Department of Gastroenterological Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan.
Ann Surg Oncol. 2023 Aug;30(8):4716-4724. doi: 10.1245/s10434-023-13458-8. Epub 2023 Apr 9.
This study aimed to investigate whether the addition of induction chemotherapy before chemoradiotherapy (CRT) and total mesorectal excision (TME) with selective lateral lymph node dissection improves disease-free survival for patients with poor-risk, mid-to-low rectal cancer.
The authors' institutional prospective database was queried for consecutive patients with clinical stage II or III, primary, poor-risk, mid-to-low rectal cancer who received neoadjuvant treatment followed by TME from 2004 to 2019. The outcomes for the patients who received induction chemotherapy before neoadjuvant CRT (induction-CRT group) were compared (via log-rank tests) with those for a propensity score-matched cohort of patients who received neoadjuvant CRT without induction chemotherapy (CRT group).
From 715 eligible patients, the study selected two matched cohorts with 130 patients each. The median follow-up duration was 5.4 years for the CRT group and 4.1 years for the induction-CRT group. The induction-CRT group had significantly higher rates of 3-year disease-free survival (83.5 % vs 71.4 %; p = 0.015), distant metastasis-free survival (84.3 % vs 75.2 %; p = 0.049), and local recurrence-free survival (98.4 % vs 94.4 %; p = 0.048) than the CRT group. The pathologically complete response rate also was higher in the induction-CRT group than in the CRT group (26.2 % vs 10.0 %; p < 0.001). Postoperative major complications (Clavien-Dindo classification ≥III) did not differ significantly between the two groups (12.3 % vs 10.8 %; p = 0.698).
The addition of induction chemotherapy to neoadjuvant CRT appeared to improve oncologic outcomes significantly, including disease-free survival, for the patients with poor-risk, mid-to-low rectal cancer who underwent TME using selective lateral lymph node dissection.
本研究旨在探讨在新辅助放化疗（CRT）和选择性侧方淋巴结清扫的全直肠系膜切除术（TME）之前加用诱导化疗是否能改善中低位、高危、局部进展期直肠癌患者的无病生存率。
作者所在机构的前瞻性数据库中检索了 2004 年至 2019 年期间连续接受新辅助治疗后行 TME 的临床分期为 II 期或 III 期、原发性、高危、中低位直肠腺癌患者的资料。比较接受新辅助 CRT 前诱导化疗（诱导-CRT 组）患者的结局（通过对数秩检验）与未接受诱导化疗的新辅助 CRT 组患者（CRT 组）的结局。
从 715 例符合条件的患者中，该研究选择了两个匹配的队列，每个队列各有 130 例患者。CRT 组的中位随访时间为 5.4 年，诱导-CRT 组为 4.1 年。诱导-CRT 组的 3 年无病生存率（83.5%比 71.4%；p=0.015）、远处转移无病生存率（84.3%比 75.2%；p=0.049）和局部无复发生存率（98.4%比 94.4%；p=0.048）显著高于 CRT 组。诱导-CRT 组的病理完全缓解率也高于 CRT 组（26.2%比 10.0%；p＜0.001）。两组的术后主要并发症（Clavien-Dindo 分级≥III 级）差异无统计学意义（12.3%比 10.8%；p=0.698）。
对于接受选择性侧方淋巴结清扫的 TME 的中低位、高危直肠癌患者，在新辅助 CRT 中加入诱导化疗似乎显著改善了包括无病生存率在内的肿瘤学结局。
