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目的:明确手术治疗在ⅡB～ⅢA期小细胞肺癌(SCLC)综合治疗中的临床价值。方法:本研究为非随机对照试验。采用目的抽样法选取2014年1月至2020年10月于浙江大学医学院附属第一医院初治的107例ⅡB～ⅢA期SCLC患者，依据患者综合治疗方案中是否行手术切除分为手术组(24例)和非手术组(83例)。收集和比较2组患者的一般资料，包括性别、年龄、TNM分期和吸烟史。随访时间(9.16±0.44)年，随访截至2024年2月23日。比较2组相同TNM分期患者的1年、2年、3年和5年生存率，以及总生存期(OS)和无进展生存期(PFS)。采用Kaplan-Meier法绘制生存曲线，Log-rank检验比较2组相同TNM分期患者的总生存率和无进展生存率。采用Cox比例风险模型进行单因素和多因素分析，探究影响SCLC患者OS和PFS的独立因素。结果:本研究纳入的107例患者中男女比例为95∶12，年龄(62.84±7.34)岁。手术组中ⅡB期患者14例、ⅢA期患者10例，非手术组中ⅡB期患者15例、ⅢA期患者68例。2组患者性别、年龄和吸烟史情况比较差异均无统计学意义(均 P>0.05)，但TNM分期分布比较差异有统计学意义( χ2＝15.27， P<0.001)。手术组与非手术组ⅡB期患者的中位OS分别为1 412 d比577 d，ⅢA期患者的中位OS分别为798 d比465 d。手术组ⅡB期、ⅢA期患者的OS均较非手术组同期患者长( Z值分别为2.62、3.06，均 P<0.05)。手术组和非手术组ⅡB期患者的1年、2年、3年和5年生存率分别为100.0%(14/14)比80.0%(12/15)、92.9%(13/14)比40.0%(6/15)、71.4%(10/14)比26.7%(4/15)、28.6%(4/14)比6.7%(1/15)。手术组和非手术组ⅢA期患者的1年、2年、3年和5年生存率分别为100.0%(10/10)比70.6%(48/68)、80.0%(8/10)比25.0%(17/68)、30.0%(3/10)比5.9%(4/68)、20.0%(2/10)比2.9%(2/68)。手术组ⅡB期、ⅢA期患者的总生存率均优于非手术组同期患者( χ2值分别为4.36、8.29，均 P<0.05)。手术组与非手术组ⅡB期患者的中位PFS分别为816 d比388 d，ⅢA期患者的中位PFS分别为535 d比262 d。手术组ⅡB期、ⅢA期患者的PFS均较非手术组同期患者长( Z值分别为2.62、3.06，均 P<0.05)。手术组ⅡB期、ⅢA期患者的无进展生存率均优于非手术组同期患者( χ2值分别为5.29、10.55，均 P<0.05)。非手术参与是影响SCLC患者OS和PFS的独立危险因素[ HR值(95% CI)分别为2.622(1.557～4.413)、3.354(1.943～5.789)，均 P<0.001]。 结论:手术参与的综合治疗与非手术参与的综合治疗相比，可以提高ⅡB～ⅢA期SCLC患者的远期生存率，延长OS和PFS，使患者生存获益。

Objective:To identify the clinical value of surgical treatment in the comprehensive treatment of stage ⅡB-ⅢA small cell lung cancer (SCLC).Methods:It was a non-randomized controlled trial involving 107 patients with stage ⅡB-ⅢA SCLC who were initially treated in the First Affiliated Hospital, Zhejiang University School of Medicine from January 2014 to October 2020 by a purposive sampling method.They were assigned into the surgery group (24 cases) and non-surgery group (83 cases) based on the performance of surgical resection in the comprehensive treatment plan or not.General data, including gender, age, tumour-node-metastasis (TNM) stage and smoking history were collected and compared between the two groups.Patients were followed up for (9.16±0.44) years until February 23, 2024.The 1-year, 2-year, 3-year, and 5-year survival rates, overall survival (OS), and progression-free survival (PFS) in patients with the same TNM stage between groups were compared.Survival curves were plotted using Kaplan-Meier curves, and Log-rank tests were used to compare the OS rate and PFS rate between groups.Univariate and multivariate analyses were performed using Cox proportional risk models to identify the independent factors for OS and PFS in SCLC patients.Results:The male to female ratio of 107 SCLC patients included in this study was 95∶12, and their mean age was (62.84±7.34) years.There were 14 stage ⅡB and 10 stage ⅢA SCLC patients in the surgery group, and 15 stage ⅡB and 68 stage ⅢA SCLC patients in the non-surgery group.No significant differences in the gender, age and smoking history were detected between groups (all P>0.05), but there was a significant difference in the distribution of TNM stage ( χ2=15.27, P<0.001).The median OS in stage ⅡB SCLC patients of surgery group and non-surgery group was 1, 412 d and 577 d, respectively.The median OS in stage ⅢA SCLC patients of surgery group and non-surgery group was 798 d and 465 d, respectively.The OS of stage ⅡB and ⅢA SCLC patients in the surgery group was significantly longer than that of patients in the same tumor stage in non-surgery group ( Z-values of 2.62, and 3.06, respectively, both P<0.05).The 1-year, 2-year, 3-year, and 5-year survival rates of stage ⅡB SCLC patients in the surgery and non-surgery groups were 100.0% (14/14) versus 80.0% (12/15), 92.9% (13/14) versus 40.0% (6/15), 71.4% (10/14) versus 26.7% (4/15), and 28.6% (4/14) versus 6.7% (1/15), respectively.The 1-year, 2-year, 3-year, and 5-year survival rates of stage ⅢA SCLC patients in the surgery and non-surgery groups were 100.0% (10/10) versus 70.6% (48/68), 80.0% (8/10) versus 25.0% (17/68), 30.0% (3/10) versus 5.9% (4/68), and 20.0% (2/10) versus 2.9% (2/68), respectively.The OS rate of both stage ⅡB and ⅢA SCLC patients in the surgery group was significantly better than that of the non-surgery group ( χ2=4.36 and 8.29, respectively, both P<0.05).The median PFS of stage ⅡB SCLC patients in the surgery and non-surgery groups was 816 d and 388 d, respectively.The median PFS of stage ⅢA SCLC patients in the surgery and non-surgery groups was 535 d and 262 d, respectively.The PFS of both stage ⅡB and ⅢA SCLC patients in the surgery group was significantly longer than that of the patients in the non-surgery group ( Z-values of 2.62, and 3.06, respectively, both P<0.05).The PFS rate of both stage ⅡB and ⅢA SCLC patients in the surgery group was significantly better than that of the non-surgery group ( χ2=5.29, and 10.55, respectively, both P<0.05).Non-surgical involvement in the comprehensive treatment plan was an independent risk factor for OS ( HR=2.622, 95% CI: 1.557-4.413) and PFS ( HR=3.354, 95% CI: 1.943-5.789) in SCLC patients (both P<0.001). Conclusions:Surgery-involved comprehensive treatment plan improves long-term survival rate and prolongs OS and PFS of stage ⅡB-ⅢA SCLC patients with a survival benefit, which is superior to the comprehensive treatment plan without surgical resection.