Combination chemotherapy of gemcitabine and cisplatin by double way plus implantation of radioactive seed 125I in treating stage Ⅲ non-small cell lung cancer

Objective To assess the therapeutic effect of combination chemotherapy of gemcitabine and cisplatin by double way plus implantation of radioactive seed 125I implantation in treating stage Ⅲ non-small cell lung cancer. Methods Sixty cases with stage Ⅲ non-small cell lung cancer were randomly divided into two groups with random number table. In group A (in interventional treatment group, n = 30),the gemcitabine 1000 mg/m2 and one third of the cisplatin 100 mg/m2 was given using seldinger technique for transcatheter bronchial arterial infusion chemotherapy on day 1. Two-thirds of the cisplatin 100 mg/m2 was infused in veins on day 2 and 3. The gemcitabine 1000 mg/m2 was infused in veins on day 8, 21 days for a period. In group B (interventional - 125I groups), the method of combination chemotherapy of gemcitabine and cisplatin was the same as in Group A. After ten days of arterial perfusion, 125I seeds were implantated, 21 days for a period. All patients received at least 2 cycles. The imaging evaluation of patients after treatment standards included complete remission (CR), partial remission (PR), stable (SD),progressive disease (PD), effective rate (CR + PR)/30 and clinical benefit rate (CR + PR + SD)/30.Non-parametric rank sum test was used to compare short-term effect of the two groups treatment of two cycles.x2 test was used to compare year survival, Kaplan-Meier method was used to calculate median survival,log-rank test method was used to difference between the groups. Results In group A, there were 17 PR,9SD and 4 PD. The overall response rate was 56. 7% (17/30) and clinical beneficial rate was 86. 7% (26/30). In Group B, there were 2 CR, 21 PR, 7 SD. The overall response rate was 76.7% (23/30) and clinical beneficial rate was 100% (30/30). There was significant difference between the two groups (P =0. 036). In group A, the 1 year survival rate was 46. 7% (14/30) and the 2 year survival rate was 36. 7%(11/30), median survival time (MST) was 10 months . In group B, the 1 year survival rate was 76. 7%(23/30) and the 2 year survival rate was 63. 3% (19/30) , median survival time (MST) was 27 months.There was a significant difference between two group in 1 year survival rate (P = 0. 017), 2 year survival rate (P = 0. 039) and median survival time (P = 0. 006). Conclusion The treatment effects of Ⅲ stage non-small cell lung cancer by gemcitabine and cisplatin combination chemotherapy with double way plus radioactive seed 125I implantation was better than gemcitabine and cisplatin combination chemotherapy with double way.     

吉西他滨、顺铂双路径用药联合125Ⅰ粒子植入治疗Ⅲ期非小细胞肺癌的临床对照研究

目的 探讨吉西他滨、顺铂双路径用药联合125I粒子植入治疗Ⅲ期非小细胞肺癌的价值.方法 60例Ⅲ期非小细胞肺癌患者应用随机数字表法随机分为两组.A组(血管介入组)30例,第1天采用Seldinger法插管进行支气管动脉化疗灌注.用药剂量:吉西他滨1000 mg/m2;顺铂100 mg/m2,第1天灌注时取总量的1/3.余量顺铂于第2天和第3大静脉滴注.第8天吉西他滨1000 mg/m2静脉滴注,21 d为1个疗程.B组(血管介入+125I粒子植入组)30例,双路径用药同A组,于动脉灌注后第10天行局麻下125I粒子植入术,21 d为1个疗程.两组均至少完成2个疗程评价.患者治疗后的影像评价标准为完全缓解(CR)、部分缓解(PR)、稳定(SD)、进展(PD).有效率为(CR+PR)/30,临床获益率为(CR+PR+SD)/30.采用非参数秩和检验比较A、B组的近期疗效(治疗2个疗程),x2检验比较年生存率,Kaplan-Meier法计算中位生存期、log-rank法检验组间中位生存期差异.结果 近期疗效.A组:PR 17例,SD稳定9例,PD 4例,有效率为56.7%(17/30),临床获益率为86.7%(26/30);B组:CR 2例,PR 21例,SD 7例,有效率为76.7%(23/30),临床获益率为100%(30/30).B组效果优于A组,差异有统计学意义(P=0.036).1年生存率B组(76.7%,23/30)高于A组(46.7%,14/30),差异有统计学意义(P=0.017).2年生存率B组(63.3%,19/30)高于A组(36.7%,11/30),差开有统计学意义(P=0.039).B组中位生存期(27个月)高于A组(10个月),组间差异有统计学意义(P=0.006).结论 吉西他滨、顺铂双路径用药联合125I粒子植入治疗Ⅲ期非小细胞肺癌的疗效明显优于单纯同方案双路径用药的疗效.

Abstract：

Objective To assess the therapeutic effect of combination chemotherapy of gemcitabine and cisplatin by double way plus implantation of radioactive seed 125I implantation in treating stage Ⅲ non-small cell lung cancer. Methods Sixty cases with stage Ⅲ non-small cell lung cancer were randomly divided into two groups with random number table. In group A (in interventional treatment group, n = 30),the gemcitabine 1000 mg/m2 and one third of the cisplatin 100 mg/m2 was given using seldinger technique for transcatheter bronchial arterial infusion chemotherapy on day 1. Two-thirds of the cisplatin 100 mg/m2 was infused in veins on day 2 and 3. The gemcitabine 1000 mg/m2 was infused in veins on day 8, 21 days for a period. In group B (interventional - 125I groups), the method of combination chemotherapy of gemcitabine and cisplatin was the same as in Group A. After ten days of arterial perfusion, 125I seeds were implantated, 21 days for a period. All patients received at least 2 cycles. The imaging evaluation of patients after treatment standards included complete remission (CR), partial remission (PR), stable (SD),progressive disease (PD), effective rate (CR + PR)/30 and clinical benefit rate (CR + PR + SD)/30.Non-parametric rank sum test was used to compare short-term effect of the two groups treatment of two cycles.x2 test was used to compare year survival, Kaplan-Meier method was used to calculate median survival,log-rank test method was used to difference between the groups. Results In group A, there were 17 PR,9SD and 4 PD. The overall response rate was 56. 7% (17/30) and clinical beneficial rate was 86. 7% (26/30). In Group B, there were 2 CR, 21 PR, 7 SD. The overall response rate was 76.7% (23/30) and clinical beneficial rate was 100% (30/30). There was significant difference between the two groups (P =0. 036). In group A, the 1 year survival rate was 46. 7% (14/30) and the 2 year survival rate was 36. 7%(11/30), median survival time (MST) was 10 months . In group B, the 1 year survival rate was 76. 7%(23/30) and the 2 year survival rate was 63. 3% (19/30) , median survival time (MST) was 27 months.There was a significant difference between two group in 1 year survival rate (P = 0. 017), 2 year survival rate (P = 0. 039) and median survival time (P = 0. 006). Conclusion The treatment effects of Ⅲ stage non-small cell lung cancer by gemcitabine and cisplatin combination chemotherapy with double way plus radioactive seed 125I implantation was better than gemcitabine and cisplatin combination chemotherapy with double way.     

125I粒子植入联合化疗治疗同期放化疗后局部复发的Ⅲ期非小细胞肺癌

目的 探讨125I粒子植入联合化疗治疗同期放化疗后局部复发的Ⅲ期NSCLC的临床疗效.方法 2006年1月至2009年1月同期放化疗后局部复发的Ⅲ期NSCLC患者34例,按随机数字表法分为2组,其中对照组(17例)给予多西他赛60 mg/m2+顺铂75 mg/m2(DP方案),治疗组(17例)行125I粒子植入+ DP方案.用放射性粒子TPS制定125I粒子治疗计划.在CT引导下经皮穿刺植入125I粒子,处方剂量为90 ～ 110 Gy,术后即刻验证肿瘤匹配周边剂量(mPD),覆盖90％靶区的剂量(D90).随访至疾病进展.研究经医院伦理委员会批准,患者均签署知情同意书.局部病变控制时间、疾病无进展时间(PFS)分析采用log-rank法,Fisher确切概率法比较2组肿瘤CR率和近期有效率.结果 125I粒子植入术后mPD为93.9～130.4 Gy,中位剂量116.7 Gy;D9o为103.6 ～148.2 Gy,中位剂量130.6 Gy.治疗组局部控制时间为4,7 ～24.0(中位时间11.6;95％ CI:8.7 ～ 14.6)个月,其中2例随访24个月局部病灶无进展;PFS为10.5 (4.7 ～ 24.0;95％ CI:7.4 ～ 13.6)个月,近期有效率为64.7％ (11/17),肿瘤CR率41.2％ (7/17),PR率23.5％ (4/17),SD率23.5％ (4/17),PD率11.8％(2/17).对照组局部控制时间4.5 ～11.4(中位时间为7.5;95％ CI:6.7 ～8.3)个月,PFS为6.5(4.5～10.5;95％ CI:5.7 ～8.3)个月,近期有效率为41.2％ (7/17),CR率5.9％ (1/17),PR率35.3％ (6/17),SD率35.3％ (6/17),PD率23.5％ (4/17).2组近期有效率差异无统计学意义(P=0.30),局部控制时间(x2=8.40,P＜0.01)、PFS(x2=6.27,P＜0.05)、肿瘤CR率(P=0.04)差异均有统计学意义.结论 125I粒子植入联合化疗对治疗放化疗后局部复发的Ⅲ期NSCLC有效、安全,其疗效优于单纯化疗.     

125I粒子植入治疗非小细胞肺癌的护理及辐射防护

肺癌是最常见的肺部原发性恶性肿瘤,由于多数患者就诊时已处于中晚期,瘤体侵犯重要脏器后常影响肿瘤的切除.125I粒子永久性组织间植入治疗是肿瘤近距离放疗的一种新兴方法,有助于肿瘤的整体杀灭,同时保证了脏器的正常生理功能,减少了组织创伤及治疗并发症,提高了患者的生存率.随着放射性粒子植入治疗技术的迅速推广,治疗过程中的辐射威胁也随之而至.目前,对125I粒子的研究局限于治疗手段和效果方面,尚未在术中使用、消毒及防护等方面进行详细研究.虽然能达到疗效是治疗的关键,但是防护的基本原则、具体方式和更新防护技术的研究也不容忽视,其研究结果势必对肿瘤的放射性粒子植入治疗有着重要意义.     

^125 I粒子植入联合化疗对不可手术切除Ⅲ期非小细胞肺癌的临床疗效

目的观察^125 I粒子植入联合吉西他滨和顺铂（简称GP）方案治疗不可手术切除Ⅲ期NSCLC的临床疗效。方法2005年1月至2008年6月的不可手术切除Ⅲ期NSCLC患者39例,给予^125 I粒子植入联合GP方案（按体表面积吉西他滨1000mg／m2,顺铂75mg／m2）化疗（联合组）。采用TPS制定”I粒子植入数量和布源方法,在CT引导下经皮穿刺组织间植人^125 I粒子,处方剂量为110—130Gy,术后应用TPS进行剂量验证。植入术后1周开始化疗。另设同时期39例不可手术切除Ⅲ期NSCLC患者为对照组,行3D—CRT序贯GP方案化疗。所有患者均经病理学检查确诊,化疗后每3个月复查胸部CT,随访24个月。比较2组患者的近期（即治疗开始后3个月）有效率、生存率、生存时间差异,数据分析采用x2检验、Kaplan—Meier法、Log-rank法。结果联合组近期有效率为71．8％（28／39）,与对照组（61．5％,24／39）相比差异无统计学意义（x2=0．93,P〉0．05）,但肿瘤CR率与对照组相比差异有统计学意义（x2=4．48,P〈0．05）;联合组和对照组的1年生存率分别为79．5％（31／39）和66．7％（26／39）,差异无统计学意义（x2=1．57,P〉0．05）,2年生存率分别为41．0％（16／39）和23．1％（9／39）,差异有统计学意义（x2=4．07,P〈0．05）。联合组和对照组的中位生存时间分别为（18．9±2．7）个月和（14．2±0．7）个月,差异有统计学意义（x2=4．63,P〈0．05）。联合组Ⅲ～Ⅳ级放射性肺炎、放射性食管炎及骨髓抑制总发生率和对照组差异有统计学意义（x2=13．94,P〈0．05）。^125I粒子植入术中发生轻度气胸2例,出现术后少量咳血痰2例,无粒子局部脱落者。结论^125I粒子植入联合GP方案化疗治疗不可手术切除Ⅲ期NSCLC有很好的肿瘤CR率及2年生存率;^125I粒子植入是有效的、安全的微创介入治疗方法。     

CT引导~(125)I粒子治疗非小细胞肺癌的辐射防护护理干预

目的 探讨在CT引导下125I粒子植入微创治疗非小细胞肺癌(NSCLC)辐射防护护理干预的措施及注意事项.方法 对89例NSCLC患者实施有计划和验证的125I粒子植入治疗,进行围手术期的全程防护护理干预,观察分析植入治疗的成功率、疗效参数和并发症发生率.结果 科学合理的辐射防护护理干预能保障放射性粒子植入的剂量学分布符合有效和微创的原则,植入治疗成功率达到100%,局部控制有效率为96.7%,1年生存率为92.2%;早期和晚期放射反应发生率分别为14.6%和1.1%.未出现放射性泄漏污染事件.结论 包含全程放疗计划和验证的125I粒子植入疗法,结合科学的辐射防护护理干预措施,对提高NSCLC的疗效和明显降低并发症的发生具有重要的临床价值.     

CT引导下植入125I粒子治疗非小细胞肺癌切除术后局部复发的疗效

目的 探讨CT引导下经皮穿刺植入125粒子近距离内照射治疗非小细胞肺癌(NSCLC)切除术后局部复发的近期效果。方法 术前活检证实为NSCLC、术后局部复发的患者32例,处方剂量为90 Gy,通过CT引导经皮穿刺植入125I粒子。在治疗前和治疗后6个月,根据CT检查比较肿瘤体积,按国际标准判定疗效。中位随访24个月（6...