Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia

Summary

To evaluate the efficacy (defined as complete clinical response at 6 months) of imiquimod vs. standard treatment (surgery) for vulvar intraepithelial neoplasia (VIN).

Timeline

Start

2013-06

Primary completion

2021-02

Completion

2021-02

Outcome

Met primary endpoint

paper 37 (80%) of 46 patients using imiquimod had CCR, compared with 41 (79%) of 52 patients after one surgical intervention, showing non-inferiority of the new treatment PMID 35483400 ↗

paper difference in proportion -0·016, 95% CI -0·15 to -0·18; p=0·0056 PMID 35483400 ↗

Publications

• Trutnovsky G, Muntinga C, Holter M, Pucher D, Bracic T, Huetter C, Ciresa-Konig A, Polterauer S, Tamussino K, van Esch E. Risk factors for recurrence of vulvar high-grade squamous intra-epithelial lesions: long-term follow-up of the PITVIN Study (primary imiquimod vs surgery for vulvar intra-epithelial neoplasia). Int J Gynecol Cancer. 2026 Apr;36(4):104560. doi: 10.1016/j.ijgc.2026.104560. Epub 2026 Feb 11.
• Muntinga CLP, de Vos van Steenwijk PJ, Kooreman LFS, Regauer S, Abdulrahman Z, Bekkers RLM, van der Burg SH, Trutnovsky G, van Esch EMG. Pre-existing infiltration with T cells and CD14+ myeloid cells is associated with treatment response to imiquimod in primary and recurrent vulvar high-grade squamous intraepithelial lesions. J Immunother Cancer. 2025 Oct 20;13(10):e012666. doi: 10.1136/jitc-2025-012666.
• Trutnovsky G, Reich O, Joura EA, Holter M, Ciresa-Konig A, Widschwendter A, Schauer C, Bogner G, Jan Z, Boandl A, Kalteis MS, Regauer S, Tamussino K. Topical imiquimod versus surgery for vulvar intraepithelial neoplasia: a multicentre, randomised, phase 3, non-inferiority trial. Lancet. 2022 May 7;399(10337):1790-1798. doi: 10.1016/S0140-6736(22)00469-X. Epub 2022 Apr 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Imiquimod	Other / unclassified	—	Topical

Indications