Rituximab Plus Dose Enhancement and Biweekly Administration of CHOP for Newly-Diagnosed Patients with Diffuse Large-B-Cell Lymphoma.

Introduction: Rituximab plus CHOP every 3 weeks is associated with a increase in the survival of elderly patients. Dose intensification and dose compression with G-CSF support may provide an advantage compared with standard-dose CHOP.

Purpose: To evaluate the efficacy and safety of Rituximab plus CHOP with increased dose of cyclophosphamide and shortened intervals between chemotherapy courses in newly-diagnosed patients with diffuse large-B-cell lymphoma.

Therapeutic scheme: Rituximab 375 mg/m² (d1), cyclophosphamide 1.500 mg/m² (d1), vincristine 1.4 mg/m² maximum 2 mg (d1), adriamycin 50 mg/m² (d1) and prednisone were given. G-CSF (5–10 μg/kg) was added on days 3 to 11 in each course. Six to 8 courses were applied at 14-day intervals.

Results: Between january 2002 and may 2005 twenty eight patients, from seven institutions, were included in this study and received 187 courses. Their median age was 48 years (19 to 59 years). The four last patients have not yet finished their treatment and were not evaluable for response. All patients exhibited alopecia and acceptable myelosupression. Thirteen episodes of fever were reported. Among 24 evaluable patients ORR was 83.3% (70.8% CR and 12.5% PR). With a median follow-up of 11 months (range 4–42) the OS and EFS at 30 months is 83% and 75%, respectively.

Conclusions: The administration of Rituximab plus CHOP every 14 days with enhanced dose of cyclophosphamide is safe. The toxicity is mainly hematological, but can be surmounted with the use of G-CSF and EPO. Recruitment of more patients and longer follow-up are required to confirm these results.