RAPIDO试验中高危局部晚期直肠癌患者在接受全新辅助治疗或放化疗后行腹会阴联合切除术的会阴伤口并发症
Perineal wound complications after total neoadjuvant therapy or chemoradiotherapy followed by abdominoperineal excision in patients with high-risk locally advanced rectal cancer in the RAPIDO trial.
作者信息
Zwart Wouter H, Dijkstra Esmée A, Hospers Geke A P, Marijnen Corrie A M, Putter Hein, Folkesson Joakim, Van de Velde Cornelis J H, Roodvoets Annet G H, Meershoek-Klein Kranenbarg Elma, Glimelius Bengt, Van Etten Boudewijn, Nilsson Per J
机构信息
Department of Medical Oncology, University Medical Centre Groningen, Groningen, the Netherlands.
Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.
出版信息
BJS Open. 2025 Mar 4;9(2). doi: 10.1093/bjsopen/zraf043.
BACKGROUND
Perineal wound complications (PWCs) occur in 15-30% of patients after abdominoperineal excision (APE) and are associated with adverse events, such as delayed wound healing, prolonged hospitalization, a delay in initiating postoperative chemotherapy, and decreased quality of life. Preoperative radiotherapy and chemotherapy are risk factors for wound complications. It is unknown whether total neoadjuvant treatment (TNT) affects the risk of PWCs compared with chemoradiotherapy (CRT).
METHODS
This study compared patients from the experimental (EXP; short-course radiotherapy, chemotherapy, and surgery as TNT) and standard-of-care (STD; CRT, surgery, and postoperative chemotherapy depending on hospital policy) treatment arms of the RAPIDO trial who underwent APE within 6 months after preoperative treatment. The primary outcome was the incidence of PWCs (infection, abscess, dehiscence, wound discharge, presacral abscess affecting the perineum) of any grade ≤ 30 days after APE. Secondary outcomes were the incidence of PWCs >30 days after APE, length of hospital stay, characteristics associated with PWCs, and oncological outcomes in patients with versus without PWC.
RESULTS
Of the 901 patients who started treatment (460 in EXP arm, 441 in STD arm), 153 (33%) and 160 (36%) underwent APE after TNT and CRT, respectively. After TNT and CRT, the incidence of PWCs ≤30 days after APE, readmission, and reoperation was 54 of 153 (35%) versus 53 of 160 (33%) (P = 0.69), 9% versus 12% (P = 0.54), and 7% versus 8% (P = 0.75), respectively. The median length of hospital stay was 2-3 days longer for patients with PWC. Univariable analysis revealed that pretreatment albumin <35 g/l, hypertension, and haemoglobin ≤ 8.0 mmol/l were associated with PWC. Oncological outcomes were similar between patients with and without PWCs.
CONCLUSION
In the RAPIDO trial, TNT and CRT resulted in a similar incidence of PWCs among patients with high-risk locally advanced rectal cancer who underwent APE.
背景
腹会阴联合切除术（APE）后，15%-30%的患者会出现会阴伤口并发症（PWC），并伴有不良事件，如伤口愈合延迟、住院时间延长、术后化疗开始延迟以及生活质量下降。术前放疗和化疗是伤口并发症的危险因素。与放化疗（CRT）相比，新辅助综合治疗（TNT）是否会影响PWC的风险尚不清楚。
方法
本研究比较了RAPIDO试验中试验组（EXP；短程放疗、化疗和手术作为TNT）和标准治疗组（STD；CRT、手术和根据医院政策进行的术后化疗）的患者，这些患者在术前治疗后6个月内接受了APE。主要结局是APE后≤30天内任何等级的PWC（感染、脓肿、裂开、伤口渗液、影响会阴的骶前脓肿）的发生率。次要结局是APE后>30天的PWC发生率、住院时间、与PWC相关的特征以及有和无PWC患者的肿瘤学结局。
结果
在开始治疗的901例患者中（EXP组460例，STD组441例），分别有153例（33%）和160例（36%）在TNT和CRT后接受了APE。TNT和CRT后，APE后≤30天的PWC发生率、再次入院率和再次手术率分别为153例中的54例（35%）对160例中的53例（33%）（P = 0.69），9%对12%（P = 0.54），以及7%对8%（P = 0.75）。发生PWC的患者中位住院时间长2-3天。单因素分析显示，治疗前白蛋白<35 g/l、高血压和血红蛋白≤8.0 mmol/l与PWC相关。有和无PWC的患者肿瘤学结局相似。
结论
在RAPIDO试验中，TNT和CRT在接受APE的高危局部晚期直肠癌患者中导致PWC的发生率相似。
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