title: Evaluation of efficacy and toxicity in two different hypofractionated 3D-conformal external beam radiotherapy schedules in localised muscle invasive bladder cancer.
abstract: OBJECTIVE
  To evaluate the efficacy as well as acute and late toxicity of two different accelerated hypofractionated 3D-conformal radiotherapy (Hypo-3DCRT) schedules in patients with bladder cancer.
  
  
  METHODS
  Between February 2006 and June 2011, 50 elderly patients with cT1-2N0 bladder carcinoma were treated with Hypo-3DCRT. Mean age was 75 years. All patients were medically inoperable, with poor performance status, who couldn't tolerate either cystectomy or radical external beam irradiation on a daily basis. A dose of 36 Gy in 6 weekly fractions (arm A, N=39) or 39.96 Gy of 3.33 Gy twice daily, once a week, for 6 weeks (arm B, N=11) were prescribed. The primary study endpoints were the evaluation of acute/late gastrointestinal (GI) toxicity according to the EORTC/RTOG scale together with the visual analogue bladder-related pain score (VAS).
  
  
  RESULTS
  The GI acute toxicities were: grade 1: arm A 24/39 (61.5%), arm B 9/11 (81.8%); grade 2: arm A 14/39 (35.9%), arm B 1/11 (9.1%); grade 3: arm A 1/39 (9.1%) (x(2), p=0.29). Only grade 1 late GI toxicity was seen and was significantly higher in arm A: arm A 17/39 (43.6%) and arm B 1/11 (9.1%) (x(2), p=0.037). The reduction of VAS score was similar in both arms (p=0.065). The median relapse free survival (RFS) was 15 and 16 months for arm A and B, respectively (log rank, p=0.71).
  
  
  CONCLUSIONS
  Beyond the non-randomized design of the trial, the Hypo-3DCRT schedules used appear to be an acceptable alternative to the traditional longer radiotherapy (RT) schedules for elderly patients unfit for daily irradiation.
authors.affiliation: 2nd Radiology Department, Radiotherapy unit, Attikon University Hospital Athens, Greece.
authors.forename: V
authors.initials: V
authors.lastname: Kouloulias
authors.forename: E
authors.initials: E
authors.lastname: Mosa
authors.forename: M
authors.initials: M
authors.lastname: Tolia
authors.forename: I
authors.initials: I
authors.lastname: Kantzou
authors.forename: N
authors.initials: N
authors.lastname: Koliarakis
authors.forename: K
authors.initials: K
authors.lastname: Platoni
authors.forename: I
authors.initials: I
authors.lastname: Georgakopoulos
authors.forename: A
authors.initials: A
authors.lastname: Siatelis
authors.forename: G
authors.initials: G
authors.lastname: Sarris
authors.forename: I
authors.initials: I
authors.lastname: Beli
authors.forename: M
authors.initials: M
authors.lastname: Chrisofos
authors.forename: N
authors.initials: N
authors.lastname: Kelekis
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D002295:Carcinoma, Transitional Cell / Q000401:mortality / Q000532:radiotherapy* / Q000556:secondary; D016009:Chi-Square Distribution; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D005260:Female; D005767:Gastrointestinal Diseases / Q000175:diagnosis / Q000209:etiology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D009361:Neoplasm Invasiveness; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D011446:Prospective Studies; D011832:Radiation Injuries / Q000175:diagnosis / Q000209:etiology; D020266:Radiotherapy, Conformal / Q000009:adverse effects / Q000401:mortality; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*