Article

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

Department of Urology, Radboud University Nijmegen Medical Centre, Inter Mail 659, PO Box 9101, Nijmegen 6500 HB, The Netherlands.
World Journal of Urology (Impact Factor: 3.42). 03/2009; 27(3):337-42. DOI: 10.1007/s00345-009-0382-4
Source: PubMed

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.

Download full-text

Full-text

Available from: Henk Vergunst, Aug 30, 2015
0 Followers
 · 
119 Views
  • Source
    • "Bioreductive prodrugs, which are activated in hypoxic environments, have been evaluated as potential anti-cancer agents to selectively kill hypoxic tumor cells. For instance, apaziquone (EO9), a bioreductive prodrug, was used through instillation to treat bladder cancer and significantly reduced the rate of tumor recurrence in the clinical trials (Hendricksen et al., 2009; Jain et al., 2009). "
    Cancer Prevention - From Mechanisms to Translational Benefits, 04/2012; , ISBN: 978-953-51-0547-3
  • [Show abstract] [Hide abstract]
    ABSTRACT: Durch die hohe Inzidenz und Rezidivrate des nicht muskelinvasiven Urothelkarzinoms kommt dieser Tumorentität eine besondere Bedeutung zu. Innovative diagnostische Verfahren stellen die „Raman spectroscopy“ und die optische Kohärenztomographie dar. Uringebundene Markersysteme spielen nach wie vor keine zentrale Rolle. An neuen therapeutischen Optionen werden die Chemohyperthermie und MMC-EMDA-Therapie vorgestellt, sowie Gemcitabine und Apaziquone als neue Substanzen für die intravesikale Therapie.
    Der Urologe 06/2012; 51(6). DOI:10.1007/s00120-012-2897-3 · 0.44 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: New developments in optical diagnostics have a potential for less invasive and improved detection of bladder cancer. To provide an overview of the technology and diagnostic yield of recently developed optical diagnostics for bladder cancer and to outline their potential future applications. A PubMed literature search was performed, and papers on Raman spectroscopy (RS), optical coherence tomography (OCT), photodynamic diagnosis (PDD) and narrow-band imaging (NBI) regarding bladder cancer were reviewed. Technology, clinical evidence, and future applications of the techniques are discussed. With RS, the molecular components of tissue can be measured objectively in qualitative and quantitative ways. The first studies demonstrating human in vivo applicability are still awaited. OCT produces high-resolution, cross-sectional images of tissue, comparable with histopathology, and provides information about depth of tumour growth. The first in vivo studies of OCT demonstrated promising diagnostic accuracy. RS and OCT are not suitable for scanning the entire bladder. PDD is a technique using fluorescence to indicate pathologic tissue. Several studies have shown that PDD increases the detection rate of bladder tumours and improves resection, resulting in fewer early recurrences. The relatively low specificity of PDD remains a problem. NBI enhances contrast of mucosal surface and microvascular structures. The NBI technique has clear advantages over PDD, and the two studies published to date have shown promising preliminary results. PDD and NBI do not contribute to histopathologic diagnosis. RS and OCT aim at providing a real-time, minimally invasive, objective prediction of histopathologic diagnosis, while PDD and NBI aim at improving visualisation of bladder tumours. For RS, OCT, and NBI, more research has to be conducted before these techniques can be implemented in the management of bladder cancer. All techniques might be of value in specific clinical scenarios.
    European Urology 04/2009; 56(2):287-96. DOI:10.1016/j.eururo.2009.02.033 · 12.48 Impact Factor
Show more