4768
document
Randomized trial of fenretinide in superficial bladder cancer using DNA flow cytometry as an intermediate end point . Retinoids have shown a potential activity in preventing tumor recurrence in superficial bladder cancer . We assessed the activity of the synthetic retinoid fenretinide in superficial bladder cancer using DNA flow cytometry and conventional cytology as surrogate biomarkers . A total of 99 subjects with resected superficial bladder cancer ( pTa , pT1 ) were randomized to either fenretinide ( 200 mg day p.o . for 24 months ) or no intervention . Cystoscopy and bladder washing for DNA flow cytometry end points ( proportion of DNA aneuploid histograms , hyperdiploid fraction , and percentage of apoptotic cells ) and proportion of abnormal cytological examinations were repeated every 4 months for up to 36 months . The primary study end point was the proportion of DNA aneuploid histograms after 12 months . This figure was 48.9 % in the fenretinide arm and 41.9 % in the control arm ( odds ratio , 1.16 ; 95 % confidence interval , 0.44-3.07 ) . There was no difference in any other response biomarker between the two groups up to 36 months , nor was any biomarker able to predict recurrence risk . Recurrence-free survival was comparable between the arms ( 27 events in the fenretinide arm versus 21 in the control arm ; P = 0.36 ) . Twelve subjects in the fenretinide arm complained of diminished dark adaptability , and nine subjects in the fenretinide arm versus one control subject had mild dermatological alterations . We conclude that fenretinide showed a lack of effect on the DNA content distribution and the morphology of urothelial cells obtained in serial bladder washings . Recurrence-free survival was comparable between groups . Because our data are hampered by the lack of predictivity of the selected biomarkers , additional studies are necessary to assess the activity of fenretinide in preventing bladder cancer .
4769
Intervention_Pharmacological
fenretinide
4770
Intervention_Pharmacological
synthetic retinoid fenretinide
4771
Intervention_Pharmacological
fenretinide ( 200 mg day p.o .
4772
Intervention_Control
no intervention
4773
Intervention_Pharmacological
fenretinide
4774
Outcome_Physical
abnormal cytological examinations
4775
Outcome_Physical
proportion of DNA aneuploid histograms
4776
Outcome_Physical
response biomarker
4777
Outcome_Mortality
Recurrence-free survival
4778
Outcome_Adverse-effects
dark adaptability
4779
Outcome_Adverse-effects
mild dermatological alterations
4780
Outcome_Physical
content distribution
4781
Outcome_Physical
morphology of urothelial cells
4782
Outcome_Mortality
Recurrence-free survival
4783
Participant_Condition
superficial bladder cancer