胰十二指肠切除术治疗导管腺癌时切缘受累的预后价值：一项法国前瞻性多中心研究的更新结果。

Prognostic Value of Resection Margin Involvement After Pancreaticoduodenectomy for Ductal Adenocarcinoma: Updates From a French Prospective Multicenter Study.

机构信息

*Department of Surgery, Paoli-Calmettes Institute, Marseille, France †Department of Surgery, La Pitié-Salpêtrière - Université Pierre and Marie Curie, Paris VI, France ‡Department of Surgery, Hautepierre Hospital, University of Strasbourg, Strasbourg, France §Department of Surgery, Hotel Dieu Hospital, University of Nantes, Nantes, France ¶Department of Surgery, Hospital de la Conception, University of Aix-Marseille, Marseille, France ||Department of Surgery, Saint Antoine Hospital, University of Paris VI, Paris, France **Department of Surgery, Purpan Hospital, University of Toulouse Hospital Centre, Toulouse, France ††Department of Surgery, Beaujon Hospital, University of Paris VII, Clichy, France ‡‡Groupement Hospitalier Edouard Herriot, Université Claude Bernard Lyon 1, France §§Department of Histopathology, Paoli-Calmettes Institute, Marseille, France ¶¶Department of Biostatistics, Paoli-Calmettes Institute, Aix Marseille Univeristy, INSERM, IRD, SESSTIM, Marseille, France.

出版信息

Ann Surg. 2017 Nov;266(5):787-796. doi: 10.1097/SLA.0000000000002432.

DOI:10.1097/SLA.0000000000002432

PMID:28953554

Abstract

OBJECTIVE

The aim of the study was to assess the relevance of resection margin status for survival after resection of pancreatic-head ductal adenocarcinoma.

SUMMARY BACKGROUND DATA

The definition and prognostic value of incomplete microscopic resection (R1) remain controversial.

METHODS

Prognostic factors were analyzed in 147 patients included in a prospective multicenter study on the impact of tumor clearance evaluated using a standardized pathology protocol.

RESULTS

Thirty patients received neoadjuvant treatment (NAT = 20%); 41 had venous resection (VR = 28%), and 70% received adjuvant chemotherapy. In-hospital mortality was 3% (5/147). Follow-up was 83 months. Tumor clearance was 0, <1.0, <1.5, and <2.0 mm in 35 (25%), 92 (65%), 95 (67%), and 109 (77%) patients, respectively. R0-resection rates decreased from 75% to 35% when changing the definition of R1 status from R1-direct invasion (0 mm) to R1 <1.0 mm. On univariate analysis, clearance <1.0 or <1.5 mm, pT stage, pN stage, LNR ≥0.2, tumor grade 3, and lymphovascular invasion were significantly associated with 5-year survival. On multivariate analysis, pN was the most powerful independent predictor (P = 0.004). Clearance <1.0 or <1.5 mm had borderline significance for the entire cohort, but was relevant in certain subgroups (upfront pancreatectomy (n = 117; P = 0.049); without VR or NAT (n = 87; P = 0.003); N+ without VR or NAT (n = 50; P = 0.004). No N0-patient had R1-0 mm. Additional independent risk predictors were (1) R1 <1.0 mm for the SMA-margin in specific subgroups (upfront pancreatectomy, N0 patients without NAT, N+ patients without NAT or VR; (2) R1-0 mm posterior-margin for the NAT group (P = 0.004).

CONCLUSION

Tumor clearance <1.0 or <1.5 mm was an independent determinants of postresection survival in certain subgroups. To avoid misinterpretation, future trials should specify the clearance margin in millimeter.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT00918853.

摘要

目的

本研究旨在评估胰腺头部导管腺癌切除术后切缘状态对生存的相关性。

摘要背景数据

不完全显微镜下切除（R1）的定义和预后价值仍存在争议。

方法

对 147 例患者的预后因素进行了分析，这些患者纳入了一项前瞻性多中心研究，该研究评估了使用标准化病理方案评估肿瘤清除情况的影响。

结果

30 例患者接受新辅助治疗（NAT=20%）；41 例患者行静脉切除术（VR=28%），70%患者接受辅助化疗。院内死亡率为 3%（5/147）。随访时间为 83 个月。肿瘤清除率分别为 0、<1.0、<1.5 和<2.0mm 的患者分别为 35（25%）、92（65%）、95（67%）和 109（77%）。当将 R1 状态的定义从 R1-直接侵犯（0mm）更改为 R1<1.0mm 时，R0 切除率从 75%降至 35%。单因素分析显示，肿瘤清除率<1.0 或<1.5mm、pT 分期、pN 分期、LNR≥0.2、肿瘤分级 3 级和脉管侵犯与 5 年生存率显著相关。多因素分析显示，pN 是最有力的独立预测因子（P=0.004）。对于整个队列，肿瘤清除率<1.0 或<1.5mm 具有边缘意义，但在某些亚组中具有相关性（直接手术切除（n=117；P=0.049）；无 VR 或 NAT（n=87；P=0.003）；无 VR 或 NAT 的 N+（n=50；P=0.004）。没有 N0 患者的 R1-0mm。其他独立的风险预测因子包括（1）对于特定亚组（直接手术切除、无 NAT 的 N0 患者、无 NAT 或 VR 的 N+患者），SMA 切缘的 R1<1.0mm；（2）对于 NAT 组，后缘的 R1-0mm（P=0.004）。