title: Novel neoadjuvant therapy paradigms for bladder cancer: results from the National Cancer Center Institute Forum.
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
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address: cdinney@mdanderson.org.
authors.forename: Colin P N
authors.initials: CP
authors.lastname: Dinney
authors.affiliation: Department of Pathology, University of California at San Diego, La Jolla, CA.
authors.forename: Donna
authors.initials: D
authors.lastname: Hansel
authors.affiliation: Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX.
authors.forename: David
authors.initials: D
authors.lastname: McConkey
authors.affiliation: Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA.
authors.forename: William
authors.initials: W
authors.lastname: Shipley
authors.affiliation: Department of Radiation Oncology, Virginia Commonwealth University, Richmond, VA.
authors.forename: Michael
authors.initials: M
authors.lastname: Hagan
authors.affiliation: Department of Solid Tumor Oncology, Cleveland Clinic, Cleveland, OH.
authors.forename: Robert
authors.initials: R
authors.lastname: Dreicer
authors.affiliation: Scott Department of Urology, Baylor College of Medicine, Houston, TX.
authors.forename: Seth
authors.initials: S
authors.lastname: Lerner
authors.affiliation: Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX.
authors.forename: Bogdan
authors.initials: B
authors.lastname: Czerniak
authors.affiliation: Quest Diagnostics, San Juan Capistrano, CA.
authors.forename: Fred
authors.initials: F
authors.lastname: Waldman
authors.affiliation: Department of Preventive Medicine, University of Southern California, Los Angeles, CA.
authors.forename: Susan
authors.initials: S
authors.lastname: Groshen
authors.affiliation: Department of Pathology, University of Washington Medical Center, Seattle, WA.
authors.forename: Lawrence D
authors.initials: LD
authors.lastname: True
authors.affiliation: Center for Applied Proteomics and Molecular Medicine, George Mason University, Fairfax, VA.
authors.forename: Emanuel
authors.initials: E
authors.lastname: Petricoin
authors.affiliation: Department of Surgery-Urology, The University of Colorado, Denver, CO.
authors.forename: Dan
authors.initials: D
authors.lastname: Theodorescu
authors.affiliation: National Cancer Institute, Bethesda, MD.
authors.forename: Andrew
authors.initials: A
authors.lastname: Hruszkewycz
authors.affiliation: Department of Medicine Genitourinary Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, NY.
authors.forename: Dean
authors.initials: D
authors.lastname: Bajorin
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D059186:Chemoradiotherapy, Adjuvant / Q000379:methods; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D054547:National Cancer Institute (U.S.); D020360:Neoadjuvant Therapy / Q000379:methods; D014481:United States; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*
keywords: Bladder cancer; Neoadjuvant chemotherapy; Radiation