Effect of Etretinate on Sputum Cytology in Smokers
Author Information
Author(s): A.M. Arnold, G.P. Browman, M.N. Levine, T. D'Souza, B. Johnstone, P. Skingley, L. Turner-Smith, R. Cayco, L. Booker, M. Newhouse, W.M. Hryniuk
Primary Institution: Hamilton Regional Cancer Centre
Hypothesis
Does administration of the synthetic retinoid, etretinate, at an oral dose of 25 mg daily, to a group of smokers with atypia on sputum sampling, produce a clinically significant reduction in the level of atypia when compared to a placebo?
Conclusion
Etretinate, at the dose used in this study, had no impact on sputum atypia as detected by sputum sampling.
Supporting Evidence
- Etretinate was detected in 92.8% of samples from subjects on active drug.
- Only 2.3% of samples from the placebo group showed etretinate.
- Compliance was high, with 86% of subjects on etretinate taking 90% or more of their medication.
- Improvements in sputum atypia were noted in both treatment groups, but were not statistically significant.
- Toxicity was mild and similar between both groups.
Takeaway
The study tested a drug called etretinate to see if it could help smokers with abnormal lung cells, but it didn't work.
Methodology
150 smokers with at least a 15 pack-year history were randomized to receive either etretinate or placebo for 6 months, with sputum samples collected and analyzed for atypia.
Potential Biases
The study was rigorously designed to minimize bias, but previous uncontrolled studies showed conflicting results.
Limitations
The study may not have detected a true treatment effect due to the nature of sputum sampling and potential observer variation.
Participant Demographics
Participants were smokers with a mean age of approximately 51 years, with a mix of genders and varying degrees of sputum atypia.
Statistical Information
P-Value
0.45
Statistical Significance
p=0.45
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