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.
Br J Radiol. 2024 Nov 1;97(1163):1879-1889. doi: 10.1093/bjr/tqae176.
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.
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.
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.
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.
A new hyperfractionated chemo-RT scheme is proposed. Histopathological major response (TRG 0-1) is associated with better clinical outcome.
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。
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。
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%。
与 HART 相比，氟尿嘧啶为基础的术前超分割放疗（HART-CT）提高了病理缓解率。这转化为 HART-CT 的 OS 和 DFS 改善，但差异未达到统计学意义。
提出了一种新的超分割放化疗方案。组织病理学主要反应（TRG 0-1）与更好的临床结果相关。
