Phase 3 trial of everolimus for metastatic renal cell carcinoma: Final results and analysis of prognostic factors

Cancer

Volumn 116, Issue 18, 2010, Pages 4256-4265

  Motzer, Robert J ^a   Escudier, Bernard ^b   Oudard, Stephane ^c   Hutson, Thomas E ^d   Porta, Camillo ^e   Bracarda, Sergio ^f   Grünwald, Viktor ^g   Thompson, John A ^h   Figlin, Robert A ⁱ   Hollaender, Norbert ^j   Kay, Andrea ^j   Ravaud, Alain ^k  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b INSTITUT GUSTAVE ROUSSY   (France)

^c HÔPITAL EUROPÉEN GEORGES POMPIDOU   (France)

^d BAYLOR UNIVERSITY MEDICAL CENTER   (United States)

^e FONDAZIONE IRCCS POLICLINICO SAN MATTEO   (Italy)

^f IRCCS POLICLINICO SAN DONATO   (Italy)

^g HANNOVER MEDICAL SCHOOL   (Germany)

^h SEATTLE CANCER CARE ALLIANCE   (United States)

ⁱ CITY OF HOPE NATIONAL MEDICAL CENTER   (United States)

^j NOVARTIS PHARMA AG   (Switzerland)

^k HÔPITAL SAINT ANDRÉ   (France)

more..

Author keywords

Everolimus; Metastatic renal cell carcinoma; Phase 3; Prognostic factors; RAD001

Indexed keywords

EVEROLIMUS; SORAFENIB; SUNITINIB; ANTINEOPLASTIC AGENT; PLACEBO; RAPAMYCIN;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASTHENIA; BILIRUBIN BLOOD LEVEL; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; CREATININE BLOOD LEVEL; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG SAFETY; DRY SKIN; DYSGEUSIA; DYSPNEA; EPISTAXIS; FATIGUE; FEMALE; FEVER; GLUCOSE BLOOD LEVEL; HEADACHE; HEMOGLOBIN BLOOD LEVEL; HUMAN; INFECTION; KIDNEY CARCINOMA; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; NAUSEA; NEUTROPHIL COUNT; OVERALL SURVIVAL; PERIPHERAL EDEMA; PHASE 3 CLINICAL TRIAL; PHOSPHATE BLOOD LEVEL; PNEUMONIA; PRIORITY JOURNAL; PROGNOSIS; PROGRESSION FREE SURVIVAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; SIDE EFFECT; STOMATITIS; THROMBOCYTE COUNT; TRIACYLGLYCEROL BLOOD LEVEL; VOMITING; ADULT; AGED; ANALOGS AND DERIVATIVES; CARCINOMA, RENAL CELL; KIDNEY NEOPLASMS; METASTASIS; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; PATHOLOGY; RETREATMENT; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CARCINOMA, RENAL CELL; DOUBLE-BLIND METHOD; HUMANS; KIDNEY NEOPLASMS; MIDDLE AGED; NEOPLASM METASTASIS; PLACEBOS; PROGNOSIS; RETREATMENT; SIROLIMUS;

EID: 77956227464     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.25219     Document Type: Article

References (15)

1. Brugarolas JB, Vazquez F, Reddy A, et al. TSC2 regulates VEGF through mTOR-dependent and -independent pathways. Cancer Cell. 2003;4:147-158.
2. Thomas GV, Tran C, Mellinghoff IK, et al. Hypoxia-inducible factor determines sensitivity to inhibitors of mTOR in kidney cancer. Nat Med. 2006;12:122-127.
3. 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.
4. Motzer RJ, Bacik J, Schwartz LH, et al. Prognostic factors for survival in previously treated patients with metastatic renal cell carcinoma. J Clin Oncol. 2004;22:454-463.
5. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000;92:205-216.
6. Robins JM, Tsiatis AA. Correcting for non-compliance in randomized trials using rank preserving structural failure time models. Commun Stat Theory Methods. 1991;20:2609-2631.
7. Korhonen PA, Laird NM, Palmgren J. Correcting for noncompliance in randomized trials: an application to the ATBC Study. Stat Med. 1999;18:2879-2897.
8. Demetri GD, Huang X, Garrett CR, et al. Novel statistical analysis of long-term survival to account for crossover in a phase III trial of sunitinib (SU) vs. placebo (PL) in advanced GIST after imatinib (IM) failure [abstract]. J Clin Oncol. 2008;26(suppl):559s. Abstract 10524.
9. Sauerbrei W, Royston P. Building multivariable prognostic and diagnostic models: transformation of the predictors by using fractional polynomials. J R Stat Soc Ser A. 1999;162: 71-94; corrigendum 2002;165:339-400.
10. Schumacher M, Hollander N, Schwarzer G, Sauerbrei W. Prognostic factor studies. In: Crowley J, Ankerst DP, eds. Handbook of Statistics in Clinical Oncology. 2nd ed. Boca Raton, FL: Chapman & Hall/CRC Press; 2006:289-333.
11. Atkins MB, Hidalgo M, Stadler WM, et al. 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. 2004;22:909-918.
12. Escudier B, Eisen T, Stadler WM, et al. Sorafenib in advanced clear-cell renal cell carcinoma. N Engl J Med. 2007;356:125-134. (Pubitemid 46089673)
13. Motzer RJ, Hutson TE, Tomczak P, et al. Sunitinib versus interferon alfa in metastatic renal cell carcinoma. N Engl J Med. 2007;356:115-124.
14. National Cancer Institute Clinical Trials (PDQV®). NCT00719264. Safety and efficacy of bevacizumab plus RAD001 versus interferon alfa-2a and bevacizumab in adult patients with kidney cancer (RECORD-2). Available at: http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=601782&version= HealthProfessional&protocolsearchid=6233420 Accessed May 22, 2009.
15. National Cancer Institute Clinical Trials (PDQ®). NCT00903175. Efficacy and safety comparison of RAD001 versus sunitinib in the first-line and second-line treatment of patients with metastatic renal cell carcinoma (RECORD-3). Available at: http://www.cancer.gov/search/ViewClinical Trials.aspx?cdrid=643730&version=Health Professional&pro tocolsearchid=6315307 Accessed June 11, 2009.