%0 Journal Article %1 Pfreundschuh.2006 %A Pfreundschuh, Michael %A Trümper, Lorenz %A Osterborg, Anders %A Pettengell, Ruth %A Trneny, Marek %A Imrie, Kevin %A Ma, David %A Gill, Devinder %A Walewski, Jan %A Zinzani, Pier-Luigi %A Stahel, Rolf %A Kvaloy, Stein %A Shpilberg, Ofer %A Jaeger, Ulrich %A Hansen, Mads %A Lehtinen, Tuula %A López-Guillermo, Armando %A Corrado, Claudia %A Scheliga, Adriana %A Milpied, Noel %A Mendila, Myriam %A Rashford, Michelle %A Kuhnt, Evelyn %A Loeffler, Markus %D 2006 %J The Lancet. Oncology %K IMISE-Publikationen %N 5 %P 379–391 %T CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group %V 7 %X BACKGROUND The role of rituximab in combination with different CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)-like chemotherapy regimens in young patients with good-prognosis diffuse large-B-cell lymphoma remains to be defined. We aimed to compare CHOP-like chemotherapy and rituximab with CHOP-like chemotherapy alone in these patients. METHODS 824 patients who were from 18 countries; aged 18-60 years; and who had no risk factors or one risk factor according to age-adjusted International Prognostic Index (IPI), stage II-IV disease, or stage I disease with bulk were enrolled. These patients were randomly assigned to six cycles of CHOP-like chemotherapy and rituximab (n=413) or to six cycles of CHOP-like chemotherapy alone (n=411). Bulky and extranodal sites received additional radiotherapy. The primary endpoint was event-free survival; secondary endpoints were response, progression under therapy, progression-free survival, overall survival, and frequency of toxic effects. Analyses were done by intention to treat and per protocol. This trial is registered at http://www.clinicaltrials.gov, NCT 00064116. FINDINGS After a median follow-up of 34 months (range 0.03-61), patients assigned chemotherapy and rituximab had increased 3-year event-free survival compared with those assigned chemotherapy alone (79\% 95\% CI 75-83 vs 59\% 54-64; difference between groups 20\% 13-27, log-rank p<0.0001), and had increased 3-year overall survival (93\% 90-95 vs 84\% 80-88; difference between groups 9\% 3-13, log-rank p=0.0001). Event-free survival was affected by treatment group, presence of bulky disease, and age-adjusted IPI: after chemotherapy and rituximab, a favourable subgroup (ie, IPI=0, no bulk) could be defined from a less-favourable subgroup (ie, IPI=1 or bulk, or both). Groups did not differ in the frequency of adverse events. INTERPRETATION Rituximab added to six cycles of CHOP is an effective treatment for young patients with good-prognosis diffuse large-B-cell lymphoma. The definition of two prognostic subgroups allows for a more refined therapeutic approach for these patients.

@article{Pfreundschuh.2006, abstract = {BACKGROUND The role of rituximab in combination with different CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)-like chemotherapy regimens in young patients with good-prognosis diffuse large-B-cell lymphoma remains to be defined. We aimed to compare CHOP-like chemotherapy and rituximab with CHOP-like chemotherapy alone in these patients. METHODS 824 patients who were from 18 countries; aged 18-60 years; and who had no risk factors or one risk factor according to age-adjusted International Prognostic Index (IPI), stage II-IV disease, or stage I disease with bulk were enrolled. These patients were randomly assigned to six cycles of CHOP-like chemotherapy and rituximab (n=413) or to six cycles of CHOP-like chemotherapy alone (n=411). Bulky and extranodal sites received additional radiotherapy. The primary endpoint was event-free survival; secondary endpoints were response, progression under therapy, progression-free survival, overall survival, and frequency of toxic effects. Analyses were done by intention to treat and per protocol. This trial is registered at http://www.clinicaltrials.gov, NCT 00064116. FINDINGS After a median follow-up of 34 months (range 0.03-61), patients assigned chemotherapy and rituximab had increased 3-year event-free survival compared with those assigned chemotherapy alone (79\% [95\% CI 75-83] vs 59\% [54-64]; difference between groups 20\% [13-27], log-rank p<0.0001), and had increased 3-year overall survival (93\% [90-95] vs 84\% [80-88]; difference between groups 9\% [3-13], log-rank p=0.0001). Event-free survival was affected by treatment group, presence of bulky disease, and age-adjusted IPI: after chemotherapy and rituximab, a favourable subgroup (ie, IPI=0, no bulk) could be defined from a less-favourable subgroup (ie, IPI=1 or bulk, or both). Groups did not differ in the frequency of adverse events. INTERPRETATION Rituximab added to six cycles of CHOP is an effective treatment for young patients with good-prognosis diffuse large-B-cell lymphoma. The definition of two prognostic subgroups allows for a more refined therapeutic approach for these patients.}, added-at = {2014-10-15T15:04:16.000+0200}, author = {Pfreundschuh, Michael and Trümper, Lorenz and Osterborg, Anders and Pettengell, Ruth and Trneny, Marek and Imrie, Kevin and Ma, David and Gill, Devinder and Walewski, Jan and Zinzani, Pier-Luigi and Stahel, Rolf and Kvaloy, Stein and Shpilberg, Ofer and Jaeger, Ulrich and Hansen, Mads and Lehtinen, Tuula and López-Guillermo, Armando and Corrado, Claudia and Scheliga, Adriana and Milpied, Noel and Mendila, Myriam and Rashford, Michelle and Kuhnt, Evelyn and Loeffler, Markus}, biburl = {https://www.bibsonomy.org/bibtex/2714d2a730f81339a667f3251a059abb6/drtester}, interhash = {46e66d54931d7037c90af896ddb32f62}, intrahash = {714d2a730f81339a667f3251a059abb6}, journal = {The Lancet. Oncology}, keywords = {IMISE-Publikationen}, number = 5, pages = {379–391}, timestamp = {2014-12-03T00:09:01.000+0100}, title = {CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group}, volume = 7, year = 2006 }