FAILURE TO ADJUVANT THERAPY AFTER PANCREATIC RESECTION FOR PANCREATIC CANCER (THE FOUNTAIN STUDY): A REAL-WORLD CONTEMPORARY ANALYSIS
Salvatore Paiella*, Giuseppe Malleo, Alice Cattelani, Fabio Casciani, Nicola Quintarelli, Claudio Bassi, Roberto Salvia
Azienda Ospedaliera Universitaria Integrata Verona Unita Operativa Chirurgia Generale e del Pancreas, Verona, Veneto, Italy
Background:Multidrug adjuvant therapy following pancreatectomy has yielded substantial improvement in the prognosis of pancreatic cancer patients with localized disease, establishing a new treatment paradigm. However, out of controlled experimentalsettings, the proportion of patients accessing modern chemotherapy regimens is largely unknown
Methods:A prospective, observational study was conducted. All consecutive patients receiving primary curative surgery for pancreatic ductal carcinoma (Jan 2019 - Jul 2022) were enrolled(#NCT03788382). The primary aim is to define actual adjuvant treatment utilization and its association with baseline and perioperative patient characteristics. Medical oncologist charts were retrieved along with close patient follow-up. A precision-based approach was used to calculate sample size
Results:317 patients underwent pancreatectomy, among which 237 (74.8%) received subsequent adjuvant therapy after a median of eight weeks (IQR 6-10) after surgery. Among such, Gemcitabine alone and FOLFIRINOX were employed in 42% and 38% of cases, respectively, followed by Gemcitabine-based(16%) and other regimes (5%). Main reasons for chemotherapy omission were postoperative failure-to-thrive (39%), baseline comorbidities (20%), and physician's decision (21%). Patient refusal and early disease recurrence also accounted for 20%. The likelihood of postoperative therapy omission steadily increased with age up to 50% for individuals older than 80. It varied across geographical areas, being twice as high for inhabitants of Northern Italy regions compared to Central and Southern areas (30 vs 15%).Older age (OR 1.10,95%CI 1.011-1.14), family history of pancreatic cancer (OR 2.46,95%CI 1.33-4.56) and developing postoperative pancreatic fistula (OR 2.54,95%CI 11.05-6.18) were primary determinant of attrition after surgery, whereas no pathological parameter influenced adjuvant therapy initiation.Adjuvant FOLFIRINOX utilization increased tenfold over the study period (from 4.1 to 44.2%).Patients receiving such a regimen were significantly younger (median 65 vs.74 years old,OR 0.86,95%CI 0.81-0.90; p<0.001) and displayed more advanced N stage (vs.
N0: N1 OR 3.10; N2 OR 2.87), while alcohol abuse (OR 0.26,95%CI 0.09-0.78) and developing severe complications (Clavien-Dindo≥3; OR 0.24,95%CI 0.07-0.85) were associated with FOLFIRINOX omission. No difference was evident in time to chemotherapy initiation between FOLFIRINOX and other schemes
Discussion:This study provides a contemporary, real-world snapshot depicting a limited utilization of adjuvant therapy following curative resection for localized pancreatic cancer. Despite FOLFIRINOX being increasingly employed in this setting, one out of four patients still fails to receive any postoperative chemotherapy, mostly due to postoperative complications, and most patients are treated with suboptimal regimens
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