<b>Background</b><b>: </b>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.<b> </b><b>Methods</b><b>: </b>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.<b> </b><b>Results</b><b>: </b>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. <b>Conclusion</b><b>: </b>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.
Santucci, C., Mignozzi, S., Malvezzi, M., et al . (2024) European Cancer Mortality Predictions for the Year 2024 with Focus on Colorectal Cancer. Annals of Oncology, 35, 308-316. https://doi.org/10.1016/j.annonc.2023.12.003
SEOM (2024) Las cifras del cáncer en España.
Balaban, E.P., Mangu, P.B., Khorana, A.K., et al . (2016) Locally Advanced, Unresectable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline. Journal of Clinical Oncology , 34, 2654-2668. https://doi.org/10.1200/JCO.2016.67.5561
Brierley, J.D., Gospodarowicz, K. and Wittekind, C. (2016) TNM Classification of Malignant Tumours. 8th Edition, Wiley Blacwell, Hoboken.
Isaji, S., Mizuno, S., Windsor, J.A., et al . (2018) International Consensus on Definition and Criteria of Borderline Resectable Pancreatic Ductal Adenocarcinoma 2017. Pancreatology , 18, 2-11. https://doi.org/10.1016/j.pan.2017.11.011
Conroy, T., Pfeiffer, P., Vilgrain, V., et al . (2023) Pancreatic Cancer: ESMO Clinical Practice Guideline for Diagnosis, Treatment and Follow-up. Annals of Oncology , 34, 987-1002. https://doi.org/10.1016/j.annonc.2023.08.009
NCCN (2024) Clinical Practice Guidelines in Oncology. Pancreatic Cancer, Version 1.
Ramsey, S.D., Onar-Thomas, A., Wheeler, S.B., et al . (2024) Real-World Databases Studies in Oncology: A Call for Standards. Journal of Clinical Oncology , 42, 977-980. https://doi.org/10.1200/JCO.23.02399
Neoptolemos, J.P., Stocken, D.D., Bassi, C., et al . (2010) Adjuvant Chemotherapywith Fluorouracil Plus Folinic Acid vs Gemcitabine Following Pancreatic Cancer Resection: A Randomized Controlled Trial. JAMA , 304, 1073-1081. https://doi.org/10.1001/jama.2010.1275
Neoptolemos, J.P., Palmer, D.H., Ghaneh, P., et al . (2017) Comparison of Adjuvant Gemcitabine and Capecitabine with Gemcitabine Monotherapy in Patients with Resected Pancreatic Cancer (ESPAC-4): A Multicentre, Open-Label, Randomised, Phase 3 Trial. The Lancet , 389, 1011-1024. https://doi.org/10.1016/S0140-6736(16)32409-6
Conroy, T., Castan, F., Lopez, A., et al . (2022) Five-Year Outcomes of FOLFIRINOX vs Gemcitabine as Adjuvant Therapy for Pancreatic Cancer: A Randomized Clinical Trial. JAMA Oncology , 8, 1571-1578. https://doi.org/10.1001/jamaoncol.2022.3829
Versteijne, E., Vogel, J.A., Besselink, M.G., et al . (2018) Meta-Analysis Comparing Upfront Surgery with Neoadjuvant Treatment in Patients with Resectable or Borderline Resectable Pancreatic Cancer. British Journal of Surgery , 105, 946-958. https://doi.org/10.1002/bjs.10870
Versteijne, E., van Dam, J.L., Suker, M., et al . (2022) Neoadjuvant Chemoradiotherapy versus Upfront Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Long-Term Results of the Dutch Randomized PREOPANC Trial. Journal of Clinical Oncology , 40, 1220-1230. https://doi.org/10.1200/JCO.21.02233
Ghaneh, P., Palmer, D., Cicconi, S., et al . (2023) Immediate Surgery Compared with Short-Course Neoadjuvant Gemcitabine Plus Capecitabine, FOLFIRINOX, or Chemoradiotherapy in Patients with Borderline Resectable Pancreatic Cancer (ESPAC5): A Four-Arm, Multicentre, Randomised, Phase 2 Trial. The Lancet Ga s troenterology and Hepatology , 8, 157-168. https://doi.org/10.1016/S2468-1253(22)00348-X
Seufferlein, T., Hammel, P., Delpero, J.R., et al . (2019) Optimizing the Management of Locally Advanced Pancreatic Cancer with a Focus on Induction Chemotherapy: Expert Opinion Based on a Review of Current Evidence. Cancer Treatment R e views , 77, 1-10. https://doi.org/10.1016/j.ctrv.2019.05.007
Suker, M., Beumer, B.R., Sadot, E., et al . (2016) FOLFIRINOX for Locally Advanced Pancreatic Cancer: A Systematic Review and Patient-Level Meta-Analysis. The Lancet Oncology , 17, 801-810. https://doi.org/10.1016/S1470-2045(16)00172-8
Hammel, P., Huguet, F., van Laethem, J.L., et al . (2016) Effect of Chemoradiotherapy vs Chemotherapy on Survival in Patients with Locally Advanced Pancreatic Cancer Controlled after 4 Months of Gemcitabine with or without Erlotinib: The LAP07 Randomized Clinical Trial. JAMA , 315, 1844-1853. https://doi.org/10.1001/jama.2016.4324
Fietkau, R., Ghadimi, M., Grützmann, R., et al . (2022) Randomized Phase III Trial of Induction Chemotherapy Followed by Chemoradiotherapy or Chemotherapy Alone for Nonresectable Locally Advanced Pancreatic Cancer: First Results of the CONKO-007 Trial. Journal of Clinical Oncology , 40, Article 4008. https://doi.org/10.1200/JCO.2022.40.16_suppl.4008
Zhou, Y., Liao, S., You, J., et al . (2022) Conversion Surgery for Initially Unresectable Pancreatic Ductal Adenocarcinoma Following Induction Therapy: A Systematic Review of the Published Literature. Updates in Surgery , 74, 43-53. https://doi.org/10.1007/s13304-021-01089-1
Halloran, C.M., Ghaneh, P., Bosonnet, L., et al . (2002) Complications of Pancreatic Cancer Resection. Digestive Surgery , 19, 138-146. https://doi.org/10.1159/000052029
Polonski, A., Izbicki, J.R. and Uzunoglu, F.G. (2019) Centralization of Pancreatic Surgery in Europe. Journal of Gastrointestinal Surgery , 23, 2081-2092. https://doi.org/10.1007/s11605-019-04215-y
Valle, J.W., Palmer, D., Jackson, R., et al . (2014) Optimal Duration and Timing of Adjuvant Chemotherapy after Definitive Surgery for Ductal Adenocarcinoma of the Pancreas: Ongoing Lessons From the ESPAC-3 Study. Journal of Clinical Oncology , 32, 504-512. https://doi.org/10.1200/JCO.2013.50.7657
Ducreux, M., Cuhna, A.S., Caramella, C., et al . (2015) Cancer of the Pancreas: ESMO Clinical Practice Guidelines for Diagnosis, Treatment and Follow-up. Annals of Oncology , 26, V56-V68. https://doi.org/10.1093/annonc/mdv295
Cloyd, J.M., Heh, V., Pawlik, T.M., et al . (2020) Neoadjuvant Therapy for Resectable and Borderline Resectable Pancreatic Cancer: A Meta-Analysis of Randomized Controlled Trials. Journal of Clinical Medicine , 9, Article 1129. https://doi.org/10.3390/jcm9041129
Park, W., Chawla, A. and O’Reilly, E.M. (2021) Pancreatic Cancer: A Review. JAMA , 326, 851-862. https://doi.org/10.1001/jama.2021.13027
Wainberg, Z.A., Melisi, D., Macarulla, T., et al . (2023) NALIRIFOX versus Nab-Paclitaxel and Gemcitabine in Treatment-Naive Patients with Metastatic Pancreatic Ductal Adenocarcinoma (NAPOLI 3): A Randomised, Open-Label, Phase 3 Trial. The Lancet , 402, 1272-1281. https://doi.org/10.1016/S0140-6736(23)01366-1