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Selected Publication:
Misut, D.
Primary Imiquimod Therapy versus Surgery for the Treatment of Vulvar Intraepithelial Neoplasia (VIN) – Analysis and Measurement of the Photo Documentation from the PITVIN Study
Humanmedizin; [ Diplomarbeit ] Medizinische Universität Graz; 2022. pp. 67
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- Authors Med Uni Graz:
- Advisor:
- Trutnovsky Gerda
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- Abstract:
- Introduction/Background Vulvar Intraepithelial Neoplasia (VIN) is a preinvasive dysplasia of atypical keratinocytes within the vulvar epithelium. The malignant potential of VIN is yet to be determined; however, it is estimated to range between 8% up to 86%. The incidence of its HPV related subtype, a vulvar high grade squamous intraepithelial lesion (vH-SIL), marks a worldwide increase particularly among premenopausal women. Currently, surgery is still the most common treatment choice for VIN/vH-SIL, however, it is neither side-effects free nor does it offer a long-lasting absence of disease recurrence. Imiquimod 5% cream has been introduced as an off-label treatment for vH-SIL, capable of altering the local immune response and eliciting the clearance of hrHPV. This thesis aims to contribute to growing evidence regarding the effectiveness, safety, and non-inferiority of topical imiquimod treatment relative to surgical excision in vH-SIL (VIN2-3) patients. Methods The thesis is conducted as a part of the analysis and interpretation of photographical documentation from the PITVIN study. It is designed as a multicenter randomized controlled trial (RCT) enrolling 110 women aged between 19-82 years with histologically confirmed vH-SIL (110 patients enrolled, 3 lost to follow-up). This thesis measured and analyzed the change in lesion number and total lesion area (sum of individual lesion areas present at the control) under the given treatment (imiquimod/surgery) throughout clinical controls. Furthermore, the influence of the baseline lesion color on the effectiveness of the treatment was assessed and evaluated. The thesis incorporates a total of 68 patients (it excludes the residual 39 patients enrolled in the PITVIN study due to incomplete data), resulting in a primary imiquimod group containing 36 patients and primary surgery group of 32 patients, respectively. Results By intention-to-treat analysis, complete clinical response six months after the baseline (at U6) was seen in 30/36 women treated with topical imiquimod (83.3%) and 28/32 (87.5%) women after surgical intervention. One year durability in patients listed as complete responders was determined at U12, with three additional patients in the imiquimod group developing complete response (33/36) - 91.7% and two additional patients in the surgery group (30/32) - 93.8%. Patients treated with topical imiquimod witnessed a statistically significant decline in the number of lesions at six months (P<0.001) and at 12 months (P<0.001), relative to the baseline lesion number. At the baseline, an equal portion of patients presented with leukoplakic lesions (75%) and pigmented lesions (25%) between imiquimod and surgical treatment groups, respectively. Correlation analysis assessing the influence of the baseline lesion color for the treatment effectiveness determined at the U6 and the U12 in both treatment groups is insignificant (p>0.05). Conclusion Primary topical 5% imiquimod treatment is an effective, safe, and non-inferior alternative to surgery in the treatment of VIN (vHSIL). Baseline lesion color should not represent a relevant criterium favoring imiquimod or surgery as an optimal primary treatment modality and is an insignificant aspect for the treatment effectiveness in vH-SIL patients.