Department of Radiation Oncology, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.
Clinical Research Secretariat, Tata Memorial Hospital and Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Homi Bhabha National Institute (HBNI), Mumbai, India.
Int J Radiat Oncol Biol Phys. 2024 Oct 1;120(2):537-543. doi: 10.1016/j.ijrobp.2024.03.023. Epub 2024 Mar 28.
The POP-RT phase 3 randomized trial showed improved biochemical failure-free survival and metastasis-free survival with whole pelvic radiation therapy versus prostate-only radiation therapy for high and very high-risk prostate cancer, albeit with worse RTOG late urinary toxicity. We report updated late urinary adverse effects and bladder dose-effect relations within this trial.
Late urinary toxicity and the cumulative severity of each symptom during the follow-up period were graded using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Bladder dosimetry in 5-Gy increments (V5, V10, V15, V65, V68Gy) in the approved radiation therapy plans was compared with urinary symptoms and overall grade 2+ toxicity. Potential factors influencing urinary toxicity were tested using multivariable logistic regression analysis. Updated urinary quality of life (QOL) scores were compared between the trial arms.
Complete combined data for late urinary symptoms and dosimetry was available for 193 of 224 patients. At a median follow-up of 75 months, cumulative late urinary CTCAE grade 3 toxicity was low and similar for whole pelvic radiation therapy and prostate-only radiation therapy (5.2% vs 4.1%, P = .49), and grade 2 toxicity was 31.3% versus 22.7%, respectively (P = .12). Cumulative rates of each urinary symptom were similar between both arms. Multivariable analysis with age at diagnosis, known diabetes, tumor stage, trial arm, prior transurethral resection of prostate, grade 2+ acute urinary toxicity, low bladder dose (V10Gy), and moderate bladder dose (V40Gy) did not identify any significant association with late urinary toxicity. Urinary QOL scores was similar between both the arms for all the symptoms.
During long-term follow-up, whole pelvic radiation therapy resulted in low (∼5%) and similar grade 3 cumulative urinary toxicity as prostate-only radiation therapy. The long-term patient-reported QOL scores were similar. No causative factors affecting the late urinary toxicity were identified.
POP-RT 阶段 3 随机试验表明，对于高危和极高危前列腺癌，全盆腔放疗联合前列腺放疗较单纯前列腺放疗可提高生化无失败生存率和无转移生存率，但 RTOG 晚期尿毒性更差。我们报告了该试验中晚期尿毒性和随访期间每个症状严重程度的更新结果。
使用不良事件常用术语标准（CTCAE）第 5.0 版对晚期尿毒性和随访期间每个症状的严重程度进行分级。将批准的放疗计划中 5-Gy 增量的膀胱剂量（V5、V10、V15、V65、V68Gy）与尿症状和总体 2+级毒性进行比较。使用多变量逻辑回归分析测试影响尿毒性的潜在因素。比较试验臂之间的更新后的尿 QOL 评分。
193 例患者中有 224 例患者可获得完整的晚期尿症状和剂量数据。中位随访时间为 75 个月时，全盆腔放疗和单纯前列腺放疗的晚期累积 CTCAE 3 级尿毒性发生率较低且相似（5.2%比 4.1%，P =.49），2 级毒性发生率分别为 31.3%和 22.7%（P =.12）。两个治疗臂之间的每个尿症状的累积发生率相似。多变量分析显示，年龄、已知糖尿病、肿瘤分期、试验臂、既往经尿道前列腺切除术、2+级急性尿毒性、低膀胱剂量（V10Gy）和中膀胱剂量（V40Gy）与晚期尿毒性均无显著相关性。所有症状的尿 QOL 评分在两个臂之间相似。
在长期随访中，全盆腔放疗导致的 3 级累积尿毒性较低（约 5%），与单纯前列腺放疗相似。长期患者报告的 QOL 评分相似。未发现影响晚期尿毒性的因果因素。
