PURPOSE: This phase II study evaluated the activity of combined treatment with the mTOR inhibitor everolimus and the PDGFR inhibitor imatinib in patients with previously-treated, advanced renal carcinoma. The primary endpoint was estimation of the 3-month progression-free rate. PATIENTS AND METHODS: Eligible patients had metastatic or unresectable clear cell renal carcinoma, at least one prior systemic therapy, no prior mTOR inhibitor therapy, performance status 0-2, and measurable disease. Treatment consisted of everolimus 2.5 mg p.o. daily and imatinib 600 mg p.o. daily. The primary endpoint was the 3-month progression-free rate. RESULTS: The study was closed after the first 19 patients because of an insufficient number of patients who were progression-free at 3 months. The 3-month progression-free rate was 49% (95% C.I. 23%, 72%) and the median progression-free survival was 2.9 months (95% C.I. 1.9, 6.2). Toxicities with an incidence of > 50% included nausea, elevated serum creatinine, edema, anemia, hypocalcemia, fatigue, diarrhea, vomiting, and dyspnea, and leukopenia. CONCLUSION: The combination of everolimus with imatinib in previously treated patients with advanced renal carcinoma did not result in a sufficient 3-month progression-free rate to warrant further investigation of this combination.
PURPOSE: This phase II study evaluated the activity of combined treatment with the mTOR inhibitor everolimus and the PDGFR inhibitor imatinib in patients with previously-treated, advanced renal carcinoma. The primary endpoint was estimation of the 3-month progression-free rate. PATIENTS AND METHODS: Eligible patients had metastatic or unresectable clear cell renal carcinoma, at least one prior systemic therapy, no prior mTOR inhibitor therapy, performance status 0-2, and measurable disease. Treatment consisted of everolimus 2.5 mg p.o. daily and imatinib 600 mg p.o. daily. The primary endpoint was the 3-month progression-free rate. RESULTS: The study was closed after the first 19 patients because of an insufficient number of patients who were progression-free at 3 months. The 3-month progression-free rate was 49% (95% C.I. 23%, 72%) and the median progression-free survival was 2.9 months (95% C.I. 1.9, 6.2). Toxicities with an incidence of > 50% included nausea, elevated serum creatinine, edema, anemia, hypocalcemia, fatigue, diarrhea, vomiting, and dyspnea, and leukopenia. CONCLUSION: The combination of everolimus with imatinib in previously treated patients with advanced renal carcinoma did not result in a sufficient 3-month progression-free rate to warrant further investigation of this combination.
Authors: Bernard Escudier; Tim Eisen; Walter M Stadler; Cezary Szczylik; Stéphane Oudard; Michael Siebels; Sylvie Negrier; Christine Chevreau; Ewa Solska; Apurva A Desai; Frédéric Rolland; Tomasz Demkow; Thomas E Hutson; Martin Gore; Scott Freeman; Brian Schwartz; Minghua Shan; Ronit Simantov; Ronald M Bukowski Journal: N Engl J Med Date: 2007-01-11 Impact factor: 91.245
Authors: B J Druker; M Talpaz; D J Resta; B Peng; E Buchdunger; J M Ford; N B Lydon; H Kantarjian; R Capdeville; S Ohno-Jones; C L Sawyers Journal: N Engl J Med Date: 2001-04-05 Impact factor: 91.245
Authors: John D Hainsworth; David R Spigel; Jeffrey A Sosman; Howard A Burris; Cindy Farley; Heather Cucullu; Kathleen Yost; Lowell L Hart; Linda Sylvester; David M Waterhouse; F Anthony Greco Journal: Clin Genitourin Cancer Date: 2007-12 Impact factor: 2.872
Authors: Heidi A Lane; Jeanette M Wood; Paul M J McSheehy; Peter R Allegrini; Anne Boulay; Joseph Brueggen; Amanda Littlewood-Evans; Sauveur-Michel Maira; Georg Martiny-Baron; Christian R Schnell; Patrizia Sini; Terence O'Reilly Journal: Clin Cancer Res Date: 2009-02-17 Impact factor: 12.531
Authors: Robert J Motzer; Jennifer Bacik; Lawrence H Schwartz; Victor Reuter; Paul Russo; Stephanie Marion; Madhu Mazumdar Journal: J Clin Oncol Date: 2004-02-01 Impact factor: 44.544
Authors: George D Demetri; Margaret von Mehren; Charles D Blanke; Annick D Van den Abbeele; Burton Eisenberg; Peter J Roberts; Michael C Heinrich; David A Tuveson; Samuel Singer; Milos Janicek; Jonathan A Fletcher; Stuart G Silverman; Sandra L Silberman; Renaud Capdeville; Beate Kiese; Bin Peng; Sasa Dimitrijevic; Brian J Druker; Christopher Corless; Christopher D M Fletcher; Heikki Joensuu Journal: N Engl J Med Date: 2002-08-15 Impact factor: 91.245
Authors: Philip Earwaker; Caroline Anderson; Frances Willenbrock; Adrian L Harris; Andrew S Protheroe; Valentine M Macaulay Journal: PLoS One Date: 2018-02-01 Impact factor: 3.240