术前区域动脉化疗联合全身化疗治疗局部晚期直肠癌的Ⅱ期临床研究

PhaseⅡclinical study of preoperative regional arterial chemotherapy combined with systemic chemotherapy in the treatment of patients with locally advanced rectal cancer

目的新辅助放化疗是局部进展期直肠癌(locally advanced rectal cancer,LARC)的标准治疗方案,但该方案具有较强毒副作用,本研究评估术前区域动脉化疗联合全身化疗(preoperative regional arterial chemotherapy combined with systemic chemotherapy,PRAC/SC)方案对LARC患者的有效性及安全性。方法34例LARC患者术前应用两周期PRAC/SC治疗,对PRAC/SC无反应者改行新辅助放化疗,3~4周后手术,术后2~4周开始行术后化疗。术后对局部复发的高危患者应用放化疗。结果所有患者术前均完成两个周期的PRAC/SC。3例巨大肿瘤患者术前改行新辅助放化疗。所有患者均行R0切除。29例患者接受术后治疗:4例接受术后放化疗并完成方案治疗,25例接受术后化疗,18例完成术后化疗。术前和术后3级化疗反应发生率分别为11.76%和24.00%,34例患者中有8例(23.52%)出现术后并发症,6例(17.65%)取得病理完全缓解。中位随访期为19个月(8~28个月),2年无病生存率为81.8%,总生存率为91.7%。结论PRAC/SC方案对局部进展期直肠癌是可行的和有效的,但对于巨大肿瘤患者,PRAC/SC方案结合新辅助放化疗可能是更有效的方法。

Objective Neoadjuvant chemoradiotherapy is the standard treatment for locally advanced rectal cancer(LARC),but it has strong toxic and side effects.This study evaluated the efficacy and safety of preoperative regional arterial chemotherapy combined with systemic chemotherapy(PRAC/SC)for patients with LARC.Methods Thirty-four patients with LARC received two cycles of PAC/SC treatment before operation,and those who did not respond to PAC/SC were transferred to neoadjuvant radiotherapy and chemotherapy.They underwent surgery 3~4 weeks later and received postoperative chemotherapy at 2~4 weeks after surgery.Postoperative radiotherapy and chemotherapy was applied to high-risk patients with local recurrence.Results All patients completed two cycles of PRAC/SC preoperatively.Three patients with giant tumors underwent preoperative neoadjuvant chemoradiotherapy.All patients underwent R0 resection.Twenty-nine patients received postoperative treatment:four received postoperative chemoradiotherapy and completed the regimen;25 received postoperative chemotherapy and 18 completed postoperative chemotherapy.The preoperative and postoperative level 3 chemotherapy response rates were 11.76%and 24.00%,respectively.Postoperative complications occurred in 8 of 34 cases(23.52%),complete pathological remission in 6 of 34 cases(17.65%).The median follow-up period was 19 months(8~28 months),the 2-year disease-free survival rate was 81.8%,and the overall survival rate was 91.7%.Conclusion PRAC/SC regimen is feasible and effective for locally advanced rectal cancer,but for patients with large tumors,the combination of PRAC/SC regimen with neoadjuvant chemoradiotherapy may be a more effective approach.