新辅助治疗强化模式改善Ⅱ/Ⅲ期直肠癌患者的疗效  

Efficacy of intensified neoadjuvant therapy regimen in improving outcomes for stage Ⅱ/Ⅲ rectal cancer patients

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作  者:武月 王文玲 王刚 陈唯唯 董洪敏 李国栋 李小凯 WU Yue;WANG Wenling;WANG Gang;CHEN Weiwei;DONG Hongmin;LI Guodong;LI Xiaokai(Department of Abdominal Oncology,the Affiliated Hospital of Guizhou Medical University,Guiyang 550004,Guizhou,China;School of Clinical Medicine,Guizhou Medical University,Guiyang 550004,Guizhou,China)

机构地区:[1]贵州医科大学附属医院腹部肿瘤科,贵州贵阳550004 [2]贵州医科大学临床医学院,贵州贵阳550004

出  处:《贵州医科大学学报》2024年第4期561-568,共8页Journal of Guizhou Medical University

基  金:贵州省教育厅创新群体重大研究项目(黔教合KY字[2018]020)。

摘  要:目的观察新辅助治疗强化模式改善伴高危因素的Ⅱ/Ⅲ期直肠癌患者疗效。方法选取伴高危因素的Ⅱ/Ⅲ期直肠癌患者123例,分为新辅助奥沙利铂(mFOLFOX6)同步放化疗(CRT)组(mFOLFOX6+CRT组,n=60)和单药氟尿嘧啶(5-FU)同步CRT组(5-FU+CRT组,n=63),mFOLFOX6+CRT组患者行盆腔常规分割放疗期间给予2周期mFOLFOX6方案同步化疗,5-FU+CRT组患者盆腔行常规分割放疗期间给予5-FU225 mg/(m^(2)·d)、持续静脉泵入第1~5天/周、连用5周,2组患者均完成术前新辅助同步CRT后5~12周行全直肠系膜切除术(TME),术后4周2组患者行术后辅助化疗;比较2组患者TME术后肿瘤完全缓解(pCR)率、肿瘤降期率、R0切除率、局部复发率、远处转移率、总生存率(OS)及不良反应发生率等。结果与5-FU+CRT组比较,mFOLFOX6+CRT组患者的p CR率升高(20.8%vs 5.9%,P=0.026)、肿瘤降期率升高(77.4%vs60.8%,P=0.067)、R0切除率降低(88.7%vs 92.2%,P=0.742),3年局部复发率降低(3.8%vs 9.8%,P=0.265)、远处转移率降低(17.0%vs 33.5%,P=0.044),及OS升高(71.7%vs 67.4%,P=0.557);调整2组患者p CR率与肿瘤的临床T、N分期及新辅助CRT与手术间隔时间的差异后,mFOLFOX6+CRT组患者更有可能达到p CR[P=0.007,OR值为7.38,95%CI(1.72~31.72)];2组患者治疗期间不良反应、术中及术后并发症发生率比较,差异均无统计学意义(P>0.05)。结论m FOLFOX6同步CRT与标准的5-FU同步CRT相比,可显著提高伴高危因素Ⅱ/Ⅲ期直肠癌患者的近期疗效(pCR率),对远期疗效也有一定改善、能降低远处转移率。Objective To evaluate the efficacy of an intensified neoadjuvant therapy regimen in improving outcomes for stageⅡ/Ⅲrectal cancer patients with high-risk factors.Methods A total of 123 stageⅡ/Ⅲrectal cancer patients with high-risk factors were enrolled and divided into two groups:neoadjuvant mFOLFOX6 concurrent chemoradiotherapy(CRT)group(mFOLFOX6+CRT,n=60)and single-agent 5-fluorouracil(5-FU)concurrent CRT group(5-FU+CRT,n=63).The mFOLFOX6+CRT group received two cycles of mFOLFOX6 concurrent with pelvic conventional fractionated radiotherapy,while the 5-FU+CRT group received 5-FU 225 mg/(m^(2)·d)continuous intravenous infusion on days 1-5 weekly for five weeks during radiotherapy.Both groups underwent total mesorectal excision(TME)5-12 weeks after completing neoadjuvant therapy,followed by adjuvant chemotherapy 4 weeks post-surgery.Pathologic complete response(pCR)rate,tumor downstaging rate,R0 resection rate,local recurrence,distant metastasis,overall survival(OS),and adverse events were compared between groups.Results The mFOLFOX6+CRT group showed significantly higher pCR rate(20.8%vs 5.9%,P=0.026),tumor downstaging rate(77.4%vs 60.8%,P=0.067),and 3-year OS(71.7%vs 67.4%,P=0.557)compared to the 5-FU+CRT group.The mFOLFOX6+CRT group also had lower 3-year local recurrence(3.8%vs 9.8%,P=0.265),distant metastasis(17.0%vs 33.5%,P=0.044),and R0 resection rates(88.7%vs 92.2%,P=0.742).After adjusting for imbalances,the mFOLFOX6+CRT group was more likely to achieve pCR(OR=7.38,95%CI was 1.72-31.72,P=0.007).There were no significant differences in adverse events or surgical complications between groups(P>0.05).Conclusion Compared to standard 5-FU concurrent CRT,neoadjuvant mFOLFOX6 concurrent CRT significantly improves short-term outcomes(pCR rate)and shows potential long-term benefits in reducing distant metastasis for stageⅡ/Ⅲrectal cancer patients with high-risk factors.

关 键 词:直肠癌 高危因素 新辅助m FOLFOX6 同步放化疗 病理完全缓解率 总生存率 

分 类 号:R735.37[医药卫生—肿瘤]

 

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