Page 49 - Demo

FOLFIRINOX reintroduction in pancreatic cancer473IntroductionThe prognosis of pancreatic ductal adenocarcinoma (PDAC) is poor (1, 2) and ranks among the leading causes of cancer mortality in the EU (3). Patients are frequently diagnosed in an advanced stage (4) in which palliative chemotherapy is the only treatment available. Compared to historic gemcitabine monotherapy (5), both FOLFIRINOX (oxaliplatin, irinotecan and fluorouracil in combination with leucovorin) and gemcitabine + nab-paclitaxel combination therapy have shown a significant overall survival (OS) improvement, both in clinical studies (6, 7) and according to real world data (8). ESMO and NCCN guidelines for pancreatic cancer (European Society for Medical Oncology (esmo.org); https://www.nccn.org) recommend FOLFIRINOX as the preferred first line treatment both in the locally advanced and metastatic setting for patients in a good clinical condition. There is no consensus on the optimal duration of FOLFIRINOX in patients with a response or disease control, but the number of cycles is typically maximized to 12 (6 months) based on recommendations in the landmark study of Conroy et al. (6). After initial chemotherapy with FOLFIRINOX a chemotherapy holiday or maintenance treatment can be considered according to the NCCN Guidelines for PDAC (https://www.nccn.org). In daily practice, chemotherapy holidays are frequently used to preserve quality of life (QOL) after 1st line FOLFIRINOX (9). For patients who experienced clinical benefit (defined as stable disease or response) and manageable toxicity of first line FOLFIRINOX, re-introduction of FOLFIRINOX can be considered when disease progresses after a 3-6 months therapy-free interval. However, there is no clinical evidence that addresses this issue or help guide this clinical treatment decision. Therefore the aim of this study was to present a comprehensive overview of the utilization, OS and progression free survival (PFS) of FOLFIRINOX reintroduction in routine daily practice.