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单次分割碳离子放疗治疗Ⅰ期周围型非小细胞肺癌的剂量递增临床试验。

A Dose Escalation Clinical Trial of Single-Fraction Carbon Ion Radiotherapy for Peripheral Stage I Non-Small Cell Lung Cancer.

机构信息

National Institute of Radiological Sciences, Chiba, Japan.

National Institute of Radiological Sciences, Chiba, Japan.

出版信息

J Thorac Oncol. 2017 Apr;12(4):673-680. doi: 10.1016/j.jtho.2016.12.012. Epub 2016 Dec 19.

DOI:10.1016/j.jtho.2016.12.012
PMID:28007628
Abstract

OBJECTIVES

Our objective was to report initial results of a dose escalation trial of single-fraction carbon ion radiotherapy for peripheral stage I NSCLC.

METHODS

Between April 2003 and February 2012, a total of 218 patients were treated. The total dose was raised from 28 to 50 Gy (relative biological effectiveness [RBE]). There were 157 male and 61 female patients, with a median age of 75 years. Of the tumors, 123 were stage T1 and 95 were stage T2. A total of 134 patients (61.5%) were medically inoperable. By histological type, there were 146 adenocarcinomas, 68 squamous cell carcinomas, three large cell carcinomas, and one mucoepidermoid carcinoma.

RESULTS

The median follow-up was 57.8 months (range 1.6-160.7). The overall survival rate at 5 years was 49.4%. The local control (LC) rate was 72.7%. A statistically significant difference in LC rate (p = 0.0001, log-rank test) was seen between patients receiving 36 Gy (RBE) or more and those receiving less than 36 Gy (RBE). In 20 patients irradiated with 48 to 50 Gy (RBE), the LC rate at 5 years was 95.0%, the overall survival rate was 69.2%, and the progression-free survival rate was 60.0% (median follow-up was 58.6 months). With dose escalation, LC tended to improve. As for adverse lung and skin reactions, there were no patients with grade 3 or higher reactions, and less than 2% had a grade 2 reaction. Regarding chest wall pain, only one patient had grade 3 late toxicity.

CONCLUSIONS

We have reported the outcome of a dose escalation study of single-fraction carbon ion radiotherapy for stage I NSCLC, showing the feasibility of obtaining excellent results comparable to those with previous fractionated regimens.

摘要

目的

本研究旨在报告单次分割碳离子放疗治疗Ⅰ期非小细胞肺癌(NSCLC)的剂量递增试验的初步结果。

方法

2003 年 4 月至 2012 年 2 月,共治疗了 218 例患者。总剂量从 28Gy 提高至 50Gy(相对生物效应[RBE])。其中,男性 157 例,女性 61 例,中位年龄 75 岁。肿瘤中,T1 期 123 例,T2 期 95 例。共有 134 例(61.5%)为医学上不可手术的患者。根据组织学类型,有 146 例腺癌、68 例鳞癌、3 例大细胞癌和 1 例黏液表皮样癌。

结果

中位随访时间为 57.8 个月(1.6-160.7 个月)。5 年总生存率为 49.4%。局部控制率(LC)为 72.7%。接受 36Gy(RBE)或更高剂量与接受低于 36Gy(RBE)剂量的患者之间,LC 率存在显著统计学差异(p=0.0001,对数秩检验)。在 20 例接受 48-50Gy(RBE)放疗的患者中,5 年 LC 率为 95.0%,总生存率为 69.2%,无进展生存率为 60.0%(中位随访时间为 58.6 个月)。随着剂量递增,LC 倾向于改善。对于肺部和皮肤不良反应,无 3 级或更高级别的反应,小于 2%的患者有 2 级反应。关于胸壁疼痛,仅有 1 例患者出现 3 级晚期毒性。

结论

我们报告了单次分割碳离子放疗治疗Ⅰ期 NSCLC 的剂量递增研究结果,结果表明获得与以往分割方案相当的优异结果是可行的。

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