TY - JOUR
T1 - Quality of life and outcome of patients with metastatic pancreatic cancer receiving first-line chemotherapy with nab-paclitaxel and gemcitabine
T2 - Real-life results from the prospective QOLIXANE trial of the Platform for Outcome, Quality of Life and Translational Research on Pancreatic Cancer registry
AU - Arbeitsgemeinschaft Internistische Onkologie (AIO)
AU - Al-Batran, Salah-Eddin
AU - Hofheinz, Ralf-Dieter
AU - Reichart, Alexander
AU - Pauligk, Claudia
AU - Schönherr, Caroline
AU - Schlag, Rudolf
AU - Siegler, Gabriele
AU - Dörfel, Steffen
AU - Koenigsmann, Michael
AU - Zahn, Mark-Oliver
AU - Schubert, Jörg
AU - Aldaoud, Ali
AU - Höffkes, Heinz-Gert
AU - Schulz, Holger
AU - Hahn, Lars
AU - Uhlig, Jens
AU - Blau, Wolfgang
AU - Stauch, Martina
AU - Weniger, Jörg
AU - Wolf, Martin
AU - Jacobasch, Lutz
AU - Bildat, Stephan
AU - Wehmeyer, Jürgen
AU - Homann, Nils
AU - Trojan, Jörg
AU - Waidmann, Oliver
AU - Fietz, Thomas
AU - Feustel, Hans-Peter
AU - Groschek, Matthias
AU - Wierecky, Jan
AU - Waibel, Karin
AU - Mahlmann, Stefan
AU - Schwindel, Uwe
AU - Peters, Uwe
AU - Schuch, Gunter
AU - Pink, Daniel
AU - Eschenburg, Henning
AU - Wörns, Marcus-A
AU - Harich, Hans-Detlev
AU - von Weikersthal, Ludwig Fischer
AU - Däßler, Klaus-Ulrich
AU - Behringer, Dirk M
AU - Messmann, Helmut
AU - Kretzschmar, Albrecht
AU - Gallmeier, Eike
AU - Forstbauer, Helmut
AU - Kunzmann, Volker
AU - Papke, Jens
AU - Büchner-Steudel, Petra
AU - Vehling-Kaiser, Ursula
N1 - © 2020 Union for International Cancer Control.
PY - 2021/3/15
Y1 - 2021/3/15
N2 - Few data exist on health-related quality of life (QoL) in patients with metastatic pancreatic cancer (mPC) receiving first-line chemotherapy (Awad L ZE, Mesbah M Boston, MA. Applying survival data methodology to analyze quality of life data, in Mesbah M, Cole BF, Ting Lee M-L (eds): Statistical Methods for Quality of Life Studies: Design, Measurements and Analysis. Kluwer Academic Publishers 2002). The QOLIXANE study is a prospective, noninterventional, multicenter substudy of the Platform for Outcome, Quality of Life and Translational Research on Pancreatic Cancer (PARAGON) registry, which evaluated QoL in patients with mPC 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% confidence interval [CI], 5.2-6.3). Median overall survival (OS) was 8.9 months (95% CI, 7.9-10.2), while median time to deterioration of GHS/QoL was 4.7 months (95% CI, 4.0-5.6). 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 nonevaluable. In the Cox regression analysis, GHS/QoL scores strongly predicted survival with a hazard ratio of 0.86 (P < .0001). Patients with mPC 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.
AB - Few data exist on health-related quality of life (QoL) in patients with metastatic pancreatic cancer (mPC) receiving first-line chemotherapy (Awad L ZE, Mesbah M Boston, MA. Applying survival data methodology to analyze quality of life data, in Mesbah M, Cole BF, Ting Lee M-L (eds): Statistical Methods for Quality of Life Studies: Design, Measurements and Analysis. Kluwer Academic Publishers 2002). The QOLIXANE study is a prospective, noninterventional, multicenter substudy of the Platform for Outcome, Quality of Life and Translational Research on Pancreatic Cancer (PARAGON) registry, which evaluated QoL in patients with mPC 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% confidence interval [CI], 5.2-6.3). Median overall survival (OS) was 8.9 months (95% CI, 7.9-10.2), while median time to deterioration of GHS/QoL was 4.7 months (95% CI, 4.0-5.6). 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 nonevaluable. In the Cox regression analysis, GHS/QoL scores strongly predicted survival with a hazard ratio of 0.86 (P < .0001). Patients with mPC 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.
KW - Adenocarcinoma/drug therapy
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Albumins/therapeutic use
KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects
KW - Deoxycytidine/analogs & derivatives
KW - Female
KW - Humans
KW - Male
KW - Middle Aged
KW - Paclitaxel/therapeutic use
KW - Pancreatic Neoplasms/drug therapy
KW - Quality of Life
KW - Registries
KW - Treatment Outcome
KW - Gemcitabine
U2 - 10.1002/ijc.33336
DO - 10.1002/ijc.33336
M3 - Original Article
C2 - 33038277
SN - 0020-7136
VL - 148
SP - 1478
EP - 1488
JO - INTERNATIONAL JOURNAL OF CANCER
JF - INTERNATIONAL JOURNAL OF CANCER
IS - 6
ER -