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Target Oncol. 2017 Aug;12(4):475-485. doi: 10.1007/s11523-017-0517-2.

Efficacy and Safety of Nintedanib Plus Docetaxel in Patients with Advanced Lung Adenocarcinoma: Complementary and Exploratory Analyses of the Phase III LUME-Lung 1 Study.

Author information

1
Lung Cancer Unit, Meir Medical Center, 4428164, Kfar Saba, Israel. Maya.Gottfried@clalit.org.il.
2
Département D'Oncologie Médicale, ICO René Gauducheau, 44805, Saint Herblain Cedex, France.
3
Dnepropetovsk Medical Academy, Municipal Clinical Hospital #4, Dnipropetrovsk, 49102, Ukraine.
4
Department of Thoracic Oncology, LungenClinic Grosshansdorf, Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), 22927, Grosshansdorf, Germany.
5
Oncology Institute, 02-781, Warsaw, Poland.
6
Department of Oncology, Herlev Hospital, 2730, Herlev, Denmark.
7
Thoracic Oncology Unit, AUO San Luigi, Department of Oncology, University of Turin, 10124, Torino, Italy.
8
Department of Thoracic Oncology, GOU VPO St Petersburg State Medical University, St Petersburg, 197022, Russia.
9
Department of Medical Oncology, Christie Hospital NHS Foundation Trust, Manchester, M20 4BX, UK.
10
Asklepios Fachkliniken München-Gauting, 82131, Gauting, Germany.
11
Boehringer Ingelheim Pharma GmbH & Co. KG, 88400, Biberach, Germany.
12
Boehringer Ingelheim Pharma GmbH & Co. KG, 55216, Ingelheim am Rhein, Germany.
13
Johannes Gutenberg University of Mainz, 55122, Mainz, Germany.

Abstract

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 ≤6 months, 11.3 versus 8.2 months (HR 0.75, 95% CI 0.61-0.92); and TEFLT <3 months, 11.0 versus 8.0 months (HR 0.74, 95% CI 0.58-0.94).

CONCLUSIONS:

Nintedanib/docetaxel demonstrated significant OS benefits in adenocarcinoma patients, which were more pronounced in patients with shorter TSFLT or TEFLT, or with PD as best response to FLT. This study was registered at ClinicalTrials.gov: NCT00805194.

PMID:
28702806
DOI:
10.1007/s11523-017-0517-2
[Indexed for MEDLINE]

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