Photodynamic therapy for high-grade squamous intraepithelial lesions: A randomized controlled trial

Area of Science:

• Gynecology
• Oncology
• Dermatology

Background:

• Cervical high-grade squamous intraepithelial lesions (HSILs) are typically treated with ablative/excisional surgery.
• Current surgical methods carry risks of cervical damage and complications in future pregnancies.
• There is a need for less invasive and safer treatment options for cervical HSILs.

Purpose of the Study:

• To evaluate the efficacy and safety of APL-1702, a novel topical treatment for cervical HSILs.
• To compare APL-1702 with placebo in a randomized controlled trial setting.
• To assess treatment response, defined by histological improvement and human papillomavirus (HPV) clearance.

Main Methods:

• A multicenter, randomized, controlled trial involving adult women with cervical HSILs.
• Participants received either APL-1702 (hexaminolevulinate ointment) or a placebo, followed by photoactivation.
• The primary endpoint was treatment response at 6 months, including normal histology or LSIL with HPV clearance.

Main Results:

• The 6-month response rate was significantly higher in the APL-1702 group (41.1%) compared to placebo (21.7%).
• APL-1702 demonstrated higher HPV16/18 clearance rates (31.4%) versus placebo (15.4%).
• Treatment-emergent adverse events were comparable between the APL-1702 and placebo groups.

Conclusions:

• APL-1702 significantly improved treatment response rates for cervical HSILs compared to placebo.
• The treatment exhibited a favorable safety profile, suggesting it as a viable alternative to surgery.
• A significant proportion of responders maintained their response during the extension phase.