Nab-paclitaxel/gemcitabine (NPG) is standard first-line therapy for metastatic pancreatic cancer (mPC), but the pivotal study did not include QoL analyses.
QoliXane/PARAGON is a platform for Outcome, Quality of Life, and Translational Research on Pancreatic Cancer. In this prospective QoL-study, patients (pts) were recruited from 95 German centers. QoL was prospectively measured (prior to and every month thereafter): therapy and efficacy were prospectively collected. QoL and efficacy endpoints were analyzed in the intention-to-treat population (ITT), defined as all pts who were enrolled. The primary endpoint was the rate of pts without deterioration of QoL/Global Health Score (QoL/GHS) at 3 mos.
601 pts were included. Median progression-free survival was 6 mos (95% CI: 5.26, 6.25). Median overall survival (OS) was 10 mos (8.22, 11.74). 1-year OS was 41%. Median survival by ECOG PS of 0, 1, 2, and 3 was 11.1 mos, 8.9 mos, 4.8 mos, and 2.1 mos (p<.0001). The KM-analysis showed that 61% and 41% of pts had maintained QoL/GHS after 3 and 6 mos, respectively. Median time to deterioration of QoL/GHS was 4.7 mos [4.04, 5.59]. Mean QoL/GHS improved from 46.1 at baseline to 52.8 after 6 mos. In the QoL response analysis, 35%, 37% and 28% of evaluable pts had improved, stable and worse QoL/GHS after 3 mos, respectively. In the Cox regression analysis, a 10-point increase in baseline QoL/GHS correlated to 13% decreased risk of death (HR = 0.87; 0.83-0.91; p<.0001).
The QoliXane/PARAGON is among the largest studies on QoL of pancreatic cancer ever conducted. It shows that a relevant group of patients have improved or maintained QoL after 3 and 6 months and that QoL is a predictor of patient’s outcome.
Clinical trial identification
Legal entity responsible for the study
IKF Klinische Krebsforschung GmbH am Krankenhaus Nordwest.
C. Schönherr, G. zur Hausen: Celgene. T.O. Götze: COIs: Lilly, MSD, BMS, Celgene, Shire, Bayer. S-E. Al-Batran: Advisory role: Merck, Roche, Celgene, Lilly, Nordic Pharma, Bristol-Myers Squibb, MSD Sharp & Dohme: Speaker: Roche, Celgene, Lilly, Nordic Pharma, AIO gGmbH, MCI, promedicis, Forum für Medizinische Fortbildung; CEO/founder of IKF Klinische Krebsforschung GmbH; Research grants: Sanofi, Merck, Roche, Celgene, Vifor, Medac, Hospira, Lilly, German Cancer Aid (Krebshilfe), German Research Foundation, the Federal Ministry of Education and Research. All other authors have declared no conflicts of interest.