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Nintedanib in combination with docetaxel for second-line treatment of advanced non-small-cell lung cancer

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References

  • Jemal A, Bray F, Center M. Global cancer statistics. CA Cancer J Clin 2011;61:69-90
  • Molina J, Yang P, Cassivi S, et al. Non-small cell lung cancer: epidemiology, risk factors, treatment and survivorship. Mayo Clinic Proc 2008;83(5):584-94
  • Crino L, Weder W, Van Meerbeeck J, Felip E. Early stage and locally advanced (non-metastatic) non-small-cell-lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010;21(Suppl 5):v103-v15
  • Gridelli C, Ardizoni A, Giardiello F, et al. Second-line treatment of advanced non-small cell lung cancer. J Thorac Oncol 2008;3(4):430-40
  • Reck M, Popat S, Reinmuth N, et al. Metastatic non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2014;25(Suppl 3):iii27-39
  • Peters S, Adjei A, Gridelli C, et al. Metastatic non-small-cell lung cancer (NSCLC): ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 2012;23(Suppl 7):vii56-64
  • Ettinger D, Akerley W, Borghaei H. Non-small cell lung cancer. J Nat Compr Canc Netw 2012;10:1236-71
  • Leighl N. Treatment paradigms for patients with metastatic non-small-cell lung cancer: first, second, and third-line. Curr Oncol 2012;19:S52-8
  • Reck M. Docetaxel plus Nintedanib versus docetaxel plus placebo in patients with previously treated non-small-cell lung cancer (LUME-Lung 1): a phase 3, double-blind, randomized controlled trial. Lancet Oncol 2014;15:143-55
  • Hanahan D, Weinberg R. The hallmarks of cancer. Cell 2000;100:57-70
  • Folkman J. What is the evidence that tumors are angiogenesis dependent? J Natl Cancer Inst 1990;82:4-6
  • Ferrara N. The role of vascular endothelial growth factor in pathological angiogenesis. Breast Cancer Res Treat 1995;36:127-37
  • Sandler A, Gray R, Perry M, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. NEJM 2006;355:2542-250
  • Novello S, Scagliotti G, Rosell R, et al. Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer. Br J Cancer 2009;3(101):1543-8
  • Scagliotti G, Novello S, von Pawel J. Phase III study of carboplatin and paclitaxel alone or with sorafenib in advanced NSCLC. J Clin Oncol 2010;28(11):1835-42
  • Paz-Ares L, Biesma B, Heigener D. Phase III, randomized, double-blind, placebo-controlled trial of gemcitabine/cisplatin alone or with sorafenib for the first-line treatment of advanced, nonsquamous NSCLC. J Clin Oncol 2012;30(25):3084-92
  • Paz-Ares L, Hirsch V, Zhang L. Monotherapy administration of sorafenib in patients with NSCLC: phase III, randomized, double-blind, placebo-controlled MISSION trial. Ann Oncol 2012;23(Suppl 9):LBA33
  • Lee J, Hirsch V, Park K. Vandetanib versus placebo in patients with advanced NSCLC after prior therapy with an EGFR tyrosine kinase inhibitor: a randomized, double-blind phase III trial (ZEPHYR). J Clin Oncol 2012;30(10):1114-21
  • Garon E, Ciuleanu T, Arrieta O. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression in platinum-based therapy (REVEL): a multicenter, double-blind, randomized phase 3 trial. Epub. Lancet 2014;384(9944):665-73
  • Perol M, Ciuleanu T, Arrieta O. REVEL: a ramdomised, double-blind, phase III study of docetaxel (DOC) and ramucirumab (RAM;IMC-1121B) versus DOC and placebo (PL) in the second-line treatment of stage IV non-small cell lung cancer (NSCLC) following disease progression after one prior platinum-based therapy. J Clin Oncol 2014;32(Suppl 5):LBA8006
  • Hilberg F, Roth G, Krssak M, et al. BIBF 1120: Triple angiokinase inhibitor with sustained receptor blockade and good antitumor efficacy. Cancer Res 2008;68(12):4474-782
  • Casanovas O, Hicklin D, Bergers G, Hanahan D. Drug resistance by evasion of antiangiogenic targeting of VEGF signaling in late-stage pancreatic islet tumors. Cancer Cell 2005;8:299-309
  • Berger W, Setinek U, Mohr T, et al. Evidence for a role of FGF-2 and FGF receptors in the proliferation of non-small cell lung cancer cells. Int J Cancer 1999;83:415-23
  • Roth G, Binder R, Colbatzky F, et al. Nintedanib: From discovery to the clinic. J Med Chem 2014;58:1053-63
  • Rothschild S. Clinical potential of Nintedanib for the second-line treatment of advanced non-small-cell lung cancer: current evidence. Lung Cancer: Targets and Therapy 2014;5:51-7
  • Hilberg F, Brandstetter I. Efficacy of BIBF 1120, a potent triple angiokinase inhibitor, in models of human non-small cell lung cancer is augmented by chemotherapy. Eur J cancer 2007;2:S380
  • Health ECDHaFSP. Community register of medicinal products for human use. Vargatef 2014
  • Stopfer P, Rathgen K, Bischoff D, et al. Pharmacokinetics and metabolism of BIBF 1120 after oral dosing in healthy male volunteers. Xenobiotica [serial on the Internet]. 2011
  • Doebele R, Conkling P, Traynor A, et al. A phase I, open-label dose-escalation study of continuous treatment with BIBF 1120 in combination with paclitaxel and carboplatin as first-line treatment in patients with advanced non-small-cell lung cancer. Ann Oncol 2012;23(8):2094-102
  • Okamoto I, Kaneda H, Satoh T, et al. Phase I safety, pharmacokinetic, and biomarker study of BIBF 1120, an oral triple tyrosine kinase inhibitor in patients with advanced solid tumors. Mol Cancer Ther 2010;9(10):2825-33
  • Ellis P, Kaiser R, Zhao Y, et al. Phase I open-label study of continuous treatment with BIBF 1120, a triple angiokinase inhibitor, and pemetrexed in pretreated non-small cell lung cancer patients. Clin Cancer Res 2010;16(10):2881-9
  • Mross K, Stefanic M, Gmehling D. Phase I study of the angiogenesis inhibitor BIBF 1120 in patients with advanced solid tumors. Clin Cancer Res 2010;16(1):311-19
  • Lee C, Attard G, Poupard L, et al. editors. A phase I study of BIBF 1120, an orally active triple angiokinase inhibitor (VEGFR, PDGFR, FGFR) in patients with advanced solid malignancies. ASCO Annual Meeting Proceedings; 2005
  • Eisen T, Shparyk Y, Macleod N, et al. Effect of small angiokinase inhibitor Nintedanib (BIBF 1120) on QT interval in patients with previously untreated, advanced renal cell cancer in an open-label, phase II study. Invest New Drugs 2013;31(5):1283-93
  • Okamoto I, Miyazaki M, Takeda M, et al. Tolerability of Nintedanib (BIBF 1120) in combination with docetaxel: a phase 1 study in Japanese patients with previously treated non-small-cell lung cancer. J Thorac Oncol 2015;10(2):346-52
  • ClinicalTrials.gov. Nintedanib plus docetaxel in Japanese patients with adenocarcinoma subtype non-small cell lung cancer after failure of first line chemotherapy. Available from: https://clinicaltrials.gov/ct2/show/NCT02300298
  • ClinicalTrials.gov. LUME-Columbus: Nintedanib plus docetaxel in advanced non-small cell lung cancer with translational research. Available from: https://clinicaltrials.gov/ct2/show/NCT02231164
  • ClinicalTrials.gov. Induction study of cisplatin, docetaxel, and Nintedanib stage IB-IIIA non-small cell lung cancer (NCLC). Available from: https://clinicaltrials.gov/ct2/show/NCT02225405
  • Reck M, Kaiser R, Eschbach C, et al. A phase II double-blind study to investigate efficacy and safety of two doses of the triple angiokinase inhibitor BIBF 1120 in patients with relapsed advanced non-small-cell lung cancer. Ann Oncol 2011;22(6):1374-81
  • ClinicalTrials.gov. Nintedanib in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Up to Two Previous Chemotherapy Regimens. (NCT01948141). Available from: https://clinicaltrials.gov/ct2/show/NCT01948141
  • ClinicalTrials.gov. A Phase I/II Study of Continuous Oral Treatment With BIBF 1120 Added to Standard Gemcitabine/Cisplatin Therapy in First Line NSCLC Patients With Squamous Cell Histology. (NCT01346540). Available from: https://clinicaltrials.gov/ct2/show/NCT01346540
  • Administration USFaD. FDA News Release: FDA approves Ofev to treat idiopathic pulmonary fibrosis. 2014
  • Boehringer Ingelheim NCCN. Four researchers awarded grants to investigate effectiveness of Nintedanib in lung, colorectal, and gastrointestinal cancers [media release]. 2014
  • Novello S, Kaiser R, Mellemgaard A, et al.et al.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. Eur J cancer 2015;51(3):317-26
  • Nasser H, Hanna RK, Richard N, et al. Lume-lung 2: A multicenter, randomized, double-blind, phase III study of Nintedanib plus pemetrexed versus placebo plus pemetrexed in patients with advanced nonsquamous non-small cell lung cancer (NSCLC) after failure of first-line chemotherapy. J Clin Oncol 2013;31(Suppl)):abstract 8034
  • ClinicalTrials.gov. Lume Lung 2 : Nintedanib Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC. (NCT00806819). Available from: https://clinicaltrials.gov/ct2/show/NCT00806819
  • European Commission DHaFS, Public Health. 2014
  • Hanahan D, Weinberg RA. Hallmarks of cancer: the next generation. Cell 2011;144(5):646-74
  • Folkman J. Seminars in Medicine of the Beth Israel Hospital, Boston. Clinical applications of research on angiogenesis. N Engl J Med 1995;333(26):1757-63
  • Wilson C, Nicholes K, Bustos D, et al. Overcoming EMT-associated resistance to anti-cancer drugs via Src/FAK pathway inhibition. Oncotarget 2014;5(17):7328-41
  • Masi G, Salvatore L, Boni L, et al. Continuation or reintroduction of bevacizumab beyond progression to first-line therapy in metastatic colorectal cancer: final results of the randomized BEBYP trial. Ann Oncol 2015;26(4):724-30
  • Paz-Ares LG, Horn L, Borghaei H, et al. Phase III, randomized trial (CheckMate 057) of nivolumab (NIVO) versus docetaxel (DOC) in advanced non-squamous cell (non-SQ) non-small cell lung cancer (NSCLC). J Clin Oncol 2015;33(Suppl):abstract LBA109

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