A RANDOMIZED CONTROLLED TRIAL EVALUATING A NOVEL CYTOTOXIC DRUG-DELIVERY SYSTEM FOR THE TREATMENT OF CERVICAL INTRAEPITHELIAL NEOPLASIA

Objective To investigate the efficacy of a novel method for the treatm ent of cervical intraepithelial neoplasia. A cytotoxic drug delivery s ystem using a bilaminar bioadhesive polymeric film was applied directl y to the cervix. This cytotoxic drug delivery system allowed the dose, the site and the duration of application of the cytotoxic drug (5-flu orouracil) to be controlled. Design A prospective, double-blind random ised controlled trial. Setting The Departments of Obstetrics and Gynae cology and Pathology of Belfast City Hospital and The Queen's Universi ty of Belfast, and the Department of Pharmacy of The Queen's Universit y of Belfast. Participants One hundred and four patients who had been referred to the colposcopy outpatient clinic because of abnormal cervi cal cytology were recruited into the trial. They were assessed colposc opically and biopsies for histopathology were obtained. Only patients with cervical intraepithelial neoplasia lesions Grades 1 and 2 were re cruited. Interventions All patients were re-assessed one, three, and s ix months after application of the cytotoxic drug delivery system by c olposcopy. Clinical endpoints were noted. Main outcome measures Pre-tr eatment histopathological biopsy results were compared with those obta ined after treatment. Results The cytotoxic drug delivery system fulfi lled the requirements for treatment of cervical intraepithelial neopla sia without causing any architechtural damage, but the chemotherapeuti c agent, 5-fluorouracil, did not provide effective treatment of diseas e. Conclusions This study showed that the delivery system was effectiv e, and further studies using this mechanism are now possible.