Analysis of patient-reported outcomes from the LUME-Lung 1 trial: A randomised, double-blind, placebo-controlled, Phase III study of second-line nintedanib in patients with advanced non-small cell lung cancer

Novello, Silvia and Kaiser, Rolf and Mellemgaard, Anders and Douillard, Jean-Yves and Orlov, Sergey and Krzakowski, Maciej and von Pawel, Joachim and Gottfried, Maya and Bondarenko, Igor and Liao, Meilin and Barrueco, Jose and Gaschler-Markefski, Birgit and Griebsch, Ingolf and Palmer, Michael and Reck, Martin (2015) Analysis of patient-reported outcomes from the LUME-Lung 1 trial: A randomised, double-blind, placebo-controlled, Phase III study of second-line nintedanib in patients with advanced non-small cell lung cancer. European Journal of Cancer, V. 51 (Iss. 3). pp. 317-326. ISSN 0959-8049

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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 EQVAS 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.

Item Type:	Article
Additional Information:	https://doi.org/10.1016/j.ejca.2014.11.015
Uncontrolled Keywords:	Anti-angiogenesis; Docetaxel; Nintedanib; Non-small cell lung cancer; Quality of life.
Subjects:	Oncology
Divisions:	Departments > Department of Oncology and Medical Radiology
Depositing User:	Елена Шрамко
Date Deposited:	31 Mar 2021 14:52
Last Modified:	31 Mar 2021 14:52
URI:	http://repo.dma.dp.ua/id/eprint/6392

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