Reproductive medicine and biology · 2025
A Multicenter Phase II Study on Photodynamic Therapy Using Talaporfin Sodium (ME2906) and a Semiconductor Laser (PNL6405CIN) for Intraepithelial Tumors of the Cervix.
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Murakami Hirotake, Sakamoto Masaru, Kato Hisamori, Miyake Kiyohiko, Umayahara Kenji, Itoh Toshiya, Matsuya Madoka, Shibata Toshiaki, Uchida Toshiyuki, Abe Masakazu, Kotani Tomomi, Itoh Hiroaki, Kanayama Naohiro
Аннотация
PURPOSE: Conization for high-grade cervical intraepithelial neoplasia (CIN2-3) often harms obstetric outcomes. Photodynamic therapy (PDT) with talaporfin sodium provides a cervix-sparing alternative with short photosensitivity. We investigated the efficacy and safety of talaporfin-PDT for CIN2-3.
METHODS: We conducted a prospective, multicenter, single-arm phase II trial (jRCT2041190087) in women ≥ 20 years with biopsy-proven CIN2-3. Patients received talaporfin sodium (40 mg/m2) and 664-nm 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.
RESULTS: Of 88 enrolled, 79 were treated and 77 (CIN2 = 7; CIN3 = 70; median age 32 years; 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-risk HPV clearance occurred in 82.4%. One recurrence (1.3%) was observed. No serious adverse events occurred; four grade ≥ 3 events resolved. Cervical length was preserved. Eleven pregnancies occurred, yielding eight full-term deliveries.
CONCLUSIONS: Talaporfin-PDT showed excellent efficacy, safety, and fertility preservation in CIN2-3, supporting its potential as a non-excisional alternative.
TRIAL REGISTRATION: This study was registered in the Japan Registry of Clinical Trials (jRCT) under the identifier jRCT2041190087.
METHODS: We conducted a prospective, multicenter, single-arm phase II trial (jRCT2041190087) in women ≥ 20 years with biopsy-proven CIN2-3. Patients received talaporfin sodium (40 mg/m2) and 664-nm 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.
RESULTS: Of 88 enrolled, 79 were treated and 77 (CIN2 = 7; CIN3 = 70; median age 32 years; 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-risk HPV clearance occurred in 82.4%. One recurrence (1.3%) was observed. No serious adverse events occurred; four grade ≥ 3 events resolved. Cervical length was preserved. Eleven pregnancies occurred, yielding eight full-term deliveries.
CONCLUSIONS: Talaporfin-PDT showed excellent efficacy, safety, and fertility preservation in CIN2-3, supporting its potential as a non-excisional alternative.
TRIAL REGISTRATION: This study was registered in the Japan Registry of Clinical Trials (jRCT) under the identifier jRCT2041190087.