BCAN 2019: FDA Collaboration in Adjuvant Trials in Muscle Invasive Bladder Cancer
Washington, DC (UroToday.com) Andrea Apolo, MD, from the National Institute of Health (NIH) in Bethesda, MD discussed adjuvant trials in muscle-invasive bladder cancer including Food and Drug Administration collaboration in trial design and endpoints. Multiple stakeholders including patient advocates were involved in a recent workshop with the FDA to improve trial design and drug approval. Patient eligibility, radiologic considerations, managing new urothelial cancer within the urinary tract and considerations for the patient were topics of discussion. Histology, prior neoadjuvant therapy, site of disease and chemotherapy type including dose and timing are some patient eligibility considerations. Histology would include >50% urothelial carcinoma would meet clinical trial enrollment and that variant histology >50% could be included in variant predominant trials. At least 3 cycles of cisplatin-based neoadjuvant chemotherapy would be required and those not meeting this requirement would be classified as receiving no neoadjuvant chemotherapy. Muscle-invasive upper tract disease should be included in adjuvant trials. Microscopic positive margins should be included and bilateral standard lymph node dissection is adequate for staging. Timing of adjuvant chemotherapy should be between 1-4 months after surgery. Elimination of placebo arms favoring treatment arms was favored with less strict guidelines regarding blinding when clinically appropriate.
Presented by: Andrea Apolo, MD, Investigator, Genitourinary Malignancies Branch, Head, Bladder Cancer Section, NIH Lasker Clinical Research Scholar, National Cancer Institute, Bethesda, MD
Written by: Stephen B. Williams, MD, Medical Director for High Value Care; Chief of Urology, Associate Professor, Director of Urologic Oncology, Director Urologic Research, The University of Texas Medical Branch at Galveston, TX and Ashish M. Kamat, MD, Professor, Department of Urology, Division of Surgery, The University of Texas, MD Anderson Cancer Center, Houston, TX at the 2019 Bladder Cancer Advocacy Network (BCAN) Think Tank August 8-10, 2019 - the Capital Hilton, Washington, DC, USA