Gynecological and obstetrical outcomes of phase I /II study of photodynamic therapy using talaporfin sodium (LaserphyrinR) and diode laser (L-PDT) for Cervical Intraepithelial Neoplasia.

We treated over 900 cases of CIN and cervical cancer with Photofrin-based PDT (P-PDT), known for its fertility-sparing potential. To assess L-PDT's safety and efficacy, we conducted a prospective Phase I/II study using a semiconductor laser and Laserphyrin, a compound with a shorter blood half-life. The study included 43 CIN2-3 cases, with Phase I optimizing laser dose (50, 75, 100 J/cm²), and Phase II evaluating efficacy and safety at 100 J/cm². Phase I showed tumor accumulation of Laserphyrin, with no dose-limiting toxicities. Minor side effects included lower abdominal pain and fever. Histological clearance was achieved in 95-98% of cases at 3 and 6 months, with no recurrences over a median 66.4 months follow-up. Fertility outcomes were positive, with a low preterm delivery rate. L-PDT demonstrated high efficacy, minimal side effects, and promising fertility outcomes, making it a viable option for uterine-preserving CIN treatment.