Afinitor, everolimus tablets for oral administration. Afinitor Disperz, everolimus tablets for oral suspension (package insert). East Hanover, Novartis Pharmaceuticals Corporation, 2016.
King TE: Interstitial lung diseases; in Longo DL, Fauci AS, Kaspar DL (eds): Harrison's Principles of Internal Medicine, ed 18. New York, McGraw Hill, 2012.
Albiges L, Chamming's F, Duclos B, Stern M, Motzer RJ, Ravaud A, Camus P: Incidence and management of mTOR inhibitor-associated pneumonitis in patients with metastatic renal cell carcinoma. Ann Oncol 2012; 23: 1943-1953.
White DA, Camus P, Endo M, Escudier B, Calvo E, Akaza H, Uemura H, Kpamegan E, Kay A, Robson M, Ravaud A, Motzer RJ: Noninfectious pneumonitis after everolimus therapy for advanced renal cell carcinoma. Am J Respir Crit Care Med 2010; 182: 396-403.
Atkinson BJ, Cauley DH, Ng C, Millikan RE, Xiao L, Corn P, Jonasch E, Tannir NM: Mammalian target of rapamycin (mTOR) inhibitor-associated non-infectious pneumonitis in patients with renal cell cancer: predictors, management, and outcomes. BJU Int 2014; 113: 376-382.
White DA, Schwartz LH, Dimitrijevic S, Scala LD, Hayes W, Gross SH: Characterization of pneumonitis in patients with advanced nonsmall cell lung cancer treated with everolimus (RAD001). J Thorac Oncol 2009; 4: 1357-1363.
Ito T, Okusaka T, Ikeda M, Igarashi H, Morizane C, Nakachi K, Tajima T, Kasuga A, Fujita Y, Furuse J: Everolimus for advanced pancreatic neuroendocrine tumours: A subgroup analysis evaluating Japanese patients in the RADIANT-3 trial. Jpn J Clin Oncol 2012; 42: 903-911.
Ellard SL, Clemons M, Gelmon KA, Norris B, Kennecke H, Chia S, Pritchard K, Eisen A, Vandenberg T, Taylor M, Sauerbrei E, Mishaeli M, Huntsman D, Walsh W, Olivo M, McIntosh L, Seymour L: 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: 4536-4541.
Peddi PF, Shatsky RA, Hurvitz SA: Noninfectious pneumonitis with the use of mTOR inhibitors in breast cancer. Cancer Treat Rev 2014; 40: 320-326.
Dancey J: mTOR signaling and drug development in cancer. Nat Rev Clin Oncol 2010; 7: 209-219.
Iacovelli R, Palazzo A, Mezi S, Morano F, Naso G, Cortesi E: Incidence and risk of pulmonary toxicity in patients treated with mTOR inhibitors for malignancy. A metaanalysis of published trials. Acta Oncol 2012; 51: 873-879.
Dabydeen DA, Jagannathan JP, Ramaiya N, Krajewski K, Schutz FA, Cho DC, Pedrosa I, Choueiri TK: Pneumonitis associated with mTOR inhibitors therapy in patients with metastatic renal cell carcinoma: incidence, radiographic findings and correlation with clinical outcome. Eur J Cancer 2012; 48: 1519-1524.
Motzer RJ, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S, Grünwald V, Thompson JA, Figlin RA, Hollaender N, Kay A, Ravaud A; RECORD-1 Study Group: Phase 3 trial of everolimus for metastatic renal cell carcinoma: final results and analysis of prognostic factors. Cancer 2010; 116: 4256-4265.
Pavel ME, Hainsworth JD, Baudin E, Peeters M, Hörsch D, Winkler RE, Klimovsky J, Lebwohl D, Jehl V, Wolin EM, Oberg K, Van Cutsem E, Yao JC; RADIANT-2 Study Group: 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: 2005-2012.
Yao JC, Shah MH, Ito T, Bohas CL, Wolin EM, Van Cutsem E, Hobday TJ, Okusaka T, Capdevila J, de Vries EG, Tomassetti P, Pavel ME, Hoosen S, Haas T, Lincy J, Lebwohl D, Öberg K; RAD001 in Advanced Neuroendocrine Tumors, Third Trial (RADIANT-3) Study Group: Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med 2011; 364: 514-523.
Baselga J, Campone M, Piccart M, Burris HA 3rd, Rugo HS, Sahmoud T, Noguchi S, Gnant M, Pritchard KI, Lebrun F, Beck JT, Ito Y, Yardley D, Deleu I, Perez A, Bachelot T, Vittori L, Xu Z, Mukhopadhyay P, Lebwohl D, Hortobagyi GN: Everolimus in postmenopausal hormone receptor-positive advanced breast cancer. N Engl J Med 2012; 366: 520-529.
Ohtsu A, Ajani JA, Bai YX, Bang YJ, Chung HC, Pan HM, Sahmoud T, Shen L, Yeh KH, Chin K, Muro K, Kim YH, Ferry D, Tebbutt NC, Al-Batran SE, Smith H, Costantini C, Rizvi S, Lebwohl D, Van Cutsem E: Everolimus for previously treated advanced gastric cancer: results of the randomized, doubleblind, phase III GRANITE-1 study. J Clin Oncol 2013; 31: 3935-3943.
Gartrell BA, Ying J, Sivendran S, Boucher KM, Choueiri TK, Sonpavde G, Oh WK, Agarwal N, Galsky MD: Pulmonary complications with the use of mTOR inhibitors in targeted cancer therapy: A systematic review and meta-analysis. Target Oncol 2014; 9: 195-204.
Okamoto I, Doi T, Ohtsu A, Miyazaki M, Tsuya A, Kurei K, Kobayashi K, Nakagawa K: Phase I clinical and pharmacokinetic study of RAD001 (everolimus) administered daily to Japanese patients with advanced solid tumors. Jpn J Clin Oncol 2010; 40: 17-23.
Tobinai K, Ogura M, Maruyama D, Uchida T, Uike N, Choi I, Ishizawa K, Itoh K, Ando K, Taniwaki M, Shimada N, Kobayashi K: Phase I study of the oral mammalian target of rapamycin inhibitor everolimus (RAD001) in Japanese patients with relapsed or refractory non-Hodgkin lymphoma. Int J Hematol 2010; 92: 563-570.
Tsukamoto T, Shinohara N, Tsuchiya N, Hamamoto Y, Maruoka M, Fujimoto H, Niwakawa M, Uemura H, Usami M, Terai A, Kanayama HO, Sumiyoshi Y, Eto M, Akaza H: Phase III trial of everolimus in metastatic renal cell carcinoma: subgroup analysis of Japanese patients from RECORD-1. Jpn J Clin Oncol 2011; 41: 17-24.
Noguchi S, Masuda N, Iwata H, Mukai H, Horiguchi J, Puttawibul P, Srimuninnimit V, Tokuda Y, Kuroi K, Iwase H, Inaji H, Ohsumi S, Noh WC, Nakayama T, Ohno S, Rai Y, Park BW, Panneerselvam A, El-Hashimy M, Taran T, Sahmoud T, Ito Y: Efficacy of everolimus with exemestane versus exemestane alone in Asian patients with HER2-negative, hormone-receptor-positive breast cancer in BOLERO-2. Breast Cancer 2014; 21: 703-714.
Ito Y, Masuda N, Iwata H, Mukai H, Horiguchi J, Tokuda Y, Kuroi K, Mori A, Ohno N, Noguchi S: BOLERO-2; a randomized phase III study of everolimus in combination with exemestane: results of the Japanese subgroup analysis. Ann Oncol 2014; 23(suppl 11):xi18.
Nozawa M, Nonomura N, Ueda T, Nishimura K, Kanayama HO, Miki T, Nakatani T, Tomita Y, Azuma H, Yoshioka T, Tsujihata M, Uemura H: Adverse event profile and dose modification of everolimus for advanced renal cell carcinoma in real-world Japanese clinical practice. Jpn J Clin Oncol 2013; 43: 1132-1138.
Hasegawa Y, Kawaguchi T, Kubo A, Ando M, Shiraishi J, Isa S, Tsuji T, Tsujino K, Ou SH, Nakagawa K, Takada M: Ethnic difference in hematological toxicity in patients with nonsmall cell lung cancer treated with chemotherapy: A pooled analysis on Asian versus non-Asian in phase II and III clinical trials. J Thorac Oncol 2011; 6: 1881-1888.
Phan VH, Moore MM, McLachlan AJ, Piquette-Miller M, Xu H, Clarke SJ: Ethnic differences in drug metabolism and toxicity from chemotherapy. Exp Opin Drug Discov 2009; 5: 243-257.
Schoffski P, Reichardt P, Blay JY, Dumez H, Morgan JA, Ray-Coquard I, Hollaender N, Jappe A, Demetri GD: A phase I-II study of everolimus (RAD001) in combination with imatinib in patients with imatinib-resistant gastrointestinal stromal tumors. Ann Oncol 2010; 21: 1990-1998.
Ravaud A, Urva SR, Grosch K, Cheung WK, Anak O, Sellami DB: Relationship between everolimus exposure and safety and efficacy: meta-analysis of clinical trials in oncology. Eur J Cancer 2014; 50: 486-495.