根治性同步放化疗联合手术治疗局部晚期宫颈癌的随机对照试验  

Concomitant chemoradiation followed by radical surgery for locally advanced cervicalcancer patients: a randomized controlled trial

作　　者：吴敏[1] 郑建清[1] 黄碧芬 陈明芬[1] 苏菁菁[1] 周云清[3] 黄双英[3] 陈少蓉[3] 李鲁宏[3] WU Min;ZHENG Jianqing;HUANG Bifen;CHEN Mingfen;SU Jingjing;ZHOU Yunqing;HUANG Shuangying;CHEN Shaorong;LI Luhong(Department of Radiation Oncology,the Second Affiliated Hospital of Fujian Medical University,Quanzhou,362000,P.R.China;Department of Obstetrics and Gynecology,Quanzhou Medical College People's Hospital Affiliated,Quanzhou,362000,P.R.China;Department of Obstetrics and Gynecology,the Second Affiliated Hospital of Fujian Medical University,Quanzhou,362000,P.R.China)

机构地区：[1]福建医科大学附属第二医院放射治疗科,福建泉州362000 [2]福建泉州医学高等专科学校附属人民医院妇产科,福建泉州362000 [3]福建医科大学附属第二医院妇产科,福建泉州362000

出　　处：《中国循证医学杂志》2018年第12期1281-1286,共6页Chinese Journal of Evidence-based Medicine

基　　金：福建医科大学附属第二医院苗圃基金项目(编号:2013MP16)

摘　　要：目的比较根治性同步放化疗联合手术与单纯根治性同步放化疗治疗局部晚期宫颈癌的疗效并对患者预后进行多因素分析。方法 2012年6月~2016年12月期间,福建医科大学附属第二医院收治的130例局部晚期宫颈癌患者使用随机数字生成器随机分为试验组和对照组。对照组采用以铂类为基础的根治性同步放化疗;试验组在对照组的基础上,联合采用广泛性全子宫切除术及盆腔淋巴结清扫术,宫旁和阴道组织各切除3 cm。计数资料采用卡方检验,等级计数资料采用Kendall’s tau-b等级资料卡方检验。采用Kaplan-Meier法、Log-rank检验、Cox比例风险模型等方法对患者的生存情况进行比较,并对影响因素进行分析。对失访患者采用意向性治疗分析(ITT分析)。结果本文为该随机对照试验的终期报告。试验组纳入68例患者,对照组纳入62例患者。试验组术后病理资料显示无癌残留率为83.8%(57/68),癌残留率为2.9%(2/68)。试验组和对照组3年(65.6%vs. 59.6%)和4年(52.5%vs. 56.3%)无进展生存率(PFS)的差异无统计学意义(χ~2=0.008,P=0.928)。试验组和对照组3年(80.3%vs. 74.6%)和4年(77.6%vs. 64.9%)总生存率(OS)的差异也无统计学意义(χ~2=0.361,P=0.548)。多因素分析显示,只有肿瘤大小和是否存在宫旁侵犯是显著影响PFS的预后因子(P<0.05);是否存在宫旁侵犯是影响OS的预后因子(P=0.078)。结论是否存在宫旁侵犯是影响局部晚期宫颈癌总生存率的重要因素。因根治性同步放化疗联合手术与单纯根治性同步放化疗治疗局部晚期宫颈癌的PFS率和OS率相当,患者获益并未增加,故目前需选择性并谨慎应用该治疗方法。Objectives To explore the efficacy of simultaneous chemoradiotherapy combined with surgery for locally advanced cervical patients and perform multivariable analysis.Methods A total of 130 cases of patients with locally advanced cervical cancer who were admitted to the Second Affiliated Hospital of Fujian Medical University from lune 2012 to December 2016 were randomly divided into case group and control group.The patients in the control group were treated with platinum-based radical concurrent chemoradiation.In the case group,patients received both treatment in the control group with the addition of extensive hysterectomy and pelvic lymph node dissection.The short-term efficacy and survival outcomes of the two groups were compared.Results The present study was the final report of this randomized controlled trial.68 patients were randomly enrolled into the case group and 50 patients into control group. The non-microscopic residual tumor (non-MRT)rates were 83.8%(57/68)and microscopic residual tumor (MRT)rates were 2.9% (2/68)in the experimental group.There was no significant difference between two groups (X^2=0.008,P=0.928) in 3-year progression-free survival rate(65.6%vs.59.6%)and 4-year progression-free survival rate (52.5%vs.56.3%),And there was no significant difference between two groups (X^2=0.361,P=0.548) in 3-year overall survival rate (80.3%vs.74.6%)and 4-year overall survival rate (77.6%vs.64.9%).Multivariable analysis showed that only tumor size and parametrial invasion were significant prognostic factors of PFS (P<0.05).And only parametrial invasion was a potential prognostic indicator affecting OS (P=0.078).Conclusion Parametrial invasion is an important prognostic factor.Radical concurrent chemoradiotherapy combined with surgical treatment of locally advanced cervical cancer has not significantly improved progression-free survival and overall survival.The treatment regimen should be applied with caution and selectivity.

关 键 词：宫颈癌 化学治疗 放射治疗 手术切除 随机对照试验 

分 类 号：R737.33[医药卫生—肿瘤]