title: Two-year follow-up of the phase II marker lesion study of intravesical apaziquone for patients with non-muscle invasive bladder cancer.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Urology, Radboud University Nijmegen Medical Centre, Inter Mail 659, PO Box 9101, Nijmegen 6500 HB, The Netherlands. k.hendricksen@uro.umcn.nl
authors.forename: Kees
authors.initials: K
authors.lastname: Hendricksen
authors.forename: Antoine G
authors.initials: AG
authors.lastname: van der Heijden
authors.forename: Erik B
authors.initials: EB
authors.lastname: Cornel
authors.forename: Henk
authors.initials: H
authors.lastname: Vergunst
authors.forename: Theo M
authors.initials: TM
authors.lastname: de Reijke
authors.forename: Erika
authors.initials: E
authors.lastname: van Boven
authors.forename: Geert A H J
authors.initials: GA
authors.lastname: Smits
authors.forename: Rajiv
authors.initials: R
authors.lastname: Puri
authors.forename: Sigrid
authors.initials: S
authors.lastname: Gruijs
authors.forename: J Alfred
authors.initials: JA
authors.lastname: Witjes
mesh_terms: D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D001388:Aziridines / Q000008:administration & dosage*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D045563:Indolequinones / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D011446:Prospective Studies; D013997:Time Factors; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000970:Antineoplastic Agents; D001388:Aziridines; D045563:Indolequinones; C060817:apaziquone