Anita Balakrishnan, Petros Barmpounakis, Nikolaos Demiris, Bodil Andersson, Alejandro Brañes, Xavier de Aretxabala, Malin Sternby Eilard, Paul Gibbs, Simon J F Harper, Emmanuel L Huguet, Asif Jah, Vasilis Kosmoliaptsis, Javier Lendoire, Siong S Liau, Shishir Maithel, Jack L Martin, Colin Noel, Raaj K Praseedom, Alejandro Serrablo, Volkan Adsay
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This study aimed to identify risk factors for positive nodes in gallbladder cancer and to compare prognostic discrimination of available nodal staging parameters.</p><p><strong>Methods: </strong>This international cohort study assessed gallbladder cancer resections undertaken between 1 January 2010 and 31 December 2020. Logistic regression was used to identify risk factors for node-positive status and develop a risk prediction score for positive nodes. Nodal staging models, including nodal site, number of positive nodes, and positive node ratio were compared for greatest prognostic discrimination in gallbladder cancer.</p><p><strong>Results: </strong>A total of 3676 patients underwent gallbladder cancer resection across 133 centres in 41 countries. Tumour (T) stage (T2, P = 0.012; T3, P = 0.002; and T4, P < 0.001), lymphovascular and perineural infiltration (P < 0.001), and tumour differentiation (P < 0.001) carried the greatest risk of positive nodes. These three parameters comprised the OMEGA Node Positivity Prediction Score (OMEGA-NOPPS) with C-statistics of 0.81 (95% confidence interval 0.78 to 0.84) in the training data set and 0.79 (0.73 to 0.85) in the test data set for identification of node-positive status, highlighting a ≥ 20% increased risk of positive nodes in poorly differentiated tumours with lymphovascular and perineural infiltration despite T1 disease.</p><p><strong>Conclusion: </strong>Data from this large multicentre study confirmed that the number of positive nodes is the most discriminative prognostic model for nodal staging in gallbladder cancer. OMEGA-NOPPS provides three simple parameters to stratify nodal involvement according to risk. 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Tumour (T) stage (T2, P = 0.012; T3, P = 0.002; and T4, P < 0.001), lymphovascular and perineural infiltration (P < 0.001), and tumour differentiation (P < 0.001) carried the greatest risk of positive nodes. These three parameters comprised the OMEGA Node Positivity Prediction Score (OMEGA-NOPPS) with C-statistics of 0.81 (95% confidence interval 0.78 to 0.84) in the training data set and 0.79 (0.73 to 0.85) in the test data set for identification of node-positive status, highlighting a ≥ 20% increased risk of positive nodes in poorly differentiated tumours with lymphovascular and perineural infiltration despite T1 disease.</p><p><strong>Conclusion: </strong>Data from this large multicentre study confirmed that the number of positive nodes is the most discriminative prognostic model for nodal staging in gallbladder cancer. OMEGA-NOPPS provides three simple parameters to stratify nodal involvement according to risk. 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引用次数: 0
摘要
背景：胆囊癌的淋巴结评估仍然具有挑战性，特别是在偶发胆囊癌中。这低估了淋巴结阳性疾病患者的数量，导致预后不准确和辅助治疗不足。本研究旨在确定胆囊癌阳性淋巴结的危险因素，并比较可用淋巴结分期参数的预后判别。方法：这项国际队列研究评估了2010年1月1日至2020年12月31日期间进行的胆囊癌切除术。采用Logistic回归识别节点阳性状态的危险因素，并为阳性节点制定风险预测评分。比较胆囊癌的淋巴结分期模型，包括淋巴结位置、阳性淋巴结数量和阳性淋巴结比例，以判断胆囊癌预后。结果：41个国家133个中心共3676名患者接受了胆囊癌切除术。肿瘤(T)分期(T2, P = 0.012；T3, p = 0.002；和T4， P < 0.001)、淋巴血管和神经周围浸润（P < 0.001）和肿瘤分化（P < 0.001）的阳性淋巴结风险最大。这三个参数组成OMEGA淋巴结阳性预测评分（OMEGA- nopps），在训练数据集中的c统计量为0.81(95%置信区间0.78 - 0.84)，在测试数据集中的c统计量为0.79(0.73 - 0.85)，用于识别淋巴结阳性状态，强调在T1疾病的低分化肿瘤伴淋巴血管和神经周围浸润的阳性淋巴结风险增加≥20%。结论：这项大型多中心研究的数据证实，阳性淋巴结的数量是胆囊癌淋巴结分期最具鉴别性的预后模型。OMEGA-NOPPS提供三个简单的参数，根据风险对淋巴结累及进行分层。偶发性胆囊癌伴淋巴血管和神经周围浸润和低分化肿瘤，包括早期T期，应考虑进一步治疗。
Assessment of nodal staging and risk factors for nodal involvement in gallbladder cancer.
Background: Nodal assessment in gallbladder cancer remains challenging, particularly in incidental gallbladder cancer. This understages the number of patients with node-positive disease, resulting in prognostic inaccuracy and insufficient adjuvant treatment. This study aimed to identify risk factors for positive nodes in gallbladder cancer and to compare prognostic discrimination of available nodal staging parameters.
Methods: This international cohort study assessed gallbladder cancer resections undertaken between 1 January 2010 and 31 December 2020. Logistic regression was used to identify risk factors for node-positive status and develop a risk prediction score for positive nodes. Nodal staging models, including nodal site, number of positive nodes, and positive node ratio were compared for greatest prognostic discrimination in gallbladder cancer.
Results: A total of 3676 patients underwent gallbladder cancer resection across 133 centres in 41 countries. Tumour (T) stage (T2, P = 0.012; T3, P = 0.002; and T4, P < 0.001), lymphovascular and perineural infiltration (P < 0.001), and tumour differentiation (P < 0.001) carried the greatest risk of positive nodes. These three parameters comprised the OMEGA Node Positivity Prediction Score (OMEGA-NOPPS) with C-statistics of 0.81 (95% confidence interval 0.78 to 0.84) in the training data set and 0.79 (0.73 to 0.85) in the test data set for identification of node-positive status, highlighting a ≥ 20% increased risk of positive nodes in poorly differentiated tumours with lymphovascular and perineural infiltration despite T1 disease.
Conclusion: Data from this large multicentre study confirmed that the number of positive nodes is the most discriminative prognostic model for nodal staging in gallbladder cancer. OMEGA-NOPPS provides three simple parameters to stratify nodal involvement according to risk. Incidental gallbladder cancer with lymphovascular and perineural infiltration and poorly differentiated tumours, including early T stages, should be considered for further treatment.
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