Risk of oral and gastrointestinal mucosal injury in patients with solid tumors treated with ramucirumab: A systematic review and meta-analysis

Expert Opinion on Drug Safety

Volumn 14, Issue 10, 2015, Pages 1495-1506

  Abdel Rahman, Omar ^a   Elhalawani, Hesham ^a  

^a AIN SHAMS UNIVERSITY   (Egypt)

Author keywords

diarrhea; gastrointestinal perforation; ramucirumab; stomatitis

Indexed keywords

RAMUCIRUMAB; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ARTICLE; BREAST METASTASIS; CANCER CHEMOTHERAPY; CANCER PATIENT; CASTRATION RESISTANT PROSTATE CANCER; DIARRHEA; DIGESTIVE SYSTEM INJURY; DIGESTIVE SYSTEM PERFORATION; GASTROINTESTINAL HEMORRHAGE; HUMAN; LIVER CELL CARCINOMA; META ANALYSIS; MOUTH INJURY; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK FACTOR; SOLID TUMOR; STOMACH CANCER; STOMATITIS; SYSTEMATIC REVIEW; CHEMICALLY INDUCED; GASTROINTESTINAL DISEASES; NEOPLASMS; PATHOPHYSIOLOGY;

ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; GASTROINTESTINAL DISEASES; HUMANS; NEOPLASMS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84942295145     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1517/14740338.2015.1074677     Document Type: Article

References (36)

1. Wilke H, Muro K, Van Cutsem EV, 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: 1224-35
2. Fuchs CS, Tomasek J, Yong CJ, 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): 31-9
3. Mackey JR, Ramos-Vazquez M, Lipatov O, 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 2015; 33 (2): 141-8
4. Tabernero J, Cohn AL, Obermannova R, et al. RAISE: a randomized, double-blind, multicenter phase III study of irinotecan, folinic acid, and 5-fluorouracil (FOLFIRI) plus ramucirumab (RAM) or placebo (PBO) in patients (pts) with metastatic colorectal carcinoma (CRC) progressive during or following first-line combination therapy with bevacizumab (bev), oxaliplatin (ox), and a fluoropyrimidine (fp). J Clin Oncol 2015; 33 (Suppl 3): Abstract 512
5. Fontanella C, Ongaro E, Bolzonello S, et al. Clinical advances in the development of novel VEGFR2 inhibitors. Ann Transl Med 2014; 2 (12): 123
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. Bozza C, Fontanella C, Buoro V, et al. Novel antiangiogenic drugs for the management of breast cancer: new approaches for an old issue? Expert Rev Clin Pharmacol 2015; 8 (2): 1-15
8. Aprile G, Rijavec E, Fontanella C, et al. Ramucirumab: preclinical research and clinical development. OncoTargets Ther 2014; 7: 1997-2006
9. Moher D, Liberati A, Tetzlaff J, Altman DG,; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. J Clin Epidemiol 2009; 62 (10): 1006-12
10. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials 1986; 7 (3): 177-88
11. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta analyses. BMJ 2003; 327 (7414): 557-60
12. Chung AS, Lee J, Ferrara N. Targeting the tumour vasculature: insights from physiological angiogenesis. Nat Rev Cancer 2010; 10: 505-14
13. Abdel-Rahman O. Vascular endothelial growth factor (VEGF) pathway and neuroendocrine neoplasms (NENs): prognostic and therapeutic considerations. Tumor Biol 2014; 35 (11): 10615-25
14. Abdel-Rahman O, Fouad M. Risk of selected gastrointestinal toxicities in patients with advanced non-small cell lung cancer receiving erlotinib: a systematic review and meta-analysis. Expert Rev Anticancer Ther 2015; 15 (4): 465-75
15. Abdel-Rahman O, Fouad M. Risk of selected gastrointestinal toxicities in breast cancer patients treated with regimens containing lapatinib; a pooled analysis of randomized controlled studies. Expert Rev Anticancer Ther 2014; 14 (10): 1229-42
16. Abdel-Rahman O, Fouad M. Risk of oral and gastrointestinal mucosal injury in patients with solid tumors treated with everolimus, temsirolimus or ridaforolimus: a comparative systematic review and meta-analysis. Expert Rev Anticancer Ther 2015; 15 (7): 1-12
17. Santoni M, Conti A, De Giorgi U, et al. Risk of gastrointestinal events with sorafenib, sunitinib and pazopanib in patients with solid tumors: A systematic review and meta analysis of clinical trials. Int J Cancer 2014; 135 (4): 763-73
18. Gruenwald V, Weikert S, Pavel ME, et al. Practical management of everolimus-related toxicities in patients with advanced solid tumors. Onkologie 2013; 36 (5): 295-302
19. Walraven M, Witteveen PO, Lolkema MP, et al. Antiangiogenic tyrosine kinase inhibition related gastrointestinal perforations: a case report and literature review. Angiogenesis 2011; 14 (2): 135-41
20. Tol J, Cats A, Mol L, et al. Gastrointestinal ulceration as a possible side effect of bevacizumab which may herald perforation. Invest New Drugs 2008; 26 (4): 393-39
21. Qi WX, Shen Z, Tang LN, 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 (8): 893-906
22. Qi WX, Sun YJ, Tang LN, et al. 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 (3): 394-403
23. Qi WX, Shen F, Qing Z, Xiao-Mao G. Risk of gastrointestinal perforation in cancer patients treated with aflibercept: a systematic review and meta-analysis. Tumor Biol 2014; 35 (11): 10715-22
24. Diaz JP, Tew WP, Zivanovic O, et al. Incidence and management of bevacizumab-associated gastrointestinal perforations in patients with recurrent ovarian carcinoma. Gynecol Oncol 2010; 116 (3): 335-9
25. Burger RA, Brady MF, Bookman MA, et al. Risk factors for GI adverse events in a phase III randomized trial of bevacizumab in first-line therapy of advanced ovarian cancer: a gynecologic oncology group study. J Clin Oncol 2014; 32 (12): 1210-17
26. Tanyi JL, McCann G, Hagemann AR, et al. Clinical predictors of bevacizumab-associated gastrointestinal perforation. Gynecol Oncol 2011; 120 (3): 464-9
27. Borofsky SE, Levine MS, Rubesin SE, et al. Bevacizumab-induced perforation of the gastrointestinal tract: clinical and radiographic findings in 11 patients. Abdom Imaging 2013; 38 (2): 265-72
28. Kube R, Meyer F, Bien N, et al. [Surgical management of bevacizumab-associated peritonitis due to perforation]. Zentralbl Chir 2009; 134 (5): 462-7
29. Available from: http://ec.europa.eu/health/documents/community-register/2014/20141219130327/anx-130327-en.pdf. [Last accessed 15 April 2015]
30. Yardley DA, Richards PD, Reeves JA, et al. Final results of a phase 2 study of ramucirumab (RAM) plus erbulin (E) versus E in advanced metastatic breast cancer (MBC). J Clin Oncol 2014; 32 (Suppl 5): Abstract 1035
31. Yoon HH, Bendell JC, Braiteh FS, et al. Ramucirumab (RAM) plus FOLFOX as front-line therapy (Rx) for advanced gastric or esophageal adenocarcinoma (GE-AC): Randomized, double-blind, multicenter phase 2 trial. J Clin Oncol 2014; 32 (15 Suppl): Abstract 4004
32. Doebele RC, Spigel D, Tehfe M, 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 2014
33. Available from: https://clinicaltrials.gov/ct2/show/results/NCT01160744?term=ramucirumab&rank=38§=X01256#all. [Last accessed 31 March 2015]
34. Zhu AX, Ryoo BY, Yen CJ, et al. Ramucirumab as second-linetreatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib: results from the randomized phase III REACH trial. Ann Oncol 2014; 25 (Suppl 5): v1-41
35. Garon EB, Ciuleanu TE, Arrieta O, 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): 665-73
36. Hussain M, Rathkopf DE, Liu G, et al. 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. J Clin Oncol 2012; 30 (Suppl 5): Abstract 97