TY - JOUR
T1 - Consensus statement on mandatory measurements in pancreatic cancer trials (COMM-PACT) for systemic treatment of unresectable disease
AU - ter Veer, Emil
AU - van Rijssen, L. Bengt
AU - Besselink, Marc G.
AU - Mali, Rosa M. A.
AU - Berlin, Jordan D.
AU - Boeck, Stefan
AU - Bonnetain, Franck
AU - Chau, Ian
AU - Conroy, Thierry
AU - van Cutsem, Eric
AU - Deplanque, Gael
AU - Friess, Helmut
AU - Glimelius, Bengt
AU - Goldstein, David
AU - Herrmann, Richard
AU - Labianca, Roberto
AU - van Laethem, Jean-Luc
AU - Macarulla, Teresa
AU - van der Meer, Jonathan H. M.
AU - Neoptolemos, John P.
AU - Okusaka, Takuji
AU - O'Reilly, Eileen M.
AU - Pelzer, Uwe
AU - Philip, Philip A.
AU - van der Poel, Marcel J.
AU - Reni, Michele
AU - Scheithauer, Werner
AU - Siveke, Jens T.
AU - Verslype, Chris
AU - Busch, Olivier R.
AU - Wilmink, Johanna W.
AU - van Oijen, Martijn G. H.
AU - van Laarhoven, Hanneke W. M.
PY - 2018
Y1 - 2018
N2 - 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.
AB - 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.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85042588299&origin=inward
U2 - https://doi.org/10.1016/S1470-2045(18)30098-6
DO - https://doi.org/10.1016/S1470-2045(18)30098-6
M3 - Review article
SN - 1470-2045
VL - 19
SP - e151-e160
JO - lancet oncology
JF - lancet oncology
IS - 3
ER -