Ⅲ期非小细胞肺癌手术与非手术综合治疗对照性临床研究

Evaluation on survival in locally advanced non-small cell lung cancer (NSCLC) for multimodality treatment with or without operation

背景与目的局部晚期非小细胞肺癌的综合治疗中手术加入是否对生存期有益仍无定论。本研究的目的是评价Ⅲ期非小细胞肺癌综合治疗计划中有手术加入和无手术加入的生存期之差别。方法自1992年5月至1999年5月,114例局部晚期非小细胞肺癌被分成两组。A组:共56例,ⅢA期39例,ⅢB期17例;中位KPS为80(70～90);综合治疗计划包括手术、化疗、放疗和中医药治疗;术式:肺叶切除加纵隔淋巴结系统清扫或淋巴结取样49例,袖式切除加纵隔淋巴结清扫5例,右侧全肺切除2例;术前或术后辅助化疗方案包括MVP、NP、TC及GP等,每4周重复,共4～6周期;肺内病灶或纵隔野放射治疗总剂量5000～6000cGy。B组:共58例,ⅢA期23例,ⅢB期35例;中位KPS为70(60～90);综合治疗计划除不作手术外,其余大致与A组相同。结果A组:①随访期内转移部位依次为淋巴结、胸膜肺、骨、脑、肝、心包、皮肤和肾上腺;②中位存活时间27个月,1、2、5年生存率分别为82.1%、60.7%和25.0%。B组:①随访期内转移部位依次为淋巴结、胸膜肺、骨、脑、肝、心包、皮肤、肾上腺、胰腺和食管;②中位存活时间13个月,1、2、5年生存率分别为53.4%、31.0%和1.7%。A组中位生存期明显优于B组(P=0.0001),两组间1、2、5年生存率差异亦均有统计学意义(χ2=9.4,P<0.01;χ2=8.9,P<0.01;χ2=11.5,P<0.01)。结论局部晚期非小细胞肺癌的综合治疗有手术加入者与不手术者相比,前者可明显改善生存期。

Background and objective It is uncertain that the effect of multimodality treatment with operation on survival for locally advanced non small cell lung cancer （NSCLC）. The aim of this study is to evaluate the effect of multimodality treatment with or without operation on survival for locally advanced NSCLC. Methods From May 1992 to May 1999, 114 patients with locally advanced NSCI.C were divided into two arms. Arm A （n-56）： 39 cases were at stage Ⅲ A, and 17 at stage ⅢB; Median KPS was 80 （range from 70 to 90 ） ; Multimodality treatment program included operation, chemotherapy, radiotherapy and traditional Chi- nese herb medicine. Of them, lobectomy plus mediastinal systematic lymph node dissection or lymph node sampling accounted for 49 cases, sleeve lobectomy plus mediastinal lymph node dissection for 5 cases, and pneumonectomy for 2 cases. Preoperative or adjuvant chemotherapy regimens included MVP （mitomycin C, vindesine, cisplatin）, NP （vinorelbine, cisplatin）, TC （paclitaxel, carboplatin）, GP （gemcitabine, cisplatin）, which were repeated every 4 weeks for 4-6 cycles. Total dose of radiotherapy for lesions in the lung or medias tinal field was 5000 6000 cCy. Arm B （n 58） ： 23 cases were at stage Ⅲ A, and 35 at stage ⅢB：, Median KPS was 70 （range from 60 to 90）; Treatment program was the same approximately as arm A except for no operation. Results Arm A： ① Metastatic locations in follow-up, in turn, showed as： lymph node, pleural-lung, bone, brain, liver, pericardium, skin and adrenal; @ Median survival was 27 months, and 1-, 2- and 5- year survival rate was 82. 1%, 60.7% and 25.0% respectively. Arm B： ①Metastatic locations in follow-up, in turn, showed as： lymph node, pleural- lung, bone, brain, liver, pericardium, skin, adrenal, pancreaticand esophageal metastasis; ② Median survival was 13 momhs, and 1 , 2 and 5-year survival rate was 53.4%, 31.0% and 1.7% respectively. Median survival duration of Arm A was significantly superior to Arm B （P= 0.0001）. There were significant differences in 1-, 2 and 5 year survival rate between the two groups （x^9.4, P〈0.01; x^2=8.9, P〈0.01;x^2=11. 5, P〈0.01）. Conclusion Compared with non-operative muhimodality treatment, operative muhimodality treatment including lobectomy or pneumonectomy with mediastinal lymph node dissection can remarkably improve the survival in patients with locally advanced NSCLC.