C Van Pachterbeke1, D Bucella2, S Rozenberg3, Y Manigart3, C Gilles3, D Larsimont4, K Vanden Houte5, M Reynders6, R Snoeck7, M Bossens2. 1. Department of Obstetrics and Gynecology, Universitary Hospital Brugmann, Brussels, Belgium. Electronic address: catherine.vanpachterbeke@chu-brugmann.be. 2. Department of Obstetrics and Gynecology, IRIS-Sud Hospital, Brussels, Belgium. 3. Department of Obstetrics and Gynecology, Universitary Hospital Saint Pierre, Brussels, Belgium. 4. Department of Pathology, Universitary Hospital Saint Pierre, Brussels, Belgium. 5. Department of Pathology, Universitary Hospital Brugmann, Brussels, Belgium. 6. Department of Virology, Universitary Hospital Saint Pierre, Brussels, Belgium. 7. Rega Institute, Leuven, Belgium.
Abstract
OBJECTIVE: Randomized controlled trial evaluating a topical treatment for cervical intraepithelial neoplasia 2 and 3 (CIN 2+) using cidofovir. METHODS:Fifty-three women with a biopsy-proven CIN 2+ were randomly assigned, 6 weeks before their planned conisation, either 3 applications of 3 ml 2% cidofovir in Intrasite gel in a cervical cap or a placebo (the same volume of Intrasite alone). A cervical sample for high-risk types of human papillomaviruses (HPV) (Hybrid Capture 2 or HC2) was taken before treatment and before conisation. The cone was submitted for pathological examination, and subsequently, along with the initial biopsy, to in situ hybridization (ISH) for high-risk HPV. RESULTS: Forty-eight patients were treated and followed according to the protocol, (23 cidofovir, and 25 placebo). Fourteen of the 23 cones were free of any CIN (60.8%) in the cidofovir group. Only 5 of 25 cones were free of any CIN (20%) in the placebo group (p<0.01). The difference remained significant in the ITT group (p<0.05). In the per-protocol and ITT populations, we observed more frequent viral clearance in the cidofovir group, but the difference was significant only when evaluated by ISH and not by HC2. No systemic toxicity was observed. Cervico-vaginal side effects of cidofovir were limited, and not statistically different from placebo. CONCLUSION: The medical topical treatment with cidofovir, at this point, cannot replace conisation, but it is a promising candidate for topical chemotherapy of CIN 2+ lesions; a larger prospective randomized study is needed to confirm our results.
RCT Entities:
OBJECTIVE: Randomized controlled trial evaluating a topical treatment for cervical intraepithelial neoplasia 2 and 3 (CIN 2+) using cidofovir. METHODS: Fifty-three women with a biopsy-proven CIN 2+ were randomly assigned, 6 weeks before their planned conisation, either 3 applications of 3 ml 2% cidofovir in Intrasite gel in a cervical cap or a placebo (the same volume of Intrasite alone). A cervical sample for high-risk types of human papillomaviruses (HPV) (Hybrid Capture 2 or HC2) was taken before treatment and before conisation. The cone was submitted for pathological examination, and subsequently, along with the initial biopsy, to in situ hybridization (ISH) for high-risk HPV. RESULTS: Forty-eight patients were treated and followed according to the protocol, (23 cidofovir, and 25 placebo). Fourteen of the 23 cones were free of any CIN (60.8%) in the cidofovir group. Only 5 of 25 cones were free of any CIN (20%) in the placebo group (p<0.01). The difference remained significant in the ITT group (p<0.05). In the per-protocol and ITT populations, we observed more frequent viral clearance in the cidofovir group, but the difference was significant only when evaluated by ISH and not by HC2. No systemic toxicity was observed. Cervico-vaginal side effects of cidofovir were limited, and not statistically different from placebo. CONCLUSION: The medical topical treatment with cidofovir, at this point, cannot replace conisation, but it is a promising candidate for topical chemotherapy of CIN 2+ lesions; a larger prospective randomized study is needed to confirm our results.
Authors: Janet S Rader; Michael W Sill; Jan H Beumer; Heather A Lankes; Doris Mangiaracina Benbrook; Francisco Garcia; Connie Trimble; J Tate Thigpen; Richard Lieberman; Rosemary E Zuna; Charles A Leath; Nick M Spirtos; John Byron; Premal H Thaker; Shashikant Lele; David Alberts Journal: Gynecol Oncol Date: 2017-03-10 Impact factor: 5.482
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