Attributable Risk of Infection to mTOR Inhibitors Everolimus and Temsirolimus in the Treatment of Cancer

References

• Yuan R, Kay A, Berg WJ, Lebwohl D. Targeting tumorigenesis: development and use of mTOR inhibitors in cancer therapy. J Hematol Oncol. 2009;2:45.
   PubMed Web of Science ®Google Scholar
• Novartis Pharmaceuticals. Prescribing information for affinitor. Novartis Pharmaceuticals; 2014. Available from: https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/afinitor.pdf
   Google Scholar
• Yao JC, Shah MH, Ito T, Bohas CL, Wolin EM, Van Cutsem E, et al. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med. 2011;364(6):514–523.
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Hudes GR, Curti BD, McDermott DF, Escudier BJ, Negrier S, et al. Phase I/II trial of temsirolimus combined with interferon alfa for advanced renal cell carcinoma. J Clin Oncol. 2007;25(25):3958–3964.
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S, et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet 2008;372(9637):449–456.
   PubMed Web of Science ®Google Scholar
• Franz DN, 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
• Baselga J, Campone M, Piccart M, Burris HA III, Rugo HS, Sahmoud T, et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med. 2012;366(6):520–529.
   PubMed Web of Science ®Google Scholar
• Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007;356(22):2271–2281.
   PubMed Web of Science ®Google Scholar
• Pfizer. Prescribing information for Torisel. New York: Pfizer, 2014. Available from: http://www.torisel.com/prescribing-information
   Google Scholar
• Galanis E, Buckner JC, Maurer MJ, Kreisberg JI, Ballman K, Boni J, et al. Phase II trial of temsirolimus (CCI-779) in recurrent glioblastomamultiforme: a North Central Cancer Treatment Group Study. J Clin Oncol. 2005;23(23):5294–5304.
   PubMed Web of Science ®Google Scholar
• Ansell SM, Inwards DJ, Rowland KM Jr., Flynn PJ, Morton RF, Moore DF, Jr., et al. Low-dose, single-agent temsirolimus for relapsed mantle cell lymphoma: a phase 2 trial in the North Central Cancer Treatment Group. Cancer 2008;113(3):508–514.
   PubMed Web of Science ®Google Scholar
• Sarkaria JN, Galanis E, Wu W, Dietz AB, Kaufmann TJ, Gustafson MP, et al. Combination of temsirolimus (CCI-779) with chemoradiation in newly diagnosed glioblastomamultiforme (GBM) (NCCTG trial N027D) is associated with increased infectious risks. Clin Cancer Res. 2010;16(22):5573–5580.
   PubMed Web of Science ®Google Scholar
• Tarhini A, Kotsakis A, Gooding W, Shuai Y, Petro D, Friedland D, et al. Phase II study of everolimus (RAD001) in previously treated small cell lung cancer. Clin Cancer Res. 2010;16(23):5900–5907.
   PubMed Web of Science ®Google Scholar
• Kaymakcalan MD, Je Y, Sonpavde G, Galsky M, Nguyen PL, Heng DY, et al. Risk of infections in renal cell carcinoma (RCC) and non-RCC patients treated with mammalian target of rapamycin inhibitors. Br J Cancer. 2013;108(12):2478–2484.
   PubMed Web of Science ®Google Scholar
• National Cancer Institute. Common Terminology Criteria for Adverse Events v3.0 (CTCAE). 2006. Available from: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf. Accessed February 12, 2015.
   Google Scholar
• Carpenter J, Roche H, Campone M, Colomer R, Jagiello-Gruszfeld A, Moore L, et al. ( Editors). Randomized 3-arm, phase 2 study of temsirolimus (CCI-779) in combination with letrozole in postmenopausal women with locally advanced or metastatic breast cancer. Proc Am Soc Clin Oncol 2005;23:A564.
   Google Scholar
• Zhu X, Wu S, Dahut WL, Parikh CR. Risks of proteinuria and hypertension with bevacizumab, an antibody against vascular endothelial growth factor: systematic review and meta-analysis. Am J Kidney Dis. 2007;49(2):186–193.
   PubMed Web of Science ®Google Scholar
• Nalluri SR, Chu D, Keresztes R, Zhu X, Wu S. Risk of venous thromboembolism with the angiogenesis inhibitor bevacizumab in cancer patients: a meta-analysis. JAMA 2008;300(19):2277–2285.
   Google Scholar
• Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17:1–12
   Google Scholar
• Pavel ME, Hainsworth JD, Baudin E, Peeters M, Horsch 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):2005–2012.
   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
• Bissler JJ, 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):817–824.
   PubMed Web of Science ®Google 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
• Hess G, Herbrecht R, Romaguera J, Verhoef G, Crump M, Gisselbrecht C, et al. 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. 2009;27(23):3822–3829.
   PubMed Web of Science ®Google Scholar
• Wolff AC, Lazar AA, Bondarenko I, Garin AM, Brincat S, Chow L, et al. Randomized phase III placebo-controlled trial of letrozole plus oral temsirolimus as first-line endocrine therapy in postmenopausal women with locally advanced or metastatic breast cancer. J Clin Oncol. 2013;31(2):195–202.
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Bukowski RM, Figlin RA, Hutson TE, Michaelson MD, Kim ST, et al. Prognostic nomogram for sunitinib in patients with metastatic renal cell carcinoma. Cancer 2008;113(7):1552–1558.
   PubMed Web of Science ®Google Scholar
• Rafii S, Roda D, Geuna E, Jimenez B, Rihawi K, Capelan M, et al. Higher Risk of Infections with PI3K–AKT–mTOR pathway inhibitors in patients with advanced solid tumors on phase I clinical trials. Clin Cancer Res. 2015;21(8):1869–1876
   PubMed Web of Science ®Google Scholar
• Zhang S, Pruitt M, Tran D, Du Bois W, Zhang K, Patel R, et al. B cell-specific deficiencies in mTOR limit humoral immune responses. J Immunol. 2013;191:1692–1703.
   PubMed Web of Science ®Google Scholar
• Ravaud A. Treatment-associated adverse event management in the advanced renal cell carcinoma patient treated with targeted therapies. Oncologist 2011;16(Suppl 2):32–44.
   PubMed Web of Science ®Google Scholar
• Eisen T, Sternberg CN, Robert C, Mulders P, Pyle L, Zbinden S, et al. Targeted therapies for renal cell carcinoma: review of adverse event management strategies. J Natl Cancer Inst. 2012;104(2):93–113.
   PubMed Web of Science ®Google Scholar