调强放疗联合FOLFOX4方案新辅助治疗局部晚期直肠癌的临床研究

目的 探讨调强放疗联合FOLFOX4方案新辅助治疗局部晚期直肠癌的客观有效率、病理缓解率及安全性。 方法 63例符合入组标准患者被随机分配到调强放疗联合卡培他滨组(对照组)和调强放疗联合FOLFOX4方案组(试验组),对照组31例患者和试验组32例患者均接受新辅助放化疗,治疗结束时评估近期疗效及毒副反应发生率,新辅助治疗结束6周后接受根治性手术,分析比较2组的病理完全缓解率、保肛率。 结果 入组的63例患者均可评价疗效;试验组完全缓解9例,部分缓解18例,总有效率为84.4%;对照组完全缓解4例,部分缓解19例,总有效率为74.2%,试验组的总有效率高于对照组,但2组差异无统计学意义(P>0.05);试验组病理完全缓解率为34.4%,对照组的病理完全缓解率为12.9%,试验组的病理完全缓解率高于对照组,2组差异有统计学意义(P<0.05);试验组的保肛率为81.3%,对照组的保肛率为58.1%,试验组的保肛率高于对照组,2组差异有统计学意义(P<0.05);2组的毒性反应较轻,血液学毒性主要为白细胞下降、贫血及血小板下降,非血液学毒性主要为恶性呕吐、腹泻及外周神经毒性等,均以Ⅰ、Ⅱ级为主,2组差异无统计学意义(P>0.05)。 结论 调强放疗联合FOLOFX4方案新辅助治疗局部晚期直肠癌可以提高总有效率、病理完全缓解率和保肛率,不增加不良反应和并发症,值得临床推广应用。 

A clinical study of intensity-modulated radiation therapy combined with folfox4 regimen as neoadjuvant therapy for locally advanced rectal cancer

Objective To investigate the efficacy and safety of neoadjuvant radiotherapy combined with FOLFOX4 regimen in the treatment of locally advanced rectal cancer. Methods Total 63 patients who met the inclusion criteria were randomly assigned to intensity-modulated radiation therapy (IMRT) combined with capecitabine group (control group, n=31) and IMRT combined with FOLFOX4 regimen group (experimental group, n=32). The efficacy and incidence of adverse reactions at the end of neoadjuvant therapy were evaluated. The radical operation was performed 6 weeks after neoadjuvant therapy, the pathological complete remission rate and anus preservation rate were analyzed and compared. Results The curative effect could be evaluated in all 63 patients. The total effective rate of the experimental group was 84. 4% and of the control group was 74. 2%, the total effective rate of the experimental group was higher than that in the control group, but there was no significant difference between two groups (P > 0. 05); The pathological complete remission rate of the experimental group was 34. 4%, and of the control group was 12. 9%, the rate of experimental group was higher than that in the control group, there was significant difference between two groups (P < 0. 05). The anal preservation rate of the experimental group was 81. 3%, and of the control group was 58. 1%, the rate of experimental group was higher than that in the control group, there was significant difference between two groups (P < 0. 05). The toxicity of the two groups were relatively light, with grade1 and grade2, there was no significant difference between two groups (P > 0. 05). Conclusion Intensity-modulated radiotherapy combined with FOLOFX4 regimen as neoadjuvant therapy for locally advanced rectal cancer can improve the response rate, pathologic complete response rate and anal preservation rate, not increasing the incidence of adverse reactions and complications, worthy of clinical application.