TITLE:
Real-World Evidence in Localized Pancreatic: Coping with Uncertainty in Unselected Populations
AUTHORS:
María I. Pamies Ramón, Diana Ibarra Anguita, Paula Rodríguez Payá, Alvaro Muñoz Abad, David Sánchez García, María Valero Revert, Beatriz Grau Mirete, Mariano Martínez Marín, Alicia Calero Amaro, Lorena Rodríguez Cazalla, Javier Gallego Plazas
KEYWORDS:
Real-World Evidence, Localized, Pancreatic, Cancer
JOURNAL NAME:
Journal of Cancer Therapy,
Vol.15 No.4,
April
24,
2024
ABSTRACT: Background: Localized pancreatic cancer, including resectable (R), borderline resectable (BR) and locally advanced unresectable disease (LAU), is considered in clinical guidelines for diverse treatment options based on clinical trials in selected populations. Hence, exploring with real world evidence (RWE) clinicians’ preferences for treatment options and their results seems pertinent. Methods: In a set of consecutive patients with localized pancreatic cancer assisted in a third level hospital from January 2013 to December 2022, medical records, symptoms, diagnostic process, distribution between subtypes, and treatment plans, with safety and efficacy results, were assessed. Results: A total of 152 patients with localized disease were included (43.4% R, 21.0% BR, 33.6% LAU). The population characteristics exemplified differences between daily practice and clinical trials. Tumor location and symptoms were as expected. Treatment plan was conditioned by PS or comorbidities in 23.0% of patients. In patients with R disease, surgery followed by different adjuvant chemotherapy (CT) regimes was the antineoplastic treatment of choice (64.8%) with efficacy results (OS 37.5 months; 95% CI 18.4 - 56.7), in the range of contemporary standards. The common use of neoadjuvant CT for BR disease (94.4%), with surgery in 50% of them, and its results (OS 30.8 months; 95% CI 10.5 - 51.2) reflected current controversies of treatment recommendations and evolution in this scenario. Paliative CT with or without radiotherapy was the standard specific treatment in LAU disease (95.1%) with survival results (PFS: 10.8 months; 95% CI 8.8 - 12.7. OS: 20.3 months; 95% CI 13.5 - 27.2) that justify the distinct character and the specific study of this entity. Conclusion: RWE for localized pancreatic cancer aroused from the analysis of this population confirms the distinct nature of patients assisted in daily practice, as well as mirrors the complexity of decision making in clinical assumptions in which achieving stronger evidence should be paramount.