Discontinuation of Everolimus Due to Related and Unrelated Adverse Events in Cancer Patients: A Meta-Analysis

References

• Khokhar N, Altman, J, Platanias, L. Emerging roles for mammalian target of rapamycin inhibitors in the treatment of solid tumors and hematological malignancies. Curr Opin Oncol 2011;23(6):578–586.
   PubMed Web of Science ®Google Scholar
• Gomez-Pinillos A, Ferrari, A. mTOR signaling pathway and mTOR inhibitors in cancer therapy. Hematol Oncol Clin North Am 2012;26(3):483–505, vii.
   PubMed Web of Science ®Google Scholar
• Mayr D, Fridrik, A. Anthracycline cardiotoxicity and lymphoma. Memo - Mag Eur Med Oncol 2014;7(1):43–46.
   Google Scholar
• Yao J, et al. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med 2011;364(6):514–523.
   PubMed Web of Science ®Google Scholar
• Motzer R, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S, et al. Phase 3 trial of everolimus for metastatic renal cell carcinoma: Final results and analysis of prognostic factors. Cancer 2010;116(18):4256–4265.
   PubMed Web of Science ®Google Scholar
• Franz D, Belousova E, Sparagana S, Bebin EM, Frost M, Kuperman R, et al. Efficacy and safety of everolimus for subependymal giant cell astrocytomas associated with tuberous sclerosis complex (EXIST-1): A multicentre, randomised, placebo-controlled phase 3 trial. Lancet 2013;381(9861):125–132.
   PubMed Web of Science ®Google Scholar
• Bissler J, Kingswood JC, Radzikowska E, Zonnenberg BA, Frost M, Belousova 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(9869):817824.
   Web of Science ®Google Scholar
• Baselga J, Campone M, Piccart M, Burris HA 3rd, Rugo HS, Sahmoud T, et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med 2012;366(6):520529.
   Web of Science ®Google Scholar
• Yao J, Fazio N, Singh S, Buzzoni R, Carnaghi C, Wolin E, et al. Everolimus for the treatment of advanced, non-functional neuroendocrine tumours of the lung or gastrointestinal tract (RADIANT-4): A randomised, placebo-controlled, phase 3 study. Lancet 2016;387(10022):968–977.
   PubMed Web of Science ®Google Scholar
• Aapro M, Andre F, Blackwell K, Calvo E, Jahanzeb M, Papazisis K, et al. Adverse event management in patients with advanced cancer receiving oral everolimus: Focus on breast cancer. Ann Oncol 2014;25(4):763–773.
   PubMed Web of Science ®Google Scholar
• Grunwald V, Weikert S, Pavel ME, Hörsch D, Lüftner D, Janni W, et al. Practical management of everolimus-related toxicities in patients with advanced solid tumors. Onkologie 2013;36(5):295–302.
   PubMedGoogle Scholar
• Rahman A, Yusuf, S, Ewer, M. Anthracycline-induced cardiotoxicity and the cardiac-sparing effect of liposomal formulation. Int J Nanomedicine 2007;2(4):567–583.
   PubMed Web of Science ®Google Scholar
• Pavel M, Hainsworth JD, Baudin E, Peeters M, Hörsch D, Winkler RE, et al. Everolimus plus octreotide long-acting repeatable for the treatment of advanced neuroendocrine tumours associated with carcinoid syndrome (RADIANT-2): A randomised, placebo-controlled, phase 3 study. Lancet 2011;378(9808):20052012.
   Web of Science ®Google Scholar
• Ohtsu A, Ajani JA, Bai YX, Bang YJ, Chung HC, Pan HM, et al. Everolimus for previously treated advanced gastric cancer: Results of the randomized, double-blind, phase III GRANITE-1 study. J Clin Oncol 2013;31(31):3935–3943.
   PubMed Web of Science ®Google Scholar
• Jadad A, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996;17(1):1–12.
   PubMedGoogle Scholar
• Andre F, O'Regan R, Ozguroglu M, Toi M, Xu B, Jerusalem G, et al. Everolimus for women with trastuzumab-resistant, HER2-positive, advanced breast cancer (BOLERO-3): A randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol 2014;15(6):580–591.
   PubMed Web of Science ®Google Scholar
• Bachelot T, Bourgier C, Cropet C, Ray-Coquard I, Ferrero JM, Freyer G, et al. Randomized phase II trial of everolimus in combination with tamoxifen in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer with prior exposure to aromatase inhibitors: A GINECO study. J Clin Oncol 2012;30(22):2718–2724.
   PubMed Web of Science ®Google Scholar
• Baselga J, Semiglazov V, van Dam P, Manikhas A, Bellet M, Mayordomo J, 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(16):26302637.
   Web of Science ®Google Scholar
• Besse B, Leighl N, Bennouna J, Papadimitrakopoulou VA, Blais N, Traynor AM, et al. Phase II study of everolimus–erlotinib in previously treated patients with advanced non-small-cell lung cancer. Ann Oncol 2014;25(2):409–415.
   PubMed Web of Science ®Google Scholar
• Huober J, Fasching PA, Hanusch C, Rezai M, Eidtmann H, Kittel K, et al. Neoadjuvant chemotherapy with paclitaxel and everolimus in breast cancer patients with non-responsive tumours to epirubicin/cyclophosphamide (EC) +/− bevacizumab—results of the randomised GeparQuinto study (GBG 44). Eur J Cancer 2013;49(10):2284–2293.
   PubMed Web of Science ®Google Scholar
• Hurvitz S, Andre F, Jiang Z, Shao Z, Mano MS, Neciosup SP, et al. Combination of everolimus with trastuzumab plus paclitaxel as first-line treatment for patients with HER2-positive advanced breast cancer (BOLERO-1): a phase 3, randomised, double-blind, multicentre trial. Lancet Oncol 2015;16(7):816–829.
   PubMed Web of Science ®Google Scholar
• Pritchard K, Burris HA 3rd, Ito Y, Rugo HS, Dakhil S, Hortobagyi GN, 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 2013;13(6):421–432. e8.
   PubMed Web of Science ®Google Scholar
• Maass N, Harbeck N, Mundhenke C, Lerchenmüller C, Barinoff J, Lück HJ, et al. Everolimus as treatment for breast cancer patients with bone metastases only: Results of the phase II RADAR study. J Cancer Res Clin Oncol 2013;139(12):2047–2056.
   PubMed Web of Science ®Google Scholar
• Zhu A, Kudo M, Assenat E, Cattan S, Kang YK, Lim HY, et al. Effect of everolimus on survival in advanced hepatocellular carcinoma after failure of sorafenib: The EVOLVE-1 randomized clinical trial. Jama 2014;312(1):57–67.
   PubMed Web of Science ®Google Scholar
• Panzuto F, Rinzivillo M, Fazio N, de Braud F, Luppi G, Zatelli MC, et al. Real-world study of everolimus in advanced progressive neuroendocrine tumors. Oncologist 2014;19(9):966–974.
   PubMed Web of Science ®Google Scholar
• Shameem R, Lacouture, M, Wu, S. Incidence and risk of high-grade stomatitis with mTOR inhibitors in cancer patients. Cancer Invest 2015;33(3):70–7.
   PubMed Web of Science ®Google Scholar
• Rugo H, Hortobagyi GN, Yao J, Pavel M, Ravaud A, Franz D, et al. Meta-analysis of stomatitis in clinical studies of everolimus: incidence and relationship with efficacy. Ann Oncol 2016;27(3):519–25.
   PubMed Web of Science ®Google Scholar
• Clarke G, Johnston S, Corrie P, Kuhn I, Barclay S. Withdrawal of anticancer therapy in advanced disease: A systematic literature review. BMC Cancer 2015;15:892.
   PubMed Web of Science ®Google Scholar
• Pirl W, Greer JA, Irwin K, Lennes IT, Jackson VA, Park ER, et al. Processes of discontinuing chemotherapy for metastatic non-small-cell lung cancer at the end of life. J Oncol Pract 2015;11(3):e405–e412.
   PubMed Web of Science ®Google Scholar
• Kaymakcalan M, Xie W, Albiges L, North SA, Kollmannsberger CK, Smoragiewicz M, et al. Risk factors and model for predicting toxicity-related treatment discontinuation in patients with metastatic renal cell carcinoma treated with vascular endothelial growth factor-targeted therapy: Results from the International Metastatic Renal Cell Carcinoma Database Consortium. Cancer 2016;122(3):411–419.
   PubMed Web of Science ®Google Scholar
• Baldo B, Pham, N. Adverse reactions to targeted and non-targeted chemotherapeutic drugs with emphasis on hypersensitivity responses and the invasive metastatic switch. Cancer Metastasis Rev 2013;32(3,4):723–761.
   PubMed Web of Science ®Google Scholar
• Gajra, AW, Hardt M, Mohile S, Owusu C, Klepin H, Gross C, et al. Predictors of early discontinuation of chemotherapy (EDC) in patients (pts) age 65 or older with stage IV non-small cell lung cancer (NSCLC) [abstract e18133]. J Clin Oncol 2012;30(suppl):e18133.
   Google Scholar
• Porta, C, Calvo E, Climent MA, Vaishampayan U, Osanto S, Ravaud A, et al. Efficacy and safety of everolimus in elderly patients with metastatic renal cell carcinoma: An exploratory analysis of the outcomes of elderly patients in the RECORD-1 Trial. Eur Urol 2012;61(4):826–33.
   PubMed Web of Science ®Google Scholar