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.
To develop a consensus on baseline and prognostic factors to be used as mandatory measurements in RCTs of resectable and borderline resectable pancreatic cancer.
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.
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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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Accepted for Publication: October 27, 2021.
Published Online: April 21, 2022. doi:10.1001/jamaoncol.2022.0168
Corresponding Authors: Hanneke W. M. van Laarhoven, MD, PhD, Department of Medical Oncology, Cancer Center, Amsterdam UMC, University of Amsterdam, Amsterdam Meibergdreef 9, Room D3-221.1, Amsterdam 1105 AZ, The Netherlands (email@example.com).
Author Contributions: Prof van Laarhoven had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Profs Besselink, Wilmink, and van Laarhoven contributed equally as last authors.
Concept and design: Pijnappel, Suurmeijer, Groot Koerkamp, Ghaneh, van Eijck, Büchler, Wilmink, van Laarhoven.
Acquisition, analysis, or interpretation of data: Pijnappel, Suurmeijer, Kos, Siveke, Salvia, Ghaneh, van Etten-Jamaludin, Abrams, Brasiuniene, Casadei, Van Laethem, Berlin, Boku, Conroy, Golcher, Sinn, Neoptolemos, van Tienhoven, Besselink, Wilmink, van Laarhoven.
Drafting of the manuscript: Pijnappel, Kos, van Etten-Jamaludin, van Laarhoven.
Critical revision of the manuscript for important intellectual content: Pijnappel, Suurmeijer, Groot Koerkamp, Kos, Siveke, Salvia, Ghaneh, van Eijck, Abrams, Brasiuniene, Büchler, Casadei, Van Laethem, Berlin, Boku, Conroy, Golcher, Sinn, Neoptolemos, van Tienhoven, Besselink, Wilmink, van Laarhoven.
Statistical analysis: Pijnappel, Kos.
Administrative, technical, or material support: Suurmeijer, Conroy, Sinn, Besselink.
Supervision: Groot Koerkamp, Salvia, Ghaneh, van Eijck, Büchler, Casadei, Boku, Wilmink, van Laarhoven.
Other—Expert in the Delphi consensus writing, review, and editing: Conroy.
Conflict of Interest Disclosures: Prof Siveke 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.
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