Everolimus Plus Exemestane for the Treatment of Advanced Breast Cancer: A Review of Subanalyses from BOLERO-2

Neoplasia (United States)

Volumn 17, Issue 3, 2015, Pages 279-288

  Hortobagyi, Gabriel N ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANASTROZOLE; EVEROLIMUS; EXEMESTANE; GAMMA GLUTAMYLTRANSFERASE; LETROZOLE; PLACEBO; ANDROSTANE DERIVATIVE; ANTINEOPLASTIC AGENT;

AGING; ANEMIA; ASIAN; BONE MARROW SUPPRESSION; BONE METASTASIS; BREAST CANCER; BREAST CARCINOMA; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER HORMONE THERAPY; DECREASED APPETITE; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; FATIGUE; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; GROUPS BY AGE; HUMAN; HYPERGLYCEMIA; HYPERLIPIDEMIA; INFECTION; NAUSEA; OUTCOME ASSESSMENT; PNEUMONIA; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; REVIEW; SIDE EFFECT; STOMATITIS; VISCERAL METASTASIS; AGE; BREAST NEOPLASMS; CANCER STAGING; FEMALE; MULTICENTER STUDY (TOPIC); PATHOLOGY; PHASE 3 CLINICAL TRIAL (TOPIC); TREATMENT OUTCOME;

AGE FACTORS; ANDROSTADIENES; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CLINICAL TRIALS, PHASE III AS TOPIC; EVEROLIMUS; FEMALE; HUMANS; MULTICENTER STUDIES AS TOPIC; NEOPLASM STAGING; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 84964693362     PISSN: 15228002     EISSN: 14765586     Source Type: Journal    
DOI: 10.1016/j.neo.2015.01.005     Document Type: Review

References (65)

1. [1] Ino, Y, Kubo, T, Tanaka, A, Kuroi, A, Tsujioka, H, Ikejima, H, Okouchi, K, Kashiwagi, M, Takarada, S, Kitabata, H, et al. Difference of culprit lesion morphologies between ST-segment elevation myocardial infarction and non-ST-segment elevation acute coronary syndrome: an optical coherence tomography study. JACC Cardiovasc Interv 4 (2011), 76–82.
2. [2] American Cancer Society, Cancer facts and figures 2014. 2014, American Cancer Society, Atlanta, GA.
3. [3] 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 76 (2002), 27–36.
4. [4] Setiawan, VW, Monroe, KR, Wilkens, LR, Kolonel, LN, Pike, MC, Henderson, BE, Breast cancer risk factors defined by estrogen and progesterone receptor status: the multiethnic cohort study. Am J Epidemiol 169 (2009), 1251–1259.
5. [5] American Cancer Society, Breast Cancer Facts and Figures 2013–2014. 2013, American Cancer Society, Atlanta, GA.
6. [6] Cleator, SJ, Ahamed, E, Coombes, RC, Palmieri, C, A 2009 update on the treatment of patients with hormone receptor-positive breast cancer. Clin Breast Cancer 9:Suppl. 1 (2009), S6–S17.
7. [7] Dodwell, D, Wardley, A, Johnston, S, Postmenopausal advanced breast cancer: options for therapy after tamoxifen and aromatase inhibitors. Breast 15 (2006), 584–594.
8. [8] Musgrove, EA, Sutherland, RL, Biological determinants of endocrine resistance in breast cancer. Nat Rev Cancer 9 (2009), 631–643.
9. [9] Osborne, CK, Schiff, R, Mechanisms of endocrine resistance in breast cancer. Annu Rev Med 62 (2011), 233–247.
10. [10] Rugo, HS, Keck, S, Reversing hormone resistance: have we found the golden key?. J Clin Oncol 30 (2012), 2707–2709.
11. [11] Normanno, N, Di Maio, M, De Maio, E, De Luca, A, de Matteis, A, Giordano, A, Perrone, F, NCI-Naple Breast Cancer Group, Mechanisms of endocrine resistance and novel therapeutic strategies in breast cancer. Endocr Relat Cancer 12 (2005), 721–747.
12. [12] Xu, Y, Sun, Q, Headway in resistance to endocrine therapy in breast cancer. J Thorac Dis 2 (2010), 171–177.
13. [13] Liu, P, Cheng, H, Roberts, TM, Zhao, JJ, Targeting the phosphoinositide 3-kinase pathway in cancer. Nat Rev Drug Discov 8 (2009), 627–644.
14. [14] Bachman, KE, Argani, P, Samuels, Y, Silliman, N, Ptak, J, Szabo, S, Konishi, H, Karakas, B, Blair, BG, Lin, C, et al. The PIK3CA gene is mutated with high frequency in human breast cancers. Cancer Biol Ther 3 (2004), 772–775.
15. [15] Saal, LH, Holm, K, Maurer, M, Memeo, L, Su, T, Wang, X, Yu, JS, Malmström, PO, Mansukhani, M, Enoksson, J, 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 65 (2005), 2554–2559.
16. [16] Akcakanat, A, Sahin, A, Shaye, AN, Velasco, MA, Meric-Bernstam, F, Comparison of Akt/mTOR signaling in primary breast tumors and matched distant metastases. Cancer 112 (2008), 2352–2358.
17. [17] Gonzalez-Angulo, AM, Ferrer-Lozano, J, Stemke-Hale, K, Sahin, A, Liu, S, Barrera, JA, Burgues, O, Lluch, AM, Chen, H, Hortobagyi, GN, et al. PI3K pathway mutations and PTEN levels in primary and metastatic breast cancer. Mol Cancer Ther 10 (2011), 1093–1101.
18. [18] Pérez-Tenorio, G, Stål, O, Activation of AKT/PKB in breast cancer predicts a worse outcome among endocrine treated patients. Br J Cancer 86 (2002), 540–545.
19. [19] Nagata, Y, Lan, KH, Zhou, X, Tan, M, Esteva, FJ, Sahin, AA, Klos, KS, Li, P, Monia, BP, Nguyen, NT, et al. PTEN activation contributes to tumor inhibition by trastuzumab, and loss of PTEN predicts trastuzumab resistance in patients. Cancer Cell 6 (2004), 117–127.
20. [20] Berns, K, Horlings, HM, Hennessy, BT, Madiredjo, M, Hijmans, EM, Beelen, K, Linn, SC, Gonzalez-Angulo, AM, Stemke-Hale, K, Hauptmann, M, et al. A functional genetic approach identifies the PI3K pathway as a major determinant of trastuzumab resistance in breast cancer. Cancer Cell 12 (2007), 395–402.
21. [21] Miller, TW, Perez-Torres, M, Narasanna, A, Guix, M, Stål, O, Pérez-Tenorio, G, Gonzalez-Angulo, AM, Hennessy, BT, Mills, GB, Kennedy, JP, et al. Loss of Phosphatase and Tensin homologue deleted on chromosome 10 engages ErbB3 and insulin-like growth factor-I receptor signaling to promote antiestrogen resistance in breast cancer. Cancer Res 69 (2009), 4192–4201.
22. [22] Novartis Pharmaceuticals Corporation, AFINITOR (everolimus) tablets for oral administration. AFINITOR DISPERZ (everolimus tablets for oral suspension), 2014, Novartis Pharmaceuticals Corporation, Hanover, NJ.
23. [23] Baselga, J, Campone, M, Piccart, M, Burris, HA III, Rugo, HS, Sahmoud, T, Noguchi, S, Gnant, M, Pritchard, KI, Lebrun, F, et al. Everolimus in postmenopausal hormone receptor-positive advanced breast cancer. N Engl J Med 366 (2012), 520–529.
24. [24] Yardley, DA, Noguchi, S, Pritchard, KI, Burris, HA III, Baselga, J, Gnant, M, Hortobagyi, GN, Campone, M, Pistilli, B, Piccart, M, et al. Everolimus plus exemestane in postmenopausal patients with HR+ breast cancer: BOLERO-2 final progression-free survival analysis. Adv Ther 30 (2013), 870–884.
25. [25] Pritchard, KI, Burris, HA III, Ito, Y, Rugo, HS, Dakhil, S, Hortobagyi, GN, Campone, M, Csöszi, T, Baselga, J, Puttawibul, P, et al. Safety and efficacy of everolimus with exemestane vs. exemestane alone in elderly patients with HER2-negative, hormone receptor-positive breast cancer in BOLERO-2. Clin Breast Cancer 13 (2013), 421–432.
26. [26] Campone, M, Lebrun, F, Noguchi, S, Pritchard, KI, Burris, HA III, Beck, JT, Ito, Y, Yardley, DA, Bachelot, T, Pistilli, B, et al. Efficacy of everolimus plus exemestane in patients who received prior chemotherapy for advanced breast cancer or recurred after adjuvant endocrine therapy in BOLERO-2. Presented at the American Society of Clinical Oncology Annual Meeting, Chicago IL, May 31–June 4, 2013.
27. − advanced breast cancer in BOLERO-2. Breast Cancer Res Treat 143 (2014), 459–467.
28. [28] Campone, M, Bachelot, T, Gnant, M, Deleu, I, Rugo, HS, Pistilli, B, Noguchi, S, Shtivelband, M, Pritchard, KI, Provencher, L, et al. Effect of visceral metastases on the efficacy and safety of everolimus in postmenopausal women with advanced breast cancer: Subgroup analysis from the BOLERO-2 study. Eur J Cancer 49 (2013), 2621–2632.
29. [29] Noguchi, S, Masuda, N, Iwata, H, Mukai, H, Horiguchi, J, Puttawibul, P, Srimuninnimit, V, Tokuda, Y, Kuroi, K, Iwase, H, et al. Efficacy of everolimus with exemestane versus exemestane alone in Asian patients with HER2-negative, hormone-receptor-positive breast cancer in BOLERO-2. Breast Cancer 21 (2014), 703–714.
30. [30] Hortobagyi, G, Noguchi, S, Neven, P, Heng, DYC, Brechenmacher, T, Ringeisen, F, Bachelot, T, Everolimus plus exemestane in patients with advanced invasive lobular carcinoma: efficacy and safety results from BOLERO-2. Presented at the American Society of Clinical Oncology Breast Cancer Symposium (ASCO-BCS), San Francisco, CA, September 4–6, 2014.
31. [31] Burris, H, Gnant, M, Hortobagyi, G, Hart, L, Yardley, DA, Eakle, J, Provencher, L, Brechenmacher, T, Saletan, S, Taran, T, et al. Characterization of response to everolimus in BOLERO-2: A phase III trial of everolimus plus exemestane in postmenopausal women with HR +, HER2 − advanced breast cancer. Abstract P2-16-17. Presented at the 36th Annual San Antonio Breast Cancer Symposium, December 10–14, 2013.
32. [32] Piccart, M, Hortobagyi, GN, Campone, M, Pritchard, KI, Lebrun, F, Ito, Y, Noguchi, S, Perez, A, Rugo, HS, Deleu, I, et al. Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2. Ann Oncol 25 (2014), 2357–2362.
33. [33] American Cancer Society, Breast Cancer Facts and Figures 2011–2012. 2012, American Cancer Society, Atlanta, GA.
34. [34] Howlader, N, Noone, AM, Krapcho, M, Neyman, N, Aminou, R, Waldron, W, Altekruse, SF, Kosary, CL, Ruhl, J, Tatalovich, Z, et al. SEER Cancer Statistics Review, 1975–2008. National Cancer Institute Web site, available at: http://seer.cancer.gov/csr/1975_2008, 2010 [April 22, 2011. Accessed October 21, 2014].
35. [35] Vetter, M, Huang, DJ, Bosshard, G, Guth, U, Breast cancer in women 80 years of age and older: a comprehensive analysis of an underreported entity. Acta Oncol 52 (2013), 57–65.
36. [36] Wildiers, H, Kunkler, I, Biganzoli, L, Fracheboud, J, Vlastos, G, Bernard-Marty, C, Hurria, A, Extermann, M, Girre, V, Brain, E, et al. Management of breast cancer in elderly individuals: recommendations of the International Society of Geriatric Oncology. Lancet Oncol 8 (2007), 1101–1115.
37. [37] Rosa Mendoza, ES, Moreno, E, Caguioa, PB, Predictors of early distant metastasis in women with breast cancer. J Cancer Res Clin Oncol 139 (2013), 645–652.
38. [38] Solomayer, EF, Diel, IJ, Meyberg, GC, Gollan, C, Bastert, G, Metastatic breast cancer: clinical course, prognosis and therapy related to the first site of metastasis. Breast Cancer Res Treat 59 (2000), 271–278.
39. [39] Mundy, GR, Metastasis to bone: causes, consequences and therapeutic opportunities. Nat Rev Cancer 2 (2002), 584–593.
40. [40] Santen, RJ, Clinical review: effect of endocrine therapies on bone in breast cancer patients. J Clin Endocrinol Metab 96 (2011), 308–319.
41. [41] Gnant, M, Baselga, J, Rugo, HS, Noguchi, S, Burris, HA, Piccart, M, Hortobagyi, GN, Eakle, J, Mukai, H, Iwata, H, et al. Effect of everolimus on bone marker levels and progressive disease in bone in BOLERO-2. J Natl Cancer Inst 105 (2013), 654–663.
42. [42] Korhonen, T, Kuukasjarvi, T, Huhtala, H, Alarmo, EL, Holli, K, Kallioniemi, A, Pylkkänen, L, The impact of lobular and ductal breast cancer histology on the metastatic behavior and long term survival of breast cancer patients. Breast 22 (2013), 1119–1124.
43. [43] Arpino, G, Bardou, VJ, Clark, GM, Elledge, RM, Infiltrating lobular carcinoma of the breast: tumor characteristics and clinical outcome. Breast Cancer Res 6 (2004), R149–R156.
44. [44] Burris, HA III, Lebrun, F, Rugo, HS, Beck, JT, Piccart, M, Neven, P, Baselga, J, Petrakova, K, Hortobagyi, GN, Komorowski, A, 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 119 (2013), 1908–1915.
45. [45] Meisel, JL, Domchek, SM, Vonderheide, RH, Giobbie-Hurder, A, Lin, NU, Winer, EP, Partridge, AH, Quality of life in long-term survivors of metastatic breast cancer. Clin Breast Cancer 12 (2012), 119–126.
46. [46] National Comprehensive Cancer Network, Inc, NCCN Clinical Practice Guidelines in Oncology. Breast Cancer, 2014 [Version 3].
47. − advanced breast cancer treated with everolimus plus exemestane versus exemestane monotherapy. Curr Med Res Opin 29 (2013), 1463–1473.
48. [48] Hortobagyi, G, Piccart, M, Rugo, H, Burris, H III, Campone, M, Noguchi, S, Perez, A, Deleu, I, Shtivelband, M, Provencher, L, et al. Correlation of molecular alterations with efficacy of everolimus in hormone receptor–positive, HER2-negative advanced breast cancer: results from BOLERO-2. Abstract LBA509. Presented at the American Society of Clinical Oncology Annual Meeting; May 31–June 4, 2013, Chicago, IL, USA, 2013.
49. [49] Rugo, HS, Pritchard, KI, Gnant, M, Noguchi, S, Piccart, M, Hortobagyi, G, Baselga, J, Perez, A, Geberth, M, Csoszi, T, et al. Incidence and time course of everolimus-related adverse events in postmenopausal women with hormone receptor-positive advanced breast cancer: insights from BOLERO-2. Ann Oncol 25 (2014), 808–815.
50. [50] Paplomata, E, Zelnak, A, O'Regan, R, Everolimus: side effect profile and management of toxicities in breast cancer. Breast Cancer Res Treat 140 (2013), 453–462.
51. [51] Porta, C, Osanto, S, Ravaud, A, Climent, MA, Vaishampayan, U, White, DA, Creel, P, Dickow, B, Fischer, P, Gornell, SS, et al. Management of adverse events associated with the use of everolimus in patients with advanced renal cell carcinoma. Eur J Cancer 47 (2011), 1287–1298.
52. [52] Moldawer, NP, Wood, LS, Management of key adverse events associated with everolimus therapy. Kidney Cancer J 8 (2010), 51–59.
53. [53] Pilotte, AP, Hohos, MB, Polson, KM, Huftalen, TM, Treister, N, Managing stomatitis in patients treated with mammalian target of rapamycin inhibitors. Clin J Oncol Nurs 15 (2011), E83–E89.
54. [54] Rugo, HS, Pritchard, KI, Gnant, M, Noguch, S, Piccart, M, Hortobagyi, GN, Burris, HA, Vittori, L, Sahmoud, T, Baselga, J, Everolimus (EVE) for postmenopausal women with advanced breast cancer (ABC) refractory to letrozole or anastrozole: long-term efficacy and safety results of the BOLERO-2 trial. Presented at the 8th European Breast Cancer Conference; Vienna, Austria, March 21–24, 2012.
55. [55] Sonis, S, Treister, N, Chawla, S, Demetri, G, Haluska, F, Preliminary characterization of oral lesions associated with inhibitors of mammalian target of rapamycin in cancer patients. Cancer 116 (2010), 210–215.
56. [56] Martins, F, de Oliveira, MA, Wang, Q, Sonis, S, Gallottini, M, George, S, Treister, N, A review of oral toxicity associated with mTOR inhibitor therapy in cancer patients. Oral Oncol 49 (2013), 293–298.
57. [57] de Oliveira, MA, Martins, E, Martins, F, Wang, Q, Sonis, S, Demetri, G, George, S, Butrynski, J, Treister, NS, Clinical presentation and management of mTOR inhibitor-associated stomatitis. Oral Oncol 47 (2011), 998–1003.
58. [58] 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 4 (2009), 135–142.
59. [59] White, DA, Camus, P, Endo, M, Escudier, B, Calvo, E, Akaza, H, Uemura, H, Kpamegan, E, Kay, A, Robson, M, et al. Noninfectious pneumonitis after everolimus therapy for advanced renal cell carcinoma. Am J Respir Crit Care Med 182 (2010), 396–403.
60. [60] Balagula, Y, Rosen, A, Tan, BH, Busam, KJ, Pulitzer, MP, Motzer, RJ, Feldman, DR, Konner, JA, Reidy-Lagunes, D, Myskowski, PL, et al. Clinical and histopathologic characteristics of rash in cancer patients treated with mammalian target of rapamycin inhibitors. Cancer 118 (2012), 5078–5083.
61. [61] Soefje, SA, Karnad, A, Brenner, AJ, Common toxicities of mammalian target of rapamycin inhibitors. Target Oncol 6 (2011), 125–129.
62. [62] Wullschleger, S, Loewith, R, Hall, MN, TOR signaling in growth and metabolism. Cell 124 (2006), 471–484.
63. [63] Busaidy, NL, Farooki, A, Dowlati, A, Perentesis, JP, Dancey, JE, Doyle, LA, Brell, JM, Siu, LL, Management of metabolic effects associated with anticancer agents targeting the PI3K-Akt-mTOR pathway. J Clin Oncol 30 (2012), 2919–2928.
64. [64] Wilson, S, Chia, SK, Treatment algorithms for hormone receptor-positive advanced breast cancer: applying the results from recent clinical trials into daily practice—insights, limitations, and moving forward. Am Soc Clin Oncol Educ Book, 2013, 10.1200/EdBook_AM.2013.33.e20.
65. [65] Johnston, SR, BOLERO-2—will this change practice in advanced breast cancer?. Breast Cancer Res, 14, 2012, 311.