Management of adverse events in patients with hormone receptor-positive breast cancer treated with everolimus: Observations from a phase III clinical trial

Supportive Care in Cancer

Volumn 21, Issue 8, 2013, Pages 2341-2349

  Peterson, Mary E ^a  

^a Banner MD Anderson Cancer Center   (United States)

Author keywords

Adverse event; Breast cancer; Everolimus; Hormone receptor; Management; mTOR inhibitor

Indexed keywords

AMLEXANOX; ANASTROZOLE; ANESTHETIC AGENT; ANTIANEMIC AGENT; ANTIBIOTIC AGENT; ANTIFUNGAL AGENT; ANTIHISTAMINIC AGENT; ANTIVIRUS AGENT; CLOBETASOL; CORTICOSTEROID; DEXAMETHASONE; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EVEROLIMUS; EXEMESTANE; GLITAZONE DERIVATIVE; INSULIN; IRON; LANOLIN ALCOHOL; LETROZOLE; LOPERAMIDE; LYSINE; METFORMIN; NONSTEROID ANTIINFLAMMATORY AGENT; ORAL ANTIDIABETIC AGENT; PLACEBO; RECOMBINANT ERYTHROPOIETIN; SULFONYLUREA DERIVATIVE; XIPAMIDE;

ADVANCED CANCER; ANEMIA; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; HERPES SIMPLEX; HORMONE RECEPTOR POSITIVE BREAST CANCER; HUMAN; HYPERGLYCEMIA; INFECTION; MACULOPAPULAR RASH; MULTICENTER STUDY (TOPIC); PAPULOPUSTULAR RASH; PHASE 3 CLINICAL TRIAL (TOPIC); PNEUMONIA; POSTMENOPAUSE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SIDE EFFECT; STOMATITIS;

EID: 84879899632     PISSN: 09414355     EISSN: 14337339     Source Type: Journal    
DOI: 10.1007/s00520-013-1826-3     Document Type: Review

References (60)

1. American Cancer Society (2012) Cancer facts and figures 2012. American Cancer Society, Atlanta, pp 1-66
2. Harvey JM, Clark GM, Osborne CK, Allred DC (1999) Estrogen receptor status by immunohistochemistry is superior to the ligand-binding assay for predicting response to adjuvant endocrine therapy in breast cancer. J Clin Oncol 17:1474-1481
3. National Comprehensive Cancer Network, Inc (2012) NCCN Clinical Practice Guidelines in Oncology. Breast Cancer V1.2012
4. National Cancer Institute (2012) SEER Statistic Fact Sheet: Breast Cancer 2012
5. Mouridsen H, Gershanovich M, Sun Y et al (2003) Phase III study of letrozole versus tamoxifen as first-line therapy of advanced breast cancer in postmenopausal women: analysis of survival and update of efficacy from the International Letrozole Breast Cancer Group. J Clin Oncol 21:2101-2109
6. Johnston S, Pippen J Jr, Pivot X et al (2009) Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol 27:5538-5546
7. Johnston SR (2010) New strategies in estrogen receptor-positive breast cancer. Clin Cancer Res 16:1979-1987
8. Yamashita H, Toyama T, Nishio M, Ando Y, Hamaguchi M, Zhang Z, Kobayashi S, Fujii Y, Iwase H (2006) p53 protein accumulation predicts resistance to endocrine therapy and decreased post-relapse survival in metastatic breast cancer. Breast Cancer Res 8:R48
9. Dodwell D, Wardley A, Johnston S (2006) Postmenopausal advanced breast cancer: options for therapy after tamoxifen and aromatase inhibitors. Breast 15:584-594
10. Hudes G, Carducci M, Tomczak P et al (2007) Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med 356:2271-2281
11. Motzer RJ, Escudier B, Oudard S et al (2010) Phase 3 trial of everolimus for metastatic renal cell carcinoma: final results and analysis of prognostic factors. Cancer 116:4256-4265
12. Hidalgo M, Buckner JC, Erlichman C, Pollack MS, Boni JP, Dukart G, Marshall B, Speicher L, Moore L, Rowinsky EK (2006) A phase I and pharmacokinetic study of temsirolimus (CCI-779) administered intravenously daily for 5 days every 2 weeks to patients with advanced cancer. Clin Cancer Res 12:5755-5763
13. Hess G, Herbrecht R, Romaguera J et al (2009) Phase III study to evaluate temsirolimus compared with investigator's choice therapy for the treatment of relapsed or refractory mantle cell lymphoma. J Clin Oncol 27:3822-3829
14. Yao JC, Shah MH, Ito T et al (2011) Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med 364:514-523
15. Dancey JE, Monzon J (2011) Ridaforolimus: a promising drug in the treatment of soft-tissue sarcoma and other malignancies. Future Oncol 7:827-839
16. Chan S, Scheulen ME, Johnston S et al (2005) Phase II study of temsirolimus (CCI-779), a novel inhibitor of mTOR, in heavily pretreated patients with locally advanced or metastatic breast cancer. J Clin Oncol 23:5314-5322
17. Baselga J, Campone M, Piccart M et al (2012) Everolimus in postmenopausal hormone receptor-positive advanced breast cancer. N Engl J Med 366:520-529
18. Hortobagyi GN, Piccart M, Rugo H, et al. (2011) Everolimus for postmenopausal women with advanced breast cancer: Updated results of the BOLERO 2 Phase III trial. Presented at San Antonio Breast Cancer Symposium, San Antonio, December 8, 2011; S3-S7
19. Baselga J, Semiglazov V, van Dam P et al (2009) 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 27:2630-2637
20. Meric-Bernstam F, Gonzalez-Angulo AM (2009) Targeting the mTOR signaling network for cancer therapy. J Clin Oncol 27:2278-2287
21. Husseinzadeh HD, Garcia JA (2011) Therapeutic rationale for mTOR inhibition in advanced renal cell carcinoma. Curr Clin Pharmacol 6:214-221
22. Novartis Pharmaceuticals Corporation (2012) Afinitor (everolimus) tablets for oral administration. Novartis Pharmaceuticals Corporation, East Hanover, NJ
23. Novartis Pharma Stein AG (2010) Zortress (tablets for oral administration). Novartis Pharma Stein AG, Stein, Switzerland
24. Novartis (2012) Certican. Zuellig Pharma, Malaysia
25. Piccart M, Baselga J, Noguchi S, et al. (2012) Final progression-free survival analysis of BOLERO-2: a phase III trial of everolimus for postmenopausal women with advanced breast cancer. Presented at: 2012 CTRC-AACR San Antonio Breast Cancer Symposium; San Antonio, December 4-8, 2012; P6-04-02
26. Wojtaszek C (2000) Management of chemotherapy-induced stomatitis. Clin J Oncol Nurs 4:263-270
27. Porta C, Ostanto S, Ravaud A et al (2011) Management of adverse events associated with the use of everolimus in patients with advanced renal cell carcinoma. Eur J Cancer 47:1287-1298
28. Pilotte AP, Hohos MB, Polson KM, Huftalen TM, Treister N (2011) Managing stomatitis in patients treated with Mammalian target of rapamycin inhibitors. Clin J Oncol Nurs 15:E83-E89
29. Kostler WJ, Hejna M, Wenzel C, Zielinski CC (2001) Oral mucositis complicating chemotherapy and/or radiotherapy: options for prevention and treatment. CA Cancer J Clin 51:290-315
30. Eilers J (2004) Nursing interventions and supportive care for the prevention and treatment of oral mucositis associated with cancer treatment. Oncol Nurs Forum 31:13-23
31. Sonis S, Treister N, Chawla S, Demetri G, Haluska F (2010) Preliminary characterization of oral lesions associated with inhibitors of mammalian target of rapamycin in cancer patients. Cancer 116:210-215
32. Harris DJ, Eilers J, Harriman A, Cashavelly BJ, Maxwell C (2008) Putting evidence into practice: evidence-based interventions for the management of oral mucositis. Clin J Oncol Nurs 12:141-152
33. Flodin NW (1997) The metabolic roles, pharmacology, and toxicology of lysine. J Am Coll Nutr 16:7-21
34. Sankhala K, Mita A, Kelly K, Mahalingam D, Giles F, Mita M (2009) The emerging safety profile of mTOR inhibitors, a novel class of anticancer agents. Target Oncol 4:135-142
35. Balagula Y, Rosen A, Tan BH et al (2012) Clinical and histopathologic characteristics of rash in cancer patients treated with mammalian target of rapamycin inhibitors. Cancer 118:5078-5083
36. Fleishman SB, Fox LP, Garfield DH, Viele CS, Messner C (2012) Tips for managing treatment-related rash and dry skin. Cancer Care, New York, pp 1-20
37. American Diabetes Association (2012) Hyperglycemia and Diabetes, Available at: URL: http://www.medicinenet.com/hyperglycemia/article.htm. Accessed February 7, 2012
38. Soefje SA, Karnad A, Brenner AJ (2011) Common toxicities of mammalian target of rapamycin inhibitors. Target Oncol 6:125-129
39. Grunwald V, Karakiewics PI, Bavbek SE et al (2012) An international expanded-access 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 48:324-332
40. Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B (2008) Management of hyperglycaemia in type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy: update regarding the thiazolidinediones. Diabetologia 51:8-11
41. Hollebecque A, Clamp A, Horsley L, Morgan JA, Bahleda R, George S, Shaw D, Lauchle JO, Ware J, Desai R, Wu J, Fu L, Jayson GC, Soria JC, Wagner AJ (2011) A phase I study evaluating the pharmacokinetics (PK) and pharmacodynamic (PD) activity of the dual PI3K/mTOR inhibitor GDC-0980 administered once weekly (QW). Presented at: AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics, November 12-16, 2011, San Francisco, CA
42. White DA, Camus P, Endo M et al (2010) Noninfectious pneumonitis after everolimus therapy for advanced renal cell carcinoma. Am J Respir Crit Care Med 182:396-403
43. Cho D, Signoretti S, Regan M, Mier JW, Atkins MB (2007) The role of mammalian target of rapamycin inhibitors in the treatment of advanced renal cancer. Clin Cancer Res 13:758s-763s
44. Duran I, Siu LL, Oza AM, Chung TB, Sturgeon J, Townsley CA, Pond GR, Seymour L, Niroumand M (2006) Characterisation of the lung toxicity of the cell cycle inhibitor temsirolimus. Eur J Cancer 42:1875-1880
45. European Association for the Study of the Liver (2012) EASL Clinical Practice Guidelines: management of chronic hepatitis B virus infection. J Hepatol 57:167-185
46. National Comprehensive Cancer Network, Inc. (2012). NCCN Clinical Practice Guidelines in Oncology. Cancer-Related Fatigue V1.2012)
47. National Institutes of Health (2009) Common terminology criteria for adverse events (CTCAE) Version 4.0. US Department of Health and Human Services, National Institutes of Health, National Cancer Institute, NIH Publication No. 03-5410
48. Eaton LH, Tipton JM (2009) Fatigue. In: Eaton LH, Tipton JM (eds) Putting evidence into practice: improving oncology patients outcomes. Oncology Nursing Society, Pittsburgh, pp 1-324
49. Benson AB III, Ajani JA, Catalano RB et al (2004) Recommended guidelines for the treatment of cancer treatment-induced diarrhea. J Clin Oncol 22:2918-2926
50. Stein A, Voigt W, Jordan K (2010) Chemotherapy-induced diarrhea: pathophysiology, frequency, and guideline-based management. Ther Adv Med Oncol 2:51-63
51. Dudgeon DJ (2002) Managing dyspnea and cough. Hematol Oncol Clin North Am 16:557-577
52. Ripamonti C (1999) Management of dyspnea in advanced cancer patients. Support Care Cancer 7:233-243
53. Glorieux P, Marion P (2009) Management of dyspnea in advanced cancer patients. BJMO 3:101-105
54. Bohlius J, Weingart O, Trelle S, Engert A (2006) Cancer-related anemia and recombinant human erythropoietin - an updated overview. Nat Clin Pract Oncol 3:152-164
55. Barrett-Lee P, Bokemeyer C, Gascon P, Nortier JW, Schneider M, Schrijvers D, Van Belle S (2005) Management of cancer-related anemia in patients with breast or gynecologic cancer: new insights based on results from the European Cancer Anemia Survey. Oncologist 10:743-757
56. National Comprehensive Cancer Network, Inc (2012) NCCN Clinical Practice Guidelines in Oncology. Cancer and Chemotherapy-Induced Anemia V1.2012, pp 1-40
57. Spivak JL, Gascon P, Ludwig H (2009) Anemia management in oncology and hematology. Oncologist 14(suppl 1):43-56
58. Henry DH (1998) Supplemental iron: a key to optimizing the response of cancer-related anemia to rHuEPO? Oncologist 3:275-278
59. Giboney PT (2005) Mildly elevated liver transaminase levels in the asymptomatic patient. Am Fam Physician 71:1105-1110
60. American Gastroenterological Association (2002) Medical position statement: evaluation of liver chemistry tests. Gastroenterology 123:1364-1366