TY - JOUR
T1 - Consensus Statement on Mandatory Measurements for Pancreatic Cancer Trials for Patients with Resectable or Borderline Resectable Disease (COMM-PACT-RB)
T2 - 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 - Brasiūnienė, 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.
N1 - Funding Information: reported grants from Bristol Myers Squibb, Celgene, Roche, Immunocore, Novartis, Shire, Bayer, Baxalta, AstraZeneca, and Servier; equity in itheranostics and Pharma15; and serving as a board member for Pharma15, all outside the submitted work. Dr Brasiūnienė reported personal fees for speaking engagements, consulting, and travel expenses from Roche, Eli Lilly, Ipsen, and Servier, all outside the submitted work. Dr Berlin reported personal fees from Ipsen, Bayer, Mirati, Clovis, Seagen, QED Therapeutics, and EMD Serono; grants for clinical trials from EMD Serono, Bristol Myers Squibb, Novartis, Immunomedics, Dragonfly, Boston Biomedical, Symphogen, I-Mab, Karyopharm, Pfizer, and Astellas; and personal fees from Novocure, Karyopharm, and Pancreatic Cancer Action Network, all outside the submitted work. Dr Boku reported grants from Ono and Takeda and personal fees from Taiho, Ono, and Bristol Myers Squibb, all outside the submitted work. Dr Sinn reported personal fees from Amgen, AstraZeneca, Sanofi, Servier, Merck Sharp & Dohme, Bristol Myers Squibb, Incyte, Pfizer, and Pierre Fabre outside the submitted work. Prof Neoptolemos reported grants from Heidelberger Stiftung Chirurgie, Dietmar Hopp Stiftung, and Stiftung Deutsche Krebshilfe outside the submitted work. Dr Wilmink reported grants from Novartis and Servier and nonfinancial support from Merck, Nordic, Celgene, and Servier, all outside the submitted work. Prof van Laarhoven reported grants, personal fees, and/or nonfinancial support from Bristol Myers Squibb, Bayer, Eli Lilly, Dragonfly, Celgene, Janssen, Incyte, Merck, Nordic Pharma, Roche, Servier; and grants from Philips, all outside the submitted work. No other disclosures were reported. Publisher Copyright: © 2022 American Medical Association.
PY - 2022/6
Y1 - 2022/6
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.
UR - http://www.scopus.com/inward/record.url?scp=85129634898&partnerID=8YFLogxK
U2 - https://doi.org/10.1001/jamaoncol.2022.0168
DO - https://doi.org/10.1001/jamaoncol.2022.0168
M3 - Review article
C2 - 35446336
SN - 2374-2437
VL - 8
SP - 929
EP - 937
JO - JAMA Oncology
JF - JAMA Oncology
IS - 6
ER -