Adverse event management of mTOR inhibitors during treatment of hormone receptorepositive advanced breast cancer: Considerations for oncologists

Clinical Breast Cancer

Volumn 14, Issue 5, 2014, Pages 297-308

  Yardley, Denise A ^a  

^a SARAH CANNON RESEARCH INSTITUTE   (United States)

Author keywords

Advanced breast cancer; Adverse events; Everolimus; Infection; mTOR; Noninfectious pneumonitis; Rash; Stomatitis

Indexed keywords

EVEROLIMUS; EXEMESTANE; MAMMALIAN TARGET OF RAPAMYCIN INHIBITOR; ANTINEOPLASTIC AGENT; MTOR PROTEIN, HUMAN; RAPAMYCIN; TARGET OF RAPAMYCIN KINASE;

ADVANCED CANCER; BREAST CANCER; CORTICOSTEROID THERAPY; HUMAN; KIDNEY GRAFT; ONCOLOGIST; PHASE 2 CLINICAL TRIAL (TOPIC); PROGRESSION FREE SURVIVAL; REVIEW; RISK FACTOR; SEVERE HEPATIC IMPAIRMENT; SIDE EFFECT; SURVIVAL RATE; UNITED STATES; UNSPECIFIED SIDE EFFECT; ANALOGS AND DERIVATIVES; ANTAGONISTS AND INHIBITORS; BREAST NEOPLASMS; FEMALE; ONCOLOGY;

ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; FEMALE; HUMANS; MEDICAL ONCOLOGY; SIROLIMUS; TOR SERINE-THREONINE KINASES;

EID: 84922641162     PISSN: 15268209     EISSN: 19380666     Source Type: Journal    
DOI: 10.1016/j.clbc.2014.03.002     Document Type: Review

References (79)

1. Ferlay J, Shin HR, Bray F, et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010; 127:2893-917.
2. National Cancer Institute. SEER Statistic Fact Sheet: Breast Cancer 2013. Available at: http://seer.cancer.gov/statfacts/html/breast.html. Accessed: November 7, 2013.
3. American Cancer Society. Cancer Facts and Figures 2014. Atlanta, GA: American Cancer Society; 2014.
4. American Cancer Society. Breast Cancer Facts and Figures: 2011-2012. Atlanta, GA: American Cancer Society; 2012, Report No. 2012.
5. Setiawan VW, Monroe KR, Wilkens LR, et al. Breast cancer risk factors defined by estrogen and progesterone receptor status: the multiethnic cohort study. Am J Epidemiol 2009; 169:1251-9.
6. Anderson WF, Chatterjee N, Ershler WB, Brawley OW. Estrogen receptor breast cancer phenotypes in the Surveillance, Epidemiology, and End Results database. Breast Cancer Res Treat 2002; 76:27-36.
7. Arimidex anastrozole tablets. [prescribing information]. Wilmington, DE: Astra-Zeneca Pharmaceuticals LP; 2004.
8. Femara letrozole tablets. 2.5 mg tablets [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2006.
9. Aromasin exemestane tablets. [prescribing information]. New York, NY: Pharmacia & Upjohn Co; 2004.
10. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Breast Cancer. version 1.2014. Available at: http://www.nccn.org/ patients/guidelines/stage-iv-breast/files/assets/basic-html/index.html#1. Accessed: March 2, 2014.
11. Riemsma R, Forbes CA, Kessels A, et al. Systematic review of aromatase inhibitors in the first-line treatment for hormone sensitive advanced or metastatic breast cancer. Breast Cancer Res Treat 2010; 123:9-24.
12. Cardoso F, Senkus-Konefka E, Fallowfield L, et al. Locally recurrent or metastatic breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol; 21 (suppl 5):v15-19.
13. Nolvadex tamoxifen citrate [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2005.
14. Howell A, Robertson JF, Abram P, et al. Comparison of fulvestrant versus tamoxifen for the treatment of advanced breast cancer in postmenopausal women previously untreated with endocrine therapy: a multinational, double-blind, randomized trial. J Clin Oncol 2004; 22:1605-13.
15. Robertson JF, Llombart-Cussac A, Rolski J, et al. Activity of fulvestrant 500 mg versus anastrozole 1 mg as first-line treatment for advanced breast cancer: results from the FIRST study. J Clin Oncol 2009; 27:4530-5.
16. Faslodex fulvestrant injection [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2004.
17. Dodwell D, Wardley A, Johnston S. Postmenopausal advanced breast cancer: options for therapy after tamoxifen and aromatase inhibitors. Breast 2006; 15:584-94.
18. Miller WR, Larionov AA. Understanding the mechanisms of aromatase inhibitor resistance. Breast Cancer Res 2012; 14:201.
19. Chlebowski RT. Changing concepts of hormone receptor-positive advanced breast cancer therapy. Clin Breast Cancer 2013; 13:159-66.
20. Johnston SR. New strategies in estrogen receptor-positive breast cancer. Clin Cancer Res 2010; 16:1979-87.
21. Bjornsti MA, Houghton PJ. The TOR pathway: a target for cancer therapy. Nat Rev Cancer 2004; 4:335-48.
22. Saal LH, Holm K, Maurer, et al. PIK3CA mutations correlate with hormone receptors, node metastasis, and ERBB2, and are mutually exclusive with PTEN loss in human breast carcinoma. Cancer Res 2005; 65:2554-9.
23. Samuels Y, Velculescu VE. Oncogenic mutations of PIK3CA in human cancers. Cell Cycle 2004; 3:1221-4.
24. deGraffenried LA, Friedrichs WE, Russell DH, et al. Inhibition of mTOR activity restores tamoxifen response in breast cancer cells with aberrant Akt activity. Clin Cancer Res 2004; 10:8059-67.
25. Kim EK, Kim HA, Koh JS, et al. Phosphorylated S6K1 is a possible marker for endocrine therapy resistance in hormone receptor-positive breast cancer. Breast Cancer Res Treat 2011; 126:93-9.
26. Perez-Tenorio G, Stal O. Activation of AKT/PKB in breast cancer predicts a worse outcome among endocrine treated patients. Br J Cancer 2002; 86:540-5.
27. Meric-Bernstam F, Gonzalez-Angulo AM. Targeting the mTOR signaling network for cancer therapy. J Clin Oncol 2009; 27:2278-87.
28. Margariti N, Fox SB, Bottini A, Generali D. "Overcoming breast cancer drug resistance with mTOR inhibitors." Could it be a myth or a real possibility in the short-term future? Breast Cancer Res Treat 2011; 128:599-606.
29. McAuliffe PF, Meric-Bernstam F, Mills GB, Gonzalez-Angulo AM. Deciphering the role of PI3K/Akt/mTOR pathway in breast cancer biology and pathogenesis. Clin Breast Cancer 2010; 10(suppl 3):S59-65.
30. Baselga J, Semiglazov V, van Dam P, et al. Phase II randomized study of neoadjuvant everolimus plus letrozole compared with placebo plus letrozole in patients with estrogen receptor-positive breast cancer. J Clin Oncol 2009; 27:2630-7.
31. Bachelot T, Bourgier C, Cropet C, et al. Randomized phase II trial of everolimus in combination with tamoxifen in patients with hormone receptorpositive, human epidermal growth factor receptor 2-negative metastatic breast cancer with prior exposure to aromatase inhibitors: a GINECO study. J Clin Oncol 2012; 30:2718-24.
32. Baselga J, Campone M, Piccart M, et al. Everolimus in postmenopausal hormone receptor-positive advanced breast cancer. N Engl J Med 2012; 366:520-9.
33. Yardley DA, Noguchi S, Pritchard KI, et al. Everolimus plus exemestane in postmenopausal patients with HR breast cancer: BOLERO-2 final progression-free survival analysis. Adv Ther 2013; 30:870-84.
34. US Food and Drug Administration. FDA approves Afinitor for advanced breast cancer. [FDA news release]. July 20, 2012. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312965.htm. Accessed: November 7, 2013.
35. Burris HA III, Lebrun F, Rugo HS, et al. Health-related quality of life of patients with advanced breast cancer treated with everolimus plus exemestane versus placebo plus exemestane in the phase 3, randomized, controlled, BOLERO-2 trial. Cancer 2013; 119:1908-15.
36. Torisel temsirolimus. injection [prescribing information]. Philadelphia, PA: Wyeth Pharmaceuticals Inc; 2008.
37. Bellmunt J, Szczylik C, Feingold J, et al. Temsirolimus safety profile and management of toxic effects in patients with advanced renal cell carcinoma and poor prognostic features. Ann Oncol 2008; 19:1387-92.
38. Merck & Co., Inc. NDA 22-576 ridaforolimus tablets. oncologic drugs advisory committee briefing document. 2012 Mar. Report No.: ODAC Briefing Document. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM 296305.pdf. Accessed: November 26, 2013.
39. Sankhala K, Mita A, Kelly K, Mahalingam D, Giles F, Mita M. The emerging safety profile of mTOR inhibitors, a novel class of anticancer agents. Target Oncol 2009; 4:135-42.
40. Campistol JM, de Fijter JW, Flechner SM, et al. mTOR inhibitor-associated dermatologic and mucosal problems. Clin Transplant 2010; 24:149-56.
41. Kreis H, Cisterne JM, Land W, et al. Sirolimus in association with mycophenolate mofetil induction for the prevention of acute graft rejection in renal allograft recipients. Transplantation 2000; 69:1252-60.
42. Yao JC, Shah MH, Ito T, et al. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med 2011; 364:514-23.
43. 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; 372:449-56.
44. Franz DN, Belousova E, Sparagna S, et al. Efficacy and safety of everolimus for subependymal giant cell astrocytomas associated with tuberous sclerosis complex EXIST-1.: a multicenter, randomized, placebo-controlled phase 3 trial. Lancet 2013; 381:125-32.
45. Afinitor everolimus tablets for oral administration [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2014.
46. Bissler JJ, Kingswood JC, Radzikowska E, et al. Everolimus for angiomyolipoma associated with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis EXIST-2.: a multicentre, randomised, double-blind, placebo-controlled trial. Lancet 2013; 381:817-24.
47. Sonis S, Treister N, Chawla S, et al. Preliminary characterization of oral lesions associated with inhibitors of mammalian target of rapamycin in cancer patients. Cancer 2010; 116:210-5.
48. Perez A, Rugo HS, Baselga J, et al. Clinical management and resolution of stomatitis in BOLERO-2. Poster presented at 49th Annual Meeting of the American Society of Clinical Oncology; May 31-June 4, 2013; Chicago, IL.
49. Grunwald V, Karakiewics PI, Bavbek SE, et al. An international expandedaccess programme of everolimus: addressing safety and efficacy in patients with metastatic renal cell carcinoma who progress after initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapy. Eur J Cancer 2012; 48:324-32.
50. de Oliveira MA, Martins E, Martins F, et al. Clinical presentation and management of mTOR inhibitor-associated stomatitis. Oral Oncol 2011; 47:998-1003.
51. 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; 47:2249-55.
52. Divers J. Management of stomatitis associated with mTOR inhibitors in hormone receptor-positive/HER-2 negative advanced breast cancer: clinical experience from a single center. Poster presented at 38th Annual Oncology Nurses' Society Congress; April 25-28, 2013; Washington, DC.
53. 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: E83-9.
54. Porta C, Ostanto 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; 47:1287-98.
55. Nicolatou-Galitis O, Nikolaidi A, Athanassiadis I, et al. Oral ulcers in patients with advanced breast cancer receiving everolimus: a case series report on clinical presentation and management. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2013; 116:e110-6.
56. Moldawer NP, Wood LS. Management of key adverse events associated with everolimus therapy. Kidney Cancer J 2010; 8:51-9.
57. Balagula Y, Rosen A, Tan BH, et al. Clinical and histopathologic characteristics of rash in cancer patients treated with mammalian target of rapamycin inhibitors. Cancer 2012; 118:5078-83.
58. National Cancer Institute. Common terminology criteria for adverse events v3. 0 CTCAE. National Cancer Institute Web site, 2006 August 9; v3.0.:1-72. Available at: http://ctep.cancer.gov/protocolDevelopment/electronic-applications/ docs/ctcaev3.pdf. Accessed: September 13, 2013.
59. Agricola K, Tudor C, Krueger DA, et al. First approved targeted medical therapy for subependymal giant-cell astrocytoma in patients with tuberous sclerosis complex: strategies to improve tolerability and patient outcomes by effective management of side effects. Presented at the 43rd Annual Educational Meeting American Association of Neuroscience Nurses; March 19-22, 2011; Kansas City, MO.
60. Ito Y, Noguchi S, Deleu I, et al. Incidence, management, and resolution of noninfectious pneumonitis in BOLERO-2. Poster presented at the 49th Annual Meeting of the American Society for Clinical Oncology; May 31-June 4, 2013; Chicago, IL.
61. 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; 27:4536-41.
62. White DA, Schwartz LH, Dimitrijevic S, et al. Characterization of pneumonitis in patients with advanced non-small cell lung cancer treated with everolimus RAD001. J Thorac Oncol 2009; 4:1357-63.
63. 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.
64. Pascual J. The use of everolimus in renal-transplant patients. Int J Nephrol Renovasc Dis 2009; 2:9-21.
65. Rugo HS, Gnant M, Geberth M, et al. Everolimus-related adverse events: safety insights from BOLERO-2. Presented at St. Gallen International Breast Cancer Conference; March 13-16, 2013; St. Gallen, Switzerland.
66. Torres HA, Davila M. Reactivation of hepatitis B virus and hepatitis C virus in patients with cancer. Nat Rev Clin Oncol 2012; 9:156-66.
67. Shiah HS, Chen CY, Hsiao CF, et al. Randomized, phase I study of everolimus in patients with advanced hepatocellular carcinoma. Poster presented at 12th World Conference on Gastrointestinal Cancers; June 30-July 3, 2010; Barcelona, Spain.
68. Zhu AX, Abrams TA, Miksad R, et al. Phase 1/2 study of everolimus in advanced hepatocellular carcinoma. Cancer 2011; 117:5094-102.
69. Soefje SA, Karnad A, Brenner AJ. Common toxicities of mammalian target of rapamycin inhibitors. Target Oncol 2011; 6:125-9.
70. Fleishman SB, Fox LP, Garfield DH, et al. Tips for managing treatment-related rash and dry skin. New York, NY: Cancer Care, Inc; 2012. Available at: http:// media.cancercare.org/publications/original/8-ccc-rash.pdf?1302555775. Accessed September 13, 2013.
71. 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; 30:2919-28.
72. 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.
73. American Diabetes Association. Standards of medical care in diabetes: 2012. Diabetes Care 2012; 35:S11-63.
74. Europea Association for Cardiovascular Prenvention & Rehabilitation, Reiner Z, Catapano AL, et al. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC). Eur Heart J 2011; 32:1769-818.
75. Genest J, McPherson R, Frohlich J, et al. 2009 Canadian Cardiovascular Society/ Canadian guidelines for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease in the adult-2009 recommendations. Can J Cardiol 2009; 25:567-79.
76. National Institutes of Health, National Heart, Lung, and Blood Institute. US Detection, evaluation, and treatment of high blood cholesterol in adults adult treatment panel III. Final report. Bethesda, MD, Department of Health and Human Services. National Institutes of Health, September 2002. NIH publication 02-5215.
77. Kasiske BL, Nashan B, Del Carmen RM, et al. A prospective, multinational pharmacoepidemiological study of clinical conversion to sirolimus immunosuppression after renal transplantation. J Transplant 2012; 2012:107180.
78. Jacobsen W, Serkova N, Hausen B, et al. Comparison of the in vitro metabolism of the macrolide immunosuppressants sirolimus and RAD. Transplant Proc 2001; 33: 514-5.
79. Verbeeck RK. Pharmacokinetics and dosage adjustment in patients with hepatic dysfunction. Eur J Clin Pharmacol 2008; 64:1147-61.