Mandatory Reporting Measurements in Trials for Potentially Resectable Pancreatic Cancer

Pijnappel, Esther N.; Suurmeijer, J Annelie; Koerkamp, B. Groot; Siveke, Jens T.; Salvia, Roberto; Ghaneh, Paula; Besselink, Marc G.; Wilmink, Johanna W.; Laarhoven, H.W.M. van

doi:10.1007/978-3-030-53786-9_8

Cited by 2 publications

(1 citation statement)

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“…We searched 3 electronic databases—Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, and Embase—for RCTs on survival outcomes among patients with resectable or borderline resectable pancreatic cancer whose treatment included surgery with or without neoadjuvant therapy as therapeutic option. We updated the search strategies described in our chapter for the European Society of Surgical Oncology and in the eSearch description in the Supplement.…”

Section: Methodsmentioning

confidence: 99%

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

et al. 2022

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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.

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Section: Methodsmentioning

confidence: 99%