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Poster display session

3970 - COnsensus statement on Mandatory Measurements in PAncreatic Cancer Trials for systemic treatment of unresectable disease (COMM-PACT)

Date

09 Sep 2017

Session

Poster display session

Topics

Pancreatic Cancer

Presenters

L. Bengt van Rijssen

Citation

Annals of Oncology (2017) 28 (suppl_5): v209-v268. 10.1093/annonc/mdx369

Authors

L..B. van Rijssen1, E. ter Veer2, M.G. Besselink1, R.M.A. Mali2, J. Berlin3, S. Boeck4, F. Bonnetain5, T. Conroy6, G. Deplanque7, D. Goldstein8, B. Glimelius9, J.P. Neoptolemos10, M. Reni11, W. Scheithauer12, J. van der Meer1, J.W. Wilmink2, M.J. van der Poel1, O.R. Busch1, M.G.H. van Oijen2, H.W.M. van Laarhoven2

Author affiliations

  • 1 Department Of Surgery, Academic Medical Center (AMC), 1105AZ - Amsterdam/NL
  • 2 Department Of Medical Oncology, Academic Medical Center (AMC), 1105AZ - Amsterdam/NL
  • 3 Medical Oncology, Vanderbilt Ingram Cancer Center, 37232-6307 - Nashville/US
  • 4 Department Of Internal Medicine Iii, Comprehensive Cancer Center, Ludwig-Maximilians-University of Munich, 81377 - Munich/DE
  • 5 Methodological And Quality Of Life Unit In Oncology (ea 3181), CHRU Besançon Jean Minjoz, 25000 - Besançon/FR
  • 6 Medical Oncology, Institut de Cancérologie de Lorraine, 54519 - Vandoeuvre-Lès-Nancy/FR
  • 7 Medical Oncology, Hopital Riviera Chablais, 1800 - Vevey/CH
  • 8 Cancer Survivors Centre, University of New South Wales Cancer Research Centre, 2052 - Sydney/AU
  • 9 Immunology, Genetics And Pathology, University Hospital, SE-751 85 - Uppsala/SE
  • 10 Surgical Oncology, University of Liverpool, Liverpool/GB
  • 11 Medical Oncology, IRCCS San Raffaele Scientific Institute, 20132 - Milan/IT
  • 12 Department Of Internal Medicine, Vienna General Hospital (AKH) - Medizinische Universität Wien, 1090 - Vienna/AT
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Resources

Abstract 3970

Background

Variations in the reporting of potentially confounding variables in studies investigating systemic treatments of unresectable pancreatic cancer challenge adequate comparisons. We establish the first international consensus on mandatory baseline- and prognostic characteristics to be taken into account in future pancreatic cancer trials for patients with unresectable disease.

Methods

A systematic review was performed for phase III trials investigating first-line systemic therapy for unresectable pancreatic cancer that were published between January 2000 and January 2016 to identify baseline characteristics and prognostic variables. The electronic databases Medline, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) were used. A structured overview was created demonstrating the reporting frequencies of baseline characteristics and prognostic relevance of identified variables. A modified Delphi panel of two rounds involving 23 leading medical-oncologists in the field of pancreatic cancer was used to develop the consensus.

Results

A total of 624 studies were identified. After screening, 39 randomized controlled trials (RCTs) with 15,863 patients were included. Thirty-two baseline characteristics and 26 prognostic characteristics were identified. After two consensus rounds, 24 baseline characteristics and twelve prognostic characteristics were designated as a mandatory reporting set for future trials. Table 1. Mandatory setTable:

746P

Baseline characteristicsPrognostic characteristics
AgeAge
AlbuminAlbumin
Biliary stentBilirubin
BilirubinCA 19.9
CA19.9CRP
C-Reactive Protein (CRP)Disease status
Disease statusLDH
GenderLiver metastasis
HistologyNLR
LDHNumber of metastatic sites
Liver metastasisPain at baseline
Loss of weight > 10%Performance status
Neutrophil lymphocyte ratio (NLR)
Number of metastatic sites
Pain at baseline
Performance status
Peritoneal metastasis
Primary tumor location
Prior chemotherapy/radiotherapy
Prior surgery
Pulmonary metastasis
Time from diagnosis
Tumor differentiation
Weight/BMI

Conclusions

The COnsensus statement on Mandatory Measurements identifies a set of baseline- and prognostic characteristics in unresectable PAncreatic Cancer Trials (COMM-PACT) that allows for adequate comparison of outcomes between studies.

Clinical trial identification

Not applicable

Legal entity responsible for the study

Not applicable

Funding

None

Disclosure

All authors have declared no conflicts of interest.

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