Variations in the reporting of potentially confounding variables in studies investigating systemic treatments of unresectable pancreatic cancer challenge adequate comparisons. We establish the first international consensus on mandatory baseline- and prognostic characteristics to be taken into account in future pancreatic cancer trials for patients with unresectable disease.
A systematic review was performed for phase III trials investigating first-line systemic therapy for unresectable pancreatic cancer that were published between January 2000 and January 2016 to identify baseline characteristics and prognostic variables. The electronic databases Medline, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) were used. A structured overview was created demonstrating the reporting frequencies of baseline characteristics and prognostic relevance of identified variables. A modified Delphi panel of two rounds involving 23 leading medical-oncologists in the field of pancreatic cancer was used to develop the consensus.
A total of 624 studies were identified. After screening, 39 randomized controlled trials (RCTs) with 15,863 patients were included. Thirty-two baseline characteristics and 26 prognostic characteristics were identified. After two consensus rounds, 24 baseline characteristics and twelve prognostic characteristics were designated as a mandatory reporting set for future trials. Table 1. Mandatory setTable:
|Baseline characteristics||Prognostic characteristics|
|C-Reactive Protein (CRP)||Disease status|
|LDH||Number of metastatic sites|
|Liver metastasis||Pain at baseline|
|Loss of weight > 10%||Performance status|
|Neutrophil lymphocyte ratio (NLR)|
|Number of metastatic sites|
|Pain at baseline|
|Primary tumor location|
|Time from diagnosis|
The COnsensus statement on Mandatory Measurements identifies a set of baseline- and prognostic characteristics in unresectable PAncreatic Cancer Trials (COMM-PACT) that allows for adequate comparison of outcomes between studies.
Clinical trial identification
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All authors have declared no conflicts of interest.