3D打印非共面模板辅助CT引导<sup>125</sup>Ⅰ粒子植入治疗锁骨上复发转移癌的剂量学研究

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郭福新, 姜玉良, 吉喆, 彭冉, 孙海涛, 王俊杰. 3D打印非共面模板辅助CT引导¹²⁵Ⅰ粒子植入治疗锁骨上复发转移癌的剂量学研究 . 北京大学学报(医学版), 2017,49(3): 506-511.
GUO Fu-xin, JIANG Yu-liang, JI Zhe, PENG Ran, SUN Hai-tao, WANG Jun-jie. 3D printed template-assisted and computed tomography image-guided 125-iodine seed implantation for supraclavicular metastatic tumor: a dosimetric study. Journal of Peking University(Health Sciences), 2017,49(3): 506-511. 复制到剪切板

Doi: 10.3969/j.issn.1671-167X.2017.03.022
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《北京大学学报（医学版）》编辑部

3D打印非共面模板辅助CT引导¹²⁵Ⅰ粒子植入治疗锁骨上复发转移癌的剂量学研究

郭福新, 姜玉良, 吉喆, 彭冉, 孙海涛, 王俊杰

北京大学第三医院肿瘤放疗科, 北京 100191

收稿日期: 2016-12-12

基金资助: 首都临床特色应用研究与成果推广科研项目(Z151100004015171)资助

摘要

目的对比3D打印个体化非共面模板辅助CT引导¹²⁵I粒子植入治疗锁骨上复发转移癌的术前计划与术后实际验证剂量,评价3D打印个体化非共面模板的剂量准确性。方法研究纳入2016年1—9月于北京大学第三医院肿瘤放疗科行3D打印个体化非共面模板辅助CT引导¹²⁵I粒子植入治疗锁骨上复发转移癌的患者14例(15个病灶),男性8例,女性6例,年龄46~79岁(平均年龄59.9岁),Karnofsky评分(KPS,百分法)60~90(中位数80)。患者既往未接受过放射治疗者1例,曾接受放射治疗但剂量不详者1例,其余12例曾接受放射治疗,中位数60 Gy (20~70 Gy)。所有患者术前均行增强CT扫描,术前计划设计,3D打印模板制作,穿刺及¹²⁵I粒子植入,处方剂量110~150 Gy。对比患者术前、术后剂量学参数,包括90%靶体积的最小吸收剂量(D₉₀)、100%处方剂量覆盖的体积占靶体积的百分比(V₁₀₀)、150%处方剂量覆盖的体积占靶体积的百分比(V₁₅₀)、200%处方剂量覆盖的体积占靶体积的百分比(V₂₀₀)、匹配周缘剂量(matched peripheral dose, mPD)、适形指数(conformal index,CI)、靶区外体积指数(external index,EI)。利用配对 t检验对术后实际剂量参数结果与术前计划所对应的参数进行比较,通过Bland-Altman法分析术前、术后剂量参数的一致性。结果术前和术后D₉₀、V₁₀₀、V₁₅₀、V₂₀₀、mPD、CI等差异均无统计学意义( P>0.05),EI差异有统计学意义( P<0.05)。经Bland-Altman法分析,D₉₀、V₁₀₀、V₁₅₀、V₂₀₀、mPD一致性欠佳,CI、EI一致性较好。结论 3D打印个体化非共面模板辅助CT引导¹²⁵I粒子植入治疗锁骨上复发转移癌方法剂量精准,可达到术前剂量设计要求。

关键词: 3D打印; 近距离放射疗法; 碘放射性同位素; 放射治疗剂量; 肿瘤转移

中图分类号:R730.55 文献标志码:A 文章编号:1671-167X(2017)03-0506-06

3D printed template-assisted and computed tomography image-guided 125-iodine seed implantation for supraclavicular metastatic tumor: a dosimetric study

GUO Fu-xin, JIANG Yu-liang, JI Zhe, PENG Ran, SUN Hai-tao, WANG Jun-jie

Department of Radiation Oncology, Peking University Third Hospital, Beijing 100191, China

△ Corresponding author’s e-mail, junjiewang_edu@sina.cn

Fund:Supported by the Capital Foundation for Clinical Charac-teristics and Application Research (Z151100004015171)

Abstract

Objective: To compare the dosimetric data between the preoperative plans and postoperative verification in personalized 3D printed template-assisted and computed tomography (CT) image-guided 125-iodine seed implantation for supraclavicular metastatic tumor, and to evaluate the accuracy and feasibility at the dosimetry level.Methods: A total of 14 patients with supraclavicular metastatic tumor (including 15 lesions) who received 3D printed template assisted and CT image-guided 125-iodine seed implantation in Department of Radiation Oncology of Peking University Third Hospital from January to September 2016 were enrolled. There were 8 males and 6 females, aged from 46 to 79 years (mean age: 59.9 years). The Karnofsky performance score (KPS) was from 60 to 90 (median of 80). There were one patient who had not received radiotherapy before, and one patient had received radiotherapy, but the dose was unknown. The remaining 12 patients had received radiotherapy, with the median of 60 Gy (20-70 Gy), and one of them with the dose unknown. All the patients underwent preoperative enhanced CT scan, preoperative planning design, 3D printing template, puncture and particle implantation, the prescription dose from 110 Gy to 150 Gy. Comparisons of the dosimetric parameters between the postoperative verification and preoperative plans were made by paired t-test. The dose parameters inclu-ded D₉₀, V₁₀₀, V₁₅₀, V₂₀₀, matched peripheral dose (mPD), conformal index (CI), and external index (EI). The agreement was evaluated between the preoperative planning and postoperative actual dose parameters using Bland-Altman analysis. Bland-Altman plot showed the difference against the average of preoperative planning and postoperative actual dose parameters with limits of agreement (LoA) (broken lines).Results: The difference of all the data between pre- and postoperation, included D₉₀, V₁₀₀, V₁₅₀, V₂₀₀, mPD, and CI, which was not statistically significant ( P>0.05). EI was statistically significant ( P<0.05). There was poor consistency of D₉₀, V₁₀₀, V₁₅₀, V₂₀₀, and mPD, but better consistency of CI and EI.Conclusion: Personalized 3D printed template-assisted and CT image-guided 125-iodine seed implantation for supraclavicular metastatic tumor is accurate and feasible.

Key words: Three-dimensional printing; Brachytherapy; Iodine radioisotopes; Radiotherapy dosage; Neoplasm metastasis

文章图片

¹²⁵I放射性粒子持续低剂量率近距离治疗是一种安全、有效、微创的治疗方法^{[1, 2]}。美国近距离放射治疗协会(American Brachytherapy Society, ABS)近期发表的《肺癌胸部近距离放射治疗指南》中也对¹²⁵I放射性粒子治疗给出了指导性建议^[3], 表明¹²⁵I放射性粒子治疗实体肿瘤取得了较好的疗效^{[4, 5, 6]}。

锁骨上淋巴结, 即斜角肌淋巴结, 位于颈横淋巴结与颈内静脉淋巴结下群连接处, 前斜角肌的前方, 靠近颈静脉角, 胸、腹、盆腔恶性肿瘤沿淋巴结途径转移时容易转移到此淋巴结区。锁骨上淋巴结作为阻止癌细胞侵入静脉的最后淋巴结, 其被侵犯的结果只能说明已经有侵入静脉的可能, 这类患者治疗效果差, 多不主张手术治疗, 同步放化疗为目前最佳治疗方案, 放化疗后复发仍无较好的局部治疗方法。本研究利用3D打印个体化非共面模板辅助CT引导¹²⁵I粒子植入治疗这部分患者, 现将结果报道于此。

1 资料与方法

1.1 一般临床资料

本研究纳入2016年1— 9月于北京大学第三医院肿瘤放疗科行3D打印个体化非共面模板辅助CT引导¹²⁵I放射性粒子植入治疗锁骨上转移肿瘤的患者14例, 入组标准:Karnofsky评分(KPS, 百分法)≥ 60, 预期生存期> 6个月, 年龄18~80岁, 有客观可测量的肿瘤病灶, 最大直径≤ 10 cm。排除标准:严重器官功能障碍、凝血功能障碍及近期服用抗凝药物者, 急性感染或慢性感染期患者, 精神异常或有精神病史者, 有广泛皮肤坏死、瘘、破溃者。

如表1所示, 患者男性8例, 女性6例, 年龄46~79岁(平均年龄59.9岁), KPS评分60~90(中位数80), 患者既往未接受过放射治疗者1例, 曾接受放射治疗但剂量不详者1例, 其余12例曾接受放射治疗, 中位数60 Gy (20~70 Gy), 处方剂量110~150 Gy(中位数130 Gy)。

表1 14例患者一般临床资料 Table 1 General information of 14 cases

1.2 仪器及设备

CT:荷兰Philips公司Brilliance Big Bore CT; 近距离放射治疗计划系统(brachytherapy treatment planning system, BTPS):北京天航科霖科技发展有限公司, KLSIRPS-3D; 3D影像软件:比利时Mate-rialise公司, Magics 19.01; 18G植入针、1820-C型和Mick200-TPV Applicator枪:美国Mick Radio-Nuclear公司; ¹²⁵I粒子:6711-99型, 粒子长4.5 mm, 直径0.8 mm, 活度0.3~0.7 mCi(1 Ci=3.7× 10¹⁰ Bq), 能量27~35 keV, 半衰期59.4 d, 北京智博医药公司; 3D光固化快速成型机:上海联泰三维科技有限公司, RS6000。

1.3 术前计划

根据患者病灶特点选择相应体位, 术前2 d内行增强CT扫描, 层厚1 mm, 真空垫固定, 根据增强CT扫描结果确定最大中心层面, 设计定位针, 体表标记参考线。CT数据传输至BTPS, 勾画肿瘤靶体积(gross tumor volume, GTV)和临近危及器官。根据处方剂量及危及器官耐受剂量设计针道, 模拟粒子空间分布。

1.4 3D打印个体化非共面模板的设计与制作

将BTPS中的针道信息数据导入3D影像软件Magics 19.01行个体化模板数字建模, 利用3D光固化快速成型机和医用光固化树脂材料加工得到3D个体化模板, 模板含有患者信息、定位标记和模拟针道等信息。

1.5 穿刺及放射性粒子植入

根据CT定位激光线, 患者通过真空垫复位, 消毒、铺巾后, 将3D打印模板借助患者外轮廓特征、定位线、模板对位参考线及摆位激光线准确对位。根据患者骨性标志穿刺定位针, 调整模板至计划位置, 穿刺其余针道至计划深度。行CT扫描确定穿刺针至计划位置, 行术中优化, 后退式植入放射性粒子, CT扫描, 行计划验证。

1.6 术后剂量学验证及计划对比

术后扫描CT图像传输到BTPS, 勾画靶区, 计算剂量学参数包括90%靶体积的最小吸收剂量(D₉₀)、100%处方剂量覆盖的体积占靶体积的百分比(V₁₀₀)、150%处方剂量覆盖的体积占靶体积的百分比(V₁₅₀)、200%处方剂量覆盖的体积占靶体积的百分比(V₂₀₀)、匹配周缘剂量(matched peripheral dose, MPD)、适形指数(conformal index, CI)、靶区外体积指数(external index, EI)等。

1.7 统计学分析

采用SPSS 18.0软件进行统计学处理, 利用配对t检验对术后实际剂量参数结果与术前计划所对应的参数进行比较, P< 0.05为差异有统计学意义。采用Medcalc 15.2.2软件, 通过Bland-Altman法分析术前、术后剂量参数的一致性。

2 结果

患者¹²⁵I放射性粒子植入情况如表2所示, 14例患者, 共15个病灶, 均顺利实施粒子植入手术, 无穿刺到血管或神经、出血量大于10 mL、粒子移位发生。

表2 14例患者¹²⁵I放射性粒子植入情况 Table 2 The 125-iodine seed implantation details of 14 cases (15 lesions)

术前及术后验证参数如表3所示。患者术前和术后剂量学参数行配对t检验如表4所示, 术前和术后GTV体积、D₉₀、V₁₀₀、V₁₅₀、V₂₀₀、mPD、CI等差异均无统计学意义(P> 0.05), EI差异有统计学意义(P< 0.05)。

通过Bland-Altman法分析, 横坐标为各剂量参数术前和术后平均值, 纵坐标为两者的差值, 以差值的均数± 1.96倍差值的标准差为95%一致性可信区间(confidence interval, CI)标绘散点图。如图1所示, D₉₀差值均数为4.0 Gy(95% CI:-6.4~14.4), 6%(1/15)高于95%一致性界限, 显示一致性不佳; D₁₀₀差值均数为-7.7 Gy(95% CI:-22.8~7.4), 6%(1/15)高于95%一致性界限, 显示一致性不佳; V₁₀₀差值均数为-1.7 Gy(95% CI:-3.4~0), 6%(1/15)低于95%一致性界限, 显示一致性不佳; V₁₅₀差值均数为-1.4(95% CI:-3.1~0.3), 6%(1/15)低于95%一致性界限, 显示一致性不佳; V₂₀₀差值均数为-0.1(95% CI:-4.7~4.4), 6%(1/15)高于95%一致性界限, 显示一致性不佳。CI差值均数为 -0.1(95% CI:-0.1~0), 0%(0/15)在95%一致性界限以内, 显示一致性较好。EI差值均数为22.4(95% CI: 4.0~40.9), 0%(0/15)在95%一致性界限以内, 显示一致性较好。

表3 患者15个病灶术前和术后验证参数 Table 3 Preoperative and postoperative dosimetry parameters in target volume of 15 lesions

表4 14例患者术前和术后验证参数比较 Table 4 Comparison of preoperative and postoperative dosimetry parameters in target volume of 14 cases

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图1 患者术前计划与术后实际剂量参数一致性Bland-Altman图Figure 1 Bland-Altman plot of the difference between preoperative planning and postoperative actual dose parameters
Bland-Altman plot showing the difference against the average of preoperative planning and postoperative actual dose parameters with limits of agreement (LoA) (broken lines). Bland-Altman plot of the difference between preoperation and postoperation D₉₀ (A), D₁₀₀ (B), V₁₀₀ (C), V₁₅₀ (D), V₂₀₀ (E), CI (F), and EI (G). CI, conformal index; EI, external index.

3 讨论

锁骨上淋巴结位置特殊, 该处淋巴结转移可导致局部破溃、压迫神经, 引起患者上肢疼痛、肿胀, 严重影响患者生活质量, 放化疗综合治疗为目前有效的治疗手段^[7]。放射治疗野内复发或新发病灶行¹²⁵I 放射性粒子治疗仍是有效的姑息治疗方式^{[8, 9, 10, 11, 12]}。

粒子植入的疗效直接取决于靶区的剂量分布, 但目前粒子植入大都由徒手穿刺, 没有标准的术式, 术后剂量验证很难达到术前计划处方剂量, 且不同术者的穿刺技巧不同, 有很大的不确定性及不可重复性。锁骨、锁骨下动脉、臂丛神经等周围正常组织影响穿刺路径, 使徒手穿刺很难达到术前处方剂量, 盲目穿刺可能导致严重并发症。在3D打印个体化非共面模板引导下¹²⁵I粒子植入可以通过CT数据设计引导柱, 使每个穿刺针道快速、简单达到术前计划穿刺角度及穿刺深度, 降低穿刺难度, 简化穿刺步骤。

国内有学者曾将3D打印模板应用于头颈部复杂病例的永久性组织间近距离治疗, 通过患者外鼻轮廓、耳轮廓对位, 证明此种方法安全可行, 具有插植针定位、定向准确的特点^{[13, 14]}, 但其治疗中仍有部分病灶的模板出现对位误差。本研究采用3D打印个体化非共面模板与CT引导相结合, 大大提高了模板复位情况, 进而提高了穿刺精度, 15块模板均实现准确对位, 与皮肤贴合紧密、位置稳定。

有研究表明, 3D打印个体化非共面模板引导¹²⁵I 放射性粒子的治疗过程中也存在以下缺点:穿刺路径过远时, 会导致针道位置偏移, 引起剂量误差; 器官(肠管、肺)或病灶自身移动、器官自身的充盈状态(胃、膀胱等)均可出现穿刺误差^{[15, 16, 17]}。

锁骨上区部位更适合3D打印个体化非共面模板引导, 此部位有如下优势:(1)病变部位浅表, 不易发生针道偏移; (2)骨性结构明显, 3D模板易于固定, 结合真空垫的固定, 更易复位; (3)3D模板引导可由任意角度进针, 可避开血管、神经及骨结构, 降低手术难度, 减少患者手术时间。

锁骨上区域血管丰富, 本研究通过以下方式避免穿刺到血管而造成出血或放射性粒子游走导致的不必要照射:(1)术前行1 mm层厚增强CT扫描, 充分获取CT信息, 显示颈部血管, 完善术前治疗计划, 设计针道时距血管2 mm以上; (2)通过真空垫, 借助患者外轮廓特征、定位线、模板对位参考线及摆位激光线、穿刺定位针准确对位, 行术中增强CT扫描, 根据术中计划剂量分布, 实时调整针道位置; (3)术后扫描粒子植入区域, 除外粒子移位, 并行术后验证计划。

本研究中, 3D打印个体化非共面模板辅助CT引导¹²⁵I放射性粒子植入治疗锁骨上转移肿瘤的术前和术后剂量学验证表明, D₉₀、mPD、V₁₀₀、V₁₅₀、V₂₀₀、CI等差异均无统计学意义(P> 0.05), 达到术前处方剂量, 同时有较好的适形性, V₁₅₀、V₂₀₀等高剂量体积也与术前计划一致, 限制了高剂量区的范围。术前及术后的体积略有差异, 术后体积较术前略大, 但差异无统计学意义, 可能与以下因素相关:(1)穿刺后病灶血肿, 肿瘤体积术后变大; (2)穿刺后靶区边界模糊, 较难确定靶区, 可能存在勾画误差。患者术后EI较术前小, 差异有统计学意义, 由于EI描述的是靶区外接受超过处方剂量体积占靶区体积的百分比^[18], EI越小说明靶区外体积越小, 我们考虑手术前后的差异为术中优化剂量的结果^{[19, 20]}。经Bland-Altman法分析, 综合考虑系统误差和偶然误差, D₉₀、V₁₀₀、V₁₅₀、V₂₀₀、mPD的一致性欠佳, 表明D₉₀、V₁₀₀、V₁₅₀、V₂₀₀、mPD尚不能完全达到术前计划, CI、EI的一致性较好, 表明剂量曲线能够达致很好的适形性, 且减少靶区外体积受照射。本研究仍存在病例数偏少等问题, 可导致统计误差, 后续需增加样本量。

综上所述, 3D打印个体化非共面模板辅助CT引导¹²⁵I放射性粒子植入治疗锁骨上转移肿瘤的方法安全、可行, 具有穿刺快速、准确的特点, 可明显提高治疗的精确性, 避免插植操作的盲目性, 可达到术前剂量设计要求, 有很好的应用前景。

The authors have declared that no competing interests exist.

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2016

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郭福新, 王俊杰. 低剂量率近距离治疗局限性前列腺癌进展[J]. 癌症进展, 2016, 1(2): 112-117.

在低危的前列腺癌患者中,低剂量率近距离治疗是安全、有效的.低剂量率近距离放疗在低-中危前列腺癌患者治疗中体现出很好的长期预后效果,现已成为主要治疗手段.近距离治疗作为一种微创的治疗手段,更易为临床患者所接受.

... ¹²⁵I放射性粒子持续低剂量率近距离治疗是一种安全、有效、微创的治疗方法^[1,2] ...

2012

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... ¹²⁵I放射性粒子持续低剂量率近距离治疗是一种安全、有效、微创的治疗方法^[1,2] ...

2016

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... 美国近距离放射治疗协会(American Brachytherapy Society, ABS)近期发表的《肺癌胸部近距离放射治疗指南》中也对¹²⁵I放射性粒子治疗给出了指导性建议^[3],表明¹²⁵I放射性粒子治疗实体肿瘤取得了较好的疗效^[4,5,6] ...

2016

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2013

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2015

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2016

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周志国, 甄婵军, 张萍, 等. 食管癌疗后锁骨上淋巴结转移挽救性放疗的临床研究[J]. 中华放射肿瘤学杂志, 2016, 25(8): 813-817.

Objective To evaluate the efficacy of salvage radiotherapy for supraclavicular lymph node metastasis (SLNM) after initial treatment in patients with esophageal cancer. Methods A total of 117 patients with SLNM after radical resection for esophageal cancer were enrolled as subjects from 2006 to 2012. All patients received three-dimensional radiotherapy with 1.8-2.0 Gy per cycle, 5 cycles a week. The survival rates were calculated using the Kaplan-Meier method and analyzed using the log-rank test. The Cox model was used for multivariate analysis. Results The follow-up rate was 100%. In all the patients, the 1-and 3-year overall survival (OS) rates were 38.5% and 14.1%, respectively. The 1-and 3-year OS rates were significantly higher in patients treated with salvage radiotherapy or radiochemotherapy (n=100) than in patients without any salvage treatment (n=17)(42% vs. 18%,P=0.008;17% vs. 0%, P=0.008). The patients treated with radiochemotherapy (n=32) had significantly higher 1-and 3-year OS rates than those treated with radiotherapy alone (n=68)(59% vs. 34%, 36% vs. 11%, P=0.002) or without any salvage treatment (n=17)(59% vs. 18%, 36% vs. 0%, P=0.002). Patients without visceral metastasis (n=80) had significantly higher 1-and 3-year OS rates than those with visceral metastasis (n=37)(44% vs. 27%,P=0.002;22% vs. 0%,P=0.002). Patients with supraclavicular doses of ≥60 Gy in salvage radiotherapy (n=75) had significantly higher 1-and 3-year OS rates than those with supraclavicular doses of vs. 25%,P=0.000;24% vs. 8%,P=0.000). The multivariate analysis using the Cox model showed that supraclavicular doses of ≥60 Gy, mediastinal metastasis, visceral metastasis, and salvage treatment method were independent factors for survival (P=0.001,0.015,0.009,0.025). Conclusions Salvage radiotherapy can improve the survival of patients with SLNM in esophageal cancer. Salvage radiotherapy or radiochemotherapy is highly recommended for patients with SLNM alone. A radiation dose of ≥60 Gy in salvage radiotherapy improves survival in patients.

目的探讨食管癌首次治疗后锁骨上淋巴结转移挽救性放疗的价值。方法收集2006—2012年符合入组条件的117例患者,应用3DRT方式,1.8~2.0Gy/次,5 次/周。Kaplan-Meier法计算生存率并Logrank法检验,Cox模型多因素分析。结果随访率100%。锁骨上淋巴结转移后的1、3年OS率分别为38.5%、14.1%。挽救放疗或放化疗(100例)与未挽救治疗(17例)的1、3年OS率分别为42%、17%与18%、0%(P=0.008);放化疗(32例)的1、3年OS率分别为59%、36%,高于单纯放疗(68例,34%、11%)和未挽救者(17例,18%、0%)(P=0.002);未合并内脏转移(80例)和合并内脏转移(37例)患者1、3年OS率分别为44%、22%和27%、0%(P=0.002);锁骨上挽救放疗剂量结论食管癌锁骨上淋巴结转移挽救性放疗可使患者生存获益,单纯锁骨上淋巴结转移患者建议积极行挽救性放疗或放化疗,挽救性放疗剂量≥60 Gy者可延长生存。

... 3 讨论锁骨上淋巴结位置特殊,该处淋巴结转移可导致局部破溃、压迫神经,引起患者上肢疼痛、肿胀,严重影响患者生活质量,放化疗综合治疗为目前有效的治疗手段^[7] ...

2011

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