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一项关于脊索瘤和软骨肉瘤质子治疗的前瞻性临床试验:可行性评估。

A prospective clinical trial of proton therapy for chordoma and chondrosarcoma: Feasibility assessment.

作者信息

Baumann Brian C, Lustig Robert A, Mazzoni Susan, Grady Sean M, O'Malley Bert W, Lee John Y K, Newman Jason G, Schuster James M, Both Stefan, Lin Alexander, Dorsey Jay F, Alonso-Basanta Michelle

机构信息

Department of Radiation Oncology, Washington University, St. Louis, Missouri.

Department of Radiation Oncology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.

出版信息

J Surg Oncol. 2019 Aug;120(2):200-205. doi: 10.1002/jso.25502. Epub 2019 May 20.

DOI:10.1002/jso.25502
PMID:31111502
Abstract

BACKGROUND/OBJECTIVES: Proton therapy (PRT) has emerged as a treatment option for chordomas/chondrosarcomas to escalate radiation dose more safely. We report results of a phase I/II trial of PRT in patients with chordoma/chondrosarcoma.

METHODS

Twenty adult patients with pathologically confirmed, nonmetastatic chordoma or chondrosarcoma were enrolled in a single-institution prospective trial of PRT from 2010 to 2014. Seventeen patients received adjuvant PRT and three received definitive PRT. Median dose was 73.8 Gy(RBE; range 68.4-79.2 Gy) using PRT-only (n = 6) or combination PRT/intensity-modulated radiotherapy (IMRT) (n = 14). Quality-of-life (QOL) and fatigue were assessed weekly and every 3 months posttreatment with the Functional Assessment of Cancer Therapy - Brain (FACTBr) and Brief Fatigue Inventory. Primary endpoint was feasibility (90% completing treatment with < 10 day treatment delay and ≤ 20% unexpected acute grade ≥ 3 toxicity).

RESULTS

Tumors included chordomas of the skull base (n = 10), sacrum (n = 5), and cervical spine (n = 3), and skull base chondrosarcomas (n = 2). Median age was 57. The 80% had positive margins/gross disease. Median follow-up was 37 months. Feasibility endpoints were met. The 3-year local control and progression-free survival was 86% and 81%. There were no deaths. Two patients had acute grade 3 toxicity (both fatigue). One had late grade 3 toxicity (epistaxis and osteoradionecrosis). There were no significant differences in patient reported fatigue or QOL from baseline to the end-of-treatment.

CONCLUSIONS

We report favorable local control, survival, and toxicity following PRT.

摘要

背景/目的:质子治疗(PRT)已成为脊索瘤/软骨肉瘤的一种治疗选择,可更安全地提高放射剂量。我们报告了PRT用于脊索瘤/软骨肉瘤患者的I/II期试验结果。

方法

2010年至2014年,20例经病理确诊的非转移性脊索瘤或软骨肉瘤成年患者参加了单机构PRT前瞻性试验。17例患者接受辅助PRT,3例接受根治性PRT。采用单纯PRT(n = 6)或PRT/调强放疗(IMRT)联合治疗(n = 14),中位剂量为73.8 Gy(相对生物效应;范围68.4 - 79.2 Gy)。治疗期间每周以及治疗后每3个月使用癌症治疗功能评估-脑(FACTBr)和简明疲劳量表评估生活质量(QOL)和疲劳情况。主要终点是可行性(90%的患者完成治疗,治疗延迟< 10天且意外急性3级及以上毒性≤ 20%)。

结果

肿瘤包括颅底脊索瘤(n = 10)、骶骨脊索瘤(n = 5)、颈椎脊索瘤(n = 3)和颅底软骨肉瘤(n = 2)。中位年龄为57岁。80%的患者切缘阳性/存在大体病变。中位随访时间为37个月。达到了可行性终点。3年局部控制率和无进展生存率分别为86%和81%。无死亡病例。2例患者出现急性3级毒性(均为疲劳)。1例患者出现晚期3级毒性(鼻出血和骨放射性坏死)。从基线到治疗结束,患者报告的疲劳或QOL无显著差异。

结论

我们报告了PRT治疗后良好的局部控制、生存率和毒性情况。

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