Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial

The Lancet - Tập 372 - Trang 449-456 - 2008
Robert J Motzer1, Bernard Escudier2, Stéphane Oudard3, Thomas E Hutson4, Camillo Porta5, Sergio Bracarda6, Viktor Grünwald7, John A Thompson8, Robert A Figlin9, Norbert Hollaender10, Gladys Urbanowitz10, William J Berg10, Andrea Kay10, David Lebwohl10, Alain Ravaud11
1Memorial Sloan Kettering Cancer Center, New York, NY, USA
2Institut Gustave Roussy, Villejuif, France
3Hôpital Européen Georges Pompidou, Paris, France
4US Oncology/Baylor-Sammons Cancer Center, Dallas, TX, USA
5IRCCS San Matteo University Hospital Foundation, Pavia, Italy
6Azienda Ospedaliera, Perugia, Italy
7Medical School Hannover, Hannover, Germany
8Cancer Care Alliance, Seattle, WA, USA
9City of Hope National Medical Center, Duarte, CA, USA
10Novartis Oncology, Florham Park, NJ, USA
11Hôpital Saint André CHU, Bordeaux, France

Tài liệu tham khảo

Kaelin, 2004, The von Hippel-Lindau tumor suppressor gene and kidney cancer, Clin Cancer Res, 10, 6290, 10.1158/1078-0432.CCR-sup-040025 Brugarolas, 2007, Renal cell carcinoma—molecular pathways and therapies, N Engl J Med, 356, 185, 10.1056/NEJMe068263 Brugarolas, 2003, TSC2 regulates VEGF through mTOR-dependent and -independent pathways, Cancer Cell, 4, 147, 10.1016/S1535-6108(03)00187-9 Thomas, 2006, Hypoxia-inducible factor determines sensitivity to inhibitors of mTOR in kidney cancer, Nat Med, 12, 122, 10.1038/nm1337 Motzer, 1996, Renal cell carcinoma, N Engl J Med, 335, 865, 10.1056/NEJM199609193351207 Coppin, 2004, Immunotherapy for advanced renal cell cancer, Cochrane Database Syst Rev, 3, 10.1002/14651858.CD001425.pub2 Motzer, 2007, Sunitinib versus interferon alfa in metastatic renal cell carcinoma, N Engl J Med, 356, 115, 10.1056/NEJMoa065044 Escudier, 2007, Sorafenib in advanced clear-cell renal cell carcinoma, N Engl J Med, 356, 125, 10.1056/NEJMoa060655 Hudes, 2007, Temsirolimus, interferon alfa, or both for advanced renal cell carcinoma, N Engl J Med, 356, 2271, 10.1056/NEJMoa066838 Escudier, 2007, Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial, Lancet, 370, 2103, 10.1016/S0140-6736(07)61904-7 Coppin, 2008, Targeted therapy for advanced renal cell carcinoma, Cochrane Database Syst Rev, 2 Jac, 2007, A phase II trial of RAD001 in patients (pts) with metastatic renal cell carcinoma (MRCC), J Clin Oncol, 25, 261S O'Donnell, 2008, Phase I pharmacokinetic and pharmacodynamic study of the oral mammalian target of rapamycin inhibitor everolimus in patients with advanced solid tumors, J Clin Oncol, 26, 1588, 10.1200/JCO.2007.14.0988 Tabernero, 2008, Dose- and schedule-dependent inhibition of the mammalian target of rapamycin pathway with everolimus: a phase I tumor pharmacodynamic study in patients with advanced solid tumors, J Clin Oncol, 26, 1603, 10.1200/JCO.2007.14.5482 Tanaka, 2008, Identifying optimal biologic doses of everolimus (RAD001) in patients with cancer based on the modeling of preclinical and clinical pharmacokinetic and pharmacodynamic data, J Clin Oncol, 26, 1596, 10.1200/JCO.2007.14.1127 Therasse, 2000, New guidelines to evaluate the response to treatment in solid tumors, J Natl Cancer Inst, 92, 205, 10.1093/jnci/92.3.205 Motzer, 2004, Prognostic factors for survival in previously treated patients with metastatic renal cell carcinoma, J Clin Oncol, 22, 454, 10.1200/JCO.2004.06.132 Aaronson, 1993, The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology, J Natl Cancer Inst, 85, 365, 10.1093/jnci/85.5.365 Cella, 2007, Development and validation of a scale to measure disease-related symptoms of kidney cancer, Value Health, 10, 285, 10.1111/j.1524-4733.2007.00183.x Lan, 1983, Discrete sequential boundaries for clinical trials, Biometrika, 70, 659, 10.2307/2336502 O'Brien, 1979, A multiple testing procedure for clinical trials, Biometrics, 35, 549, 10.2307/2530245 Johnson, 2003, End points and United States Food and Drug Administration approval of oncology drugs, J Clin Oncol, 21, 1404, 10.1200/JCO.2003.08.072 Amato, 2006, A phase II trial of RAD001 in patients (pts) with metastatic renal cell carcinoma (MRCC), J Clin Oncol, 24 Atkins, 2004, 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, 909, 10.1200/JCO.2004.08.185