Ocular effects of fenretinide, a vitamin A analog, in a chemoprevention trial of bladder cancer

L. Baglietto, R. Torrisi, G. Arena, F. Tosetti, A. G. Gonzaga, W. Pasquetti, C. Robertson, A. Decensi

Research output: Contribution to journalArticlepeer-review


Fenretinide is a vitamin A derivative under investigation in cancer prevention trials. Because all available pharmacologic and toxicologic data were obtained from breast cancer patients, we measured plasma drug, metabolite, and vitamin A levels and studied their relationship with visual and ocular symptoms in a cohort formed mostly by male subjects belonging to a bladder cancer prevention trial. After 1 year, the mean plasma retinol levels (± standard deviation [SD]) were 168.2 ± 75.8 ng/ml in 31 subjects treated with fenretinide and 594.5 ± 168.4 ng/ml in 36 control subjects (P <.001). Plasma retinol levels were correlated inversely to drug and metabolite concentrations, which in turn were correlated inversely to the interval from last drug intake. The decline of plasma vitamin A levels accounted for a 41.7% cumulative incidence of diminished dark adaptability in the retinoid arm as compared to 6.8% in the control arm (odds ratio = 13.8; 95% confidence interval, 2.9-66.1). Although compliance as assessed by capsule count was high, three subjects originally assigned to the treatment group who proved to be noncompliers (8.8%, or 3 of 34) had no detectable plasma drug or metabolite levels. Our data confirm the specific pharmacologic and visual effects of fenretinide also in a male population and strengthen the importance of multiple blood measurements to monitor treatment compliance in prevention trials.

Original languageEnglish
Pages (from-to)369-375
Number of pages7
JournalCancer Detection and Prevention
Issue number4
Publication statusPublished - 2000


  • Chemoprevention
  • Fenretinide
  • Night vision
  • Vitamin A

ASJC Scopus subject areas

  • Cancer Research
  • Oncology


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