Colin P N Dinney1, Donna Hansel2, David McConkey3, William Shipley4, Michael Hagan5, Robert Dreicer6, Seth Lerner7, Bogdan Czerniak8, Fred Waldman9, Susan Groshen10, Lawrence D True11, Emanuel Petricoin12, Dan Theodorescu13, Andrew Hruszkewycz14, Dean Bajorin15. 1. Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address: cdinney@mdanderson.org. 2. Department of Pathology, University of California at San Diego, La Jolla, CA. 3. Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX. 4. Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA. 5. Department of Radiation Oncology, Virginia Commonwealth University, Richmond, VA. 6. Department of Solid Tumor Oncology, Cleveland Clinic, Cleveland, OH. 7. Scott Department of Urology, Baylor College of Medicine, Houston, TX. 8. Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX. 9. Quest Diagnostics, San Juan Capistrano, CA. 10. Department of Preventive Medicine, University of Southern California, Los Angeles, CA. 11. Department of Pathology, University of Washington Medical Center, Seattle, WA. 12. Center for Applied Proteomics and Molecular Medicine, George Mason University, Fairfax, VA. 13. Department of Surgery-Urology, The University of Colorado, Denver, CO. 14. National Cancer Institute, Bethesda, MD. 15. Department of Medicine Genitourinary Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, NY.
Abstract
OBJECTIVE: To bridge gaps in translational science and develop the concepts for 2 novel biomarker-driven clinical trials: one in the presurgical setting and the other in the setting of bladder preservation with chemoradiation. METHODS AND MATERIALS: The National Cancer Institute sponsored a forum, "Novel Neoadjuvant Therapy for Bladder Cancer," which brought leading clinical and laboratory-based scientists together with the advocacy community. RESULTS: The group designed a neoadjuvant clinical trial to compare the clinical efficacy of the two frontline chemotherapy regimens (gemcitabine plus cisplatin versus MVAC) and the ability of a gene expression profiling-based algorithm (CoXEN) to predict complete pathological response. The trial was recently opened under the leadership of the Southwest Oncology Group (SWOG, S1314), receiving support for the biomarker studies from the NCI's BISQFP resource. A second clinical trial was planned that will examine the relationship between expression of the DNA repair protein MRE11 and complete response in patients treated with concurrent 5-fluorouracil/mitomycin C plus radiation. CONCLUSION: The meeting provided a unique opportunity to launch a collective effort to establish molecular-based therapies for muscle-invasive urothelial cancer. The goal is to use this framework to develop comparable trials with immunotherapy in non-muscle invasive cancers and to exploit the neoadjuvant platform to develop targeted therapy in muscle-invasive disease.
OBJECTIVE: To bridge gaps in translational science and develop the concepts for 2 novel biomarker-driven clinical trials: one in the presurgical setting and the other in the setting of bladder preservation with chemoradiation. METHODS AND MATERIALS: The National Cancer Institute sponsored a forum, "Novel Neoadjuvant Therapy for Bladder Cancer," which brought leading clinical and laboratory-based scientists together with the advocacy community. RESULTS: The group designed a neoadjuvant clinical trial to compare the clinical efficacy of the two frontline chemotherapy regimens (gemcitabine plus cisplatin versus MVAC) and the ability of a gene expression profiling-based algorithm (CoXEN) to predict complete pathological response. The trial was recently opened under the leadership of the Southwest Oncology Group (SWOG, S1314), receiving support for the biomarker studies from the NCI's BISQFP resource. A second clinical trial was planned that will examine the relationship between expression of the DNA repair protein MRE11 and complete response in patients treated with concurrent 5-fluorouracil/mitomycin C plus radiation. CONCLUSION: The meeting provided a unique opportunity to launch a collective effort to establish molecular-based therapies for muscle-invasive urothelial cancer. The goal is to use this framework to develop comparable trials with immunotherapy in non-muscle invasive cancers and to exploit the neoadjuvant platform to develop targeted therapy in muscle-invasive disease.
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