Consensus Statement on Mandatory Measurements for Pancreatic Cancer Trials for Patients With Resectable or Borderline Resectable Disease (COMM-PACT-RB)

Abstract

IMPORTANCEPancreatic cancer is the third most common cause of cancer death; however, randomized clinical trials (RCTs) of survival in patients with resectable pancreatic cancer lack mandatory measures for reporting baseline and prognostic factors, which hampers comparisons between outcome measures.OBJECTIVE To develop a consensus on baseline and prognostic factors to be used as mandatory measurements in RCTs of resectable and borderline resectable pancreatic cancer. EVIDENCE REVIEWWe performed a systematic literature search of the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, and Embase for RCTs on resectable and borderline resectable pancreatic cancer with overall survival as the primary outcome. We produced a systematic summary of all baseline and prognostic factors identified in the RCTs. A Delphi panel that included 13 experts was surveyed to reach a consensus on mandatory and recommended baseline and prognostic factors.FINDINGS The 42 RCTs that met inclusion criteria reported a total of 60 baseline and 19 prognostic factors. After 2 Delphi rounds, agreement was reached on 50 mandatory baseline and 20 mandatory prognostic factors for future RCTs, with a distinction between studies of neoadjuvant vs adjuvant treatment.CONCLUSION AND RELEVANCE This findings of this systematic review and international expert consensus have produced this Consensus Statement on Mandatory Measurements in Pancreatic Cancer Trials for Resectable and Borderline Resectable Disease (COMM-PACT-RB). The baseline and prognostic factors comprising the mandatory measures will facilitate better comparison across RCTs and eventually will enable improved clinical practice among patients with resectable and borderline resectable pancreatic cancer.

Is the Delphi’s Oracle Pertinent to Patients With Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma?

“…To the Editor Pijnappel and colleagues must be commended for their attempt to develop a consensus on factors to be used as mandatory measurements in randomized clinical trials (RCTs) of resectable and borderline resectable pancreatic cancer through a systematic literature search and a Delphi panel published recently in JAMA Oncology .…”

“…Accordingly, a prognostic factor must be able to predict the clinical outcome before treatment (eg, at time of enrollment into a clinical trial). The authors properly state that studies eligible for their analysis had to include patients with evidence of resectable or borderline resectable pancreatic cancer. Panel agreement on mandatory baseline and prognostic factors for future RCTs is reported.…”

“…What is puzzling in this exercise is the incoherent selection for the final analysis of about two-thirds of RCTs addressing adjuvant therapies (ATs), ie, including patients whose cancer was previously resected . This choice, apart from disregarding their inclusion criteria, implies that authors took for granted that prognostic factors for the AT (resected) population are generalizable to the neoadjuvant (NAT; resectable) population.…”

“…Albeit the authors indicated AT and NAT factors for RCTs separately in a complex proposal, the former are not pertinent with the study objectives, and all are based on unfocused, protean literature research. Furthermore, all mandatory and recommended baseline and prognostic factors for RCTs on NAT reported in eBoxes 3, 5, 9, and 11 in the Supplement are unavailable at time of enrollment.…”

Is the Delphi’s Oracle Pertinent to Patients With Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma?—Reply

“…In Reply First, we would like to thank Dr Reni and colleagues for the kind words and questions. Our study had a broad focus and included randomized clinical trials (RCTs) on resectable and borderline resectable pancreatic cancer considering overall survival as the primary outcome. As surgical resection is part of the standard treatment for patients with resectable and borderline resectable pancreatic cancer, potentially in combination with neoadjuvant therapy (NAT) and/or adjuvant therapy (AT), patients after resection were also included.…”