VitA I Stadio
Sottotitolo
Studio randomizzato sul trattamento adiuvante con Vitamina A ad alte dosi nei pazienti con tumore polmonare in stadio I.
Disegno Studio
Prospettico randomizzato di fase III
Centro
Multicentrico
Anno di inizio
1982
Ruolo di Ugo Pastorino
Principal Investigator
Numero di pazienti
307
Stato
Concluso
Anno di conclusione
1993
Sinossi
Vitamin A and retinoids are strong inhibitors of epithelial cancer promotion and progression in experimental carcinogenesis, and may be able to prevent the occurrence of upper aerodigestive cancer in subjects heavily exposed to tobacco smoking, such as patients already cured for an early stage lung cancer.
Patients and Methods: The adjuvant effect of high dose vitamin A was tested on 307 patients with stage I non small-cell lung cancer. After curative surgery, patients were randomly assigned to retinol palmitate administration (per os, 300,000 I.U. daily, for 12 mos.) or to control without treatment.
After a median follow-up of 46 months, the number of patients with either recurrence or new primary tumors was 56 (37%) in the treated arm, and 75 (48%) in the control arm. Eighteen patients developed a second primary tumor in the treated group, and 29 patients developed 33 second primary tumors in the control group. A statistically significant difference in favor of treatment was observed on time to new primaries in the field of prevention (P=0.045, logrank test). The treatment difference in terms of disease-free interval was close to statistical significance (P=0.054, logrank test) and just significant when adjusted for primary tumor classification (P=0.038, Cox regression model).
Daily oral administration of high dose vitamin A is effective in reducing the number of new primary tumors related to tobacco consumption, and may improve the disease-free interval in patients curatively resected for stage I lung cancer. The impact of such a treatment on survival needs to be further explored.
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