Nintedanib in ovarian cancer

References

• Jayson GC, Kohn EC, Kitchener HC, et al. Ovarian cancer. Lancet. 2014;384(9951):1376–1388.
   PubMed Web of Science ®Google Scholar
• Ferlay J, Soerjomataram I, Dikshit R, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer J Int Du Cancer. 2015;136(5):E359–86.
   PubMed Web of Science ®Google Scholar
• Sant M, Chirlaque Lopez MD, Agresti R, et al. Survival of women with cancers of breast and genital organs in Europe 1999-2007: results of the EUROCARE-5 study. Eur J Cancer. 2015;51(15):2191–2205. doi: 10.1016/j.ejca.2015.07.022.
   PubMed Web of Science ®Google Scholar
• Thigpen T, duBois A, McAlpine J, et al. First-line therapy in ovarian cancer trials. Int J Gynecol Cancer. 2011;21(4):756–762.
   PubMed Web of Science ®Google Scholar
• Hanahan D, Weinberg RA. The hallmarks of cancer. Cell. 2000;100(1):57–70.
   PubMed Web of Science ®Google Scholar
• Zand B, Coleman RL, Sood AK. Targeting angiogenesis in gynecologic cancers. Hematol Oncol Clin North Am. 2012;26(3):543–63, viii.
   PubMed Web of Science ®Google Scholar
• Butler JM, Kobayashi H, Rafii S. Instructive role of the vascular niche in promoting tumour growth and tissue repair by angiocrine factors. Nat Rev Cancer. 2010;10(2):138–146.
   PubMed Web of Science ®Google Scholar
• Ferrara N. VEGF and the quest for tumour angiogenesis factors. Nat Rev Cancer. 2002;2(10):795–803.
   PubMed Web of Science ®Google Scholar
• Jayson GC, Kerbel R, Ellis LM, et al. Antiangiogenic therapy in oncology: current status and future directions. Lancet. 2016;388(10043):518–529. doi: 10.1016/S0140-6736(15)01088-0.
   PubMed Web of Science ®Google Scholar
• Ellis LM, Hicklin DJ. VEGF-targeted therapy: mechanisms of anti-tumour activity. Nat Rev Cancer. 2008;8(8):579–591.
   PubMed Web of Science ®Google Scholar
• Perren TJ, Swart AM, Pfisterer J, et al. A Phase 3 trial of bevacizumab in ovarian cancer. N England J Med. 2011;365(26):2484–2496.
   PubMed Web of Science ®Google Scholar
• Coleman R, Bradya M, Herzog T, et al. A phase III randomized controlled clinical trial of carboplatin and paclitaxel alone or in combination with bevacizumab followed by bevacizumab and secondary cytoreductive surgery in platinum-sensitive, recurrent ovarian, peritoneal primary and fallopian cancer (Gynaecologic Oncology Group 0213). In: Society of Gynecologic Oncology Annual meeting on Women’s Cancer; 2015 Mar 28-31; Chicago (IL);Elseiver. 2015.
   Google Scholar
• OFEV (nintedanib) approved in the EU for the treatment of IPF [press release]; cited Nov 30. Available from: https://www.boehringer-ingelheim.com/press-release/ofev-nintedanib-approved-eu-treatment-ipf
   Google Scholar
• cited 2016 Dec 1. Available from: http://www.cancer.gov/about-cancer/treatment/drugs/fda-bevacizumab - Anchor-Ovarian
   Google Scholar
• Oza AM, Cook AD, Pfisterer J, et al. Standard chemotherapy with or without bevacizumab for women with newly diagnosed ovarian cancer (ICON7): overall survival results of a phase 3 randomised trial. Lancet Oncol. 2015;16(8):928–936.
   PubMed Web of Science ®Google Scholar
• Burger RA, Brady MF, Bookman MA, et al. Incorporation of bevacizumab in the primary treatment of ovarian cancer. N Engl J Med. 2011;365(26):2473–2483.
   PubMed Web of Science ®Google Scholar
• Aghajanian C, Blank SV, Goff BA, et al. OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol. 2012;30(17):2039–2045.
   PubMed Web of Science ®Google Scholar
• Pujade-Lauraine E, Hilpert F, Weber B, et al. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: the AURELIA open-label randomized phase III trial. J Clin Oncol. 2014;32(13):1302–1308.
   PubMed Web of Science ®Google Scholar
• Poveda AM, Selle F, Hilpert F, et al. Bevacizumab combined with weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan in platinum-resistant recurrent ovarian cancer: analysis by chemotherapy cohort of the randomized Phase III AURELIA Trial. J Clin Oncol. 2015;33(32):3836–3838.
   PubMed Web of Science ®Google Scholar
• McLachlan J, Lima JP, Dumas L, et al. Targeted agents and combinations in ovarian cancer: where are we now? Expert Rev Anticancer Ther. 2016;16(4):441–454.
   PubMed Web of Science ®Google Scholar
• du Bois A, Floquet A, Kim JW, et al. Incorporation of pazopanib in maintenance therapy of ovarian cancer. J Clin Oncol. 2014;32(30):3374–3382.
   PubMed Web of Science ®Google Scholar
• Ledermann JA, Embleton AC, Raja F, et al. Cediranib in patients with relapsed platinum-sensitive ovarian cancer (ICON6): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;387(10023):1066–1074.
   PubMed Web of Science ®Google Scholar
• Ledermann JA, Embleton AC, Parmar MKB, et al. Overall survival results of ICON6: A trial of chemotherapy and cediranib in relapsed ovarian cancer. In: ASCO annual meeting; 2017 Jun 2; Chicago; American Society of Clinical Oncology (ASCO). 2017.
   Google Scholar
• Liu JF, Barry WT, Birrer M, et al. Combination cediranib and olaparib versus olaparib alone for women with recurrent platinum-sensitive ovarian cancer: a randomised phase 2 study. Lancet Oncol. 2014;15(11):1207–1214.
   PubMed Web of Science ®Google Scholar
• Monk BJ, Poveda A, Vergote I, et al. Anti-angiopoietin therapy with trebananib for recurrent ovarian cancer (TRINOVA-1): a randomised, multicentre, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2014;15(8):799–808.
   PubMed Web of Science ®Google Scholar
• Marth C, Vergote I, Scambia G, et al. ENGOT-ov-6/TRINOVA-2: randomised, double-blind, phase 3 study of pegylated liposomal doxorubicin plus trebananib or placebo in women with recurrent partially platinum-sensitive or resistant ovarian cancer. Eur J Cancer. 2017;70:111–121.
   PubMed Web of Science ®Google Scholar
• Nintedanib (BIBF 1120) in Mesothelioma. 2016 cited 2016 Aug 5. Available from: http://clinicaltrials.gov/ct2/show/NCT01907100?term=nintedanib+mesothelioma&rank=1
   Google Scholar
• Roth GJ, Binder R, Colbatzky F, et al. Nintedanib: from discovery to the clinic. J Med Chem. 2015;58(3):1053–1063.
   PubMed Web of Science ®Google Scholar
• McCluggage WG. Morphological subtypes of ovarian carcinoma: a review with emphasis on new developments and pathogenesis. Pathology. 2011;43(5):420–432.
   PubMed Web of Science ®Google Scholar
• Ingelheim B Reference ID: 3643917; cited 2016 Apr 18. http://www.accessdata.fda.gov/drugsatfda_docs/label/…/205832s000lbl.pdf
   Google Scholar
• Hilberg F, Roth GJ, Krssak M, et al. BIBF 1120: triple angiokinase inhibitor with sustained receptor blockade and good antitumor efficacy. Cancer Res. 2008;68(12):4774–4782.
   PubMed Web of Science ®Google Scholar
• Hilberg F. 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.
   Google Scholar
• Kutluk CB, Ostapoff KT, Gerber DE, et al. 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. 2013;12(6):992–1001.
   PubMed Web of Science ®Google Scholar
• Bill R, Fagiani E, Zumsteg A, et al. Nintedanib is a highly effective therapeutic for neuroendocrine carcinoma of the pancreas (PNET) in the Rip1Tag2 transgenic mouse model. Clin Cancer Res. 2015;21(21):4856–4867.
   PubMed Web of Science ®Google Scholar
• Stopfer P, Rathgen K, Bischoff D, et al. Pharmacokinetics and metabolism of BIBF 1120 after oral dosing to healthy male volunteers. Xenobiotica. 2011;41(4):297–311.
   PubMed Web of Science ®Google Scholar
• Kropff M, Kienast J, Bisping G, et al. An open-label dose-escalation study of BIBF 1120 in patients with relapsed or refractory multiple myeloma. Anticancer Res. 2009;29(10):4233–4238.
   PubMed Web of Science ®Google Scholar
• Mross K, Stefanic M, Gmehling D, et al. Phase I study of the angiogenesis inhibitor BIBF 1120 in patients with advanced solid tumors. Clin Cancer Res. 2010;16(1):311–319.
   PubMed Web of Science ®Google Scholar
• 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):2825–2833.
   PubMed Web of Science ®Google Scholar
• du Bois A, Huober J, Stopfer P, et al. A phase I open-label dose-escalation study of oral BIBF 1120 combined with standard paclitaxel and carboplatin in patients with advanced gynecological malignancies. Ann Oncol. 2010;21(2):370–375.
   PubMed Web of Science ®Google Scholar
• Doebele RC, Conkling P, Traynor AM, 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):2094–2102.
   PubMed Web of Science ®Google Scholar
• Ellis PM, 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):2881–2889.
   PubMed Web of Science ®Google Scholar
• Reck M. Nintedanib: examining the development and mechanism of action of a novel triple angiokinase inhibitor. Expert Rev Anticancer Ther. 2015;15(5):579–594.
   PubMed Web of Science ®Google Scholar
• Bousquet G, Alexandre J, Le Tourneau C, et al. Phase I study of BIBF 1120 with docetaxel and prednisone in metastatic chemo-naive hormone-refractory prostate cancer patients. Br J Cancer. 2011;105(11):1640–1645.
   PubMed Web of Science ®Google Scholar
• 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):1374–1381.
   PubMed Web of Science ®Google Scholar
• Van Cutsem E, Prenen H, D’Haens G, et al. A phase I/II, open-label, randomised study of nintedanib plus mFOLFOX6 versus bevacizumab plus mFOLFOX6 in first-line metastatic colorectal cancer patients. Ann Oncol. 2015;26(10):2085–2091.
   PubMed Web of Science ®Google Scholar
• Molife LR, Omlin A, Jones RJ, et al. Randomized Phase II trial of nintedanib, afatinib and sequential combination in castration-resistant prostate cancer. Future Oncol. 2014;10(2):219–231.
   PubMed Web of Science ®Google Scholar
• Ledermann JA, Hackshaw A, Kaye S, et al. 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. 2011;29(28):3798–3804.
   PubMed Web of Science ®Google Scholar
• du Bois A, Kristensen G, Ray-Coquard I, et al. Standard first-line chemotherapy with or without nintedanib for advanced ovarian cancer (AGO-OVAR 12): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2016;17(1):78–89.
   PubMed Web of Science ®Google Scholar
• Vergote I, Rustin GJS, Eisenhauer EA, et al. Re: new guidelines to evaluate the response to treatment in solid tumors [ovarian cancer]. J Natl Cancer Inst. 2000;92(18):1534–1535.
   PubMedGoogle Scholar
• Zhao Y, Adjei AA. Targeting angiogenesis in cancer therapy: moving beyond vascular endothelial growth factor. Oncologist. 2015;20(6):660–673.
   PubMed Web of Science ®Google Scholar
• Kehoe S. Nintedanib and ovarian cancer: standardise surgery in trials? Lancet Oncol. 2016;17(1):9–11.
   PubMed Web of Science ®Google Scholar
• Low Dose Cyclophosphamide +/– Nintedanib in Advanced Ovarian Cancer (METRO-BIBF). 2016. [Cited 2016 Aug 5]. Available from: https://clinicaltrials.gov/ct2/show/NCT01610869?term=metrobibf&rank=1
   Google Scholar
• BIBF 1120 in Bevacizumab Resistant, Persistent, or Recurrent Epithelial Ovarian Cancer. 2016. [Cited 2016 Aug 5]. Available from: https://clinicaltrials.gov/ct2/show/NCT01669798
   Google Scholar
• Study of Nintedanib Plus Bevacizumab in Advanced Solid Tumors. 2016. [Cited 2016 Aug 5]. Available from: https://clinicaltrials.gov/ct2/show/NCT02835833
   Google Scholar
• Trial Of Pembrolizumab And Nintedanib (PEMBIB). 2016. [Cited 2016 Aug 5]. Available from: https://clinicaltrials.gov/ct2/show/NCT02856425
   Google Scholar
• A Randomised Phase II Study of Nintedanib (BIBF1120) Compared to Chemotherapy in Patients with Recurrent Clear Cell Carcinoma of the Ovary or Endometrium. 2016. [Cited 2016 Aug 5]. Available from: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-002109-735
   Google Scholar
• Glasspool RM, McNeish IA, Paul J, et al. NiCCC (ENGOT-GYN1): A randomized phase II study of nintedanib (BIBF1120) compared to chemotherapy in patients with recurrent clear-cell carcinoma of the ovary or endometrium. J Clin Oncol. 2016;34(15_suppl):TPS5603–TPS.
   Web of Science ®Google Scholar
• Coward J, Kulbe H, Chakravarty P, et al. Interleukin-6 as a therapeutic target in human ovarian cancer. Clin Cancer Res. 2011;17(18):6083–6096.
   PubMed Web of Science ®Google Scholar
• Collinson F, Hutchinson M, Craven RA, et al. Predicting response to bevacizumab in ovarian cancer: a panel of potential biomarkers informing treatment selection. Clin Cancer Res. 2013;19(18):5227–5239.
   PubMed Web of Science ®Google Scholar
• Backen A, Renehan AG, Clamp AR, et al. The combination of circulating Ang1 and Tie2 levels predicts progression-free survival advantage in bevacizumab-treated patients with ovarian cancer. Clin Cancer Res. 2014;20(17):4549–4558.
   PubMed Web of Science ®Google Scholar
• Emblem KE, Mouridsen K, Bjornerud A, et al. Vessel architectural imaging identifies cancer patient responders to anti-angiogenic therapy. Nat Med. 2013;19(9):1178–1183.
   PubMed Web of Science ®Google Scholar
• Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004;350(23):2335–2342.
   PubMed Web of Science ®Google Scholar
• Schmidinger M, Bellmunt J. Plethora of agents, plethora of targets, plethora of side effects in metastatic renal cell carcinoma. Cancer Treat Rev. 2010;36(5):416–424.
   PubMed Web of Science ®Google Scholar
• Friedlander M, Hancock KC, Rischin D, et al. A Phase II, open-label study evaluating pazopanib in patients with recurrent ovarian cancer. Gynecol Oncol. 2010;119(1):32–37.
   PubMed Web of Science ®Google Scholar
• Reck M, Kaiser R, Mellemgaard A, et al. 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. 2014;15(2):143–155.
   PubMed Web of Science ®Google Scholar
• Jubb AM, Harris AL. Biomarkers to predict the clinical efficacy of bevacizumab in cancer. Lancet Oncol. 2010;11(12):1172–1183.
   PubMed Web of Science ®Google Scholar
• Jain RK, Duda DG, Willett CG, et al. Biomarkers of response and resistance to antiangiogenic therapy. Nat Rev Clin Oncol. 2009;6(6):327–338.
   PubMed Web of Science ®Google Scholar
• Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib. 2016 cited 2016 Aug 5. Available from: http://clinicaltrials.gov/ct2/show/NCT01024920?term=nintedanib+renal&rank=1
   Google Scholar
• Hembree TN, Teer JK, Hakam A, et al. Genetic investigation of uterine carcinosarcoma: case report and cohort analysis. Cancer Control. 2016;23(1):61–66.
   PubMed Web of Science ®Google Scholar