Objective: The objective of the study was to compare the dose parameter and clinical efficacy of three-dimensional-printed template (3D-PT)-guided and traditional ¹²⁵I seed implantation in treatment of gynecological tumors.
Materials and Methods: A total of 28 patients with gynecological tumors treated with radioactive seed implantation in Hebei General Hospital from January 2016 to December 2018 were retrospectively analyzed. Twelve patients (template group) were guided by 3D-PT and the remaining 16 patients (traditional group) were guided by computed tomography (CT) with traditional technique. Preoperative treatment plan (preplan) was completed through a treatment planning system. In the template group, 3D-PT was printed according to preplan and seeds were implanted under the guidance of 3D-PT and CT. In the traditional group, seeds were implanted under the guidance of single CT directly according to the preplan. Postoperative verification plan (post-plan) was completed. Dose–volume histogram (DVH) was calculated and D80, D90, V90, V100, and V150 were obtained according to DVH. Then, deviation of the dosimetric parameters D80, D90, V90, V100, and V150 between the preplan and postplan were compared within the two groups. The difference and percentage of difference of the above dosimetric parameters between the preplan and postplan within the two groups were calculated using the formula X_d = X_post-plan– X_pre-plan, and X_d% = (X_post-plan– X_pre-plan)/X_pre-plan × 100%. Doses were calculated to determine whether the differences there were statistically significant. Efficacy evaluation was completed according to RECISIT 1.1. Local control rate and effective rate of 2-months postplan were compared between the two groups. Survival analysis was completed by the Kaplan–Meier method. The patients were followed up for 12 months, and their survival rate was calculated and compared.
Results: There was no significant difference between the two groups for all the parameters, except for D80 of the preplan and postplan in the traditional group (P = 0.000). All the differences and percentage of difference were calculated and it was found that the X_d difference of D80 (P = 0.035), D90 (P = 0.023), V90 (P = 0.047), V100 (P = 0.032), and V150 (P = 0.031), as well as the X_d% difference of D80 (P = 0.032), D90 (P = 0.034), V90 (P = 0.042), V100 (P = 0.036), and V150 (P = 0.044) of the two groups was statistically significant, thus indicating that the dosimetric parameter fluctuation in the template group was more stable. The result of the curative effect after 2 months were as follows: the local control rate and effective rate of the template group were 100% (12/12) and 83.3% (10/12), while those of the traditional group were 100% (16/16) and 81.2% (13/16). There was no statistically significant difference in the curative effect between the two groups. After 6–27 months (median = 12 months) of follow-up, the median survival time of the template group and traditional group were 17 (10–23) and 16 (11–20) months, respectively, and the 1-year overall survival rate was 63% and 79% (P = 0.111), respectively, with no statistically significant difference observed.
Conclusion: 3D-PT-guided ¹²⁵I seed implantation is safe and effective in the treatment of gynecological tumors.


中文翻译：

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3D打印模板引导与传统125I种子植入治疗妇科肿瘤的比较：剂量学和疗效研究


目的：本研究的目的是比较三维打印模板（3D-PT）引导下与传统¹²⁵ I 粒子植入治疗妇科肿瘤的剂量参数和临床疗效。
材料和方法：回顾性分析2016年1月至2018年12月在河北省总医院接受放射性粒子植入术治疗的28例妇科肿瘤患者。12 名患者（模板组）采用 3D-PT 引导，其余 16 名患者（传统组）采用传统技术进行计算机断层扫描（CT）引导。术前治疗计划（preplan）是通过治疗计划系统完成的。在模板组中，按照预先计划打印3D-PT，并在3D-PT和CT的指导下植入种子。传统组在单次CT引导下直接按照预案植入种子。完成术后验证计划（post-plan）。计算剂量-体积直方图 (DVH) 并根据 DVH 获得 D80、D90、V90、V100 和 V150。然后，比较两组剂量学参数D80、D90、V90、V100和V150在计划前和计划后的偏差。使用公式X计算两组内上述剂量学参数的差异和差异百分比_d = X_后计划– X_前计划，并且 X _d % = (X_后计划– X_前计划)/X_前计划× 100%。计算剂量以确定差异是否具有统计学意义。根据 RECISIT 1.1 完成疗效评估。比较两组的局部控制率和计划后2个月的有效率。生存分析通过 Kaplan-Meier 方法完成。对患者进行12个月的随访，计算并比较其生存率。
结果：除传统组preplan和postplan的D80外，两组各参数均无显着差异（P = 0.000）。所有的差异和差的百分比计算，并将其结果发现，X _d D80的差异（P = 0.035），D90（P = 0.023），V90（P = 0.047），V100（P = 0.032），和V150（P = 0.031），以及作为X _d％D80的差异（P = 0.032），D90（P = 0.034），V90（P = 0.042），V100（P = 0.036），和V150（P= 0.044) 两组均有统计学意义，说明模板组剂量学参数波动较为稳定。2个月后的疗效结果如下：模板组局部控制率和有效率分别为100%（12/12）和83.3%（10/12），而传统组为100% (16/16) 和 81.2% (13/16)。两组疗效差异无统计学意义。随访6-27个月（中位数=12个月）后，模板组和传统组的中位生存时间分别为17（10-23）和16（11-20）个月，1年总生存率分别为 63% 和 79% ( P = 0.111)，没有观察到统计学上的显着差异。
结论： 3D-PT引导下¹²⁵ I粒子植入治疗妇科肿瘤安全有效。