Pharmacokinetics and Phase I Trial of Retinol and 13-cis-Retinoic Acid

Goodman, Gary E.; Alberts, David S.; Peng, Yitian; Beaudry, Jacqueline L.; Einspahr, Janine G.; Leigh, Susan; Miles, Nelson J.; Davis, Thomas P.; Meyskens, F. L.

doi:10.1159/000407033

Cited by 2 publications

(1 citation statement)

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“…36] or no change [37][38][39], In our trial, both retinol and RBP values were higher in the treatment arm compared to the control arm. whose values appeared relatively stable over the time and consistent with the expected average value in the general population.…”

Section: Discussionmentioning

confidence: 71%

Safety of High-Dose Vitamin A

et al. 1991

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The paper reports on the efficacy and side effects of high-dose vitamin A, administered as adjuvant treatment for resected stage I lung cancer in a randomized clinical trial. After a median follow-up of 28 months, 283 patients were evaluable: 138 allocated to treatment with retinol palmitate (300,000 IU daily for at least 12 months) and 145 to standard observation. The clinical results available to date do well justify a continuation of the study. Skin dryness and desquamation were the most frequent symptoms, affecting 60% of all treated patients. Other symptoms such as dyspepsia, headache, nosebleeds and mild hair loss occurred in less than 10% of patients, and were self-terminating. Only in 4 patients (3%) was the treatment interrupted because of symptoms potentially related to vitamin A administration. As for laboratory tests, Γ-GT levels were abnormally elevated in 69% of treated patients vs. 39% of controls at 24 months (mean 149 vs. 58 IU/1; p < 0.05). Serum triglyceride concentrations over 150mg/dl were seen in 74% of treated patients vs. 43% of controls at 12 months (mean 283 vs. 179mg/dl; p < 0.05). There were no other laboratory signs of toxicity attributable to vitamin A. In our experience, high-dose retinoyl palmitate administration was a well-tolerated and safe treatment. The long-term impact on lipid metabolism still remains to be determined.

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Section: Discussionmentioning

confidence: 71%