Topical Imiquimod for the Treatment of High-Grade Squamous Intraepithelial Lesions of the Cervix: A Randomized Controlled Trial
To evaluate the histologic response rate of high-grade squamous intraepithelial lesions (HSIL) of the cervix after topical application of 5% imiquimod cream. In this phase II trial, women with cervical HSIL (cervical intraepithelial neoplasia [CIN] 2-3) were randomly assigned to 250 mg of 5% imiquim...
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Veröffentlicht in: | Obstetrics and gynecology (New York. 1953) 2021-06, Vol.137 (6), p.1043-1053 |
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creator | Fonseca, Bruno O. Possati-Resende, Júlio C. Salcedo, Mila P. Schmeler, Kathleen M. Accorsi, Guilherme S. Fregnani, José H. T. G. Antoniazzi, Marcio Pantano, Naitielle P. Santana, Iara V. V. Matsushita, Graziela M. dos Reis, Ricardo |
description | To evaluate the histologic response rate of high-grade squamous intraepithelial lesions (HSIL) of the cervix after topical application of 5% imiquimod cream.
In this phase II trial, women with cervical HSIL (cervical intraepithelial neoplasia [CIN] 2-3) were randomly assigned to 250 mg of 5% imiquimod cream applied to the cervix weekly for 12 weeks, followed by loop electrosurgical excision procedure (LEEP) without preceding treatment. The sample size was calculated based on the HSIL regression rates previously reported by Grimm et al. The primary outcome was rate of histologic regression (to CIN 1 or less) in LEEP specimens. Prespecified secondary endpoints included surgical margin status and adverse events. Outcomes were stratified by human papillomavirus type and lesion grade (CIN 2 or CIN 3). Results were reported according to per protocol (PP) and intention-to-treat (ITT) analyses.
Ninety women were enrolled: 49 in the experimental group and 41 in the control group. In the PP population, histologic regression was observed in 23 of 38 participants (61%) in the experimental group compared with 9 of 40 (23%) in the control group (P=.001). Surgical margins were negative for HSIL in 36 of 38 participants (95%) in the experimental group and 28 of 40 (70%) in the control group (P=.004). In the ITT population, rates of histologic regression also were significantly higher in the experimental group. Rates of adverse events in the experimental group were 74% (28/38) in the PP population and 78% (35/45) in the ITT population. Adverse events were mild, with abdominal pain being the most common. Three patients in the experimental group had grade 2 adverse events, including vaginal ulcer, vaginal pruritus with local edema, and moderate pelvic pain.
Weekly topical treatment with imiquimod is effective in promoting regression of cervical HSIL.
ClinicalTrials.gov, NCT03233412. |
doi_str_mv | 10.1097/AOG.0000000000004384 |
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In this phase II trial, women with cervical HSIL (cervical intraepithelial neoplasia [CIN] 2-3) were randomly assigned to 250 mg of 5% imiquimod cream applied to the cervix weekly for 12 weeks, followed by loop electrosurgical excision procedure (LEEP) without preceding treatment. The sample size was calculated based on the HSIL regression rates previously reported by Grimm et al. The primary outcome was rate of histologic regression (to CIN 1 or less) in LEEP specimens. Prespecified secondary endpoints included surgical margin status and adverse events. Outcomes were stratified by human papillomavirus type and lesion grade (CIN 2 or CIN 3). Results were reported according to per protocol (PP) and intention-to-treat (ITT) analyses.
Ninety women were enrolled: 49 in the experimental group and 41 in the control group. In the PP population, histologic regression was observed in 23 of 38 participants (61%) in the experimental group compared with 9 of 40 (23%) in the control group (P=.001). Surgical margins were negative for HSIL in 36 of 38 participants (95%) in the experimental group and 28 of 40 (70%) in the control group (P=.004). In the ITT population, rates of histologic regression also were significantly higher in the experimental group. Rates of adverse events in the experimental group were 74% (28/38) in the PP population and 78% (35/45) in the ITT population. Adverse events were mild, with abdominal pain being the most common. Three patients in the experimental group had grade 2 adverse events, including vaginal ulcer, vaginal pruritus with local edema, and moderate pelvic pain.
Weekly topical treatment with imiquimod is effective in promoting regression of cervical HSIL.
ClinicalTrials.gov, NCT03233412.</description><identifier>ISSN: 0029-7844</identifier><identifier>EISSN: 1873-233X</identifier><identifier>DOI: 10.1097/AOG.0000000000004384</identifier><identifier>PMID: 33957649</identifier><language>eng</language><publisher>United States: Lippincott Williams & Wilkins</publisher><subject>Contents ; Original Research</subject><ispartof>Obstetrics and gynecology (New York. 1953), 2021-06, Vol.137 (6), p.1043-1053</ispartof><rights>Lippincott Williams & Wilkins</rights><rights>Copyright © 2021 The Authors. Published by Wolters Kluwer Health, Inc.</rights><rights>2021 The Authors. Published by Wolters Kluwer Health, Inc. 2021</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4071-d9ab290fd10e7a792ae7513bba9ac767d6ce5dffab27ffe369743bcf659f65c53</citedby><cites>FETCH-LOGICAL-c4071-d9ab290fd10e7a792ae7513bba9ac767d6ce5dffab27ffe369743bcf659f65c53</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33957649$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Fonseca, Bruno O.</creatorcontrib><creatorcontrib>Possati-Resende, Júlio C.</creatorcontrib><creatorcontrib>Salcedo, Mila P.</creatorcontrib><creatorcontrib>Schmeler, Kathleen M.</creatorcontrib><creatorcontrib>Accorsi, Guilherme S.</creatorcontrib><creatorcontrib>Fregnani, José H. T. G.</creatorcontrib><creatorcontrib>Antoniazzi, Marcio</creatorcontrib><creatorcontrib>Pantano, Naitielle P.</creatorcontrib><creatorcontrib>Santana, Iara V. V.</creatorcontrib><creatorcontrib>Matsushita, Graziela M.</creatorcontrib><creatorcontrib>dos Reis, Ricardo</creatorcontrib><title>Topical Imiquimod for the Treatment of High-Grade Squamous Intraepithelial Lesions of the Cervix: A Randomized Controlled Trial</title><title>Obstetrics and gynecology (New York. 1953)</title><addtitle>Obstet Gynecol</addtitle><description>To evaluate the histologic response rate of high-grade squamous intraepithelial lesions (HSIL) of the cervix after topical application of 5% imiquimod cream.
In this phase II trial, women with cervical HSIL (cervical intraepithelial neoplasia [CIN] 2-3) were randomly assigned to 250 mg of 5% imiquimod cream applied to the cervix weekly for 12 weeks, followed by loop electrosurgical excision procedure (LEEP) without preceding treatment. The sample size was calculated based on the HSIL regression rates previously reported by Grimm et al. The primary outcome was rate of histologic regression (to CIN 1 or less) in LEEP specimens. Prespecified secondary endpoints included surgical margin status and adverse events. Outcomes were stratified by human papillomavirus type and lesion grade (CIN 2 or CIN 3). Results were reported according to per protocol (PP) and intention-to-treat (ITT) analyses.
Ninety women were enrolled: 49 in the experimental group and 41 in the control group. In the PP population, histologic regression was observed in 23 of 38 participants (61%) in the experimental group compared with 9 of 40 (23%) in the control group (P=.001). Surgical margins were negative for HSIL in 36 of 38 participants (95%) in the experimental group and 28 of 40 (70%) in the control group (P=.004). In the ITT population, rates of histologic regression also were significantly higher in the experimental group. Rates of adverse events in the experimental group were 74% (28/38) in the PP population and 78% (35/45) in the ITT population. Adverse events were mild, with abdominal pain being the most common. Three patients in the experimental group had grade 2 adverse events, including vaginal ulcer, vaginal pruritus with local edema, and moderate pelvic pain.
Weekly topical treatment with imiquimod is effective in promoting regression of cervical HSIL.
ClinicalTrials.gov, NCT03233412.</description><subject>Contents</subject><subject>Original Research</subject><issn>0029-7844</issn><issn>1873-233X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNpdkV9rFDEUxYModq1-A5E8-jI1_2ay8UFYlrpdWCjoCr6FzMxNJ5qZ7CYzrfriVzdja60GLsklv3NyyUHoJSVnlCj5ZnW5OSMPluBL8Qgt6FLygnH--TFaEMJUIZdCnKBnKX3JEK0Uf4pOOFelrIRaoJ_7cHCN8Xjbu-Pk-tBiGyIeO8D7CGbsYRhxsPjCXXXFJpoW8MfjZPowJbwdxmjg4DLsXbbYQXJhSDM-69cQr923t3iFP5ihDb37AS1ehywK3ufjPmbRc_TEGp_gxd1-ij69P9-vL4rd5Wa7Xu2KRhBJi1aZmiliW0pAGqmYAVlSXtdGmUZWsq0aKFtrMyWtBV4pKXjd2KpUuZqSn6J3t76Hqe6hbWCe3etDdL2J33UwTv97M7hOX4VrvaScKTobvL4ziOE4QRp171ID3psB8mdoVjLBK0HLGRW3aBNDShHs_TOU6Dk7nbPT_2eXZa8ejngv-hPWX9-b4EeI6aufbiDqDowfu99-FStJwQijpMpdMQdO-S97TKeq</recordid><startdate>20210601</startdate><enddate>20210601</enddate><creator>Fonseca, Bruno O.</creator><creator>Possati-Resende, Júlio C.</creator><creator>Salcedo, Mila P.</creator><creator>Schmeler, Kathleen M.</creator><creator>Accorsi, Guilherme S.</creator><creator>Fregnani, José H. T. G.</creator><creator>Antoniazzi, Marcio</creator><creator>Pantano, Naitielle P.</creator><creator>Santana, Iara V. V.</creator><creator>Matsushita, Graziela M.</creator><creator>dos Reis, Ricardo</creator><general>Lippincott Williams & Wilkins</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20210601</creationdate><title>Topical Imiquimod for the Treatment of High-Grade Squamous Intraepithelial Lesions of the Cervix: A Randomized Controlled Trial</title><author>Fonseca, Bruno O. ; Possati-Resende, Júlio C. ; Salcedo, Mila P. ; Schmeler, Kathleen M. ; Accorsi, Guilherme S. ; Fregnani, José H. T. G. ; Antoniazzi, Marcio ; Pantano, Naitielle P. ; Santana, Iara V. V. ; Matsushita, Graziela M. ; dos Reis, Ricardo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4071-d9ab290fd10e7a792ae7513bba9ac767d6ce5dffab27ffe369743bcf659f65c53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Contents</topic><topic>Original Research</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Fonseca, Bruno O.</creatorcontrib><creatorcontrib>Possati-Resende, Júlio C.</creatorcontrib><creatorcontrib>Salcedo, Mila P.</creatorcontrib><creatorcontrib>Schmeler, Kathleen M.</creatorcontrib><creatorcontrib>Accorsi, Guilherme S.</creatorcontrib><creatorcontrib>Fregnani, José H. T. G.</creatorcontrib><creatorcontrib>Antoniazzi, Marcio</creatorcontrib><creatorcontrib>Pantano, Naitielle P.</creatorcontrib><creatorcontrib>Santana, Iara V. V.</creatorcontrib><creatorcontrib>Matsushita, Graziela M.</creatorcontrib><creatorcontrib>dos Reis, Ricardo</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Obstetrics and gynecology (New York. 1953)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Fonseca, Bruno O.</au><au>Possati-Resende, Júlio C.</au><au>Salcedo, Mila P.</au><au>Schmeler, Kathleen M.</au><au>Accorsi, Guilherme S.</au><au>Fregnani, José H. T. G.</au><au>Antoniazzi, Marcio</au><au>Pantano, Naitielle P.</au><au>Santana, Iara V. V.</au><au>Matsushita, Graziela M.</au><au>dos Reis, Ricardo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Topical Imiquimod for the Treatment of High-Grade Squamous Intraepithelial Lesions of the Cervix: A Randomized Controlled Trial</atitle><jtitle>Obstetrics and gynecology (New York. 1953)</jtitle><addtitle>Obstet Gynecol</addtitle><date>2021-06-01</date><risdate>2021</risdate><volume>137</volume><issue>6</issue><spage>1043</spage><epage>1053</epage><pages>1043-1053</pages><issn>0029-7844</issn><eissn>1873-233X</eissn><abstract>To evaluate the histologic response rate of high-grade squamous intraepithelial lesions (HSIL) of the cervix after topical application of 5% imiquimod cream.
In this phase II trial, women with cervical HSIL (cervical intraepithelial neoplasia [CIN] 2-3) were randomly assigned to 250 mg of 5% imiquimod cream applied to the cervix weekly for 12 weeks, followed by loop electrosurgical excision procedure (LEEP) without preceding treatment. The sample size was calculated based on the HSIL regression rates previously reported by Grimm et al. The primary outcome was rate of histologic regression (to CIN 1 or less) in LEEP specimens. Prespecified secondary endpoints included surgical margin status and adverse events. Outcomes were stratified by human papillomavirus type and lesion grade (CIN 2 or CIN 3). Results were reported according to per protocol (PP) and intention-to-treat (ITT) analyses.
Ninety women were enrolled: 49 in the experimental group and 41 in the control group. In the PP population, histologic regression was observed in 23 of 38 participants (61%) in the experimental group compared with 9 of 40 (23%) in the control group (P=.001). Surgical margins were negative for HSIL in 36 of 38 participants (95%) in the experimental group and 28 of 40 (70%) in the control group (P=.004). In the ITT population, rates of histologic regression also were significantly higher in the experimental group. Rates of adverse events in the experimental group were 74% (28/38) in the PP population and 78% (35/45) in the ITT population. Adverse events were mild, with abdominal pain being the most common. Three patients in the experimental group had grade 2 adverse events, including vaginal ulcer, vaginal pruritus with local edema, and moderate pelvic pain.
Weekly topical treatment with imiquimod is effective in promoting regression of cervical HSIL.
ClinicalTrials.gov, NCT03233412.</abstract><cop>United States</cop><pub>Lippincott Williams & Wilkins</pub><pmid>33957649</pmid><doi>10.1097/AOG.0000000000004384</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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title | Topical Imiquimod for the Treatment of High-Grade Squamous Intraepithelial Lesions of the Cervix: A Randomized Controlled Trial |
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