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

• 1:贵州医科大学附属医院腹部肿瘤科
• 2:贵州医科大学临床医学院

摘要(Abstract)：

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(m FOLFOX6)同步放化疗(CRT)组(m FOLFOX6+CRT组，n=60)和单药氟尿嘧啶(5-FU)同步CRT组(5-FU+CRT组，n=63),m FOLFOX6+CRT组患者行盆腔常规分割放疗期间给予2周期m FOLFOX6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(p CR)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，m FOLFOX6+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，m FOLFOX6+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(p CR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 of123 stageⅡ/Ⅲrectal cancer patients with high-risk factors were enrolled and divided into two groups:neoadjuvant m FOLFOX6 concurrent chemoradiotherapy (CRT) group (m FOLFOX6+CRT,n=60) and single-agent 5-fluorouracil (5-FU) concurrent CRT group (5-FU+CRT,n=63).The m FOLFOX6+CRT group received two cycles of m FOLFOX6 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 (p CR) rate,tumor downstaging rate,R0 resection rate,local recurrence,distant metastasis,overall survival (OS),and adverse events were compared between groups.Results The m FOLFOX6+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 m FOLFOX6+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 m FOLFOX6+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 m FOLFOX6 concurrent CRT significantly improves short-term outcomes (p CR rate) and shows potential long-term benefits in reducing distant metastasis for stageⅡ/Ⅲrectal cancer patients with high-risk factors.

关键词(KeyWords)： 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
rectal cancer;high-risk factors;neoadjuvant m FOLFOX6;concurrent chemoradiotherapy;pathologic complete response rate;overall survival rate

Abstract:

Keywords:

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

作者(Author): 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

DOI: 10.19367/j.cnki.2096-8388.2024.04.012

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