Two-year follow-up of the phase II marker lesion study of intravesical apaziquone for patients with non-muscle invasive bladder cancer

• Published in: World journal of urology Vol. 27; no. 3; pp. 337 - 342
• Main Authors: Hendricksen, Kees, van der Heijden, Antoine G., Cornel, Erik B., Vergunst, Henk, de Reijke, Theo M., van Boven, Erika, Smits, Geert A. H. J., Puri, Rajiv, Gruijs, Sigrid, Witjes, J. Alfred
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer-Verlag 01.06.2009; Springer Nature B.V
• Subjects: Administration, Intravesical; Adult; Aged; Aged, 80 and over; Antineoplastic Agents - administration & dosage; Aziridines - administration & dosage; Carcinoma, Transitional Cell - drug therapy; Carcinoma, Transitional Cell - pathology; Female; Follow-Up Studies; Humans; Indolequinones - administration & dosage; Male; Medicine; Medicine & Public Health; Middle Aged; Neoplasm Invasiveness; Nephrology; Oncology; Prospective Studies; Time Factors; Topic Paper; Urinary Bladder Neoplasms - drug therapy; Urinary Bladder Neoplasms - pathology; Urology; Chemotherapy; Marker lesion; Bladder neoplasms; Apaziquone; EO9
• ISSN: 0724-4983; 1433-8726
• DOI: 10.1007/s00345-009-0382-4

Objectives To study the time-to-recurrence and duration of response in non-muscle invasive bladder cancer (NMIBC) patients, with a complete ablative response after intravesical apaziquone instillations. Methods Transurethral resection of bladder tumour(s) (TURBT) was performed in patients with multiple pTa-T1 G1-2 urothelial cell carcinoma (UCC) of the bladder, with the exception of one marker lesion of 0.5–1.0 cm. Intravesical apaziquone was administered at weekly intervals for six consecutive weeks, without maintenance instillations. A histological confirmed response was obtained 2–4 weeks after the last instillation. Routine follow-up (FU) was carried out at 6, 9, 12, 18 and 24 months from the first apaziquone instillation. Results At 3 months FU 31 of 46 patients (67.4%) had a complete response (CR) to ablative treatment. Side-effects on the long-term were only mild. Two CR patients dropped out during FU. On intention-to-treat (ITT) analysis 49.5% of the CR patients were recurrence-free at 24 months FU, with a median duration of response of 18 months. Of 15 no response (NR) patients, only two received additional prophylactic instillations after TURBT. On ITT-analysis 26.7% of the NR patients were recurrence-free (log rank test, P  = 0.155). The overall recurrence-free survival was 39% (18 of 46 patients) at 24 months FU. Conclusions The CR of the marker lesion in 67% of patients was followed by a recurrence-free rate of 56.5% at 1-year FU, and 49.5% at 2-year FU. These long-term results are good in comparison with the results of other ablative studies.