Department of Radiation Oncology, Heidelberg University Hospital, Germany; Heidelberg Institute of Radiation Oncology (HIRO), Germany; National Center for Tumor Diseases (NCT), Heidelberg, Germany.
Department of Nuclear Medicine, Heidelberg University Hospital, Germany.
Radiother Oncol. 2021 Jun;159:8-16. doi: 10.1016/j.radonc.2021.01.029. Epub 2021 Feb 4.
To investigate the role of combined ion-beam radiotherapy (CIBRT) with protons and carbon ions in a multimodal treatment strategy of inoperable osteosarcoma; final analysis of a one-armed, single center phase I/II trial.
Between August 2011 until September 2018, 20 patients with primary (N = 18), metastatic (N = 3), or recurrent (N = 2) inoperable pelvic (70%) or craniofacial (30%) osteosarcoma were treated with protons up to 54 Gy (RBE) and a carbon ion boost of 18 Gy (RBE) and followed until May 2019. A Fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) was performed before CIBRT in search for a prognostic factor. The primary endpoint was toxicity. Secondary endpoints included treatment response, global, local and distant progression free survival (PFS, LPFS and DPFS) and overall (OS), among others.
The median age was 20; all patients finished treatment per protocol. LPFS, DPFS, PFS and OS were 73%, 74%, 60% and 75% after one year and 55%, 65% 65.3%, 45% and 68% after two years, respectively. The median clinical target volume (CTV) was 1042 cc and 415 cc for the primary and boost plan, respectively. Craniofacial localization, lower uptake of FDG in PET/CT and boost plan CTV ≤ median were associated with improved overall survival (p = 0.039, p = 0.016 and p = 0.0043, respectively). No acute toxicities > grade III were observed. We observed one case of secondary acute myeloid leukemia (AML) seven months after CIBRT for recurrent disease and one case of hearing loss.
CIBRT shows a favorable toxicity profile and promising results particularly for patients with inoperable craniofacial osteosarcoma.
为了探讨质子和碳离子联合离子束放疗（CIBRT）在不可切除骨肉瘤多模式治疗策略中的作用，对一项单臂、单中心的 I/II 期试验进行最终分析。
2011 年 8 月至 2018 年 9 月，20 例原发性（N=18）、转移性（N=3）或复发性（N=2）不可切除骨盆（70%）或颅面（30%）骨肉瘤患者接受质子放疗 54Gy（RBE）和碳离子推量 18Gy（RBE）治疗，随访至 2019 年 5 月。在 CIBRT 前进行氟脱氧葡萄糖（18F-FDG）正电子发射断层扫描/计算机断层扫描（PET/CT）检查，寻找预后因素。主要终点是毒性。次要终点包括治疗反应、总体、局部和远处无进展生存（PFS、LPFS 和 DPFS）和总生存（OS）等。
中位年龄为 20 岁；所有患者均按方案完成治疗。一年后 LPFS、DPFS、PFS 和 OS 分别为 73%、74%、60%和 75%，两年后分别为 55%、65%、65.3%、45%和 68%。原发性和推量计划的CTV 中位体积分别为 1042cc 和 415cc。颅面定位、PET/CT 中 FDG 摄取较低和推量计划 CTV≤中位数与总生存改善相关（p=0.039、p=0.016 和 p=0.0043）。未观察到 3 级以上急性毒性。我们观察到 1 例复发后接受 CIBRT 治疗的急性髓系白血病（AML）和 1 例听力损失。
CIBRT 显示出良好的毒性特征和有前途的结果，特别是对不可切除颅面骨肉瘤患者。
