中华放射医学与防护杂志

左扬松,沈文沂,濮娟,等.Ⅲ_a-pN₂非小细胞肺癌术后同步放化疗与单纯化疗随机对照研究[J].中华放射医学与防护杂志,2014,34(3):196-200.Zuo Yangsong,Shen Wenyi,Pu Juan,et al.Comparison of efficacy for postoperative chemotherapy and concurrent radiochemotherapy in patients with Ⅲ_a-pN₂ non-small cell lung cancer：a randomized controlled trial[J].Chin J Radiol Med Prot,2014,34(3):196-200

Ⅲ_a-pN₂非小细胞肺癌术后同步放化疗与单纯化疗随机对照研究

Comparison of efficacy for postoperative chemotherapy and concurrent radiochemotherapy in patients with Ⅲ_a-pN₂ non-small cell lung cancer：a randomized controlled trial

投稿时间：2013-07-15

DOI：10.3760/cma.j.issn.0254-5098.2014.03.010

中文关键词: 非小细胞肺癌手术 Ⅲ_a-pN₂期术后放化疗生存

英文关键词:Non-small cell lung cancer Surgery Ⅲ_a-pN₂ Postoperative concurrent radiochemotherapy Survival

基金项目:

作者	单位	E-mail
左扬松	223400 涟水, 江苏省涟水县人民医院放疗科
沈文沂	223400 涟水, 江苏省涟水县人民医院放疗科
濮娟	223400 涟水, 江苏省涟水县人民医院放疗科
嵇建	南京医科大学附属淮安第一医院
陶光州	南京医科大学附属淮安第一医院
嵇建国	江苏省淮安市肿瘤医院
苏锡龙	江苏省淮安市第二人民医院
朱卫国	南京医科大学附属淮安第一医院
徐达夫	南京医科大学附属淮安第一医院	jshaxdf@126.com

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中文摘要:

目的通过随机对照研究、比较非小细胞肺癌（NSCLC）患者放化疗（POCRT）和单纯化疗（POCT）的疗效。方法对术后140例病理分期为Ⅲ_a-pN₂的NSCLC患者用随机信封法分为POCRT组和POCT组，每组70例。两组化疗方案均采用紫杉醇和顺铂，共化疗4个周期。在第1、21、43、64天给予紫杉醇175 mg/m²，顺铂60 mg/m²静脉滴注。POCRT组在化疗的第1天给予同期放疗，50.4 Gy/28次。结果 POCRT组5年总生存率为37.9%；POCT组5年总生存率为27.5%，POCRT组死亡风险比为0.69（95%CI，0.457~1.044，χ²=3.224，P>0.05）。POCRT组5年无复发生存率为30.3%；POCT组5年无复发生存率为18.8%，POCT组复发风险比为1.49（95%CI，1.008~2.204，χ²=4.193，P<0.05）。亚组分析显示POCRT组能明显提高pN₂淋巴结≥2枚患者总生存率（χ²=5.308，P<0.05）。POCRT组复发率（χ²=5.308，P<0.05）和远处转移率（χ²=3.840，P<0.05）均显著低于POCT组。POCRT组1例患者死于脓毒血症，POCRT组发生3，4级放射性食管炎高于POCT组（χ²=8.010，P<0.05），两组血液学毒性相似且可耐受。结论和POCT相比，POCRT能减少 Ⅲ_a-pN₂的非小细胞肺癌患者的局部复发率和远处转移率，提高无复发生存率，POCRT未能提高总生存率。

英文摘要:

Objective To compare the efficacy of postoperative concurrent radiochemotherapy (POCRT) and postoperative chemotherapy (POCT) alone on Ⅲ_a-pN₂ non-small cell lung cancer (NSCLC).Methods A total of 140 postoperative patients with Ⅲ_a-pN₂ NSCLC were randomly divided into 2 equal groups: POCRT and POCT groups. For chemotherapy paclitaxel at a dose of 175 mg/m² and cisplatin a dose of 60 mg/m² were injected intravenously at 1, 22, 43, and 64 d. Totally 4 cycles were adopted with an interval of 21 d. The patients in the POCRT group additionally received radiotherapy (50.4 Gy/28 times) at 1 d of treatment. Follow-up was conducted at least 5 years or until the death of the patients. Results The 5-year overall survival rate of the POCRT group was 37.9%, and the POCT group was 27.5%. The hazard ratio for death of the POCRT group was 0.69 (95% CI: 0.457-1.044, χ²=3.224,P>0.05). The 5-year relapse-free survival rate of the POCRT group was 30.3%, and the POCT group was 18.8%. The recurrence hazard ratio of the POCT group was 1.49 (95%CI: 1.008-2.204, χ²=4.193,P<0.05). Subgroup analysis revealed that POCRT significantly increased the overall survival rate of the patients with ≥2 pN₂ lymph nodes (χ²=5.308,P<0.05). The POCRT group had a significantly lower relapse (χ²=5.308,P<0.05) and distant metastasis (χ²=3.840,P<0.05) rates as compared to that of the POCT group. One case died of pyemia and 9 cases who suffered from grades 3 or 4 radiation esophagitis. These 2 groups showed similar and tolerable hematologic toxicities. Conclusions Compared with POCT, POCRT significantly reduces the local relapse and distant metastasis rates, and increases the relapse-free survival rate of the patients with Ⅲ_a-pN₂ NSCLC, however, it fails to raise the overall survival rate.

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