A randomized trial of hypofractionated schedules of palliative radiotherapy in the management of bladder carcinoma: Results of Medical Research Council Trial BA09
Gm. Duchesne et al., A randomized trial of hypofractionated schedules of palliative radiotherapy in the management of bladder carcinoma: Results of Medical Research Council Trial BA09, INT J RAD O, 47(2), 2000, pp. 379-388
Citations number
13
Categorie Soggetti
Radiology ,Nuclear Medicine & Imaging","Onconogenesis & Cancer Research
Journal title
INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS
Purpose: To compare the efficacy and toxicity of two hypofractionated radio
therapy schedules for the improvement of local symptoms from muscle-invasiv
e bladder cancer.
Methods and Materials: A multicenter randomized. trial was conducted compar
ing the efficacy and toxicity of two radiotherapy schedules (35 Gy in 10 fr
actions and 21 Gy in 3 fractions) for symptomatic improvement in patients c
onsidered unsuitable for curative treatment through disease stage or comorb
idity. The primary outcome measures were overall symptomatic improvement of
bladder-related symptoms at 3 months and changes in bladder- and bowel-rel
ated symptoms from pretreatment to end-of-treatment and 3-month assessments
. Overall symptomatic improvement was defined prospectively as the improvem
ent in one bladder-related symptom of at least one grade at 3 months, with
no deterioration in any other bladder-related symptom.
Results: Five hundred patients were recruited, but data on symptomatic impr
ovement at 3 months was only available on 272 patients. Of these, 68% achie
ved symptomatic improvement (71% for 35 Gy, 64% for 21 Gy), with no evidenc
e of a difference in efficacy or toxicity between the two arms. There was n
o evidence of a difference in survival between the two schedules (hazard ra
tio [HR] = 0.99, 95% CI 0.82-1.21, p = 0.933).
Conclusion: This is the largest prospective trial to date in the palliative
treatment of bladder cancer, and provides baseline data against which othe
r results may be compared. The use of 21 Gy in 3 fractions appears as effec
tive as 35 Gy in 10 fractions, although modest differences in survival, sym
ptomatic improvement rates, and toxicity can not be reliably excluded. (C)
2000 Elsevier Science Inc.