一项评估骨髓保护、图像引导的盆腔强度调制放疗（IMRT）联合铯-131 近距离放疗增强、辅助化疗和长期激素阻断治疗高危、非转移性前列腺癌患者的 II 期研究。
A Phase II Study Evaluating Bone Marrow-Sparing, Image-guided Pelvic Intensity-Modulated Radiotherapy (IMRT) With Cesium-131 Brachytherapy Boost, Adjuvant Chemotherapy, and Long-Term Hormonal Ablation in Patients With High Risk, Nonmetastatic Prostate Cancer.
机构信息
Department of Radiation Oncology.
Department of Medicine and Greenebaum Comprehensive Cancer Center.
出版信息
Am J Clin Oncol. 2019 Mar;42(3):285-291. doi: 10.1097/COC.0000000000000520.
PURPOSE/OBJECTIVE(S): Management of localized high-risk prostate cancer remains challenging. At our institution we performed a prospective phase II study of 2 years of androgen deprivation therapy (ADT), pelvic radiation, Cesium (Cs)-131 brachytherapy boost, and adjuvant docetaxel in high risk, localized prostate cancer with a primary endpoint of 3-year disease-free survival.
MATERIALS/METHODS: Acute/chronic hematologic, gastrointestinal (GI) and genitourinary (GU) toxicities were scored based on the CTCAE v3.0/RTOG-EORTC criteria, respectively. Actuarial biochemical recurrence free survival (bRFS), bRFSdisease free survival (DFS) and overall survival (OS) were calculated. Patients had a median age of 62 years (range, 45 to 82), median Gleason score 8 (74% Gleason 8-10), median PSA of 11.2 (range, 2.8 to 96), and 47% cT2-T3a stage disease. Androgen deprivation was given for 2 years, 45 Gy whole-pelvis IMRT was followed by an 85 Gy Cs-131 boost to the prostate gland, and adjuvant docetaxel was given for 4 cycles.
RESULTS
In total 38 patients enrolled from 2006 to 2014, with 82% completing protocol specified treatment, and 84.2% completing 4 cycles of docetaxel. Median follow-up for the entire and alive cohorts were 44 months and 58 months (range, 3.4 to 118), respectively. Acute grade ≥2 GI and GU toxicity rates were 18.4% and 23.7%, respectively. Chronic grade ≥2 GI and GU toxicity rates were 2.6% and 2.6%, respectively. Twelve patients (31.6%) developed grade 4 hematologic toxicity, with no grade 5 toxicity. The 5-year DFS, bRFS and OS rates were 74.1%, 86.0%, and 80.3%, respectively.
CONCLUSIONS
This aggressive pilot multimodal approach appears to be safe and well-tolerated, providing disease control in a significant proportion of patients with particularly high-risk prostate cancer.
目的
局限性高危前列腺癌的治疗仍具有挑战性。在本机构，我们进行了一项前瞻性Ⅱ期研究，对 38 例局限性高危前列腺癌患者给予为期 2 年的雄激素剥夺治疗（ADT）、盆腔放疗、铯（Cs）-131 近距离放疗加量和辅助多西他赛治疗，主要终点为 3 年无病生存率。
材料和方法
根据 CTCAE v3.0/RTOG-EORTC 标准，分别对急性/慢性血液学、胃肠道（GI）和泌尿生殖系统（GU）毒性进行评分。计算生化无复发生存（bRFS）、bRFS 无病生存率（DFS）和总生存率（OS）。患者中位年龄 62 岁（范围：45 至 82 岁），中位 Gleason 评分为 8 分（74% Gleason 评分 8-10 分），中位 PSA 为 11.2ng/ml（范围：2.8 至 96ng/ml），47%患者为 cT2-T3a 期疾病。ADT 治疗 2 年，给予 45Gy 全盆腔调强放疗（IMRT），随后对前列腺给予 85Gy 的 Cs-131 加量放疗，给予辅助多西他赛治疗 4 个周期。
结果
2006 年至 2014 年期间共入组 38 例患者，82%的患者完成了方案规定的治疗，84.2%的患者完成了 4 个周期的多西他赛治疗。全组和存活患者的中位随访时间分别为 44 个月和 58 个月（范围：3.4 至 118 个月）。急性≥2 级 GI 和 GU 毒性发生率分别为 18.4%和 23.7%。慢性≥2 级 GI 和 GU 毒性发生率分别为 2.6%和 2.6%。12 例患者（31.6%）发生 4 级血液学毒性，无 5 级毒性。5 年 DFS、bRFS 和 OS 率分别为 74.1%、86.0%和 80.3%。
结论
这种积极的多模式初始治疗方案似乎安全且耐受良好，为高危前列腺癌患者提供了显著的疾病控制。
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