Comparison of Three Schedules of Intravesical Epirubicin in Patients with Non–Muscle-Invasive Bladder Cancer

• Published in: European urology Vol. 53; no. 5; pp. 984 - 991
• Main Authors: Hendricksen, Kees, Witjes, Wim P.J, Idema, Jan G, Kums, Jan J.M, van Vierssen Trip, Oncko B, de Bruin, Marcel J.F.M, Vergunst, Henk, Caris, Christien T.M, Janzing-Pastors, Maria H.D, Witjes, J. Alfred
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier B.V 01.05.2008; Elsevier
• Subjects: Administration, Intravesical; Adult; Aged; Aged, 80 and over; Antibiotics, Antineoplastic - administration & dosage; Biological and medical sciences; Bladder cancer; Bladder neoplasms; Carcinoma, Transitional Cell - drug therapy; Carcinoma, Transitional Cell - pathology; Cystoscopy; Drug Administration Schedule; Epirubicin; Epirubicin - administration & dosage; Female; Follow-Up Studies; Humans; Intravesical chemotherapy; Male; Medical sciences; Middle Aged; Neoplasm Invasiveness - pathology; Neoplasm Staging; Nephrology. Urinary tract diseases; Non–muscle-invasive; Prospective Studies; Treatment Outcome; Tumors of the urinary system; Urinary Bladder Neoplasms - drug therapy; Urinary Bladder Neoplasms - pathology; Urinary system involvement in other diseases. Miscellaneous; Urinary tract. Prostate gland; Urology; Urothelial cell carcinoma; Urothelial cell carcinoma; Epirubicin; Bladder neoplasms; Bladder cancer; Non–muscle-invasive; Intravesical chemotherapy; Antineoplastic agent; Nephrology; Bladder carcinoma; Bladder cancer,Bladder neoplasms,Epirubicin,Intravesical chemotherapy,Non-muscle-invasive,Urothelial cell carcinoma; Urology; Myocyte; Urinary bladder; Muscle; Invasive cancer; Human; Urinary system disease; Urinary tract disease; Malignant tumor; Bladder tumor; Antibiotic; Chemotherapy; Treatment; Urinary system; Schedule; Non invasive method; Anthracyclins; Bladder disease; Intravesical administration; Comparative study; Cancer
• ISSN: 0302-2838; 1873-7560
• DOI: 10.1016/j.eururo.2007.12.033

Abstract Objectives To study the additive effect of either an early instillation or maintenance instillations of adjuvant intravesical epirubicin, as compared to the epirubicin “standard” treatment schedule only, in patients with non–muscle-invasive bladder cancer. Methods Patients with intermediate- and high-risk urothelial cell carcinoma of the bladder, except carcinoma in situ, were randomised for adjuvant intravesical instillations with 50 mg epirubicin/50 ml NaCl for 1 h. Group 1 received 4 weekly and 5 monthly instillations (standard schedule), group 2 received the same schedule as group 1, but with an additional instillation <48 h after transurethral resection of bladder tumour (TURBT), and group 3 received the same scheme as group 1, but with additional instillations at 9 and 12 mo (maintenance schedule). Standard follow-up was 5 yr and consisted of cystoscopy, cytology, and registration of adverse events. Results A total of 731 patients were eligible for quasi intention-to-treat analysis. Side-effects were minimal for all treatment groups. After 5-yr follow-up, respectively, 44.4%, 42.7%, and 45.0% (log-rank test, p = 0.712) of the patients in groups 1, 2, and 3 were recurrence free, and 90.0%, 87.7%, and 88.2% (log-rank test, p = 0.593) of the patients, respectively, were progression free. Conclusions In the quasi intention-to-treat analysis there is no difference in the 5-yr recurrence-free period between the treatment groups, despite one instillation within 48 h of TURBT or two maintenance instillations up to 1 yr, in addition to the “standard” schedule.