Incidence and risk of treatment-related mortality in cancer patients treated with the mammalian target of rapamycin inhibitors

Annals of Oncology

Volumn 24, Issue 8, 2013, Pages 2092-2097

  Choueiri, T K ^a   Je, Y ^b   Sonpavde, G ^c   Richards, C J ^d   Galsky, M D ^e   Nguyen, P L ^a,f   Schutz, F ^g   Heng, D Y ^h   Kaymakcalan, M D ^a  

^a DANA FARBER CANCER INSTITUTE   (United States)

^b Kyung Hee University   (South Korea)

^c UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^d BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^e MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^f BRIGHAM AND WOMEN S HOSPITAL   (United States)

^g FEDERAL UNIVERSITY OF SÃO PAULO   (Brazil)

^h UNIVERSITY OF CALGARY   (Canada)

Author keywords

Cancer; Fatal adverse events; Meta analysis; mTOR inhibitors; Renal cell carcinoma

Indexed keywords

EVEROLIMUS; MAMMALIAN TARGET OF RAPAMYCIN INHIBITOR; PLACEBO; TEMSIROLIMUS;

ARTICLE; CANCER INCIDENCE; CANCER MORTALITY; CANCER PATIENT; CANCER RISK; CAUSE OF DEATH; CONTROLLED STUDY; DISEASE ASSOCIATION; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; HIGH RISK POPULATION; HUMAN; KIDNEY CARCINOMA; MAJOR CLINICAL STUDY; META ANALYSIS; OUTCOME ASSESSMENT; PATIENT ASSESSMENT; PRIORITY JOURNAL; QUALITY CONTROL; RISK ASSESSMENT; RISK FACTOR; TISSUE CHARACTERIZATION;

CANCER; FATAL ADVERSE EVENTS; META-ANALYSIS; MTOR INHIBITORS; RENAL CELL CARCINOMA;

ANTINEOPLASTIC AGENTS; CARCINOMA, RENAL CELL; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY NEOPLASMS; PROTEIN KINASE INHIBITORS; RISK; SIROLIMUS; TOR SERINE-THREONINE KINASES;

EID: 84879694541     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdt155     Document Type: Article

References (32)

1. Laplante M, Sabatini DM. mTOR signaling in growth control and disease. Cell 2012; 149(2): 274-293.
2. Fasolo A, Sessa C. Targeting mTOR pathways in human malignancies. Curr Pharm Des 2012; 18(19): 2766-2777.
3. Albanell J, Dalmases A, Rovira A, Rojo F. mTOR signalling in human cancer. Clin Transl Oncol 2007; 9(8): 484-493.
4. Husseinzadeh H, Garcia J. Therapeutic rationale for mTOR inhibition in advanced renal cell carcinoma. Curr Clin Pharmacol 2011; 6(3): 214-221.
5. Motzer RJ, Escudier B, Oudard S et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet 2008; 372: 449-456.
6. Motzer RJ, Escudier B, Oudard S et al Phase 3 trial of everolimus for metastatic renal cell carcinoma. Cancer 2010; 116(18): 4256-4265.
7. Krueger DA, Care MM, Holland K et al. Everolimus for subependymal giant-cell astrocytomas in tuberous sclerosis. N Engl J Med 2010; 363(19): 1801-1811.
8. Baselga J, Campone M, Piccart M et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med 2012; 366(6): 520-529.
9. Yao JC, Shah MH, Ito T et al. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med 2011; 364(6): 514-523.
10. Hudes G, Carducci M, Tomczak P et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med 2007; 356(22): 2271-2281.
11. Seruga B, Sterling L, Wang L, Tannock IF. Reporting of serious adverse drug reactions of targeted anticancer agents in pivotal phase III clinical trials. J Clin Oncol 2011; 29(2): 174-185.
12. Porta C, Osanto S, Ravaud A et al. Management of adverse events assoicated with the use of everolimus in patients with advanced renal cell carcinoma. Eur J Cancer 2011; 47(9): 1287-1298.
13. Eisen T, Sternberg C, Robert C et al. Targeted therapies for renal cell carcinoma: review of adverse event management strategies. J Natl Cancer Inst 2012; 104 (2): 93-113.
14. Boers-Doets CB, Epstein JB, Raber-Durlacher JE et al. Oral adverse events associated with tyrosine kinase and mammalian target of rapamycin inhibitors in renal cell carcinoma: a structured literature review. Oncologist 2012; 17(1): 135-144.
15. Jadad AR, Moore RA, Carroll D et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996; 17(1): 1-12.
16. Moher D, Liberati A, Tetzlaff J et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. J Clin Epidemiol 2009; 62 (10): 1006-1012.
17. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003; 327: 557-560.
18. Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics 1994; 50(4): 1088-1101.
19. Egger M, Davey-Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997; 315: 629-634.
20. Negrier S, Gravis G, Perol D et al. Temsirolimus and bevacizumab, or sunitinib, or interferon alfa and bevacizumab for patients with advanced renal cell carcinoma (TORAVA): a randomized phase 2 trial. Lancet Oncol 2011; 12(7): 673-680.
21. Baselga J, Semiglazov V, van Dam P et al. Phase II randomized study of neoadjuvant everolimus plus letrozole compared with placebo letrozole in patients with estrogen receptor-positive breast cancer. J Clin Oncol 2009; 27(16): 2630-2637.
22. Pavel ME, Hainsworth JD, Baudin E 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: 2005-2012.
23. Hess G, Herbrecht R, Romaguera J 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.
24. White DA, Camus P, Endo M et al. Noninfectious pneumonitis after everolimus therapy for advanced renal cell carcinoma. Am J Respir Crit Care Med 2010; 82 (3): 396-403.
25. Dabydeen DA, Jagannathan JP, Ramaiya N et al. 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(10): 1519-1524.
26. Peuvrel L, Quereux G, Brocard A et al. Onychopathy induced by temsirolimus, a mammalian target of rapamycin inhibitor. Dermatology 2012; 224(3): 204-208.
27. Kulke MH, Bergsland EK, Yao JC. Glycemic control in patients with insulinoma treated with everolimus. N Engl J Med 2009; 360(2): 195-197.
28. Raymond E, Alexandre J, Faivre S et al. Safety and pharmacokinetics of escalated doses of weekly intravenous infusion of CCI-779, a novel mTOR inhibitor, in patients with cancer. J Clin Oncol 2004; 22(12): 2336-2347.
29. Mita MM, Mita AC, Chu QS et al. Phase I trial of the novel mammalian target of rapamycin inhibitor deforolimus (AP23573; MK-8669) administered intravenously daily for 5 days ever 2 weeks to patients with advanced malignancies. J Clin Oncol 2008; 26(3): 361-367.
30. Andrassy J, Graeb C, Rentsch M et al. mTOR inhibition and its effect on cancer in transplantation. Transplantation 2005; 80(S1): S171-S174.
31. Heng DYC, Choueiri TK, Lee JL et al. An In-Depth multicentered populationbased analysis of outcomes of patients with metastatic renal cell carcinoma (mRCC) that do not meet eligibility criteria for clinical trials. 2012. Genitourinary Cancers Symposium. San Franscisco, CA; 2012.
32. Ladewski LA, Belknap SM, Nebeker JR et al. Dissemination of information on potentially fatal adverse drug reactions for cancer drugs from 2000 to 2001: first results from the research on adverse drug events and reports project. J Clin Oncol 2003; 21(20): 3859-3866.