2 期试验中联合挽救性放疗和激素治疗寡转移性盆腔淋巴结复发前列腺癌（OLIGOPELVIS GETUG P07）的早期毒性
Early Toxicity of a Phase 2 Trial of Combined Salvage Radiation Therapy and Hormone Therapy in Oligometastatic Pelvic Node Relapses of Prostate Cancer (OLIGOPELVIS GETUG P07).
机构信息
Department of Radiation Oncology, Institut de Cancérologie de l'Ouest, Nantes, St-Herblain, France.
Department of Biostatistics, Institut de Cancérologie de l'Ouest, Boulevard J. Monod, Nantes, St-Herblain, France.
出版信息
Int J Radiat Oncol Biol Phys. 2019 Apr 1;103(5):1061-1067. doi: 10.1016/j.ijrobp.2018.12.020. Epub 2018 Dec 14.
PURPOSE
Limited pelvic nodal relapse of prostatic cancer is a paramount challenge for locoregional salvage treatments. Salvage whole pelvis radiation therapy as considered in the BLINDED trial is an attractive option, but there are concerns about its toxicity. This article describes early toxicity with the technique.
METHODS AND MATERIALS
BLINDED was a prospective multicenter phase 2 trial investigating high-dose salvage pelvic irradiation with an additional dose to the fluorocholine-based positron emission tomography-positive pelvic lymph nodes, combined with 6-month androgen blockade. The prescribed dose was 54 Gy in 1.8 Gy fractions with up to 66 Gy in 2.2 Gy fractions to the pathologic pelvic lymph nodes. Early toxicity was defined as toxicity until 1 year after radiation therapy. Patients quality of life was assessed using the European Organisation for Research and Treatment of Cancer questionnaires (QLQ-C30 and QLQ-PR25).
RESULTS
Seventy-four patients were recruited in 15 French radiation oncology departments between August 2014 and July 2016. Seven were excluded before treatment because of violation of the inclusion criteria. The intention-to-treat analysis therefore included 67 patients. Half had received prior prostatic irradiation. Median age was 67.7 ± 6.5 years. Grade 2 acute urinary toxicity was observed in 9 of 67 patients (13.4%), and grade 2 1-year toxicity occurred in 4 of 67 patients (6%). Three patients (4.4%) had grade 3 urinary toxicity. Grade 2 acute digestive toxicity was observed in 10 of 67 patients (14.9%), and grade 2 1-year toxicity occurred in 4 of 67 patients (6%). Patients with prior prostate bed irradiation did not exhibit increased urinary or digestive toxicity. The European Organisation for Research and Treatment of Cancer questionnaire scores at 1 year did not worsen significantly.
CONCLUSIONS
The acute and 1-year toxicity of the BLINDED protocol was satisfactory, even in patients with a history of prostatic irradiation.
目的
前列腺癌的局限性盆腔淋巴结复发是局部挽救治疗的主要挑战。BLINDED 试验中考虑的挽救性全骨盆放疗是一种有吸引力的选择，但存在对其毒性的担忧。本文描述了该技术的早期毒性。
方法和材料
BLINDED 是一项前瞻性多中心 2 期试验，研究了高剂量挽救性盆腔照射，外加氟脱氧葡萄糖基于正电子发射断层扫描阳性的盆腔淋巴结剂量，联合 6 个月雄激素阻断。规定剂量为 54 Gy，1.8 Gy 分次，病理盆腔淋巴结最大剂量为 66 Gy，2.2 Gy 分次。早期毒性定义为放射治疗后 1 年内的毒性。使用欧洲癌症研究与治疗组织问卷（QLQ-C30 和 QLQ-PR25）评估患者的生活质量。
结果
2014 年 8 月至 2016 年 7 月，15 个法国放射肿瘤学部门共招募了 74 例患者。7 例因违反纳入标准而在治疗前被排除。因此，意向治疗分析包括 67 例患者。半数患者曾接受过前列腺照射。中位年龄为 67.7±6.5 岁。67 例患者中有 9 例（13.4%）出现 2 级急性尿毒性，4 例（6%）出现 1 年 2 级毒性。3 例（4.4%）患者出现 3 级尿毒性。67 例患者中有 10 例（14.9%）出现 2 级急性消化道毒性，4 例（6%）出现 1 年 2 级毒性。有前列腺床照射史的患者尿毒性或消化道毒性无增加。1 年时欧洲癌症研究与治疗组织问卷评分无明显恶化。
结论
即使在有前列腺照射史的患者中，BLINDED 方案的急性和 1 年毒性也令人满意。
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