Consensus statement on mandatory measurements in pancreatic cancer trials (COMM-PACT) for systemic treatment of unresectable disease - 28/03/18

Doi : 10.1016/S1470-2045(18)30098-6

Emil ter Veer, MSc ^a,^{*
Contributed equally}, L Bengt van Rijssen, MD ^b,^{*
Contributed equally}, Marc G Besselink, ProfMD ^b, Rosa M A Mali, BSc ^a, Jordan D Berlin, ProfMD ^c, Stefan Boeck, ProfMD ^d, Franck Bonnetain, ProfMD ^e,^{^{†
Prof Franck Bonnetain died May 20, 2017}}, Ian Chau, MD ^f, Thierry Conroy, ProfMD ^g, Eric Van Cutsem, ProfMD ^h, Gael Deplanque, MD ⁱ, Helmut Friess, ProfMD ^j, Bengt Glimelius, ProfMD ^k, David Goldstein, ProfMD ^l, Richard Herrmann, ProfMD ^m, Roberto Labianca, MD ⁿ, Jean-Luc Van Laethem, ProfMD ^o, Teresa Macarulla, MD ^p, Jonathan H M van der Meer, MD ^b, John P Neoptolemos, ProfMD ^q, Takuji Okusaka, MD ^r, Eileen M O’Reilly, Prof ^s, Uwe Pelzer, MD ^t,^u,^v, Philip A Philip, ProfMD ^w, Marcel J van der Poel, MD ^b, Michele Reni, MD ^x, Werner Scheithauer, ProfMD ^y, Jens T Siveke, ProfMD ^z,^aa, Chris Verslype, ProfMD ^ab, Olivier R Busch, ProfMD ^b, Johanna W Wilmink, MD ^a, Martijn G H van Oijen, PhD ^a, Hanneke W M van Laarhoven, ProfMD ^a,⁎

^a Department of Medical Oncology, Cancer Center Amsterdam, Academic Medical Center, Amsterdam, Netherlands

^b Department of Surgery, Cancer Center Amsterdam, Academic Medical Center, Amsterdam, Netherlands

^c Department of Medicine, Vanderbilt-Ingram Cancer Center, Vanderbilt University, Nashville, TN, USA

^d Department of Internal Medicine III, Comprehensive Cancer Center, Klinikum Grosshadern, Ludwig-Maximilians—University of Munich, Munich, Germany

^e Methodology and Quality of Life in Oncology Unit, University Hospital of Besançon, Besançon, France

^f Royal Marsden NHS Foundation Trust, London and Surrey, UK

^g Department of Medical Oncology, Institut de Cancérologie de Lorraine and Lorraine University, Vandoeuvre-lès-Nancy, France

^h Department of Gastroenterology and Digestive Oncology, University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium

ⁱ Department of Oncology, Hôpital Riviera-Chablais, Vevey, Switzerland

^j Department of Surgery, Technical University of Munich, Klinikum rechts der Isar, Munich, Germany

^k Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden

^l Nelune Cancer Centre, Prince of Wales Hospital, Prince of Wales Clinical School University of New South Wales, Randwick, NSW, Australia

^m Department of Medical Oncology, University Hospital Basel, Basel, Switzerland

ⁿ Cancer Center, ASST Papa Giovanni XXIII, Bergamo, Italy

^o Department of Gastroenterology, Gastrointestinal Cancer Unit, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium

^p Vall d’Hebron University Hospital (HUVH), Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain

^q Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK

^r Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan

^s Gastrointestinal Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, NY, USA

^t Department of Hematology, Oncology and Tumor Immunology, Charité—Universitätsmedizin Berlin, Berlin, Germany

^u Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany

^v Berlin Institute of Health, Berlin, Germany

^w Department of Oncology, Karmanos Cancer Center, Wayne State University, Detroit, MI, USA

^x Department of Medical Oncology, IRCCS San Raffaele Scientific Institute, Milan, Italy

^y Department of Internal Medicine I, Medical University Vienna, Vienna, Austria

^z Division of Solid Tumor Translational Oncology, West German Cancer Cancer, University Hospital Essen, Essen, Germany

^aa German Cancer Consortium (DKTK, partner site Essen) and German Cancer Research Center, DKFZ, Heidelberg, Germany

^ab Department of Digestive Oncology, University Hospitals Leuven, Leuven, Belgium

^* Correspondence to: Prof Hanneke W M van Laarhoven, Department of Medical Oncology, Academic Medical Center, 1100 DD Amsterdam, Netherlands Department of Medical Oncology Academic Medical Center Amsterdam DD 1100 Netherlands

Summary

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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Vol 19 - N° 3

P. e151-e160 - mars 2018 Retour au numéro

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Consensus statement on mandatory measurements in pancreatic cancer trials (COMM-PACT) for systemic treatment of unresectable disease - 28/03/18

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