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
Department of Urology, Radboud University Nijmegen Medical Centre, Inter Mail 659, PO Box 9101, Nijmegen 6500 HB, The Netherlands.
World J Urol. 2009 Jun;27(3):337-42. doi: 10.1007/s00345-009-0382-4. Epub 2009 Feb 13.
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.
研究非肌层浸润性膀胱癌（NMIBC）患者在膀胱内灌注阿帕唑醌后达到完全消融反应后的复发时间和反应持续时间。
对患有多发pTa-T1 G1-2级膀胱尿路上皮癌（UCC）的患者进行经尿道膀胱肿瘤切除术（TURBT），但有一个0.5-1.0 cm的标记性病变除外。膀胱内每周灌注一次阿帕唑醌，连续六周，不进行维持灌注。在最后一次灌注后2-4周获得组织学确认的反应。从第一次阿帕唑醌灌注开始，在6、9、12、18和24个月进行常规随访（FU）。
在随访3个月时，46例患者中有31例（67.4%）对消融治疗有完全反应（CR）。长期副作用仅为轻度。两名CR患者在随访期间退出。在意向性治疗（ITT）分析中，49.5%的CR患者在随访24个月时无复发，反应的中位持续时间为18个月。在15例无反应（NR）患者中，只有2例在TURBT后接受了额外的预防性灌注。在ITT分析中，26.7%的NR患者无复发（对数秩检验，P = 0.155）。在随访24个月时，总体无复发生存率为39%（46例患者中的18例）。
67%的患者标记性病变达到CR后，1年随访时无复发率为56.5%，2年随访时为49.5%。与其他消融研究的结果相比，这些长期结果良好。
