Page 140 - Strategies for non-invasive managementof high-grade cervical intraepithelial neoplasia - prognostic biomarkers and immunotherapy Margot Maria Koeneman

Chapter 7
currently not available, but seem necessary to determine the clinical applicability of imiquimod therapy. Nevertheless, despite the high rate of side effects, the respondents of the current study generally considered imiquimod treatment of VAIN and CIN to be successful.
The current study is the first to provide insights regarding the awareness, off-label application, and attitudes of gynecologists with regard to imiquimod treatment of VAIN and CIN. The study has several limitations. First, although the questionnaire was tested before application, formal validation has not been performed. A pilot test was considered to be infeasible considering the small target population. However, we do not believe that the lack of validation influenced the response rate, because only two respondents did not finish the questionnaire, and those that did not respond at all could not have seen the questionnaire. Second, participation in the survey was voluntary. As a result, respondents who have a special interest or opinion with regard to the subject may have been more likely to participate, thus resulting in selection bias. The last limitation may be the moderate response rate of the study However, this response rate is comparable to the response rates of other surveys on the knowledge and attitudes of physicians with regard to several medical issues.[17,18,19] Moreover, the absolute number of respondents is substantial. In addition, the survey encompassed the majority of the hospitals that were contacted (60%).Thus, the results of this survey seem to be generally reliable and valuable.
Conclusions
The responding gynecologists had limited awareness of imiquimod as an experimental treatment modality for VAIN and CIN. Far fewer actually used this treatment in clinical practice. This is probably due to the limited evidence of imiquimod efficacy for these diseases, the fact that imiquimod treatment has not yet been incorporated in treatment guidelines, and the common side effects of the therapy. As a result, off-label application of imiquimod is currently limited to selected patients, if the benefits of imiquimod therapy outweighed its side effects. The treatment results in these patients were generally good. To facilitate more widespread implementation of imiquimod in clinical practice, more evidence regarding its efficacy, clinical applicability, and long-term outcomes is needed, followed by incorporation of imiquimod as a treatment modality in treatment guidelines. Treatment efficacy, clinical applicability, and long-term outcomes will be addressed by the authors in a randomized controlled trial: TOPIC trial (TOPical treatment with Imiquimod of high-grade CIN, ClinicalTrial.gov identifier: NCT02329171).[20] This trial aims to confirm and assess the efficacy of vaginal imiquimod treatment for CIN and to provide additional evidence on the rate of disease recurrence and the quality of life of the patients during and after this treatment.
138