Academic Unit of Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.
Ann Surg Oncol. 2012 Dec;19(13):4012-8. doi: 10.1245/s10434-012-2497-x. Epub 2012 Jul 21.
Multimodal strategies before surgery are often used to improve outcomes, but disease progression (precluding surgical resection) and inoperability at planned surgery still occur following neoadjuvant treatment. The standards of reporting of these outcomes have not previously been considered. This study examined reporting of rates of progression to surgical resection and inoperability at planned surgery following neoadjuvant treatment in surgical oncology, using esophageal cancer as a case study.
A systematic review identified randomized trials and prospective nonrandomized studies reporting short-term outcomes of neoadjuvant treatment and surgery for esophageal cancer.
Of 4,763 abstracts, 224 papers were retrieved and 76 studies included (8 randomized trials and 68 cohort studies of 19,441 esophagectomies). Articles reported outcomes of preoperative chemotherapy (n = 33, 43.4 %), chemoradiotherapy (n = 13, 17.1 %), or both within one paper (n = 18, 23.7 %) and 12 (15.8 %) did not specify the type of neoadjuvant treatment. Also, 20 papers (26.3 %) reported numbers of patients not progressing to surgery after neoadjuvant treatment (with rates of nonprogression ranging between 2.0 and 35.3 %). In addition, 24 papers (31.6 %) reported rates of inoperability at planned surgery (with inoperability rates ranging between 0 and 26.2 %). More randomized controlled trials (RCTs) than observational studies reported nonprogression (4 randomized and 16 nonrandomized studies, 95 % CI -9.6 to 62.6 %, p = 0.108) and inoperability (6 randomized trials and 18 observational studies, 95 % CI 16.8-80.3 %, p = 0.005). Some 17 and 10 articles provided reasons for the observed rates of nonprogression and inoperability, respectively.
Reporting rates of progression to surgery after neoadjuvant treatment and inoperability at planned surgery for esophageal cancer were poor, limiting data synthesis and comparisons. It is suggested that core outcome sets for trials in surgical oncology are developed with inclusion of these important endpoints. Collaboration between medical and surgical oncologists is necessary to achieve this.
手术前的多模态策略通常用于改善预后,但新辅助治疗后仍会出现疾病进展(排除手术切除)和计划手术时无法手术。这些结果的报告标准以前没有被考虑过。本研究以食管癌为例,检查了新辅助治疗后手术切除和计划手术时无法手术的进展率的报告情况。
系统综述确定了报告新辅助治疗和食管癌手术短期结果的随机试验和前瞻性非随机研究。
在 4763 篇摘要中,检索到 224 篇论文,纳入 76 项研究(8 项随机试验和 68 项队列研究共 19441 例食管癌切除术)。文章报告了术前化疗(n=33,43.4%)、放化疗(n=13,17.1%)或两者均在一篇论文中(n=18,23.7%)和 12 项(15.8%)未具体说明新辅助治疗的类型。此外,20 篇论文(26.3%)报告了新辅助治疗后未进展至手术的患者数量(无进展率在 2.0%至 35.3%之间)。此外,24 篇论文(31.6%)报告了计划手术时无法手术的发生率(无法手术率在 0%至 26.2%之间)。与观察性研究相比,更多的随机对照试验(RCT)报告了无进展(4 项 RCT 和 16 项非随机研究,95%CI-9.6%至 62.6%,p=0.108)和无法手术(6 项 RCT 和 18 项观察性研究,95%CI16.8%至 80.3%,p=0.005)。分别有 17 篇和 10 篇文章提供了无进展和无法手术观察率的原因。
新辅助治疗后手术切除和计划手术时无法手术的进展率报告较差,限制了数据综合和比较。建议制定外科肿瘤学试验的核心结局集,纳入这些重要的终点。需要医学和外科肿瘤学家之间的合作来实现这一目标。