Department of Medical Oncology, Hospital Universitario La Paz (IdiPAZ), Madrid, Spain.
Clinical Research Unit (imas12-CIBERESP), Hospital Universitario 12 de Octubre, Madrid, Spain.
ESMO Open. 2022 Jun;7(3):100485. doi: 10.1016/j.esmoop.2022.100485. Epub 2022 May 14.
The role of neoadjuvant chemotherapy (NC) in resectable pancreatic cancer (RPC) has yet to be defined. This review aims to analyze the benefit of NC in RPC compared with upfront surgery (US) in terms of overall survival (OS) and disease-free survival (DFS).
PubMed, CENTRAL (The Cochrane Library), and Embase were systematically reviewed until 3 November 2021. Abstract proceedings and virtual meeting presentations from the American Society of Clinical Oncology and the European Society of Medical Oncology conferences, reference articles of published clinical trials, and review articles were considered. Only randomized clinical trials (RCTs) comparing NC administration with or without radiotherapy previous with surgery (experimental arm) versus US followed by adjuvant chemotherapy with or without radiotherapy (control arm) for RPC were included.
A total of 1135 studies were screened. Of these, 1117 studies were primarily excluded. Of the remaining 18 studies, 5 were excluded because of no adequate trial design for this work and 7 others had no available results. Finally, 6 trials with 469 patients with pancreatic cancer randomized to NC (n = 212) or US (n = 257) were selected. Compared with US, NC significantly improved OS [hazard ratio (HR) 0.75; 95% confidence interval (CI) 0.58-0.98; P = 0.033] and DFS (HR 0.73; 95% CI 0.59-0.89; P = 0.002). While the NC approach was not significantly associated with lower resection rate [relative risk (RR) 0.92; 95% CI 0.84-1.01; P = 0.069], the R0 resection rate was significantly higher for NC than for US (RR 1.31; 95% CI 1.13-1.52; P = 0.0004).
This is the first meta-analysis of RCTs showing that NC improves OS for RPC compared with US followed by adjuvant therapy. Ongoing RCTs should confirm these findings with FOLFIRINOX to generalize the indication of NC.
新辅助化疗（NC）在可切除胰腺癌（RPC）中的作用尚未确定。本综述旨在分析与直接手术（US）相比，NC 在 RPC 患者的总生存（OS）和无病生存（DFS）方面的获益。
系统检索了 PubMed、CENTRAL（Cochrane 图书馆）和 Embase，检索截至 2021 年 11 月 3 日。还考虑了美国临床肿瘤学会和欧洲肿瘤内科学会会议的摘要会议演讲、已发表临床试验的参考文献文章和综述文章。仅纳入了比较 NC 联合或不联合放疗治疗与手术（实验组）与 US 后辅助化疗联合或不联合放疗治疗（对照组）的 RPC 的随机临床试验（RCT）。
共筛选出 1135 项研究，其中 1117 项主要排除。在其余的 18 项研究中，5 项因本研究的试验设计不充分而被排除，另外 7 项因无可用结果而被排除。最终，纳入了 6 项 RCT，共纳入了 469 例随机分配至 NC（n=212）或 US（n=257）的胰腺癌患者。与 US 相比，NC 显著改善了 OS[风险比（HR）0.75；95%置信区间（CI）0.58-0.98；P=0.033]和 DFS（HR 0.73；95% CI 0.59-0.89；P=0.002）。尽管 NC 方法与较低的切除率无显著相关性[相对风险（RR）0.92；95% CI 0.84-1.01；P=0.069]，但 NC 的 R0 切除率显著高于 US（RR 1.31；95% CI 1.13-1.52；P=0.0004）。
这是第一项 RCT 荟萃分析，表明与 US 后辅助治疗相比，NC 可改善 RPC 患者的 OS。正在进行的 RCT 应使用 FOLFIRINOX 证实这些发现，以推广 NC 的适应证。
