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- Title
Two-year follow-up of the phase II marker lesion study of intravesical apaziquone for patients with non-muscle invasive bladder cancer.
- 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
- Abstract
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. 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. 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. 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.
- Subjects
CANCER patients; BLADDER cancer; TRANSURETHRAL prostatectomy; URETHRA surgery; CANCER treatment; MEDICAL care
- Publication
World Journal of Urology, 2009, Vol 27, Issue 3, p337
- ISSN
0724-4983
- Publication type
Article
- DOI
10.1007/s00345-009-0382-4