{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,17]],"date-time":"2026-04-17T04:17:48Z","timestamp":1776399468260,"version":"3.51.2"},"reference-count":28,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,11,30]],"date-time":"2025-11-30T00:00:00Z","timestamp":1764460800000},"content-version":"vor","delay-in-days":333,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,1,1]],"date-time":"2025-01-01T00:00:00Z","timestamp":1735689600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100004169","name":"Meiji Seika Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004169","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Reprod Medicine &amp; Biology"],"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Conization for high\u2010grade cervical intraepithelial neoplasia (CIN2\u20133) often harms obstetric outcomes. Photodynamic therapy (PDT) with talaporfin sodium provides a cervix\u2010sparing alternative with short photosensitivity. We investigated the efficacy and safety of talaporfin\u2010PDT for CIN2\u20133.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      We conducted a prospective, multicenter, single\u2010arm phase II trial (jRCT2041190087) in women \u2265\u200920\u2009years with biopsy\u2010proven CIN2\u20133. Patients received talaporfin sodium (40\u2009mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      ) and 664\u2010nm laser irradiation. Efficacy was evaluated by cytology\/histology from weeks 12 to 24; the primary endpoint was complete response (CR) versus an 85% threshold. Safety, HPV status, cervical length, and reproductive outcomes were monitored.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 88 enrolled, 79 were treated and 77 (CIN2\u2009=\u20097; CIN3\u2009=\u200970; median age 32\u2009years; 93.5% desiring future pregnancy) were evaluable. CR was achieved in all 77 (100%; lower 95% CI: 96.2%), including 95.8% in CIN3. High\u2010risk HPV clearance occurred in 82.4%. One recurrence (1.3%) was observed. No serious adverse events occurred; four grade \u2265\u20093 events resolved. Cervical length was preserved. Eleven pregnancies occurred, yielding eight full\u2010term deliveries.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Talaporfin\u2010PDT showed excellent efficacy, safety, and fertility preservation in CIN2\u20133, supporting its potential as a non\u2010excisional alternative.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>This study was registered in the Japan Registry of Clinical Trials (jRCT) under the identifier jRCT2041190087<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/rmb2.70001","type":"journal-article","created":{"date-parts":[[2025,11,30]],"date-time":"2025-11-30T12:10:08Z","timestamp":1764504608000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["A Multicenter Phase\n                    <scp>II<\/scp>\n                    Study on Photodynamic Therapy Using Talaporfin Sodium (\n                    <scp>ME2906<\/scp>\n                    ) and a Semiconductor Laser (\n                    <scp>PNL6405CIN<\/scp>\n                    ) for Intraepithelial Tumors of the Cervix"],"prefix":"10.1002","volume":"24","author":[{"given":"Hirotake","family":"Murakami","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynecology Hamamatsu University School of Medicine  Hamamatsu Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masaru","family":"Sakamoto","sequence":"additional","affiliation":[{"name":"Department of Gynecology Sasaki Foundation Kyoundo Hospital  Tokyo Japan"},{"name":"Department of Obstetrics and Gynecology The Jikei University School of Medicine  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hisamori","family":"Kato","sequence":"additional","affiliation":[{"name":"Department of Gynecology Kanagawa Preventive Medicine Association  Yokohama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kiyohiko","family":"Miyake","sequence":"additional","affiliation":[{"name":"Department of Gynecology Niizashiki Chuo General Hospital  Niiza Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenji","family":"Umayahara","sequence":"additional","affiliation":[{"name":"Department of Gynecology Sasaki Foundation Kyoundo Hospital  Tokyo Japan"},{"name":"Department of Obstetrics and Gynecology The Jikei University School of Medicine  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshiya","family":"Itoh","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Hamamatsu University School of Medicine  Hamamatsu Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Madoka","family":"Matsuya","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Hamamatsu University School of Medicine  Hamamatsu Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshiaki","family":"Shibata","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Hamamatsu University School of Medicine  Hamamatsu Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshiyuki","family":"Uchida","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Hamamatsu University School of Medicine  Hamamatsu Japan"},{"name":"Department of Nursing, Faculty of Health Science Tokoha University  Shizuoka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masakazu","family":"Abe","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Hamamatsu University School of Medicine  Hamamatsu Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomomi","family":"Kotani","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Hamamatsu University School of Medicine  Hamamatsu Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroaki","family":"Itoh","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Hamamatsu University School of Medicine  Hamamatsu Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naohiro","family":"Kanayama","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Hamamatsu University School of Medicine  Hamamatsu Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,11,30]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1917338"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(06)68181-6"},{"key":"e_1_2_12_4_1","article-title":"Fertility and Early Pregnancy Outcomes After Treatment for Cervical Intraepithelial Neoplasia: Systematic Review and Meta\u2010Analysis","volume":"349","author":"Kyrgiou M.","year":"2014","journal-title":"BMJ (Clinical Research Ed.)"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/IGC.0b013e3181f16c5f"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1080\/14767058.2019.1619687"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2024.45871"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41390-024-03346-6"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-021-99185-0"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2022.12.316"},{"issue":"11","key":"e_1_2_12_11_1","article-title":"Obstetric Outcomes After Conservative Treatment for Cervical Intraepithelial Lesions and Early Invasive Disease","volume":"11","author":"Kyrgiou M.","year":"2017","journal-title":"Cochrane Database of Systematic Reviews"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0169-5002(03)00242-3"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.18632\/oncotarget.14029"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.3171\/2013.7.JNS13415"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1155\/DTE.5.183"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1093\/jjco\/hyz001"},{"key":"e_1_2_12_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.gore.2024.101405"},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.3802\/jgo.2018.29.e46"},{"key":"e_1_2_12_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10147-003-0354-4"},{"key":"e_1_2_12_20_1","doi-asserted-by":"publisher","DOI":"10.1159\/000087812"},{"key":"e_1_2_12_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(98)24019-0"},{"key":"e_1_2_12_22_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1751-1097.2011.01060.x"},{"key":"e_1_2_12_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/lsm.10111"},{"key":"e_1_2_12_24_1","doi-asserted-by":"publisher","DOI":"10.3390\/ph12030107"},{"key":"e_1_2_12_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pdpdt.2010.06.005"},{"key":"e_1_2_12_26_1","doi-asserted-by":"publisher","DOI":"10.1111\/jog.13113"},{"issue":"2","key":"e_1_2_12_27_1","first-page":"1785","article-title":"Cold\u2010Knife Conization Versus Photodynamic Therapy With Topical 5\u2010Aminolevulinic Acid (5\u2010ALA) in Cervical Intraepithelial Neoplasia (CIN) II With Associated Human Papillomavirus Infection: A Comparison of Preliminary Results","volume":"23","author":"Bodner K.","year":"2003","journal-title":"Anticancer Research"},{"key":"e_1_2_12_28_1","doi-asserted-by":"publisher","DOI":"10.1002\/lsm.20686"},{"key":"e_1_2_12_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinsp.2024.100537"}],"container-title":["Reproductive Medicine and Biology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/rmb2.70001","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/rmb2.70001","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/rmb2.70001","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,28]],"date-time":"2026-01-28T08:55:41Z","timestamp":1769590541000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/rmb2.70001"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,1]]},"references-count":28,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2025,1]]}},"alternative-id":["10.1002\/rmb2.70001"],"URL":"https:\/\/doi.org\/10.1002\/rmb2.70001","archive":["Portico"],"relation":{},"ISSN":["1445-5781","1447-0578"],"issn-type":[{"value":"1445-5781","type":"print"},{"value":"1447-0578","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,1]]},"assertion":[{"value":"2025-10-02","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-21","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-30","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70001"}}