title: 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.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.affiliation: Department of Oncology, University of Turin, Italy. Electronic address: silvia.novello@unito.it.
authors.forename: Silvia
authors.initials: S
authors.lastname: Novello
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
authors.forename: Rolf
authors.initials: R
authors.lastname: Kaiser
authors.affiliation: Department of Oncology, Herlev University Hospital, Copenhagen, Denmark.
authors.forename: Anders
authors.initials: A
authors.lastname: Mellemgaard
authors.affiliation: Department of Medical Oncology, Centre René Gauducheau, Nantes, France.
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Douillard
authors.affiliation: Department of Thoracic Oncology, St. Petersburg State Medical University, St. Petersburg, Russia.
authors.forename: Sergey
authors.initials: S
authors.lastname: Orlov
authors.affiliation: The Maria Sklodowska-Curie Institute of Oncology, Warsaw, Poland.
authors.forename: Maciej
authors.initials: M
authors.lastname: Krzakowski
authors.affiliation: Pneumology Clinic, Asklepios Fachkliniken, Gauting, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: von Pawel
authors.affiliation: Lung Cancer Unit, Meir Medical Center, Kfar Saba, Israel.
authors.forename: Maya
authors.initials: M
authors.lastname: Gottfried
authors.affiliation: Clinical Facility, Dnepropetrovsk Medical Academy, City Clinical Hospital #4, Dnepropetrovsk, Ukraine.
authors.forename: Igor
authors.initials: I
authors.lastname: Bondarenko
authors.affiliation: Shanghai Chest Hospital, Shanghai, China.
authors.forename: Meilin
authors.initials: M
authors.lastname: Liao
authors.affiliation: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
authors.forename: José
authors.initials: J
authors.lastname: Barrueco
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
authors.forename: Birgit
authors.initials: B
authors.lastname: Gaschler-Markefski
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
authors.forename: Ingolf
authors.initials: I
authors.lastname: Griebsch
authors.affiliation: Keele University, Keele, United Kingdom.
authors.forename: Michael
authors.initials: M
authors.lastname: Palmer
authors.affiliation: Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Grosshansdorf, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Reck
mesh_terms: D000230:Adenocarcinoma / Q000175:diagnosis / Q000188:drug therapy / Q000401:mortality; D000328:Adult; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D018450:Disease Progression; D000077143:Docetaxel; D004311:Double-Blind Method; D006304:Health Status; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D008175:Lung Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D010919:Placebos; D011788:Quality of Life; D057566:Self Report; D011795:Surveys and Questionnaires; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D010919:Placebos; D043823:Taxoids; D000077143:Docetaxel; C530716:nintedanib
keywords: Anti-angiogenesis; Docetaxel; Nintedanib; Non-small cell lung cancer; Quality of life