APL-1702 For Cervical HSIL: Post-Hoc Analysis of Long-Term Recurrence in a Global Multicenter Phase III Trial

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. 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). 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%). 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.

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Publication Details

Journal
Photodiagnosis and Photodynamic Therapy
Published
2025-11-01
DOI
https://doi.org/10.1016/j.pdpdt.2025.105157
Primary Topic
Cervical Cancer and HPV Research
Type
article
Field-Weighted Citation Impact
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article

APL-1702 For Cervical HSIL: Post-Hoc Analysis of Long-Term Recurrence in a Global Multicenter Phase III Trial

Chun Zhang, Jingxin Cheng, Qi Zhou, Chenran Wang et al.
Photodiagnosis and Photodynamic Therapy
Cervical Cancer and HPV Research
article

APL-1702 For Cervical HSIL: Post-Hoc Analysis of Long-Term Recurrence in a Global Multicenter Phase III Trial

Chun Zhang, Jingxin Cheng, Qi Zhou, Chenran Wang, Limin Feng, Yuan Wang, Tianhua Qin, Fei Chen, Feng Wang, Chunlin Chen, Yi Chen, T. Lin, Hongqin Zhao, Eileen He
article en

Abstract

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. 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). 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%). 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.

Photodiagnosis and Photodynamic TherapyVol. 56
Sun Yat-sen University (CN), Chongqing University (CN), Wenzhou Medical University (CN), Peking Union Medical College Hospital (CN), First Affiliated Hospital of Wenzhou Medical University (CN), Beijing Tian Tan Hospital (CN), Maternal and Child Health Hospital of Xinjiang Uygur Autonomous Region (CN), Nanfang Hospital (CN), First People's Hospital of Foshan (CN), Fifth Affiliated Hospital of Sun Yat-sen University (CN), Wuxi Fourth People's Hospital (CN), Shanghai East Hospital (CN), Central Hospital of Wuhan (CN), Chongqing Cancer Hospital (CN), Tris Pharma (United States) (US)
Openalex Percentile: Top 54%
Cervical Cancer and HPV Research
DOIOpen Access PDFOpenAlex
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