Division of Radiation Therapy, Radiation and Proton Therapy Center, Shizuoka Cancer Center, Shizuoka, Japan.
Department of Radiation Oncology, Graduate School of Medicine, Juntendo University, Tokyo, Japan.
Jpn J Clin Oncol. 2021 Jan 1;51(1):100-105. doi: 10.1093/jjco/hyaa158.
Palliative radiotherapy is the standard of care for bone metastases. However, skeletal-related events, defined as a pathologic fracture, paraplegia, surgery or radiotherapy for local recurrence, or severe pain in previously irradiated bone with radio-resistant histology type still present high incidence. The primary objective of this study was to determine whether zoledronic acid hydrate and palliative radiotherapy could prevent local skeletal-related events.
Eligible patients with bone metastases from renal cell carcinoma were treated with zoledronic acid hydrate every 3 or 4 weeks and concurrent palliative radiotherapy of 30 Gy in 3 Gy fractions. The criteria for radiotherapy were established by the treating physician, but patients with complicated bone metastases (impending pathological fracture or spinal cord compression) which needed immediate surgery were excluded. The primary endpoint was the local skeletal-related event-free survival rate at 1 year.
Twenty-seven patients were included in the study. The median age was 65 (range, 50-84) years. Radiotherapy dose was 30 Gy for all patients except 1 whose radiotherapy was terminated due to brain metastasis progression at 18 Gy. Zoledronic acid hydrate was administered in a median of 12 (range, 0-34) times. The median follow-up period was 12 months and 19 months in patients who were still alive. Of 27 patients in the efficacy analysis, the 1-year local skeletal-related event-free rate was 77.6% (80% confidence interval, 66.2-89.0). Common grade 3 toxicities were hypocalcemia (1 [4%]), sGPT level increase (1 [4%]) and sGOT level increase (1 [4%]). There was no grade 4 or 5 toxicity.
Zoledronic acid hydrate administration and palliative radiotherapy were a well-tolerated and promising treatment reducing skeletal-related events for bone metastases from renal cell carcinoma.
姑息性放疗是治疗骨转移的标准方法。然而，骨骼相关事件（定义为病理性骨折、截瘫、局部复发的手术或放疗，或先前照射过的骨组织发生严重疼痛且具有抗辐射组织学类型）仍有很高的发生率。本研究的主要目的是确定唑来膦酸水合物和姑息性放疗是否可以预防局部骨骼相关事件。
符合条件的肾细胞癌骨转移患者接受唑来膦酸水合物每 3 或 4 周治疗，并同时接受 30Gy 分 3Gy 剂量的姑息性放疗。放疗标准由治疗医生确定，但排除了需要立即手术的复杂骨转移患者（即将发生病理性骨折或脊髓压迫）。主要终点是 1 年时的局部骨骼相关事件无进展生存率。
27 例患者纳入研究。中位年龄为 65 岁（范围为 50-84 岁）。除 1 例因脑转移进展而在 18Gy 时终止放疗的患者外，所有患者的放疗剂量均为 30Gy。唑来膦酸水合物的中位给药次数为 12 次（范围为 0-34 次）。中位随访时间为 12 个月和 19 个月，分别为仍存活的患者。在 27 例可评估疗效的患者中，1 年局部骨骼相关事件无进展率为 77.6%（80%可信区间，66.2-89.0）。常见的 3 级毒性反应为低钙血症（1 例[4%]）、sGPT 水平升高（1 例[4%]）和 sGOT 水平升高（1 例[4%]）。无 4 级或 5 级毒性反应。
唑来膦酸水合物给药和姑息性放疗是一种耐受良好且有前途的治疗方法，可降低肾细胞癌骨转移的骨骼相关事件。
