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

被引:36
作者
Hendricksen, Kees [1 ]
van der Heijden, Antoine G. [1 ]
Cornel, Erik B. [2 ]
Vergunst, Henk [3 ]
de Reijke, Theo M. [4 ]
van Boven, Erika [5 ]
Smits, Geert A. H. J. [6 ]
Puri, Rajiv [7 ]
Gruijs, Sigrid [8 ]
Witjes, J. Alfred [1 ]
机构
[1] Radboud Univ Nijmegen, Med Ctr, Dept Urol, NL-6500 HB Nijmegen, Netherlands
[2] Twente Hosp Grp Hengelo, Dept Urol, Hengelo, Netherlands
[3] Canisius Wilhelmina Ziekenhuis, Dept Urol, Nijmegen, Netherlands
[4] Univ Amsterdam, Acad Med Ctr, Dept Urol, NL-1105 AZ Amsterdam, Netherlands
[5] Maasziekenhuis, Dept Urol, Boxmeer, Netherlands
[6] Rijnstate Hosp, Dept Urol, Arnhem, Netherlands
[7] Bradford Hosp Natl Hlth Serv Trust, Dept Urol, Bradford, W Yorkshire, England
[8] INC Res Netherlands BV, Amsterdam, Netherlands
关键词
Apaziquone; Bladder neoplasms; Chemotherapy; EO9; Marker lesion; TRANSITIONAL-CELL CARCINOMA; CHEMORESECTION; TA-T1; TA;
D O I
10.1007/s00345-009-0382-4
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:337 / 342
页数:6
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