Fast track — ArticlesCHOP-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
Introduction
Young patients (ie, age 18–60 years) with low-risk (ie, no risk factor according to age-adjusted International Prognostic Index [IPI]) and low-intermediate risk (ie, one risk factor according to age-adjusted IPI) diffuse large-B-cell lymphoma1 are thought to have a good outlook; by contrast, young patients with a poor outlook (ie, intermediate-high and high risk) present with two or three risk factors according to age-adjusted IPI.
A study by SWOG (Southwest Oncology Group)2 reported that three cycles of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) followed by involved-field radiotherapy was more effective than eight cycles of CHOP alone in patients with limited stage diffuse large-B-cell lymphoma with regard to progression-free survival and overall survival. Furthermore, the Deutsche Studiengruppe für Hochmaligne Non-Hodgkin-Lymphome (DSHNHL) showed3 that the addition of etoposide to CHOP—ie, CHOEP—improves the event-free survival of these patients. The Groupe d'Etude des Lymphomes de l'Adulte (GELA) noted4 that dose-intensive doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (ACVBP) plus sequential consolidation chemotherapy was more effective than was combined chemoradiotherapy for patients with stage I or stage II aggressive lymphoma and no risk factor according to age-adjusted IPI.
In elderly patients, the GELA5, 6 and a US Intergroup study7 showed that the addition of a monoclonal antibody to CD20—rituximab—to CHOP improved event-free survival and overall survival.5, 6, 7 Because young patients who have good-prognosis disease have a better outlook than do elderly patients, whether young patients might benefit from rituximab is unclear, particularly if they receive more efficacious chemotherapy regimens such as CHOEP. To address these questions, and to reassess the role of age-adjusted IPI for treatment regimens with rituximab, the MabThera International Trial Group (MInT)—which consists of cooperative groups from 18 countries—designed the MInT study.
Section snippets
Patients
Eligible were patients aged 18–60 years with untreated CD20-positive diffuse large-B-cell lymphoma defined by the local pathologist according to WHO criteria,8 and who had no risk factors or one risk factor according to age-adjusted IPI in stage II–IV disease or who had stage I disease with bulk; eligible patients had sufficient performance status as assessed by the treating physician (ie, 0–3 on Eastern Cooperative Oncology Group scale). Exclusion criteria were: life expectancy less than 3
Results
Between May 16, 2000, and Oct 22, 2003, 824 patients were enrolled at 172 participating institutions from 18 countries. 410 patients were randomly assigned to CHOP-like chemotherapy alone and 413 to CHOP-like chemotherapy plus rituximab. One patient was excluded because of missing informed consent. Figure 1 shows the trial profile; table 2 shows the baseline characteristics of patients.
The first planned interim analysis was started after 100 events were recorded on Nov 7, 2003, and was
Discussion
We have shown that the addition of rituximab to six cycles of a CHOP-like chemotherapy improves the outcome of all subgroups of patients with good-prognosis diffuse large-B-cell lymphoma without increased toxic effects. To our knowledge, these findings are the best reported for this group of patients to date in a randomised trial. Furthermore, our findings lend support to the previously reported therapeutic benefit of the more-intensive CHOEP regimen over that of CHOP;3 however, we noted that
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