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
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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.
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Patient-reported outcomes showed no impact of nintedanib plus docetaxel on quality of life.
“However, no impact on QoL has been reported by the analysis of patient-reported outcomes [103].”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [103]
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- Authors
- Novello, S., Kaiser, R., Mellemgaard, A., Douillard, J.-Y., Orlov, S., Krzakowski, M., von Pawel, J., Gottfried, M., Bondarenko, I., Liao, M., Barrueco, J., Gaschler-Markefski, B., Griebsch, I., Palmer, M., & Reck, M.
- Affiliations
- University of Turin (IT)
- Boehringer Ingelheim (Germany) (DE)
- Herlev Hospital (DK)
- The Maria Sklodowska-Curie National Research Institute of Oncology (PL)
- Meir Medical Center (IL)
- Dnipro State Medical University (UA)
- Shanghai Chest Hospital (CN)
- Boehringer Ingelheim (United States) (US)
- Keele University (GB)
- LungenClinic Grosshansdorf (DE)
- Corresponding author
- Novello, Silvia
- ORCID
- Venue
- European Journal of Cancer
- Publisher
- Elsevier BV
- Published
- 2015-02
- Volume
- 51
- Issue
- 3
- Pages
- 317-326
- ISSN
- 0959-8049 (ISSN-L)
- OpenAlex
- W1981608915
- Cited by
- 66
- References
- 23
- Citations by year
- 2025: 8 · 2024: 3 · 2023: 5 · 2022: 2 · 2021: 2 · 2020: 4 · 2019: 7 · 2018: 9 · 2017: 8 · 2016: 9 · 2015: 9
- FWCI
- 6.94
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- European Journal of Cancer (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Institutional Research Information System University of Turin (University of Turin) (submittedVersion, other-oa)
- Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
- INFM-OAR (INFN Catania) (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Keywords
- nintedanib, non-small cell lung cancer, second-line therapy, docetaxel, patient-reported outcomes, health-related quality of life, cough, dyspnea, pain, gastrointestinal adverse effects, advanced adenocarcinoma
- MeSH terms
- Docetaxel, Adenocarcinoma, Adult, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Double-Blind Method, Health Status, Humans, Indoles, Lung Neoplasms, Placebos, Quality of Life, Surveys and Questionnaires, Treatment Outcome, Chemotherapy, Adjuvant, Disease Progression, Taxoids, Self Report
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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