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Title: Nintedanib Plus Pemetrexed/Cisplatin in Patients With Malignant Pleural Mesothelioma: Phase II Results From the Randomized, Placebo-Controlled LUME-Meso Trial
Austin Authors: Grosso, Federica;Steele, Nicola;Novello, Silvia;Nowak, Anna K;Popat, Sanjay;Greillier, Laurent;John, Thomas ;Leighl, Natasha B;Reck, Martin;Taylor, Paul;Planchard, David;Sørensen, Jens Benn;Socinski, Mark A;von Wangenheim, Ute;Loemb´e, Ars`ene Bienvenu;Barrueco, Jos´e;Morsli, Nassim;Scagliotti, Giorgio
Affiliation: Azienda Ospedaliera SS Antonio e Biagio General Hospital, Alessandria
L'università di Torino, Azienda Sanitaria Ospedale San Luigi Gonzaga, Turin, Italy
University of Western Australia, Crawley, Western Australia, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Olivia Newton-John Cancer Research Institute, Austin Health, Heidelberg, Victoria, Australia
The Royal Marsden Hospital National Health Service (NHS) Foundation Trust, London, United Kingdom
The Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom
University Hospitals of South Manchester NHS Trust, Wythenshawe, Manchester, United Kingdom
Assitance Publique Hôpitaux de Marseille, Aix Marseille University, Marseille
Institut Gustave Roussy, Villejuif
Boehringer Ingelheim France S.A.S., Paris, France
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Lung Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany
Rigshospitalet - Finsencentret, Copenhagen, Denmark
Florida Hospital Cancer Institute, Orlando, FL, USA
Arsène Bienvenu Loembé, Boehringer Ingelheim B.V., Alkmaar, the Netherlands
Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA
Issue Date: 1-Nov-2017 2017-09-11
Publication information: Journal of Clinical Oncology 2017; 35(31): 3591-3600
Abstract: Purpose LUME-Meso is a phase II/III randomized, double-blind trial designed to assess efficacy and safety of nintedanib plus chemotherapy as first-line treatment of malignant pleural mesothelioma (MPM). Phase II results are reported here. Patients and Methods Chemotherapy-naïve patients with unresectable, nonsarcomatoid MPM (Eastern Cooperative Oncology Group performance status 0 to 1), stratified by histology (epithelioid or biphasic), were randomly assigned in a 1:1 ratio to up to six cycles of pemetrexed and cisplatin plus nintedanib (200 mg twice daily) or placebo followed by nintedanib plus placebo monotherapy until progression. The primary end point was progression-free survival (PFS). Results Eighty-seven patients were randomly assigned. The median number of pemetrexed and cisplatin cycles was six; the median treatment duration for nintedanib was 7.8 months and 5.3 months for placebo. Primary PFS favored nintedanib (hazard ratio [HR], 0.56; 95% CI, 0.34 to 0.91; P = .017), which was confirmed in updated PFS analyses (HR, 0.54; 95% CI, 0.33 to 0.87; P = .010). A trend toward improved overall survival also favored nintedanib (HR, 0.77; 95% CI, 0.46 to 1.29; P = .319). Benefit was evident in epithelioid histology, with a median overall survival gain of 5.4 months (HR, 0.70; 95% CI, 0.40 to 1.21; P = .197; median [nintedanib v placebo], 20.6 months v 15.2 months) and median PFS gain of 4.0 months (HR, 0.49; 95% CI, 0.30 to 0.82; P = .006; median [nintedanib v placebo], 9.7 v 5.7 months). Neutropenia was the most frequent grade ≥ 3 adverse event (AE; nintedanib 43.2% v placebo 12.2%); rates of febrile neutropenia were low (4.5% in nintedanib group v 0% in placebo group). AEs leading to discontinuation were reported in 6.8% of those receiving nintedanib versus 17.1% of those in the placebo group. Conclusion Addition of nintedanib to pemetrexed plus cisplatin resulted in PFS improvement. AEs were manageable. The clinical benefit was evident in patients with epithelioid histology. The confirmatory phase III part of the study is ongoing.
DOI: 10.1200/JCO.2017.72.9012
PubMed URL:
Type: Journal Article
Appears in Collections:Journal articles

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