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Intravesical Epirubicin Versus Doxorubicin for Superficial Bladder Tumors (Stages pTa and pT1): a Randomized Prospective Study

1997; Lippincott Williams & Wilkins; Volume: 158; Issue: 1 Linguagem: Inglês

10.1097/00005392-199707000-00018

1527-3792

Bedeir Ali‐El‐Dein, Mahmoud El‐Baz, Adel Nabeeh, Sameh Shamaa, Albair Ashamallah,

Urological Disorders and Treatments

No AccessJournal of UrologyClinical Urology: Original Article1 Jul 1997Intravesical Epirubicin Versus Doxorubicin for Superficial Bladder Tumors (Stages pTa and pT1): a Randomized Prospective Study Bedeir Ali-El-Dein, Mahmoud El-Baz, Adel Nabeeh M. Aly, Sameh Shamaa, and Albair Ashamallah Bedeir Ali-El-DeinBedeir Ali-El-Dein , Mahmoud El-BazMahmoud El-Baz , Adel Nabeeh M. AlyAdel Nabeeh M. Aly , Sameh ShamaaSameh Shamaa , and Albair AshamallahAlbair Ashamallah View All Author Informationhttps://doi.org/10.1097/00005392-199707000-00018AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We performed a prospective, randomized, controlled study to compare intravesical epirubicin and doxorubicin as adjuvant therapy after endoscopic resection of superficial bladder tumor. Materials and Methods: We randomly allocated 253 eligible patients to 4 study arms. Seven to 14 days after transurethral bladder tumor resection instillation of the intravesical agent was instituted, including 50 and 80 mg. epirubicin in study arms 1 and 2, respectively, and 50 mg. doxorubicin in arm 3. Control arm 4 included patients who underwent transurethral bladder tumor resection alone. Instillation was repeated weekly for 8 weeks and monthly thereafter to complete 1 year of treatment. All patients were followed every 3 months by cystourethroscopy, urine cytology and deoxyribonucleic acid flow cytometry for 12 to 48 months (mean 30.1). Results: Rates of recurrence were significantly lower in the chemotherapy groups than in controls (p <0.001) and in the epirubicin groups than in the doxorubicin group (p = 0.02). In arms 1 to 4 recurrence rates were 25, 17.6, 36.7 and 65.6%, respectively. Recurrence rates per 100 patient months were 0.83, 0.60, 1.18 and 2.73, respectively, which were significant statistically, and lower after chemotherapy in general and epirubicin in particular (p <0.05). Mean interval to first recurrence was 16, 15.4, 18.9 and 6.3 months, respectively, with a significant difference between the chemotherapy and control groups (p 0.05). We studied the relationships among different risk factors, and patterns of recurrence and progression. For pT1 tumors recurrence rates in arms 1 to 4 were 26.3, 17.8, 39.3 and 70.9%, respectively, which were significantly lower in the chemotherapy group than in controls (p <0.001) and in the epirubicin groups than in the doxorubicin group (p = 0.01). Toxic and untoward side effects developed in 10 (15.6%), 16 (23.5%) and 25 (41.7%) patients in chemotherapy arms 1 to 3, respectively, with a marginal insignificant difference between low and high dose epirubicin (p = 0.3), and significantly lower toxicity rates in arms 1 and 2 than in 3 (p = 0.002). A contracted bladder developed in 2.1% of all patients who received chemotherapy. Conclusions: This study demonstrates that epirubicin has better efficacy and lower toxicity than doxorubicin when used as an intravesical agent. References 1 Herr, H. W. and Laudone, V. P.: Intravesical therapy for superficial bladder cancer. AUA Update Series, vol. VIII, lesson 12, 1989. Google Scholar 2 Shoukry, I.: Management of superficial bladder tumors. Bladder cancer symposium, NCl-ESO, Cairo, Egypt, November 2-4, 1988 Google Scholar 3 : The management of superficial bladder cancer.. Cancer1980; 45: 1856. 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Google Scholar From the Departments of Pathology and Internal Medicine, and Urology and Nephrology Center, Faculty of Medicine, Mansoura University, Mansoura, Egypt.© 1997 by American Urological Association, Inc.FiguresReferencesRelatedDetailsCited byKoya M, Simon M and Soloway M (2018) Complications of Intravesical Therapy for Urothelial Cancer of the BladderJournal of Urology, VOL. 175, NO. 6, (2004-2010), Online publication date: 1-Jun-2006.KOGA H, KUROIWA K, YAMAGUCHI A, OSADA Y, TSUNEYOSHI M and NAITO S (2018) A Randomized Controlled Trial of Short-Term Versus Long-Term Prophylactic Intravesical Instillation Chemotherapy for Recurrence After Transurethral Resection of Ta/T1 Transitional Cell Carcinoma of the BladderJournal of Urology, VOL. 171, NO. 1, (153-157), Online publication date: 1-Jan-2004.Soloway M, Sofer M and Vaidya A (2018) Contemporary Management Of Stage T1 Transitional Cell Carcinoma Of The BladderJournal of Urology, VOL. 167, NO. 4, (1573-1583), Online publication date: 1-Apr-2002.ALI-EL-DEIN B, NABEEH A, ISMAIL E and GHONEIM M (2018) SEQUENTIAL BACILLUS CALMETTE-GUERIN AND EPIRUBICIN VERSUS BACILLUS CALMETTE-GUERIN ALONE FOR SUPERFICIAL BLADDER TUMORS: A RANDOMIZED PROSPECTIVE STUDYJournal of Urology, VOL. 162, NO. 2, (339-342), Online publication date: 1-Aug-1999. Volume 158Issue 1July 1997Page: 68-74 Advertisement Copyright & Permissions© 1997 by American Urological Association, Inc.MetricsAuthor Information Bedeir Ali-El-Dein More articles by this author Mahmoud El-Baz More articles by this author Adel Nabeeh M. Aly More articles by this author Sameh Shamaa More articles by this author Albair Ashamallah More articles by this author Expand All Advertisement PDF downloadLoading ...