Department of Orthopedic Surgery and Trauma Surgery, University Medical Center Mannheim, Mannheim Medical Faculty, Heidelberg University, Mannheim, Germany.
Department of Radiation Oncology, University Medical Center Mannheim, Mannheim Medical Faculty, Heidelberg University, Mannheim, Germany.
Radiat Oncol. 2020 Nov 12;15(1):263. doi: 10.1186/s13014-020-01715-z.
The spine represents the site which is most frequently affected by bone metastases in patients with systemic cancer. Of all local treatment options, combined kyphoplasty and intraoperative radiotherapy (Kypho-IORT) provides both, instantaneous stabilization and immediate pain relief. We here report on the long-term outcomes of the largest cohort treated with Kypho-IORT to date.
Between 2009 and 2019 a total of 104 patients underwent Kypho-IORT to vertebral tumors in the thoracic, lumbar, or sacral spine with transpedicular kyphoplasty and intraoperative irradiation with a needle-shaped electronic brachytherapy source at our center. Patients were treated either on trial, within the prospective Kypho-IORT studies (NCT01280032 and NCT02773966), or, after completion of the study, off trial but compliant with the study protocol. Follow-up and imaging with computed tomography (CT) or magnetic resonance imaging was scheduled after 3 and 6 months and then bi-annually.
A total of 143 vertebrae (89 thoracic spine, 53 lumbar spine, and 1 sacral spine) were treated in 104 patients. The median follow-up was 14.5 months (range 0.4-109). Local progression occurred in 10 patients (10 vertebrae) after a median time of 22.3 months (range 1.5-73) resulting in local control rates of 97.1, 95.9, and 94.2% at 6, 12, and 24 months, respectively. Overall survival was 74.6, 61.7, and 50.3% at 6, 12, and 24 months, respectively. A single serious adverse event was reported.
In addition to immediate pain reduction and stabilization, Kypho-IORT shows excellent long-term local control with minimal side effects.
脊柱是癌症全身转移患者中最常发生骨转移的部位。在所有局部治疗方法中，经皮椎体后凸成形术联合术中放疗（Kypho-IORT）既能即刻稳定脊柱，又能即刻缓解疼痛。在此，我们报告了迄今为止接受 Kypho-IORT 治疗的最大队列的长期结果。
2009 年至 2019 年，我们中心共对 104 例胸、腰或骶椎脊柱肿瘤患者行经皮椎体后凸成形术联合术中电子近距离放疗（通过针状电子近距离放疗源）治疗。这些患者的治疗方案为临床试验（NCT01280032 和 NCT02773966）内的前瞻性 Kypho-IORT 研究或研究完成后的试验外治疗，但符合研究方案。患者接受随访和影像学检查，包括 CT 或 MRI，分别在术后 3 个月和 6 个月，然后每 6 个月进行一次。
共对 104 例患者的 143 个椎体（89 个胸椎、53 个腰椎和 1 个骶椎）进行了治疗。中位随访时间为 14.5 个月（范围为 0.4-109）。10 例患者（10 个椎体）在中位时间 22.3 个月（范围为 1.5-73）后发生局部进展，6、12 和 24 个月的局部控制率分别为 97.1%、95.9%和 94.2%。总生存率分别为 74.6%、61.7%和 50.3%。仅报告了 1 例严重不良事件。
除了即刻缓解疼痛和稳定脊柱外，Kypho-IORT 还具有极好的长期局部控制效果，且副作用极小。
