Original Investigation 

February 14, 2024

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

Tara M. Mackay, Anouk E. J. Latenstein, Simone Augustinus, et al

JAMA Surg. Published online February 14, 2024. doi:10.1001/jamasurg.2023.7872

Key Points

Question  Can enhanced nationwide implementation of guideline-based best practices in the Netherlands in pancreatic cancer care improve 1-year survival?

Findings  In this Dutch multicenter, stepped-wedge randomized clinical trial including 5887 patients, 1-year survival was 24% after implementation of 5 best practices compared with 23% before, and did not significantly differ.

Meaning  The finding that most patients received no tumor-directed treatment paired with the poor survival highlights the need for more personalized treatment options in pancreatic cancer.

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