291例局部进展期直肠癌术前新辅助放化疗的临床意义分析

目的 评价局部进展期直肠癌(LARC)术前新辅助放化疗的疗效及安全性。方法 2003—2012年间291例LARC接受了术前新辅助放化疗+手术±术后辅助化疗。放疗为2DRT、3DRT,45~50 Gy分23~25次。化疗方案包括FOLFOX6、XELOX及单药希罗达等,术前化疗2~4周期。放疗结束后3~8周手术,遵循全直肠系膜切除术原则。134例患者术后接受了辅助化疗。Kaplan-Meier法计算OS、DFS、RFS和DMFS等,Logrank法检验和单因素预后分析,Cox模型多因素预后分析。结果 全组均完成术前新辅助放化疗及手术。R0切除率为98.9%,保肛率为53.6%。T降期73.1%,N降期83.6%,临床分期降期79.4%。pCR率为26.8%,3级血液系统反应为7.9%,3级腹泻为7.2%,3级放射性皮炎为2.7%。术后会阴部疼痛占12.3%,伤口延迟愈合占8.2%。随访率94.5%,5年样本量为95例。5年OS、DFS、RFS和DMFS分别为76.6%、72.1%、88.8%和79.7%,5年LR率为7.5%,远处转移率为15.8%。术后病理分期是预后影响因素。结论 术前新辅助放化疗提高了LARC的R0切除率及保肛率,并使肿瘤显著降期,不良反应较轻且未增加手术并发症,LR率低且远期生存率得到改善。术前新辅助放化疗作为LARC标准治疗策略宜推广应用。

Efficacy and safety of preoperative neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer:a clinical analysis of 291 patients

Objective To evaluate the efficacy and safety of neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer (LARC) before surgery. Methods A total of 291 LARC patients who received preoperative chemoradiotherapy and surgery with or without postoperative adjuvant chemotherapy from March 2003 to May 2012 were included in the study. The radiotherapy delivered was two-dimensional conformal radiotherapy (2DRT) and three-dimensional conformal radiotherapy (3DRT), and the total dose ranged from 45 to 50 Gy in 23－25 fractions. All the patients received preoperative chemotherapy including FOLFOX6, XELOX, and Xeloda for 2－4 cycles. Surgery following the principle of total mesorectal excision was performed 3－8 weeks after radiotherapy. Postoperative adjuvant chemotherapy was delivered to 134 patients. The overall survival (OS), disease-free survival (DFS),relapse-free survival (RFS), and distant metastasis-free survival (DMFS) were determined using the Kaplan-Meier method, and survival difference analysis and univariate prognostic analysis were performed using the log-rank test. Multivariate prognostic analysis was performed using the Cox proportional hazard model. Results All the patients completed the preoperative neoadjuvant chemoradiotherapy and surgery. The rate of radical resection (R0) was 98.9%, and the sphincter preservation rate was 53.6%. The downstaging rates in tumor (T) stage, node (N) stage, and clinical stage were 73.1%, 83.6%, and 79.4%, respectively. Pathologic complete response rate was 26.8%. Grade 3 adverse hematologic reactions, grade 3 diarrhea, and grade 3 radiodermatitis were observed in 7.9%, 7.2% and 2.7% of total patients, respectively. Postoperative perineal pain and delayed wound healing were reported in 12.3% and 8.2% of total patients, respectively. The follow-up rate was 94.5% and the 5-year sample size was 95 patients. The 5-year OS, DFS, RFS, and DMFS were 76.6%, 72.1%, 88.8%, and 79.7%, respectively. The 5-year local recurrence rate and distant metastasis rate were 7.5% and 15.8%, respectively. Multivariate analysis revealed that the postoperative pathological staging was a prognostic influencing factor. Conclusions Preoperative neoadjuvant chemoradiotherapy increases the R0 and sphincter preservation rates, and results in significant tumor downstaging. Treatment-related adverse reactions are moderate and perioperative complications are not increased. The local recurrence rate is low and long-term survival rate is increased. Clinical application of preoperative neoadjuvant chemoradiotherapy as a standard treatment regimen for LARC is highly recommended.