Abstract 1533P
Background
Pancreatic cancer (PCA) is often diagnosed at an advanced stage, because most of the patients have no symptoms until the cancer metastasized. In the majority of study cases research focuses on therapy outcomes and prognosis. With poor prognosis and no chance of long-term survival, quality of life becomes a very significant purpose of pancreatic cancer care. The PARAGON Platform is designed to see a bigger picture by acquiring QoL data and further outcome of pts. with localized, locally advanced and metastatic PCA and a sample collection for future biomarker analysis. Therefor the platform-design of PARAGON compared to its predecessor QoliXane covers the whole clinical-life circle in pancreas cancer patients.
Methods
The multicenter, prospective PARAGON study includes outcome data, pts reported outcomes, and tumor tissues of PCA from 80 German study sites. Patients diagnosed with PCA planned for neoadjuvant, adjuvant or 1st line therapy were enrolled. Data assessment includes data on demography, basic parameters, anamnesis, comorbidities, therapies, outcome and survival as well as PRO`s in QoL.
Results
600 pts were enrolled in the Qolixane part of the study with pts. treated with NPG in first line situation. Now further 73 pts. have already been included in the new Paragon- platform including different lines of therapy. The 600 pts. of Qolixane part showed a median PFS of 5.85 months (95% CI, 5.23 to 6.25) and median OS (mOS) of 8.91 months (95% CI, 7.89 to 10.19) with NPG in 1st line. MOS in ECOG 0 pts was 11.18 months (95% CI, 9.83 to 12.69) and therefore significantly better (p = 0.027) than in ECOG 1 pts with 8.52 months (7.36 to 10.19).
Conclusions
The QoliXane part of Paragon was able to show a big picture of 600 pts treated with NPG in 1st line in a real world scenario and Paragon will soon be able to get a complete picture on all lines of therapy. First data of Paragon will be presented at the meeting.
Clinical trial identification
NCT04119362.
Editorial acknowledgement
Legal entity responsible for the study
Institut für Klinische Krebsforschung IKF GmbH.
Funding
Celgene Internation IL SARL, Couvet, Switzerland.
Disclosure
All authors have declared no conflicts of interest.