Photodiagnosis and photodynamic therapy · 2026
Intravesical hematoporphyrin photodynamic therapy combined with pirarubicin for intermediate and high-risk non-muscle-invasive bladder cancer: A multicenter, prospective single-arm cohort.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Li Haitao, Long Gongwei, Hu Linjun, Wang Qingbin, Cao Zhihong, Xie Chengming, Xing Sijia, Liang Hao, Wang Wenlong, Wu Yuan, Jiao Wen, Tian Jun
Аннотация
INTRODUCTION: Photodynamic therapy (PDT) has been investigated as an alternative treatment modality for non-muscle-invasive bladder cancer (NMIBC); however, its clinical application has been limited due to lack of high-quality evidence. We conducted a multicenter prospective cohort study to evaluate the efficacy and safety of combining PDT with intravesical chemotherapy in the management of NMIBC.
PATIENTS AND METHODS: This multicenter, prospective, single-arm cohort study (registered with the Chinese Clinical Trial Registry; ChiCTR2100046736) enrolled patients with intermediate- and high-risk NMIBC. Following transurethral resection of bladder tumor (TURBT), eligible patients received intravesical instillation of hematoporphyrin derivative for PDT, with light energy delivered at 16.8-20 J/cm². Subsequently, standard intravesical pirarubicin chemotherapy was administered. Cystoscopy, with biopsies when necessary, was performed every three months to monitor tumor recurrence and progression. The primary endpoints included 12-month recurrence and progression rates, with adverse events documented and classified according to the Clavien-Dindo system.
RESULTS: Between May 2021 and October 2024, 135 patients were enrolled from 4 institutions, with 132 patients included in the final analysis. The cohort comprised patients with high-risk features: over 50% had T1 (40.9%) or carcinoma in situ (Tis; 13.6%) lesions; 68.2% were identified as high grade, and 71.2% were classified as high risk per European Association of Urology (EAU) criteria. Based on the European Organization for Research and Treatment of Cancer (EORTC) risk table, the 12-month recurrence rate following combination therapy was 9.1% (3/33) in the lower-risk subgroup (scores 1-4), 29.5% (26/88) in the intermediate-risk subgroup (scores 5-9), and 54.5% (6/11) in the higher-risk subgroup (scores ≥10). These rates were significantly lower than those reported in historical EORTC cohorts (24.0% [95% CI: 21.0-26.0], 38.0% [35.0-41.0], and 61.0% [55.0-67.0], respectively). The 12-month progression rates were 0% (0/43) in the lower-risk subgroup (scores 0-6), 3.2% (2/62) in the intermediate-risk subgroup (scores 7-13), and 14.8% (4/27) in the higher-risk subgroup (scores ≥14). The progression rate in patients with a progression score of 0-13 was notably lower than historical data. Adverse events occurred in 93 patients (70.5%). The most common were pollakiuria (29.5%), dysuria (25%), noninfectious cystitis (23.5%), and hematuria (22%). Most complications were transient and self-limited.
CONCLUSIONS: The combination of PDT and intravesical chemotherapy was associated with significantly reduced recurrence rates in selected NMIBC patients, with mild and transient complications. Further studies are warranted to definitively establish the role of PDT in the standard management of NMIBC.
PATIENTS AND METHODS: This multicenter, prospective, single-arm cohort study (registered with the Chinese Clinical Trial Registry; ChiCTR2100046736) enrolled patients with intermediate- and high-risk NMIBC. Following transurethral resection of bladder tumor (TURBT), eligible patients received intravesical instillation of hematoporphyrin derivative for PDT, with light energy delivered at 16.8-20 J/cm². Subsequently, standard intravesical pirarubicin chemotherapy was administered. Cystoscopy, with biopsies when necessary, was performed every three months to monitor tumor recurrence and progression. The primary endpoints included 12-month recurrence and progression rates, with adverse events documented and classified according to the Clavien-Dindo system.
RESULTS: Between May 2021 and October 2024, 135 patients were enrolled from 4 institutions, with 132 patients included in the final analysis. The cohort comprised patients with high-risk features: over 50% had T1 (40.9%) or carcinoma in situ (Tis; 13.6%) lesions; 68.2% were identified as high grade, and 71.2% were classified as high risk per European Association of Urology (EAU) criteria. Based on the European Organization for Research and Treatment of Cancer (EORTC) risk table, the 12-month recurrence rate following combination therapy was 9.1% (3/33) in the lower-risk subgroup (scores 1-4), 29.5% (26/88) in the intermediate-risk subgroup (scores 5-9), and 54.5% (6/11) in the higher-risk subgroup (scores ≥10). These rates were significantly lower than those reported in historical EORTC cohorts (24.0% [95% CI: 21.0-26.0], 38.0% [35.0-41.0], and 61.0% [55.0-67.0], respectively). The 12-month progression rates were 0% (0/43) in the lower-risk subgroup (scores 0-6), 3.2% (2/62) in the intermediate-risk subgroup (scores 7-13), and 14.8% (4/27) in the higher-risk subgroup (scores ≥14). The progression rate in patients with a progression score of 0-13 was notably lower than historical data. Adverse events occurred in 93 patients (70.5%). The most common were pollakiuria (29.5%), dysuria (25%), noninfectious cystitis (23.5%), and hematuria (22%). Most complications were transient and self-limited.
CONCLUSIONS: The combination of PDT and intravesical chemotherapy was associated with significantly reduced recurrence rates in selected NMIBC patients, with mild and transient complications. Further studies are warranted to definitively establish the role of PDT in the standard management of NMIBC.