局部进展期直肠癌加速术前超分割放疗与术前超分割放化疗的随机临床试验。

Randomized clinical trial on accelerated preoperative hyperfractionated radiotherapy versus preoperative hyperfractionated radio-chemotherapy in locally advanced rectal cancer.

机构信息

IInd Radiotherapy and Chemotherapy Clinic and Teaching Hospital, Maria Sklodowska-Curie National Research Institute of Oncology, 44-100 Gliwice, Poland.

Radiotherapy Department, Maria Sklodowska-Curie National Research Institute of Oncology, 44-100 Gliwice, Poland.

出版信息

Br J Radiol. 2024 Nov 1;97(1163):1879-1889. doi: 10.1093/bjr/tqae176.

DOI:10.1093/bjr/tqae176

PMID:39240387

Abstract

OBJECTIVES

The aim of this study was to compare pathological response rates after preoperative hyperfractionated radiotherapy with co-administration of chemotherapy based on 5FU (HART-CT) versus preoperative hyperfractionated radiotherapy (HART) in patients with resectable rectal cancer.

METHODS

Patients with T2/N+ or T3/any N rectal cancer were randomized either to HART twice a day (28 fractions of 1.5 Gy) to total dose 42 Gy or to HART-CT. Tumour regression grade was postoperatively assessed according to the 4-point scale as recommended by the American Joint Committee on Cancer (AJCC). The secondary endpoints included overall survival (OS), disease-free survival (DFS), toxicity of preoperative treatment, locoregional, and distant failure rates. There were 187 patients eligible for analysis: 95 in HART and 92 in the HART-CT. Median follow-up was 5.6 years.

RESULTS

The analysis demonstrated a significantly higher chance of achieving pathologic complete response in HART-CT arm: complete response was achieved in 4/95, 4% (HART) and 11/92, 12% (HART-CT) (P = .045). The differences in OS and DFS, while tending to favour HART-CT, were not significant: OS (P = .13, hazard ratio [HR] = 0.82, 95% CI, 0.63-1.06) and DFS (P = .32; HR = 0.88, 95% CI, 0.69-1.13). The locoregional failure and distant metastases rates did not statistically differ between the trial arms. The rate of late complications was similar (P = .51), grade 3+ being 8% versus 11% in the HART/HART-CT group, respectively.

CONCLUSIONS

The hyperfractionated preoperative radiotherapy with concurrent 5-Fu-based chemotherapy (HART-CT) improved pathological response rate compared to HART. This translated into favourable OS and DFS in HART-CT, but the differences did not reach the threshold for significance.

ADVANCES IN KNOWLEDGE

A new hyperfractionated chemo-RT scheme is proposed. Histopathological major response (TRG 0-1) is associated with better clinical outcome.

摘要

目的

本研究旨在比较术前超分割放疗联合氟尿嘧啶化疗（HART-CT）与术前超分割放疗（HART）在可切除直肠癌患者中的病理缓解率。

方法

将 T2/N+或 T3/任何 N 期直肠腺癌患者随机分为两组，一组接受每日两次超分割放疗（28 次，每次 1.5Gy，总剂量 42Gy），另一组接受 HART-CT。术后根据美国癌症联合委员会（AJCC）推荐的 4 分制评估肿瘤消退分级。次要终点包括总生存（OS）、无病生存（DFS）、术前治疗毒性、局部和远处失败率。共有 187 例患者符合分析条件：HART 组 95 例，HART-CT 组 92 例。中位随访时间为 5.6 年。

结果

分析显示 HART-CT 组获得病理完全缓解的机会明显更高：完全缓解分别为 4/95，4%（HART）和 11/92，12%（HART-CT）（P=0.045）。OS 和 DFS 虽然倾向于 HART-CT，但差异无统计学意义：OS（P=0.13，风险比[HR] = 0.82，95%CI，0.63-1.06）和 DFS（P=0.32；HR=0.88，95%CI，0.69-1.13）。试验组间局部区域失败和远处转移率无统计学差异。晚期并发症发生率相似（P=0.51），HART/HART-CT 组分别为 8%和 11%。