Adverse event management in patients with advanced cancer receiving oral everolimus: Focus on breast cancer

Annals of Oncology

Volumn 25, Issue 4, 2014, Pages 763-773

  Aapro, M ^a   Andre, F ^b,c   Blackwell, K ^d   Calvo, E ^e   Jahanzeb, M ^f   Papazisis, K ^g   Porta, C ^h   Pritchard, K ⁱ   Ravaud, A ^j  

^a CLINIQUE DE GENOLIER   (Switzerland)

^b INSERM   (France)

^c INSTITUT GUSTAVE ROUSSY   (France)

^d DUKE UNIVERSITY MEDICAL CENTER   (United States)

^e Centro Integral Oncologico Clara Campal   (Spain)

^f UNIVERSITY OF MIAMI   (United States)

^g Euromedica General Clinic   (Greece)

^h FONDAZIONE IRCCS POLICLINICO SAN MATTEO   (Italy)

ⁱ UNIVERSITY OF TORONTO   (Canada)

^j HÔPITAL SAINT ANDRÉ   (France)

more..

Author keywords

Everolimus; Infections; Metabolic abnormality; Pneumonitis; Rash; Stomatitis

Indexed keywords

ANALGESIC AGENT; CORTICOSTEROID; CORTISONE; EVEROLIMUS; EXEMESTANE; FIBRIC ACID DERIVATIVE; INSULIN; MOUTHWASH; RAPAMYCIN;

ADVANCED CANCER; ADVERSE DRUG REACTION; BREAST CANCER; CLINICAL FEATURE; CLINICAL PROTOCOL; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FOOD INTAKE; HUMAN; HYPERGLYCEMIA; HYPERLIPIDEMIA; INFECTION; METABOLIC DISORDER; MOUTH HYGIENE; MOUTH PAIN; ORAL MUCOSITIS; PATIENT EDUCATION; PERSONAL EXPERIENCE; PNEUMONIA; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY OF LIFE; RASH; REVIEW; SIGNAL TRANSDUCTION; STOMATITIS; TREATMENT RESPONSE; ANALOGS AND DERIVATIVES; BREAST NEOPLASMS; CANCER STAGING; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; ORAL DRUG ADMINISTRATION; PATHOLOGY;

ADMINISTRATION, ORAL; BREAST NEOPLASMS; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HUMANS; NEOPLASM STAGING; SIROLIMUS;

EID: 84897056068     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdu021     Document Type: Review

References (48)

1. Afinitor® (everolimus) tablets [summary of product characteristics]. Horsham, UK: Novartis Europharm Limited, 2012. http://www.ema.europa.eu/docs/en_GB/ document_library/EPAR_Product_Information/human/001038/WC500022814.pdf (11 December 2013, date last accessed).
2. Afinitor® (everolimus) tablets [package insert]. East Hanover, NJ: Novartis, 2012. http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s018lbl.pdf (11 December 2013, date last accessed).
3. Ellard SL, Clemons M, Gelmon KA et al. Randomized phase II study comparing two schedules of everolimus in patients with recurrent/metastatic breast cancer: NCIC Clinical Trials Group IND.163. J Clin Oncol 2009;27:4536-4541.
4. Tabernero J, Rojo F, Calvo E et al. Dose-and schedule-dependent inhibition of the mammalian target of rapamycin pathway with everolimus: a phase I tumor pharmacodynamic study in patients with advanced solid tumors. J Clin Oncol 2008;26:1603-1610.
5. Baselga J, Campone M, Piccart M et al. Everolimus in postmenopausal hormonereceptor- positive advanced breast cancer. N Engl J Med 2012;366:520-529.
6. Yao JC, Shah MH, Ito T et al. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med 2011;364:514-523.
7. Soefje SA, Karnad A, Brenner AJ. Common toxicities of mammalian target of rapamycin inhibitors. Target Oncol 2011;6:125-129.
8. Motzer RJ, Escudier B, Oudard S et al. Phase 3 trial of everolimus for metastatic renal cell carcinoma: final results and analysis of prognostic factors. Cancer 2010; 116:4256-4265.
9. Motzer RJ, Escudier B, Oudard S et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet 2008;372:449-456.
10. Paplomata E, Zelnak A, O'Regan R. Everolimus: side effect profile and management of toxicities in breast cancer. Breast Cancer Res Treat 2013;140:453-462.
11. Cardoso F, Costa A, Norton L et al. 1st International consensus guidelines for advanced breast cancer (ABC 1). Breast 2012;21:242-252.
12. Sivendran S, Agarwal N, Gartrell B et al. Metabolic complications with the use of mTOR inhibitors for cancer therapy. Cancer Treat Rev 2014;40:190-196.
13. Laplante M, Sabatini DM. mTOR signaling in growth control and disease. Cell 2012;149:274-293.
14. Chi H. Regulation and function of mTOR signalling in T cell fate decisions. Nat Rev Immunol 2012;12:325-338.
15. Piccart M, Noguchi S, Pritchard KI et al. Everolimus for postmenopausal women with advanced breast cancer: updated results of the BOLERO-2 phase III trial. In Poster presented at:2012 ASCO Annual Meeting;1-5 June, 2012; Chicago, IL. Abstract 559.
16. Rugo HS, Pritchard KI, Gnant M et al. Incidence and time course of everolimusrelated adverse events in postmenopausal women with hormone receptor-positive advanced breast cancer: insights from BOLERO-2. Ann Oncol 2014;25:808-815.
17. Albiges L, Chamming's F, Duclos B et al. Incidence and management of mTOR inhibitor-associated pneumonitis in patients with metastatic renal cell carcinoma. Ann Oncol 2012;23:1943-1953.
18. Moldawer NP, Wood LS. Management of key adverse events associated with everolimus therapy. Kidney Cancer J 2010;8:51-59.
19. Pilotte AP, Hohos MB, Polson KM et al. Managing stomatitis in patients treated with Mammalian target of rapamycin inhibitors. Clin J Oncol Nurs 2011;15: E83-E89.
20. Porta C, Osanto S, Ravaud A et al. Management of adverse events associated with the use of everolimus in patients with advanced renal cell carcinoma. Eur J Cancer 2011;47:1287-1298.
21. Nathan DM, Buse JB, Davidson MB et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009;32: 193-203.
22. Boers-Doets CB, Epstein JB, Raber-Durlacher JE et al. Oral adverse events associated with tyrosine kinase and mammalian target of rapamycin inhibitors in renal cell carcinoma: a structured literature review. Oncologist 2012;17:135-144.
23. Busaidy NL, Farooki A, Dowlati A et al. Management of metabolic effects associated with anticancer agents targeting the PI3K-Akt-mTOR pathway. J Clin Oncol 2012;30:2919-2928.
24. Martins F, de Oliveira MA, Wang Q et al. A review of oral toxicity associated with mTOR inhibitor therapy in cancer patients. Oral Oncol 2013;49:293-298.
25. White DA, Camus P, Endo M et al. Noninfectious pneumonitis after everolimus therapy for advanced renal cell carcinoma. Am J Respir Crit Care Med 2010;182: 396-403.
26. Rugo HS, Gnant M, Geberth M et al. Everolimus-related adverse events: safety insights from BOLERO-2. In: Poster presented at: St. Gallen International Breast Cancer Conference;13-16 March, 2013; St. Gallen, Switzerland. Poster 274. 2013.
27. de Oliveira MA, Martins EMF, Wang Q et al. Clinical presentation and management of mTOR inhibitor-associated stomatitis. Oral Oncol 2011;47:998-1003.
28. clinicaltrials.gov. Open-label, phase II, study of everolimus plus letrozole in postmenopausal women with ER+ metastatic breast cancer (Bolero-4). http://www.clinicaltrials.gov/ct2/show/NCT01698918?term=bolero-4&rank=1 (11 December 2013, date last accessed).
29. Ferte C, Paci A, Zizi M et al. Natural history, management and pharmacokinetics of everolimus-induced-oral ulcers: insights into compliance issues. Eur J Cancer 2011;47:2249-2255.
30. Raymond E, Alexandre J, Faivre S et al. Safety and pharmacokinetics of escalated doses of weekly intravenous infusion of CCI-779, a novel mTOR inhibitor, in patients with cancer. J Clin Oncol 2004;22:2336-2347.
31. Divers J. Management of stomatitis associated with mTOR inhibitors in hormone receptor-positive/HER2-negative advanced breast cancer: clinical experiences from a single center. Oncol Nurs Forum 2013;40: E223-E224. Abstract 136314.
32. Atkinson BJ, Cauley DH, Ng C et al. mTOR inhibitor associated noninfectious pneumonitis in patients with renal cell cancer: management, predictors, and outcomes. BJU Int 2014;113(3):376-382.
33. Lee SR, Kim YM, Jung JY et al. Everolimus-induced interstitial pneumonitits in a patient with metastatic renal cell carcinoma: a case report. Korean J Med 2012; 83(4):520-524.
34. Jerusalem G, Ellard S, Fasolo A et al. Non-infectious pneumonitis (NIP) in breast cancer (BC) patients treated with everolimus (Afinitor™) containing therapy: analysis of five studies. Cancer Res 2009;69(24 suppl 3): Abstract 1115.
35. Albiges L, Antoun S, Martin L et al. Effect of everolimus therapy on skeletal muscle wasting in patients with metastatic renal cell carcinoma (mRCC): results from a placebo-controlled study. In: Poster presented at: American Society of Clinical Oncology's 2011 Annual Meeting;3-7 June, 2011; Chicago, IL. Poster 319.
36. American Diabetes Association. Diabetes Basics. http://www.diabetes.org/ diabetes-basics/diagnosis/?loc=DropDownDB-diagnosis (11 December 2013, date last accessed).
37. Rodriguez-Pascual J, Cheng E, Maroto P et al. Emergent toxicities associated with the use of mTOR inhibitors in patients with advanced renal carcinoma. Anticancer Drugs 2010;21:478-486.
38. National Institutes of Health. National Cholesterol Education Program (NCEP) Expert Panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). Final report. http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3full.pdf (11 December 2013, date last accessed).
39. Kobayashi T. From improved survival to potential cure in patients with metastatic breast cancer. Breast Cancer 2012;19:187-190.
40. Genest J, Frohlich J, Fodor G et al. Recommendations for the management of dyslipidemia and the prevention of cardiovascular disease: summary of the 2003 update. CMAJ 2003;169:921-924.
41. International task force for prevention of coronary heart disease. Treatment guidelines for dyslipidemia. http://www.chd-taskforce.com/pdf/2004_06_09_zurich.pdf (11 December 2013, date last accessed).
42. Ewald N, Hardt PD, Kloer HU. Severe hypertriglyceridemia and pancreatitis: presentation and management. Curr Opin Lipidol 2009;20:497-504.
43. Momin SB, Peterson A, Del Rosso JQ. A status report on drug-associated acne and acneiform eruptions. J Drugs Dermatol 2010;9:627-636.
44. Plewig G, Jansen T. Acneiform dermatoses. Dermatology 1998;196(1):102-107.
45. Ramirez-Fort MK, Case EC, Rosen AC et al. Rash to the mTOR inhibitor everolimus: systematic review and meta-analysis. Am J Clin Oncol 2012 December 13 [epub ahead of print], doi:10.1097/COC.0b013e318277d62f.
46. Di Lorenzo G, Porta C, Bellmunt J et al. Toxicities of targeted therapy and their management in kidney cancer. Eur Urol 2011;59:526-540.
47. Patnaik JL, Byers T, Diguiseppi C et al. The influence of comorbidities on overall survival among older women diagnosed with breast cancer. J Natl Cancer Inst 2011;103:1101-1111.
48. Pirimoglu ZM, Arslan C, Buyukbayrak EE et al. Glucose tolerance of premenopausal women after menopause due to surgical removal of ovaries. Climacteric 2011;14: 453-457.