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潘忠勉, 陈琦, 李力. 伴中危风险因素ⅠB~ⅡA期宫颈鳞癌辅助化疗与同步放化疗预后的前瞻随机对照研究[J]. 肿瘤防治研究, 2021, 48(7): 714-718. DOI: 10.3971/j.issn.1000-8578.2021.20.0905
引用本文: 潘忠勉, 陈琦, 李力. 伴中危风险因素ⅠB~ⅡA期宫颈鳞癌辅助化疗与同步放化疗预后的前瞻随机对照研究[J]. 肿瘤防治研究, 2021, 48(7): 714-718. DOI: 10.3971/j.issn.1000-8578.2021.20.0905
PAN Zhongmian, CHEN Qi, LI Li. Prognosis of Stage ⅠB-ⅡA Cervical Squamous Cell Carcinoma Patients with Intermediate Risk Factors Treated with Adjuvant Chemotherapy Versus Concurrent Chemoradiotherapy: A Prospective Randomized Controlled Trial[J]. Cancer Research on Prevention and Treatment, 2021, 48(7): 714-718. DOI: 10.3971/j.issn.1000-8578.2021.20.0905
Citation: PAN Zhongmian, CHEN Qi, LI Li. Prognosis of Stage ⅠB-ⅡA Cervical Squamous Cell Carcinoma Patients with Intermediate Risk Factors Treated with Adjuvant Chemotherapy Versus Concurrent Chemoradiotherapy: A Prospective Randomized Controlled Trial[J]. Cancer Research on Prevention and Treatment, 2021, 48(7): 714-718. DOI: 10.3971/j.issn.1000-8578.2021.20.0905

伴中危风险因素ⅠB~ⅡA期宫颈鳞癌辅助化疗与同步放化疗预后的前瞻随机对照研究

Prognosis of Stage ⅠB-ⅡA Cervical Squamous Cell Carcinoma Patients with Intermediate Risk Factors Treated with Adjuvant Chemotherapy Versus Concurrent Chemoradiotherapy: A Prospective Randomized Controlled Trial

  • 摘要:
    目的 比较辅助化疗与同步放化疗对伴中危风险因素ⅠB~ⅡA期宫颈鳞癌患者预后的影响,探讨术后辅助化疗的安全有效性。
    方法 选取广西医科大学附属肿瘤医院190例患者,随机分为两组:单纯化疗组(CT组95例)和同步放化疗组(CCRT组95例),失访10例。生存率计算和生存曲线比较采用Kaplan-Meier生存分析法和Log rank检验,并采用Cox比例风险回归模型进行多因素分析。
    结果 中位随访36.7月,主要终点可评估的患者共180例。分别有3.30%(CT组)及10.11%(CCRT组)的患者出现了G3/G4级的血液学不良反应(P=0.019);4.40%(CT组)及17.98%(CCRT组)的患者出现了严重的胃肠道不良反应(P=0.000),22.48%发生放疗相关的不良反应。两组间的局部复发率(P=0.317)及远处复发率(P=0.224)差异无统计学意义。PFS及OS在两组间亦无显著的统计学差异。
    结论 伴中危风险因素ⅠB~ⅡA期宫颈鳞癌患者术后化疗与同步放化疗的疗效无显著差别,但不良反应较同步放化疗显著减少。

     

    Abstract:
    Objective To compare the prognosis of stage ⅠB-ⅡA cervical squamous cell carcinoma patients with intermediate risk factrs between adjuvant chemotherapy and concurrent chemoradiotherapy, and to explore the safety and effectiveness of adjuvant chemotherapy after surgery.
    Methods A total of 190 patients treated at the Affiliated Cancer Hospital of Guangxi Medical University were selected and randomly divided into two groups: chemotherapy group (CT group, n=95) and concurrent chemoradiotherapy group (CCRT group, n=95). Ten patients lost to follow-up. Kaplan-Meier method and Log rank test were used for OS calculation and survival curve comparison. Cox proportional-hazards regression model was used for multivariate analysis.
    Results After a median follow-up of 36.7 months, 190 patients were evaluable. The incidence of G3/G4 blood system toxicity were 3.3% in CT group and 10.11% in CCRT group (P=0.019), the incidence of severe gastrointestinal toxicity were 4.4% in CT group and 17.98% in CCRT group, the incidence of radiation-related response was 22.48%. There was no significant difference in the local recurrence rate or distant recurrence rate between two groups (P > 0.05). There was no statistically significant difference in PFS and OS between two groups (P > 0.05).
    Conclusion There is no significant difference between postoperative chemotherapy and concurrent chemoradiotherapy on stage ⅠB-ⅡA cervical squamous cell carcinoma patients with intermediate risk facfors, but the adverse reactions of postoperative chemotherapy are significantly reduced compared with concurrent chemoradiotherapy.

     

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