Abstract 1562P
Background
The real world of clinical care of pancreatic ductal adenocarcinoma (PDAC) is poorly understood. The aim of the observational prospective study is to describe the therapeutic management for naïve patients (pts) with PDAC and evaluate the agreement with recommendations provided by the Italian Association of Medical Oncology (AIOM 2017). As secondary aims, to estimate Overall Survival (OS), Disease-Free Survival (DFS) and Progression-Free Survival (PFS) of pts.
Methods
This is an observational, multicenter prospective, Italian study. Participating institutions were selected to represent different geographical and expertise areas (high-volume with >50 pts; medium-volume with 25-50 pts; low-volume with <25 pts treated /year). The treatment recommendation was related only to the physician’s choice: the Study includes 3 different groups of treatment-naïve consenting pts with pathological diagnosis of PDAC: 1) pts receiving adjuvant therapy after resection; 2) pts receiving primary chemotherapy; 3) metastatic pts. Here we present the results of the accrual between November 2017 and October 2019, in order to get an appropriate evaluation of agreement with current Guidelines.
Results
659 eligible pts were enrolled in 43 Italian centers: Nord 494 (75%), Centre 84 (13%), South 81 (12%); high-volume 431 (66%); medium-volume 121 (18%); low-volume 107 (16%). Home to hospital distance was ≤50 km for 88% of pts.Median age was 69.0 (range 35.6-89.1); 52% male; 93% ECOG PS 0-1; clinical stage: 8% I, 15% II, 25% III, and 52 % IV. Guidelines adherence was 74% in group 1; 97% in group 2; 98% in group 3. The most frequently administered regimens were: Group 1 (N=148): gemcitabine (G) 39%; nab-paclitaxel + G (AG) and FOLFIRINOX 21% each; group 2 (N=174) AG 57%; FOLFIRINOX 26%; G 13%; group 3 (N=337) AG 74%; G 16%; FOLFIRINOX 6%.
Conclusions
A constant update of medical knowledge and a continuous revision of therapeutic guidelines are crucial to handover progress in real time in the clinical practice. Retrieving real-world data to verify guidelines adherence allows driving educational policies of scientific societies. The data of our study, whose enrollment is ongoing, show a very high rate of adherence with some attrition in the adjuvant setting.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Associazione Italiana Oncologia Medica (AIOM).
Funding
Celgene, Italia.
Disclosure
M. Reni: Advisory/Consultancy: Celgene. All other authors have declared no conflicts of interest.