Topical imiquimod compared with conization to treat cervical high-grade squamous intraepithelial lesions: Multicenter, randomized controlled trial

In a previous phase II trial, we showed that topical imiquimod (IMQ) therapy is an efficacious treatment for high-grade squamous intraepithelial lesion (HSIL). Aim of the present study was to investigate the non-inferiority of a 16-week topical, self-applied IMQ therapy compared to large loop excisi...

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Vydané v:	Gynecologic oncology Ročník 165; číslo 1; s. 23 - 29
Hlavní autori:	Polterauer, Stephan, Reich, Olaf, Widschwendter, Andreas, Hadjari, Laudia, Bogner, Gerhard, Reinthaller, Alexander, Joura, Elmar, Trutnovsky, Gerda, Ciresa-Koenig, Alexandra, Ganhoer-Schimboeck, Julia, Boehm, Ina, Berger, Regina, Langthaler, Eva, Aberle, Stephan W., Heinze, Georg, Gleiss, Andreas, Grimm, Christoph
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	United States Elsevier Inc 01.04.2022
Predmet:	Cervical intraepithelial neoplasia CIN Conization Hematology, Oncology, and Palliative Medicine High-grade squamous intraepithelial lesion HPV HSIL Human papillomavirus Imiquimod Large loop excision of the transformation zone LLETZ Obstetrics and Gynecology Large loop excision of the transformation zone High-grade squamous intraepithelial lesion Conization Human papillomavirus Imiquimod Cervical intraepithelial neoplasia CIN LLETZ HPV HSIL
ISSN:	0090-8258, 1095-6859, 1095-6859
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Abstract	In a previous phase II trial, we showed that topical imiquimod (IMQ) therapy is an efficacious treatment for high-grade squamous intraepithelial lesion (HSIL). Aim of the present study was to investigate the non-inferiority of a 16-week topical, self-applied IMQ therapy compared to large loop excision of the transformation zone (LLETZ) in patients diagnosed with HSIL. Phase III randomized, controlled, multicenter, open trial performed by Austrian Gynecologic Oncology group. Patients with histologically proven cervical intraepithelial neoplasia (CIN)2 (30 years and older) or CIN3 (18 years and older) and satisfactory colposcopy were randomized to topical IMQ treatment or LLETZ. Successful treatment was defined as negative HPV high-risk test result 6 months after start of the treatment. Secondary endpoints were histological outcome and HPV clearance rates. Within 3 years 93 patients were randomized, received the allocated treatment and were available for ITT analysis. In the IMQ group negative HPV test at 6 months after treatment start was observed in 22/51 (43.1%) of patients compared to 27/42 (64.3%) in the LLETZ group on ITT analysis (rate difference 21.2%-points, 95% two-sided CI: 0.8 to 39.1). In the IMQ group histologic regression 6 months after treatment was observed in 32/51 (63%) of patients and complete histologic remission was observed in 19/51 (37%) of patients. Complete surgical resection was observed in 84% after LLETZ. In women with HSIL, IMQ treatment results in lower HPV clearance rates when compared to LLETZ. LLETZ remains the standard for women with HSIL when treatment is required. Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT01283763, EudraCT number: 2012-004518-32. •The study compared local Imiquimod therapy to LLETZ in patients diagnosed with HSIL.•HPV clearance was observed in 43% and 64% after Imiquimod and LLETZ, respectively.•LLETZ remains the standard therapy for women with HSIL when treatment is required.
AbstractList	In a previous phase II trial, we showed that topical imiquimod (IMQ) therapy is an efficacious treatment for high-grade squamous intraepithelial lesion (HSIL). Aim of the present study was to investigate the non-inferiority of a 16-week topical, self-applied IMQ therapy compared to large loop excision of the transformation zone (LLETZ) in patients diagnosed with HSIL. Phase III randomized, controlled, multicenter, open trial performed by Austrian Gynecologic Oncology group. Patients with histologically proven cervical intraepithelial neoplasia (CIN)2 (30 years and older) or CIN3 (18 years and older) and satisfactory colposcopy were randomized to topical IMQ treatment or LLETZ. Successful treatment was defined as negative HPV high-risk test result 6 months after start of the treatment. Secondary endpoints were histological outcome and HPV clearance rates. Within 3 years 93 patients were randomized, received the allocated treatment and were available for ITT analysis. In the IMQ group negative HPV test at 6 months after treatment start was observed in 22/51 (43.1%) of patients compared to 27/42 (64.3%) in the LLETZ group on ITT analysis (rate difference 21.2%-points, 95% two-sided CI: 0.8 to 39.1). In the IMQ group histologic regression 6 months after treatment was observed in 32/51 (63%) of patients and complete histologic remission was observed in 19/51 (37%) of patients. Complete surgical resection was observed in 84% after LLETZ. In women with HSIL, IMQ treatment results in lower HPV clearance rates when compared to LLETZ. LLETZ remains the standard for women with HSIL when treatment is required. Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT01283763, EudraCT number: 2012-004518-32. •The study compared local Imiquimod therapy to LLETZ in patients diagnosed with HSIL.•HPV clearance was observed in 43% and 64% after Imiquimod and LLETZ, respectively.•LLETZ remains the standard therapy for women with HSIL when treatment is required. AbstractObjectiveIn a previous phase II trial, we showed that topical imiquimod (IMQ) therapy is an efficacious treatment for high-grade squamous intraepithelial lesion (HSIL). Aim of the present study was to investigate the non-inferiority of a 16-week topical, self-applied IMQ therapy compared to large loop excision of the transformation zone (LLETZ) in patients diagnosed with HSIL. MethodsPhase III randomized, controlled, multicenter, open trial performed by Austrian Gynecologic Oncology group. Patients with histologically proven cervical intraepithelial neoplasia (CIN)2 (30 years and older) or CIN3 (18 years and older) and satisfactory colposcopy were randomized to topical IMQ treatment or LLETZ. Successful treatment was defined as negative HPV high-risk test result 6 months after start of the treatment. Secondary endpoints were histological outcome and HPV clearance rates. ResultsWithin 3 years 93 patients were randomized, received the allocated treatment and were available for ITT analysis. In the IMQ group negative HPV test at 6 months after treatment start was observed in 22/51 (43.1%) of patients compared to 27/42 (64.3%) in the LLETZ group on ITT analysis (rate difference 21.2%-points, 95% two-sided CI: 0.8 to 39.1). In the IMQ group histologic regression 6 months after treatment was observed in 32/51 (63%) of patients and complete histologic remission was observed in 19/51 (37%) of patients. Complete surgical resection was observed in 84% after LLETZ. ConclusionIn women with HSIL, IMQ treatment results in lower HPV clearance rates when compared to LLETZ. LLETZ remains the standard for women with HSIL when treatment is required. Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT01283763, EudraCT number: 2012-004518-32. In a previous phase II trial, we showed that topical imiquimod (IMQ) therapy is an efficacious treatment for high-grade squamous intraepithelial lesion (HSIL). Aim of the present study was to investigate the non-inferiority of a 16-week topical, self-applied IMQ therapy compared to large loop excision of the transformation zone (LLETZ) in patients diagnosed with HSIL. Phase III randomized, controlled, multicenter, open trial performed by Austrian Gynecologic Oncology group. Patients with histologically proven cervical intraepithelial neoplasia (CIN)2 (30 years and older) or CIN3 (18 years and older) and satisfactory colposcopy were randomized to topical IMQ treatment or LLETZ. Successful treatment was defined as negative HPV high-risk test result 6 months after start of the treatment. Secondary endpoints were histological outcome and HPV clearance rates. Within 3 years 93 patients were randomized, received the allocated treatment and were available for ITT analysis. In the IMQ group negative HPV test at 6 months after treatment start was observed in 22/51 (43.1%) of patients compared to 27/42 (64.3%) in the LLETZ group on ITT analysis (rate difference 21.2%-points, 95% two-sided CI: 0.8 to 39.1). In the IMQ group histologic regression 6 months after treatment was observed in 32/51 (63%) of patients and complete histologic remission was observed in 19/51 (37%) of patients. Complete surgical resection was observed in 84% after LLETZ. In women with HSIL, IMQ treatment results in lower HPV clearance rates when compared to LLETZ. LLETZ remains the standard for women with HSIL when treatment is required. ClinicalTrials.gov Identifier: NCT01283763, EudraCT number: 2012-004518-32. In a previous phase II trial, we showed that topical imiquimod (IMQ) therapy is an efficacious treatment for high-grade squamous intraepithelial lesion (HSIL). Aim of the present study was to investigate the non-inferiority of a 16-week topical, self-applied IMQ therapy compared to large loop excision of the transformation zone (LLETZ) in patients diagnosed with HSIL.OBJECTIVEIn a previous phase II trial, we showed that topical imiquimod (IMQ) therapy is an efficacious treatment for high-grade squamous intraepithelial lesion (HSIL). Aim of the present study was to investigate the non-inferiority of a 16-week topical, self-applied IMQ therapy compared to large loop excision of the transformation zone (LLETZ) in patients diagnosed with HSIL.Phase III randomized, controlled, multicenter, open trial performed by Austrian Gynecologic Oncology group. Patients with histologically proven cervical intraepithelial neoplasia (CIN)2 (30 years and older) or CIN3 (18 years and older) and satisfactory colposcopy were randomized to topical IMQ treatment or LLETZ. Successful treatment was defined as negative HPV high-risk test result 6 months after start of the treatment. Secondary endpoints were histological outcome and HPV clearance rates.METHODSPhase III randomized, controlled, multicenter, open trial performed by Austrian Gynecologic Oncology group. Patients with histologically proven cervical intraepithelial neoplasia (CIN)2 (30 years and older) or CIN3 (18 years and older) and satisfactory colposcopy were randomized to topical IMQ treatment or LLETZ. Successful treatment was defined as negative HPV high-risk test result 6 months after start of the treatment. Secondary endpoints were histological outcome and HPV clearance rates.Within 3 years 93 patients were randomized, received the allocated treatment and were available for ITT analysis. In the IMQ group negative HPV test at 6 months after treatment start was observed in 22/51 (43.1%) of patients compared to 27/42 (64.3%) in the LLETZ group on ITT analysis (rate difference 21.2%-points, 95% two-sided CI: 0.8 to 39.1). In the IMQ group histologic regression 6 months after treatment was observed in 32/51 (63%) of patients and complete histologic remission was observed in 19/51 (37%) of patients. Complete surgical resection was observed in 84% after LLETZ.RESULTSWithin 3 years 93 patients were randomized, received the allocated treatment and were available for ITT analysis. In the IMQ group negative HPV test at 6 months after treatment start was observed in 22/51 (43.1%) of patients compared to 27/42 (64.3%) in the LLETZ group on ITT analysis (rate difference 21.2%-points, 95% two-sided CI: 0.8 to 39.1). In the IMQ group histologic regression 6 months after treatment was observed in 32/51 (63%) of patients and complete histologic remission was observed in 19/51 (37%) of patients. Complete surgical resection was observed in 84% after LLETZ.In women with HSIL, IMQ treatment results in lower HPV clearance rates when compared to LLETZ. LLETZ remains the standard for women with HSIL when treatment is required.CONCLUSIONIn women with HSIL, IMQ treatment results in lower HPV clearance rates when compared to LLETZ. LLETZ remains the standard for women with HSIL when treatment is required.ClinicalTrials.gov Identifier: NCT01283763, EudraCT number: 2012-004518-32.CLINICAL TRIAL REGISTRATIONClinicalTrials.gov Identifier: NCT01283763, EudraCT number: 2012-004518-32.
Author	Bogner, Gerhard Heinze, Georg Gleiss, Andreas Ciresa-Koenig, Alexandra Reinthaller, Alexander Hadjari, Laudia Joura, Elmar Aberle, Stephan W. Langthaler, Eva Grimm, Christoph Trutnovsky, Gerda Reich, Olaf Berger, Regina Ganhoer-Schimboeck, Julia Boehm, Ina Polterauer, Stephan Widschwendter, Andreas
Author_xml	– sequence: 1 givenname: Stephan surname: Polterauer fullname: Polterauer, Stephan email: stephan.polterauer@meduniwien.ac.at organization: Department of Obstetrics and Gynecology, Division General Gynecology and Gynecologic Oncology, Medical University of Vienna, Vienna, Austria – sequence: 2 givenname: Olaf surname: Reich fullname: Reich, Olaf organization: Department of Obstetrics & Gynecology, Medical University of Graz, Austria – sequence: 3 givenname: Andreas surname: Widschwendter fullname: Widschwendter, Andreas organization: Department of Obstetrics and Gynaecology, Medical University of Innsbruck, Innsbruck, Austria – sequence: 4 givenname: Laudia surname: Hadjari fullname: Hadjari, Laudia organization: Department of Gynecology, Ordensklinikum Linz, Linz, Austria – sequence: 5 givenname: Gerhard surname: Bogner fullname: Bogner, Gerhard organization: Department of Obstetrics and Gynecology (OB/GYN), Paracelsus Medical University, Muellner Hauptstr. 48, A-5020 Salzburg, Austria – sequence: 6 givenname: Alexander surname: Reinthaller fullname: Reinthaller, Alexander organization: Department of Obstetrics and Gynecology, Division General Gynecology and Gynecologic Oncology, Medical University of Vienna, Vienna, Austria – sequence: 7 givenname: Elmar surname: Joura fullname: Joura, Elmar organization: Department of Obstetrics and Gynecology, Division General Gynecology and Gynecologic Oncology, Medical University of Vienna, Vienna, Austria – sequence: 8 givenname: Gerda surname: Trutnovsky fullname: Trutnovsky, Gerda organization: Department of Obstetrics & Gynecology, Medical University of Graz, Austria – sequence: 9 givenname: Alexandra surname: Ciresa-Koenig fullname: Ciresa-Koenig, Alexandra organization: Department of Obstetrics and Gynaecology, Medical University of Innsbruck, Innsbruck, Austria – sequence: 10 givenname: Julia surname: Ganhoer-Schimboeck fullname: Ganhoer-Schimboeck, Julia organization: Department of Gynecology, Ordensklinikum Linz, Linz, Austria – sequence: 11 givenname: Ina surname: Boehm fullname: Boehm, Ina organization: Department of Obstetrics and Gynecology (OB/GYN), Paracelsus Medical University, Muellner Hauptstr. 48, A-5020 Salzburg, Austria – sequence: 12 givenname: Regina surname: Berger fullname: Berger, Regina organization: Department of Obstetrics and Gynaecology, Medical University of Innsbruck, Innsbruck, Austria – sequence: 13 givenname: Eva surname: Langthaler fullname: Langthaler, Eva organization: Department of Pathology, Medical University of Vienna, Vienna, Austria – sequence: 14 givenname: Stephan W. surname: Aberle fullname: Aberle, Stephan W. organization: Center for Virology, Medical University of Vienna, Vienna, Austria – sequence: 15 givenname: Georg surname: Heinze fullname: Heinze, Georg organization: Section for Clinical Biometrics, Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, 1090 Vienna, Austria – sequence: 16 givenname: Andreas surname: Gleiss fullname: Gleiss, Andreas organization: Section for Clinical Biometrics, Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna, 1090 Vienna, Austria – sequence: 17 givenname: Christoph surname: Grimm fullname: Grimm, Christoph organization: Department of Obstetrics and Gynecology, Division General Gynecology and Gynecologic Oncology, Medical University of Vienna, Vienna, Austria
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Keywords	Large loop excision of the transformation zone High-grade squamous intraepithelial lesion Conization Human papillomavirus Imiquimod Cervical intraepithelial neoplasia CIN LLETZ HPV HSIL
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Snippet	In a previous phase II trial, we showed that topical imiquimod (IMQ) therapy is an efficacious treatment for high-grade squamous intraepithelial lesion (HSIL).... AbstractObjectiveIn a previous phase II trial, we showed that topical imiquimod (IMQ) therapy is an efficacious treatment for high-grade squamous...
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SubjectTerms	Cervical intraepithelial neoplasia CIN Conization Hematology, Oncology, and Palliative Medicine High-grade squamous intraepithelial lesion HPV HSIL Human papillomavirus Imiquimod Large loop excision of the transformation zone LLETZ Obstetrics and Gynecology
Title	Topical imiquimod compared with conization to treat cervical high-grade squamous intraepithelial lesions: Multicenter, randomized controlled trial
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