APL-1702 For Cervical HSIL: Post-Hoc Analysis of Long-Term Recurrence in a Global Multicenter Phase III Trial
Year: 2025
Type: conference-abstract
Abstract: Significance Cervical high-grade squamous intraepithelial lesion (HSIL), a high-risk HPV-driven precancerous condition, has a 12-month postoperative recurrence rate of 26%. APL-1702, an innovative photodynamic therapy (PDT) combining hexyl aminolevulinate (5% HAL HCl) and LED light, provides a non-surgical treatment alternative. Approach In this randomized, double-blind, international multicenter trial, 402 patients (2:1 randomization) received 1-2 treatments of APL-1702 or placebo within 6 months. HSIL 12-month recurrence was assessed through: response recurrence (12-month non-responders among 6-month responders) and histologic regression recurrence (12-month HSIL recurrence among 6-month histologic regression cases). Results Among the patients who completed 12-month follow-up without missing data, in the APL-1702 group, the response recurrence rate: 13.8% (CIN2: 17.1%; CIN3: 8.3%); the histologic regression recurrence rate: 13.2% (CIN2: 14.6%; CIN3: 10.7%). Conclusions APL-1702 demonstrated lower 12-month recurrence rates, particularly in CIN3, supporting its potential as a non-surgical option with low-recurrence risk for HSIL patients.
Authors: Fei Chen, Tiecheng Lin, Jingxin Cheng, Hongqin Zhao, Tianhua Qin, Feng Wang, Limin Feng, Qi Zhou, Yuan Wang, Chun Zhang, Chunlin Chen, Eileen He, Yilei Chen, Chenran Wang
Institutions: Peking Union Medical College Hospital, Shanghai Drug Administration, First People's Hospital of Foshan, Shanghai East Hospital, First Affiliated Hospital of Wenzhou Medical University, Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region, Sun Yat-sen University, Fifth Affiliated Hospital of Sun Yat-sen University, Capital Medical University, Beijing Tian Tan Hospital, Chongqing University, Chongqing Cancer Hospital, Wuxi Fourth People's Hospital, Central Hospital of Wuhan, Nanfang Hospital
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,610
OpenAlex ID: W4416391483
Cites:
Cited by:
Related to: