Risk of cardiovascular adverse events in patients with solid tumors treated with ramucirumab: A meta analysis and summary of other VEGF targeted agents

Critical Reviews in Oncology/Hematology

Volumn 102, Issue , 2016, Pages 89-100

  Abdel Rahman, Omar ^a   ElHalawani, Hesham ^a  

^a AIN SHAMS UNIVERSITY   (Egypt)

Author keywords

Bleeding; Hypertension; Ramucirumab; Thrombosis

Indexed keywords

RAMUCIRUMAB; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY; VASCULOTROPIN A; VEGFA PROTEIN, HUMAN;

ARTERIAL THROMBOEMBOLISM; ARTERY THROMBOSIS; BLEEDING; BRAIN ISCHEMIA; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CASTRATION RESISTANT PROSTATE CANCER; COLORECTAL CANCER; CONGESTIVE HEART FAILURE; DEEP VEIN THROMBOSIS; DISEASE ASSOCIATION; DRUG MONITORING; HEART MUSCLE ISCHEMIA; HUMAN; HYPERTENSION; INCIDENCE; INTESTINE ISCHEMIA; LIMB ISCHEMIA; LIVER CELL CARCINOMA; LUNG EMBOLISM; NON SMALL CELL LUNG CANCER; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK ASSESSMENT; SOLID TUMOR; STOMACH CANCER; SYSTEMATIC REVIEW; VEIN THROMBOSIS; VENOUS THROMBOEMBOLISM; ANTAGONISTS AND INHIBITORS; CHEMICALLY INDUCED; HEART DISEASE; NEOPLASMS; RISK;

ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; HEART DISEASES; HUMANS; NEOPLASMS; RISK; VASCULAR ENDOTHELIAL GROWTH FACTOR A;

EID: 84964662752     PISSN: 10408428     EISSN: 18790461     Source Type: Journal    
DOI: 10.1016/j.critrevonc.2016.04.003     Document Type: Review

References (53)

1. Abdel-Rahman O., ElHalawani H. Proteinuria in patients with solid tumors treated with ramucirumab: a systematic review and meta-analysis. Chemotherapy 2014, 60(5-6):325-333.
2. Abdel-Rahman O., ElHalawani H. Risk of oral and gastrointestinal mucosal injury in patients with solid tumors treated with ramucirumab: a systematic review and meta-analysis. Expert Opin. Drug Saf. 2015, 1-12.
3. Abdel-Rahman O., ElHalawani H. Risk of hematological toxicities in patients with solid tumors treated with ramucirumab: a meta-analysis. Future Oncol. 2015, 11(21):2949-2961.
4. Abdel-Rahman O., Fouad M. Risk of cardiovascular toxicities in patients with solid tumors treated with sorafenib: an updated systematic review and meta-analysis. Future Oncol. 2014, 10(12):1981-1992.
5. Abdel-Rahman O., Fouad M. Risk of cardiovascular toxicities in patients with solid tumors treated with sunitinib, axitinib, cediranib or regorafenib: an updated systematic review and comparative meta-analysis. Crit. Rev. Oncol. Hematol. 2014, 92(3):194-207.
6. Abdel-Rahman O. Targeting vascular endothelial growth factor (VEGF) pathway in gastric cancer: preclinical and clinical aspects. Crit. Rev. Oncol. Hematol. 2015, 93(1):18-27.
7. Akutsu N., Sasaki S., Takagi H., Motoya M., Shitani M., Igarashi M., et al. Development of hypertension within 2 weeks of initiation of sorafenib for advanced hepatocellular carcinoma is a predictor of efficacy. Int. J. Clin. Oncol. 2015, 20(1):105-110.
8. Azizi M., Chedid A., Oudard S. Home blood-pressure monitoring in patients receiving sunitinib. N. Engl. J. Med. 2008, 358(1):95-97.
9. Baffert F., Le T., Sennino B., Thurston G., Kuo C.J., Hu-Lowe D., et al. Cellular changes in normal blood capillaries undergoing regression after inhibition of VEGF signaling. Am. J. Physiol. Heart Circ. Physiol. 2006, 290(2):H547-H559.
10. Chung A.S., Lee J., Ferrara N. Targeting the tumour vasculature: insights from physiological angiogenesis. Nat. Rev. Cancer 2010, 10(7):505-514.
11. (accessed 01.04.15). http://pi.lilly.com/us/cyramza-pi.pdf.
12. de Jesus-Gonzalez N., Robinson E., Moslehi J., Humphreys B.D. Management of antiangiogenic therapy-induced hypertension. Hypertension 2012, 60(3):607-615.
13. DerSimonian R., Laird N. Meta-analysis in clinical trials. Control Clin. Trials 1986, 7(3):177-188.
14. Dirix L., Maes H., Sweldens C. Treatment of arterial hypertension (AHT) associated with angiogenesis inhibitors. Ann. Oncol. 2007, 18(6):1121-1122.
15. Doebele R.C., Spigel D., Tehfe M., Thomas S., Reck M., Verma S., et al. Phase 2, randomized, open-label study of ramucirumab in combination with first-line pemetrexed and platinum chemotherapy in patients with nonsquamous, advanced/metastatic non-small cell lung cancer. Cancer 2015, 121(6):883-892.
16. ElHalawani H., Abdel-Rahman O. Critical evaluation of ramucirumab in the treatment of advanced gastric and gastroesophageal cancers. Ther. Clin. Risk Manag. 2015, 11:1123.
17. Feliu J., Salud A., Safont M.J., García-Girón C., Aparicio J., Losa F., et al. Correlation of hypertension and proteinuria with outcome in elderly bevacizumab-treated patients with metastatic colorectal cancer. PLoS One 2015, 10(1):e0116527.
18. Fontanella C., Ongaro E., Bolzonello S., Guardascione M., Fasola G., Aprile G. Clinical advances in the development of novel VEGFR2 inhibitors. Annals of translational medicine 2014, 2. (12).
19. Fuchs C.S., Tomasek J., Yong C.J., Dumitru F., Passalacqua R., Goswami C., et al. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet 2014, 383(9911):31-39.
20. Fukumura D., Gohongi T., Kadambi A., Izumi Y., Ang J., Yun C.-O., et al. Predominant role of endothelial nitric oxide synthase in vascular endothelial growth factor-induced angiogenesis and vascular permeability. Proc. Natl. Acad. Sci. 2001, 98(5):2604-2609.
21. 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(9944):665-673.
22. Hang X.F., Xu W.S., Wang J.X., Wang L., Xin H.G., Zhang R.Q., et al. Risk of high-grade bleeding in patients with cancer treated with bevacizumab: a meta-analysis of randomized controlled trials. Eur. J. Clin. Pharmacol. 2011, 67(6):613-623.
23. Higgins J.P., Thompson S.G., Deeks J.J., Altman D.G. Measuring inconsistency in meta-analyses. BMJ: British Medical Journal 2003, 327(7414):557.
24. A phase II randomized study of cixutumumab (IMC-A12: CIX) or ramucirumab (IMC-1121B: RAM) plus mitoxantrone (M) and prednisone (P) in patients (pts) with metastatic castrate-resistant prostate cancer (mCRPC) following disease progression (PD) on docetaxel (DCT) therapy. ASCO Annual Meeting Proceedings 2012.
25. Izzedine H., Rixe O., Billemont B., Baumelou A., Deray G. Angiogenesis inhibitor therapies: focus on kidney toxicity and hypertension. Am. J. Kidney Dis. 2007, 50(2):203-218.
26. Kappers M.H., van Esch J.H., Sluiter W., Sleijfer S., Danser A.J., van den Meiracker A.H. Hypertension induced by the tyrosine kinase inhibitor sunitinib is associated with increased circulating endothelin-1 levels. Hypertension 2010, 56(4):675-681.
27. Langenberg M.H., van Herpen C.M., De Bono J., Schellens J.H., Unger C., Hoekman K., et al. Effective strategies for management of hypertension after vascular endothelial growth factor signaling inhibition therapy: results from a phase II randomized, factorial, double-blind study of Cediranib in patients with advanced solid tumors. J. Clin. Oncol. 2009, 27(36):6152-6159.
28. Mackey J.R., Ramos-Vazquez M., Lipatov O., McCarthy N., Krasnozhon D., Semiglazov V., et al. Primary results of ROSE/TRIO-12, a randomized placebo-controlled phase III trial evaluating the addition of ramucirumab to first-line docetaxel chemotherapy in metastatic breast cancer. J. Clin. Oncol. 2014, 57. 2014: JCO.
29. Maitland M.L., Kasza K.E., Karrison T., Moshier K., Sit L., Black H.R., et al. Ambulatory monitoring detects sorafenib-induced blood pressure elevations on the first day of treatment. Clin. Cancer Res. 2009, 15(19):6250-6257.
30. Maitland M.L., Bakris G.L., Black H.R., Chen H.X., Durand J.-B., Elliott W.J., et al. Initial assessment, surveillance, and management of blood pressure in patients receiving vascular endothelial growth factor signaling pathway inhibitors. J. Natl. Cancer Inst. 2010.
31. Mir O., Coriat R., Ropert S., Cabanes L., Blanchet B., Camps S., et al. Treatment of bevacizumab-induced hypertension by amlodipine. Invest. New Drugs 2012, 30(2):702-707.
32. Moher D., Liberati A., Tetzlaff J., Altman D.G. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann. Intern. Med. 2009, 151(4):264-269.
33. 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(19):2277-2285.
34. (accessed 15.3.16). http://https://clinicaltrials.gov/ct2/show/results/NCT01160744%3Fterm=ramucirumab%26rank=38%26sect=X01256#all.
35. Peng L., Bu Z., Zhou Y., Ye X., Liu J., Zhao Q. Hemorrhagic events in cancer patients treated with aflibercept: a meta-analysis. Tumor Biol. 2014, 35(9):9419-9427.
36. Qi W.-X., Fu S., Zhang Q., Guo X.-M. Bevacizumab increases the risk of severe congestive heart failure in cancer patients: an up-to-date meta-analysis with a focus on different subgroups. Clin. Drug Investig. 2014, 34(10):681-690.
37. Qi W.-X., Shen Z., Tang L.-N., Yao Y. Risk of hypertension in cancer patients treated with aflibercept: a systematic review and meta-analysis. Clin. Drug Investig. 2014, 34(4):231-240.
38. 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(5):460-468.
39. Ranpura V., Hapani S., Chuang J., Wu S. Risk of cardiac ischemia and arterial thromboembolic events with the angiogenesis inhibitor bevacizumab in cancer patients: a meta-analysis of randomized controlled trials. Acta Oncol. 2010, 49(3):287-297.
40. Rautiola J., Donskov F., Peltola K., Joensuu H., Bono P. Sunitinib-induced hypertension, neutropaenia and thrombocytopaenia as predictors of good prognosis in patients with metastatic renal cell carcinoma. BJU Int. 2016, 117(1):110-117.
41. Richards C.J., Je Y., Schutz F.A., Heng D.Y., Dallabrida S.M., Moslehi J.J., et al. Incidence and risk of congestive heart failure in patients with renal and nonrenal cell carcinoma treated with sunitinib. J. Clin. Oncol. 2011, 29(25):3450-3456.
42. Robinson E.S., Khankin E.V., Choueiri T.K., Dhawan M.S., Rogers M.J., Karumanchi S.A., et al. Suppression of the nitric oxide pathway in metastatic renal cell carcinoma patients receiving vascular endothelial growth factor-signaling inhibitors. Hypertension 2010, 56(6):1131-1136.
43. Saltz L.B., Cox J.V., Blanke C., Rosen L.S., Fehrenbacher L., Moore M.J., et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. N. Engl. J. Med. 2000, 343(13):905-914.
44. Tabernero J., Yoshino T., Cohn A.L., Obermannova R., Bodoky G., Garcia-Carbonero R., et al. Ramucirumab versus placebo in combination with second-line FOLFIRI in patients with metastatic colorectal carcinoma that progressed during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine (RAISE): a randomised, double-blind, multicentre, phase 3 study. Lancet Oncol. 2015, 16(5):499-508.
45. Exposure-response (ER) relationship of ramucirumab (RAM) from two global, randomized, double-blind, phase 3 studies of patients (Pts) with advanced second-line gastric cancer. ASCO Annual Meeting Proceedings 2015.
46. Wang Z., Xu J., Nie W., Huang G., Tang J., Guan X. Risk of hypertension with regorafenib in cancer patients: a systematic review and meta-analysis. Eur. J. Clin. Pharmacol. 2014, 70(2):225-231.
47. Wang J., Wang Z., Zhao Y. Incidence and risk of hypertension with ramucirumab in cancer patients: a meta-analysis of published studies. Clin. Drug Investig. 2015, 35(4):221-228.
48. Webb D.J. DORADO: opportunity postponed lessons from studies of endothelin receptor antagonists in treatment-resistant hypertension. Hypertension 2010, 56(5):806-807.
49. Wilke H., Muro K., Van Cutsem E., Oh S.-C., Bodoky G., Shimada Y., et al. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014, 15(11):1224-1235.
50. Wood A.J., Abernethy D.R., Schwartz J.B. Calcium-antagonist drugs. N. Engl. J. Med. 1999, 341(19):1447-1457.
51. Yardley D., Richards P., Reeves J., Dees E., Osborne C., Soliman H. Final results of a phase 2 study of ramucirumab (RAM) plus eribulin (E) versus E in advanced metastatic breast cancer (MBC). J. Clin. Oncol. 2014, 32:5s.
52. Ramucirumab (RAM) plus FOLFOX as front-line therapy (Rx) for advanced gastric or esophageal adenocarcinoma (GE-AC): randomized, double-blind, multicenter phase 2 trial. ASCO Annual Meeting Proceedings 2014.
53. Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib: results from the randomized phase III REACH study. ESMO Congress 2014.