Nintedanib: A Review of Its Use as Second-Line Treatment in Adults with Advanced Non-Small Cell Lung Cancer of Adenocarcinoma Histology

Targeted Oncology

Volumn 10, Issue 2, 2015, Pages 303-310

  Dhillon, Sohita ^a  

^a SPRINGER   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ABC TRANSPORTER; AFATINIB; BEVACIZUMAB; CERITINIB; CRIZOTINIB; CYTOCHROME P450; CYTOCHROME P450 3A4; DOCETAXEL; ERLOTINIB; FIBROBLAST GROWTH FACTOR RECEPTOR; GEFITINIB; LIVER ENZYME; NINTEDANIB; ORGANIC ANION TRANSPORTER B; PLACEBO; PLATELET DERIVED GROWTH FACTOR RECEPTOR; SOLUTE CARRIER ORGANIC ANION TRANSPORTER 1B1; SOLUTE CARRIER ORGANIC ANION TRANSPORTER 1B3; SORAFENIB; SUNITINIB; VASCULOTROPIN; VASCULOTROPIN RECEPTOR; ANGIOGENESIS INHIBITOR; ANTINEOPLASTIC AGENT; INDOLE DERIVATIVE; PROTEIN KINASE INHIBITOR; TAXOID;

ADULT; ADVANCED CANCER; ANTIANGIOGENIC ACTIVITY; ARTICLE; BLEEDING; CANCER GROWTH; CONTRAST ENHANCEMENT; DIARRHEA; DIGESTIVE SYSTEM PERFORATION; DISEASE COURSE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE REDUCTION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG METABOLISM; DRUG POTENTIATION; DRUG TOLERABILITY; DRUG WITHDRAWAL; EPISTAXIS; FEBRILE NEUTROPENIA; GASTROINTESTINAL SYMPTOM; HEMOPTYSIS; HISTOPATHOLOGY; HUMAN; HYPERTENSION; IC50; LUNG ADENOCARCINOMA; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; NON SMALL CELL LUNG CANCER; NUCLEAR MAGNETIC RESONANCE IMAGING; OVERALL SURVIVAL; PHARMACODYNAMICS; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; STEADY STATE; THROMBOEMBOLISM; URINARY EXCRETION; VOMITING; ADENOCARCINOMA; CARCINOMA, NON-SMALL-CELL LUNG; DISEASE FREE SURVIVAL; ENZYMOLOGY; LUNG NEOPLASMS; MORTALITY; PATHOLOGY; RISK FACTOR; SURVIVAL ANALYSIS; TIME FACTOR; TREATMENT OUTCOME;

ADENOCARCINOMA; ANGIOGENESIS INHIBITORS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, NON-SMALL-CELL LUNG; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; HUMANS; INDOLES; LUNG NEOPLASMS; PROTEIN KINASE INHIBITORS; QUALITY OF LIFE; RISK FACTORS; SURVIVAL ANALYSIS; TAXOIDS; TIME FACTORS; TREATMENT OUTCOME;

EID: 84930542973     PISSN: 17762596     EISSN: 1776260X     Source Type: Journal    
DOI: 10.1007/s11523-015-0367-8     Document Type: Article

References (35)

1. Reck M, Popat S, Reinmuth N et al (2014) Metastatic non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 25(Suppl 3):iii27–39
2. Weiss JM, Stinchcombe TE (2013) Second-line therapy for advanced NSCLC. Oncologist 18(8):947–53
3. Crino L, Metro G (2014) Therapeutic options targeting angiogenesis in nonsmall cell lung cancer. Eur Respir Rev 23(131):79–91
4. Gori B, Ricciardi S, Fulvi A et al (2011) New antiangiogenics in non-small cell lung cancer treatment: Vargatef™ (BIBF 1120) and beyond. Ther Clin Risk Manag 7:429–40
5. Pirker R (2014) Novel drugs against non-small-cell lung cancer. Curr Opin Oncol 26(2):145–51
6. Keating GM (2014) Bevacizumab: a review of its use in advanced cancer. Drugs 74(16):1891–925
7. Roth GJ, Heckel A, Colbatzky F et al (2009) Design, synthesis, and evaluation of indolinones as triple angiokinase inhibitors and the discovery of a highly specific 6-methoxycarbonyl-substituted indolinone (BIBF 1120). J Med Chem 52(14):4466–80
8. European Medicines Agency. Vargatef (nintedanib): summary of product characteristics. 2015. http://www.ema.europa.eu. Accessed 23 Mar 2015.
9. Hilberg F, Roth GJ, Krssak M et al (2008) BIBF 1120: triple angiokinase inhibitor with sustained receptor blockade and good antitumor efficacy. Cancer Res 68(12):4774–82
10. Kutluk Cenik B, Ostapoff KT, Gerber DE et al (2013) BIBF 1120 (nintedanib), a triple angiokinase inhibitor, induces hypoxia but not EMT and blocks progression of preclinical models of lung and pancreatic cancer. Mol Cancer Ther 12(6):992–1001
11. Hilberg F, Brandstetter I (2007) Efficacy of BIBF 1120, a potent triple angiokinase inhibitor, in models of human non-small cell lung cancer is augmented by chemotherapy [abstract no. C7-03]. J Thorac Oncol 2(8):S380
12. Xiang QF, Wang F, Su XD et al (2011) Effect of BIBF 1120 on reversal of ABCB1-mediated multidrug resistance. Cell Oncol (Dordr) 34(1):33–44
13. Mross K, Stefanic M, Gmehling D et al (2010) Phase I study of the angiogenesis inhibitor BIBF 1120 in patients with advanced solid tumors. Clin Cancer Res 16(1):311–9
14. Okamoto I, Kaneda H, Satoh T et al (2010) 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 9(10):2825–33
15. Okamoto I, Miyazaki M, Takeda M et al (2014) 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 10(2):346–52
16. Doebele RC, Conkling P, Traynor AM et al (2012) 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 23(8):2094–102
17. Ellis PM, Kaiser R, Zhao Y et al (2010) 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 16(10):2881–9
18. Daga H, Takeda K, Okada H, et al. Safety and efficacy of nintedanib (BIBF 1120) plus pemetrexed in Japanese patients with advanced or recurrent non-small cell lung cancer (NSCLC): a phase I study [abstract no. 8056]. J Clin Oncol. 2013;31(15 Suppl).
19. Quintela-Fandino M, Urruticoechea A, Guerra J et al (2014) Phase I clinical trial of nintedanib plus paclitaxel in early HER-2-negative breast cancer (CNIO-BR-01-2010/GEICAM-2010-10 study). Br J Cancer 111(6):1060–4
20. Reck M, Kaiser R, Eschbach C et al (2011) 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 22(6):1374–81
21. Ledermann JA, Hackshaw A, Kaye S et al (2011) Randomized phase II placebo-controlled trial of maintenance therapy using the oral triple angiokinase inhibitor BIBF 1120 after chemotherapy for relapsed ovarian cancer. J Clin Oncol 29(28):3798–804
22. du Bois A, Kristensen G, Ray-Coquard I et al (2013) AGO-OVAR 12: a randomized placebo-controlled GCIG/ENGOT-intergroup phase III trial of standard frontline chemotherapy +/− nintedanib for advanced ovarian cancer [abstract no. 37397]. Int J Gynecol Cancer 23(8 Suppl 1):7–8
23. Reck M, Kaiser R, Mellemgaard A et al (2014) 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, randomised controlled trial. Lancet Oncol 15(2):143–55
24. Hanna NH, Kaiser R, Sullivan RN, 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 [abstract no. 8034]. J Clin Oncol. 2013;31(15 Suppl).
25. Kaiser R, Barrueco JR, Reck M et al (2013) Identification of a clinical biomarker for 2nd line combination with nintedanib in adenocarcinoma non-small cell lung cancer (NSCLC) patients in two phase Ill trials [abstract no. 3479]. Eur J Cancer 49(Suppl 2):S822
26. Eisen T, Shparyk Y, Macleod N et al (2013) 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 31(5):1283–93
27. Stopfer P, Rathgen K, Bischoff D et al (2011) Pharmacokinetics and metabolism of BIBF 1120 after oral dosing to healthy male volunteers. Xenobiotica 41(4):297–311
28. Mellemgaard A, Orlov S, Krzakowski M et al (2014) Effect of nintedanib (BIBF 1120) combined with standard 2nd-line docetaxel in NSCLC patients who received prior pemetrexed in LUME-Lung 1: a randomised, placebo-controlled Phase III trial [abstract no. 471P]. Ann Oncol 25(Suppl 4):iv157
29. Krzakowski M, Mellemgaard A, Orlov S et al (2014) Prior taxane use in the LUME-Lung 1 phase III trial and the effect on outcome following 2nd-line treatment with nintedanib (BIBF 1120) and docetaxel in patients with advanced NSCLC [abstract no. 473P]. Ann Oncol 25(Suppl 4):iv158
30. Novello S, Kaiser R, Mellemgaard A et al (2014) 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. Eur J Cancer 51(3):317–26
31. Reck M, Mellemgaard A, Orlov SV, et al. Antiangiogenic-specific adverse events (AEs) in patients with non-small cell lung cancer (NSCLC) treated with nintedanib (N) and docetaxel (D) [abstract no. 8100 plus poster]. J Clin Oncol. 2014;32(15 Suppl).
32. Reck M, Heigener D, Reinmuth N (2014) Nintedanib for the treatment of patients with advanced non-small-cell lung cancer. Expert Rev Clin Pharmacol 7(5):579–90
33. Hilberg F, Haslinger C, Garin Chesa P, et al. Molecular correlates of clinical benefit from antiangiogenic therapy for patients with lung adenocarcinoma: a hypothesis [abstract no. e22080]. J Clin Oncol. 2014;32(15 Suppl).
34. Ballas MS, Chachoua A (2011) Rationale for targeting VEGF, FGF, and PDGF for the treatment of NSCLC. Onco Targets Ther 4:43–58
35. Popat S, Mellemgaard A, Fahrbach K et al (2015) Nintedanib plus docetaxel as second-line therapy in patients with non-small-cell lung cancer: a network meta-analysis. Future Oncol 11(3):409–20