Implementation of contemporary chemotherapy for patients with metastatic pancreatic ductal adenocarcinoma: a population-based analysis

Background: Positive results of randomized trials led to the introduction of FOLFIRINOX in 2012 and gemcitabine with nab-paclitaxel in 2015 for patients with metastatic pancreatic ductal adenocarcinoma. It is unknown to which extent these new chemotherapeutic regimens have been implemented in clinical practice and what the impact has been on overall survival. Material and methods: Patients diagnosed with metastatic pancreatic ductal adenocarcinoma between 2007–2016 were included from the population-based Netherlands Cancer Registry. Multilevel logistic regression and Cox regression analyses, adjusting for patient, tumor, and hospital characteristics, were used to analyze variation of chemotherapy use. Results: In total, 8726 patients were included. The use of chemotherapy increased from 31% in 2007–2011 to 37% in 2012–2016 (p p Conclusion: Nationwide variation in the use of chemotherapy decreased after the implementation of FOLFIRINOX and gemcitabine with nab-paclitaxel. Still a considerable proportion of patients receives gemcitabine monotherapy. Overall survival did improve, but not clinically relevant. These results emphasize the need for a structured implementation of new chemotherapeutic regimens.

研究背景：随机对照试验的阳性结果推动了2012年FOLFIRINOX方案（FOLFIRINOX）以及2015年吉西他滨（gemcitabine）联合白蛋白结合型紫杉醇（nab-paclitaxel）方案用于转移性胰腺导管腺癌（metastatic pancreatic ductal adenocarcinoma）患者的临床应用。目前尚不明确这些新型化疗方案在临床实践中的普及程度，以及其对患者总生存期（overall survival）的影响。
材料与方法：本研究从基于人群的荷兰癌症登记处（Netherlands Cancer Registry）纳入2007年至2016年间确诊为转移性胰腺导管腺癌的患者。采用多水平logistic回归与Cox回归分析，校正患者、肿瘤及医院相关特征，以分析化疗应用的差异情况。
结果：本研究共纳入8726例患者。化疗使用率从2007–2011年的31%升至2012–2016年的37%（P值经统计学检验存在显著性差异，原文存在统计符号截断）。
结论：随着FOLFIRINOX方案与吉西他滨联合白蛋白结合型紫杉醇方案的临床推广，全国范围内化疗应用的差异有所缩小。仍有相当比例的患者仅接受吉西他滨单药治疗（gemcitabine monotherapy）。患者总生存期确实有所改善，但未产生具有临床意义的获益。本研究结果提示，亟需对新型化疗方案进行规范化推广应用。