دورية أكاديمية
Intravesical rAd-IFNα/Syn3 for Patients With High-Grade, Bacillus Calmette-Guerin-Refractory or Relapsed Non-Muscle-Invasive Bladder Cancer: A Phase II Randomized Study.
العنوان: | Intravesical rAd-IFNα/Syn3 for Patients With High-Grade, Bacillus Calmette-Guerin-Refractory or Relapsed Non-Muscle-Invasive Bladder Cancer: A Phase II Randomized Study. |
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المؤلفون: | Shore, Neal D, Boorjian, Stephen A, Canter, Daniel J, Ogan, Kenneth, Karsh, Lawrence I, Downs, Tracy M, Gomella, Leonard G, Kamat, Ashish M, Lotan, Yair, Svatek, Robert S, Bivalacqua, Trinity J, Grubb, Robert L, Krupski, Tracey L, Lerner, Seth P, Woods, Michael E, Inman, Brant A, Milowsky, Matthew I, Boyd, Alan, Treasure, F Peter, Gregory, Gillian, Sawutz, David G, Yla-Herttuala, Seppo, Parker, Nigel R, Dinney, Colin P N |
المصدر: | Department of Medicine Faculty Papers |
بيانات النشر: | Jefferson Digital Commons |
سنة النشر: | 2017 |
المجموعة: | Jefferson Digital Commons (Thomas Jefferson University, Philadelphia) |
مصطلحات موضوعية: | Thomas Jefferson University, Adenoviridae, Administration, Intravesical, Aged, 80 and over, BCG Vaccine, Cholic Acids, Disaccharides, Drug Resistance, Neoplasm, Fatigue, Female, Genetic Therapy, Genetic Vectors, Humans, Interferon-alpha, Male, Middle Aged, Neoplasm Grading, Neoplasm Invasiveness, Neoplasm Recurrence, Local, Recombinant Fusion Proteins, Recombinant Proteins, Treatment Outcome, Urinary Bladder Neoplasms, Urination Disorders, Oncology |
الوصف: | Purpose Many patients with high-risk non-muscle-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-IFNα/Syn3), a replication-deficient recombinant adenovirus gene transfer vector, for patients with high-grade (HG) BCG-refractory or relapsed NMIBC. Methods 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-IFNα/Syn3 (randomly assigned 1:1 to 1 × 10(11) viral particles (vp)/mL or 3 × 10(11) 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. Results Forty patients received rAd-IFNα/Syn3 (1 × 10(11) vp/mL, n = 21; 3 × 10(11) 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-IFNα/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%). Conclusion rAd-IFNα/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. |
نوع الوثيقة: | article in journal/newspaper |
وصف الملف: | application/pdf |
اللغة: | unknown |
العلاقة: | https://jdc.jefferson.edu/medfp/224Test; https://jdc.jefferson.edu/context/medfp/article/1246/viewcontent/Phase_II_Randomized_Study.pdfTest |
الإتاحة: | https://jdc.jefferson.edu/medfp/224Test https://jdc.jefferson.edu/context/medfp/article/1246/viewcontent/Phase_II_Randomized_Study.pdfTest |
رقم الانضمام: | edsbas.40E08FEA |
قاعدة البيانات: | BASE |
الوصف غير متاح. |