Long-term outcomes of clinical complete responders after neoadjuvant treatment for rectal cancer in the International Watch & Wait Database (IWWD): an international multicentre registry study
Long-term outcomes of clinical complete responders after neoadjuvant treatment for rectal cancer in the International Watch & Wait Database (IWWD): an international multicentre registry study
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DOI：
10.1016/s0140-6736(18)31078-x
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发表时间：
2018-06-23
期刊：
影响因子：
168.9
通讯作者：
van de Velde, Cornelis J. H.
中科院分区：
文献类型：
--
作者：
van der Valk, Maxime J. M.;Hilling, Denise E.;van de Velde, Cornelis J. H.
观察和等待（W&W）策略在新辅助治疗后达到完全临床应答（cCR）的直肠癌患者中是一种新的策略，为患者提供了避免大切除手术的机会。然而，证据是基于专家中心的小型到中型系列。国际观察与等待数据库（IWWD）旨在描述W&W策略在合并个体患者数据的大规模登记中的结果。我们报告的描述性分析后，超过1000例患者在registry.Methods参与中心通过在线，高度安全，加密的研究数据服务器在注册表中输入数据的结果。数据包括基线特征、新辅助治疗、成像方案、局部再生长和远处转移的发生率以及生存状态。所有在新辅助治疗后省略标准治疗（全直肠系膜切除术）的直肠癌患者都有资格入选IWWD。对于本分析，我们仅选择了重新评估时无残留肿瘤体征的患者（cCR）。我们分析了局部再生长患者的比例、远处转移患者的比例、5年总生存率和5年疾病特异性生存率。结果在2015年4月14日至2017年6月30日期间，我们从47个参与机构（15个国家）的数据库中确定了1009例接受新辅助治疗并由W&W管理的患者。我们纳入了880例（87%）cCR患者。中位随访时间为3.3年（95% CI 3.1-3.6）。局部再生长的2年累积发生率为25.2%（95% CI 22.2-28.5%），88%的局部再生长是在前2年诊断的，97%的局部再生长位于肠壁。880例患者中有71例（8%）诊断为远处转移。5-年总生存率为85%（95%CI 80.9-87.7%），5年疾病特异性生存率为94%（91-96%）。解释该数据集具有用W&W方法治疗的直肠癌患者的最大系列，包括来自先前队列系列的约50%的数据和50%的未发表数据。局部再生主要发生在前2年和肠壁，强调内镜监测的重要性，以确保延迟治疗性手术的选择。W&W后局部无法挽救的疾病是罕见的。版权所有（C）2018爱思唯尔有限公司保留所有权利。
Background The strategy of watch and wait (W&W) in patients with rectal cancer who achieve a complete clinical response (cCR) after neoadjuvant therapy is new and offers an opportunity for patients to avoid major resection surgery. However, evidence is based on small-to-moderate sized series from specialist centres. The International Watch & Wait Database (IWWD) aims to describe the outcome of the W&W strategy in a large-scale registry of pooled individual patient data. We report the results of a descriptive analysis after inclusion of more than 1000 patients in the registry.Methods Participating centres entered data in the registry through an online, highly secured, and encrypted research data server. Data included baseline characteristics, neoadjuvant therapy, imaging protocols, incidence of local regrowth and distant metastasis, and survival status. All patients with rectal cancer in whom the standard of care (total mesorectal excision surgery) was omitted after neoadjuvant therapy were eligible to be included in the IWWD. For the present analysis, we only selected patients with no signs of residual tumour at reassessment (a cCR). We analysed the proportion of patients with local regrowth, proportion of patients with distant metastases, 5-year overall survival, and 5-year disease-specific survival.Findings Between April 14, 2015, and June 30, 2017, we identified 1009 patients who received neoadjuvant treatment and were managed by W&W in the database from 47 participating institutes (15 countries). We included 880 (87%) patients with a cCR. Median follow-up time was 3.3 years (95% CI 3.1-3.6). The 2-year cumulative incidence of local regrowth was 25.2% (95% CI 22.2-28.5%), 88% of all local regrowth was diagnosed in the first 2 years, and 97% of local regrowth was located in the bowel wall. Distant metastasis were diagnosed in 71 (8%) of 880 patients. 5-year overall survival was 85% (95% CI 80.9-87.7%), and 5-year disease-specific survival was 94% (91-96%).Interpretation This dataset has the largest series of patients with rectal cancer treated with a W&W approach, consisting of approximately 50% data from previous cohort series and 50% unpublished data. Local regrowth occurs mostly in the first 2 years and in the bowel wall, emphasising the importance of endoscopic surveillance to ensure the option of deferred curative surgery. Local unsalvageable disease after W&W was rare. .Copyright (C) 2018 Elsevier Ltd. All rights reserved.