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Everolimus long-term use in patients with tuberous sclerosis complex: Four-year update of the EXIST-2 study

Bissler, John J., Kingswood, J. Chris, Radzikowska, Elzbieta, Zonnenberg, Bernard A., Belousova, Elena, Frost, Michael D., Sauter, Matthias, Brakemeier, Susanne, de Vries, Petrus J., Berkowitz, Noah, Voi, Maurizio, Peyrard, Severine, Budde, Klemens·2017·PLOS ONE
DOI 10.1371/journal.pone.0180939PMC PMC5549893
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Crossref · 10.1371/journal.pone.0180939

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Figures

Fig 1 CONSORT flow diagram of patient disposition in the double-blind followed by open-label periods. aPatients with angiomyolipoma progression were unblinded at the end of the double-blind phase, and patients who were on placebo were allowed to cross over to open-label everolimus.
Fig 1 CONSORT flow diagram of patient disposition in the double-blind followed by open-label periods. aPatients with angiomyolipoma progression were unblinded at the end of the double-blind phase, and patients who were on placebo were allowed to cross over to open-label everolimus.CC BY · PubMed Central
Fig 2 Best percentage reduction in the sum volume of target renal angiomyolipomas each individual patient reported at any time point in the study in 101 evaluable patients.a a11 patients were considered “non-evaluable” due to missing overall angiomyolipoma response status at each radiological assessment. Among the 12 patients with a best overall response with the status “not evaluable”, only one patient reported at least one radiological assessment with a non-missing overall angiomyolipoma response status.
Fig 2 Best percentage reduction in the sum volume of target renal angiomyolipomas each individual patient reported at any time point in the study in 101 evaluable patients.a a11 patients were considered “non-evaluable” due to missing overall angiomyolipoma response status at each radiological assessment. Among the 12 patients with a best overall response with the status “not evaluable”, only one patient reported at least one radiological assessment with a non-missing overall angiomyolipoma response status.CC BY · PubMed Central
Fig 3 Renal angiomyolipoma response rate with everolimus over time.
Fig 3 Renal angiomyolipoma response rate with everolimus over time.CC BY · PubMed Central
Fig 4 Time to renal angiomyolipoma progression.
Fig 4 Time to renal angiomyolipoma progression.CC BY · PubMed Central
Fig 5 Reduction in SEGA volume with everolimus over time in patients with renal angiomyolipomas.
Fig 5 Reduction in SEGA volume with everolimus over time in patients with renal angiomyolipomas.CC BY · PubMed Central
Fig 6 Median GFR (A) and creatinine (B) over time. Medians are connected by lines, means are displayed as dots. Boxes are drawn from P25 to P75. Whiskers extend from P10 to P90. # indicates values that lie outside [P10, P90]. *Baseline assessment is the last performed before start of everolimus. Post-baseline laboratory assessments performed at unplanned schedule or more than 28 days after discontinuation of everolimus are not presented. Only results from central laboratory are included. Abbreviations: BL = baseline; GFR = glomerular filtration rate; P = percentile.
Fig 6 Median GFR (A) and creatinine (B) over time. Medians are connected by lines, means are displayed as dots. Boxes are drawn from P25 to P75. Whiskers extend from P10 to P90. # indicates values that lie outside [P10, P90]. *Baseline assessment is the last performed before start of everolimus. Post-baseline laboratory assessments performed at unplanned schedule or more than 28 days after discontinuation of everolimus are not presented. Only results from central laboratory are included. Abbreviations: BL = baseline; GFR = glomerular filtration rate; P = percentile.CC BY · PubMed Central

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Cites

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Research works printed but not linked: 24

  1. JP Osborne, 1991, Epidemiology of tuberous sclerosis, Ann N Y Acad Sci, 615, 125, 10.1111/j.1749-6632.1991.tb37754.x · DOI
  2. P Curatolo, 2008, Tuberous sclerosis, Lancet, 372, 657, 10.1016/S0140-6736(08)61279-9 · DOI
  3. K Budde, 2012, Tuberous sclerosis complex-associated angiomyolipomas: focus on mTOR inhibition, Am J Kidney Dis, 59, 276, 10.1053/j.ajkd.2011.10.013 · DOI
  4. JA Cook, 1996, A cross sectional study of renal involvement in tuberous sclerosis, J Med Genet, 33, 480, 10.1136/jmg.33.6.480 · DOI
  5. DH Ewalt, 1998, Renal lesion growth in children with tuberous sclerosis complex, J Urol, 160, 141, 10.1016/S0022-5347(01)63072-6 · DOI
  6. FJ O'Callaghan, 2004, An epidemiological study of renal pathology in tuberous sclerosis complex, BJU Int, 94, 853, 10.1111/j.1464-410X.2004.05046.x · DOI
  7. SK Rakowski, 2006, Renal manifestations of tuberous sclerosis complex: incidence, prognosis, and predictive factors, Kidney Int, 70, 1777, 10.1038/sj.ki.5001853 · DOI
  8. CP Nelson, 2002, Contemporary diagnosis and management of renal angiomyolipoma, J Urol, 168, 1315, 10.1016/S0022-5347(05)64440-0 · DOI
  9. RA Rabenou, 2015, Differentiation of sporadic versus tuberous sclerosis complex-associated angiomyolipoma, AJR Am J Roentgenol, 205, 292, 10.2214/AJR.14.14255 · DOI
  10. K Yamakado, 2002, Renal angiomyolipoma: relationships between tumor size, aneurysm formation, and rupture, Radiology, 225, 78, 10.1148/radiol.2251011477 · DOI
  11. MJ Eijkemans, 2015, Long-term follow-up assessing renal angiomyolipoma treatment patterns, morbidity, and mortality: an observational study in tuberous sclerosis complex patients in the Netherlands, Am J Kidney Dis, 66, 638, 10.1053/j.ajkd.2015.05.016 · DOI
  12. P Sooriakumaran, 2010, Angiomyolipomata: challenges, solutions, and future prospects based on over 100 cases treated, BJU Int, 105, 101, 10.1111/j.1464-410X.2009.08649.x · DOI
  13. P Curatolo, 2012, mTOR inhibitors in tuberous sclerosis complex, Curr Neuropharmacol, 10, 404, 10.2174/157015912804499537 · DOI
  14. DA Krueger, 2013, Tuberous sclerosis complex surveillance and management: recommendations of the 2012 International Tuberous Sclerosis Complex Consensus Conference, Pediatr Neurol, 49, 255, 10.1016/j.pediatrneurol.2013.08.002 · DOI
  15. JJ Bissler, 2013, Everolimus for angiomyolipoma associated with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis (EXIST-2): a multicentre, randomised, double-blind, placebo-controlled trial, Lancet, 381, 817, 10.1016/S0140-6736(12)61767-X · DOI
  16. JJ Bissler, 2016, Everolimus for renal angiomyolipoma in patients with tuberous sclerosis complex or sporadic lymphangioleiomyomatosis: extension of a randomized controlled trial, Nephrol Dial Transplant, 31, 111, 10.1093/ndt/gfv249 · DOI
  17. AS Levey, 2006, Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate, Ann Intern Med, 145, 247, 10.7326/0003-4819-145-4-200608150-00004 · DOI
  18. R Brookmeyer, 1982, A Confidence Interval for the Median Survival Time, Biometrics, 38, 29, 10.2307/2530286 · DOI · Paper page
  19. DN Franz, 2013, 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, 381, 125, 10.1016/S0140-6736(12)61134-9 · DOI · Paper page
  20. DA Krueger, 2010, Everolimus for subependymal giant-cell astrocytomas in tuberous sclerosis, N Engl J Med, 363, 1801, 10.1056/NEJMoa1001671 · DOI
  21. DA Krueger, 2013, Everolimus long-term safety and efficacy in subependymal giant-cell astrocytoma, Neurology, 80, 574, 10.1212/WNL.0b013e3182815428 · DOI
  22. DN Franz, 2015, Everolimus for subependymal giant cell astrocytoma: 5-year final analysis, Ann Neurol, 78, 929, 10.1002/ana.24523 · DOI
  23. J Trelinska, 2015, Complications of mammalian target of rapamycin inhibitor anticancer treatment among patients with tuberous sclerosis complex are common and occasionally life-threatening, Anticancer Drugs, 26, 437, 10.1097/CAD.0000000000000207 · DOI · Paper page
  24. BJ Siroky, 2014, Evidence for pericyte origin of TSC-associated renal angiomyolipomas and implications for angiotensin receptor inhibition therapy, Am J Physiol Renal Physiol, 307, F560, 10.1152/ajprenal.00569.2013 · DOI

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Metadata

Authors
Bissler, J. J., Kingswood, J. C., Radzikowska, E., Zonnenberg, B. A., Belousova, E., Frost, M. D., Sauter, M., Brakemeier, S., de Vries, P. J., Berkowitz, N., Voi, M., Peyrard, S., & Budde, K.
ORCID
Bissler, John J.
Venue
PLOS ONE
Publisher
Public Library of Science (PLoS)
Published
2017-08-09
Volume
12
Issue
8
Pages
e0180939
ISSN
1932-6203
DOI
10.1371/journal.pone.0180939
PMC
PMC5549893
Cited by
157
References
2
Language
en
Licence
creativecommons.org/licenses/by/4.0/ (vor)
Funders
Novartis Pharmaceuticals Corporation

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