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 registry

被引：11

作者：

Al-Batran, Salah-Eddin ^{[1
,3
]}

Hofheinz, Ralf-Dieter ^{[2
]}

Reichart, Alexander ^{[1
,3
]}

Pauligk, Claudia ^{[3
]}

Schoenherr, Caroline ^{[3
]}

Schlag, Rudolf ^{[4
]}

Siegler, Gabriele ^{[5
]}

Doerfel, Steffen ^{[6
]}

Koenigsmann, Michael ^{[7
]}

Zahn, Mark-Oliver ^{[8
]}

Schubert, Joerg ^{[9
]}

Aldaoud, Ali ^{[10
]}

Hoeffkes, Heinz-Gert ^{[11
,12
]}

Schulz, Holger ^{[13
]}

Hahn, Lars ^{[14
]}

Uhlig, Jens ^{[15
]}

Blau, Wolfgang ^{[16
]}

Stauch, Martina ^{[17
]}

Weniger, Joerg ^{[18
]}

Wolf, Martin ^{[19
]}

Jacobasch, Lutz ^{[20
]}

Bildat, Stephan ^{[21
,22
]}

Wehmeyer, Juergen ^{[23
]}

Homann, Nils ^{[24
]}

Trojan, Joerg ^{[25
]}

Waidmann, Oliver ^{[25
]}

Fietz, Thomas ^{[26
]}

Feustel, Hans-Peter ^{[27
]}

Groschek, Matthias ^{[28
]}

Wierecky, Jan ^{[29
]}

Waibel, Karin ^{[30
]}

Mahlmann, Stefan ^{[31
]}

Schwindel, Uwe ^{[32
]}

Peters, Uwe ^{[33
]}

Schuch, Gunter ^{[34
]}

Pink, Daniel ^{[35
,36
]}

Eschenburg, Henning ^{[37
]}

Woerns, Marcus-A. ^{[38
]}

Harich, Hans-Detlev ^{[39
]}

von Weikersthal, Ludwig Fischer ^{[40
]}

Daessler, Klaus-Ulrich ^{[41
]}

Behringer, Dirk M. ^{[42
]}

Messmann, Helmut ^{[43
]}

Kretzschmar, Albrecht ^{[44
]}

Gallmeier, Eike ^{[45
]}

Forstbauer, Helmut ^{[46
]}

Kunzmann, Volker ^{[47
]}

Papke, Jens ^{[48
]}

Buechner-Steudel, Petra ^{[49
]}

Vehling-Kaiser, Ursula ^{[50
]}

机构：

[1] UCT Univ Canc Ctr, Krankenhaus Nordwest, Frankfurt, Germany

[2] Univ Med Mannheim, Interdisziplinares Tumorzentrum, Mannheim, Germany

[3] Krankenhaus NW Frankfurt, Inst Klin Krebsforsch IKF GmbH, Frankfurt, Germany

[4] Gemeinschaftspraxis Schlag Schottker, Wurzburg, Germany

[5] Klinikum Nurnberg PMU, Nurnberg, Germany

[6] Onkozentrum Dresden, Dresden, Germany

[7] MediProjekt GbR, Hannover, Germany

[8] MVZ Onkol Kooperat Harz, Goslar, Germany

[9] Elblandklinikum Riesa, Riesa, Germany

[10] HELIOS Pk Klinikum, Pankreaszentrum Leipzig, Leipzig, Germany

[11] Univ Med Marburg, Klinikum Fulda, Fulda, Germany

[12] MVZ Osthessen GmbH, Fulda, Germany

[13] Pioh Frechen Koln Praxis Internist Onkol & Hamato, Frechen, Germany

[14] Dokusan Gesell Med Studien GmbH & Co KG, Herne, Germany

[15] Hamatol Onkol Schwerpunktpraxis, Naunhof, Germany

[16] Univ Klinikum Giessen & Marburg, Med Klin 4 5, Giessen, Germany

[17] Schwerpunktpraxis Hamatol Onkol, Kronach, Germany

[18] Gemeinschaftspraxis Hamatol & Onkol Dres Wenige B, Erfurt, Germany

[19] Klinikum Kassel GmbH, Klin Hamatol & Onkol, Kassel, Germany

[20] Onkol Gemeinschaftspraxis Dr Med Lutz Jacobasch, Dresden, Germany

[21] Klinikum Herford, Med Klin 2, Herford, Germany

[22] Onkol Zentrum, MVZ Onkol, Herford, Germany

[23] Gemeinschaftspraxis Hamatol & Onkol, Munster, Germany

[24] Klinikum Wolfsburg, Med Klin 2, Wolfsburg, Germany

[25] Klinikum JW Goethe Univ Frankfurt, Frankfurt, Germany

[26] Schwerpunktpraxis Hamatol, Onkol & Gastroenterol Dres Banhardt Fietz Hertkor, Singen, Germany

[27] Onkol Schwerpunktpraxis Speyer, Speyer, Germany

[28] Clin Res Stolberg GmbH, Stolberg, Germany

[29] Schwerpunkt Hamatol Onkol & Palliativmed, Uberortliche Gemeinschaftspraxis, Hamburg, Germany

[30] Medius Kliniken gGmbH, Medius Klin Ostfildern Ruit, Ostfildern Ruit, Germany

[31] Westpfalz Klinikum GmbH, Kaiserslautern, Germany

[32] GPR Gesundheits & Pflegezentrum gGmbH, Med Klin 1, Russelsheim, Germany

[33] Ambulantes Tumorzentrum Spandau Dres Peters & Sae, Berlin, Germany

[34] Hamatol Onkol Praxis Altona HOPA, Hamburg, Germany

[35] Ernst Moritz Arndt Univ Greifswald, Klin & Poliklin Innere Med C, Hamatol & Onkol, Transplantationszentrum,Palliativmed, Greifswald, Germany

[36] HELIOS Klinikum Bad Saarow, Sarkomzentrum Berlin Brandenburg, Klin Hamatol Onkol & Palliativmed, Brandenburg, Germany

[37] Internist Gemeinschaftspraxis Dres, Gustrow, Germany

[38] Univ Med Mainz, Med Klin & Poliklin 1, Mainz, Germany

[39] Onkol Hof MVZ Dres Kasper Harich, Hof, Germany

[40] Gesundheitszentrum St Marien GmbH, Praxis Hamatol & Internist Onkol, Amberg, Germany

[41] Praxis Dipl Med Klaus Ulrich Dassler, Freital, Germany

[42] Augusta Kranken Anstalt gGmbH, Bochum, Germany

[43] Univ Klinikum Augsburg, Med Klin 3, Augsburg, Germany

[44] MVZ Mitte Onkol Schwerpunktpraxis, Leipzig, Germany

[45] Univ Klinikum Giessen & Marburg GmbH, Klin Innere Med, Marburg, Germany

[46] GOSPL Gesell Onkol Studien, Troisdorf, Germany

[47] Univ Klin Wurzburg, Zentrum Innere Med, Med Klin & Poliklin 2, Wurzburg, Germany

[48] Praxis Prof Dr Med Jens Papke, Neustadt, Germany

[49] Univ Klinikum Halle Saale, Klin & Poliklin Innere Med 1, Halle, Germany

[50] VK&K Studien GbR, Landshut, Germany

来源：

INTERNATIONAL JOURNAL OF CANCER | 2021年 / 148卷 / 06期

关键词：

chemotherapy; pancreatic cancer; PARAGON; QOLIXANE; quality of life; registry; PLUS GEMCITABINE; SURVIVAL; FOLFIRINOX; IMPACT; THERAPY; MPACT;

D O I：

10.1002/ijc.33336

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：1478 / 1488

页数：11

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