Quality of Life and outcome of patients with metastatic pancreatic cancer receiving first-line chemotherapy with nab-paclitaxel and gemcitabine: Real life results from the prospective QOLIXANE trial of the Platform for Outcome, Quality of Life, and Translational Research on Pancreatic Cancer (PARAGON) registry
Mené en Allemagne dans un contexte de vie réelle auprès de 600 patients atteints d'un cancer métastatique du pancréas, cette étude évalue l'intérêt, du point de vue de la durée sans détérioriation de la qualité de vie, et l'efficacité, du point de vue de la survie sans progression, d'un traitement de première ligne combinant gemcitabine et nab-paclitaxel
Few data exists on health-related quality of life (QoL) in patients with metastatic pancreatic cancer receiving first-line chemotherapy 1. The QOLIXANE study is a prospective, non-interventional, multicenter sub-study of the Platform for Outcome, Quality of Life, and Translational Research on Pancreatic Cancer (PARAGON) registry, which evaluated QoL in patients with metastatic pancreatic cancer receiving first-line gemcitabine and nab-paclitaxel chemotherapy in real-life setting. QoL was prospectively measured via EORTC QLQ-C30 questionnaires at baseline and every month thereafter. Therapy and efficacy parameters were prospectively collected. Main objectives were the rate of patients without deterioration of Global Health Status/QoL (GHS/QoL) at 3 and 6 months. Six hundred patients were enrolled in 95 German study sites. Median progression-free survival was 5.9 months (95% CI, 5.2 to 6.3). Median overall survival (OS) was 8.9 months (95% CI, 7.9 to 10.2), while median time to deterioration of GHS/QoL was 4.7 months (95% CI, 4.0 to 5.6). With a baseline GHS/QoL score of 46 (SD, 22.8), baseline QoL of the patients was severely impaired, in most cases due to loss in role functioning and fatigue. In the Kaplan–Meier analysis, 61% and 41% of patients had maintained GHS/QoL after 3 and 6 months, respectively. However, in the QoL response analysis, 35% and 19% of patients had maintained (improved or stable) GHS/QoL after 3 and 6 months, respectively, while 14% and 9% had deteriorated GHS/QoL with the remaining patients being non-evaluable. In the Cox regression analysis, GHS/QoL scores strongly predicted survival with a HR of 0.86 (p<0.0001). Patients with metastatic pancreatic cancer have poor QoL at baseline that deteriorates within a median of 4.7 months. Treatment with gemcitabine and nab-paclitaxel is associated with maintained QoL in relevant proportions of patients. However, overall, results remain poor, reflecting the aggressive nature of the disease.