setting.…”

Elevating the Horizon: Emerging Molecular and Genomic Targets in the Treatment of Advanced Urothelial Carcinoma

“…Nevertheless, due to poor accrual, investigators usually design small, single-arm, phase II trials whose results are not likely to change the treatment paradigm, as demonstrated by a 2013 analysis of ongoing trials for metastatic urothelial carcinoma. 12 Based on these observations, the Bladder Cancer Advocacy Network Clinical Trials Working Group released a report emphasizing the urgent need for communication and collaboration among investigators to overcome this major barrier to developing effective treatments for urothelial carcinoma. 12 …”

“…12 Based on these observations, the Bladder Cancer Advocacy Network Clinical Trials Working Group released a report emphasizing the urgent need for communication and collaboration among investigators to overcome this major barrier to developing effective treatments for urothelial carcinoma. 12 …”