Renzulli Pietro, Lowy Adam, Maibach Rudolf, Egeli Rudolf A, Metzger Urs, Laffer Urban T
Department of Visceral and Transplantation Surgery, Inselspital, University of Berne, Switzerland.
Surgery. 2006 Mar;139(3):296-304. doi: 10.1016/j.surg.2005.08.023.
Past studies have identified surgeon- and institution- related characteristics as prognostic factors in colorectal cancer surgery. The present work assesses the influence of the surgeon's and the hospital's caseload on long-term results of colorectal cancer surgery.
The data on 2706 patients from 2, randomized, colorectal cancer trials (Swiss Group for Clinical Cancer Research [SAKK] 40/81, SAKK 40/87) investigating adjuvant intraportal and systemic chemotherapy and 1 concurrent registration study (SAKK 40/88) were reviewed. A first analysis included 1809 eligible, nonmetastatic patients from all 3 studies. A subsequent subgroup analysis included 915 eligible patients from both randomized trials. Overall survival (OS), disease-free survival (DFS), and local recurrence (LR) were analyzed in multivariate models taking into account the possible effect of clustering. The main potential covariates were surgeon's annual caseload (>5 operations/year vs < or =5 operations/year), hospital's annual caseload (>26 operations/year vs < or =26 operations/year), tumor site, T stage, and nodal status.
Primary analysis of all 3 studies combined found a high surgeon's caseload to be positively associated with OS (P = .025) and marginally with DFS (P = .058). Separate analysis for each trial, however, showed that a high surgeon's caseload was beneficial for outcome in both randomized trials but not in the registration study. A subgroup analysis of 915 patients with 376 rectal and 539 colonic primaries from both randomized trials, therefore, was performed. Neither age, gender, year of operation, adjuvant chemotherapy (intraportal vs systemic vs operation alone), hospital academic status (university vs non-university), training status of the surgeon (certified surgeon vs surgeon-in-training), nor inclusion in 1 of the 2 randomized trials (SAKK 40/81 vs SAKK 40/87) was a significant predictor of outcome. However, both high surgeon's and high hospital's annual caseloads were independent, beneficial prognostic factors for OS (P = .0003, P = .044) and DFS (P = .0008, P = .020), and marginally significant factors for LR (P = .057, P = .055).
High surgeon's and hospital's annual caseloads are strong, independent prognostic factors for extending overall and disease-free survival and reducing the rate of local recurrence in 2 randomized colorectal cancer trials.
过去的研究已将外科医生和机构相关特征确定为结直肠癌手术的预后因素。本研究评估外科医生和医院的工作量对结直肠癌手术长期结果的影响。
回顾了来自2项随机结直肠癌试验(瑞士临床癌症研究组[SAKK]40/81、SAKK 40/87)中关于2706例患者的数据,这2项试验研究辅助门静脉内和全身化疗,以及1项同期注册研究(SAKK 40/88)的数据。首次分析纳入了来自所有3项研究的1809例符合条件的非转移性患者。随后的亚组分析纳入了来自2项随机试验的915例符合条件的患者。在多变量模型中分析总生存期(OS)、无病生存期(DFS)和局部复发(LR),同时考虑聚类的可能影响。主要的潜在协变量包括外科医生的年工作量(>5例手术/年对比≤5例手术/年)、医院的年工作量(>26例手术/年对比≤26例手术/年)、肿瘤部位、T分期和淋巴结状态。
对所有3项研究进行综合的初步分析发现,外科医生工作量高与OS呈正相关(P = 0.025),与DFS呈边缘性相关(P = 0.058)。然而,对每项试验单独分析显示,外科医生工作量高对2项随机试验的结果有益,但对注册研究的结果无益处。因此,对来自2项随机试验的915例患者进行了亚组分析,其中包括376例直肠原发癌和539例结肠原发癌。年龄、性别、手术年份、辅助化疗(门静脉内化疗对比全身化疗对比单纯手术)、医院学术地位(大学医院对比非大学医院)、外科医生的培训状态(认证外科医生对比实习外科医生),以及是否纳入2项随机试验中的1项(SAKK 40/81对比SAKK 40/87)均不是结果的显著预测因素。然而,外科医生和医院的年工作量高均是OS(P = 0.0003,P = 0.044)和DFS(P = 0.0008,P = 0.020)的独立有益预后因素,且是LR的边缘性显著因素(P = 0.057,P = 0.055)。
在2项随机结直肠癌试验中,外科医生和医院的年工作量高是延长总生存期和无病生存期以及降低局部复发率的强大独立预后因素。