PURPOSE: The optimal dose of intravesical bacillus Calmette-Gu  rin for the treatment of nonmuscle invasive @entity150 is controversial. We investigated if induction therapy with low dose bacillus Calmette-Gu  rin could achieve a complete response rate similar to that of standard dose bacillus Calmette-Gu  rin, with less @entity137 and higher quality of life. MATERIALS AND METHODS: After transurethral resection, @entity1 with unresectable multiple nonmuscle invasive @entity150 and/or @entity189 in situ were randomized to receive standard (80 mg) or low dose (40 mg) bacillus Calmette-Gu  rin instillation induction therapy (weekly, 8 times). The primary end point was noninferiority of low dose bacillus Calmette-Gu  rin with a null hypothesis of  a 15% decrease in complete response rate. Secondary end points were recurrence-free survival, progression-free survival, overall survival, @entity1 compliance, adverse events and quality of life using the EORTC QLQ-C30. RESULTS: In an intent to treat analysis of 166 @entity1 the complete response rates for low dose and standard dose bacillus Calmette-Gu  rin were 79% (95% CI 0.70-0.88) and 85% (95% CI 0.77-0.92), respectively. Dunnett-Gent analysis revealed that the null hypothesis of inferiority of low dose bacillus Calmette-Gu  rin in terms of complete response could not be rejected (p = 0.119). However, there were no significant differences between the groups in terms of recurrence, progression and overall survival. Low dose bacillus Calmette-Gu  rin was associated with significantly less fever (p = 0.001) and micturition @entity158 (p = 0.047), and significantly higher quality of life scores for global quality of life, role functioning and functional impairment. CONCLUSIONS: The noninferiority of low dose bacillus Calmette-Gu  rin was not proven. However, low dose bacillus Calmette-Gu  rin was associated with lower @entity137 and higher quality of life compared to standard dose bacillus Calmette-Gu  rin in @entity1 with nonmuscle invasive @entity150 .

Randomized Controlled Study of the Efficacy, Safety and Quality of Life with Low Dose bacillus Calmette-Gu  rin Instillation Therapy for Nonmuscle Invasive XXXX .

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity189 :: ('MESH:D002277', 'Disease') :: ['carcinoma'] @entity150 :: ('MESH:D001749', 'Disease') :: ['bladder cancer'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain']
@entity150 :: (MESH:D001749,Disease) :: ['Bladder Cancer']
