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Randomized Controlled Trial
. 2024 Apr 1;159(4):429-437.
doi: 10.1001/jamasurg.2023.7872.

Implementation of Best Practices in Pancreatic Cancer Care in the Netherlands: A Stepped-Wedge Randomized Clinical Trial

Tara M Mackay  1   2 , Anouk E J Latenstein  1   2 , Simone Augustinus  1   2 , Lydia G van der Geest  3 , Auke Bogte  4 , Bert A Bonsing  5 , Geert A Cirkel  6 , Lieke Hol  7 , Olivier R Busch  1   2 , Marcel den Dulk  8   9   10 , Lydi M J W van Driel  11 , Sebastiaan Festen  12 , Derk-Jan A de Groot  13 , Jan-Willem B de Groot  14 , Bas Groot Koerkamp  15 , Nadia Haj Mohammad  6 , Joyce T Haver  2   16 , Erwin van der Harst  17 , Ignace H de Hingh  18 , Marjolein Y V Homs  19 , Maartje Los  6 , Saskia A C Luelmo  20 , Vincent E de Meijer  21 , Leonie Mekenkamp  22 , I Quintus Molenaar  23 , Gijs A Patijn  24 , Rutger Quispel  25 , Tessa E H Römkens  26 , Hjalmar C van Santvoort  23 , Martijn W J Stommel  24 , Niels G Venneman  25 , Robert C Verdonk  4 , Frederike G I van Vilsteren  26 , Judith de Vos-Geelen  27 , C Henri van Werkhoven  27 , Jeanin E van Hooft  28 , Casper H J van Eijck  15 , Johanna W Wilmink  2   29 , Hanneke W M van Laarhoven  2   29 , Marc G Besselink  1   2 ; Dutch Pancreatic Cancer Group
Collaborators, Affiliations
Randomized Controlled Trial

Implementation of Best Practices in Pancreatic Cancer Care in the Netherlands: A Stepped-Wedge Randomized Clinical Trial

Tara M Mackay et al. JAMA Surg. .

Abstract

Importance: Implementation of new cancer treatment strategies as recommended by evidence-based guidelines is often slow and suboptimal.

Objective: To improve the implementation of guideline-based best practices in the Netherlands in pancreatic cancer care and assess the impact on survival.

Design, setting, and participants: This multicenter, stepped-wedge cluster randomized trial compared enhanced implementation of best practices with usual care in consecutive patients with all stages of pancreatic cancer. It took place from May 22, 2018 through July 9, 2020. Data were analyzed from April 1, 2022, through February 1, 2023. It included all patients in the Netherlands with pathologically or clinically diagnosed pancreatic ductal adenocarcinoma. This study reports 1-year follow-up (or shorter in case of deceased patients).

Intervention: The 5 best practices included optimal use of perioperative chemotherapy, palliative chemotherapy, pancreatic enzyme replacement therapy (PERT), referral to a dietician, and use of metal stents in patients with biliary obstruction. A 6-week implementation period was completed, in a randomized order, in all 17 Dutch networks for pancreatic cancer care.

Main outcomes and measures: The primary outcome was 1-year survival. Secondary outcomes included adherence to best practices and quality of life (European Organisation for Research and Treatment of Cancer [EORTC] global health score).

Results: Overall, 5887 patients with pancreatic cancer (median age, 72.0 [IQR, 64.0-79.0] years; 50% female) were enrolled, 2641 before and 2939 after implementation of best practices (307 during wash-in period). One-year survival was 24% vs 23% (hazard ratio, 0.98, 95% CI, 0.88-1.08). There was no difference in the use of neoadjuvant chemotherapy (11% vs 11%), adjuvant chemotherapy (48% vs 51%), and referral to a dietician (59% vs 63%), while the use of palliative chemotherapy (24% vs 30%; odds ratio [OR], 1.38; 95% CI, 1.10-1.74), PERT (34% vs 45%; OR, 1.64; 95% CI, 1.28-2.11), and metal biliary stents increased (74% vs 83%; OR, 1.78; 95% CI, 1.13-2.80). The EORTC global health score did not improve (area under the curve, 43.9 vs 42.8; median difference, -1.09, 95% CI, -3.05 to 0.94).

Conclusions and relevance: In this randomized clinical trial, implementation of 5 best practices in pancreatic cancer care did not improve 1-year survival and quality of life. The finding that most patients received no tumor-directed treatment paired with the poor survival highlights the need for more personalized treatment options.

Trial registration: ClinicalTrials.gov Identifier: NCT03513705.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Augustinus reported grants from Deltaplan Alveesklierkanker during the conduct of the study. Dr D. de Groot reported grants from Siemens PUSH and Roche outside the submitted work. Dr Haj Mohammad reported consulting fees from Merck, AstraZeneca, Servier, Eli Lilly, and Bristol Myers Squibb outside the submitted work. Dr Werkhoven reported grants from LimmaTech, bioMerieux, and DaVolterra, and consultant fees from Sanofi-Pasteur and MSD/Merck outside the submitted work. Dr van Hooft reported lecture fees from Cook Medical, Boston Scientific, AbbVie, and study monitor fees from Olympus outside the submitted work. Dr van Eijck reported consultant fees from AIM ImmunoTech outside the submitted work. Dr Wilmink reported grants from MSD, Servier, and Nordic, and personal fees from AstraZeneca outside the submitted work. Dr van Laarhoven reported consultant or advisory roles at Amphera, AstraZeneca, Beigene, BMS, Daiichy-Sankyo, Dragonfly, Eli Lilly, MSD, Nordic Pharma, and Servier; research funding and/or medication supply from Bayer, Bristol Myers Squibb, Celgene, Janssen, Incyte, Eli Lilly, MSD, Nordic Pharma, Philips, Roche, and Servier; speaker role fees from Astellas, Benecke, Daiichy-Sankyo, Jaap, Medtalks, Novartis, and Travel Congress Management B.V; employment and leadership from Amsterdam UMC, the Netherlands (head of the department of medical oncology); and was an honorary European Society for Medical Oncology chair (upper gastrointestinal faculty). No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Trial Profile
Figure 2.
Figure 2.. One-Year Overall Survival Among Patient Groups
See this image and copyright information in PMC

Comment in

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