Consensus Statement on Mandatory Measurements for Pancreatic Cancer Trials for Patients With Resectable or Borderline Resectable Disease (COMM-PACT-RB): A Systematic Review and Delphi Consensus Statement
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Consensus Statement on Mandatory Measurements for Pancreatic Cancer Trials for Patients With Resectable or Borderline Resectable Disease (COMM-PACT-RB): A Systematic Review and Delphi Consensus Statement. / Pijnappel, Esther N; Suurmeijer, J Annelie; Koerkamp, Bas Groot; Kos, Milan; Siveke, Jens T; Salvia, Roberto; Ghaneh, Paula; van Eijck, Casper H J; van Etten-Jamaludin, Faridi S; Abrams, Ross; Brasiuniene, Birute; Büchler, Markus W; Casadei, Riccardo; van Laethem, Jean-Luc; Berlin, Jordan; Boku, Narikazu; Conroy, Thierry; Golcher, Henriette; Sinn, Marianne; Neoptolemos, John P; van Tienhoven, Geertjan; Besselink, Marc G; Wilmink, Johanna W; van Laarhoven, Hanneke W M.
in: JAMA ONCOL, Jahrgang 8, Nr. 6, 01.06.2022, S. 929-937.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Consensus Statement on Mandatory Measurements for Pancreatic Cancer Trials for Patients With Resectable or Borderline Resectable Disease (COMM-PACT-RB): A Systematic Review and Delphi Consensus Statement
AU - Pijnappel, Esther N
AU - Suurmeijer, J Annelie
AU - Koerkamp, Bas Groot
AU - Kos, Milan
AU - Siveke, Jens T
AU - Salvia, Roberto
AU - Ghaneh, Paula
AU - van Eijck, Casper H J
AU - van Etten-Jamaludin, Faridi S
AU - Abrams, Ross
AU - Brasiuniene, Birute
AU - Büchler, Markus W
AU - Casadei, Riccardo
AU - van Laethem, Jean-Luc
AU - Berlin, Jordan
AU - Boku, Narikazu
AU - Conroy, Thierry
AU - Golcher, Henriette
AU - Sinn, Marianne
AU - Neoptolemos, John P
AU - van Tienhoven, Geertjan
AU - Besselink, Marc G
AU - Wilmink, Johanna W
AU - van Laarhoven, Hanneke W M
PY - 2022/6/1
Y1 - 2022/6/1
N2 - IMPORTANCE: Pancreatic 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 REVIEW: We 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.
AB - IMPORTANCE: Pancreatic 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 REVIEW: We 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.
KW - Delphi Technique
KW - Humans
KW - Neoadjuvant Therapy
KW - Pancreatic Neoplasms/drug therapy
U2 - 10.1001/jamaoncol.2022.0168
DO - 10.1001/jamaoncol.2022.0168
M3 - SCORING: Journal article
C2 - 35446336
VL - 8
SP - 929
EP - 937
JO - JAMA ONCOL
JF - JAMA ONCOL
SN - 2374-2437
IS - 6
ER -
