Gerald W Prager1, Leopold Oehler2, Armin Gerger3, Brigitte Mlineritsch4, Johannes Andel5, Andreas Petzer6, Klaus Wilthoner7, Thamer Sliwa8, Petra Pichler9, Thomas Winder10, Sonja Heibl11, Birgit Gruenberger12, Friedrich Laengle13, Eva Hubmann14, Markus Korger15, Martin Pecherstorfer16, Angela Djanani17, Hans-Joerg Neumann18, Kathrin Philipp-Abbrederis19, Ewald Wöll20, Robert Trondl21, Catharina Arnold-Schrauf22, Wolfgang Eisterer23. 1. Medical University of Vienna, Department of Oncology, Währinger Gürtel 18-20, 1090, Vienna, Austria. Electronic address: gerald.prager@meduniwien.ac.at. 2. Sankt Josef Krankenhaus, Internal Medicine 2, Auhofstraße 189, 1130, Vienna, Wien, Austria. Electronic address: leopold.oehler@sjk-wien.at. 3. Medical University of Graz, Clinical Institute of Oncology, Auenbruggerplatz 15, 8036, Graz, Austria. Electronic address: armin.gerger@klinikum-graz.at. 4. Universitätsklinik Salzburg, University Clinic for Internal Medicine III, Müllner Haupstraße 48, 5020, Salzburg, Austria. Electronic address: brigitte@mlineritsch.com. 5. Pyhrn-Eisenwurzen Klinikum, Internal Medicine II, Sierningerstraße 170, 4400, Steyr, Austria. Electronic address: johannes.andel@ooeg.at. 6. Ordensklinikum Linz BHS - EKH, Internal Medicine I, Medical Oncology and Hematology, Seilerstätte 4, 4010, Linz Austria. Electronic address: andreas.petzer@ordensklinikum.at. 7. Landeskrankenhaus Vöcklabruck, Vöcklabruck, Internal Medicine, Hemato-Oncology, Dr. Wilhelm-Bock-Straße 1, 4840 Vöcklabruck, Austria. Electronic address: Klaus.Wilthoner@ooeg.at. 8. Hanuschkrankenhaus, Medicine III for Hematology and Oncology, Heinrich-Collin-Straße 30, 1140, Wien, Vienna, Austria. Electronic address: thamer.sliwa@gmail.com. 9. Universitätsklinikum St. Pölten, Internal Medicine I, Dunant-Platz 1, 3100, Sankt Pölten, Austria. Electronic address: petra.pichler@stpoelten.lknoe.at. 10. Landeskrankenhaus Feldkirch, Internal Medicine II, Carinagasse 47, 6807, Feldkirch, Austria. Electronic address: Thomas.Winder@vlkh.net. 11. Klinikum Wels-Grieskirchen, Internal Medicine IV, Grieskirchner Straße 42, 4600, Wels, Austria. Electronic address: sonja.heibl@klinikum-wegr.at. 12. Landesklinikum Wiener Neustadt, Internal Medicine for Hematology and Internal Oncology, Corvinusring 2-5, 2700, Wiener Neustadt, Austria. Electronic address: Birgit.Gruenberger@wienerneustadt.lknoe.at. 13. Landesklinikum Wiener Neustadt, Department of Surgery, Corvinusring 2-5, 2700, Wiener Neustadt, Austria. Electronic address: friedrich.laengle@wienerneustadt.lknoe.at. 14. Krankenhaus der Barmherzigen Brüder, Internal Medicine, Marschallgasse 12, 8020, Graz, Austria. Electronic address: eva.hubmann@bbgraz.at. 15. Krankenhaus der Barmherzigen Brüder, Internal Medicine II, Johannes von Gott-Platz 1, 7000, Eisenstadt, Austria. Electronic address: markus.korger@bbeisen.at. 16. Karl Landsteiner University of Health Sciences, Department of Internal Medicine, University Hospital, 3500, Krems an der Donau, Austria. Electronic address: martin.pecherstorfer@krems.lknoe.at. 17. Medical University of Innsbruck, Institute of Gastroenterology, Internal Medicine I, Institute of Gastroenterology, Anichstraße 35, 6020, Innsbruck, Austria. Electronic address: angela.djanani@tirol-kliniken.at. 18. Krankenhaus der Elisabethinen, Internal Medicine, Völkermarkter Straße 15-19, 9020, Klagenfurt, Austria. Electronic address: hansjoerg.neumann@ekh.at. 19. Medical University of Innsbruck, Institute of Hematology and Oncology, Internal Medicine V, Institute of Hematology and Oncology, Anichstraße 35, 6020, Innsbruck, Austria. Electronic address: kathrin.philipp-abbrederis@tirol-kliniken.at. 20. Krankenhaus Zams, Internal Medicine, Sanatoriumstraße 43, 6511, Zams, Austria. Electronic address: ewald.woell@krankenhaus-zams.at. 21. Celgene Austria GmbH, EuroPlaza Building E, Technologiestraße 10, 1120, Vienna, Austria. Electronic address: robert.trondl@bms.com. 22. Celgene Austria GmbH, EuroPlaza Building E, Technologiestraße 10, 1120, Vienna, Austria. Electronic address: catharina.arnold-schrauf@bms.com. 23. Klinikum Klagenfurt Am Wörthersee, Internal Medicine and Oncology, Feschnigstraße 11, 9020, Klagenfurt, Austria. Electronic address: wolfgang.eisterer@kabeg.at.
Abstract
BACKGROUND: Pancreatic cancer (PC) ranks among the deadliest malignancies worldwide. In the MPACT study, first-line nab-paclitaxel plus gemcitabine (nab-P/G) demonstrated activity (median overall survival [OS], 8.7 months) and tolerability in patients with metastatic PC (mPC). However, the clinical evidence of nab-P/G in the elderly (>70 years), who account for the majority of patients with mPC, is limited. This is the first prospective, multicentre, non-interventional study evaluating the tolerability and effectiveness of nab-P/G in younger (≤70 years) versus elderly (>70 years) patients with mPC in the daily clinical routine. METHODS: Eligible patients with mPC were treated with nab-P/G and observed until disease progression or unacceptable toxicity. The primary objectives were safety and tolerability of nab-P/G, and the secondary objectives were efficacy and real-life dosing. RESULTS: A total of 317 patients with mPC (median age, 70 years) were recruited, of which 299, aged ≤70 (n = 162) and >70 (n = 137) years, were eligible for analysis. Baseline characteristics and the safety profile were comparable between the groups. However, fatigue (22.8% versus 13.0%) and decreased appetite (8.8% versus 1.2%) were more frequent in elderly patients. Younger versus elderly patients equally benefited in terms of objective response rate (36% versus 48%), median progression-free survival (5.6 versus 5.5 months; hazard ratio [HR] = 1.03; p = 0.81) and OS (10.6 versus 10.2 months; HR = 0.89; p = 0.4). In addition, the median treatment duration (5 versus 4 cycles), relative dose intensity (70% versus 74%) or reasons for treatment discontinuation were similar. Most patients (56.2% versus 47.4%) benefited from a second-line therapy. CONCLUSION: This prospective real-world analysis confirms the feasibility and tolerability of nab-P/G treatment and reveals OS data similar for younger patients and elderly patients aged >70 years. CLINICALTRIALS. GOV REGISTRATION: NCT02555813. AUSTRIAN NIS REGISTRY: NIS005071.
BACKGROUND:Pancreatic cancer (PC) ranks among the deadliest malignancies worldwide. In the MPACT study, first-line nab-paclitaxel plus gemcitabine (nab-P/G) demonstrated activity (median overall survival [OS], 8.7 months) and tolerability in patients with metastatic PC (mPC). However, the clinical evidence of nab-P/G in the elderly (>70 years), who account for the majority of patients with mPC, is limited. This is the first prospective, multicentre, non-interventional study evaluating the tolerability and effectiveness of nab-P/G in younger (≤70 years) versus elderly (>70 years) patients with mPC in the daily clinical routine. METHODS: Eligible patients with mPC were treated with nab-P/G and observed until disease progression or unacceptable toxicity. The primary objectives were safety and tolerability of nab-P/G, and the secondary objectives were efficacy and real-life dosing. RESULTS: A total of 317 patients with mPC (median age, 70 years) were recruited, of which 299, aged ≤70 (n = 162) and >70 (n = 137) years, were eligible for analysis. Baseline characteristics and the safety profile were comparable between the groups. However, fatigue (22.8% versus 13.0%) and decreased appetite (8.8% versus 1.2%) were more frequent in elderly patients. Younger versus elderly patients equally benefited in terms of objective response rate (36% versus 48%), median progression-free survival (5.6 versus 5.5 months; hazard ratio [HR] = 1.03; p = 0.81) and OS (10.6 versus 10.2 months; HR = 0.89; p = 0.4). In addition, the median treatment duration (5 versus 4 cycles), relative dose intensity (70% versus 74%) or reasons for treatment discontinuation were similar. Most patients (56.2% versus 47.4%) benefited from a second-line therapy. CONCLUSION: This prospective real-world analysis confirms the feasibility and tolerability of nab-P/G treatment and reveals OS data similar for younger patients and elderly patients aged >70 years. CLINICALTRIALS. GOV REGISTRATION: NCT02555813. AUSTRIAN NIS REGISTRY: NIS005071.