Department of Medical Oncology, Cancer Center Amsterdam, Academic Medical Center, Amsterdam, Netherlands.
Department of Surgery, Cancer Center Amsterdam, Academic Medical Center, Amsterdam, Netherlands.
Lancet Oncol. 2018 Mar;19(3):e151-e160. doi: 10.1016/S1470-2045(18)30098-6.
Variations in the reporting of potentially confounding variables in studies investigating systemic treatments for unresectable pancreatic cancer pose challenges in drawing accurate comparisons between findings. In this Review, we establish the first international consensus on mandatory baseline and prognostic characteristics in future trials for the treatment of unresectable pancreatic cancer. We did a systematic literature search to find phase 3 trials investigating first-line systemic treatment for locally advanced or metastatic pancreatic cancer to identify baseline characteristics and prognostic variables. We created a structured overview showing the reporting frequencies of baseline characteristics and the prognostic relevance of identified variables. We used a modified Delphi panel of two rounds involving an international panel of 23 leading medical oncologists in the field of pancreatic cancer to develop a consensus on the various variables identified. In total, 39 randomised controlled trials that had data on 15 863 patients were included, of which 32 baseline characteristics and 26 prognostic characteristics were identified. After two consensus rounds, 23 baseline characteristics and 12 prognostic characteristics were designated as mandatory for future pancreatic cancer trials. The COnsensus statement on Mandatory Measurements in unresectable PAncreatic Cancer Trials (COMM-PACT) identifies a mandatory set of baseline and prognostic characteristics to allow adequate comparison of outcomes between pancreatic cancer studies.
研究不可切除胰腺癌的系统治疗时，报告潜在混杂变量的方式存在差异，这给准确比较研究结果带来了挑战。在本综述中，我们就不可切除胰腺癌治疗未来试验中强制性的基线和预后特征达成了首个国际共识。我们对评估局部晚期或转移性胰腺癌一线系统治疗的 III 期试验进行了系统文献检索，以确定基线特征和预后变量。我们创建了一个结构概述，展示了基线特征的报告频率以及确定变量的预后相关性。我们使用两轮改良 Delphi 小组的方法，召集了 23 位胰腺癌领域的国际领先肿瘤内科专家，对各种确定的变量达成共识。共有 39 项随机对照试验纳入了 15863 例患者的数据，其中确定了 32 个基线特征和 26 个预后特征。经过两轮共识会议，23 个基线特征和 12 个预后特征被指定为未来胰腺癌试验的强制性特征。《不可切除胰腺癌临床试验强制性测量共识声明》（COMM-PACT）确定了一套强制性的基线和预后特征，以确保在胰腺癌研究之间能够充分比较结果。
