【摘要】 目的探讨采取新辅助化疗(NACT)联合手术治疗与同步放化疗治疗的国际妇产科联盟(FIGO)临床分期为Ⅱ_B期宫颈癌患者的疗效及其影响因素。方法选取2010年1月至2018年12月,大连医科大学附属第二医院收治的196例Ⅱ_B期宫颈癌患者为研究对象。按照治疗方案,将其分为联合手术治疗组(n=95,采取NACT联合手术治疗)与同步放化疗组(n=101,仅采取同步放化疗)。采用回顾性分析方法,收集2组患者总体生存(OS)期、无进展生存(PFS)期及治疗相关不良反应情况。采用Kaplan-Meier法计算2组患者5年OS率、PFS率等,并采用对数秩检验进行比较。对本研究所有患者的OS期、PFS期影响因素,进行多因素Cox比例风险回归分析。对2组患者的治疗相关不良反应率比较,采用χ~2检验。本研究遵循的程序符合2013年新修订的《世界医学协会赫尔辛基宣言》要求。结果 (1)本研究联合手术治疗组患者的5年OS率、PFS率分别为91.9%与84.0%,均显著高于同步放化疗组的64.2%与64.8%,并且差异均有统计学意义(χ~2=5.920、P=0.015,χ~2=4.560、P=0.033)。(2)对本研究所有患者的OS期与PFS期影响因素的多因素Cox比例风险回归分析结果显示,治疗方式是其OS期的独立影响因素(HR=0.267,95%CI:0.094～0.758,P=0.013);治疗方式、肿瘤组织病理类型、肿瘤细胞分化程度、肿瘤直径、患者年龄,均非其PFS期的独立影响因素(P>0.05)。(3)对联合手术治疗组患者OS期与PFS期影响因素的多因素Cox比例风险回归分析结果显示,手术切缘情况为其OS期、PFS期的独立影响因素(HR=0.027,95%CI:0.003～0.281,P=0.003;HR=0.004,95%CI:0.000～0.197,P=0.006)。(4)联合手术治疗组患者的放射性膀胱炎发生率为4.2%(4/95),显著低于同步放化疗组的13.9%(14/101),并且差异有统计学意义(χ~2=5.467、P=0.019)。结论对于Ⅱ_B期宫颈癌患者采取术前NACT,再联合手术治疗的疗效优于同步放化疗。采取NACT联合手术治疗患者的手术切缘情况,为其OS期、PFS期的独立影响因素。由于本研究仅为回顾性研究,仍需多中心、大样本、随机对照试验进一步证实NACT联合手术治疗该病患者的疗效及其影响因素。更多还原

【Abstract】 Objective To explore the efficacy of neoadjuvant chemotherapy(NACT) combined with surgery and concurrent radiochemotherapy in the treatment of cervical cancer patients with International Federation of Gynecology(FIGO) clinical stage Ⅱ_B and its influencing factors. Methods From January 2010 to December 2018, a total of 196 cervical cancer patients with stage Ⅱ_B who were treated in the Second Affiliated Hospital of Dalian Medical University were selected as research subjects. According to different treatment protocols, they were divided into combined with surgical treatment group(n=95, received NACT combined with surgical treatment) and concurrent radiochemotherapy group(n=101, received concurrent radiochemotherapy only). Retrospective analysis was used to collect overall survival(OS) time, progression-free survival(PFS) time and treatment-related adverse reactions of patients in two groups. The 5-year OS rate and PFS rate of patients in two groups were calculated by Kaplan-Meier method, and was compared by log-rank test. Multivariate Cox proportional hazards regression analysis was performed on analyzing influencing factors of OS time and PFS time of all patients. The incidence of treatment-related adverse reactions between two groups was compared by chi-square test. The procedure followed in this study complied with World Medical Association Declaration of Helsinki revised in 2013. Results(1)The 5-year OS rate and PFS rate of combined surgical treatment group were 91.9% and 84.0%, respectively, which were significantly higher than 64.2% and 64.8% of concurrent radiochemotherapy group, the differences were statistically significant between two groups(χ~2=5.920, P=0.015; χ~2=4.560, P=0.033).(2)The results of multivariate Cox proportional hazard regression analysis of OS and PFS time of all patients in this study showed that treatment method is an independent influencing factor for OS time of these patients(HR=0.267, 95%CI: 0.094-0.758, P=0.013); while treatment methods, pathological types, tumor differentiation, tumor diameter, and age were not independent influencing factors of PFS time of these patients(P>0.05).(3)The multivariate Cox proportional hazard regression analysis of OS and PFS time of patients in combined surgical treatment group showed that surgical margin status was an independent influencing factor for OS and PFS time of these patients(HR=0.027, 95%CI: 0.003-0.281, P=0.003; HR=0.004, 95%CI: 0.000-0.197, P=0.006).(4)The incidence of radiation cystitis of combined surgical treatment group was 4.2%(4/95), which was significantly lower than 13.9%(14/101) of concurrent radiochemotherapy group, and the difference was statistically significant(χ~2=5.467, P=0.019). Conclusions For cervical cancer patients with stage Ⅱ_B, preoperative NACT combined with surgical treatment can get better therapeutic effect than those of concurrent radiochemotherapy. For patients undergoing NACT combined with surgery, the status of surgical margin is an independent influencing factor for OS Time and PFS time of these patients. As this study is just a retrospectively study, multi-center, large-sample, and randomized controlled trials are still needed to further confirmed the efficacies of NACT combined with surgery and its influencing factors.更多还原