Radiation Oncology Department, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy; School of Medicine and Surgery, University of Milan Bicocca, Milan, Italy.
School of Medicine and Surgery, University of Milan Bicocca, Milan, Italy.
Int J Radiat Oncol Biol Phys. 2024 Dec 1;120(5):1394-1403. doi: 10.1016/j.ijrobp.2024.06.030. Epub 2024 Jul 4.
To assess late gastrointestinal (GI) and genitourinary (GU) side effects in patients with organ-confined unfavorable prostate cancer (PCa) treated with single-dose ablative radiation therapy (SDRT).
Thirty patients enrolled in a single-arm prospective trial received 24 Gy SDRT to the whole prostate with urethra-sparing and organ motion control delivered on a Linac platform with a 10 MV flattening filter-free single partial arc. Androgen deprivation therapy was prescribed as per standard of care. Treatment-related acute and late GU and GI toxicities (Common Terminology Criteria for Adverse Events_v5 scale) and quality of life (QoL) outcomes (European Organisation for Research and Treatment of Cancer [EORTC] QLQ-PR25/C30, International Prostate Symptom Score [IPSS]) were assessed at different time points. Minimal important difference (MID) was established as a change of >0.5 pooled standard deviations from baseline. Statistical analysis included analysis of variance and logistic regression.
Median follow-up was 18 months (range, 6-31 months), with no ≥G3 late side effects observed. G2 late GI and G2 late GU toxicities occurred in 1 and 2 patients, respectively. GI toxicity of any grade correlated with maximum rectal dose (P = .021). Lower baseline QoL score (P = .025), higher baseline IPSS score (P = .049), acute GU toxicity (P = .029), and acute urinary domain MID (P = .045) predicted GU toxicity of any grade. In multivariate analysis (MVA), only baseline QoL score (odds ratio [OR], 0.95, P = .031) and acute GU toxicity (OR, 8.4, P = .041) remained significant. Significant QoL change was observed only in the urinary domain (P = .005), with a median increase from 8 to 17. Late urinary MID correlated with acute urinary MID (P = .003), acute QoL MID (P = .029), acute GU toxicity (P = .030), and lower baseline urinary score (P = .033). In MVA, only acute urinary MID predicted late urinary MID (OR, 9.7, P = .035).
Our findings provide promising data on the feasibility and safety of 24 Gy whole-gland SDRT with urethra-sparing and organ motion control, in association with androgen deprivation therapy and an adequate prophylactic medication, in organ-confined unfavorable PCa. Long-term follow-up is needed to confirm these results.
评估接受单次消融放射治疗（SDRT）的局限性前列腺癌（PCa）患者的晚期胃肠道（GI）和泌尿生殖系统（GU）副作用。
30 名患者参加了一项单臂前瞻性试验，他们接受了 24 Gy 的 SDRT 治疗，整个前列腺均接受了保留尿道和器官运动控制的治疗，使用配备 10 MV 无均整滤波器的单部分弧形直线加速器平台进行治疗。雄激素剥夺治疗是按照标准治疗方案进行的。使用欧洲癌症研究与治疗组织（EORTC）生活质量问卷（QLQ-PR25/C30）和国际前列腺症状评分（IPSS）评估治疗相关的急性和晚期 GU 和 GI 毒性（不良事件通用术语标准第五版[CTCAE v5]）和生活质量（QoL）结果。建立最小重要差异（MID）为自基线变化超过 0.5 个 pooled 标准差。统计分析包括方差分析和逻辑回归。
中位随访时间为 18 个月（范围 6-31 个月），未观察到≥G3 级晚期副作用。1 名患者出现 G2 级晚期 GI 毒性，2 名患者出现 G2 级晚期 GU 毒性。任何等级的 GI 毒性均与直肠最大剂量相关（P=0.021）。较低的基线 QoL 评分（P=0.025）、较高的基线 IPSS 评分（P=0.049）、急性 GU 毒性（P=0.029）和急性尿域 MID（P=0.045）预测任何等级的 GU 毒性。在多变量分析（MVA）中，仅基线 QoL 评分（优势比[OR]，0.95，P=0.031）和急性 GU 毒性（OR，8.4，P=0.041）仍然具有统计学意义。仅在尿域观察到显著的 QoL 变化（P=0.005），中位数从 8 增加到 17。晚期尿域 MID 与急性尿域 MID（P=0.003）、急性 QoL MID（P=0.029）、急性 GU 毒性（P=0.030）和较低的基线尿域评分（P=0.033）相关。在 MVA 中，仅急性尿域 MID 预测晚期尿域 MID（OR，9.7，P=0.035）。
我们的研究结果提供了有希望的数据，表明在局限性前列腺癌中，采用保留尿道和器官运动控制的 24 Gy 全腺 SDRT，联合雄激素剥夺治疗和适当的预防性药物治疗是可行和安全的。需要长期随访来证实这些结果。
