Eligibility and Radiologic Assessment in Adjuvant Clinical Trials in Bladder Cancer.

To harmonize eligibility criteria and radiographic disease assessments in clinical trials of adjuvant therapy for muscle-invasive bladder cancer (MIBC).

National experts in bladder cancer clinical trial research, including medical and urologic oncologists, radiologists, biostatisticians, and patient advocates, convened at a public workshop on November 28, 2017, to discuss eligibility, radiographic entry criteria, and assessment of disease recurrence in adjuvant clinical trials in patients with MIBC.

The key workshop conclusions for adjuvant MIBC clinical trials included the following points: (1) patients with urothelial carcinoma with divergent histologic differentiation should be allowed to enroll; (2) neoadjuvant chemotherapy is defined as at least 3 cycles of neoadjuvant cisplatin-based combination chemotherapy; (3) patients with muscle-invasive, upper-tract urothelial carcinoma should be included in adjuvant trials of MIBC; (4) patients with severe renal insufficiency can enroll into trials using agents that are not renally excreted; (5) patients with microscopic surgical margins can be included; (6) patients should undergo a standard bilateral lymph node dissection prior to enrollment; (7) computed tomographic (CT) imaging should be performed within 4 weeks prior to enrollment. For patients with renal insufficiency who cannot undergo CT imaging with contrast, noncontrast chest CT and magnetic resonance imaging of the abdomen and pelvis with gadolinium should be done; (8) biopsy of indeterminate lesions to evaluate for malignant disease should be done when feasible; (9) a uniform approach to evaluate indeterminate radiographic lesions when biopsy is not feasible should be included in any trial design; (10) a uniform approach to determining the date of recurrence is important in interpreting adjuvant trial results; and (11) new high-grade, upper-tract primary tumors and new MIBC tumors should be considered recurrence events.

A uniform approach to eligibility criteria, definitions of no evidence of disease, and definitions of disease recurrence may lead to more consistent interpretations of adjuvant trial results in MIBC.

JAMA oncology. 2019 Oct 31 [Epub ahead of print]

Andrea B Apolo, Matthew I Milowsky, Lauren Kim, Brant A Inman, Ashish M Kamat, Gary Steinberg, Mohammadhadi Bagheri, Venkatesh P Krishnasamy, Jamie Marko, Colin P Dinney, Rick Bangs, Randy F Sweis, Virginia Ellen Maher, Amna Ibrahim, Ke Liu, Ryan Werntz, Frank Cross, Julia A Beaver, Harpreet Singh, Richard Pazdur, Gideon M Blumenthal, Seth P Lerner, Dean F Bajorin, Jonathan E Rosenberg, Sundeep Agrawal

National Institutes of Health, Bethesda, Maryland., Department of Medicine, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill., Department of Surgery, Duke Cancer Institute, Durham, North Carolina., Department of Urology, The University of Texas MD Anderson Cancer Center, Houston., NYU Langone Health, New York, New York., University of Chicago Medicine, Chicago, Illinois., Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland., Department of Urology, Baylor College of Medicine, Houston, Texas., Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.