PMID- 32927350 OWN - NLM STAT- MEDLINE DCOM- 20210621 LR - 20210621 IS - 1872-8332 (Electronic) IS - 0169-5002 (Linking) VI - 148 DP - 2020 Oct TI - Non-interventional LUME-BioNIS study of nintedanib plus docetaxel after chemotherapy in adenocarcinoma non-small cell lung cancer: A subgroup analysis in patients with prior immunotherapy. PG - 159-165 LID - S0169-5002(20)30576-6 [pii] LID - 10.1016/j.lungcan.2020.08.004 [doi] AB - OBJECTIVES: To evaluate the effectiveness and safety of nintedanib plus docetaxel in patients with advanced adenocarcinoma non-small cell lung cancer (NSCLC) previously treated with both chemo- and immunotherapy. MATERIALS AND METHODS: LUME-BioNIS is a European, prospective, multicenter, non-interventional study of patients with advanced adenocarcinoma NSCLC, who initiated nintedanib plus docetaxel after first-line chemotherapy in routine practice according to the approved nintedanib EU label. The primary objective is to explore whether molecular biomarkers can predict overall survival (OS). Information on clinical or radiologic progression and death, and adverse drug reactions (ADRs)/fatal adverse events (AEs) was collected during follow-up. Here, we report a subgroup analysis evaluating outcomes in immunotherapy-pretreated patients. RESULTS: Of 260 enrolled patients, 67 (25.8%) had prior immunotherapy and were included in this subgroup analysis. Prior immunotherapy was administered in first-line in 20 patients (29.9%; combined with chemotherapy in 4 patients [6.0%]) and later-lines in 47 patients (70.1%), and most commonly comprised nivolumab (39 patients; 58.2%), atezolizumab (14 patients; 20.9%) and pembrolizumab (11 patients; 16.4%). Nintedanib plus docetaxel was given in second-line in 10 patients (14.9%) and in later-lines in 57 patients (85.1%). Median OS was 8.8 months (95% confidence interval [CI]: 7.0-11.5) and median progression-free survival (PFS) was 4.6 months (95% CI: 3.5-5.7). Among 55 patients with available data, rates of objective response and disease control were 18.2% and 78.2%, respectively. In 65 patients evaluable for safety, the most common on-treatment ADRs/AEs were malignant neoplasm progression (19 patients; 29.2%), diarrhea (21 patients; 32.3%) and nausea (10 patients; 15.4%). CONCLUSIONS: Used according to the approved nintedanib label in routine practice, nintedanib plus docetaxel demonstrated clinical effectiveness, with no unexpected safety findings, in patients with prior chemotherapy and first- or later-line immunotherapy. These data add to the real-world evidence that can inform clinical decisions in the changing therapeutic landscape. CI - Copyright (c) 2020 The Authors. Published by Elsevier B.V. All rights reserved. FAU - Reck, Martin AU - Reck M AD - Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), German Center of Lung Research (DZL), Wohrendamm 80, 22927, Grosshansdorf, Germany. Electronic address: M.Reck@lungenclinic.de. FAU - Syrigos, Kostas AU - Syrigos K AD - National and Kapodistrian University of Athens, Sotiria General Hospital, Mesogion 152, Athens 115 27, Greece. Electronic address: ksyrigos@med.uoa.gr. FAU - Miliauskas, Skaidrius AU - Miliauskas S AD - Lithuanian University of Health Sciences, Department of Pulmonology, Medical Academy, Kaunas, A. Mickeviciaus g. 9, Kaunas 44307, Lithuania. Electronic address: Skaidrius.Miliauskas@kaunoklinikos.lt. FAU - Zochbauer-Muller, Sabine AU - Zochbauer-Muller S AD - Medical University of Vienna, Department of Medicine I, Wahringer Gurtel 18-20, 1090 Vienna, Austria. Electronic address: sabine.zoechbauer-mueller@meduniwien.ac.at. FAU - Fischer, Jurgen R AU - Fischer JR AD - Department of Oncology, Lungenklinik Lowenstein, D-74245 Lowenstein, Germany. Electronic address: juergen.fischer@klinik-loewenstein.de. FAU - Buchner, Hannes AU - Buchner H AD - Staburo GmbH, Munich, Germany. Electronic address: hannes.buchner.ext@boehringer-dingelheim.com. FAU - Kitzing, Thomas AU - Kitzing T AD - Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173 D-55216 Ingelheim am Rhein, Germany. Electronic address: thomas.kitzing@boehringer-ingelheim.com. FAU - Kaiser, Rolf AU - Kaiser R AD - Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Strasse 173 D-55216 Ingelheim am Rhein, Institute of Pharmacology, Johannes Gutenberg-University Mainz, Saarstrasse 21, 55122 Mainz, Germany. Electronic address: rolf.kaiser@boehringer-ingelheim.com. FAU - Radonjic, Dejan AU - Radonjic D AD - Boehringer Ingelheim International GmbH, Binger Strasse 173 D-55216 Ingelheim am Rhein, Germany. Electronic address: dejan.radonjic@boehringer-ingelheim.com. FAU - Kerr, Keith AU - Kerr K AD - Department of Pathology, Aberdeen Royal Infirmary, Foresterhill Rd, Aberdeen AB25 2ZN, United Kingdom. Electronic address: k.kerr@abdn.ac.uk. LA - eng PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20200808 PL - Ireland TA - Lung Cancer JT - Lung cancer (Amsterdam, Netherlands) JID - 8800805 RN - 0 (Indoles) RN - 0 (Taxoids) RN - 15H5577CQD (Docetaxel) RN - G6HRD2P839 (nintedanib) SB - IM MH - *Adenocarcinoma/drug therapy MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects MH - *Carcinoma, Non-Small-Cell Lung/drug therapy MH - Docetaxel/therapeutic use MH - Humans MH - Immunotherapy MH - Indoles MH - *Lung Neoplasms/drug therapy MH - Prospective Studies MH - Taxoids/therapeutic use MH - Treatment Outcome OTO - NOTNLM OT - Adenocarcinoma OT - Angiogenesis inhibitors OT - Carcinoma OT - Immunotherapy OT - Non-small cell lung OT - Observational study OT - Prospective studies OT - Treatment outcome EDAT- 2020/09/15 06:00 MHDA- 2021/06/22 06:00 CRDT- 2020/09/14 20:20 PHST- 2020/06/04 00:00 [received] PHST- 2020/08/03 00:00 [revised] PHST- 2020/08/04 00:00 [accepted] PHST- 2020/09/15 06:00 [pubmed] PHST- 2021/06/22 06:00 [medline] PHST- 2020/09/14 20:20 [entrez] AID - S0169-5002(20)30576-6 [pii] AID - 10.1016/j.lungcan.2020.08.004 [doi] PST - ppublish SO - Lung Cancer. 2020 Oct;148:159-165. doi: 10.1016/j.lungcan.2020.08.004. Epub 2020 Aug 8.