Silvia Novello1, Rolf Kaiser2, Anders Mellemgaard3, Jean-Yves Douillard4, Sergey Orlov5, Maciej Krzakowski6, Joachim von Pawel7, Maya Gottfried8, Igor Bondarenko9, Meilin Liao10, José Barrueco11, Birgit Gaschler-Markefski2, Ingolf Griebsch2, Michael Palmer12, Martin Reck13. 1. Department of Oncology, University of Turin, Italy. Electronic address: silvia.novello@unito.it. 2. Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany. 3. Department of Oncology, Herlev University Hospital, Copenhagen, Denmark. 4. Department of Medical Oncology, Centre René Gauducheau, Nantes, France. 5. Department of Thoracic Oncology, St. Petersburg State Medical University, St. Petersburg, Russia. 6. The Maria Sklodowska-Curie Institute of Oncology, Warsaw, Poland. 7. Pneumology Clinic, Asklepios Fachkliniken, Gauting, Germany. 8. Lung Cancer Unit, Meir Medical Center, Kfar Saba, Israel. 9. Clinical Facility, Dnepropetrovsk Medical Academy, City Clinical Hospital #4, Dnepropetrovsk, Ukraine. 10. Shanghai Chest Hospital, Shanghai, China. 11. Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA. 12. Keele University, Keele, United Kingdom. 13. Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Grosshansdorf, Germany.
Abstract
INTRODUCTION: The LUME-Lung 1 trial (NCT00805194; Study 1199.13) demonstrated a significant overall survival (OS) advantage for nintedanib plus docetaxel compared with placebo plus docetaxel as second-line therapy for patients with advanced non-small cell lung cancer (NSCLC) and adenocarcinoma histology. Patient-reported outcomes (PROs) for symptoms and health-related quality of life (QoL) are reported here. METHODS: PROs were assessed at screening, on Day 1 of each 21-day treatment cycle, at the end of active treatment, and at the first follow-up visit. PRO instruments were the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and Lung Cancer-13 supplement, and the EuroQol disease-generic questionnaire (EQ-5D and EQ-VAS). Analyses of PRO items for lung cancer-specific symptoms of cough, dyspnoea and pain were prespecified. RESULTS:Rates of questionnaire completion were high. There was no significant difference in time to deterioration of global health status/QoL, or symptoms of cough, dyspnoea or pain, between the treatment groups for both the overall study population and the adenocarcinoma population. Time to deterioration of some gastrointestinal events was shorter with nintedanib versus placebo. Longitudinal analysis for the adenocarcinoma population showed comparable changes between the groups in symptom scores over time, with numerical differences in favour of nintedanib for cough and pain scales, and significant reductions in some pain items with nintedanib versus placebo. There was no statistically significant difference in EQ-5D or EQ-VAS between the groups. CONCLUSION: The significant OS benefit observed with the addition of nintedanib to docetaxel therapy was achieved with no detrimental effect on patient self-reported QoL.
RCT Entities:
INTRODUCTION: The LUME-Lung 1 trial (NCT00805194; Study 1199.13) demonstrated a significant overall survival (OS) advantage for nintedanib plus docetaxel compared with placebo plus docetaxel as second-line therapy for patients with advanced non-small cell lung cancer (NSCLC) and adenocarcinoma histology. Patient-reported outcomes (PROs) for symptoms and health-related quality of life (QoL) are reported here. METHODS: PROs were assessed at screening, on Day 1 of each 21-day treatment cycle, at the end of active treatment, and at the first follow-up visit. PRO instruments were the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and Lung Cancer-13 supplement, and the EuroQol disease-generic questionnaire (EQ-5D and EQ-VAS). Analyses of PRO items for lung cancer-specific symptoms of cough, dyspnoea and pain were prespecified. RESULTS: Rates of questionnaire completion were high. There was no significant difference in time to deterioration of global health status/QoL, or symptoms of cough, dyspnoea or pain, between the treatment groups for both the overall study population and the adenocarcinoma population. Time to deterioration of some gastrointestinal events was shorter with nintedanib versus placebo. Longitudinal analysis for the adenocarcinoma population showed comparable changes between the groups in symptom scores over time, with numerical differences in favour of nintedanib for cough and pain scales, and significant reductions in some pain items with nintedanib versus placebo. There was no statistically significant difference in EQ-5D or EQ-VAS between the groups. CONCLUSION: The significant OS benefit observed with the addition of nintedanib to docetaxel therapy was achieved with no detrimental effect on patient self-reported QoL.
Authors: E Charton; B Cuer; F Cottone; F Efficace; C Touraine; Z Hamidou; F Fiteni; F Bonnetain; M-C Woronoff-Lemsi; C Bascoul-Mollevi; A Anota Journal: Qual Life Res Date: 2019-11-27 Impact factor: 4.147
Authors: Luis Corrales; Amanda Nogueira; Francesco Passiglia; Angela Listi; Christian Caglevic; Marco Giallombardo; Luis Raez; Edgardo Santos; Christian Rolfo Journal: Front Med (Lausanne) Date: 2017-02-28
Authors: Bernhard Englinger; Daniela Lötsch; Christine Pirker; Thomas Mohr; Sushilla van Schoonhoven; Bernd Boidol; Charles-Hugues Lardeau; Melanie Spitzwieser; Pál Szabó; Petra Heffeter; Irene Lang; Margit Cichna-Markl; Bettina Grasl-Kraupp; Brigitte Marian; Michael Grusch; Stefan Kubicek; Gergely Szakács; Walter Berger Journal: Oncotarget Date: 2016-08-02