Lydia G van der Geest, Bert A Bonsing, Olivier R Busch, Gijs A Patijn, Hjalmar C van Santvoort, Johanna W Wilmink, Marc G Besselink, Lydi M J W van Driel, Tara M Mackay, Simone Augustinus, Jeanin E van Hooft, Auke Bogte, Geert A Cirkel, Lieke Hol, Derk-Jan A de Groot, Joyce T Haver, Saskia A C Luelmo, Leonie Mekenkamp, Frederike G I van Vilsteren, C Henri van Werkhoven, Vincent E de Meijer, Martijn W J Stommel, Marjolein Y V Homs, Nadia Haj Mohammad, Hanneke W M van Laarhoven, Tessa E H Römkens, Rutger Quispel, Marcel den Dulk, Robert C Verdonk, Niels G Venneman, Anouk E J Latenstein, Casper H J van Eijck, Maartje Los, Sebastiaan Festen, Bas Groot Koerkamp, Erwin van der Harst, Ignace H de Hingh, Judith de Vos-Geelen, I Quintus Molenaar, Jan-Willem B de Groot
Journal: JAMA surgery 2024;159(4):429-437
PMID: 38353966
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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