Hospices Civils de Lyon, Lyon, France.
Université Lyon 1, Lyon, France.
Br J Radiol. 2021 Aug 1;94(1124):20210242. doi: 10.1259/bjr.20210242.
The present multicenter Phase II study evaluated the rate of late grade ≥2 gastrointestinal (GI) toxicities at 3 years, after hypofractionated radiotherapy (HFR) of prostate cancer with injection of hyaluronic acid (HA) between the prostate and the rectum.
Between 2010 and 2013, 36 patients with low- or intermediate-risk prostate cancer were treated by HFR/IMRT-IGRT. 20 fractions of 3.1 Gy were delivered, 5 days per week for a total dose of 62 Gy. A transperineal injection of 10cc of HA was performed between the rectum and the prostate. Late toxicities were evaluated between 3 and 36 months after the end of treatment (CTCAE v4).
Median pretreatment prostate-specific antigen was 8 ng ml. Among the 36 included patients, 2 were not evaluated because they withdrew the study in the first 3 months of follow-up, and 4 withdrew between 3 and 36 months, the per protocol population was therefore composed.Late grade ≥2 GI toxicities occurred in 4 (12%) patients with 3 (9%) Grade 2 rectal bleedings and one diarrhoea. Therefore, the inefficacy hypothesis following Fleming one-stage design cannot be rejected. None of the patients experienced late Grade 3-4 toxicities. Among the 30 patients completing the 36 months' visit, none still had a grade ≥2 GI toxicity. Late grade ≥2 genitourinary (GU) toxicities occurred in 14 (41%) patients. The most frequent toxicities were dysuria and pollakiuria. Four patients still experienced a grade ≥2 GU toxicity at 36 months.The biochemical relapse rate (nadir +2 ng ml) was 6% (2 patients). Overall, HA was very well tolerated with no pain or discomfort.
Despite the inefficacy of HA injection was not rejected, we observed the absence of Grade 3 or 4 rectal toxicity as well as a rate of Grade 2 rectal bleeding below 10% at 36 months of follow-up. Late urinary toxicities are the most frequent but the rate decreases largely at 3 years.
With an injection of HA, hypofractionated irradiation in 4 weeks is well tolerated with no Grade 3 or 4 GI toxicity and a rate of Grade 2 rectal bleeding below 10% at 36 months of follow-up.
本多中心二期研究评估了前列腺癌患者接受前列腺和直肠之间注射透明质酸（HA）的短程分割放疗（HFR）后 3 年时晚期≥2 级胃肠道（GI）毒性的发生率。
2010 年至 2013 年间，36 例低危或中危前列腺癌患者接受 HFR/IMRT-IGRT 治疗。给予 20 次 3.1Gy 的分割剂量，每周 5 天，总剂量为 62Gy。经会阴直肠与前列腺之间注射 10ccHA。治疗结束后 3 至 36 个月（CTCAE v4）评估晚期毒性。
中位预处理前列腺特异性抗原为 8ng/ml。在 36 例纳入患者中，2 例因在随访的前 3 个月内退出研究而未进行评估，4 例在 3 至 36 个月期间退出，因此，符合方案人群由 30 例患者组成。4 例（12%）患者发生晚期≥2 级 GI 毒性，其中 3 例（9%）为 2 级直肠出血，1 例为腹泻。因此，弗莱明单阶段设计的无效假设不能被拒绝。无患者发生晚期 3-4 级毒性。30 例完成 36 个月随访的患者中，无 1 例仍存在≥2 级 GI 毒性。14 例（41%）患者发生晚期≥2 级泌尿生殖系统（GU）毒性。最常见的毒性是尿频和多尿。4 例患者在 36 个月时仍存在≥2 级 GU 毒性。生化复发率（最低点+2ng/ml）为 6%（2 例）。总体而言，HA 注射耐受性良好，无疼痛或不适。
尽管 HA 注射的疗效未被否定，但我们观察到 36 个月随访时直肠无 3 或 4 级毒性，2 级直肠出血率低于 10%。晚期尿毒性最常见，但在 3 年内大量减少。
通过 HA 注射，4 周内短程分割照射具有良好的耐受性，无 3 或 4 级 GI 毒性，36 个月随访时 2 级直肠出血率低于 10%。
