%0 Journal Article %1 Trumper.2008 %A Trümper, L. %A Zwick, C. %A Ziepert, Marita %A Hohloch, K. %A Schmits, R. %A Mohren, M. %A Liersch, R. %A Bentz, M. %A Graeven, U. %A Wruck, U. %A Hoffmann, M. %A Metzner, B. %A Hasenclever, Dirk %A Loeffler, Markus %A Pfreundschuh, Michael %D 2008 %J Annals of oncology : official journal of the European Society for Medical Oncology / ESMO %K IMISE-Publikationen %N 3 %P 538–544 %T Dose-escalated CHOEP for the treatment of young patients with aggressive non-Hodgkin's lymphoma: I. A randomized dose escalation and feasibility study with bi- and tri-weekly regimens %V 19 %X BACKGROUND\r\nTo determine the maximum tolerated dose of a bi- and tri-weekly combination chemotherapy with cyclophosphamide, doxorubicin, vincristine and prednisone plus etoposide (CHOEP) regimen without stem-cell support.\r\nPATIENTS AND METHODS\r\nRandomized phase I/II multicenter four-level (cyclophosphamide: 1000-1200-1400-1600 mg/m2; doxorubicin: 55-60-65-70 mg/m2; etoposide: 375-450-525-600 mg/m2) dose escalation study with CHOEP-14 and CHOEP-21 in young patients (18-60 years) with newly diagnosed aggressive non-Hodgkin's lymphoma. Dose-limiting toxicity was defined as thrombocytopenia <80,000/mm3 and leukocytopenia <2500/mm3 on days 16 (CHOEP-14) and 23 (CHOEP-21) or prolonged (>4 days) leukocytopenia (<1000/mm3) or thrombocytopenia (<20,000/mm3).\r\nRESULTS\r\nOne hundred and thirty-nine patients (high-CHOEP-14: 47, high-CHOEP-21: 92) were randomly allocated to the study. Maximal tolerated dose was level 2 for CHOEP-14 and level 4 for CHOEP-21. With a less favorable profile of patients in CHOEP-14, 4-year event-free survival was 47.9\% after high-CHOEP-14 and 66.2\% after high-CHOEP-21, 4-year overall survival 62.1\% after high-CHOEP-14 and 73.4\% after high-CHOEP-21, respectively.\r\nCONCLUSION\r\nSignificant dose escalations of CHOEP are possible with granulocyte colony-stimulating factor support, with different chemotherapy models favoring the maximally escalated bi- or tri-weekly regimen, respectively. Because a higher total dose can be achieved with six cycles of the tri-weekly compared with the biweekly regimen, CHOEP-21 at dose escalation level 3 was chosen for a nationwide randomized comparison with baseline CHOEP-21 in a subsequent phase III trial.

@article{Trumper.2008, abstract = {BACKGROUND\r\nTo determine the maximum tolerated dose of a bi- and tri-weekly combination chemotherapy with cyclophosphamide, doxorubicin, vincristine and prednisone plus etoposide (CHOEP) regimen without stem-cell support.\r\nPATIENTS AND METHODS\r\nRandomized phase I/II multicenter four-level (cyclophosphamide: 1000-1200-1400-1600 mg/m2; doxorubicin: 55-60-65-70 mg/m2; etoposide: 375-450-525-600 mg/m2) dose escalation study with CHOEP-14 and CHOEP-21 in young patients (18-60 years) with newly diagnosed aggressive non-Hodgkin's lymphoma. Dose-limiting toxicity was defined as thrombocytopenia <80,000/mm3 and leukocytopenia <2500/mm3 on days 16 (CHOEP-14) and 23 (CHOEP-21) or prolonged (>4 days) leukocytopenia (<1000/mm3) or thrombocytopenia (<20,000/mm3).\r\nRESULTS\r\nOne hundred and thirty-nine patients (high-CHOEP-14: 47, high-CHOEP-21: 92) were randomly allocated to the study. Maximal tolerated dose was level 2 for CHOEP-14 and level 4 for CHOEP-21. With a less favorable profile of patients in CHOEP-14, 4-year event-free survival was 47.9\% after high-CHOEP-14 and 66.2\% after high-CHOEP-21, 4-year overall survival 62.1\% after high-CHOEP-14 and 73.4\% after high-CHOEP-21, respectively.\r\nCONCLUSION\r\nSignificant dose escalations of CHOEP are possible with granulocyte colony-stimulating factor support, with different chemotherapy models favoring the maximally escalated bi- or tri-weekly regimen, respectively. Because a higher total dose can be achieved with six cycles of the tri-weekly compared with the biweekly regimen, CHOEP-21 at dose escalation level 3 was chosen for a nationwide randomized comparison with baseline CHOEP-21 in a subsequent phase III trial.}, added-at = {2014-10-15T15:04:29.000+0200}, author = {Trümper, L. and Zwick, C. and Ziepert, Marita and Hohloch, K. and Schmits, R. and Mohren, M. and Liersch, R. and Bentz, M. and Graeven, U. and Wruck, U. and Hoffmann, M. and Metzner, B. and Hasenclever, Dirk and Loeffler, Markus and Pfreundschuh, Michael}, biburl = {https://www.bibsonomy.org/bibtex/20c0eacfca3880b94fe94602193cd77b4/drtester}, interhash = {083fcb02c360d35dc3c091b9c5643756}, intrahash = {0c0eacfca3880b94fe94602193cd77b4}, journal = {Annals of oncology : official journal of the European Society for Medical Oncology / ESMO}, keywords = {IMISE-Publikationen}, number = 3, pages = {538–544}, timestamp = {2014-12-03T00:09:16.000+0100}, title = {Dose-escalated CHOEP for the treatment of young patients with aggressive non-Hodgkin's lymphoma: I. A randomized dose escalation and feasibility study with bi- and tri-weekly regimens}, volume = 19, year = 2008 }