Diabetes and Performance Status Predict Severe, Persistent Radiation Proctitis: Long-Term Endoscopic Findings From STELLAR Trial
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 74 participants or records.
Read the paper
Related studies
- Preliminary Toxicity Analysis of 3DCRT versus IMRT on the High Dose Arm of the RTOG 0126 Prostate Cancer Trial
- Adaptive Radiotherapy for Head and Neck Cancer: Initial Clinical Outcomes from a Prospective Trial
- American Association of Physicists in Medicine Task Group 263: Standardizing Nomenclatures in Radiation Oncology
- Motion Management Strategies and Technical Issues Associated with Stereotactic Body Radiotherapy of Thoracic and Upper Abdominal Tumors: A Review from NRG Oncology
- High-dose-rate interstitial brachytherapy as a monotherapy for localized prostate cancer: treatment description and preliminary results of a phase I/II clinical trial
- Highly efficient training, refinement, and validation of a knowledge-based plan quality control system for radiotherapy clinical trials
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.