Pirus Ghadjar, Jürg Bernhard, George N. Thalmann, and Daniel M. Aebersold, Inselspital, Bern University Hospital, and University of Bern; Stefanie Hayoz, Lukas Stalder, and Christine Biaggi-Rudolf, Swiss Group for Clinical Cancer Research Coordinating Center; Jürg Bernhard, International Breast Cancer Study Group Coordinating Center, Bern; Daniel R. Zwahlen, Kantonsspital Graubünden, Chur; Philipp Gut, Kantonsspital Luzern, Luzern; Ludwig Plasswilm, Kantonsspital St Gallen, St Gallen; Alexandros Papachristofilou, University Hospital Basel, Basel; Marcin Sumila, Hirslanden Hospital Group, Zürich; Helmut Kranzbühler, Stadtspital Triemli, Zürich; Yousef Najafi, University Hospital Zürich, Zürich; Ngwa C. Azinwi, Istituto Oncologico della Svizzera Italiana, Bellinzona; Christiane Reuter, Kantonsspital Münsterlingen, Münsterlingen; Stephan Bodis, Kantonsspital Aarau, Aarau; Khanfir Kaouthar, Hôpital Valais, Sion, Switzerland; Pirus Ghadjar and Peter Wust, Charité Universitätsmedizin, Berlin; Tobias Hölscher, University Hospital Dresden, Dresden; Matthias Gluckenberger, University Hospital Würzburg, Würzburg; Guido Hildebrandt, University Hospital Rostock, Rostock; Arndt-Christian Müller, University Hospital Tübingen, Tübingen, Germany; and Piet Ost, Ghent University Hospital, Ghent, Belgium.
J Clin Oncol. 2015 Dec 10;33(35):4158-66. doi: 10.1200/JCO.2015.63.3529. Epub 2015 Nov 2.
Patients with biochemical failure (BF) after radical prostatectomy may benefit from dose-intensified salvage radiation therapy (SRT) of the prostate bed. We performed a randomized phase III trial assessing dose intensification.
Patients with BF but without evidence of macroscopic disease were randomly assigned to either 64 or 70 Gy. Three-dimensional conformal radiation therapy or intensity-modulated radiation therapy/rotational techniques were used. The primary end point was freedom from BF. Secondary end points were acute toxicity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0) and quality of life (QoL) according to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires C30 and PR25.
Three hundred fifty patients were enrolled between February 2011 and April 2014. Three patients withdrew informed consent, and three patients were not eligible, resulting in 344 patients age 48 to 75 years in the safety population. Thirty patients (8.7%) had grade 2 and two patients (0.6%) had grade 3 genitourinary (GU) baseline symptoms. Acute grade 2 and 3 GU toxicity was observed in 22 patients (13.0%) and one patient (0.6%), respectively, with 64 Gy and in 29 patients (16.6%) and three patients (1.7%), respectively, with 70 Gy (P = .2). Baseline grade 2 GI toxicity was observed in one patient (0.6%). Acute grade 2 and 3 GI toxicity was observed in 27 patients (16.0%) and one patient (0.6%), respectively, with 64 Gy, and in 27 patients (15.4%) and four patients (2.3%), respectively, with 70 Gy (P = .8). Changes in early QoL were minor. Patients receiving 70 Gy reported a more pronounced and clinically relevant worsening in urinary symptoms (mean difference in change score between arms, 3.6; P = .02).
Dose-intensified SRT was associated with low rates of acute grade 2 and 3 GU and GI toxicity. The impact of dose-intensified SRT on QoL was minor, except for a significantly greater worsening in urinary symptoms.
根治性前列腺切除术（RP）后发生生化失败（BF）的患者可能从前列腺床剂量强化挽救性放疗（SRT）中获益。我们进行了一项评估剂量强化的随机 III 期试验。
BF 但无肉眼疾病证据的患者被随机分配至 64 或 70 Gy 组。采用三维适形放疗或调强放疗/旋转技术。主要终点为无 BF 生存。次要终点为根据国立癌症研究所不良事件通用术语标准（第 4.0 版）评估的急性毒性和欧洲癌症研究与治疗组织生活质量问卷核心 30 项（C30）和前列腺癌 25 项（PR25）评估的生活质量（QoL）。
2011 年 2 月至 2014 年 4 月间，共纳入 350 例患者。3 例患者撤回知情同意，3 例患者不符合入组条件，因此，安全人群中有 344 例 48 至 75 岁的患者。30 例（8.7%）患者基线时有 2 级泌尿生殖系（GU）症状，2 例（0.6%）患者有 3 级 GU 症状。64 Gy 组有 22 例（13.0%）和 1 例（0.6%）患者出现急性 2 级和 3 级 GU 毒性，70 Gy 组有 29 例（16.6%）和 3 例（1.7%）患者出现急性 2 级和 3 级 GU 毒性（P =.2）。1 例（0.6%）患者基线时有 2 级胃肠道（GI）毒性。64 Gy 组有 27 例（16.0%）和 1 例（0.6%）患者出现急性 2 级和 3 级 GI 毒性，70 Gy 组有 27 例（15.4%）和 4 例（2.3%）患者出现急性 2 级和 3 级 GI 毒性（P =.8）。早期 QoL 变化较小。接受 70 Gy 治疗的患者报告尿症状显著且具有临床相关性恶化（臂间变化评分的平均差值，3.6；P =.02）。
剂量强化 SRT 与较低的急性 2 级和 3 级 GU 和 GI 毒性发生率相关。剂量强化 SRT 对 QoL 的影响较小，除了尿症状显著恶化外。
