Tolerability of the synthetic retinoid fenretinide® (HPR)

Alberto Costa, Winfred Malone, Marjorie Perloff, Fiamma Buranelli, Tiziana Campa, Giovanni Dossena, Andrea Magni, Maria Pizzichetta, Claudio Andreoli, Marcella Del Vecchio, Franca Formelli, Angelo Barbieri

Research output: Contribution to journalArticlepeer-review

Abstract

Fenretinide®, N-(4-hydroxyphenyl)retinamide (HPR), is a synthetic retinoid which has been proven effective in inducing cell differentiation and in inhibiting carcinogen induced mammary tumors in rodents. Because of its efficacy and low toxicity in animals, HPR has been proposed for chemopreventive evaluation in humans. Thus, a randomized trial has been conducted to select a dose which can be administered over a lengthy period of time and with acceptable toxicity. The retinoid was administered orally to patients already operated on for breast cancer in daily doses of 100, 200 and 300 mg for 6 months and subsequently at 200 mg for another 6 months. No acute toxicity was found. Dermatological toxicity was minimal and no liver function abnormalities were observed. Nausea and headaches were infrequent and always mild. Menstrual irregularities were recorded with similar frequency in the treatment and placebo groups and appeared to be more age related than drug dependent. After 6 months of treatment one of 25 patients taking 300 mg HPR daily experienced impaired night vision, confirmed by the electroretinogram, and resolved by interruption of treatment. Because the 300 mg daily dose is possibly associated with impaired dark adaptation, the recommended dose for chemoprevention trials of HPR is 200 mg per day.

Original languageEnglish
Pages (from-to)805-808
Number of pages4
JournalEuropean Journal of Cancer and Clinical Oncology
Volume25
Issue number5
DOIs
Publication statusPublished - 1989

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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