An international expanded-access programme of everolimus: Addressing safety and efficacy in patients with metastatic renal cell carcinoma who progress after initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapy

European Journal of Cancer

Volumn 48, Issue 3, 2012, Pages 324-332

  Grünwald, Viktor ^a   Karakiewicz, Pierre I ^b   Bavbek, Sevil E ^c   Miller, Kurt ^d   Machiels, Jean Pascal ^e   Lee, Se Hoon ^f   Larkin, James ^g   Bono, Petri ^h   Rha, Sun Young ^i,p   Castellano, Daniel ^j   Blank, Christian U ^k   Knox, Jennifer J ^l   Hawkins, Robert ^m   Anak, Oezlem ⁿ   Rosamilia, Marianne ⁿ   Booth, Jocelyn ⁿ   Pirotta, Nicoletta ⁿ   Bodrogi, István ^o   Romedi, M ^p   Ferrandini, S ^p   Rondinon, M ^p   Pittman, K ^p   Goldstein, D ^p   Shapiro, J ^p   Troon, S ^p   Yip, D ^p   Mainwaring, P ^p   Zigeuner, R ^p   Loidl, W ^p   Greil, R F ^p   Schmidinger, M ^p   De Greve J ^p   Rottey, S ^p   Vermorken, J ^p   Machiels, J ^p   Gil, T ^p   Gennigens, C ^p   Roumeguere, T ^p   Barrios, C ^p   Mathias, C ^p   Assi, H ^p   Hotte, S ^p   Karakiewicz, P ^p   Knox, J ^p   Spadafora, S ^p   Wood, L ^p   Zalewski, P ^p   Mackensie, M ^p   Bjarnason, G ^p   Lalancette, A ^p   Chan, A ^p   Higgins, B ^p   North, S ^p   Soulieres, D ^p   Asselah, J ^p   Sperlich, C ^p   Miller, W ^p   Yadav, S ^p   El Maraghi, R ^p   Godoy, J ^p   Prausova J ^p   Katolicka, J ^p   Petruzelka, L ^p   Kiss, I ^p   Bono, P ^p   Lapela, M ^p   Miller, K ^p   Bergmann, L ^p   Beck, J ^p,p   Jager E ^p   Kindler, M ^p   Overkamp, F ^p   Wirth, M ^p   Holzer W ^p   Gschwend, J ^p   Stenzl, A ^p   Gauler, T ^p   Niederwieser, D ^p   Marschner, N ^p   Luck A ^p   Tessen, H ^p   Eichelberg, C ^p   Steiner, T ^p   Goebell, P ^p   Kettner, E ^p   Bakhshandeh Bath, A ^p   Wilhelm, M ^p   Schmitz, S ^p   Jacob, A ^p   Bierer, S ^p   Kube, U ^p   Staehler, M ^p   Engel, E ^p   Frambach, M ^p   Schellenberger, U ^p   Albers, P ^p   Simon, J ^p   Gleissler, M ^p   Klotz, T ^p   Repp, R ^p   Kroning H ^p   Westermann, J ^p   Rebmann, U ^p   Brehmer, B ^p   Niederle, N ^p   Grund, C ^p   Verpoort, K ^p   Fonara, P ^p   Rassweiler, J ^p   Bamias, A ^p   Fountzilas, G ^p   Razis, E ^p   Mouratidou, D ^p   Georgoulias, V ^p   Samantas, E ^p   Bodrogi, I ^p   Mangel, L ^p   Szanto, J ^p   Berger, R ^p   Pe'er, A ^p   Sella, A ^p   Ben Yosef, R ^p   Nechushtan, H ^p   Crino L ^p   Bracarda, S ^p   Ciuffreda, L ^p   Graiff, C ^p   Falcone, A ^p   Roselli, M ^p   Sternberg, C ^p   Santoro, A ^p   Ruggeri, E ^p   Bearz, A ^p   Venturini, M ^p   Aglietta, M ^p   Amadori, D ^p   Di Costanzo, F ^p   Bari, M ^p   Gebbia, N ^p   Conte, P ^p   Bonetti, A ^p   Bordonaro, R ^p   Cascinu, S ^p   Contu, A ^p   Cruciani, G ^p   Gasparro, D ^p   Nardi, M ^p   Lelli, G ^p   Lo Re, G ^p   Boccardo, F ^p   Lorusso, V ^p   Maiello, E ^p   Manente, P ^p   Passalacqua, R ^p   Piantedosi, F ^p   Porta, C ^p   Sacco, C ^p   Tondini, C ^p   De Placido, S ^p   Carteni, G ^p   Dogliotto, L ^p   Rosti, G ^p   Milella, M ^p   Roila, F ^p   Amoroso, D ^p   Farina, G ^p   Al Khatib, H ^p   Lee, S ^p   Kim, T ^p   Ahn, J ^p   Lim, H ^p   Chung, I ^p   Kim, J ^p   Chung, J ^p   Ghosn, M ^p   Shameseddine, A ^p   Lugo, R ^p   Cabrera, P ^p   Osanto, S ^p   Groenewegen, G ^p   Blank, C ^p   van den Eertwegh, F ^p   van Herpen, C ^p   Oosting, S ^p   Soetekouw, P ^p   Lilleby, W ^p   Klepp, O ^p   Guren, T ^p   Alcedo, J ^p   Karlov, P ^p   Nosov, D ^p   Roman, L ^p   Rusakov, I ^p   Bazarbashi, S ^p   Toh, C ^p   Mardiak, J ^p   Constenla, M ^p   Solans, F Garcia del Muro ^p   Maroto Ray, J ^p   Bellmunt Mollins, J ^p   Castellano, D ^p   Duran Martinez, I ^p   Mellado Gonzalez, B ^p   Domenech Santasusana, M ^p   Lopez Brea Piqueras, M ^p   Campillo Fuentes, J ^p   Gonzalez Larriba, J ^p   Luque Caro, R ^p   Meana Garcia, A ^p   Aparicio, L ^p   Batista Lopez, N ^p   Calderero Aragon, V ^p   Valverde Morales, C ^p   Figueiras, M ^p   Contreras Ibanez, J ^p   Gonzalez Billalabeitia, E ^p   Estrada, E ^p   Arranz, J ^p   Lambea Sorrosal, J ^p   Lozano, A ^p   de Villena, M Codes ^p   Espinosa, E ^p   Lopez, R ^p   Perez Garcia, J ^p   Laurell, A ^p   Stierner, U ^p   Cwikiel, M ^p   Borner, M ^p   Dietrich, P Y ^p   Rothermundt, C ^p   Pu, Y ^p   Chang, Y ^p   Ou, Y ^p   Chuang, C ^p   Liao, Y ^p   Srimuninnimit, V ^p   Sriuranpong, V ^p   Buyukberber, S ^p   Yalcin, B ^p   Goker, E ^p   Yalcin, S ^p   Geldart, T ^p   Wagstaff, J ^p   Nicholson, S ^p   Chowdhury, S ^p   Bahl, A ^p   Jones, R ^p   Azzabi, A ^p   Chao, D ^p   Fife, K ^p   Hawkins, R ^p   Mead, G ^p   Nathan, P ^p   Pandha, H ^p   Hajdenberg, J ^p   Gabrail, N ^p   Nimeh, N ^p   Logan, T ^p   Flaig, T ^p   Schraeder, R ^p   Rini, B ^p   O'Rourke, M ^p   Alemany, C ^p   Kessinger, A ^p   Amin, A ^p   Arriaga, M ^p   Rodriguez, J ^p   more..

^a HANNOVER MEDICAL SCHOOL   (Germany)

^b CENTRE HOSPITALIER DE L UNIVERSITÉ DE MONTRÉAL   (Canada)

^c ISTANBUL UNIVERSITY   (Turkey)

^d CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^e CLINIQUES UNIVERSITAIRES SAINT LUC   (Belgium)

^f Seoul National University Hospital   (South Korea)

^g ROYAL MARSDEN HOSPITAL   (United Kingdom)

^h HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

ⁱ Yonsei University College of Medicine   (South Korea)

^j HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

^k NETHERLANDS CANCER INSTITUTE   (Netherlands)

^l Princess Margaret Hospital   (Canada)

^m CHRISTIE HOSPITAL   (United Kingdom)

ⁿ NOVARTIS PHARMA AG   (Switzerland)

^o NATIONAL INSTITUTE OF ONCOLOGY   (Hungary)

^p NONE

more..

Author keywords

Advanced kidney cancer; mTOR inhibitor; RAD001; REACT; Safety; Second line therapy

Indexed keywords

EVEROLIMUS;

ANEMIA; CANCER CHEMOTHERAPY; CLINICAL TRIAL (TOPIC); DRUG EFFICACY; DRUG MONITORING; DRUG SAFETY; DYSPNEA; FATIGUE; HUMAN; HYPERGLYCEMIA; KIDNEY CARCINOMA; OUTCOME ASSESSMENT; PATIENT MONITORING; PLEURA EFFUSION; PNEUMONIA; PRIORITY JOURNAL; REVIEW; STOMATITIS; TREATMENT DURATION; TREATMENT RESPONSE;

EID: 84856225907     PISSN: 09598049     EISSN: 18790852     Source Type: Journal    
DOI: 10.1016/j.ejca.2011.06.054     Document Type: Article

References (25)

1. R.J. Motzer, B. Escudier, S. Oudard for the RECORD-1 Study Group Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial Lancet 372 9637 2008 449 456
2. R.J. Motzer, B. Escudier, and S. Oudard Phase 3 trial of everolimus for metastatic renal cell carcinoma: final results and analysis of prognostic factors Cancer 116 18 2010 4256 4265
3. P. Therasse, S.G. Arbuck, and E.A. Eisenhauer New guidelines to evaluate the response to treatment in solid tumors J Natl Cancer Inst 92 3 2000 205 216 (Pubitemid 30099779)
4. R.J. Motzer, J. Bacik, and L.H. Schwartz Prognostic factors for survival in previously treated patients with metastatic renal cell carcinoma J Clin Oncol 22 3 2004 454 463 (Pubitemid 41079774)
5. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™). Kidney Cancer. Version 1.2011. http://www.nccn.org/professionals/physician-gls/pdf/kidney.pdf [accessed February 18, 2011].
6. B. Ljungberg, N.C. Cowan, and D.C. Hanbury EAU guidelines on renal cell carcinoma: the 2010 update Eur Urol 58 3 2010 398 406
7. B. Escudier, and V. Kataja Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up Ann Oncol 21 Suppl. 5 2010 v137 v139
8. T.M. de Reijke, J. Bellmunt, and H. van Poppel EORTC-GU group expert opinion on metastatic renal cell cancer Eur J Cancer 45 5 2009 765 773
9. E. Calvo, P. Maroto, and X.G. del Muro Updated recommendations from the Spanish Oncology Genitourinary Group on the treatment of advanced renal cell carcinoma Cancer Metastasis Rev 29 Suppl. 1 2010 1 10
10. Patard J-J, Baumert H, Corréas J-M, et al. Oncology Committee of the French Association of Urology (AFU). [Recommendations onco-urology 2010: kidney cancer]. Prog Urol 2010;20(Suppl. 4):S323-43.
11. Chaves SS. The pre-travel consultation. Travel-related vaccine-preventable diseases: Hepatitis B. In: Online 2010 Yellow Book. Atlanta, GA: Centers for Disease Control and Prevention, Department of Health and Human Services. http://wwwnc.cdc.gov/travel/yellowbook/2010/chapter-2/hepatitis-b. aspx#849 [accessed June 15, 2011].
12. National Cancer Institute. Common terminology criteria for adverse events (CTCAE). Version 4.0. National Institutes of Health, US Department of Health and Human Services; 2009.
13. J. Brugarolas Renal-cell carcinoma - molecular pathways and therapies N Engl J Med 356 2 2007 185 187 (Pubitemid 46089681)
14. B.I. Rini Metastatic renal cell carcinoma: many treatment options, one patient J Clin Oncol 27 19 2009 3225 3234
15. C.N. Sternberg, I.D. Davis, and J. Mardiak Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial J Clin Oncol 28 6 2010 1061 1068
16. J. Bellmunt, T. Eisen, C. Szczylik, P. Mulders, and C. Porta A new patient-focused approach to the treatment of metastatic renal cell carcinoma: establishing customized treatment options BJU Int 2010 10.1111/j.1464-410X.2010. 09829.x
17. T.K. Choueiri, and M.B. Atkins Sunitinib in RCC - expanded access equals expanded benefit? Nat Rev Clin Oncol 6 2009 679 680
18. D. Strumberg Efficacy of sunitinib and sorafenib in non-clear cell renal cell carcinoma: results from expanded access studies J Clin Oncol 26 20 2008 3469 3471
19. M.E. Gore, C. Szczylik, and C. Porta Safety and efficacy of sunitinib for metastatic renal-cell carcinoma: an expanded-access trial Lancet Oncol 10 8 2009 757 763
20. W.M. Stadler, R.A. Figlin, and D.F. McDermott Safety and efficacy results of the advanced renal cell carcinoma sorafenib expanded access program in North America Cancer 116 5 2010 1272 1280
21. M.B. Atkins, M. Hidalgo, and W.M. Stadler Randomized phase II study of multiple dose levels of CCI-779, a novel mammalian target of rapamycin kinase inhibitor, in patients with advanced refractory renal cell carcinoma J Clin Oncol 22 5 2004 909 918 (Pubitemid 41103603)
22. R.A. Figlin, E. Brown, and A.J. Armstrong NCCN Task Force Report: mTOR inhibition in solid tumors J Natl Compr Canc Netw 6 Suppl. 5 2008 S1 S20
23. B. Escudier, T. Eisen, W.M. Stadler for the TARGET Study Group Sorafenib in advanced clear-cell renal-cell carcinoma N Engl J Med 356 2 2007 125 134 (Pubitemid 46089673)
24. R.J. Motzer, T.E. Hutson, and P. Tomczak Sunitinib versus interferon alfa in metastatic renal-cell carcinoma N Engl J Med 356 2 2007 115 124 (Pubitemid 46089672)
25. D.A. White, P. Camus, and M. Endo Noninfectious pneumonitis after everolimus therapy for advanced renal cell carcinoma Am J Respir Crit Care Med 182 3 2010 396 403