BACKGROUND: We performed a phase I study to determine the dose and safety of everolimus as a combination chemotherapy in peripheral T-cell lymphoma (PTCL). METHODS: Four dose levels (2.5 to 10 mg) of everolimus from days 1 to 14 with CHOP (750 mg/m(2) cyclophosphamide, 50 mg/m(2) doxorubicin, and 1.4 mg/m(2) (maximum 2 mg) vincristine on day 1, and 100 mg/day prednisone on days 1 to 5) every 21 days were planned. RESULTS: Fifteen patients newly diagnosed with stage III/IV PTCL were enrolled. One of 6 patients at dose level 2 (5 mg everolimus) had grade 3 hepatotoxicity and 3 of 6 patients at level 3 (7.5 mg everolimus) had grade 4 hematologic toxicities (two grade 4 thrombocytopenia and one grade 4 neutropenia with fever lasting more than 3 days). The recommended dose of everolimus for combination was 5 mg. There were no differences in steady state trough concentrations of everolimus between cycles 1 and 2 for all three dose levels. All evaluable patients achieved response (8 complete and 6 partial). CONCLUSIONS: Everolimus (5 mg) can be safely combined with CHOP leading to a feasible and effective regimen for PTCL. The subsequent phase II is now in progress.
BACKGROUND: We performed a phase I study to determine the dose and safety of everolimus as a combination chemotherapy in peripheral T-cell lymphoma (PTCL). METHODS: Four dose levels (2.5 to 10 mg) of everolimus from days 1 to 14 with CHOP (750 mg/m(2) cyclophosphamide, 50 mg/m(2) doxorubicin, and 1.4 mg/m(2) (maximum 2 mg) vincristine on day 1, and 100 mg/day prednisone on days 1 to 5) every 21 days were planned. RESULTS: Fifteen patients newly diagnosed with stage III/IV PTCL were enrolled. One of 6 patients at dose level 2 (5 mg everolimus) had grade 3 hepatotoxicity and 3 of 6 patients at level 3 (7.5 mg everolimus) had grade 4 hematologic toxicities (two grade 4 thrombocytopenia and one grade 4 neutropenia with fever lasting more than 3 days). The recommended dose of everolimus for combination was 5 mg. There were no differences in steady state trough concentrations of everolimus between cycles 1 and 2 for all three dose levels. All evaluable patients achieved response (8 complete and 6 partial). CONCLUSIONS: Everolimus (5 mg) can be safely combined with CHOP leading to a feasible and effective regimen for PTCL. The subsequent phase II is now in progress.
Authors: Christoph Renner; Pier Luigi Zinzani; Rémy Gressin; Dirk Klingbiel; Pierre-Yves Dietrich; Felicitas Hitz; Mario Bargetzi; Walter Mingrone; Giovanni Martinelli; Andreas Trojan; Krimo Bouabdallah; Andreas Lohri; Emmanuel Gyan; Christine Biaggi; Sergio Cogliatti; Francesco Bertoni; Michele Ghielmini; Peter Brauchli; Nicolas Ketterer Journal: Haematologica Date: 2012-02-07 Impact factor: 9.941
Authors: Francisco Vega; L Jeffrey Medeiros; Vasiliki Leventaki; Coralyn Atwell; Jeong Hee Cho-Vega; Ling Tian; Francois-Xavier Claret; George Z Rassidakis Journal: Cancer Res Date: 2006-07-01 Impact factor: 12.701
Authors: Pawel Wlodarski; Monika Kasprzycka; Xiaobin Liu; Michal Marzec; Erle S Robertson; Artur Slupianek; Mariusz A Wasik Journal: Cancer Res Date: 2005-09-01 Impact factor: 12.701
Authors: Hans-Guido Wendel; Abba Malina; Zhen Zhao; Lars Zender; Scott C Kogan; Carlos Cordon-Cardo; Jerry Pelletier; Scott W Lowe Journal: Cancer Res Date: 2006-08-01 Impact factor: 12.701
Authors: Patrick B Johnston; David J Inwards; Joseph P Colgan; Betsy R Laplant; Brian F Kabat; Thomas M Habermann; Ivana N Micallef; Luis F Porrata; Stephen M Ansell; Craig B Reeder; Vivek Roy; Thomas E Witzig Journal: Am J Hematol Date: 2010-05 Impact factor: 10.047
Authors: T E Witzig; C B Reeder; B R LaPlant; M Gupta; P B Johnston; I N Micallef; L F Porrata; S M Ansell; J P Colgan; E D Jacobsen; I M Ghobrial; T M Habermann Journal: Leukemia Date: 2010-12-07 Impact factor: 11.528
Authors: Patrick B Johnston; Betsy LaPlant; Ellen McPhail; Thomas M Habermann; David J Inwards; Ivana N Micallef; Joseph P Colgan; Grzegorz S Nowakowski; Stephen M Ansell; Thomas E Witzig Journal: Lancet Haematol Date: 2016-06-05 Impact factor: 18.959