BACKGROUND: Nintedanib is a triple angiokinase inhibitor approved with docetaxel for adenocarcinoma non-small cell lung cancer after first-line chemotherapy (FLT). In the phase III LUME-Lung 1 study, overall survival (OS) was significantly longer with nintedanib/docetaxel than with placebo/docetaxel in all adenocarcinoma patients and those with time from start of FLT (TSFLT) <9 months. OBJECTIVE: This study sought to extend analyses from the LUME-Lung 1 study, specifically for adenocarcinoma patients, to explore the impact of clinically relevant characteristics on outcomes such as time to progression after FLT. PATIENTS AND METHODS: Exploratory analyses were conducted of the overall and European LUME-Lung 1 adenocarcinoma population according to age, prior therapy, and tumor dynamics. Analyses also used TSFLT and time from end of FLT (TEFLT). RESULTS: Treatment with nintedanib/docetaxel significantly improved OS in European patients independently of age or prior therapy. Analyses of several patient subgroups showed improvements in median OS: TSFLT <6 months, 9.5 versus 7.5 months (hazard ratio [HR] 0.73, 95% confidence interval [CI] 0.55-0.98); chemorefractory to FLT, 9.1 versus 6.9 months (HR 0.72, 95% CI 0.52-0.99); progressive disease (PD) as best response to FLT, 9.8 versus 6.3 months (HR 0.62, 95% CI 0.41-0.94); TEFLT
Gottfried, M.
Bennouna, J.
Bondarenko, I.
Douillard, J. Y.
Heigener, D. F.
Krzakowski, M.
Mellemgaard, A.
Novello, S.
Orlov, S.
Summers, Y.
von Pawel, J.
Stohr, J.
Kaiser, R.
Reck, M.
Keywords
- Adenocarcinoma/*drug therapy/mortality/pathology
- Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
- Double-Blind Method
- Europe/epidemiology
- Female
- Humans
- Indoles/administration & dosage/adverse effects
- Lung Neoplasms/*drug therapy/mortality/pathology
- Male
- Middle Aged
- Survival Analysis
- Taxoids/administration & dosage/adverse effects