Lukas Smolej, MD, Researcher, department of clinical haematology, 2^nd Clinic of Internal Medicine, Charles University Hospital, Hradec Kralove, Czech Republic, presented the findings here on June 3^rd.

The retrospective study was undertaken to determine the clinical benefit of adding rituximab to a CHOP regimen (cyclophosphamide, doxorubicin, oncovin, and prednisolone) or other chemotherapy in the first-line treatment of patients with newly diagnosed diffuse large B-cell lymphoma, Dr. Smolej said.

The analysis included 94 patients with a median age of 58.5 years who were treated at a single centre between January 2001 and November 2004. Twenty-seven percent were at tumour stage I, 35% at stage II, 18% at stage III, and 20% at stage IV.

Sixty patients (64%) received a standard dose and schedule of CHOP with or without rituximab, while the remaining 34 patients (36%) received other chemotherapy regimens, with or without rituximab.

Patients treated with rituximab received 375 mg/m² IV on day 1 of each treatment cycle. Patients were treated every 21 days for a median of 6 cycles.

To date, 75 patients are evaluable for efficacy -- 32 in the rituximab plus chemotherapy group who were followed for a median of 11.5 months, and 43 in the chemotherapy alone group who were followed for a median of 25.5 months.

Complete responses were seen more frequently in the rituximab plus chemotherapy group than in the chemotherapy alone group (97% vs 74%, P =.01). Subsequent relapse was significantly more frequent after chemotherapy alone than rituximab plus chemotherapy (39% vs 9%, P =.007). There was also a trend towards an increased early relapse rate with chemotherapy alone (23% compared with 6% for rituximab plus chemotherapy, P =.05).

Median progression-free survival was significantly increased in the rituximab plus chemotherapy group (median not reached) compared with chemotherapy alone (19.8 months, P =.007). Median event-free survival was also significantly better in the rituximab group (median not reached) compared to chemotherapy alone (26.1 months, P =.007).

These data lend support to the addition of rituximab to chemotherapy for the first-line management of diffuse large B-cell lymphoma in clinical practice, the investigators concluded. However, they warned that longer follow-up is needed to determine any overall survival benefit.


[Presentation title: Rituximab Improves Outcomes in Patients With Diffuse Large B-Cell Lymphoma: a Single Centre Retrospective Study. Abstract 0249]

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