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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.
- Source :
-
The Lancet. Oncology [Lancet Oncol] 2006 May; Vol. 7 (5), pp. 379-91. - Publication Year :
- 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.<br />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.<br />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.<br />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.
- Subjects :
- Adolescent
Adult
Antibodies, Monoclonal, Murine-Derived
Cyclophosphamide
Disease-Free Survival
Doxorubicin
Humans
Lymphoma, B-Cell diagnosis
Lymphoma, Non-Hodgkin diagnosis
Middle Aged
Prednisone
Prognosis
Rituximab
Survival Rate
Treatment Outcome
Vincristine
Antibodies, Monoclonal therapeutic use
Antineoplastic Agents therapeutic use
Antineoplastic Combined Chemotherapy Protocols
Lymphoma, B-Cell drug therapy
Lymphoma, Non-Hodgkin drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1470-2045
- Volume :
- 7
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- The Lancet. Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 16648042
- Full Text :
- https://doi.org/10.1016/S1470-2045(06)70664-7