Department of Radiation Oncology, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Pierre Benite, France; EMR3738, Université Lyon 1, Lyon, France.
Pole Information Médicale Evaluation Recherche, Hospices Civils de Lyon, Lyon, France; Université Lyon 1, Lyon, France; EA SIS, Université de Lyon, Lyon, France.
Int J Radiat Oncol Biol Phys. 2015 Mar 15;91(4):730-6. doi: 10.1016/j.ijrobp.2014.11.027.
Hypofractionated radiation therapy (RT) in prostate cancer can be developed only if the risk of rectal toxicity is controlled. In a multicenter phase 2 trial, hypofractionated irradiation was combined with an injection of hyaluronic acid (HA) to preserve the rectal wall. Tolerance of the injection and acute toxicity rates are reported.
The study was designed to assess late grade 2 toxicity rates. The results described here correspond to the secondary objectives. Acute toxicity was defined as occurring during RT or within 3 months after RT and graded according to the Common Terminology Criteria for Adverse Events version 4.0. HA tolerance was evaluated with a visual analog scale during the injection and 30 minutes after injection and then by use of the Common Terminology Criteria at each visit.
From 2010 to 2012, 36 patients with low-risk to intermediate-risk prostate cancer were included. The HA injection induced a mean pain score of 4.6/10 ± 2.3. Thirty minutes after the injection, 2 patients still reported pain (2/10 and 3/10), which persisted after the intervention. Thirty-three patients experienced at least 1 acute genitourinary toxicity and 20 patients at least 1 acute gastrointestinal toxicity. Grade 2 toxicities were reported for 19 patients with urinary obstruction, frequency, or both and for 1 patient with proctitis. No grade 3 or 4 toxicities were reported. At the 3-month visit, 4 patients described grade 2 obstruction or frequency, and no patients had any grade 2 gastrointestinal toxicities.
The injection of HA makes it possible to deliver hypofractionated irradiation over 4 weeks with a dose per fraction of > 3 Gy, with limited acute rectal toxicity.
只有控制直肠毒性风险，前列腺癌的短程放疗才能得以发展。在一项多中心 2 期试验中，短程放疗与透明质酸（HA）注射相结合，以保护直肠壁。报告了注射的耐受性和急性毒性发生率。
该研究旨在评估迟发性 2 级毒性发生率。此处描述的结果对应于次要目标。急性毒性定义为在放疗期间或放疗后 3 个月内发生，并根据 4.0 版常见不良事件术语标准进行分级。HA 耐受性通过注射期间和注射后 30 分钟的视觉模拟评分进行评估，然后在每次就诊时使用常见不良事件术语标准进行评估。
2010 年至 2012 年，共纳入 36 例低危至中危前列腺癌患者。HA 注射引起的平均疼痛评分为 4.6/10 ± 2.3。注射后 30 分钟，仍有 2 名患者报告疼痛（2/10 和 3/10），干预后仍持续存在。33 名患者至少经历了 1 次急性泌尿生殖系统毒性，20 名患者至少经历了 1 次急性胃肠道毒性。19 名患者报告了尿路梗阻、尿频或两者兼有，1 名患者报告了直肠炎，均为 2 级毒性。未报告 3 级或 4 级毒性。在 3 个月的随访中，4 名患者描述了 2 级梗阻或尿频，没有患者有任何 2 级胃肠道毒性。
HA 注射可在 4 周内进行短程放疗，每次分割剂量>3 Gy，急性直肠毒性有限。
