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. 2018 Mar;19(3):e151-e160.
doi: 10.1016/S1470-2045(18)30098-6.

Consensus statement on mandatory measurements in pancreatic cancer trials (COMM-PACT) for systemic treatment of unresectable disease

Emil Ter Veer  1 , L Bengt van Rijssen  2 , Marc G Besselink  2 , Rosa M A Mali  1 , Jordan D Berlin  3 , Stefan Boeck  4 , Franck Bonnetain  5 , Ian Chau  6 , Thierry Conroy  7 , Eric Van Cutsem  8 , Gael Deplanque  9 , Helmut Friess  10 , Bengt Glimelius  11 , David Goldstein  12 , Richard Herrmann  13 , Roberto Labianca  14 , Jean-Luc Van Laethem  15 , Teresa Macarulla  16 , Jonathan H M van der Meer  2 , John P Neoptolemos  17 , Takuji Okusaka  18 , Eileen M O'Reilly  19 , Uwe Pelzer  20 , Philip A Philip  21 , Marcel J van der Poel  2 , Michele Reni  22 , Werner Scheithauer  23 , Jens T Siveke  24 , Chris Verslype  25 , Olivier R Busch  2 , Johanna W Wilmink  1 , Martijn G H van Oijen  1 , Hanneke W M van Laarhoven  26
Affiliations

Consensus statement on mandatory measurements in pancreatic cancer trials (COMM-PACT) for systemic treatment of unresectable disease

Emil Ter Veer et al. Lancet Oncol. 2018 Mar.

Abstract

Variations in the reporting of potentially confounding variables in studies investigating systemic treatments for unresectable pancreatic cancer pose challenges in drawing accurate comparisons between findings. In this Review, we establish the first international consensus on mandatory baseline and prognostic characteristics in future trials for the treatment of unresectable pancreatic cancer. We did a systematic literature search to find phase 3 trials investigating first-line systemic treatment for locally advanced or metastatic pancreatic cancer to identify baseline characteristics and prognostic variables. We created a structured overview showing the reporting frequencies of baseline characteristics and the prognostic relevance of identified variables. We used a modified Delphi panel of two rounds involving an international panel of 23 leading medical oncologists in the field of pancreatic cancer to develop a consensus on the various variables identified. In total, 39 randomised controlled trials that had data on 15 863 patients were included, of which 32 baseline characteristics and 26 prognostic characteristics were identified. After two consensus rounds, 23 baseline characteristics and 12 prognostic characteristics were designated as mandatory for future pancreatic cancer trials. The COnsensus statement on Mandatory Measurements in unresectable PAncreatic Cancer Trials (COMM-PACT) identifies a mandatory set of baseline and prognostic characteristics to allow adequate comparison of outcomes between pancreatic cancer studies.

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Conflict of interest statement

Declaration of interests

JDB reports personal fees from Celgene, Symphogen, Genentech and Roche, Vertex, Janssen Oncology, EMD Serono, Boston Biomedical, and Pharmacyclics, outside the submitted work. SB reports grants and personal fees from Celgene and Roche, outside the submitted work. EVC reports grants from Bayer, Boehringer, Lilly, Novartis, Merck, Amgen, Celgene, and Roche, and had an advisory role for Bayer, Boehringer, Lilly, and Novartis, outside the submitted work. GD reports grants from MSD and Celgene, and personal fees from Bristol-Myers Squibb, Bayer, and Merck, outside the submitted work. DG reports grants from Amgen, Pfizer, Celgene, Bayer, and Sirtex Medical, outside the submitted work. JPN reports grants from Mylan, Clovis Oncology, Ventana Medical Systems, Boehringer Ingelheim, Nucana, Astellas, AstraZeneca, and Taiho Pharmaceutical, outside the submitted work. MR reports grants from Celgene, and had an advisory role for Novocure, Halozyme, Baxalta, Pfizer, Merck, and Novartis, outside the submitted work. JTS reports grants from Celgene, Bristol-Myers Squibb, Novartis, and Boehringer, and had an advisory role for Merrimack, Baxalta, Celgene, and Lilly, outside the submitted work. MGHvO reports grants from Bayer, Lilly, Merck, Roche, and Amgen, outside the submitted work. HWMvL reports grants from Lilly, Nordic, Celgene, Bayer, Merck Serono, MSD, and Roche, and had an advisory role for Lilly, Celgene, and Bayer, outside the submitted work. All other authors declare no competing interests.

Figures

Figure 1:
Figure 1:. Literature search
Using PRISMA guidelines, a flowchart of our literature search used in the identification of baseline and prognostic characteristics that helped to inform our scaled grading system. CENTRAL=Cochrane Central Register of Controlled Trials. ASCO=American Society of Clinical Oncology. ESMO=European Society for Medical Oncology. PRISMA=Preferred Reporting Items for Systematic Reviews and Meta-Analyses. RCT=randomised controlled trial.
Figure 2:
Figure 2:. Consensus strategy
Flow diagram of the procedures followed in the first and second consensus rounds by the expert panel to establish which baseline and prognostic characteristics should be in the mandatory and recommended sets for clinical trial reporting. As prognostic characteristics should be reported also in baseline tables, prognostics characteristics in the mandatory and recommended sets were also added to their corresponding baseline sets; these included C-reactive protein concentration, lactate dehydrogenase concentration, and neutrophil-to-lymphocyte ratio in the mandatory set, and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 score on a physical-functioning subscale in the recommended set.
Figure 3:
Figure 3:. Identified baseline and prognostic characteristics
(A) Baseline characteristics. The y-axis shows the identified baseline characteristics and the x-axis shows the number of randomised controlled trials in which the characteristic was reported. (B) Prognostic characteristics analysed in multivariate Cox or logistic regression in the randomised controlled trials. The x-axis shows the number of patients, and the number of randomised controlled trials are in parentheses. The bars represent the corresponding number of patients in which the given factor was statistically significant (p≤0·05) or non-significant (p>0·05) in the multivariate analysis of the randomised controlled trial. CA=cancer antigen. BMI=body-mass index. BUN=blood-urea-nitrogen concentration. LDH=lactate dehydrogenase. QoL=quality of life. DVT=deep-venous thrombosis. γGT=γ-glutamyltransferase. SMAD-4=small mothers against decapentaplegic homolog-4. *These characteristics fit the scaled grading system.
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