Anti-angiogenic-specific adverse events in patients with non-small cell lung cancer treated with nintedanib and docetaxel

Lung Cancer

Volumn 90, Issue 2, 2015, Pages 267-273

  Reck, Martin ^a   Mellemgaard, Anders ^b   von Pawel, Joachim ^c   Gottfried, Maya ^d   Bondarenko, Igor ^e   Cheng, Ying ^f   Zarogoulidis, Kostas ^g   Luft, Alexander ^h   Bennouna, Jaafar ⁱ   Barrueco, José ^j   Aboshady, Hesham ^j   Hocke, Julia ^k   Kaiser, Rolf ^k   Douillard, Jean Yves ⁱ  

^a Member of the German Center for Lung Research   (Germany)

^b GENTOFTE UNIVERSITY HOSPITAL   (Denmark)

^c Pneumology Clinic   (Germany)

^d MEIR MEDICAL CENTER   (Israel)

^e Dnipropetrovsk State Medical Academy   (Ukraine)

^f JILIN PROVINCIAL CANCER HOSPITAL   (China)

^g Aristotle University and Hippokration General Hospital   (Greece)

^h Leningrad Regional Clinical Hospital   (Russian Federation)

ⁱ CENTRE RENÉ GAUDUCHEAU   (France)

^j BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^k BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

more..

Author keywords

Angiogenesis inhibitors; Drug related side effects and adverse reactions; Non small cell lung cancer

Indexed keywords

DOCETAXEL; NINTEDANIB; PLACEBO; ANGIOGENESIS INHIBITOR; ANTINEOPLASTIC AGENT; INDOLE DERIVATIVE; TAXOID;

ABSCESS; ACNE; ADVANCED CANCER; ARTERIAL THROMBOEMBOLISM; ARTICLE; BLADDER PERFORATION; BLEEDING; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CEREBROVASCULAR ACCIDENT; CHEST WALL ABSCESS; COMPARATIVE STUDY; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DERMATITIS; DISEASE COURSE; DISSEMINATED INTRAVASCULAR CLOTTING; DRUG INDUCED DISEASE; DRUG SAFETY; EPISTAXIS; FISTULA; HAND FOOT SYNDROME; HEART INFARCTION; HEMOPTYSIS; HISTOLOGY; HUMAN; HYPERTENSION; INCIDENCE; INTESTINE PERFORATION; LARYNGEAL FISTULA; LARYNX DISORDER; LUNG ABSCESS; LUNG ADENOCARCINOMA; LUNG EMBOLISM; LUNG HEMORRHAGE; MAJOR CLINICAL STUDY; NON SMALL CELL LUNG CANCER; OVERALL SURVIVAL; PERIPROCTITIC ABSCESS; PHASE 3 CLINICAL TRIAL; POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RASH; SKIN ABSCESS; SQUAMOUS CELL LUNG CARCINOMA; STEVENS JOHNSON SYNDROME; STOMACH PERFORATION; STOMATITIS; SUPERIOR CAVA VEIN OBSTRUCTION; TOXIC EPIDERMAL NECROLYSIS; VEIN THROMBOSIS; VENOUS THROMBOEMBOLISM; ADENOCARCINOMA; CARCINOMA, NON-SMALL-CELL LUNG; CARCINOMA, SQUAMOUS CELL; DISEASE FREE SURVIVAL; LUNG NEOPLASMS; TREATMENT OUTCOME;

ADENOCARCINOMA; ANGIOGENESIS INHIBITORS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, NON-SMALL-CELL LUNG; CARCINOMA, SQUAMOUS CELL; DISEASE-FREE SURVIVAL; HUMANS; INDOLES; LUNG NEOPLASMS; TAXOIDS; TREATMENT OUTCOME;

EID: 84945589791     PISSN: 01695002     EISSN: 18728332     Source Type: Journal    
DOI: 10.1016/j.lungcan.2015.08.003     Document Type: Article

References (40)

1. Carmeliet P., Jain R.K. Molecular mechanisms and clinical applications of angiogenesis. Nature 2011, 473:298-307.
2. Kerbel R.S. Tumor angiogenesis. N. Engl. J. Med. 2008, 358:2039-2049.
3. Chen H.X., Cleck J.N. Adverse effects of anticancer agents that target the VEGF pathway. Nat. Rev. Clin. Oncol. 2009, 6:465-477.
4. Keefe D., Bowen J., Gibson R., Tan T., Okera M., Stringer A. Noncardiac vascular toxicities of vascular endothelial growth factor inhibitors in advanced cancer: a review. Oncologist 2011, 16:432-444.
5. Kamba T., McDonald D.M. Mechanisms of adverse effects of anti-VEGF therapy for cancer. Br. J. Cancer 2007, 96:1788-1795.
6. Ferrara N., Kerbel R.S. Angiogenesis as a therapeutic target. Nature 2005, 438:967-974.
7. Hilberg F., Roth G.J., Krssak M., Kautschitsch S., Sommergruber W., Tontsch-Grunt U., et al. BIBF 1120: triple angiokinase inhibitor with sustained receptor blockade and good antitumor efficacy. Cancer Res. 2008, 68:4774-4782.
8. Reck M., Kaiser R., Mellemgaard A., Douillard J.Y., Orlov S., Krzakowski M., 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, 15:143-155.
9. Stopfer P., Rathgen K., Bischoff D., Ludtke S., Marzin K., Kaiser R., et al. Pharmacokinetics and metabolism of BIBF 1120 after oral dosing to healthy male volunteers. Xenobiotica 2011, 41:297-311.
10. Ellis P.M., Kaiser R., Zhao Y., Stopfer P., Gyorffy S., Hanna N. 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, 16:2881-2889.
11. Doebele R.C., Conkling P., Traynor A.M., Otterson G.A., Zhao Y., Wind S., 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, 23:2094-2102.
12. Soria J.C., Hollebecque A., Massard C., Deutsch E., Varga A., Morsli N., et al. Phase I study of afatinib (BIBW 2992), an ERBB family blocker plus nintedanib (BIBF 1120), a triple angiokinase inhibitor, in patients with advanced solid tumours. Ann. Oncol. 2012, 23. abstract 979.
13. ® (nintedanib) Summary of Product Characteristics 2014.
14. Ellis P.M., Al-Saleh K. Multitargeted anti-angiogenic agents and NSCLC: clinical update and future directions. Crit. Rev. Oncol. Hematol. 2012, 84:47-58.
15. Johnson D.H., Fehrenbacher L., Novotny W.F., Herbst R.S., Nemunaitis J.J., Jablons D.M., et al. Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer. J. Clin. Oncol. 2004, 22:2184-2191.
16. Kabbinavar F.F., Hambleton J., Mass R.D., Hurwitz H.I., Bergsland E., Sarkar S. Combined analysis of efficacy: the addition of bevacizumab to fluorouracil/leucovorin improves survival for patients with metastatic colorectal cancer. J. Clin. Oncol. 2005, 23:3706-3712.
17. Elice F., Rodeghiero F. Side effects of anti-angiogenic drugs. Thromb. Res. 2012, 129(Suppl. 1):S50-S53.
18. Reck M., von Pawel J., Zatloukal P., Ramlau R., Gorbounova V., Hirsh V., et al. Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAil. J. Clin. Oncol. 2009, 27:1227-1234.
19. Sandler A., Gray R., Perry M.C., Brahmer J., Schiller J.H., Dowlati A., et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N. Engl. J. Med. 2006, 355:2542-2550.
20. Garon E.B., Ciuleanu T.E., Arrieta O., Prabhash K., Syrigos K.N., Goksel T., et al. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet 2014, 384:665-673.
21. Mayer E.L., Dallabrida S.M., Rupnick M.A., Redline W.M., Hannagan K., Ismail N.S., et al. Contrary effects of the receptor tyrosine kinase inhibitor vandetanib on constitutive and flow-stimulated nitric oxide elaboration in humans. Hypertension 2011, 58:85-92.
22. Ranpura V., Pulipati B., Chu D., Zhu X., Wu S. Increased risk of high-grade hypertension with bevacizumab in cancer patients: a meta-analysis. Am. J. Hypertens. 2010, 23:460-468.
23. Yang J.C.-H., Sequist L.V., Schuler M.H., Mok T., Yamamoto N., O'Byrne K.J., et al. Overall survival (OS) in patients (pts) with advanced non-small cell lung cancer (NSCLC) harboring common (Del19/L858R) epidermal growth factor receptor mutations (EGFR mut): pooled analysis of two large open-label phase III studies (LUX-Lung 3 [LL3] and LUX-Lung 6 [LL6]) comparing afatinib with chemotherapy (CT). J. Clin. Oncol. 2014, 32:8004.
24. Zhu X., Stergiopoulos K., Wu S. Risk of hypertension and renal dysfunction with an angiogenesis inhibitor sunitinib: systematic review and meta-analysis. Acta Oncol. 2009, 48:9-17.
25. Qi W.X., Shen Z., Lin F., Sun Y.J., Min D.L., Tang L.N., et al. Incidence and risk of hypertension with vandetanib in cancer patients: a systematic review and meta-analysis of clinical trials. Br. J. Clin. Pharmacol. 2013, 75:919-930.
26. Qi W.X., Min D.L., Shen Z., Sun Y.J., Lin F., Tang L.N., et al. Risk of venous thromboembolic events associated with VEGFR-TKIs: a systematic review and meta-analysis. Int. J. Cancer 2013, 132:2967-2974.
27. Qi W.X., He A.N., Shen Z., Yao Y. Incidence and risk of hypertension with a novel multi-targeted kinase inhibitor axitinib in cancer patients: a systematic review and meta-analysis. Br. J. Clin. Pharmacol. 2013, 76:348-357.
28. Houk B.E., Bello C.L., Poland B., Rosen L.S., Demetri G.D., Motzer R.J. Relationship between exposure to sunitinib and efficacy and tolerability endpoints in patients with cancer: results of a pharmacokinetic/pharmacodynamic meta-analysis. Cancer Chemother. Pharmacol. 2010, 66:357-371.
29. Rugo H.S., Herbst R.S., Liu G., Park J.W., Kies M.S., Steinfeldt H.M., et al. Phase I trial of the oral antiangiogenesis agent AG-013736 in patients with advanced solid tumors: pharmacokinetic and clinical results. J. Clin. Oncol. 2005, 23:5474-5483.
30. Eisen T., Shparyk Y., Jones R., MacLeod N.J., Temple G., Finnigan H., et al. Phase II efficacy and safety study of nintedanib versus sunitinib in previously untreated renal cell carcinoma (RCC) patients. J. Clin. Oncol. 2013, 31(Suppl 15). (abstract 4506).
31. Qi W.X., Shen Z., Tang L.N., Yao Y. Bevacizumab increases the risk of gastrointestinal perforation in cancer patients: a meta-analysis with a focus on different subgroups. Eur. J. Clin. Pharmacol. 2014, 70:893-906.
32. Qi W.X., Sun Y.J., Tang L.N., Shen Z., Yao Y. Risk of gastrointestinal perforation in cancer patients treated with vascular endothelial growth factor receptor tyrosine kinase inhibitors: a systematic review and meta-analysis. Crit. Rev. Oncol. Hematol. 2014, 89:394-403.
33. Elice F., Rodeghiero F., Falanga A., Rickles F.R. Thrombosis associated with angiogenesis inhibitors. Best Pract. Res. Clin. Haematol. 2009, 22:115-128.
34. Ferroni P., Formica V., Roselli M., Guadagni F. Thromboembolic events in patients treated with anti-angiogenic drugs. Curr. Vasc. Pharmacol. 2010, 8:102-113.
35. Nalluri S.R., Chu D., Keresztes R., Zhu X., Wu S. Risk of venous thromboembolism with the angiogenesis inhibitor bevacizumab in cancer patients: a meta-analysis. JAMA 2008, 300:2277-2285.
36. Eisen T., Sternberg C.N., Robert C., Mulders P., Pyle L., Zbinden S., et al. Targeted therapies for renal cell carcinoma: review of adverse event management strategies. J. Natl. Cancer Inst. 2012, 104:93-113.
37. Ishak R.S., Aad S.A., Kyei A., Farhat F.S. Cutaneous manifestations of anti-angiogenic therapy in oncology: review with focus on VEGF inhibitors. Crit. Rev. Oncol. Hematol. 2014, 90:152-164.
38. Chu D., Lacouture M.E., Weiner E., Wu S. Risk of hand-foot skin reaction with the multitargeted kinase inhibitor sunitinib in patients with renal cell and non-renal cell carcinoma: a meta-analysis. Clin. Genitourin. Cancer 2009, 7:11-19.
39. Lacouture M.E., Wu S., Robert C., Atkins M.B., Kong H.H., Guitart J., et al. Evolving strategies for the management of hand-foot skin reaction associated with the multitargeted kinase inhibitors sorafenib and sunitinib. Oncologist 2008, 13:1001-1011.
40. Chu D., Lacouture M.E., Fillos T., Wu S. Risk of hand-foot skin reaction with sorafenib: a systematic review and meta-analysis. Acta Oncol. 2008, 47:176-186.