{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T15:21:27Z","timestamp":1787239287166,"version":"build-2736575974"},"reference-count":29,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"30","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2017,10,20]]},"abstract":"<jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Many patients with high-risk non\u2013muscle-invasive bladder cancer (NMIBC) are either refractory to bacillus Calmette-Guerin (BCG) treatment or may experience disease relapse. We assessed the efficacy and safety of recombinant adenovirus interferon alfa with Syn3 (rAd\u2013IFN\u03b1\/Syn3), a replication-deficient recombinant adenovirus gene transfer vector, for patients with high-grade (HG) BCG-refractory or relapsed NMIBC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      In this open-label, multicenter (n = 13), parallel-arm, phase II study ( ClinicalTrials.gov identifier: NCT01687244), 43 patients with HG BCG-refractory or relapsed NMIBC received intravesical rAd\u2013IFN\u03b1\/Syn3 (randomly assigned 1:1 to 1 \u00d7 10\n                      <jats:sup>11<\/jats:sup>\n                      viral particles (vp)\/mL or 3 \u00d7 10\n                      <jats:sup>11<\/jats:sup>\n                      vp\/mL). Patients who responded at months 3, 6, and 9 were retreated at months 4, 7, and 10. The primary end point was 12-month HG recurrence-free survival (RFS). All patients who received at least one dose were included in efficacy and safety analyses.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Forty patients received rAd\u2013IFN\u03b1\/Syn3 (1 \u00d7 10\n                      <jats:sup>11<\/jats:sup>\n                      vp\/mL, n = 21; 3 \u00d7 10\n                      <jats:sup>11<\/jats:sup>\n                      vp\/mL, n = 19) between November 5, 2012, and April 8, 2015. Fourteen patients (35.0%; 90% CI, 22.6% to 49.2%) remained free of HG recurrence 12 months after initial treatment. Comparable 12-month HG RFS was noted for both doses. Of these 14 patients, two experienced recurrence at 21 and 28 months, respectively, after treatment initiation, and one died as a result of an upper tract tumor at 17 months without a recurrence. rAd\u2013IFN\u03b1\/Syn3 was well tolerated; no grade four or five adverse events (AEs) occurred, and no patient discontinued treatment because of an adverse event. The most frequently reported drug-related AEs were micturition urgency (n = 16; 40%), dysuria (n = 16; 40%), fatigue (n = 13; 32.5%), pollakiuria (n = 11; 28%), and hematuria and nocturia (n = 10 each; 25%).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>rAd\u2014IFN\u03b1\/Syn3 was well tolerated. It demonstrated promising efficacy for patients with HG NMIBC after BCG therapy who were unable or unwilling to undergo radical cystectomy.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco.2017.72.3064","type":"journal-article","created":{"date-parts":[[2017,8,23]],"date-time":"2017-08-23T15:59:54Z","timestamp":1503503994000},"page":"3410-3416","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":150,"title":["Intravesical rAd\u2013IFN\u03b1\/Syn3 for Patients With High-Grade, Bacillus Calmette-Guerin\u2013Refractory or Relapsed Non\u2013Muscle-Invasive Bladder Cancer: A Phase II Randomized Study"],"prefix":"10.1200","volume":"35","author":[{"given":"Neal D.","family":"Shore","sequence":"first","affiliation":[{"name":"Neal D. Shore, Carolina Urologic Research Center, Myrtle Beach, SC; Stephen A. Boorjian, Mayo Clinic, Rochester, MN; Daniel J. Canter, Ochsner Health System, New Orleans, LA; Kenneth Ogan, Emory University, Atlanta, GA; Lawrence I. Karsh, The Urology Center of Colorado, Denver, CO; Tracy M. Downs, University of Wisconsin, Madison, WI; Leonard G. Gomella, Thomas Jefferson University, Philadelphia, PA; Ashish M. Kamat and Colin P.N. Dinney, University of Texas MD Anderson Cancer Center; Seth P. Lerner,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen A.","family":"Boorjian","sequence":"additional","affiliation":[{"name":"Neal D. Shore, Carolina Urologic Research Center, Myrtle Beach, SC; Stephen A. Boorjian, Mayo Clinic, Rochester, MN; Daniel J. Canter, Ochsner Health System, New Orleans, LA; Kenneth Ogan, Emory University, Atlanta, GA; Lawrence I. Karsh, The Urology Center of Colorado, Denver, CO; Tracy M. Downs, University of Wisconsin, Madison, WI; Leonard G. Gomella, Thomas Jefferson University, Philadelphia, PA; Ashish M. Kamat and Colin P.N. Dinney, University of Texas MD Anderson Cancer Center; Seth P. Lerner,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel J.","family":"Canter","sequence":"additional","affiliation":[{"name":"Neal D. Shore, Carolina Urologic Research Center, Myrtle Beach, SC; Stephen A. Boorjian, Mayo Clinic, Rochester, MN; Daniel J. Canter, Ochsner Health System, New Orleans, LA; Kenneth Ogan, Emory University, Atlanta, GA; Lawrence I. Karsh, The Urology Center of Colorado, Denver, CO; Tracy M. Downs, University of Wisconsin, Madison, WI; Leonard G. Gomella, Thomas Jefferson University, Philadelphia, PA; Ashish M. Kamat and Colin P.N. Dinney, University of Texas MD Anderson Cancer Center; Seth P. Lerner,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth","family":"Ogan","sequence":"additional","affiliation":[{"name":"Neal D. Shore, Carolina Urologic Research Center, Myrtle Beach, SC; Stephen A. Boorjian, Mayo Clinic, Rochester, MN; Daniel J. Canter, Ochsner Health System, New Orleans, LA; Kenneth Ogan, Emory University, Atlanta, GA; Lawrence I. Karsh, The Urology Center of Colorado, Denver, CO; Tracy M. Downs, University of Wisconsin, Madison, WI; Leonard G. Gomella, Thomas Jefferson University, Philadelphia, PA; Ashish M. Kamat and Colin P.N. Dinney, University of Texas MD Anderson Cancer Center; Seth P. Lerner,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence I.","family":"Karsh","sequence":"additional","affiliation":[{"name":"Neal D. Shore, Carolina Urologic Research Center, Myrtle Beach, SC; Stephen A. Boorjian, Mayo Clinic, Rochester, MN; Daniel J. Canter, Ochsner Health System, New Orleans, LA; Kenneth Ogan, Emory University, Atlanta, GA; Lawrence I. Karsh, The Urology Center of Colorado, Denver, CO; Tracy M. Downs, University of Wisconsin, Madison, WI; Leonard G. Gomella, Thomas Jefferson University, Philadelphia, PA; Ashish M. Kamat and Colin P.N. Dinney, University of Texas MD Anderson Cancer Center; Seth P. Lerner,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tracy M.","family":"Downs","sequence":"additional","affiliation":[{"name":"Neal D. Shore, Carolina Urologic Research Center, Myrtle Beach, SC; Stephen A. Boorjian, Mayo Clinic, Rochester, MN; Daniel J. Canter, Ochsner Health System, New Orleans, LA; Kenneth Ogan, Emory University, Atlanta, GA; Lawrence I. Karsh, The Urology Center of Colorado, Denver, CO; Tracy M. Downs, University of Wisconsin, Madison, WI; Leonard G. Gomella, Thomas Jefferson University, Philadelphia, PA; Ashish M. Kamat and Colin P.N. Dinney, University of Texas MD Anderson Cancer Center; Seth P. Lerner,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leonard G.","family":"Gomella","sequence":"additional","affiliation":[{"name":"Neal D. Shore, Carolina Urologic Research Center, Myrtle Beach, SC; Stephen A. Boorjian, Mayo Clinic, Rochester, MN; Daniel J. Canter, Ochsner Health System, New Orleans, LA; Kenneth Ogan, Emory University, Atlanta, GA; Lawrence I. Karsh, The Urology Center of Colorado, Denver, CO; Tracy M. Downs, University of Wisconsin, Madison, WI; Leonard G. Gomella, Thomas Jefferson University, Philadelphia, PA; Ashish M. Kamat and Colin P.N. Dinney, University of Texas MD Anderson Cancer Center; Seth P. Lerner,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashish M.","family":"Kamat","sequence":"additional","affiliation":[{"name":"Neal D. Shore, Carolina Urologic Research Center, Myrtle Beach, SC; Stephen A. Boorjian, Mayo Clinic, Rochester, MN; Daniel J. Canter, Ochsner Health System, New Orleans, LA; Kenneth Ogan, Emory University, Atlanta, GA; Lawrence I. Karsh, The Urology Center of Colorado, Denver, CO; Tracy M. Downs, University of Wisconsin, Madison, WI; Leonard G. Gomella, Thomas Jefferson University, Philadelphia, PA; Ashish M. Kamat and Colin P.N. Dinney, University of Texas MD Anderson Cancer Center; Seth P. Lerner,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yair","family":"Lotan","sequence":"additional","affiliation":[{"name":"Neal D. Shore, Carolina Urologic Research Center, Myrtle Beach, SC; Stephen A. Boorjian, Mayo Clinic, Rochester, MN; Daniel J. Canter, Ochsner Health System, New Orleans, LA; Kenneth Ogan, Emory University, Atlanta, GA; Lawrence I. Karsh, The Urology Center of Colorado, Denver, CO; Tracy M. Downs, University of Wisconsin, Madison, WI; Leonard G. Gomella, Thomas Jefferson University, Philadelphia, PA; Ashish M. Kamat and Colin P.N. Dinney, University of Texas MD Anderson Cancer Center; Seth P. Lerner,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert S.","family":"Svatek","sequence":"additional","affiliation":[{"name":"Neal D. Shore, Carolina Urologic Research Center, Myrtle Beach, SC; Stephen A. Boorjian, Mayo Clinic, Rochester, MN; Daniel J. Canter, Ochsner Health System, New Orleans, LA; Kenneth Ogan, Emory University, Atlanta, GA; Lawrence I. Karsh, The Urology Center of Colorado, Denver, CO; Tracy M. Downs, University of Wisconsin, Madison, WI; Leonard G. Gomella, Thomas Jefferson University, Philadelphia, PA; Ashish M. Kamat and Colin P.N. Dinney, University of Texas MD Anderson Cancer Center; Seth P. Lerner,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Trinity J.","family":"Bivalacqua","sequence":"additional","affiliation":[{"name":"Neal D. Shore, Carolina Urologic Research Center, Myrtle Beach, SC; Stephen A. Boorjian, Mayo Clinic, Rochester, MN; Daniel J. Canter, Ochsner Health System, New Orleans, LA; Kenneth Ogan, Emory University, Atlanta, GA; Lawrence I. Karsh, The Urology Center of Colorado, Denver, CO; Tracy M. Downs, University of Wisconsin, Madison, WI; Leonard G. Gomella, Thomas Jefferson University, Philadelphia, PA; Ashish M. Kamat and Colin P.N. Dinney, University of Texas MD Anderson Cancer Center; Seth P. Lerner,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"III","given":"Robert L.","family":"Grubb","sequence":"additional","affiliation":[{"name":"Neal D. Shore, Carolina Urologic Research Center, Myrtle Beach, SC; Stephen A. Boorjian, Mayo Clinic, Rochester, MN; Daniel J. Canter, Ochsner Health System, New Orleans, LA; Kenneth Ogan, Emory University, Atlanta, GA; Lawrence I. Karsh, The Urology Center of Colorado, Denver, CO; Tracy M. Downs, University of Wisconsin, Madison, WI; Leonard G. Gomella, Thomas Jefferson University, Philadelphia, PA; Ashish M. Kamat and Colin P.N. Dinney, University of Texas MD Anderson Cancer Center; Seth P. Lerner,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tracey L.","family":"Krupski","sequence":"additional","affiliation":[{"name":"Neal D. Shore, Carolina Urologic Research Center, Myrtle Beach, SC; Stephen A. 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