International journal of radiation oncology, biology, physics · 2026
Diabetes and Performance Status Predict Severe, Persistent Radiation Proctitis: Long-Term Endoscopic Findings From STELLAR Trial.
Клиническое исследование III фазыСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Wang Ningyu, Xu Tongzhen, Li Haoyue, Shuai Jiacheng, Ma Huiying, Fang Hui, Song Yongwen, Chen Bo, Lu Ningning, Jing Hao, Liu Xin, Qi Shunan, Zhang Wenwen, Liu Yueping, Li Yexiong, Wang Shulian, Dou Lizhou, Jin Jing, Tang Yuan
Аннотация
PURPOSE: To characterize the long-term endoscopic natural history of chronic radiation proctitis (CRP) and identify predictors of severe lesions in patients with locally advanced rectal cancer from the STELLAR study (NCT02533271) .
METHODS AND MATERIALS: This secondary analysis included 74 patients with locally advanced rectal cancer undergoing anal-preserving surgery after neoadjuvant therapy (39: short-course radiation therapy/total neoadjuvant therapy [TNT] and 35: long-course chemoradiation therapy [CRT]). Systematic endoscopic follow-up (>2 years) was performed, with mucosal damage graded by the Vienna Rectoscopy Score (VRS). Multivariate analyses identified factors for severe (VRS ≥3) and persistent severe CRP.
RESULTS: The incidence of VRS ≥3 CRP was 33.3% (TNT) versus 20.0% (CRT) (P = .197). Endoscopic severity peaked at 2 years after radiation. A distinct recovery trend was observed in the TNT group, but not in the CRT group. Diabetes mellitus was an independent risk factor for both severe CRP (hazard ratio [HR], 5.46; 95% CI, 1.25-23.89; P = .024) and persistent severe CRP (HR, 6.09; 95% CI, 1.23-30.23; P = .027). Eastern Cooperative Oncology Group performance status 1 predicted persistent severe CRP (HR, 8.81; 95% CI, 1.50-51.68; P = .016).
DISCUSSION: Hypofractionated radiation therapy (TNT) did not increase severe CRP risk and showed a favorable recovery pattern. Diabetes and reduced performance status are strong, independent predictors of severe and persistent endoscopic injury, enabling risk-stratified patient management. These findings support tailored surveillance and preventive strategies for high-risk individuals.
METHODS AND MATERIALS: This secondary analysis included 74 patients with locally advanced rectal cancer undergoing anal-preserving surgery after neoadjuvant therapy (39: short-course radiation therapy/total neoadjuvant therapy [TNT] and 35: long-course chemoradiation therapy [CRT]). Systematic endoscopic follow-up (>2 years) was performed, with mucosal damage graded by the Vienna Rectoscopy Score (VRS). Multivariate analyses identified factors for severe (VRS ≥3) and persistent severe CRP.
RESULTS: The incidence of VRS ≥3 CRP was 33.3% (TNT) versus 20.0% (CRT) (P = .197). Endoscopic severity peaked at 2 years after radiation. A distinct recovery trend was observed in the TNT group, but not in the CRT group. Diabetes mellitus was an independent risk factor for both severe CRP (hazard ratio [HR], 5.46; 95% CI, 1.25-23.89; P = .024) and persistent severe CRP (HR, 6.09; 95% CI, 1.23-30.23; P = .027). Eastern Cooperative Oncology Group performance status 1 predicted persistent severe CRP (HR, 8.81; 95% CI, 1.50-51.68; P = .016).
DISCUSSION: Hypofractionated radiation therapy (TNT) did not increase severe CRP risk and showed a favorable recovery pattern. Diabetes and reduced performance status are strong, independent predictors of severe and persistent endoscopic injury, enabling risk-stratified patient management. These findings support tailored surveillance and preventive strategies for high-risk individuals.